Aldara

1.

NAME OF THE MEDICINAL PRODUCT

ALDARA 5% cream

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5 %).

100 mg of cream contains 5 mg of imiquimod.

Excipients:

Methyl hydroxybenzoate (E218)

Propyl hydroxybenzoate (E216)

Cetyl alcohol

Stearyl alcohol

For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Cream.

White to slightly yellow cream.

4.

CLINICAL PARTICULARS

4.1 Therapeutic indications

Imiquimod cream is indicated for the topical treatment of :

 External genital and perianal warts (condylomata acuminata) in adults.

 Small superficial basal cell carcinomas (sBCCs) in adults.

 Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or

scalp in immunocompetent adult patients when size or number of lesions limit the efficacy

and/or acceptability of cryotherapy and other topical treatment options are contraindicated or

less appropriate.

4.2 Posology and method of administration

Posology

The application frequency and duration of treatment with imiquimod cream is different for each

indication.

External genital warts in adults:

Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday, and Friday; or

Tuesday, Thursday, and Saturday) prior to normal sleeping hours, and should remain on the skin for

6 to 10 hours. Imiquimod cream treatment should continue until the clearance of visible genital or

perianal warts or for a maximum of 16 weeks per episode of warts.

For quantity to be applied see 4.2 Method of administration.

Superficial basal cell carcinoma in adults:

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Apply imiquimod cream for 6 weeks, 5 times per week (example: Monday to Friday) prior to normal

sleeping hours, and leave on the skin for approximately 8 hours.

For quantity to be applied see 4.2 Method of administration.

Actinic keratosis in adults

Treatment should be initiated and monitored by a physician. Imiquimod cream should be applied

3 times per week (example: Monday, Wednesday and Friday) for four weeks prior to normal sleeping

hours, and left on the skin for approximately 8 hours. Sufficient cream should be applied to cover the

treatment area. After a 4-week treatment-free period, clearance of AKs should be assessed. If any

lesions persist, treatment should be repeated for another four weeks.

The maximum recommended dose is one sachet. The maximum recommended treatment duration is

8 weeks.

An interruption of dosing should be considered if intense local inflammatory reactions occur (see

section 4.4) or if infection is observed at the treatment site. In this latter case, appropriate other

measures should be taken. Each treatment period should not be extended beyond 4 weeks due to

missed doses or rest periods.

If the treated lesion(s) show an incomplete response at the follow-up examination at 4-8 weeks after

the second treatment period, a different therapy should be used (see section 4.4)

Information applicable to all indications:

If a dose is missed, the patient should apply the cream as soon as he/she remember and then he/she

should continue with the regular schedule. However the cream should not be applied more than once a

day.

Paediatric patients

Use in the paediatric patient population is not recommended. There are no data available on the use of

imiquimod in children and adolescents in the approved indications.

Aldara should not be used in children with molluscum contagiosum due to lack of efficacy in this

indication (see section 5.1).

Method of administration

External genital warts:

Imiquimod cream should be applied in a thin layer and rubbed on the clean wart area until the cream

vanishes. Only apply to affected areas and avoid any application on internal surfaces. Imiquimod

cream should be applied prior to normal sleeping hours. During the 6 to 10 hour treatment period,

showering or bathing should be avoided. After this period it is essential that imiquimod cream is

removed with mild soap and water. Application of an excess of cream or prolonged contact with the

skin may result in a severe application site reaction (see sections 4.4, 4.8 and 4.9). A single-use sachet

is sufficient to cover a wart area of 20 cm 2 (approx. 3 inches 2 ). Sachets should not be re-used once

opened. Hands should be washed carefully before and after application of cream.

Uncircumcised males treating warts under the foreskin should retract the foreskin and wash the area

daily (see section 4.4).

Superficial basal cell carcinoma:

Before applying imiquimod cream, patients should wash the treatment area with mild soap and water

and dry thoroughly. Sufficient cream should be applied to cover the treatment area, including one

centimetre of skin surrounding the tumour. The cream should be rubbed into the treatment area until

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the cream vanishes. The cream should be applied prior to normal sleeping hours and remain on the

skin for approximately 8 hours. During this period, showering and bathing should be avoided. After

this period it is essential that imiquimod cream is removed with mild soap and water.

Sachets should not be re-used once opened. Hands should be washed carefully before and after

application of cream.

Response of the treated tumour to imiquimod cream should be assessed 12 weeks after the end of

treatment. If the treated tumour shows an incomplete response, a different therapy should be used (see

section 4.4).

A rest period of several days may be taken (see section 4.4) if the local skin reaction to imiquimod

cream causes excessive discomfort to the patient, or if infection is observed at the treatment site. In

this latter case, appropriate other measures should be taken.

Actinic keratosis:

Before applying imiquimod cream, patients should wash the treatment area with mild soap and water

and dry thoroughly. Sufficient cream should be applied to cover the treatment area. The cream should

be rubbed into the treatment area until the cream vanishes. The cream should be applied prior to

normal sleeping hours and remain on the skin for approximately 8 hours. During this period,

showering and bathing should be avoided. After this period it is essential that imiquimod cream is

removed with mild soap and water. Sachets should not be re-used once opened. Hands should be

washed carefully before and after application of cream.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings and special precautions for use

External genital warts, superficial basal cell carcinoma and actinic keratosis:

Avoid contact with the eyes, lips and nostrils.

Imiquimod has the potential to exacerbate inflammatory conditions of the skin.

Imiquimod cream should be used with caution in patients with autoimmune conditions (refer to section

4.5). Consideration should be given to balancing the benefit of imiquimod treatment for these patients

with the risk associated with a possible worsening of their autoimmune condition.

Imiquimod cream should be used with caution in organ transplant patients (refer to section 4.5).

Consideration should be given to balancing the benefit of imiquimod treatment for these patients with

the risk associated with the possibility of organ rejection or graft-versus-host disease.

Imiquimod cream therapy is not recommended until the skin has healed after any previous drug or

surgical treatment. Application to broken skin could result in increased systemic absorption of

imiquimod leadling to a greater risk of adverse events (refer to section 4.8 and 4.9)

The use of an occlusive dressing is not recommended with imiquimod cream therapy.

The excipients methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetyl alcohol and

stearyl alcohol may cause allergic reactions.

Rarely, intense local inflammatory reactions including skin weeping or erosion can occur after only a

few applications of imiquimod cream. Local inflammatory reactions may be accompanied, or even

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preceded, by flu-like systemic signs and symptoms including malaise, pyrexia, nausea, myalgias and

rigors. An interruption of dosing should be considered.

Imiquimod should be used with caution in patients with reduced haematologic reserve (refer to section

4.8d).

External genital warts:

There is limited experience in the use of imiquimod cream in the treatment of men with foreskin-

associated warts. The safety database in uncircumcised men treated with imiquimod cream three times

weekly and carrying out a daily foreskin hygiene routine is less than 100 patients. In other studies, in

which a daily foreskin hygiene routine was not followed, there were two cases of severe phimosis and

one case of stricture leading to circumcision. Treatment in this patient population is therefore

recommended only in men who are able or willing to follow the daily foreskin hygiene routine. Early

signs of stricture may include local skin reactions (e.g. erosion, ulceration, oedema, induration), or

increasing difficulty in retracting the foreskin. If these symptoms occur, the treatment should be

stopped immediately. Based on current knowledge, treating urethral, intra-vaginal, cervical, rectal or

intra-anal warts is not recommended. Imiquimod cream therapy should not be initiated in tissues

where open sores or wounds exist until after the area has healed.

Local skin reactions such as erythema, erosion, excoriation, flaking and oedema are common. Other

local reactions such as induration, ulceration, scabbing, and vesicles have also been reported. Should

an intolerable skin reaction occur, the cream should be removed by washing the area with mild soap

and water. Treatment with imiquimod cream can be resumed after the skin reaction has moderated.

The risk of severe local skin reactions may be increased when imiquimod is used at higher than

recommended doses (see section 4.2). However, in rare cases severe local reactions that have required

treatment and/or caused temporary incapacitation have been observed in patients who have used

imiquimod according to the instructions. Where such reactions have occurred at the urethral meatus,

some women have experienced difficulty in urinating, sometimes requiring emergency catheterisation

and treatment of the affected area.

No clinical experience exists with imiquimod cream immediately following treatment with other

cutaneously applied drugs for treatment of external genital or perianal warts. Imiquimod cream should

be washed from the skin before sexual activity. Imiquimod cream may weaken condoms and

diaphragms, therefore concurrent use with imiquimod cream is not recommended. Alternative forms of

contraception should be considered.

In immunocompromised patients, repeat treatment with imiquimod cream is not recommended.

While limited data have shown an increased rate of wart reduction in HIV positive patients,

imiquimod cream has not been shown to be as effective in terms of wart clearance in this patient

group.

Superficial basal cell carcinoma:

Imiquimod has not been evaluated for the treatment of basal cell carcinoma within 1 cm of the eyelids,

nose, lips or hairline.

During therapy and until healed, affected skin is likely to appear noticeably different from normal

skin. Local skin reactions are common but these reactions generally decrease in intensity during

therapy or resolve after cessation of imiquimod cream therapy. There is an association between the

complete clearance rate and the intensity of local skin reactions (e.g. erythema). These local skin

reactions may be related to the stimulation of local immune response. If required by the patient’s

discomfort or the severity of the local skin reaction, a rest period of several days may be taken.

Treatment with imiquimod cream can be resumed after the skin reaction has moderated.

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The clinical outcome of therapy can be determined after regeneration of the treated skin,

approximately 12 weeks after the end of treatment.

No clinical experience exists with the use of imiquimod cream in immunocompromised patients.

No clinical experience exists in patients with recurrent and previously treated BCCs, therefore use for

previously treated tumours is not recommended.

Data from an open label clinical trial suggest that large tumours (>7.25 cm 2 ) are less likely to respond

to imiquimod therapy.

The skin surface area treated should be protected from solar exposure.

Actinic keratosis

Lesions clinically atypical for AK or suspicious for malignancy should be biopsied to determine

appropriate treatment.

Imiquimod has not been evaluated for the treatment of actinic keratoses on the eyelids, the inside of

the nostrils or ears, or the lip area inside the vermilion border.

There are very limited data available on the use of imiquimod for the treatment of actinic keratoses in

anatomical locations other than the face and scalp. The available data on actinic keratosis on the

forearms and hands do not support efficacy in this indication and therefore such use is not

recommended.

Imiquimod is not recommended for the treatment of AK lesions with marked hyperkeratosis or

hypertrophy as seen in cutaneous horns.

During therapy and until healed, affected skin is likely to appear noticeably different from normal

skin. Local skin reactions are common but these reactions generally decrease in intensity during

therapy or resolve after cessation of imiquimod cream therapy. There is an association between the

complete clearance rate and the intensity of local skin reactions (e.g. erythema). These local skin

reactions may be related to the stimulation of local immune response. If required by the patient’s

discomfort or the intensity of the local skin reaction, a rest period of several days may be taken.

Treatment with imiquimod cream can be resumed after the skin reaction has moderated.

Each treatment period should not be extended beyond 4 weeks due to missed doses or rest periods.

The clinical outcome of therapy can be determined after regeneration of the treated skin,

approximately 4-8 weeks after the end of treatment.

No clinical experience exists with the use of imiquimod cream in immunocompromised patients.

No data are available on re-treating actinic keratoses that have cleared after one or two courses of

treatment and subsequently recur, and any such use is therefore not recommended.

Data from an open-label clinical trial suggest that subjects with more than 8 AK lesions showed a

decreased rate of complete clearance compared to patients with less than 8 lesions.

The skin surface area treated should be protected from solar exposure.

4.5 Interaction with other medicinal products and other forms of interaction

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No interaction studies have been performed. This includes studies with immunosuppressive drugs.

Interactions with systemic drugs would be limited by the minimal percutaneous absorption of

imiquimod cream.

Due to its immunostimulating properties, imiquimod cream should be used with caution in patients

who are receiving immunosuppressive medication (see Section 4.4).

4.6 Pregnancy and lactation

For imiquimod no clinical data on exposed pregnancies are available. Animal studies do not indicate

direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition

or postnatal development (see 5.3). Caution should be exercised when prescribing to pregnant women.

As no quantifiable levels (>5 ng/ml) of imiquimod are detected in the serum after single and multiple

topical doses, no specific advice can be given on whether to use or not in lactating mothers.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. From the

undesirable effects noted in section 4.8, it is unlikely that treatment will have any effect on the ability

to drive and use machines.

4.8 Undesirable effects

a)

General Description:

External genital warts:

In the pivotal trials with 3 times a week dosing, the most frequently reported adverse drug reactions

judged to be probably or possibly related to imiquimod cream treatment were application site reactions

at the wart treatment site (33.7% of imiquimod treated patients). Some systemic adverse reactions,

including headache (3.7%), influenza-like symptoms (1.1%), and myalgia (1.5%) were also reported.

Patient reported adverse reactions from 2292 patients treated with imiquimod cream in placebo

controlled and open clinical studies are presented below. These adverse events are considered at least

possibly causally related to treatment with imiquimod.

Superficial basal cell carcinoma:

In trials with 5 times per week dosing 58% of patients experienced at least one adverse event. The

most frequently reported adverse events from the trials judged probably or possibly related to

imiquimod cream are application site disorders, with a frequency of 28.1%. Some systemic adverse

reactions, including back pain (1.1%) and influenza-like symptoms (0.5%) were reported by

imiquimod cream patients.

Patient reported adverse reactions from 185 patients treated with imiquimod cream in placebo

controlled phase III clinical studies for superficial basal cell carcinoma are presented below. These

adverse events are considered at least possibly causally related to treatment with imiquimod.

Actinic keratosis

In the pivotal trials with 3 times per week dosing for up to 2 courses each of 4 weeks, 56% of

imiquimod patients reported at least one adverse event. The most frequently reported adverse event

from these trials judged probably or possibly related to imiquimod cream was application site

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reactions (22% of imiquimod treated patients). Some systemic adverse reactions, including myalgia

(2%) were reported by imiquimod treated patients.

Patient reported adverse reactions from 252 patients treated with imiquimod cream in vehicle

controlled phase III clinical studies for actinic keratosis are presented below. These adverse events are

considered at least possibly causally related to treatment with imiquimod.

b) Tabular Listing of adverse events:

Frequencies are defined as Very common (1/10), Common (1/100 to <1/10) and Uncommon

(1/1,000 to <1/100). Lower frequencies from clinical trials are not reported here.

External genital

warts

(3x/ wk,16wks)

N = 2292

Superficial basal

cell carcinoma

(5x/wk, 6 wks)

N = 185

Actinic keratosis

(3x/wk, 4 or 8 wks)

N = 252

Infections and infestations:

Infection

Common

Uncommon

Pustules

Common

Uncommon

Herpes simplex

Uncommon

Genital candidiasis

Uncommon

Vaginitis

Uncommon

Bacterial infection

Uncommon

Fungal infection

Uncommon

Upper respiratory tract infection

Uncommon

Vulvitis

Uncommon

Rhinitis

Uncommon

Influenza

Uncommon

Blood and lymphatic system

disorders:

Lymphadenopathy

Uncommon

Common

Uncommon

Metabolism and nutrition disorders:

Anorexia

Uncommon

Common

Psychiatric disorders:

Insomnia

Uncommon

Depression

Uncommon

Irritability

Uncommon

Nervous system disorders:

Headache

Common

Paraesthesia

Uncommon

Dizziness

Uncommon

Migraine

Uncommon

Somnolence

Uncommon

Eye disorders

Conjunctival irritation

Uncommon

Eyelid oedema

Uncommon

Ear and labyrinth disorders:

Tinnitus

Uncommon

Vascular disorders:

Flushing

Uncommon

Respiratory, thoracic and

mediastinal disorders:

Pharyngitis

Uncommon

Rhinitis

Uncommon

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Nasal congestion

Uncommon

Pharyngo laryngeal pain

Uncommon

Gastrointestinal disorders:

Nausea

Common

Uncommon

Common

Abdominal pain

Uncommon

Diarrhoea

Uncommon

Vomiting

Uncommon

Rectal disorder

Uncommon

Rectal tenesmus

Uncommon

Dry mouth

Uncommon

Skin and subcutaneous tissue

disorders:

Pruritus

Uncommon

Dermatitis

Uncommon

Folliculitis

Uncommon

Rash erythematous

Uncommon

Eczema

Uncommon

Rash

Uncommon

Sweating increased

Uncommon

Urticaria

Uncommon

Actinic keratosis

Uncommon

Erythema

Uncommon

Face oedema

Uncommon

Skin ulcer

Uncommon

Musculoskeletal and connective

tissue disorders:

Myalgia

Common

Arthralgia

Uncommon

Common

Back pain

Uncommon

Common

Pain in extremity

Uncommon

Renal and urinary disorders:

Dysuria

Uncommon

Reproductive system and breast

disorders:

Genital pain male

Uncommon

Penile disorder

Uncommon

Dyspareunia

Uncommon

Erectile dysfunction

Uncommon

Uterovaginal prolapse

Uncommon

Vaginal pain

Uncommon

Vaginitis atrophic

Uncommon

Vulval disorder

Uncommon

General disorders and

administration site conditions:

Application site pruritus

Very common

Application site pain

Very common

Common

Application site burning

Common

Application site irritation

Common

Application site erythema

Common

Application site reaction

Common

Application site bleeding

Common

Uncommon

Application site papules

Common

Uncommon

Application site paraesthesia

Common

Uncommon

Application site rash

Common

9

Fatigue

Common

Pyrexia

Uncommon

Influenza-like illness

Uncommon

Pain

Uncommon

Asthenia

Uncommon

Malaise

Uncommon

Rigors

Uncommon

Application site dermatitis

Uncommon

Application site discharge

Uncommon

Application site hyperaesthesia

Uncommon

Application site inflammation

Uncommon

Application site oedema

Uncommon

Application site scabbing

Uncommon

Application site scar

Uncommon

Application site skin breakdown

Uncommon

Application site swelling

Uncommon

Application site ulcer

Uncommon

Application site vesicles

Uncommon

Application site warmth

Uncommon

Lethargy

Uncommon

Discomfort

Uncommon

Inflammation

Uncommon

c)

Frequently occurring adverse events:

External genital warts:

Investigators of placebo controlled trials were required to evaluate protocol mandated clinical signs

(skin reactions). These protocol mandated clinical sign assessments indicate that local skin reactions

including erythema (61%), erosion (30%), excoriation/flaking/scaling (23%) and oedema (14%) were

common in these placebo controlled clinical trials with imiquimod cream applied three times weekly

(see section 4.4). Local skin reactions, such as erythema, are probably an extension of the

pharmacologic effects of imiquimod cream.

Remote site skin reactions, mainly erythema (44%), were also reported in the placebo controlled trials.

These reactions were at non-wart sites which may have been in contact with imiquimod cream. Most

skin reactions were mild to moderate in severity and resolved within 2 weeks of treatment

discontinuation. However, in some cases these reactions have been severe, requiring treatment and/or

causing incapacitation. In very rare cases, severe reactions at the urethral meatus have resulted in

dysuria in women (see section 4.4).

Superficial basal cell carcinoma:

Investigators of the placebo controlled clinical trials were required to evaluate protocol mandated

clinical signs (skin reactions). These protocol mandated clinical sign assessments indicate that severe

erythema (31%) severe erosions (13%) and severe scabbing and crusting (19%) were very common in

these trials with imiquimod cream applied 5 times weekly. Local skin reactions, such as erythema, are

probably an extension of the pharmacologic effect of imiquimod cream.

Skin infections during treatment with imiquimod have been observed. While serious sequelae have not

resulted, the possibility of infection in broken skin should always be considered.

Actinic keratosis

10

In clinical trials of imiquimod cream 3 times weekly for 4 or 8 weeks the most frequently occurring

application site reactions were itching at the target site (14%) and burning at the target site (5%).

Severe erythema (24%) and severe scabbing and crusting (20%) were very common. Local skin

reactions, such as erythema, are probably an extension of the pharmacologic effect of imiquimod

cream. See 4.2 and 4.4 for information on rest periods.

Skin infections during treatment with imiquimod have been observed. While serious sequelae have not

resulted, the possibility of infection in broken skin should always be considered.

d) Adverse events applicable to all indications:

Reports have been received of localised hypopigmentation and hyperpigmentation following

imiquimod cream use. Follow-up information suggests that these skin colour changes may be

permanent in some patients. In a follow-up of 162 patients five years after treatment for sBCC a mild

hypopigmentation was observed in 37% of the patients and a moderate hypopigmentation was

observed in 6% of the patients. 56% of the patients have been free of hypopigmentation;

hyperpigmentation has not been reported.

Clinical studies investigating the use of imiquimod for the treatment of actinic keratosis have detected

a 0.4% (5/1214) frequency of alopecia at the treatment site or surrounding area. Postmarketing reports

of suspected alopecia occurring during the treatment of sBCC and EGW have been received.

Reductions in haemoglobin, white blood cell count, absolute neutrophils and platelets have been

observed in clinical trials. These reductions are not considered to be clinically significant in patients

with normal haematologic reserve. Patients with reduced haematologic reserve have not been studied

in clinical trials. Reductions in haematological parameters requiring clinical intervention have been

reported from postmarketing experience. There have been postmarketing reports of elevated liver

enzymes.

Rare reports have been received of exacerbation of autoimmune conditions.

Rare cases of remote site dermatologic drug reactions, including erythema multiforme, have been

reported from clinical trials. Serious skin reactions reported from postmarketing experience include

erythema multiforme, Stevens Johnson syndrome and cutaneous lupus erythematosus.

e)

Paediatric patients:

Imiquimod was investigated in controlled clinical studies with paediatric patients (see sections 4.2 and

5.1). There was no evidence for systemic reactions. Application site reactions occurred more

frequently after imiquimod than after vehicle, however, incidence and intensity of these reactions were

not different from that seen in the licensed indications in adults. There was no evidence for serious

adverse reaction caused by imiquimod in paediatric patients.

4.9 Overdose

When applied topically, systemic overdosage with imiquimod cream is unlikely due to minimal

percutaneous absorption. Studies in rabbits reveal a dermal lethal dose of greater than 5 g/kg.

Persistent dermal overdosing of imiquimod cream could result in severe local skin reactions.

Following accidental ingestion, nausea, emesis, headache, myalgia and fever could occur after a single

dose of 200 mg imiquimod which corresponds to the content of approximately 16 sachets. The most

clinically serious adverse event reported following multiple oral doses of  200 mg was hypotension

which resolved following oral or intravenous fluid administration.

5.

PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Chemotherapeutics for topical use, antivirals : ATC Code : D06BB10.

Imiquimod is an immune response modifier. Saturable binding studies suggest a membrane receptor

for imiquimod exists on responding immune cells. Imiquimod has no direct antiviral activity. In

animal models imiquimod is effective against viral infections and acts as an antitumour agent

principally by induction of alpha interferon and other cytokines. The induction of alpha interferon and

other cytokines following imiquimod cream application to genital wart tissue has also been

demonstrated in clinical studies.

Increases in systemic levels of alpha interferon and other cytokines following topical application of

imiquimod were demonstrated in a pharmacokinetic study.

External genital warts:

Clinical Efficacy

The results of 3 phase III pivotal efficacy studies showed that treatment with imiquimod for sixteen

weeks was significantly more effective than treatment with vehicle as measured by total clearance of

treated warts.

In 119 imiquimod-treated female patients, the combined total clearance rate was 60% as compared to

20% in 105 vehicle-treated patients (95% CI for rate difference: 20% to 61% , p<0.001). In those

imiquimod patients who achieved total clearance of their warts, the median time to clearance was

8 weeks.

In 157 imiquimod-treated male patients, the combined total clearance rate was 23% as compared to

5% in 161 vehicle-treated patients (95%CI for rate difference: 3% to 36% , p<0.001). In those

imiquimod patients who achieved total clearance of their warts, the median time to clearance was

12 weeks .

Superficial basal cell carcinoma:

Clinical efficacy:

The efficacy of imiquimod 5 times per week for 6 weeks was studied in two double-blind vehicle

controlled clinical trials. Target tumours were histologically confirmed single primary superficial basal

cell carcinomas with a minimum size of 0.5 cm 2 and a maximum diameter of 2 cm. Tumours located

within 1 cm of the eyes, nose, mouth, ears or hairline were excluded. In a pooled analysis of these two

studies, histological clearance was noted in 82% (152/185) of patients. When clinical assessment was

also included, clearance judged by this composite endpoint was noted in 75% (139/185) of patients.

These results were statistically significant (p<0.001) by comparison with the vehicle group, 3%

(6/179) and 2% (3/179) respectively. There was a significant association between the intensity of local

skin reactions (e.g. erythema) seen during the treatment period and complete clearance of the basal cell

carcinoma.

Five -year data from a long-term open-label uncontrolled study indicate that an estimated 77.9%

[95% CI (71.9%, 83.8%)] of all the subjects who initially received treatment became clinically clear

and remained clear at 60 months.

Actinic keratosis:

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Clinical efficacy:

The efficacy of imiquimod applied 3 times per week for one or two courses of 4 weeks, separated by a

4 week treatment-free period, was studied in two double-blind vehicle controlled clinical trials.

Patients had clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions on the

balding scalp or face within a contiguous 25 cm 2 treatment area. 4-8 AK lesions were treated. The

complete clearance rate (imiquimod minus placebo) for the combined trials was 46.1% (CI 39.0%,

53.1%).

One-year data from two combined observational studies indicate a recurrence rate of 27%

(35/128 patients) in those patients who became clinically clear after one or two courses of treatment.

The recurrence rate for individual lesions was 5.6% (41/737). Corresponding recurrence rates for

vehicle were 47% (8/17 patients) and 7.5% (6/80 lesions). The rate of progression to squamous cell

carcinoma (SCC) was reported in 1.6% (2/128 patients).

There are no data on recurrence and progression rates beyond 1 year.

Paediatric patients:

The approved indications genital warts, actinic keratosis and superficial basal cell carcinoma are

conditions not generally seen within the paediatric population and were not studied.

Aldara Cream has been evaluated in four randomised, vehicle controlled, double-blind trials in

children aged 2 to 15 years with molluscum contagiosum (imiquimod n = 576, vehicle n = 313) .

These trials failed to demonstrate efficacy of imiquimod at any of the tested dosage regimens (3x/week

for ≤ 16 weeks and 7x/week for ≤ 8 weeks).

5.2 Pharmacokinetic properties

External genital warts, superficial basal cell carcinoma and actinic keratosis:

Less than 0.9% of a topically applied single dose of radiolabelled imiquimod was absorbed through

the skin of human subjects. The small amount of drug which was absorbed into the systemic

circulation was promptly excreted by both urinary and faecal routes at a mean ratio of approximately

3 to 1. No quantifiable levels (>5 ng/ml) of drug were detected in serum after single or multiple topical

doses.

Systemic exposure (percutaneous penetration) was calculated from recovery of carbon-14 from 14C

imiquimod in urine and faeces.

Minimal systemic absorption of imiquimod 5% cream across the skin of 58 patients with actinic

keratosis was observed with 3 times per week dosing for 16 weeks. The extent of percutaneous

absorption did not change significantly between the first and last doses of this study. Peak serum drug

concentrations at the end of week 16 were observed between 9 and 12 hours and were 0.1, 0.2, and

1.6 ng/mL for the applications to face (12.5 mg, 1 single-use sachet), scalp (25 mg, 2 sachets) and

hands/arms (75 mg, 6 sachets), respectively. The application surface area was not controlled in the

scalp and hands/ arms groups. Dose proportionality was not observed. An apparent half-life was

calculated that was approximately 10 times greater than the 2 hour half-life seen following

subcutaneous dosing in a previous study, suggesting prolonged retention of drug in the skin. Urinary

recovery was less than 0.6% of the applied dose at week 16 in these patients.

Paediatric patients:

The pharmacokinetic properties of imiquimod following single and multiple topical application in

paediatric patients with molluscum contagiosum (MC) have been investigated. The systemic exposure

data demonstrated that the extent of absorption of imiquimod following topical application to the MC

lesional skin of the paediatric patients aged 6-12 years was low and comparable to that observed in

13

healthy adults and adults with actinic keratosis or superficial basal cell carcinoma. In younger patients

aged 2-5 years absorption, based on C max values, was higher compared to adults.

5.3 Preclinical safety data

Non-clinical data revealed no special hazard for humans based on conventional studies of safety

pharmacology, mutagenicity and teratogenicity.

In a four-month rat dermal toxicity study, significantly decreased body weight and increased spleen

weight were observed at 0.5 and 2.5 mg/kg; similar effects were not seen in a four month mouse

dermal study. Local dermal irritation, especially at higher doses, was observed in both species.

A two-year mouse carcinogenicity study by dermal administration on three days a week did not induce

tumours at the application site. However, the incidences of hepatocellular tumours among treated

animals were greater than those for controls. The mechanism for this is not known, but as imiquimod

has low systemic absorption from human skin, and is not mutagenic, any risk to humans from systemic

exposure is likely to be low. Furthermore, tumours were not seen at any site in a 2-year oral

carcinogenicity study in rats.

Imiquimod cream was evaluated in a photocarcinogenicity bioassay in albino hairless mice exposed to

simulated solar ultraviolet radiation (UVR). Animals were administered imiquimod cream three times

per week and were irradiated 5 days per week for 40 weeks. Mice were maintained for an additional

12 weeks for a total of 52 weeks. Tumours occurred earlier and in greater number in the group of mice

administered the vehicle cream in comparison with the low UVR control group. The significance for

man is unknown. Topical administration of imiquimod cream resulted in no tumour enhancement at

any dose, in comparison with the vehicle cream group.

6.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

isostearic acid

benzyl alcohol

cetyl alcohol

stearyl alcohol

white soft paraffin

polysorbate 60

sorbitan stearate

glycerol

methyl hydroxybenzoate (E218)

propyl hydroxybenzoate (E216)

xanthan gum

purified water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25°C.

14

Sachets should not be re-used once opened.

6.5 Nature and contents of container

Boxes of 12 or 24 single-use polyester/aluminium foil sachets, containing 250 mg of cream.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

7.

MARKETING AUTHORISATION HOLDER

Meda AB

Pipers väg 2A

170 73 Solna

Sweden

8.

MARKETING AUTHORISATION NUMBER(S)

EU/1/98/080/001-002

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 18/09/1998

Date of last renewal: 03/09/2008

10. DATE OF REVISION OF THE TEXT

15

ANNEX II

A. MANUFACTURING AUTHORISATION HOLDER

RESPONSIBLE FOR BATCH RELEASE

B. CONDITIONS OF THE MARKETING AUTHORISATION

16

A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH

RELEASE

Name and address of the manufacturer responsible for batch release

3M Health Care Limited, Derby Road, Loughborough, Leicester, LE11 5SF, United Kingdom.

B

CONDITIONS OF THE MARKETING AUTHORISATION

 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON

THE MARKETING AUTHORISATION HOLDER

Medicinal product subject to medicinal prescription

 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND

EFFECTIVE USE OF THE MEDICINAL PRODUCT

Not applicable

 OTHER CONDITIONS

17

ANNEX III

18

A. LABELLING

19

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

1.

NAME OF THE MEDICINAL PRODUCT

Aldara 5% cream

imiquimod

2.

STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5 %).

100 mg cream contains 5 mg imiquimod

3.

LIST OF EXCIPIENTS

Excipients : isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin,

polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E218), propyl hydroxybenzoate

(E216), xanthan gum, purified water.

See package leaflet for further information.

4.

PHARMACEUTICAL FORM AND CONTENTS

Cream

12 sachets. Each containing 250 mg of cream.

24 sachets. Each containing 250 mg of cream.

5.

METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Cutaneous use

6.

SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children

7.

OTHER SPECIAL WARNING(S), IF NECESSARY

For single use only. Discard any cream remaining in a sachet after use.

8.

EXPIRY DATE

Exp.

9.

SPECIAL STORAGE CONDITIONS

Do not store above 25C

20

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF

APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Meda AB

Box 906

170 09 Solna

Sweden

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/98/080/001

EU/1/98/080/002

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Aldara

21

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

SACHET TEXT

1.

NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION

Aldara 5% cream

Imiquimod

Cutaneous use

2.

METHOD OF ADMINISTRATION

3.

EXPIRY DATE

Exp.

4.

BATCH NUMBER

Lot

5.

CONTENTS BY WEIGHT

250 mg cream

6.

OTHER

22

B. PACKAGE LEAFLET

23

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aldara 5% cream

Imiquimod

Read all of this leaflet carefully before you start using this medicine.

-

Keep this leaflet. You may need to read it again.

-

If you have any further questions, please ask your doctor or your pharmacist.

-

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even

if their symptoms are the same as yours.

-

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

please tell your doctor or pharmacist.

In this leaflet :

1. What Aldara cream is and what it is used for

2. Before you use Aldara cream

3. How to use Aldara cream

4. Possible side effects

5. How to store Aldara cream

6. Further information

1.

WHAT IS ALDARA CREAM AND WHAT IT IS USED FOR

Aldara cream may be used for three different conditions. Your doctor may prescribe Aldara cream for

the treatment of:

 Warts (condylomata acuminata) on the surface of the genitals (sexual organs) and around the

anus (back passage)

 Superficial basal cell carcinoma.

This is a common slow-growing form of skin cancer with a very small likelihood of spread to

other parts of the body. It usually occurs in middle-aged and elderly people, especially those

who are fair-skinned and is caused by too much sun exposure. If left untreated, basal cell

carcinoma can disfigure, especially on the face – therefore early recognition and treatment are

important.

 Actinic keratosis

Actinic keratoses are rough areas of skin found in people who have been exposed to a lot of

sunshine over the course of their lifetime. Some are skin coloured, others are greyish, pink,

red or brown. They can be flat and scaly, or raised, rough, hard and warty. Aldara should only

be used for flat actinic keratoses on the face and scalp in patients with a healthy immune

system where your doctor has decided that Aldara is the most appropriate treatment for you.

Aldara cream helps your body´s own immune system to produce natural substances which help fight

your basal cell carcinoma, actinic keratosis or the virus that has caused your warts.

2.

BEFORE YOU USE ALDARA CREAM

Do not use Aldara cream :

- If you are allergic to imiquimod (the active ingredient) or any of the ingredients of the cream.

Children and adolescents:

24

-

Use in children and adolescents is not recommended.

Take special care with Aldara cream:

 If you have previously used Aldara cream or other similar preparations tell your doctor before

starting this treatment.

 Tell your doctor if you have problems with your immune system.

 Do not use Aldara cream until the area to be treated has healed after previous drug or surgical

treatment.

 Avoid contact with the eyes, lips and nostrils. In the event of accidental contact, remove cream

by rinsing with water.

 Do not apply the cream internally.

 Do not use more cream than your doctor has advised.

 Do not cover the treated area with bandages or other dressings after you have applied Aldara

cream.

 If the treated site becomes too uncomfortable, wash the cream off with mild soap and water.

As soon as the problem has stopped you may restart to apply the cream.

 Tell your doctor if you have an abnormal blood count.

Because of the way Aldara works, there is a possibility that the cream may worsen existing

inflammation in the treatment area.

 If you are being treated for genital warts follow these additional precautions:

Men with warts under the foreskin should pull the foreskin back each day and wash underneath

it. If not washed daily the foreskin may be more likely to show signs of tightness, swelling and

wearing away of the skin and result in difficulty in pulling it back. If these symptoms occur,

stop the treatment immediately and call your doctor.

If you have open sores: do not start using Aldara cream until after the sores have healed.

If you have internal warts: do not use Aldara cream in the urethra (the hole from which urine is

passed), the vagina (birth canal), the cervix (internal female organ), or anywhere inside your

anus (rectum).

Do not use this medication for more than one course if you have problems with your immune

system, either due to illness or because of the medicines you are already taking. If you think this

applies to you talk to your doctor.

If you are HIV positive you should inform your doctor as Aldara cream has not been shown to

be as effective in HIV positive patients. If you decide to have sexual relations while you still

have warts, apply Aldara cream after - not before - sexual activity. Aldara cream may weaken

condoms and diaphragms, therefore the cream should not be left on during sexual activity.

Remember, Aldara cream does not protect against giving HIV or other sexually transmitted

diseases to someone else.

 If you are being treated for basal cell carcinoma or actinic keratosis follow these additional

precautions:

Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment

with Aldara cream. Wear protective clothing and wide brimmed hats when outdoors.

Whilst using Aldara cream and until healed, the treatment area is likely to appear noticeably different

from normal skin.

Using other medicines:

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines,

including those obtained without a prescription.

25

There are no medicines known to be incompatible with Aldara cream.

Pregnancy and breast-feeding:

Ask your doctor or pharmacist for advice before taking any medicine.

You must tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss

the risks and benefits of using Aldara cream during pregnancy. Studies in animals do not indicate

direct or indirect harmful effects in pregnancy.

Do not breast-feed your infant during treatment with Aldara cream, as it is not known whether

imiquimod is secreted in human milk.

Important information about some of the ingredients of Aldara cream:

Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) may cause allergic reactions

(possibly delayed). Cetyl and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).

3.

HOW TO USE ALDARA CREAM

Children and adolescents:

Use in children and adolescents is not recommended.

Adults:

Always use Aldara cream exactly as your doctor has told you. Check with your doctor or pharmacist if

you are not sure.

Wash hands carefully before and after applying the cream. Do not cover the treated area with

bandages or other dressings after you have applied Aldara cream.

Open a new sachet each time you use the cream. Dispose of any cream left in the sachet after use. Do

not save the opened sachet for use at a later date.

The treatment frequency and duration differ for genital warts, basal cell carcinoma and actinic

keratosis (see specific instructions for each indication).

 If you are being treated for genital warts:

Application Instructions – (Mon, Wed and Fri)

1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry

thoroughly.

2. Open a new sachet and squeeze some cream onto your fingertip.

3. Apply a thin layer of Aldara cream onto clean, dry wart area and rub gently into the skin until cream

vanishes.

26

4. After application of the cream, throw away the opened sachet and wash hands with soap and water.

5. Leave Aldara cream on the warts for 6 to 10 hours. Do not shower or bathe during this time.

6. After 6 to 10 hours wash the area where Aldara cream was applied with mild

soap and water.

Apply Aldara cream 3 times per week. For example, apply the cream on Monday, Wednesday and

Friday. One sachet contains enough cream to cover a wart area of 20 cm 2 (approx. 3 square inches).

Men with warts under the foreskin should pull the foreskin back each day and wash underneath it (see

section 2 “Take special care with Aldara cream:”)

Continue to use Aldara cream as instructed until your warts have completely gone (half the females

who clear will do so in 8 weeks, half the males who clear will do so in 12 weeks but in some patients

warts may clear as early as 4 weeks).

Do not use Aldara cream for more than 16 weeks in the treatment of each episode of warts.

If you have the impression that the effect of Aldara cream is too strong or too weak, talk to your

doctor or pharmacist.

 If you are being treated for basal cell carcinoma:

Application Instructions – (Mon, Tues, Wed, Thurs and Fri)

1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry

thoroughly.

2. Open a new sachet and squeeze some cream onto your fingertip.

3. Apply Aldara cream to the affected area and 1cm (approx. 0.5 inch) around the affected area. Rub

gently into the skin until the cream vanishes.

4. After application of the cream, throw away the opened sachet. Wash hands with soap and water.

5. Leave Aldara cream on the skin for about 8 hours. Do not shower or bathe during this time.

6. After about 8 hours, wash the area where Aldara cream was applied with mild soap and water.

Apply sufficient Aldara cream to cover the treatment area and 1 cm (about ½ an inch) around the

treatment area each day for 5 consecutive days each week for 6 weeks. For example, apply the cream

from Monday to Friday. Do not apply the cream on Saturday and Sunday.

 If you are being treated for actinic keratosis

Application Instructions – (Mon, Wed and Fri)

1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry

thoroughly.

2. Open a new sachet and squeeze some cream onto your fingertip.

3. Apply the cream to the affected area. Rub gently into the area until the cream vanishes.

4. After application of the cream, throw away the opened sachet. Wash hands with soap and water.

5. Leave Aldara cream on the skin for about 8 hours. Do not shower or bathe during this time.

6. After about 8 hours, wash the area where Aldara cream was applied with

mild soap and water.

Apply Aldara cream 3 times per week. For example, apply the cream on Monday, Wednesday and

Friday. One sachet contains enough cream to cover an area of 25 cm 2 (approx. 4 square inches).

Continue treatment for four weeks. Four weeks after finishing this first treatment, your doctor will

assess your skin. If the lesions have not all disappeared, a further four weeks of treatment may be

necessary.

If you use more Aldara cream than you should:

27

Wash the extra away with mild soap and water. When any skin reaction has gone you may then

continue with your treatment.

If you accidentally swallow Aldara cream please contact your doctor.

If you forget to use Aldara cream:

If you miss a dose, apply cream as soon as you remember and then continue in your regular schedule.

Do not apply the cream more than once per day.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

The frequency of side effects is classified as follows:

Very common side effects (likely to occur in more than 1 in 10 patients)

Common side effects (likely to occur in fewer than 1 in 10 patients)

Uncommon side effects (likely to occur in fewer than 1 in 100 patients)

Rare side effects (likely to occur in fewer than 1 in 1,000 patients)

Very rare side effects (likely to occur in fewer than 1 in 10,000 patients).

Like all medicines, Aldara cream can cause side effects, although not everybody gets them.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Aldara

cream.

Some patients have experienced changes in skin colour in the area where Aldara cream was applied.

While these changes have tended to improve with time, in some patients they may be permanent.

If your skin reacts badly when using Aldara cream, stop applying the cream, wash the area with mild

soap and water and contact your doctor or pharmacist.

In some individuals a lowering of blood counts was noted. A lowering of blood counts might make

you more susceptible to infections, make you bruise more easily or cause fatigue. If you notice any of

these symptoms, tell your doctor.

Serious skin reactions have been reported rarely. If you experience skin lesions or spots on your skin that

start out as small red areas and progress to look like mini targets, possibly with symptoms such as

itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth

sores, stop using Aldara cream and tell your doctor immediately.

A small number of patients have experienced hair loss at the treatment site or surrounding area.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet,

please tell your doctor or pharmacist.

● If you are being treated for genital warts:

Many of the undesirable effects of Aldara cream are due to its local action on your skin.

Very common effects include redness (61% patients), wearing away of the skin (30% patients),

flakiness and swelling. Hardening under the skin, small open sores, a crust that forms during healing,

and small bubbles under the skin may also occur. You might also feel itching (32% patients), a

burning sensation (26% patients) or pain in areas where you have applied Aldara cream (8% patients).

Most of these skin reactions are mild and the skin will return to normal within about 2 weeks after

stopping treatment.

Commonly some patients (4% or less) have experienced headache, uncommonly fevers and flu like

symptoms joint and muscle pains; prolapse of the womb; pain on intercourse in females; erection

difficulties; increase in sweating; feeling sick; stomach and bowel symptoms; ringing in the ears;

28

flushing; tiredness; dizziness; migraine; pins and needles; insomnia; depression; loss of appetite; swollen

glands; bacterial, viral and fungal infections (e.g. cold sores); vaginal infection including thrush; cough

and colds with sore throat.

Very rarely severe and painful reactions have occurred, particularly when more cream has been used

than recommended. Painful skin reactions at the opening of the vagina have very rarely made it difficult

for some women to pass urine. If this occurs you should seek medical help immediately.

● If you are being treated for basal cell carcinoma:

Many of the undesirable effects of Aldara cream are due to its local action on your skin. Local skin

reactions can be a sign that the drug is working as intended.

Very Commonly the treated skin may be slightly itchy.

Common effects include: pins and needles, small swollen areas in the skin, pain, burning, irritation,

bleeding, redness or rash.

If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. He/she may

advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment).

If there is pus (matter) or other suggestion of infection, discuss this with your doctor. Apart from

reactions in the skin, other common effects include swollen glands and back pain.

Uncommonly some patients experience changes at the application site (discharge, inflammation,

swelling, scabbing, skin breakdown, blisters, dermatitis) or irritability, feeling sick, dry mouth, flu-like

symptoms and tiredness.

● If you are being treated for actinic keratosis

Many of the undesirable effects of Aldara cream are due to its local action on your skin. Local skin

reactions can be a sign that the drug is working as intended.

Very commonly the treated skin may be slightly itchy.

Common effects include pain, burning, irritation or redness.

If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. He/she may

advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment).

If there is pus (matter) or other suggestion of infection, discuss this with your doctor. Apart from

reactions in the skin, other common effects include headache, anorexia, nausea, muscle pain, joint pain

and tiredness.

Uncommonly some patients experience changes at the application site (bleeding, inflammation,

discharge, sensitivity, swelling, small swollen areas in the skin, pins and needles, scabbing, scarring,

ulceration or a feeling of warmth or discomfort), or inflammation of the lining of the nose, stuffy nose,

flu or flu-like symptoms, depression, eye irritation, swelling of the eyelid, throat pain, diarrhoea,

actinic keratosis, redness, swelling of the face, ulcers, pain in extremity, fever, weakness or shivering.

5. HOW TO STORE ALDARA CREAM

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use after the expiry date stated on the label.

Sachets should not be re-used once opened.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist to

29

dispose of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What Aldara cream contains:

-

The active substance is imiquimod. Each sachet contains 250 mg cream (100 mg cream contains

5 mg imiquimod).

-

The other ingredients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft

paraffin, polysorbate 60, sorbitan stearate , glycerol , methyl hydroxybenzoate (E218) , propyl

hydroxybenzoate (E216) , xanthan gum , purified water.

What Aldara cream looks like and contents of the pack:

-

Each Aldara 5% cream sachet contains 250 mg of a white to slightly yellow cream.

-

Each box contains 12 or 24 single-use polyester/aluminium foil sachets. Not all pack sizes may

be marketed.

MARKETING AUTHORISATION HOLDER:

Meda AB

Box 906

170 09 Solna

Sweden

MANUFACTURER :

3M Health Care Limited

Derby Road

Loughborough

Leicestershire

LE11 5SF, United Kingdom

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder.

België/Belgique/Belgien

Meda Pharma S.A./N.V.

Chaussée de la Hulpe 166

Terhulpsesteenweg

1170 Brussels

Tél/Tel: +32 (0)2 5 04 08 11

Luxembourg/Luxemburg

Meda Pharma S.A./N.V.

Chaussée de la Hulpe 166

Terhulpsesteenweg

B-1170 Brussels

Belgique / Belgien

Tél/Tel: +32 (0)2 5 04 08 11

България

Екофарм ЕООД

Бул. Черни връх 14; бл.3.

1421 София

Тел.: + 359 2 950 44 10

Magyarország

MEDA PHARMA Hungary Kereskedelmi Kft.

1139 Budapest

Váci ut 91

Tel: +36 1 236 3410

Česká republika

MEDA Pharma s.r.o.

Kodaňská 1441 / 46

100 10 Praha 10

Tel: +420 234 064 203

Malta

Alfred Gera and Sons Ltd.

10,Triq il -Masgar

Qormi QRM3217

Tel: +356 21 446205

30

Danmark

Meda AS

Solvang 8

3450 Allerød

Tlf: +45 44 52 88 88

Nederland

MEDA Pharma B.V.

Krijgsman 20

1186 DM Amstelveen

Tel: +31 (0)20 751 65 00

Deutschland

MEDA Pharma GmbH & Co. KG

Benzstraße 1

61352 Bad Homburg

Tel: +49 (0) 6172 888 01

Norge

Meda A/S

Askerveien 61

1384 Asker

Tlf: +47 66 75 33 00

Eesti

Meda Pharma SIA

Narva mnt. 11D

EE10151 Tallinn

Tel: +372 62 61 025

Österreich

MEDA Pharma GmbH

Guglgasse 15

1110 Wien

Tel: + 43 (0)1 86 390 0

Ελλάδα

MEDA Pharmaceuticals A.E.

Ευρυτανίας, 3

GR-15231 Χαλάνδρι-Αττική

Τηλ: +30 210 6 77 5690

Polska

Meda Pharmaceuticals Sp.z.o.o.

Al. Jana Pawla II/15

00-828 Warszawa

Tel: +48 22 697 7100

España

Meda Pharma S.A.U.

Avenida de Castilla, 2

Parque Empresarial San Fernando

Edificio Berlín

28830 San Fernando de Henares (Madrid)

Tel: +34 91 669 93 00

Portugal

MEDA Pharma - Produtos Farmacêuticos, S.A.

Rua do Centro Cultural, 13

1749-066 Lisboa

Tel: +351 21 842 0300

France

MEDA Pharma

25 Bd de l´Amiral Bruix

F-75016 PARIS

Tél: +33 (0)1 56 64 10 70

România

SODIMED SRL

B-dul Timişoara, nr. 100G, sector 6

Bucureşti

Tel.: + 40 (0) 21 408 63 34

Ireland

Meda Pharma

Office 10

Dunboyne Business Park

Dunboyne

Co Meath

Tel: +353 1 802 66 24

Slovenija

Veldos d.o.o.

Germova 3

8000 Novo Mesto

Tel: +386 (0)7 33 80 420

Ísland

Meda AB

Box 906

170 09 Solna

Svíþjóð

Sími: +46 8 630 1900

Slovenská republika

MEDA Pharma spol. s. r.o .

Trnavská cesta 50

821 02 Bratislava

Tel: +421 2 4914 0172

Italia

Meda Pharma S.p.A.

Suomi/Finland

Meda Oy

31

Viale Brenta, 18

20139 Milano

Tel: +39 02 57 416 1

Vaisalantie 4/Vaisalavägen 4

FIN-02130 Espoo/Esbo

Puh/Tel: +358 20 720 9550

Κύπρος

Χρ.Γ. Παπαλοΐζου Λτδ

Λεωφ. Ακροπόλεως 25,

2006 Λευκωσία

Τηλ. +357 22 49 03 05

Sverige

Meda AB

Box 906

170 09 Solna

Tel: +46 (0)8 630 1900

Latvija

Meda Pharma SIA

Ojāra Vācieša iela 13

LV-1004 Rīga

Tālr: +371 7 805 140

United Kingdom

Meda Pharmaceuticals Ltd.

Skyway House

Parsonage Road

Takeley

Bishop´s Stortford

CM22 6PU

Tel .: + 44 845 460 0000

Lietuva

Meda Pharma SIA

Veiverių g. 134

LT-46352 Kaunas

Tel. + 370 37330509

This leaflet was last approved in (MM/YYYY)

32

European Drugs Encyclopedia

European Drugs
Encyclopedia