ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Altargo 1% ointment
2.
1 g contains 10 mg retapamulin (1% w/w).
For a full list of excipients, see section 6.1.
3.
Ointment
Smooth, off-white ointment.
4.
Short term treatment of the following superficial skin infections:
Impetigo.
Infected small lacerations, abrasions, or sutured wounds.
See sections 4.4 and 5.1 for important information regarding the clinical activity of
retapamulin against different types of
Staphylococcus aureus.
Consideration should be given to official guidance on the appropriate use of antibacterial
agents.
Retapamulin is for cutaneous use only.
Adults (aged 18-65 years), adolescents (aged 12-17 years), infants and children (aged
from nine months to 11 years)
A thin layer of ointment should be applied to the affected area twice daily for five days.
The area treated may be covered with sterile bandage or gauze dressing.
Safety and efficacy have not been established in the following:
•
Impetiginous lesions >10 in number and exceeding 100 cm2 in total surface area.
•
Infected lesions that exceed 10 cm in length or a total surface area >100 cm
2
.
In patients aged less than 18 years the total surface area treated should be no more than 2% of
the body surface area.
2
Patients not showing a clinical response within two to three days should be re-evaluated and
alternative therapy should be considered (see section 4.4).
Infants under nine months of age
The safety and efficacy of retapamulin ointment has not been established in paediatric
patients less than nine months of age.
Elderly (aged 65 and older)
No dosage adjustment is necessary.
Renal impairment
No dosage adjustment is necessary. See section 5.3.
Hepatic impairment
No dosage adjustment is necessary. See section 5.3.
Known or suspected hypersensitivity to retapamulin or to the excipient.
In the event of a sensitisation or severe local irritation from the use of retapamulin ointment,
treatment should be discontinued, the ointment carefully wiped off, and appropriate
alternative therapy for the infection instituted.
Retapamulin ointment must be kept away from the eyes and mucous membranes. Epistaxis
has been reported with use of Altargo on nasal mucosa.
Care must be taken to avoid ingestion.
Retapamulin should not be used to treat infections known or thought likely to be due to
MRSA (see section 5.1).
In clinical studies of secondarily infected open wounds, the efficacy of retapamulin was
inadequate in patients with infections caused by methicillin-resistant
Staphylococcus aureus
(MRSA). The reason for the reduced clinical efficacy observed in these patients is unknown.
Alternative therapy should be considered if there is no improvement or a worsening in the
infected area after 2-3 days of treatment.
Retapamulin should not be used to treat abscesses.
Retapamulin ointment contains butylated hydroxytoluene, which may cause local skin
reaction (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
As with other antibacterial agents, prolonged use of retapamulin may result in overgrowth of
non-susceptible micro-organisms, including fungi.
3
The effect of concurrent application of retapamulin and other topical products to the same
area of skin has not been studied, and is not recommended.
In human liver microsomes, retapamulin was shown to be a strong inhibitor of CYP3A4.
However, since plasma concentrations of retapamulin during topical application have been
low (see section 5.2), it is not expected that concurrent systemic administration of CYP3A4
substrates will result in clinically important inhibition of their metabolism by retapamulin.
Co-administration of oral ketoconazole 200mg twice daily increased mean retapamulin
AUC
(0-24)
and C
max
by 81% after topical application of retapamulin 1% ointment on the
abraded skin of healthy adult males. Nevertheless, the highest plasma concentrations
recorded were low (
<
10.5 ng/ml in the absence of ketoconazole and
<
17 ng/ml in the
presence of ketoconazole.
Systemic exposure to retapamulin has been low following topical application of 1% ointment
in adult and paediatric patients aged 2 years and older (maximum plasma concentration < 20
ng/mL). Therefore it is not expected that clinically important increases in plasma
concentrations of retapamulin will occur in patients aged 2 years and older who are also
receiving CYP3A4 inhibitors.
In children aged from 9 months to 2 years it is possible that higher plasma concentrations may
occasionally occur during treatment with retapamulin 1% ointment compared to older
children and adults. Therefore caution is advised if retapamulin 1% ointment is administered
to children in this age group who are also receiving CYP3A4 inhibitors, as further increase in
systemic exposure to retapamulin may occur upon CYP3A4 inhibition.
See section 5.2 regarding plasma concentrations of retapamulin observed in patients in
different age groups.
Pregnancy
No clinical data on exposed pregnancies are available. Animal studies have shown
reproductive toxicity after oral administration and are insufficient with respect to effects on
parturition and fetal/postnatal development (see Section 5.3).
Retapamulin ointment should only be used in pregnancy when topical antibacterial therapy is
clearly indicated and the use of retapamulin is considered to be preferable to administration of
a systemic antibacterial agent.
Lactation
It is unknown whether retapamulin is excreted in human breast milk. Minimal systemic
exposure is observed in adults, therefore exposure of the breast-feeding infant is likely to be
negligible. The excretion of retapamulin in milk has not been studied in animals. A decision
on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with
Altargo should be made taking into account the benefit of breast-feeding to the child and the
benefit of Altargo therapy to the woman.
No studies on the effects on the ability to drive and use machines have been performed.
Altargo is administered topically and is unlikely to have an effect on the ability to drive or use
machines.
4
In clinical studies in which 2150 patients with superficial skin infections applied Altargo, the
most commonly reported adverse reaction was application site irritation, which affected
approximately 1% of patients.
The following convention has been used for the classification of frequency:
Common
>
1/100 to <1/10
Uncommon
(cannot be estimated from the available data)
Within each frequency grouping, undesirable effects are presented in order of decreasing
seriousness.
Organ systems
Common
Uncommon
Unknown
Immune System
Disorders
Hypersensitivity,
including angioedema
General disorders and
administration site
conditions
Application
site reactions
Application site
reactions
Application site
irritation (including
burning sensation)
Irritation
Pain
Pruritus
Erythema
Skin and
subcutaneous tissue
disorders
Contact dermatitis
Any signs or symptoms of overdose, either topically or by accidental ingestion, should be
treated symptomatically.
No specific antidote is known.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Dermatologicals ATC code: D06AX13
Mode of action
Retapamulin is a semi-synthetic derivative of the compound pleuromutilin, which is isolated
through fermentation from
Clitopilus passeckerianus
(formerly
Pleurotus passeckerianus
).
Retapamulin selectively inhibits bacterial protein synthesis by interacting at a unique site on
the 50S subunit of the bacterial ribosome that is distinct from the binding sites of other non-
pleuromutilin antibacterial agents that interact with the ribosome.
5
Not known
>
1/1000 to <1/100
Data indicate that the binding site involves ribosomal protein L3 and is in the region of the
ribosomal P site and peptidyl transferase centre. By virtue of binding to this site,
pleuromutilins inhibit peptidyl transfer, partially block P-site interactions, and prevent normal
formation of active 50S ribosomal subunits. Therefore the pleuromutilins appear to inhibit
bacterial protein synthesis by multiple mechanisms.
Retapamulin is predominantly bacteriostatic against
S. aureus
and
S. pyogenes.
Mechanism of Resistance
Due to its distinct mode of action, target specific cross-resistance with other classes of
antibacterial agents is rare.
In vitro
, three mechanisms have been identified which reduce susceptibility to
retapamulin. One involves mutations in ribosomal protein L3, the second is a non-
specific efflux mechanism (ABC transporter
vgaAv
). This non-target specific efflux
mechanism has also been demonstrated to reduce the
in vitro
activity of streptogramin
A.
Susceptibility to pleuromutilins can also be affected by the Cfr rRNA methyltransferase,
which confers cross-resistance to phenicols, lincosamides and streptogramin A in
staphylococci.
Retapamulin MICs of 2-64 µg/ml have been reported for clinical isolates of
S. aureus
possessing either the efflux or cfr resistance mechanisms described above. For
S. aureus
isolates with laboratory-generated mutations in ribosomal protein L3, retapamulin MICs were
0.25-4 µg/ml. While the
S. aureus
epidemiological cut off value for retapamulin is 0.5 µg/ml,
the clinical significance of isolates with elevated retapamulin MICs is unknown due to the
potential for high local concentrations (20,000 µg/ml) of retapamulin on the skin.
No development of resistance was observed during treatment with retapamulin in the clinical
study programme and all clinical isolates were inhibited by retapamulin concentrations of
<
2μg/ml.
Antibacterial spectrum
The prevalence of acquired resistance may vary geographically and with time for selected
species, and local information on resistance is desirable, particularly when treating severe
infections. As necessary, expert advice should be sought when the local prevalence of
resistance is such that the utility of the agent in at least some types of infection is
questionable.
Commonly susceptible species
Staphylococcus aureus*
$
Streptococcus pyogenes*
Streptococcus agalactiae
Inherently resistant organisms
6
Enterobacteriaceae
Pseudomonas aeruginosa
Enterococcus faecalis
$
In vitro,
retapamulin was equally active against methicillin-susceptible and methicillin-
resistant strains of
S. aureus
. However, see section 4.4 and below regarding clinical efficacy
against MRSA. Retapamulin should not be used to treat infections known or thought likely to
be due to MRSA.
* Activity has been satisfactorily demonstrated in clinical studies
Information from clinical trials
Very few MRSA were isolated in studies in impetigo and all were clinical successes
(100%:
8/8)
.
In studies in impetigo and in two studies of secondarily infected open wounds (SIOW),
clinical success rates were high for retapamulin in patients with mupirocin-resistant
S. aureus
(100%: 11/11) or fusidic acid-resistant
S. aureus
(96.7%: 29/30). However, in the two studies
that enrolled patients with SIOW the efficacy of retapamulin in infections due to MRSA was
inadequate (75.7%). No differences were observed in the
in vitro
activity of retapamulin
versus
S. aureus
whether the isolates were susceptible or resistant to methicillin.
The explanation for lower clinical efficacy against MRSA in SIOW is unclear and it may
have been influenced by the presence of a particular MRSA clone. In the case of treatment
failure associated with
S. aureus
, the presence of strains possessing additional virulence
factors (such as Panton-Valentine Leukocidin) should be considered.
Clinical Success Rates at Follow up for SIOW patie
nts with
S. aureus
Phenotype/PFGE
type
RETAPAMULIN
Cephalexin
n/N
Success
Rate (%)
95% Exact
CI
n/N
Success
Rate (%)
S. aureus
(all)
337/379
88.9
(85.3,91.9) 155/186
83.3
MRSA
$
28/37
75.7
(58.8,88.2)
21/26
80.8
MSSA
309/342 90.4 (86.7,93.3) 133/159 83.6
CI: confidence interval. Exact CI is calculated using the F-distribution method.
$
: the response rate for MRSA due to PVL+ MRSA was 8/13 (62%)
5.2
Pharmacokinetic properties
Absorption
Healthy adults
In a study conducted in healthy adult subjects, 1% retapamulin ointment was applied daily to
intact and to abraded skin under occlusion for up to 7 days. Systemic exposure following
topical application of retapamulin through intact skin was very low. The geometric mean C
max
value in plasma after application to 200 cm
2
of abraded skin was 9.75 ng/ml on day 1 and
8.79 ng/ml on day 7, and the maximum individual systemic exposure (C
max
) recorded was
22.1 ng/ml.
Patients from the age of 2 years
7
Single plasma samples were obtained from 516 adult and paediatric patients who received
topical treatment with retapamulin 1% ointment twice daily for 5 days for the treatment of
secondarily infected traumatic lesions. Sampling occurred pre-dose for adult subjects on days
3 or 4, and between 0-12 hours after the last application for paediatric subjects on days 3 or 4.
The majority of samples (89%) were below the lower limit of quantitation (0.5 ng/ml). Of the
samples that had measurable concentrations 90% had retapamulin concentrations less than
2.5 ng/ml. The maximum measured plasma concentration of retapamulin was 10.7 ng/ml in
adults and 18.5 ng/ml in paediatric patients (aged 2-17 years).
Patients aged from 2 months to 24 months
Single plasma samples were obtained approximately 4-8 hours after the first application on
days 3 or 4 from patients aged from 2 months to 2 years with impetigo or with secondarily
infected traumatic lesions or dermatoses (note that retapamulin is not indicated for use in
secondarily infected dermatoses). Retapamulin concentrations were measurable in 46%
(36/79) of samples (range 0.52 to 177.3 ng/ml) but the majority of these samples (27/36;
75%) contained < 5.0 ng/ml.
Among the children aged from 9 months to 2 years plasma concentrations of retapamulin
were measurable in 32% (16/50) of samples. A single retapamulin concentration (95.1 ng/ml)
exceeded the highest concentration observed in patients aged 2-17 years (18.5 ng/ml). This
plasma concentration was observed in a child with a secondary infected dermatosis, for which
retapamulin is not indicated for use.
Retapamulin is not recommended for use in children aged less than 9 months. In children
aged from 2 months to 9 months plasma concentrations of retapamulin were measurable in
69% (20/29) of samples. Four plasma retapamulin concentrations (26.9, 80.3, 174.3, and
177.3 ng/ml) exceeded the highest concentration observed in patients aged 2-17 years
(18.5 ng/ml).
Distribution
Due to the very low systemic exposures, tissue distribution of retapamulin has not been
investigated in humans.
In vitro
, retapamulin was shown to be a P-glycoprotein (Pgp) substrate and inhibitor.
However, the maximum individual systemic exposure in humans following topical
application of 1% ointment on 200 cm
2
of abraded skin (C
max
= 22 ng/ml; AUC
(0-24)
= 238
ng.h/ml) was 660-fold lower than the retapamulin IC
50
for Pgp inhibition.
Retapamulin is approximately 94% bound to human plasma proteins.
Metabolism
The
in vitro
oxidative metabolism of retapamulin in human liver microsomes was primarily
mediated by CYP3A4 with minor contributions from CYP2C8 and CYP2D6 (see section 4.5).
Elimination
Retapamulin elimination in humans has not been investigated.
Special Patient Populations
No pharmacokinetic data are available in children aged less than 2 years, or in patients with
renal or hepatic impairment. However, due to the low systemic plasma levels that have been
observed, no safety problems are foreseen.
8
5.3 Preclinical safety data
Repeated-dose toxicity
In 14-day (50, 150 or 450 mg/kg)
oral toxicity studies in rats there was evidence of adaptive
hepatic and thyroid changes. Neither of these findings is of clinical relevance.
In monkeys dosed orally (50, 150 or 450 mg/kg) for 14 days there was dose-related emesis.
Carcinogenesis, mutagenesis, reproductive toxicity
Long-term studies in animals to evaluate carcinogenic potential have not been conducted with
retapamulin.
There was no evidence of genotoxicity when evaluated in
vitro
for gene mutation and/or
chromosomal effects in the mouse lymphoma cell assay, in cultured human peripheral blood
lymphocytes, or when evaluated
in vivo
for chromosomal effects in a rat micronucleus test.
There was no evidence of impaired fertility in male or female rats at oral doses of 50, 150, or
450 mg/kg/day, resulting in exposure margins of up to 5-times the highest human estimated
exposure (topical application to 200 cm
2
abraded skin: AUC 238 ng.h/ml).
In an embryotoxicity study in rats, developmental toxicity (decreased fetal body weight and
delayed skeletal ossification) and maternal toxicity were observed at oral doses of ≥ 150
mg/kg/day (corresponding to ≥ 3 times the human estimated exposure (see above). There
were no treatment-related malformations in rats.
Retapamulin was given as a continuous intravenous infusion to pregnant rabbits from day 7 to
day 19 of gestation. Maternal toxicity was demonstrated at dosages of ≥ 7.2 mg/kg/day
corresponding to ≥ 8 times the estimated human exposure (see above). There was no
treatment-related effect on embryo-fetal development.
No studies to evaluate effects of retapamulin on pre-/postnatal development were performed.
However, there were no systemic effects on juvenile rats with topical application of
retapamulin ointment.
6.
6.1 List of excipients
White soft paraffin.
Butylated hydroxytoluene
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Unopened:
2 years.
In-use:
7 days.
9
6.4
Special precautions for storage
Do not store above
25°C.
6.5
Nature and contents of container
0.5 g aluminium foil sachet. Carton of 12 sachets.
5 g, 10 g and 15 g aluminium tubes with a plastic screw cap. Carton of 1 tube.
Not all pack sizes may be marketed.
6.6
Special precautions for disposal and other handling
Any remaining ointment at the end of treatment should be discarded.
Any unused product or waste material should be disposed of in accordance with local
requirements.
7.
Glaxo Group Ltd
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom
8.
EU/1/07/390/001
EU/1/07/390/002
EU/1/07/390/003
EU/1/07/390/004
9.
24/05/2007
Detailed information on this medicine is available on the European Medicines Agency
(EMEA) web site:
http://www.ema.europa.eu
/.
10
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING
AUTHORISATION
11
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Glaxo Operations UK Ltd. (trdg as Glaxo Wellcome Operations)
Harmire Road
Barnard Castle
Durham, DL12 8DT
United Kingdom
B. CONDITIONS OF THE MARKETING AUTHORISATION
Medicinal product subject to medical prescription.
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable.
•
OTHER CONDITIONS
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of
the Marketing Authorisation is in place and functioning before and whilst the product is on
the market.
Risk Management plan
The MAH commits to performing the studies and additional pharmacovigilance activities
detailed in the Pharmacovigilance Plan, as agreed in version 1 of the Risk Management Plan
(RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any
subsequent updates of the RMP agreed by the CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human
use, the updated RMP should be submitted at the same time as the next Periodic Safety
Update Report (PSUR).
In addition, an updated RMP should be submitted
•
When new information is received that may impact on the current Safety
Specification, Pharmacovigilance Plan or risk minimisation activities.
•
Within 60 days of an important (pharmacovigilance or risk minimisation) milestone
being reached.
•
At the request of the EMEA.
12
ANNEX III
LABELLING AND PACKAGE LEAFLET
13
A. LABELLING
14
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR 5 g, 10 g, 15 g TUBE
1.
Altargo 1% ointment
Retapamulin
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
1 g contains: 10 mg retapamulin (1% w/w)
3.
LIST OF EXCIPIENTS
Also contains:
White soft paraffin
E321
See package leaflet for further information
4.
ointment
5 g x 1 tube
10 g x 1 tube
15 g x 1 tube
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cutaneous use only
Do not swallow
Apply to the affected area as directed by your doctor
Read the package leaflet before 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
Do not use in the eyes or on mucous membranes
8.
EXPIRY DATE
15
EXP
9.
SPECIAL STORAGE CONDITIONS
Do not store above
25°C.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL
PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCTS, IF APPROPRIATE
11.
Glaxo Group Ltd
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom
12.
EU/1/07/390/002 5 g
EU/1/07/390/003 10 g
EU/1/07/390/004 15 g
13.
BATCH NUMBER
Lot
14.
GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15.
INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
Altargo
16
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR 0.5 g SACHET
1.
Altargo 1% ointment
Retapamulin
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
1 g contains: 10 mg retapamulin (1% w/w)
3.
LIST OF EXCIPIENTS
Also contains:
White soft paraffin
E321
See package leaflet for further information
4.
Ointment
0.5 g x 12 sachets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cutaneous use only
Do not swallow
Apply to the affected area as directed by your doctor
Read the package leaflet before 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
Do not use in the eyes or on mucous membranes
8.
EXPIRY DATE
17
EXP
9.
SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL
PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCTS, IF APPROPRIATE
11.
Glaxo Group Ltd
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom
12.
EU/1/07/390/001
13.
BATCH NUMBER
Lot
14.
GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15.
INSTRUCTIONS ON USE
16.
INFORMATION IN BRAILLE
Altargo
18
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING
UNITS
5 g, 10 g 15 g TUBE
Altargo 1% ointment
Retapamulin
Cutaneous use.
2.
METHOD OF ADMINISTRATION
Read the package leaflet before use.
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Lot
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
5 g
10 g
15 g
6.
OTHER
Do not use in the eyes or on mucous membranes
19
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING
UNITS
0.5 g SACHET
Altargo 1% ointment
Retapamulin
Cutaneous use.
2.
METHOD OF ADMINISTRATION
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Lot
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
0.5 g
6.
OTHER
Do not use in the eyes or on mucous membranes
Do not store above
25°C.
Read the package leaflet before use
20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
Altargo 1% ointment
Retapamulin
Read all of this leaflet carefully before you start using this medicine.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms seem 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 Altargo is and what it is used for
2. Before you use Altargo
3. How to use Altargo
4. Possible side effects
5.
How to store Altargo
6.
Further information
1.
WHAT ALTARGO IS AND WHAT IT IS USED FOR
Altargo is used to treat bacterial infections affecting small areas of skin. Infections that may
be treated include impetigo (which causes crusting scabs on infected areas), cuts, grazes and
stitched wounds.
Altargo is for adults and children aged nine months and older.
2.
BEFORE YOU USE ALTARGO
Do not use Altargo:
If you are allergic (hypersensitive) to retapamulin or any of the other ingredients of Altargo.
Take special care with Altargo:
If you notice any worsening of the infection or develop increased redness, irritation or other
signs and symptoms at the site of application you should stop using Altargo and tell your
doctor. See also section 4 of this leaflet.
If there is no improvement in your infection after two to three days of treatment contact your
doctor.
Using other medicines:
Do not apply other ointments, creams or lotions to the area being treated with Altargo unless
specifically instructed to do so by your doctor.
22
-
Keep this leaflet. You may need to read it again.
Tell your doctor or healthcare provider:
If the patient is a child less than two years old it is important that you tell your doctor about
any other medicines that the child is being given, including medicines bought without a
prescription. It is possible that using Altargo in children who are taking certain medicines
(such as some medicines used to treat fungal infections) could result in blood concentrations
of Altargo that are higher than usual. This might lead to side effects. Your doctor will decide
if Altargo can be used for a child aged less than 2 years old who is taking other medicines.
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before using any medicine.
Do not use Altargo if you are pregnant, or planning to become pregnant. Ask your doctor or
pharmacist for advice.
Do not use Altargo if you are breast-feeding a baby. Ask your doctor or pharmacist for
advice.
3.
HOW TO USE ALTARGO
Always use Altargo exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
Altargo is for use on the skin only. It must not be put in the eyes, on the mouth or lips, inside
the nose or inside the female genital area. If the ointment accidentally gets on to these areas,
wash the area with water and consult your doctor if you experience discomfort. If you
accidentally use Altargo inside your nose you could have a nose bleed.
Wash your hands before and after applying the ointment.
How to apply Altargo
A thin layer of ointment is usually put on the infected skin twice a day for five days.
After applying your ointment, you may cover the treated area with a sterile bandage or gauze
dressing, unless your doctor has told you to leave it uncovered.
Keep using Altargo for as long as your doctor advises.
If you use too much Altargo
Carefully wipe off the extra ointment.
Problems with overdosage with this medicine are unlikely.
If you forget to use Altargo
Apply the ointment as soon as you remember, and apply the next dose at the usual time.
If you accidentally swallow Altargo
Contact your doctor or pharmacist for advice.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
23
Like all medicines, Altargo can cause side effects, although not everybody gets them.
These side effects have occurred on the skin where Altargo has been applied:
Common side effects
- skin irritation
This may affect up to 1 in 10 people.
Uncommon side effects
- pain, itching, redness or rash (contact dermatitis)
These may affect up to 1 in 100 people.
Other side effects
- a burning sensation
- an allergic reaction
It is not known how many people this may affect.
Altargo contains butylated hydroxytoluene (E321), which may cause local skin reactions (e.g.
contact dermatitis), or irritation to the eyes and mucous membranes.
If you develop signs of a local reaction, such as itching, swelling, redness or pain where you
have used Altargo: Tell your doctor.
If you have a severe reaction (e.g. severe itching or severe rash, swelling of the face, lips, or
tongue): Stop using Altargo, carefully wipe off the ointment, and contact your doctor or
pharmacist immediately.
If any of the side effects gets serious, or if you notice any side-effects that are not mentioned
in this leaflet: Tell your doctor or pharmacist.
5.
HOW TO STORE ALTARGO
Keep out of the reach and sight of children.
Do not store above
25°C.
Do not use Altargo after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
Discard open tubes 7 days after opening.
Return any unused Altargo to your pharmacist.
6.
FURTHER INFORMATION
What Altargo contains
-
The active substance is retapamulin.
24
-
The other ingredients are white soft paraffin
and
butylated hydroxytoluene (E321), a
preservative.
What Altargo looks like and contents of the pack
Altargo is a smooth, off-white ointment.
It is supplied in an aluminium tube with a plastic cap, containing either 5, 10 or 15 grams of
ointment, or in an aluminium foil sachet containing 0.5 g of ointment.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Manufacturer
Glaxo Group Ltd
Glaxo Operations UK, Ltd, (trading as Glaxo
Wellcome Operations)
Harmire Road
Barnard Castle
County Durham
DL12 8DT
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 0NN
United Kingdom
25
For any information about this medicinal product, please contact the local representative of
the Marketing Authorisation Holder:
België/Belgique/Belgien
GlaxoSmithKline s.a./n.v.
Tél/Tel: + 32 (0)2 656 21 11
Luxembourg/Luxemburg
GlaxoSmithKline s.a./n.v.
Tél/Tel: + 32 (0)2 656 21 11
България
ГлаксоСмитКлайн ЕООД
Teл.: + 359 2 953 10 34
Magyarország
GlaxoSmithKline Kft.
Tel.: + 36 1 225 5300
Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 222 001 111
gsk.czmail@gsk.com
Malta
GlaxoSmithKline Malta
Tel: + 356 21 238131
Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
dk-info@gsk.com
Nederland
GlaxoSmithKline BV
Tel: + 31 (0)30 6938100
nlinfo@gsk.com
Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel.: + 49 (0)89 36044 8701
produkt.info@gsk.com
Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00
firmapost@gsk.no
Eesti
GlaxoSmithKline Eesti OÜ
Tel: + 372 6676 900
estonia@gsk.com
Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
at.info@gsk.com
Ελλάδα
GlaxoSmithKline A.E.B.E.
Τηλ: + 30 210 68 82 100
Polska
GSK Commercial Sp. z o.o.
Tel.: + 48 (0)22 576 9000
España
Stiefel Farma, S.A.
Tel: + 34 902 202 700
es-ci@gsk.com
France
Laboratoire GlaxoSmithKline
Tél.: + 33 (0)1 39 17 84 44
diam@gsk.com
România
GlaxoSmithKline (GSK) S.R.L.
Tel: + 4021 3028 208
Ireland
GlaxoSmithKline (Ireland) Limited
Tel: + 353 (0)1 4955000
Slovenija
GlaxoSmithKline d.o.o.
Tel: + 386 (0)1 280 25 00
medical.x.si@gsk.com
26
Ísland
GlaxoSmithKline ehf.
Simi: + 354 530 3700
Slovenská republika
GlaxoSmithKline Slovakia s. r. o.
Tel: + 421 (0)2
48 26 11 11
recepcia.sk@gsk.com
Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 9218 111
Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30
Finland.tuoteinfo@gsk.com
Κύπρος
GlaxoSmithKline Cyprus Ltd
Τηλ: + 357 22 39 70 00
Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
info.produkt@gsk.com
United Kingdom
GlaxoSmithKline UK
Tel: + 44 (0)800 221441
customercontactuk@gsk.com
Lietuva
GlaxoSmithKline Lietuva UAB
Tel: + 370 5 264 90 00
info.lt@gsk.com
This leaflet was last approved
on
Detailed information on this medicine is available on the European Medicines Agency
(EMEA) web site:
http://www.ema.europa.eu
/.
27
Source: European Medicines Agency
- Please bookmark this page (add it to your favorites).
- If you wish to link to this page, you can do so by referring to the URL address below this line.
https://theodora.com/drugs/eu/altargo.html
Copyright © 1995-2021 ITA all rights reserved.