ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Qutenza 179 mg cutaneous patch
2.
Each 280 cm
2
cutaneous patch contains a total of 179 mg of capsaicin or 640 micrograms of capsaicin
per cm
2
of patch (8 % w/w).
Excipient
Each 50 g tube of cleansing gel for Qutenza contains 0.2 mg/g butylhydroxyanisole (E320).
For a full list of excipients, see section 6.1.
3.
Cutaneous patch.
Each patch is 14 cm x 20 cm (280 cm
2
) and consists of an adhesive side containing the active
substance and an outer surface backing layer. The adhesive side is covered with a removable, clear,
unprinted, diagonally cut, release liner. The outer surface of the backing layer is imprinted with
‘capsaicin 8%’.
4.
Qutenza is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either
alone or in combination with other medicinal products for pain.
Qutenza should be applied to the most painful skin areas (using up to a maximum of 4 patches). The
painful area should be determined by the physician and marked on the skin. Qutenza must be applied
to intact, non-irritated, dry skin, and allowed to remain in place for 30 minutes for the feet (e.g. HIV-
associated neuropathy) and 60 minutes for other locations (e.g. postherpetic neuralgia). Qutenza
treatments may be repeated every 90 days, as warranted by the persistence or return of pain.
The Qutenza cutaneous patch should be applied by a physician or by a health care professional under
the supervision of a physician.
Nitrile gloves should be worn at all times while handling Qutenza and cleaning treatment areas. Latex
gloves should NOT be worn as they do not provide adequate protection.
Patches should not be held near eyes or mucous membranes.
Direct contact with Qutenza, used gauze or used cleansing gel should be avoided.
If necessary, hairs in the affected area should be clipped to promote patch adherence (do not shave).
The treatment area(s) should be gently washed with soap and water. Following hair removal and
washing, the skin should be thoroughly dried.
The treatment area should be pre-treated with a topical anaesthetic prior to application of Qutenza to
reduce application related discomfort. The topical anaesthetic should be applied to cover the entire
2
Qutenza treatment area and surrounding 1 to 2 cm. The topical anaesthetic should be used in
accordance with the product’s instructions for use. In clinical trials, patients were pre-treated with
topical lidocaine (4%) or lidocaine (2.5%)/prilocaine (2.5%) for 60 minutes.
Qutenza is a single use patch and can be cut to match the size and shape of the treatment area. Qutenza
should be cut prior to removal of the release liner. The release liner should NOT be removed until just
prior to application. There is a diagonal cut in the release liner to aid in its removal. A section of the
release liner should be peeled and folded and the adhesive side of the printed patch placed on the
treatment area. The patch should be held in place. The release liner should slowly and carefully be
peeled from underneath with one hand while the patch should simultaneously be smoothed onto the
skin with the other.
To ensure Qutenza maintains contact to the treatment area, stretchable socks or rolled gauze may be
used.
The Qutenza patches should be removed gently and slowly by rolling them inward to minimize the
risk of aerosolisation of capsaicin. After removal of Qutenza, cleansing gel should be applied liberally
to the treatment area and left on for at least one minute. Cleansing gel should be wiped off with dry
gauze to remove any remaining capsaicin from the skin. After the cleansing gel has been wiped off,
the area should be gently washed with soap and water.
Acute pain during and following the procedure should be treated with local cooling (such as a cool
compress) and oral analgesics (e.g., short-acting opioids).
See section 6.6 for the instructions for handling and disposal of the treatment materials.
Patients with renal and/or hepatic impairment
No dose adjustment is required for patients with renal or hepatic impairment.
Paediatric population
Qutenza is not recommended for use in children and adolescents due to lack of data on safety and
efficacy.
Hypersensitivity to the active substance or to any of the excipients.
Health care professionals should wear nitrile gloves when handling patches and cleansing treatment
areas.
Qutenza should be used only on dry, intact (unbroken) skin and not on the face, above the hairline of
the scalp, and/or in proximity to mucous membranes.
Care must be taken to avoid unintentional contact with the patches or other materials that have come in
contact with the treated areas. Exposure of the skin to capsaicin results in transient erythema and
burning sensation, with mucous membranes being particularly susceptible. Inhalation of airborne
capsaicin can result in coughing or sneezing. Used patches should be disposed of immediately after
use in an appropriate medical waste container (see section 6.6).
If Qutenza comes in contact with skin not intended to be treated, cleansing gel should be applied for
one minute and wiped off with dry gauze to remove any remaining capsaicin from the skin surface.
After the cleansing gel has been wiped off, the area should be gently washed with soap and water. If
burning of eyes, skin, or airway occurs, the affected individual should be removed from the vicinity of
3
Qutenza. Eyes or mucous membranes should be flushed or rinsed with water. Appropriate medical
care should be provided if shortness of breath develops.
As a result of treatment-related increases in pain, transient increases in blood pressure (on average
< 8.0 mm Hg) may occur during and shortly after the Qutenza treatment. Blood pressure should be
monitored during the treatment procedure. Patients experiencing increased pain should be provided
with supportive treatment such as local cooling or oral analgesics (i.e., short acting opioids). For
patients with unstable or poorly controlled hypertension or a recent history of cardiovascular events,
the risk of adverse cardiovascular reactions due to the potential stress of the procedure should be
considered prior to initiating Qutenza treatment.
Patients using high doses of opioids may not respond to oral opioid analgesics when used for acute
pain during and following the treatment procedure. A thorough history should be reviewed prior to
initiating treatment and an alternative pain reduction strategy in place prior to Qutenza treatment in
patients with suspected high opioid tolerance.
Though no treatment-related reductions in neurological function have been observed in clinical studies
with Qutenza, minor and temporary changes in sensory function (e.g., heat detection) have been
reported following administration of capsaicin. Patients with increased risk for adverse reactions due
to minor changes in sensory function should be cautious when using Qutenza.
There is only limited experience with Qutenza in patients with Painful Diabetic Neuropathy (PDN).
Repeated treatments with Qutenza in patients with PDN have not been studied.
The cleansing gel for Qutenza contains butylhydroxyanisole, which may cause local skin reactions
(e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
No formal interaction studies with other medicinal products have been performed as only transient low
levels of systemic absorption have been shown to occur with Qutenza.
No clinical data on exposed pregnancies are available.
Studies in animals have not shown teratogenic effects.
Based on human pharmacokinetics, which show transient, low systemic exposure to capsaicin, the
likelihood that Qutenza increases the risk of developmental abnormalities when given to pregnant
women is very low. However, caution should be exercised when prescribing to pregnant women.
No clinical data on breast-feeding women are available.
Studies in lactating rats exposed to Qutenza everyday for 3 hours showed measurable levels of
capsaicin in the mothers’ milk. It is unknown whether capsaicin is excreted in human breast milk. As
a precautionary measure, it is advisable to not breast-feed on the day of treatment.
No studies on the effects of Qutenza on the ability to drive and use machines have been performed.
However, application of Qutenza is unlikely to have any direct effects on the central nervous system,
as only very low, transient levels of capsaicin are systemically absorbed and there is no evidence that
capsaicin affects cognition, memory or reaction times.
4
Of the 1,327 patients treated with Qutenza in randomized controlled trials, 883 (67%) reported adverse
reactions considered related to the medicinal product by the investigator. The most commonly
reported adverse reactions were transient local applications site burning, pain, erythema and pruritus.
Adverse reactions were transient, self-limited and usually mild to moderate in intensity. In all
controlled studies, the discontinuation rate due to adverse reactions was 0.8% for patients receiving
Qutenza and 0.6% for patients receiving control.
In Table 1 below all adverse reactions, which occurred at an incidence greater than control and in
more than one patient in controlled clinical trials in patients with PHN and painful HIV-AN, are listed
by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10) and
uncommon (≥ 1/1,000 to < 1/100).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1:
Treatment-emergent related adverse reaction incidence in controlled trials
System organ class and
frequency
Adverse reaction
Infections and infestations
Uncommon
Herpes zoster
Nervous system disorders
Uncommon
Dysgeusia, hypoaesthesia, burning sensation
Eye disorders
Uncommon
Eye irritation
Cardiac disorders
Uncommon
First degree atrio-ventricular (AV) block, tachycardia, palpitations
Vascular disorders
Uncommon
Hypertension
Respiratory, thoracic and
mediastinal disorders
Uncommon
Cough, throat irritation
Gastrointestinal disorders
Uncommon
Nausea
Skin and subcutaneous tissue
disorders
Uncommon
Pruritus
Musculoskeletal and
connective tissue disorders
Uncommon
Pain in extremity, muscle spasms
General disorders and
administration site
conditions
Very common
Application site pain, application site erythema
Common
Application site pruritus, application site papules, application site vesicles,
application site oedema, application site swelling, application site dryness
Uncommon
Application site urticaria, application site paraesthesia, application site
dermatitis, application site hyperaesthesia, application site inflammation,
application site reaction, application site irritation, application site bruising,
peripheral oedema
Investigations
Uncommon
Increased blood pressure
No treatment-related reductions in neurological function, as evaluated by Quantitative Sensory Testing
(QST) and neurological examinations, have been observed during clinical studies in patients with
peripheral neuropathic pain. Temporary, minor changes in heat detection (1°C to 2°C) and sharp
sensations were detected at the Qutenza application site in healthy volunteer studies.
5
No case of overdose has been reported. Qutenza is required to be administered by a physician or under
the supervision of a physician. Therefore, overdosing is unlikely to occur. Overdose may be associated
with severe application site reactions, e.g. application site pain, application site erythema, application
site pruritus. In case of suspected overdose, the patches should be removed gently, cleansing gel
should be applied for one minute and then wiped off with dry gauze and the area should be gently
washed with soap and water. Supportive measures should be taken as clinically needed. There is no
antidote to capsaicin.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other local anaesthetics, ATC code: N01BX04
Mechanism of action
Capsaicin, or 6-nonenamide, N-[(4-hydroxy-3-methoxyphenyl) methyl]-8-methyl, (6E), is a highly
selective agonist for the transient receptor potential vanilloid 1 receptor (TRPV1). The initial effect of
capsaicin is the activation of TRPV1-expressing cutaneous nociceptors, which results in pungency and
erythema due to the release of vasoactive neuropeptides.
Pharmacodynamic effects
Following capsaicin exposure, cutaneous nociceptors become less sensitive to a variety of stimuli.
These later-stage effects of capsaicin are frequently referred to as “desensitization” and are thought to
underlie the pain relief. Sensations from non TRPV1-expressing cutaneous nerves are expected to
remain unaltered, including the ability to detect mechanical and vibratory stimuli. Capsaicin-induced
alterations in cutaneous nociceptors are reversible and it has been reported and observed that normal
function (the detection of noxious sensations) returns within weeks in healthy volunteers.
Clinical Efficacy
Efficacy of a single 30-minute application of Qutenza to the feet has been shown in controlled clinical
trials conducted in patients with painful HIV-AN. Efficacy of a single 60-minute application of
Qutenza to locations other than the feet has been shown in controlled clinical trials conducted in
patients with PHN. Pain reduction was observed as early as week 1 and was maintained throughout
the 12-week study period. Qutenza has been shown to be effective when used alone or when used in
combination with systemic medicinal products for neuropathic pain.
5.2 Pharmacokinetic properties
The capsaicin contained in Qutenza is intended for delivery into the skin.
In vitro
data (active
substance dissolution and skin permeation assays) demonstrate that the rate of release of capsaicin
from Qutenza is linear during the application time. Based on
in vitro
studies, approximately 1% of
capsaicin is estimated to be absorbed into the epidermal and dermal layers of skin during one-hour
applications. As the amount of capsaicin released from the patch per hour is proportional to the surface
area of application, this amounts to an estimated total maximum possible dose for a 1000 cm
2
area of
application of approximately 7 mg. Assuming 1000 cm
2
of patch area delivers approximately 1% of
capsaicin from the patch to a 60 kg person, the maximum potential exposure to capsaicin is
approximately 0.12 mg/kg, once every 3 months.
6
According to the EC Scientific Committee on Food, the average European oral intake of capsaicin is
1.5 mg/day (0.025 mg/kg/day for a 60 kg person) and the highest dietary exposure is 25 to 200 mg/day
(up to 3.3 mg/kg/day for a 60 kg person).
Pharmacokinetic data in humans showed transient, low (< 5 ng/ml) systemic exposure to capsaicin in
about one third of PHN patients, in 3% of patients with PDN and in no HIV-AN patients following
60-minute applications of Qutenza. No data are available following 30-minute treatments. In general,
the proportions of PHN patients with systemic exposure to capsaicin increased with larger treatment
areas and with longer treatment durations. The highest concentration of capsaicin detected in patients
treated for 60 minutes was 4.6 ng/mL, which occurred immediately after Qutenza removal. Most
quantifiable levels were observed at the time of Qutenza removal, with a clear trend towards
disappearance by 3 to 6 hours after Qutenza removal. No detectable levels of metabolites were
observed in any subject.
A population pharmacokinetic analysis of patients treated for 60 and 90 minutes indicated that
capsaicin levels in plasma peaked around 20 minutes after Qutenza removal and declined very rapidly,
with a mean elimination half-life of about 130 minutes.
5.3 Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety
pharmacology, single-dose toxicity, and repeated-dose toxicity.
Genotoxicity studies performed with capsaicin show a weak mutagenic response in the mouse
lymphoma assay and negative responses in the Ames, mouse micronucleus and chromosomal
aberration in human peripheral blood lymphocytes assays.
A carcinogenicity study performed in mice indicates that capsaicin is not carcinogenic.
A reproductive toxicology study conducted in rats showed a statistically significant reduction in the
number and percent of motile sperms in rats treated 3 hours/day beginning 28 days before
cohabitation, through cohabitation and continuing through the day before sacrifice. Although neither
statistically significant nor dose dependent, the Fertility Index and the number of pregnancies per
number of rats in cohabitation were reduced in all capsaicin-treated groups.
A teratology study conducted in rabbits did not show any potential for fetotoxicity. Delays in skeletal
ossification (reductions in ossified metatarsals) were observed in a rat teratology study at dose levels
higher than human therapeutic levels; the significance of this finding in humans is unknown. Peri- and
post-natal toxicology studies, conducted in rats do not show potential for reproductive toxicity.
Lactating rats exposed to Qutenza daily for 3 hours showed measurable levels of capsaicin in the
mothers’ milk.
A mild sensitization was seen in a cutaneous sensitization study with guinea pigs.
6.
6.1 List of excipients
Patch
Matrix:
silicone adhesives
diethylene glycol monoethyl ether
silicone oil
ethylcellulose N50 (E462)
7
Backing layer:
polyester backing film
printing ink containing Pigment White 6
Removable protective layer:
polyester release liner
Cleansing gel
macrogol 300
carbomer
purified water
sodium hydroxide (E524)
disodium edetate
butylhydroxyanisole (E320)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Unopened sachet: 4 years
After opening sachet: apply Qutenza within 2 hours
6.4 Special precautions for storage
Qutenza cutaneous patch: Store flat in the original sachet and carton. Store below 25°C.
Cleansing gel: Store below 25°C.
6.5 Nature and contents of container
The Qutenza patch is stored in a paper coated aluminium foil sachet with acrylnitrile-acrylic acid
copolymer heat seal layer.
Qutenza is available in a kit containing one or two individually sealed Qutenza patches and a 50 g tube
of cleansing gel.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Health care professionals should wear nitrile gloves when handling patches and cleansing treatment
areas.
Used and unused patches and all other materials that have been in contact with the treated area should
be disposed of by sealing them in a polyethylene medical waste bag and placing in an appropriate
medical waste container.
7.
Astellas Pharma Europe B.V.
Elisabethhof 19
2353 EW Leiderdorp
8
Netherlands
8.
EU/1/09/524/001-002
9.
15/05/2009
Detailed information on this product is available on the website of the European Medicines Agency
(EMEA) http://www.emea.europa.eu
9
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER(S)
RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
10
A.
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) responsible for batch release
GP Grenzach Produktions GmbH
Emil-Barell-Strasse 7
D-79639 Grenzach-Wyhlen
Germany
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
The MAH shall agree the details of an educational programme for health care practitioners with the
National Competent Authorities and implement such programme nationally before launch.
This educational programme will include:
-
recommendations regarding the general handling and disposal measures for Qutenza
-
instructions regarding the administration of Qutenza
-
warnings and precautions, including the need:
•
to monitor blood pressure during the treatment procedure
•
to provide supportive treatment if patients experience increased pain during Qutenza
administration
•
in patients with unstable or poorly controlled hypertension or recent cardiovascular
events: to evaluate, prior to initiating Qutenza treatment, the risk of adverse
cardiovascular reactions due to the potential stress of the procedure
•
in patients using high doses of opioids and with suspected high opioid tolerance: to put in
place an alternative pain reduction strategy prior to initiating Qutenza treatment, as these
patients may not respond to oral opioid analgesics when used for acute pain during and
following the treatment procedure
•
to warn patients about the increased risk for adverse reactions due to temporary changes
in sensory function (e.g. heat detection) following administration of Qutenza
•
to warn patients about the risk of causal local reactions (e.g. contact dermatitis) and of
irritation of the eyes and mucous membranes associated with the cleansing gel of
Qutenza.
•
OTHER CONDITIONS
Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance, as presented in Module 1.8.1. of the
Marketing Authorisation Application, 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 10.0 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.
11
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 OF 1 OR 2 PATCHES
1.
Qutenza 179 mg cutaneous patch
capsaicin
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each 280 cm
2
cutaneous patch contains a total of 179 mg of capsaicin or 640 micrograms of capsaicin
per cm
2
of patch (8% w/w).
3.
LIST OF EXCIPIENTS
Patch
Matrix:
silicone adhesives
diethylene glycol monoethyl ether
silicone oil
ethylcellulose N50 (E462)
Backing layer:
polyester backing film
printing ink containing Pigment White 6
Removable protective layer:
polyester release liner
Cleansing gel
macrogol 300
carbomer
purified water
sodium hydroxide (E524)
disodium edetate
butylhydroxyanisole (E320)
See package leaflet for further information.
4.
Each carton contains 1 sachet containing 1 cutaneous patch and 1 tube of cleansing gel (50 g).
Each carton contains 2 sachets, each containing 1 cutaneous patch and 1 tube of cleansing gel (50 g).
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
15
Cutaneous use.
Instructions for use
1.
Nitrile gloves should be worn when handling patches and cleansing treatment areas
2.
Outline treatment area. Clip excessive hair. Clean treatment area.
3
.
Apply topical anaesthetic to treatment area. Wait up to 60 minutes, or according to product’s
instructions for use.
4
.
Remove anaesthetic. Gently clean with soap and water and dry thoroughly.
5
.
Cut patch to match treatment area size. Place non-glossy side up while preparing. Do not
remove release liner from the patch until ready for application.
6
.
Remove patch release liner and apply to the skin. Keep in place for 30 or 60 minutes depending
on the location of treatment. Gauze wraps or socks may be used to promote contact between
patch and skin.
7
.
Remove patch and apply cleansing gel. Wait for one minute and then wipe skin clean with dry
gauze. Gently clean treated area with soap and water.
For more detailed instructions, please refer to the Summary of Product Characteristics or the package
leaflet.
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
8.
EXPIRY DATE
EXP
Use the patch within 2 hours of opening the sachet.
9.
SPECIAL STORAGE CONDITIONS
Store flat in the original sachet and carton. Store below 25°C.
16
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Dispose of used and unused patches, gauze wipes and all other materials placed in contact with the
treated area by sealing in a polyethylene bag and placing in an appropriate medical waste container.
Astellas Pharma Europe B.V.
Elisabethhof 19
2353 EW Leiderdorp
Netherlands
EU/1/09/524/001 1 patch
EU/1/09/524/002 2 patches
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted
17
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
SACHET OF ONE PATCH
1.
Qutenza 179 mg cutaneous patch
capsaicin
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each 280 cm
2
cutaneous patch contains a total of 179 mg of capsaicin or 640 micrograms of capsaicin
per cm
2
of patch (8% w/w).
3.
LIST OF EXCIPIENTS
Patch
Matrix:
silicone adhesives
diethylene glycol monoethyl ether
silicone oil
ethylcellulose N50 (E462)
Backing layer:
polyester backing film
printing ink containing Pigment White 6
Removable protective layer:
polyester release liner
See the package leaflet for further information
4.
One cutaneous patch
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cutaneous use.
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.
18
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP
Use the patch within 2 hours of opening the sachet.
9.
SPECIAL STORAGE CONDITIONS
Store flat in the original sachet and carton. Store below 25°C.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Dispose of used and unused patches, gauze wipes and all other materials placed in contact with the
treated area by sealing in a polyethylene bag and placing in an appropriate medical waste container.
Astellas Pharma Europe B.V.
Elisabethhof 19
2353 EW Leiderdorp
Netherlands
EU/1/09/524/001 1 patch
EU/1/09/524/002 2 patches
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted
19
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
TUBE OF CLEANSING GEL - LABEL
1.
Cleansing Gel for use with Qutenza
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
3.
LIST OF EXCIPIENTS
Contains macrogol 300, carbomer, purified water, sodium hydroxide (E524), disodium edetate and
butylhydroxyanisole (E320); See package leaflet for further information.
4.
50 g
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cutaneous use. See the package leaflet for further information.
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
8.
EXPIRY DATE
EXP
9.
SPECIAL STORAGE CONDITIONS
Store below 25°C.
20
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Dispose of cleansing gel tube by sealing in a polyethylene bag along with other used Qutenza
components and placing in an appropriate medical waste container.
Astellas Pharma Europe B.V.
Elisabethhof 19
2353 EW Leiderdorp
Netherlands
EU/1/09/524/001 1 patch
EU/1/09/524/002 2 patches
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
Qutenza 179 mg cutaneous patch
capsaicin
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, ask your doctor.
•
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.
In this leaflet
:
1.
What Qutenza is and what it is used for
3.
How to use Qutenza
4.
Possible side effects
5.
How to store Qutenza
6.
Further information
1.
WHAT QUTENZA IS AND WHAT IT IS USED FOR
Qutenza is used to relieve pain in people without diabetes who have nerve pain due to damage in
nerves in the skin. Damaged nerves in your skin may occur as a result of a variety of diseases such as
shingles and HIV infection, certain medicines and other conditions. Qutenza can be used either alone
or in combination with other medicines that you may take to treat your pain.
2.
BEFORE YOU USE QUTENZA
Do not use Qutenza
•
if you are allergic (hypersensitive) to capsaicin, chilli peppers or any other ingredients in the
Qutenza cutaneous patch (see section 6 at the end of the leaflet)
Take special care with Qutenza
Do not use Qutenza on any part of your head or face.
Do not use Qutenza on broken skin or open wounds.
Do not touch Qutenza or other materials that have come in contact with the treated areas as it may
cause burning and stinging. Do not touch your eyes, mouth or other sensitive areas. Sniffing or
inhaling close to the Qutenza patches may cause coughing or sneezing.
It is usual for the skin to sting or become red and burn during and after Qutenza treatment for a short
while. Because of the pain, your blood pressure may go up and therefore, your doctor will measure
your blood pressure several times during your treatment. If you experience a lot of pain, your doctor
will apply local cooling or give you medicine for pain.
If you have unstable or poorly controlled high blood pressure or recently had heart problems, your
doctor will consider the risk of adverse reactions to your heart or blood pressure due to the potential
stress of the procedure before treating you with Qutenza.
23
2.
Before you use Qutenza
If you are using high doses of opioids, you may not respond to oral opioid analgesics when used for
acute pain during and following the treatment procedure. In this case, your doctor will use other
measures to reduce your pain following Qutenza treatment.
Though no changes have been seen in the function of the nerves in patients treated with Qutenza,
small, short-term changes in the ability to feel when something is hot or sharp have been seen after use
of capsaicin.
Use in children and adolescents
Qutenza is not recommended for treatment in patients under 18 years of age.
Using other medicines
Qutenza acts locally on your skin and is not expected to influence other medicines. Please tell your
doctor if you are taking or have recently taken any other medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
Qutenza should be used with caution if you are pregnant and/or breastfeeding. If you are pregnant, or
think you may be pregnant, or breast-feeding tell your doctor before Qutenza treatment.
Driving and using machines
There are no studies of the effects of Qutenza on the ability to drive and use machines. When using
Qutenza, only very small amounts of the active substance may be present in the blood stream for a
very short time. Therefore, Qutenza is unlikely to have any direct effects on your thinking or your
ability to drive or use machinery.
Important information about some of the ingredients of the cleansing gel for Qutenza
The cleansing gel for Qutenza contains butylhydroxyanisole which may cause local skin reactions (e.g.
contact dermatitis), or irritation of the eyes and mucous membranes.
3.
HOW TO USE QUTENZA
Qutenza should only be applied by your doctor or by a nurse under the supervision of your doctor.
Qutenza is for use on your skin.
Your doctor will mark the most painful areas on your skin with a pen or marker.
Before placing the Qutenza patches on the skin, the treatment area(s) will be washed with soap and
water and dried. Hair in treatment areas will be clipped.
Before placing the Qutenza patches on the skin, your doctor or nurse will apply a numbing gel or
cream to reduce stinging.
Your doctor or nurse will wear gloves to prepare the Qutenza patches for you. Do not sniff or inhale
close to the Qutenza patches as this may cause coughing or sneezing.
Qutenza may be cut into smaller pieces to fit the treatment area. No more than 4 patches should be
used at the same time. Your doctor or nurse will remove the patches after 30 minutes if you’re being
treated for nerve pain on your feet or 60 minutes if you’re being treated for nerve pain on other parts
of your body. Do not touch the patch with your hands as it may cause burning and stinging.
24
Usually you will feel some pain relief on the first day the patch is applied. It may take up to 1-14 days
until the full pain relief of Qutenza takes effect. If after that time you still have a lot of pain, please talk
to your doctor.
Qutenza therapy may be repeated at 90-day intervals, if necessary.
You may be given pain medicines to take for the pain you experience with Qutenza therapy.
It is common for the skin to sting or become red and burn during Qutenza treatment.
Disposable socks may be worn on top of the Qutenza patches if your feet are being treated.
Sometimes your doctor or nurse may put a bandage on top of the Qutenza patch to keep the patch
firmly on your skin.
At the end of the Qutenza treatment your doctor or nurse will clean the treated skin with cleansing gel
from a tube supplied with the kit. Cleansing gel will be left on your skin for one minute and then
wiped off to remove any remaining medicine that may be left on your skin after treatment. After the
cleansing gel has been wiped off, the area will be gently washed with soap and water.
Do not touch your eyes, mouth or other sensitive areas.
If you accidentally touch the Qutenza patch
or treated skin before cleansing gel is applied it may burn and/or sting. Call your doctor immediately.
Do not attempt to remove the patch yourself. Your doctor or nurse will remove it for you.
Do not take Qutenza patches away from the clinic.
Do not use Qutenza patches at home.
If you have any further questions on the use of this product, ask your doctor or pharmacist
.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Qutenza can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Very common side effects:
•
redness, pain on the area where the patch is applied
Common side effects:
•
itching, bumps, blisters, swelling, dryness on the area where the patch is applied
Uncommon side effects:
•
wheals, prickling sensation, inflammation of the skin, increased sensitivity, inflammation, skin
reaction, irritation, bruising on the area where the patch is applied.
•
high blood pressure, slowing of the electrical signals in the heart, rapid beating of the heart,
abnormal awareness of the beating of the heart, decreased taste, reduced sensations in limbs,
25
burning sensation, eye irritation, cough, throat irritation, nausea, itching, pain in limbs, muscle
spasms, shingles, swelling of limbs.
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist immediately.
5.
HOW TO STORE QUTENZA
Keep out of the reach and sight of children.
Do not use Qutenza after the expiry date printed on the carton after EXP. The expiry date refers to the
last day of that month.
Qutenza cutaneous patch: Store flat in original sachet and carton. Store below 25°C.
Cleansing gel: Store below 25°C.
After opening sachet, Qutenza should be applied within 2 hours.
Disposal of used and unused Qutenza patches and socks and gloves.
These items may sting your fingers if you touch them. Your doctor or nurse will put them in a
polyethylene bag before safely discarding them. Qutenza patches and treatment-related materials
should be disposed of properly.
6.
FURTHER INFORMATION
What Qutenza contains
The active substance is capsaicin. Each 280 cm
2
patch contains a total of 179 mg of capsaicin or
640 micrograms of capsaicin per cm
2
of patch (8% w/w).
The other ingredients of the Qutenza cutaneous patch are:
Matrix:
silicone adhesives
diethylene glycol monoethyl ether
silicone oil
ethylcellulose N50 (E462)
Backing layer:
polyester backing film
printing ink containing Pigment White 6
Removable protective layer:
polyester release liner
The Qutenza patch is supplied with a tube of cleansing gel, which contains no active substance.
Cleansing gel contains:
macrogol 300
carbomer
purified water
sodium hydroxide (E524)
disodium edetate
26
butylhydroxyanisole (E320)
What Qutenza looks like and contents of the pack
Qutenza is a cutaneous patch for use on your skin.
Each patch is 14 cm x 20 cm (280 cm
2
) and consists of an adhesive side containing the active
substance and an outer surface backing layer. The adhesive side is covered with a removable, clear,
unprinted, diagonally cut, release liner. The outer surface of the backing layer is imprinted with
‘capsaicin 8%’.
Each Qutenza carton contains 1 or 2 sachets and 1 tube of cleansing gel (50 g). Not all pack sizes may
be marketed.
Marketing Authorisation Holder:
Astellas Pharma Europe B.V.
Elisabethhof 19
2353 EW Leiderdorp
Netherlands
Manufacturer:
GP Grenzach Produktions GmbH (GP)
Emil-Barell-Strasse 7
D-79639 Grenzach-Wyhlen Germany
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:
België/Belgique/Belgien
Astellas Pharma B.V. Branch
Tél/Tel: + 32 (0)2 5580710
Luxembourg/Luxemburg
Astellas Pharma B.V.Branch
Belgique/Belgien
Tél/Tel: + 32 (0)2 5580710
България
Астелас Фарма ЕООД
Teл.: + 359 2 862 53 72
Magyarország
Astellas Pharma Kft.
Tel.: + 36 (06)1 3614673
Česká republika
Astellas Pharma s.r.o.
Tel: +420 236 080300
Malta
E.J. Busuttil Ltd.
Tel: +356 21447184
Danmark
Astellas Pharma a/s
Tlf: + 45 43 430355
Nederland
Astellas Pharma B.V.
Tel: + 31 (0)71 5455745
Deutschland
Astellas Pharma GmbH
Tel: + 49 (0)89 454401
Norge
Astellas Pharma
Tlf: + 47 66 76 46 00
Eesti
Astellas Pharma Europe B.V.
Holland
Tel: +31 (0)71 5455745
Österreich
Astellas Pharma Ges.m.b.H.
Tel: + 43 (0)1 8772668
27
Ελλάδα
Astellas Pharmaceuticals AEBE
Τηλ: +30 210 8189900
Polska
Astellas Pharma Sp.z.o.o.
Tel.: + 48 225451 111
España
Astellas Pharma S.A.
Tel: + 34 91 4952700
Portugal
Astellas Farma, Lda.
Tel: + 351 21 4401320
France
Astellas Pharma S.A.S.
Tél: + 33 (0)1 55917500
România
S.C.Astellas Pharma SRL
Tel: +40 (0)21 361 04 95
Ireland
Astellas Pharma Co. Ltd.
Tel: + 353 (0)1 4671555
Slovenija
Astellas Pharma Europe B.V.
Nizozemska
Tel: +31 (0)71 5455745
Ísland
Vistor hf
Sími: + 354 535 7000
Slovenská republika
Astellas Pharma s.r.o.,
Tel: +421 2 4444 2157
Italia
Astellas Pharma S.p.A.
Tel: + 39 (0)2 921381
Suomi/Finland
Astellas Pharma
Puh/Tel: + 358 (0)9 85606000
Κύπρος
Astellas Pharmaceuticals AEBE
Τηλ: +30 210 8189900
Sverige
Astellas Pharma AB
Tel: + 46 (0)40-650 15 00
Latvija
Astellas Pharma Europe B.V.
Nīderlande
Tel: + 31 (0)71 5455745
United Kingdom
Astellas Pharma Ltd.
Tel: + 44 (0) 1784 419615
Lietuva
Astellas Pharma Europe B.V.
Nyderlandai
Tel. +31 (0)71 5455745
This leaflet was last approved in
MM/YYYY
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web
site: http://www.emea.europa.eu
The following information is intended for medical or healthcare professionals only.
A complete Summary of Product Characteristics (SPC) is provided with this leaflet.
28
Source: European Medicines Agency
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