Panretin 0.1 % gel

Panretin belongs to a group of medicines that are related to vitamin A and known as retinoids

Panretin is used in patients with AIDS-related Kaposi?s sarcoma (KS) and is for the treatment of the KS lesions:

• that are on the skin only;
• which have not responded to your HIV treatment;
• where the skin or lesion is not broken;
• where the surrounding skin is not swollen;
• or if your doctor thinks that other treatments are not suitable for you.

Panretin does not treat KS that is inside the body.

Do not use Panretin

• if you are allergic to alitretinoin or to similar medicines containing retinoids.
• if you are allergic to any of the other ingredients of Panretin
• if you are pregnant
• if you are breast-feeding
• on KS lesions close to any other skin complaint

Take special care with Panretin

• Panretin is not approved for use in children and adolescents under 18 years of age.
• Do not apply the gel on or near sensitive parts of your body such as eyes, nostrils, mouth, lips, vagina, tip of the penis, rectum, or anus.
• Do not apply the gel to healthy skin around a KS lesion. Panretin may cause unwanted irritation or redness on healthy skin.
• Do not use insect repellents containing DEET ( N,N-diethyl- m-toluamide) or other products containing DEET while using Panretin.
• Avoid prolonged exposure of the treated area to sunlight or other ultraviolet (UV) light (such as tanning lamps).
• Mineral oil may be used between Panretin applications in order to help prevent excessive dryness or itching. However, mineral oil must not be applied for at least two hours before or after the application of Panretin.
• Women of child-bearing age must use an effective method of birth control while using Panretin, and for one month after finishing treatment.

Using other medicines
Avoid the use of other products on your treated KS lesions such as insect repellents that you use on your skin.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Use of Panretin with food and drink

It is recommended that you should not eat more vitamin A in your diet than the amount suggested by your doctor.

Pregnancy
DO NOT use Panretin if you are pregnant or thinking of becoming pregnant. Your doctor can give you more information. You must use an effective method of birth control while using Panretin, and for one month after finishing treatment.

Breast-feeding
Do not breast-feed your baby while you are using Panretin. Care should be taken not to bring your baby into contact with areas of your skin treated recently with Panretin.

Driving and using machines
Panretin is unlikely to affect your ability to drive or use machines.

Always use Panretin gel exactly as your doctor has told you. If you are not sure, you should check with your doctor or pharmacist.

To open for the first time, use the pointed portion of the cap to puncture the metal safety seal.

How to apply Panretin: For cutaneous use (on the skin) only

Apply Panretin twice a day to start with, once in the morning and once in the evening. After that, your doctor will decide how often you should apply the gel depending on the response of your KS and any side effects.

Apply Panretin to your KS lesions using a clean finger. Place a generous coating of gel over the whole surface of each lesion that you want to treat. You do not need to rub the gel into the lesion. You need to avoid applying the gel to the healthy skin around the lesion. Carefully applying the gel only to the area of the KS lesion will help to lessen any irritation or redness that may occur. Proper application will leave some gel visible on the surface of the lesion when you are finished.

• Immediately after application, wipe the finger(s) you have used to apply the gel and any healthy skin touched by the gel with a disposable tissue. Wash your hands using soap and water and wipe the healthy skin touched by the gel.
• Allow the gel to dry for three to five minutes before covering a treated area with loose clothing. Do not cover the treated lesions with any bandage or other material.
• A mild soap is recommended when bathing or showering.
• If you think that the effect of Panretin is too strong or too weak, talk to your doctor or pharmacist.
• Avoid showering, bathing, or swimming for at least three hours after any application.
• Avoid scratching the treated areas.
• Panretin contains alcohol. Keep away from naked flame.

Your doctor will tell you how long your treatment will last.

• Do not be discouraged if you do not see immediate improvement.
• It may take up to 12 weeks for any improvement to show.
• Do not stop treatment at the first sign of improvement.
• You may need to reduce the number of daily applications, or stop using Panretin for a short while, if you develop unwanted skin effects. It is important that you consult your doctor, who will tell you what to do.

If you use more Panretin than you should
There has been no experience with overdose of Panretin.

If you forget to take Panretin
Do not use a double dose to make up for forgotten individual doses. Apply the next dose at the usual time.

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

Like all medicines, Panretin can have side effects, although not everybody gets them. The side effects are most likely to appear at the site where Panretin was applied and typically begins as redness. With continued application of Panretin redness and irritation may increase and swelling at the site of the application may develop. If your side effects become too uncomfortable, with intense redness and irritation, rash, swelling, or pain, you should ask your doctor for advice on adjusting the dosage of your treatment. Most patients can continue to use Panretin by altering the number of times a day it is applied. Sometimes it is necessary to interrupt treatment, your doctor will inform you about this.

The following side effects have been noted on the skin where Panretin has been applied:

Very common (can occur in more than 1 in 10 patients treated):

Rash, scaling, irritation, redness
Cracking, scabbing, crusting, draining, oozing
Pain, burning, soreness
Itching

Common (can occur in less than 1 in 10 but in more than 1 in 100 patients treated):

Flaking, peeling, dry skin
Swelling, inflammation
Stinging, tingling
Bleeding
Skin discoloration
Skin ulcer

Uncommon (can occur in less than 1 in 100 but in more than 1 in 1000 patients treated):

Infection
Allergic reaction
Swollen lymph glands
Pale skin

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.

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the end of the tube. Do not store above 25°C.Store in the original container in order to protect from light.Keep the container tightly closed. Always use the cap to close the tube tightly after each use.

After opening, use within 90 days.

The opening of the Panretin tube is covered by a metal safety seal. If this seal has been punctured or is not visible when you first open the package, DO NOT USE and return the product to your pharmacy.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Panretin contains

• The active substance is alitretinoin. 1 g of gel contains 1 mg of alitretinoin
• The other ingredients are ethanol, macrogol 400, hydroxypropylcellulose, and butylhydroxytoluene.

What Panretin looks like and contents of the pack

Panretin is a clear yellow gel. It is supplied in a multi-use 60 g epoxy-lined aluminium tube. Each carton contains one tube of gel.

Marketing Authorisation Holder

Eisai Ltd.
Mosquito Way
Hatfield
Hertfordshire
AL10 9SN
United Kingdom

Manufacturer

Eisai Manufacturing Limited
Mosquito Way
Hatfield
Hertfordshire
AL10 9SN
United Kingdom

Eisai B.V.
Strawinskylaan 909
1077 XX Amsterdam
The Netherlands

For any information about this medicine please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien Cephalon BV TélTel 31 0497 551 050 LuxembourgLuxemburg Cephalon BV TélTel 31 0497 551 050

Cephalon Sp. zo.o. Te. 48022 50 40 890 Magyarország Cephalon Sp. zo.o. Tel 480 22 50 40 890

eská republika Cephalon Sp. zo.o. Tel 480 22 50 40 890 Malta Eisai Ltd. Tel 44 020 8600 1400

Danmark Cephalon Pharma ApS Tlf 45 3694 4868 Nederland Cephalon BV Tel 31 0497 551 050

Deutschland Cephalon GmbH Tel 49 089 89 55 70 0 Norge Cephalon Pharma ApS Tlf 45 3694 4868

Eesti Cephalon Sp. zo.o. Tel 480 22 50 40 890 Österreich Cephalon GmbH Tel 49 089 89 55 70 0

Ferrer-Galenica A.E. 30 210 52 81 700 Polska Cephalon Sp. zo.o. Tel 480 22 50 40 890

España FERRER FARMA S.A. Tel 34 93 600 37 00 Portugal Ferrer Azevedos, S.A. Tel 351 21 4725900

France Cephalon France Tél 33 01 49 81 81 00 România Cephalon Sp. zo.o. Tel 48022 50 40 890

Ireland Cephalon Pharma Ireland Ltd Tel 44 0 800 783 4869 Slovenija Cephalon Sp. zo.o. Tel 480 22 50 40 890

Ísland Cephalon Pharma ApS Sími 45 3694 4868 Slovenská republika Cephalon Sp. zo.o. Tel 48022 50 40 890

Italia SIGMA-TAU Tel 39 06 91391 SuomiFinland Cephalon Pharma ApS PuhTel 45 3694 4868

Eisai Ltd. 44 020 8600 1400 Sverige Cephalon Pharma ApS Tel 45 3694 4868

Latvija Cephalon Sp. zo.o. Tel 48022 50 40 890 United Kingdom Cephalon Ltd Tel 44 0 800 783 4869

Lietuva

Cephalon Sp. zo.o.Tel: +48(0)22 50 40 890

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