Panretin
alitretinoin
Panretin 0.1% gel Alitretinoin
Keep this leaflet. You may need to read it again.
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 signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What Panretin is and what it is used for
What you need to know before you use Panretin
How to use Panretin
Possible side effects
How to store Panretin
Contents of the pack and other information
Medicinal product no longer authorised
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
if your doctor thinks that other treatments are not suitable for you. Panretin does not treat KS that is inside the body.
if you are allergic to alitretinoin or to similar medicines containing retinoids
if you are allergic to any of the other ingredients of this medicine (listed in section 6)
if you are pregnant
if you are planning a pregnancy
if you are breast-feeding
on KS lesions close to any other skin complaint
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.
Avoid the use of other products on your treated KS lesions such as insect repellents that you use
on your skin.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
It is recommended that you should not eat more vitamin A in your diet than the amount
suggested by your doctor.
DO NOT use Panretin if you are pregnant or thinking of becoming pregnant. Your doctor can
give you more information.
Medicinal product no longer authorised
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.
Panretin is unlikely to affect your ability to drive or use machines.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
To open for the first time, use the pointed portion of the cap to puncture the metal safety seal.
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.
There has been no experience with overdose of Panretin.
Do not use a double dose to make up for forgotten individual doses. Apply the next dose at the
usual time.
Medicinal product no longer authorised
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: Verycommon(canoccurinmorethan1in10patientstreated):
Rash, scaling, irritation, redness
Cracking, scabbing, crusting, draining, oozing Pain, burning, soreness
Itching
Common(canoccurinlessthan1in10butinmorethan1in100patientstreated): Flaking, peeling, dry skin
Swelling, inflammation
Stinging, tingling Bleeding
Skin discoloration Skin ulcer
Uncommon(canoccurinlessthan1in100butinmorethan1in1000patientstreated): 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.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via thenationalreporting system listed in Appendix V. By reporting side effects you can help provide more information
on the safety of this medicine.
Keep this medicine out of the sight and reach 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.
Medicinal product no longer authorised
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, DONOTUSE 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.
The active substance is alitretinoin. 1 g of gel contains 1 mg of alitretinoin.
The other ingredients are ethanol, macrogol 400, hydroxypropylcellulose, and butylhydroxytoluene.
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.
Eisai GmbH Lyoner Straße 36
60528 Frankfurt am Main
Germany
Eisai Manufacturing Limited
Mosquito Way Hatfield Hertfordshire AL10 9SN
United Kingdom
Or
Eisai GmbH Lyoner Straße 36
60528 Frankfurt am Main Germany
For any information about this medicine please contact the local representative of the Marketing Authorisation Holder.
Eisai SA/NV
Tél/Tel: +32 (0)800 158 58
Eisai GmbH
Teл.: + 49 (0) 69 66 58 50
Medicinal product no longer authorised
(Германия)
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Vokietija) Luxembourg/Luxemburg Eisai SA/NV
Tél/Tel: +32 (0)800 158 58
(Belgique/Belgien)
Eisai GesmbH organizačni složka
Tel.: + 420 242 485 839
Eisai AB
Tlf: + 46 (0) 8 501 01 600
(Sverige)
Eisai GmbH
Tel.: + 49 (0) 69 66 58 50
(Németország)
Eisai GmbH
Tel.: + 49 (0) 69 66 58 50
(Il-Ġermanja)
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
Eisai B.V.
Tél/Tel: + 31 (0) 900 575 3340
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Saksamaa)
Eisai AB
Tlf: +46 (0) 8 501 01 600
(Sverige)
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Eisai GesmbH
Tel: + 43 (0) 1 535 1980-0
Eisai Farmacéutica, S.A.
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Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Niemcy)
Eisai SAS
Tél: + (33) 1 47 67 00 05
Eisai Farmacêutica, Unipessoal Lda
Tel: + 351 214 875 540
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Njemačka)
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germania)
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Germany) Ísland Eisai AB
Sími: + 46 (0)8 501 01 600
(Svíþjóð)
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Nemčija)
Eisai GesmbH organizačni složka Tel.: + 420 242 485 839
(Česká republika)
Eisai S.r.l.
Tel: + 39 02 5181401
Eisai AB
Puh/Tel: + 46 (0) 8 501 01 600
(Ruotsi)
Eisai GmbH
Medicinal product no longer authorised
Tel: + 49 (0) 69 66 58 50
(Γερμανία)
Eisai AB
Tel: + 46 (0) 8 501 01 600
Eisai GmbH
Tel: + 49 (0) 69 66 58 50
(Vācija)
Eisai Europe Ltd.
Tel: + 44 (0)208 600 1400