LEDAGA 160 MCG/G Gel

Зміст інструкції

1. Ledaga 160 micrograms/g gel
   1. What is Ledaga and what is it used for
   2. What you need to know before using Ledaga
   3. How to use Ledaga
   4. Possible side effects
   5. How to store Ledaga
   6. Contents of the pack and other information

Ledaga 160 micrograms/g gel

clormetina

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Ledaga is and what it is used for
• 2. What you need to know before you use Ledaga
• 3. How to use Ledaga
• 4. Possible side effects
• 5. How to store Ledaga
• 6. Contents of the pack and other information

1. What is Ledaga and what is it used for

Ledaga contains the active substance clormethine. This is an anti-tumoural medicine used on the
skin to treat cutaneous T-cell lymphoma, mycosis fungoides type (CTCL type-MF).
CTCL type-MF is a condition in which some cells of the body's immune system,
called T-lymphocytes, become cancerous and affect the skin. Clormethine is a type of anti-tumoural medicine called an “alkylating agent”; it binds to the DNA of cells that multiply, such as
cancer cells, blocking their growth and multiplication.
The use of Ledaga is only for adults.

2. What you need to know before using Ledaga

Do not use Ledaga

• if you are allergic (hypersensitive) to chlorambucil or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Ledaga.

• Contact with the eyes must be avoided. Do not apply the medicine near the eyes, inside the nostrils, inside the ear and on the lips.
• If Ledaga comes into contact with your eyes, it may cause pain, burning, swelling, redness, light sensitivity and blurred vision. It can also cause blindness and serious permanent damage to your eyes. If Ledaga comes into contact with your eyes, immediately wash your eyes for at least 15 minutes with plenty of water, with a solution known as "0.9% sodium chloride solution" or with an eye wash solution and seek medical attention (including an ophthalmologist) as soon as possible.
• If this medicine comes into contact with your mouth or nose, it may cause pain, redness and lesions that may be serious. Immediately wash the affected area for at least 15 minutes with plenty of water and seek medical attention as soon as possible.
• This medicine may cause skin reactions such as skin inflammation (redness and swelling), itching, blisters, lesions and skin infections (see section 4). The risk of skin inflammation increases if Ledaga is applied to the face, in the genital area, anus and skin folds.
• Tell your doctor if you have had an allergic reaction to chlorambucil. Contact your doctor or seek immediate medical attention if you have an allergic reaction to Ledaga (see section 4).
• Skin tumors (abnormal growth of skin cells) have been reported after the application of chlorambucil to the skin, although it is not known whether chlorambucil can cause them. Your doctor will check your skin for the appearance of skin tumors during and after treatment with Ledaga. Tell your doctor if you have new areas of lesion or ulcers on your skin.
• Direct contact of the skin with Ledaga, in subjects other than the patient, such as those who assist them, must be avoided. The risks of direct contact with the skin include skin inflammation (dermatitis), eye, mouth, nose lesions and skin tumors. If someone assisting the patient accidentally comes into contact with Ledaga, they should immediately wash the affected area for at least 15 minutes. Remove and wash any contaminated clothing. Immediate medical attention should be obtained if Ledaga has entered their eyes, mouth or nose.

Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age as safety and
efficacy have not been established for this age group.

Other medicines and Ledaga
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning a
pregnancy, ask your doctor for advice before taking this medicine.
There is limited experience regarding chlorambucil in pregnant women. In addition, the use of this
medicine is not recommended during pregnancy and in women of childbearing potential who do not use a
method of contraception.
It is not known whether Ledaga is present in breast milk and whether there is a risk that the infant may
be exposed to Ledaga through contact with the mother's skin. Therefore, breastfeeding is not recommended
while taking this medicine. You should talk to your doctor before
breastfeeding, so as to assess whether it is preferable or not to breastfeed or to use Ledaga.

Driving and using machines
This medicine is not expected to have any effect on your ability to
drive or use machines.

Ledaga contains propylene glycol and butylhydroxytoluene
Propylene glycol may cause skin irritation. Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Ledaga

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The use of Ledaga is exclusively cutaneous.
The recommended dose is the application of a thin layer once a day in the affected area of the
skin. The dose is the same for both elderly patients (65 years and over) and younger patients
(18 years and over).
Your doctor may interrupt the treatment if you present with severe skin inflammation (e.g.
redness and swelling), blisters and ulcers. Your doctor may resume treatment when
your symptoms improve.
Instructions for use:

• Use Ledaga exactly as your doctor or pharmacist has told you.
• Anyone assisting the patient must wear disposable nitrile gloves when applying this medicine to the patient (these are a special type of glove; ask your doctor or pharmacist if you have any questions).
• Remove the cap from the tube immediately before use. Use the cap to puncture the seal.
• Apply Ledaga immediately or within 30 minutes, after taking it from the refrigerator.
• Apply a thin layer of this medicine to completely dry skin at least 4 hours before or 30 minutes after a shower or bath.
• Apply Ledaga to the affected areas of the skin. In case of exposure to Ledaga in areas of skin that are not affected, wash the aforementioned exposed areas with water and soap.
• After applying the medicine, allow the area to dry for 5-10 minutes before covering with clothing.
• For patients who apply the gel themselves, wash your hands immediately with water and soap after application.
• For those assisting patients and applying the gel, carefully remove the gloves (remove them from the inside out to avoid contact with Ledaga) then wash your hands thoroughly with water and soap.
• Ledaga is supplied inside a plastic, transparent, resealable, child-resistant bag. If this is not the case, ask your pharmacist.
• With clean hands, put Ledaga back in the box, then put the box back in the plastic bag. Return it to the fridge after each use.
• Do not cover the treated area with occlusive, non-breathable or waterproof dressings after applying this medicine.
• While Ledaga is drying on the skin, avoid contact with open flames or lit cigarettes. Ledaga contains alcohol and is therefore considered flammable.
• Do not apply moisturizers or other skin products (including medicines to be applied to the skin) for 2 hours before and 2 hours after the daily application of Ledaga.
• Keep out of reach of children and away from food by storing Ledaga in its box inside the plastic bag.

If you use more Ledaga than you should
Do not apply Ledaga more than once a day. If you apply more than recommended, talk
to your doctor.

If you forget to use Ledaga
Do not use a double dose to make up for a forgotten dose. Apply the next dose when
scheduled.

If you stop using Ledaga
Your doctor will decide how long you should use Ledaga and when the treatment should be
stopped. Do not stop using this medicine until your doctor tells you to do so.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Ledaga immediately and tell your doctor if you experience allergic reactions (Hypersensitivity).
These reactions may include some or all of the following symptoms:

• Swelling of the lips, face, throat and tongue
• Redness
• Difficulty breathing

Other possible side effects
See your doctor or pharmacist as soon as possible if you notice any of the following side effects
listed below.

Very commonside effects in the treated area (may affect more than 1 in 10 people)

• Skin inflammation (dermatitis)
• Skin infection
• Tingling (itching)

Commonside effects in the treated area (may affect 1 in 10 people)

• Skin ulcers
• Blisters
• Skin darkening

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ledaga

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube and the carton after
EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (+2 °C to +8 °C) for the entire time, ensuring that the tube is inside
the carton and in the transparent, resealable, child-resistant plastic bag.
Do not use a tube of Ledaga that has been opened or closed after 60 days of storage in the refrigerator.
Ask your pharmacist how to dispose of the nitrile gloves used, the plastic bag and the medicine
that is no longer used. Do not dispose of any medicine in wastewater or household waste. This
will help protect the environment.

6. Contents of the pack and other information

What Ledaga contains

• The active ingredient is chlorambucil. One gram of gel contains 160 micrograms of chlorambucil.
• The other ingredients are: diethyl glycol monoethyl ether, propylene glycol (E 1520), isopropyl alcohol, glycerol (E 422), lactic acid (E 270), hydroxypropylcellulose (E 463), sodium chloride, racemic menthol, disodium edetate, butylhydroxytoluene (E 321). See paragraph 2 for further information regarding propylene glycol and butylhydroxytoluene.

Description of the appearance of Ledaga and contents of the pack
Ledaga is a colorless, transparent gel.
Each aluminum tube contains 60 grams of gel and has a white screw cap.

Marketing authorization holderand manufacturer
Helsinn Birex Pharmaceuticals Ltd.
Damastown
Mulhuddart
Dublin 15
Ireland
For further information on this medicinal product, contact the local representative of the marketing
authorization holder:

Lietuva
Recordati AB.
Tel: + 46 8 545 80 230
Švedija

България
Recordati Rare Diseases
Teл.: +33 (0)1 47 73 64 58
Франция

België/Belgique/Belgien
Recordati
Tél/Tel: +32 2 46101 36

Luxembourg/Luxemburg
Recordati
Tél/Tel: +32 2 46101 36
Belgique/Belgien

Česká republika
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
Francie

Magyarország
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
Franciaország

Danmark
Recordati AB.
Tlf: + 46 8 545 80 230
Sverige

Malta
Recordati Rare Diseases
Tel: +33 1 47 73 64 58
Franza

Deutschland
Recordati Rare Diseases Germany GmbH
Tel: +49 731 140 554 0

Nederland
Recordati
Tel: +32 2 46101 36
België

Eesti
Recordati AB.
Tel: + 46 8 545 80 230
Rootsi

Norge
Recordati AB.
Tlf: + 46 8 545 80 230
Sverige

Ελλάδα
Recordati Hellas
Τηλ: +30 210 6773822

Österreich
Recordati Rare Diseases Germany GmbH
Tel: +49 731 140 554 0
Deutschland

España
Recordati Rare Diseases Spain S.L.U.
Tel: + 34 91 659 28 90

Polska
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
Francja

France
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58

Portugal
Jaba Recordati S.A.
Tel: +351 21 432 95 00

Hrvatska
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
Francuska

România
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
Franţa

Ireland
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
France

Slovenija
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
Francija

Ísland
Recordati AB.
Simi: + 46 8 545 80 230
Svíþjóð

Slovenská republika
Recordati Rare Diseases
Tel: +33 (0)1 47 73 64 58
Francúzsko

Italia
Recordati Rare Diseases Italy Srl
Tel: +39 02 487 87 173

Suomi/Finland
Recordati AB.
Puh/Tel : +46 8 545 80 230
Sverige

Κύπρος
Recordati Rare Diseases
Τηλ : +33 1 47 73 64 58
Γαλλία

Sverige
Recordati AB.
Tel : +46 8 545 80 230

United Kingdom (Northern Ireland)
Recordati Rare Diseases
Tél: +33 (0)1 47 73 64 58
France
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, http://www.ema.europa.eu/

Latvija
Recordati AB.
Tel: + 46 8 545 80 230
Zviedrija