Ledaga 160 micrograms/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Ledaga 160 micrograms/g gel

chlordiazepoxide

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Ledaga is and what it is used for

Ledaga contains the active substance chlormethine. It is an anticancer medicine applied to the skin to treat cutaneous T-cell lymphoma of the mycosis fungoides type (CTCL-MF).

CTCL-MF is a condition in which certain cells of the body's immune system, called T-cells, become cancerous and affect the skin. Chlormethine is a type of anticancer medicine known as an "alkylating agent". This medicine prevents the multiplication and spread of dividing cells (such as cancer cells) by binding to DNA.

The use of Ledaga is indicated in adults only.

2. What you need to know before using Ledaga

Do not use Ledaga

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Ledaga.

• Avoid contact with the eyes. Do not apply the medicine near the eyes, on the lips, or inside the nostrils or ears.
• Contact with the eyes may cause pain, burning, swelling, redness, light sensitivity, and blurred vision. It may also lead to blindness and serious, permanent eye damage. If Ledaga comes into contact with the eyes, rinse them immediately for at least 15 minutes with plenty of water, with a "0.9% sodium chloride solution", or with an ophthalmic solution, and seek medical assistance (including consultation with an ophthalmologist) as soon as possible.
• If the medicine comes into contact with the mouth or nose, it may cause pain, redness, and ulcers, which could be severe. Immediately wash the affected area for at least 15 minutes with plenty of water, and seek medical help as soon as possible.
• This medicine may cause skin reactions such as inflammation (redness and swelling), itching, blisters, ulcers, and infections (see section 4). The risk of skin inflammation increases when Ledaga is applied to the face, genital area, anus, or skin folds.
• Inform your doctor if you have ever had an allergic reaction to chlormethine. Consult your doctor or seek emergency medical help if you experience allergic reactions to Ledaga (see section 4).
• Cases of skin cancer (abnormal growth of skin cells) have been reported after topical application of chlormethine, although it is unknown whether this medicine was the cause. Your doctor will examine your skin for possible cancer during and after treatment with Ledaga. Inform your doctor if you notice new skin lesions or ulcers.
• Anyone (e.g., caregiver) other than the patient should avoid skin contact with Ledaga. Risks of direct skin contact include inflammation (dermatitis), injury to the eyes, mouth, or nose, and skin cancer. Caregivers who are accidentally exposed to Ledaga should immediately wash the affected area for at least 15 minutes. Remove all contaminated clothing and wash it. Seek medical help immediately if Ledaga comes into contact with the eyes, mouth, or nose.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as its safety and efficacy have not been established in this age group.

Other medicines and Ledaga

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

There are no data or the data are limited regarding the use of chlormethine in pregnant women. Therefore, the use of Ledaga is not recommended during pregnancy, or in women of childbearing potential who are not using contraceptive methods.

It is unknown whether Ledaga passes into breast milk, and there is a risk that the infant may be exposed to Ledaga through skin contact with the mother. Therefore, breastfeeding is not recommended during treatment with this medicine. You should talk to your doctor before starting breastfeeding to decide whether it is better to start breastfeeding or to use Ledaga.

Driving and use of machines

This medicine is not expected to have any effect on your ability to drive or operate machinery.

Ledaga contains propylene glycol and butylated hydroxytoluene

Propylene glycol may cause skin irritation. Butylated hydroxytoluene may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Ledaga

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Ledaga is intended for topical use only.

The recommended dose is the application of a thin layer once daily to the affected areas. The dose is the same for elderly patients (65 years of age and older) as for younger adults (18 years of age and older).

Your doctor may discontinue your treatment if you develop severe skin inflammation (redness and swelling), blisters, or ulcers. Once symptoms improve, your doctor may instruct you to resume treatment.

Instructions for use:

• Follow exactly the instructions for administering Ledaga as given by your doctor or pharmacist.
• Caregivers should wear disposable nitrile gloves (a special type of glove; if in doubt, consult your doctor or pharmacist) when applying this medicine to patients.
• Remove the cap from the tube just before use. Pierce the seal with the cap.
• Apply Ledaga immediately after removing it from the refrigerator or within 30 minutes thereafter.
• Apply a thin layer of the medicine to completely dry skin, at least 4 hours before or 30 minutes after showering or washing.
• Apply Ledaga to the affected areas of skin. If Ledaga comes into contact with unaffected areas of skin, patients should wash the exposed areas with water and soap.
• Allow the area to dry for 5 to 10 minutes after applying the medicine before covering it with clothing.
• If the patient applies the gel themselves, wash hands immediately with water and soap after application.
• If a caregiver applies the gel, carefully remove the gloves (turning them inside out when removing to avoid contact with Ledaga), then thoroughly wash hands with water and soap.
• Ledaga is supplied with a transparent, resealable, child-resistant plastic bag. If this is not the case, consult your pharmacist.
• With clean hands, return Ledaga to its original carton and place the carton back into the plastic bag. Return the medicine to the refrigerator after each use.
• Do not cover the treated area with occlusive dressings (airtight or waterproof) after applying this medicine.
• Until Ledaga has dried on the skin, avoid exposure to open flames or lit cigarettes. Ledaga contains alcohol and is therefore flammable.
• Do not apply moisturizing creams or any other products (including other medicines) to the skin within 2 hours before or 2 hours after the daily application of Ledaga.
• Keep Ledaga out of the reach of children and away from food, stored in its carton 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 the recommended amount, consult your doctor.

If you forget to use Ledaga

Do not use a double dose to make up for missed doses. Apply the next dose at the scheduled time.

If you stop using Ledaga

Your doctor will determine how long you should use Ledaga and when treatment can be discontinued. Do not stop treatment with this medicine unless instructed by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

STOP using Ledaga and inform your doctor immediately if you experience an allergic reaction (hypersensitivity).

An allergic reaction may include all or some of the following symptoms:

• Swelling of the lips, face, throat, or tongue.
• Skin rash.
• Difficulty breathing.

Other adverse effects are the following:

Inform your doctor as soon as possible if you experience any of the following adverse effects:

Very common adverse effects at the treated area (may affect more than 1 in 10 people):

• Skin inflammation
• Skin infections
• Itching (pruritus)

Common adverse effects at the treated area (may affect up to 1 in 10 people):

• Skin ulcers
• Blisters
• Darkening of the skin

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ledaga

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the tube label and on the carton after EXP. The expiry date refers to the last day of the month indicated.

Store in the refrigerator (between 2 °C and 8 °C) at all times, ensuring that the tube is kept in the carton inside the transparent, resealable, child-resistant plastic bag.

Do not use the Ledaga tube, whether opened or unopened, after more than 60 days of storage in the refrigerator.

Ask your pharmacist how to dispose of nitrile gloves, plastic bags, and medicines you no longer need. Medicines must not be disposed of via wastewater or household waste. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ledaga

• The active substance is chlorambucil. Each gram of gel contains 160 micrograms of chlorambucil.
• The other components are: diethylene glycol monoethyl ether, propylene glycol (E 1520), isopropyl alcohol, glycerol (E 422), lactic acid (E 270), hydroxypropyl cellulose (E 463), sodium chloride, racemic menthol, disodium edetate, and butylhydroxytoluene (E 321).

See the end of section 2 for further information on propylene glycol and butylhydroxytoluene.

Appearance of the product and contents of the pack

Ledaga is a colourless, transparent gel.

Each aluminium tube contains 60 grams of gel and has a white screw cap.

Marketing Authorisation Holder and Manufacturer:

Helsinn Birex Pharmaceuticals Ltd.

Damastown

Mulhuddart

Dublin 15

Ireland

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu