LEDAGA 160 micrograms/g GEL

2. What you need to know before you use Ledaga

Do not use Ledaga

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

Warnings and precautions

Talk to your doctor or pharmacist before you start using Ledaga.

• Avoid contact with the eyes. Do not apply the medicine near the eyes, on the lips, or inside the nasal or ear orifices.
• Eye contact with Ledaga can cause pain, burning, swelling, redness, sensitivity to light, and blurred vision. It can also cause blindness and serious and permanent eye damage. If Ledaga comes into contact with the eyes, rinse them immediately for at least 15 minutes with a large amount of water, with a "0.9% sodium chloride solution" or with an eye solution, and seek medical attention (including consultation with an ophthalmologist) as soon as possible.
• If the medicine comes into contact with the mouth or nose, it can cause pain, redness, and ulcers that can be serious. Rinse the affected area immediately for at least 15 minutes with a large amount of water, and seek medical attention as soon as possible.
• This medicine can 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.
• Tell your doctor if you have ever had an allergic reaction to clormetina. Talk to your doctor or seek emergency medical attention if you experience allergic reactions to Ledaga (see section 4).
• There have been reports of skin cancer (abnormal growth of skin cells) after applying clormetina to the skin, although it is not known if this medicine was the cause. Your doctor will examine your skin to detect possible cancer during and after treatment with Ledaga. Tell your doctor if you notice new damaged areas or ulcers on the skin.
• Anyone (e.g., caregiver) except the patient should avoid skin contact with Ledaga. The risks of direct contact with the skin are inflammation (dermatitis), eye damage, mouth or nose damage, and skin cancer. Caregivers who accidentally come into contact with Ledaga should rinse the affected area immediately for at least 15 minutes. Remove all contaminated clothing and wash it. Seek medical attention 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

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

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

There are limited or no data on the use of clormetina in pregnant women. Therefore, the use of Ledaga is not recommended during pregnancy, nor in women of childbearing age who are not using contraceptive methods.

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

Driving and using machines

This medicine is not expected to affect 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 (such as contact dermatitis) or eye and mucous membrane irritation.

3. How to use Ledaga

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist.

Ledaga is only indicated for use on the skin.

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

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

Instructions for use:

• Follow the instructions for administration of Ledaga exactly as indicated by your doctor or pharmacist.
• Caregivers should use disposable nitrile gloves (a special type of gloves; if in doubt, consult your doctor or pharmacist) to apply 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.
• Apply a thin layer of the medicine to completely dry skin, at least 4 hours before or 30 minutes after showering or bathing.
• Apply Ledaga to the affected areas of the skin. If Ledaga comes into contact with unaffected areas of the 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 you are the patient applying the gel, wash your hands with water and soap immediately after application.
• If you are the caregiver applying the gel, carefully remove the gloves (turning them inside out when removing them to avoid contact with Ledaga) and then wash your hands thoroughly with water and soap.
• Ledaga is supplied with a transparent plastic bag with a child-resistant closure. If it is not, consult your pharmacist.
• With clean hands, put Ledaga back in its original box and the box in the plastic bag. Put the medicine back in the refrigerator after each use.
• Do not cover the treated area with airtight or waterproof dressings after applying this medicine.
• Until Ledaga has dried on the skin, avoid exposure to direct flames or lit cigarettes. Ledaga contains alcohol and is therefore considered flammable.
• Do not apply moisturizing creams or any other products to the skin (including medicines) in the 2 hours before or 2 hours after the daily application of Ledaga.
• Keep Ledaga out of the reach of children and away from contact with food, storing it in the 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 the recommended amount, talk to your doctor.

If you forget to use Ledaga

Do not take a double dose to make up for forgotten doses. Apply the next dose when it is due.

If you stop using Ledaga

Your doctor will decide how long you should use Ledaga and when you can stop treatment. Do not stop treatment with this medicine unless your doctor tells you to.

If you have any further questions on 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 and tell your doctor immediatelyif you experience an allergic reaction (hypersensitivity)

An allergic reaction can occur with the following symptoms:

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

Other side effects are:

Tell your doctor as soon as possible if you experience any of the following side effects:

Very common side effects in the treated area (may affect more than 1 in 10 patients):

• Skin inflammation
• Skin infections
• Itching (pruritus)

Common side effects in the treated area (may affect up to 1 in 10 patients):

• Skin ulcers
• Blisters
• Darkening of the skin

Reporting of side effects

If you experience 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 the Spanish Medicines Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side 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 which is stated on the label of the tube and on the carton after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C) at all times, ensuring the tube is in the box inside the transparent plastic bag with a child-resistant closure.

Do not use the Ledaga tube, whether opened or unopened, if more than 60 days have passed since storage in the refrigerator.

Ask your pharmacist how to dispose of the nitrile gloves, plastic bag, and medicines you no longer need. Medicines should 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 clormetina. Each gram of gel contains 160 micrograms of clormetina.
• The other ingredients are: diethylene 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, and butylhydroxytoluene (E 321).

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

Appearance and packaging of the product

Ledaga is a clear, colorless gel.

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

Marketing authorization holder and manufacturer:

Helsinn Birex Pharmaceuticals Ltd.

Damastown

Mulhuddart

Dublin 15

Ireland

You can request more information about this medicine from the local representative of the marketing authorization holder.

Date of last revision of this leaflet:

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