Label: Patient Information

Ledaga 160 micrograms/g gel

clormetina

Read this label carefully before starting to use this medication, as it contains important information for you.

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

Ledaga contains the active ingredient clormetina. It is a cancer medication that is applied to the skin to treat cutaneous T-cell lymphoma of the type mycosis fungoides (CTCL-MF).

CTCL-MF is a disease in which certain cells of the body's immune system, called T cells, become cancerous and affect the skin. Clormetina is a type of cancer medication called an "alkylating agent". This medication prevents the multiplication and proliferation of cells that are dividing (such as cancer cells), by binding to DNA.

The use of Ledaga is only indicated for adults.

No use Ledaga

• If you are allergic (hypersensitive) to chloramphenicol or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ledaga.

• Avoid contact with the eyes. Do not apply the medication near the eyes, on the lips, or inside the nostrils or ears.
• Upon contact with the eyes, Ledaga may cause pain, burning, swelling, redness, light sensitivity, and blurred vision. It may also cause blindness and severe and permanent eye injuries. In case of Ledaga 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 assistance (including an ophthalmologist) as soon as possible.
• If the medication comes into contact with the mouth or nose, it may cause pain, redness, and ulcers that could be severe. Rinse the affected area immediately for at least 15 minutes with a large amount of water, and seek medical assistance as soon as possible.
• This medication 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 chloramphenicol. Consult your doctor or seek emergency medical attention if you experience allergic reactions to Ledaga (see section 4).
• Cases of skin cancer (abnormal cell growth in the skin) have been reported after topical application of chloramphenicol, although it is unknown if this medication was the cause. Your doctor will examine your skin to detect any possible skin cancer during and after treatment with Ledaga. Inform your doctor if you notice new damaged or ulcerated skin areas.
• Anyone (e.g., the caregiver) except the patient should avoid skin contact with Ledaga. The risks of direct skin contact include inflammation (dermatitis), eye injuries, mouth or nose injuries, and skin cancer. Caregivers who accidentally come into contact with Ledaga should immediately rinse the affected area for at least 15 minutes. Remove all contaminated clothing and wash it. Seek immediate medical attention if Ledaga comes into contact with the eyes, mouth, or nose.

Children and adolescents

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

Other medications and Ledaga

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

There are no data or limited data available on the use of chloramphenicol in pregnant women. Therefore, it is not recommended to use Ledaga during pregnancy, or in women of childbearing age who are not using contraceptive methods.

The passage of Ledaga into breast milk and the risk of the infant being exposed to Ledaga through skin contact with the mother are unknown. Therefore, breastfeeding is not recommended during the use of this medication. You should discuss this with your doctor before starting breastfeeding to decide whether to start breastfeeding or use Ledaga.

Driving and operating machinery

No adverse effects on your ability to drive and operate machinery are expected from this medication.

Ledaga contains propylene glycol and butylhydroxytoluene

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult 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 on the affected areas. The dose is the same for elderly patients (65 years and older) as for adults under 18 years.

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

Usage Instructions:

• Follow exactly the administration instructions for Ledaga as indicated by your doctor or pharmacist.
• Caregivers must use disposable nitrile gloves (a special type of glove; in case of doubt, consult your doctor or pharmacist) to apply this medication to patients.
• Remove the cap from the tube just before using it. 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 medication to completely dry skin, at least 4 hours before or 30 minutes after bathing or washing.
• Apply Ledaga to the affected skin areas. If Ledaga comes into contact with unaffected skin areas, patients should wash the exposed areas with water and soap.
• Allow the area to dry for 5 to 10 minutes after applying the medication before covering it with clothing.
• If the patient applies the gel, wash hands with water and soap immediately after application.
• If the caregiver applies the gel, carefully remove the gloves (turning them inside out to avoid contact with Ledaga) and then wash hands thoroughly with water and soap.
• Ledaga is supplied with a transparent plastic bag with a closure and child-resistant. If not, consult your pharmacist.
• With clean hands, return Ledaga to its original box and this, to the plastic bag. Return the medication to the refrigerator after each use.
• Do not cover the treated area with waterproof or airtight dressings after applying this medication.
• Until Ledaga has dried on the skin, avoid approaching open flames or lit cigarettes. Ledaga contains alcohol and is considered flammable.
• Do not apply moisturizing creams or any other products on the skin (not even medications) within 2 hours before or after the daily application of Ledaga.
• Keep Ledaga out of the reach of children and 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, consult your doctor.

If you forgot to use Ledaga

Do not use a double dose to compensate for missed doses. Apply the next dose when it is due.

If you interrupt treatment with Ledaga

Your doctor will determine how long you should use Ledaga and when you can stop treatment. Do not interrupt treatment with this medication unless your doctor instructs you to.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

STOP using Ledaga and inform your doctorimmediatelyif you experience an allergic reaction (hypersensitivity)

An allergic reaction may be accompanied by any or all of the following symptoms:

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

Other adverse effects are as follows:

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

Adverse effectsvery frequentin the treated area (may affect more than 1 in 10 patients):

• Skin inflammation
• Skin infections
• Itching (pruritus)

Adverse effectscommonin the treated area (may affect up to 1 in 10 patients):

• Skin ulcers
• Blisters
• Skin darkening

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the tube label and on the box after CAD. The expiration date is 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 in the box inside the transparent plastic bag with a closure and child-resistant.

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, the plastic bag, and the medications that you no longer need. Medications should not be thrown down the drain or in the trash. This will help protect the environment.

Composition of Ledaga

• The active ingredient is clormetina. Each gram of gel contains 160 micrograms of clormetina.
• The other components are: dietilenglicol monoetiléter, propilenglicol (E 1520), alcohol isopropílico, glicerol (E 422), ácido láctico (E 270), hidroxipropilcelulosa (E 463), cloruro de sodio, mentol racémico, edetato disódico, and butilhidroxitolueno (E 321).

See the end of section 2 for more information on propilenglicol and butilhidroxitolueno.

Appearance of the product and contents of the container

Ledaga is a transparent, colorless gel.

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

Holder of the marketing authorization and responsible for manufacturing:

Helsinn Birex Pharmaceuticals Ltd.

Damastown

Mulhuddart

Dublin 15

Ireland

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

Date of the last review of this leaflet:

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

.