TRECLINAC 10 mg/g + 0.25 mg/g GEL

2. What you need to know before you start using Treclinac

DO NOT use Treclinac:

• If you are pregnant.
• If you plan to become pregnant.
• If you are allergic to clindamycin, tretinoin, or any of the other components of this medicine (listed in section 6).
• If you are allergic to lincomycin.
• If you have chronic inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis).
• If you have a history of colitis with previous antibiotic use, characterized by significant or abnormal diarrhea, or abdominal pain.
• If you or a family member has ever had skin cancer.
• If you have acute eczema, characterized by inflamed, red, dry, and scaly skin.
• If you have rosacea, a skin disease that affects the face and is characterized by redness, pimples, and flaking.
• If you have any other acute inflammatory skin disorder (e.g., folliculitis), especially around the mouth (perioral dermatitis).
• If you have certain forms of acne vulgaris characterized by pustular or nodulocystic acne lesions (acne conglobata and acne fulminans).

If you are in any of the above situations, do not use this medicine and consult your doctor.

Warnings and precautions

• Avoid contact of this medicine with the mouth, eyes, mucous membranes, and damaged or eczematous skin. Be careful when applying it to sensitive skin areas. In case of accidental contact with the eyes, rinse the area with plenty of warm water.
• If you are a woman of childbearing age, do not use Treclinac unless you are using a contraceptive method (see also the section "Pregnancy, breastfeeding, and fertility").
• If you experience prolonged or significant diarrhea, or if you have abdominal cramps, discontinue use of this medicine and consult your doctor immediately.
• If you have atopic eczema (chronic inflammation and itching of the skin), consult your doctor before using this medicine.
• Avoid exposure to natural or artificial light (such as a sunlamp). This is because this medicine can make your skin more susceptible to sunburn and other harmful effects of the sun.

When outdoors, use an effective sun protection product with a Sun Protection Factor (SPF) of at least 30, along with protective elements (e.g., a hat).

If you get sunburned despite these measures, discontinue the medication until your skin is healed.

• Inform your doctor if you experience acute skin inflammation when using this medicine.
• Treclinac should not be applied at the same time as other products used on the skin, including cosmetics (see also the section "Using Treclinac with other medicines").

Using Treclinac with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription or herbal medicines. This is because Treclinac may affect the mechanism of action of other medicines. Similarly, other medicines may affect the way Treclinac works.

If you have used any product containing sulfur, salicylic acid, benzoyl peroxide, or resorcinol, or any chemical abrasive agent, you need to wait until the effect of these has diminished before starting to use this medicine. Your doctor will indicate when to start using Treclinac.

During treatment with Treclinac, do not use medicated cleansers or soap solutions that have a strong drying effect. Be cautious when using products that have a drying effect: abrasive soaps, soaps and cosmetics, and products with high concentrations of alcohol, astringents, spicy or mineral substances.

Consult your doctor before using this medicine with other medicines that contain erythromycin or metronidazole, aminoglycosides, other antibiotics, or corticosteroids, or if you are receiving medicines for neuromuscular blockade, such as muscle relaxants used in anesthesia.

Warfarin or similar medicines - used to thin the blood. You are more likely to have bleeding. Your doctor may need to perform regular blood tests to check that your blood is clotting correctly.

Pregnancy, breastfeeding, and fertility

DO NOT use Treclinac if you are pregnant or plan to become pregnant. Your doctor can provide more information.

Do not use this medicine if you are breastfeeding. It is unknown whether Treclinac can pass into breast milk and cause harm to the newborn.

If you are a woman of childbearing age, use contraceptive measures while using this medicine and for up to one month after finishing treatment.

Driving and using machines

It is unlikely that Treclinac will have any effect on your ability to drive or use machines.

Treclinac contains methylparaben, propylparaben, butylhydroxytoluene, and polysorbate 80

This medicine may cause allergic reactions (possibly delayed) because it contains methylparaben (E218) and propylparaben (E216).

This medicine may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxytoluene (E321).

This medicine may cause allergic reactions because it contains polysorbate 80 (E433).

3. How to use Treclinac

Follow your doctor's instructions for using this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Once daily, at bedtime, apply an amount of Treclinac equivalent to a pea size.

Method of administration

Wash your face carefully with a mild soap and lukewarm water, and dry the skin by gently patting it with a towel. Place a pea-sized amount of the medicine on the tip of your finger. Gently apply the gel, placing it on the forehead, chin, nose, and both cheeks, and then spread it evenly over the entire face.

Do not use more than the amount suggested by your doctor, or more frequently than indicated. Excessive medication can irritate the skin without providing faster or better results.

Duration of treatment

To achieve optimal results with Treclinac, it is necessary to use the product properly and not interrupt its application as soon as the acne starts to improve. Normally, it may take several weeks before an optimal effect is achieved. In some cases, up to 12 weeks may be necessary. Consult your doctor if symptoms persist for more than 12 weeks, as your doctor will need to reassess your treatment.

If you use more Treclinac than you should

You will not get faster or better results if you apply more Treclinac than recommended. If you apply too much, redness, flaking, or discomfort may occur. In these cases, wash your face carefully with a mild soap and lukewarm water. The use of this medicine will be discontinued until all these symptoms have disappeared.

An overdose can also cause stomach and intestine side effects, including stomach pain, nausea, vomiting, and diarrhea. In such cases, discontinue the use of this medicine and contact your doctor.

Treclinac is intended for use on the skin only. In case of accidental ingestion, contact your doctor or go to a medical center, or call the Toxicology Information Service. Phone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Treclinac

If you forget to use Treclinac at bedtime, apply the next dose at the usual time. Do not apply a double dose to make up for the forgotten dose.

If you have any further questions about using 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.

Uncommon: may affect up to 1 in 100 people

• Acne, dry skin, skin redness, increased sebum production, photosensitivity reaction, itching, exanthema, exfoliative exanthema, skin exfoliation, sunburn.
• Reactions at the application site, such as burning, inflamed skin, dryness, and skin redness.

Rare: may affect up to 1 in 1,000 people

• Hypersensitivity.
• Hypothyroidism (symptoms may include fatigue, weakness, weight gain, dry hair, rough and pale skin, hair loss, increased sensitivity to cold).
• Headache.
• Eye irritation.
• Gastroenteritis (inflammation of any part of the gastrointestinal tract), nausea.
• Skin inflammation, herpes simplex (fever blisters), macular exanthema (small, smooth, red spots), skin hemorrhages, burning sensation on the skin, skin depigmentation, irritated skin.
• Symptoms at the application site such as irritation, swelling, superficial skin injury, color change, itching, flaking.
• Feeling of heat, pain.

Reporting side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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 Treclinac

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

Do not store above 25°C. Do not freeze.

Keep the tube tightly closed.

Do not use this medicine after the expiry date which is stated on the carton and tube after "EXP". The expiry date is the last day of the month shown.

Shelf life after first opening: 3 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Treclinac

• The active substances are clindamycin and tretinoin.

1 g of gel contains 10 mg (1%) of clindamycin (as clindamycin phosphate) and 0.25 mg (0.025%) of tretinoin.

• The other ingredients are: purified water, glycerol, carbomer, methylparaben (E218), polysorbate 80 (E433), disodium edetate, anhydrous citric acid, propylparaben (E216), butylhydroxytoluene (E321), tromethamine.

Appearance of Treclinac and pack contents

This medicine is a translucent yellow gel.

This medicine is available in aluminum tubes containing 30 g or 60 g of gel.

Not all pack sizes may be marketed.

Marketing Authorization Holder and manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

MEDA Pharma GmbH & Co.KG

Benzstrasse, 1

61352 Bad Homburg (Germany)

or

Madaus GmbH

Lütticher Straße 5

53842 Troisdorf

Germany

You can obtain further information on this medicine by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of last revision of this leaflet:October 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es.