Treclinac 10 mg/g + 0.25 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Treclinac 10 mg/g + 0.25 mg/g Gel

clindamycin/tretinoin

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

• Keep this leaflet as 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 and must not be given to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Treclinac is and what it is used for

Treclinac contains clindamycin and tretinoin as active substances.

Clindamycin is an antibiotic. It inhibits the growth of bacteria associated with acne and reduces inflammation caused by these bacteria.

Tretinoin normalizes the growth of the skin's surface cells and promotes the normal shedding of cells that block hair follicles in acne-affected areas. This helps prevent sebum accumulation and the formation of early acne lesions (blackheads and pimples).

These active substances are more effective when used in combination than when used separately.

Treclinac is used on the skin to treat acne in patients aged 12 years and older.

2. What you need to know before 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 antibiotic-associated colitis, 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 suffer from rosacea, a skin condition affecting the face characterized by redness, pimples, and scaling.
• 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 acne lesions or deep nodular-cystic acne (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, or with damaged or eczematous skin. Exercise caution when applying to sensitive areas of the skin. In case of accidental contact with the eyes, rinse thoroughly with plenty of lukewarm water.
• If you are a woman of childbearing potential, you must not use Treclinac unless you are using a contraceptive method (see also section “Pregnancy, breastfeeding and fertility”).
• If prolonged or severe diarrhea occurs, or if you experience abdominal cramps, stop using 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 sunlamps). This is because this medicine may make your skin more susceptible to sunburn and other harmful effects of sunlight.

Whenever outdoors, use an effective sunscreen product with a Sun Protection Factor (SPF) of at least 30, together with protective measures (e.g., a hat).

If, despite these precautions, you develop a sunburn on your face, stop the treatment until your skin has healed.

• Inform your doctor if acute skin inflammation develops while using this medicine.
• Treclinac should not be applied at the same time as other topical products, including cosmetics (see also section “Use of Treclinac with other medicines”).

Use of Treclinac with other medicines

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

If you have used any product containing sulfides, salicylic acid, benzoyl peroxide, or resorcinol, or any chemical abrasive agent, you must wait until the effects of these have subsided before starting to use this medicine. Your doctor will advise you when to start using Treclinac.

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

Consult your doctor before using this medicine together with other medicines containing erythromycin or metronidazole, aminoglycosides, other antibiotics, or corticosteroids, or if you are receiving neuromuscular blocking agents, such as muscle relaxants used in anesthesia.

Warfarin or similar medicines – used to thin the blood. You may be more likely to bleed. Your doctor may need to perform regular blood tests to ensure your blood is clotting properly.

Pregnancy, breastfeeding and fertility

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

Do not use this medicine if you are breastfeeding. It is unknown whether Treclinac passes into breast milk and could harm the newborn.

If you are a woman of childbearing potential, use contraceptive measures while using this medicine and for one month after stopping treatment.

Driving and using machines

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

Treclinac contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, butylated hydroxytoluene, and polysorbate 80

This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

This medicine may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylated hydroxytoluene (E321).

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

3. How to use Treclinac

Follow exactly the instructions given by your doctor for the administration of this medicine. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

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

Method of administration

Wash your face carefully with a mild soap and lukewarm water, and dry the skin by gently patting with a towel. Place an amount of medication equivalent to the size of a pea onto the fingertip. Gently apply the gel by placing it on the forehead, chin, nose, and both cheeks, then spread it evenly over the entire face.

Do not use more than the amount recommended by your doctor, or more frequently than indicated. Excessive medication may 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 appropriately and not interrupt treatment as soon as acne begins to improve. It usually takes several weeks to achieve an optimal effect. In some cases, up to 12 weeks may be required. Consult your doctor if symptoms persist beyond 12 weeks, as your doctor will need to re-evaluate your treatment.

If you use more Treclinac than you should

You will not achieve faster or better results by applying more Treclinac than recommended. If too much is applied, redness, peeling, or discomfort may occur. In such cases, wash the face carefully with mild soap and lukewarm water. The use of this medicine should be discontinued until all these symptoms have disappeared.

An overdose may also cause gastrointestinal side effects, including stomach pain, nausea, vomiting, and diarrhea. In such cases, you should stop using this medicine and contact your doctor.

Treclinac is intended for topical use only. In case of accidental ingestion, contact your doctor or go to a medical center, or call the Toxicology Information Service at telephone number (91) 562 04 20, indicating the medication 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 missed dose.

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 may cause adverse effects, although not everyone will experience them.

Uncommon: may affect up to 1 in 100 people

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

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

• Hypersensitivity.
• Hypofunction of the thyroid gland (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 (cold sores), macular rash (small, flat, red spots), skin hemorrhages, burning sensation in the skin, loss of skin pigmentation, irritated skin.
• Symptoms at the application site such as irritation, swelling, superficial skin lesion, change in skin color, itching, scaling.
• Feeling of warmth, pain.

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 may also report them directly via 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 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 stated on the carton and on the tube after "EXP". The expiry date refers to the last day of the month indicated.

Expiry after first opening: 3 months.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other 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 components are: purified water, glycerol, carbomer, methylparaben (E 218), polysorbate 80 (E433), disodium edetate, anhydrous citric acid, propylparaben (E 216), butylhydroxytoluene (E321), tromethamine.

Appearance of Treclinac and contents of the pack

This medicine is a yellow translucent gel.

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

Only certain 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

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the most recent review of this leaflet: October 2024

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