Acnatac

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Acnatac (Treclin), 10 mg/g + 0,25 mg/g, gel
clindamycin + tretinoin
Acnatac and Treclin are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

1. What Acnatac is and what it is used for

Acnatac contains the active substances clindamycin and tretinoin.
Clindamycin is an antibiotic. It inhibits the growth of bacteria associated with acne and reduces the inflammatory response caused by these bacteria.
Tretinoin normalizes cell growth in the outer layer of the skin and promotes proper desquamation of cells that block the openings of hair follicles in acne-affected areas. This prevents the accumulation of sebum and the formation of early acne lesions (closed comedones and open comedones).
These active substances are more effective when used in combination than when used separately.
Acnatac is applied to the skin in the treatment of acne in patients aged 12 years and older.

2. Important information before using Acnatac

When NOT TO USE Acnatac:

• if the patient is pregnant;
• if the patient is planning pregnancy;
• if the patient is allergic to clindamycin, tretinoin or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to lincomycin;
• if the patient has chronic inflammatory bowel disease (e.g. ulcerative colitis or Crohn's disease);
• if the patient has previously experienced antibiotic-associated colitis characterized by prolonged or significant diarrhoea or abdominal cramps;
• if the patient or a family member has ever been diagnosed with skin cancer; Page 1 of 5
• if the patient has acute acne characterized by inflammatory, red, dry and flaky skin lesions;
• if the patient has rosacea, a facial skin condition characterized by redness, skin peeling and presence of eruptions;
• if the patient has other acute inflammatory skin conditions (e.g. folliculitis), especially around the mouth (perioral dermatitis);
• if the patient has been diagnosed with specific forms of acne vulgaris characterized by nodular-cystic lesions (conglobate acne and fulminant acne).

If any of the above situations apply to the patient, use of the medicine must be discontinued and
the patient should consult a doctor.
Warnings and precautions

• Avoid contact with the mouth, eyes, mucous membranes, as well as with damaged skin or skin affected by acne. Exercise caution when applying to sensitive areas. If the product accidentally gets into the eye, rinse thoroughly with plenty of lukewarm water.
• If prolonged or significant diarrhoea or abdominal cramps occur, stop using this medicine and consult a doctor immediately.
• If the patient has atopic dermatitis (chronic inflammatory skin condition with itching), consult a doctor before using this medicine.
• Avoid exposure to natural or artificial light (e.g. sunbeds), as this medicine may increase susceptibility to sunburn and other adverse effects of sunlight. When outdoors, always use effective sun protection products with a sun protection factor (SPF) of at least 30, and wear protective clothing (e.g. a hat). If sunburn does occur on the face, discontinue use of the medicine until the skin has healed.
• If an acute inflammatory skin reaction occurs during treatment with this medicine, consult a doctor.
• Acnatac should not be used simultaneously with other topical products, including cosmetics (see also the section titled "Acnatac and other medicines").

Acnatac and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken,
as well as any medicines you plan to take. This includes medicines available without a prescription and herbal preparations. Acnatac may affect the way certain other medicines work. Likewise, certain other medicines may affect the way Acnatac works.
If the patient has used any products containing sulfur, salicylic acid, benzoyl peroxide or resorcinol, or caustic chemical substances, wait until the effects of these products have subsided before starting treatment with this medicine. Your doctor will advise when you may begin using Acnatac.
While using Acnatac, avoid using medicated soaps, skin-cleansing products or peeling solutions with strong drying effects. Exercise caution when using the following products, which may have a drying effect: abrasive soaps, soap and cosmetics, as well as products containing high concentrations of alcohol, astringents, spices or lemon juice.
Consult your doctor before using this medicine simultaneously with other medicinal products containing erythromycin or metronidazole, aminoglycosides, other antibiotics or corticosteroids, or when taking neuromuscular blocking agents (e.g. muscle relaxants used during general anaesthesia).
Warfarin or similar medicines used to reduce blood clotting: increased risk of bleeding may occur. Your doctor may recommend regular blood tests to monitor blood clotting.
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Pregnancy, breastfeeding and fertility
DO NOT use Acnatac during pregnancy or when planning pregnancy. Your doctor can provide further information.
This medicine should not be used by women who are breastfeeding. It is not known whether Acnatac passes into breast milk and could thereby harm the infant.
Driving and operating machinery
Acnatac is unlikely to affect the ability to drive or operate machinery.
Acnatac contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), butylated hydroxytoluene (E 321) and polysorbate 80
Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) may cause allergic reactions (possibly delayed-type).
Butylated hydroxytoluene (E 321) may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Polysorbate 80 may cause allergic reactions.

3. How to use Acnatac

This medicine should always be used exactly as recommended by your doctor. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Apply a pea-sized amount of Acnatac to the skin once daily before bedtime.
Instructions for use
Gently wash your face with mild soap and warm water, then pat the skin dry with a towel.
Squeeze a pea-sized amount of gel onto the fingertip, and apply the gel pointwise to the forehead, chin, nose, and cheeks. Gently and evenly spread the gel over the entire face.
Do not use more medicine than prescribed by your doctor or use it more often than recommended. Using more than the recommended amount may cause skin irritation and will not provide better results or make them appear faster.
Duration of treatment
For optimal treatment results, Acnatac should be used correctly and treatment should not be stopped immediately after acne lesions begin to improve. Usually, the optimal treatment effect becomes visible only after several days, and in some cases it may take up to 12 weeks. If symptoms persist beyond 12 weeks, consult your doctor, as a reassessment of the treatment may be necessary.
Use of more than the recommended dose of Acnatac
Using Acnatac in larger amounts than recommended will not produce better results or make them appear faster. Excessive use of the medicine may cause strong redness, skin peeling, or discomfort. In such cases, gently wash the face with mild soap and lukewarm water. Discontinue use of the medicine until all symptoms have resolved.
Overdose may lead to adverse effects involving the stomach and intestines, such as stomach pain, nausea, vomiting, and diarrhea. In such cases, stop using this medicine and consult your doctor.
Acnatac is intended for topical use only. In case of accidental ingestion, seek immediate medical attention from a doctor or the nearest hospital emergency department.
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Missed dose of Acnatac
If you miss applying Acnatac before bedtime, apply the next dose at the previously scheduled time. Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Not common: may affect up to 1 in 100 people

• Acne, dry skin, redness of the skin, increased sebum secretion, photosensitivity, itching, rash, scaly rash, skin peeling, sunburn
• Reactions at the site of application to the skin, such as burning, inflammation, dryness of the skin, redness of the skin.

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

• Hypersensitivity
• Hypothyroidism (symptoms include feeling tired, 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
• Dermatitis, herpes virus (cold sores), macular rash (presence of small, flat, red spots), skin bleeding, burning sensation of the skin, loss of skin pigment, skin irritation
• Symptoms at the site of application to the skin, such as irritation, swelling, superficial skin damage, change in skin color, itching, skin peeling
• Feeling of heat, pain.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store the medicine Acnatac

Keep the medicine out of sight and reach of children.
Do not store at temperatures above 25°C. Do not freeze.
Keep the tube tightly closed.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Shelf-life after first opening of the tube: 3 months.
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Medicines must 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 package and other information

What Acnatac contains

• The active substances in this medicine are clindamycin and tretinoin. 1 gram of gel contains 10 mg (1%) clindamycin (as clindamycin phosphate) and 0,25 mg (0,025%) tretinoin.
• Other ingredients are: purified water, glycerol, carbomers, methyl parahydroxybenzoate (E 218), polysorbate 80, disodium edetate, citric acid, propyl parahydroxybenzoate (E 216), butylhydroxytoluene (E 321), trometamol.

What Acnatac looks like and contents of the pack
The medicine is a pale yellow, semi-transparent gel.
It is available in an aluminium tube containing 30 g of gel.
For further information, contact the responsible party or the parallel importer.
Responsible party in Ireland, country of export:
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland
Manufacturer:
Meda Pharma GmbH & Co. KG, Benzstrasse 1, 61352 Bad Homburg, Germany
Madaus GmbH, 51101 Cologne, Germany
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Irish licence number (country of export): PA23355/034/001
Parallel import licence number: 307/25
This medicine is authorised for marketing in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria, Bulgaria, Cyprus, Czech Republic, Germany, Denmark, Greece, Finland, Iceland, Italy,
Poland, Portugal, Romania, Sweden, Slovakia: Acnatac
Malta: Treclin
Estonia, Spain, United Kingdom (Northern Ireland), Latvia, Lithuania, Netherlands: Treclinac
Belgium, Luxembourg: Treclinax
Norway, Slovenia: Zalna
France: Zanea
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