Acnatac

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Acnatac

10 mg/g + 0.25 mg/g, gel

clindamycin + tretinoin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Acnatac and what is it used for

Acnatac contains the active substances clindamycin and tretinoin.
Clindamycin is an antibiotic. It inhibits the growth of bacteria associated with acne and the inflammatory reaction caused by these bacteria.
Tretinoin normalizes the growth of cells in the outer layer of the skin and causes proper exfoliation of cells blocking the hair follicles in areas changed by acne. This prevents the accumulation of sebum and the formation of early acne lesions (closed and open comedones).
The aforementioned active substances work more effectively in combination than when used separately.
Acnatac is used on the skin to treat acne in patients aged 12 and older.

2. Important information before using Acnatac

When NOT to use Acnatac:

If any of the above situations apply to the patient, they should stop using the medicine and consult a doctor.

Warnings and precautions

• One should avoid contact of the medicine with the mouth, eyes, and mucous membranes, as well as with damaged or rash-affected skin. Caution should be exercised when applying to sensitive skin areas. If the product accidentally gets into the eye, it should be rinsed with a large amount of lukewarm water.
• In case of prolonged or significant diarrhea or abdominal cramps, one should stop using this medicine and immediately consult a doctor.
• If the patient has atopic dermatitis (chronic skin inflammation with itching), they should consult a doctor before using the medicine.
• One should avoid exposure to natural or artificial light (e.g., using sunlamps), as this medicine may cause increased susceptibility to sunburn and other adverse effects of solar radiation. When outdoors, one should always use effective sunscreens with a sun protection factor (SPF) of at least 30, as well as protective clothing (e.g., a hat). If sunburn occurs on the face despite this, one should stop using the medicine until the skin has healed.
• In case of an acute inflammatory skin reaction during the use of this medicine, one should consult a doctor.
• Acnatac should not be used at the same time as other topical preparations, including cosmetics (see also the section "Acnatac and other medicines").

Acnatac and other medicines

One should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes over-the-counter medicines and herbal preparations. Acnatac may affect the way some other medicines work. Also, some other medicines may affect the way Acnatac works.
If the patient has used any preparations containing sulfur, salicylic acid, benzoyl peroxide, or resorcinol, or caustic chemicals, they should wait until the effects of these substances have subsided before starting to use Acnatac. The doctor will inform the patient when they can start using Acnatac.
While using Acnatac, one should not use medicinal soaps, skin cleansers, or peeling solutions with a strong drying effect. Caution should be exercised 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 and astringents, spices, or lemon juice.
One should consult their doctor before using this medicine at the same time as other medicinal products containing erythromycin or metronidazole, aminoglycosides, other antibiotics, or corticosteroids, as well as when taking medicines that block nerve-muscle conduction (e.g., muscle relaxants used during general anesthesia).
Warfarin or similar medicines used to reduce blood clotting: it is possible that the risk of bleeding may increase. The doctor may recommend regular blood tests to check blood clotting.

Pregnancy, breastfeeding, and fertility

Acnatac should NOT be used during pregnancy or when planning to become pregnant. The attending physician may provide more information.
Women who are breastfeeding should NOT use this medicine. It is not known whether Acnatac can pass into breast milk and harm the baby.

Driving and using machines

Acnatac is unlikely to affect the ability to drive or use machines.

Acnatac contains methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), and butylhydroxytoluene (E 321).

Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) may cause allergic reactions (probably delayed-type).
Butylhydroxytoluene (E 321) may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use Acnatac

This medicine should always be used as directed by the doctor. In case of doubts, one should consult a doctor or pharmacist.

Recommended dose:

A pea-sized amount of Acnatac should be applied to the skin once a day before bedtime.

Method of administration

The face should be gently washed with a mild soap and warm water, then dried with a towel.
A pea-sized amount of gel should be squeezed onto the fingertip, applied pointwise to the forehead, chin, nose, and cheeks, and gently and evenly spread over the entire face.
The medicine should not be used in larger quantities than directed by the doctor or more frequently than prescribed. Using too much medicine may cause skin irritation, and will not ensure better results or make them appear sooner.

Duration of treatment

To achieve the best results, Acnatac should be used correctly and treatment should not be stopped immediately after noticing an improvement in acne lesions. The optimal treatment effect may only become visible after several days, and in some cases, it may take up to 12 weeks. If symptoms persist for more than 12 weeks, one should consult a doctor, as it may be necessary to reassess the treatment.

Using more than the recommended dose of Acnatac

Using Acnatac in larger quantities than recommended will not produce better effects or make them appear sooner. Using too much medicine may cause severe redness and flaking of the skin or discomfort. In such cases, the face should be gently washed with a mild soap and lukewarm water. The medicine should be stopped until all symptoms have subsided.
Overdose may cause side effects such as gastrointestinal disorders; including stomach pain, nausea, vomiting, and diarrhea. In such cases, one should stop using the medicine and consult a doctor.
Acnatac is intended for use on the skin only. In case of accidental ingestion, one should immediately consult a doctor or the nearest hospital emergency department.

Missing a dose of Acnatac

If a dose of Acnatac is missed before bedtime, the next dose should be applied at the previously established time. A double dose should not be used to make up for a missed dose.
In case of any further doubts about using this medicine, one should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Acnatac 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, hypersensitivity to light, itching, rash, flaky rash, skin flaking, sunburn
• reactions at the site of application to the skin, such as burning, inflammation, dry skin, skin redness.

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

• hypersensitivity
• hypothyroidism (symptoms 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 virus (cold sore), maculopapular rash (presence of small, flat, red, patchy lesions), skin bleeding, burning sensation of the skin, skin discoloration, skin irritation
• reactions at the site of application to the skin, such as irritation, swelling, superficial skin damage, skin discoloration, itching, skin flaking
• feeling of heat, pain.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Acnatac

The medicine should be stored out of sight and reach of children.
Do not store above 25°C. Do not freeze.
Store 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 specified month.
Shelf life after first opening the tube: 3 months.
Medicines should not be disposed of via wastewater or household waste. One should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Acnatac contains

• The active substances of Acnatac are clindamycin and tretinoin. 1 gram 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, carbomers, methyl parahydroxybenzoate (E 218), polysorbate 80, disodium edetate, citric acid, propyl parahydroxybenzoate (E 216), butylhydroxytoluene (E 321), tromethamine.

What Acnatac looks like and what the packaging contains

Acnatac is a semi-transparent yellow gel.
Acnatac is available in an aluminum tube containing 30 g of gel.
For more detailed information, one should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the 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:

InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, the country of export:41202/17/13-08-2019

Parallel import authorization number: 311/23

This medicinal product is authorized in the Member States of the European Economic Area and in 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

Date of leaflet approval: 29.12.2023

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