Acnatac

Package Leaflet: Information for the User

Acnatac, (10 mg + 0.25 mg)/g, Gel

clindamycin + tretinoin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package 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 pack 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 the proper shedding of cells that block the hair follicles in areas affected by acne. This prevents the accumulation of sebum and the formation of early acne lesions (closed and open comedones).
The active substances work more effectively in combination than when used separately.
Acnatac is used on the skin to treat acne in patients aged 12 years 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

• Avoid contact of the medicine with the mouth, eyes, and mucous membranes, as well as with damaged or eczematous skin. Be cautious when applying to sensitive skin areas. If the product accidentally gets into the eye, rinse it with a large amount of lukewarm water.
• In case of prolonged or significant diarrhea or abdominal cramps, stop using the medicine and consult a doctor immediately.
• If the patient has atopic eczema (chronic skin inflammation with itching), consult a doctor before using the medicine.
• Avoid exposure to natural or artificial light (e.g., using sunlamps), as this medicine may increase the risk of sunburn and other adverse effects of solar radiation. When outdoors, 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, stop using the medicine until the skin has healed.
• In case of an acute inflammatory skin reaction during the use of this medicine, 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

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those available without a prescription and herbal preparations. Acnatac may affect the way some other medicines work. Some other medicines may also affect the way Acnatac works.
If you have used any preparations containing sulfur, salicylic acid, benzoyl peroxide, or resorcinol, or caustic chemicals, wait until the effects of these substances have subsided before starting Acnatac. Your doctor will tell you when you can start using Acnatac.
Do not use medicinal soaps, skin cleansers, or astringent solutions during Acnatac treatment. Be cautious 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.
Consult your doctor before using this medicine with other medicinal products containing erythromycin or metronidazole, aminoglycosides, other antibiotics, or corticosteroids, as well as when taking muscle relaxants (e.g., muscle relaxants used during general anesthesia).
Warfarin or similar medicines used to reduce blood clotting: the risk of bleeding may be increased. Your doctor may recommend regular blood tests to check blood clotting.

Pregnancy, breastfeeding, and fertility

Do not use Acnatac during pregnancy or when planning to become pregnant. Your doctor 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 your ability to drive or use machines.

Acnatac contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, butylhydroxytoluene, and polysorbate 80.

Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) may cause allergic reactions (possibly delayed).
Butylhydroxytoluene (E 321) may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.
Polysorbate 80 (E 433) may cause allergic reactions.

3. How to use Acnatac

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended dose:

Apply a pea-sized amount of Acnatac to the skin once daily before bedtime.

Method of administration

Gently wash your face with a mild soap and lukewarm water, then dry the skin with a towel.
Place a pea-sized amount of gel on the tip of your finger, apply the gel to the forehead, chin, nose, and cheeks, and gently spread it evenly over the entire face.
Do not use more medicine than your doctor has prescribed or use it more often than recommended. Using too much medicine may cause skin irritation and will not provide better results or make them appear faster.

Duration of treatment

To achieve the best results, use Acnatac correctly and do not stop treatment as soon as you notice an improvement in acne lesions. The optimal effect of treatment may only become apparent after a few days, and in some cases, it may take up to 12 weeks. If symptoms persist for more than 12 weeks, consult your doctor, as it may be necessary to reassess the treatment.

Using more than the recommended dose of Acnatac

Using more Acnatac than recommended will not produce better results or make them appear faster. Using too much medicine may cause severe redness and flaking of the skin or discomfort. In such cases, gently wash your face with a mild soap and lukewarm water. Stop using the medicine until all symptoms have subsided.
Overdose may cause side effects such as gastrointestinal disorders, including stomach pain, nausea, vomiting, and diarrhea. In such cases, stop using the medicine and consult a doctor.
Acnatac is for use on the skin only. If accidentally swallowed, seek medical attention immediately.

Missing a dose of Acnatac

If you miss a dose of Acnatac before bedtime, apply the next dose at the usual time. Do not use a double dose to make up for the missed dose.
If you have any further questions about using this medicine, ask your 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, redness of the skin, increased sebum production, sensitivity to light, itching, rash, flaky rash, flaking of the skin, sunburn
• reactions at the site of application, 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 fatigue, weakness, weight gain, dry hair, rough and pale skin, hair loss, increased sensitivity to cold)
• headache
• eye irritation
• gastrointestinal inflammation (inflammation of any part of the digestive tract), nausea
• skin inflammation, herpes virus (cold sore), patchy 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, such as irritation, swelling, superficial skin damage, skin discoloration, itching, flaking of the skin
• feeling of heat, pain.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Acnatac

Keep the 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 tube after "EXP".
The expiry date refers to the last day of the month.
Shelf life after first opening the tube: 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 other information

What Acnatac contains

• The active substances are clindamycin and tretinoin. 1 gram of gel contains 10 mg (1%) clindamycin (as clindamycin phosphate) and 0.25 mg (0.025%) tretinoin.
• The other ingredients are: purified water, glycerol, carbomers, methyl parahydroxybenzoate (E 218), polysorbate 80 (E 433), disodium edetate, anhydrous citric acid, propyl parahydroxybenzoate (E 216), butylhydroxytoluene (E 321), trometamol.

What Acnatac looks like and contents of the pack

Acnatac is a semi-transparent yellow gel.
Acnatac is available in aluminum tubes containing 30 g or 60 g of gel.
Not all pack sizes may be marketed.

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
Madaus GmbH
51101 Köln
Germany

For further information, please contact the marketing authorization holder:

Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00

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 last revision of the leaflet: 10/2024