Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Acnatac, 10 mg/g + 0,25 mg/g, gel
clindamycin + tretinoin
Please read this leaflet carefully before using this medicine, as it contains important information for you.

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

Table of contents of the leaflet:

What Acnatac is and what it is used for
What you need to know before using Acnatac
How to use Acnatac
Possible side effects
How to store Acnatac
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 the growth of cells in the outer layer of the skin and promotes normal desquamation of cells blocking 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 topically for 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;
if the patient has acute acne characterized by inflammatory, red, dry, and scaly skin lesions; Page 1 of 5
if the patient has rosacea, a facial skin condition characterized by redness, scaling, and presence of pimples;
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 should be discontinued and
medical advice should be sought.
Warnings and precautions

Avoid contact of the medicine with the mouth, eyes, mucous membranes, as well as with damaged skin or skin affected by acne. Exercise caution when applying to sensitive areas of the skin. If the product accidentally gets into the eye, rinse thoroughly with plenty of lukewarm water.
If prolonged or significant diarrhoea or abdominal cramps occur, discontinue use of this medicine and seek immediate medical advice.
If the patient has atopic dermatitis (chronic itchy skin inflammation), consult a doctor before using the medicine.
Avoid exposure to natural or artificial light (e.g. sunlamps), as this medicine may increase susceptibility to sunburn and other adverse effects of sunlight. When outdoors, always use effective sunscreen 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 currently used or recently used, 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, some other
medicines may affect the action of Acnatac.
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 have subsided before starting
treatment with this medicine. Your doctor will inform you when you may begin using Acnatac.
While using Acnatac, do not use medicated soaps, skin-cleansing preparations, or peeling solutions
with strong drying effects. Exercise caution when using the following drying products: abrasive
soaps, soap and cosmetics, and 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,
as well as 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.
Pregnancy, breastfeeding and fertility
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DO NOT use Acnatac during pregnancy or when planning pregnancy. Your treating doctor can
provide further information.
This medicine should not be used by breastfeeding women. It is unknown 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 as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Recommended dose:
Apply a pea-sized amount of Acnatac to the skin once daily before bedtime.
Method of application
Gently wash the face with mild soap and warm water, then dry the skin with a towel.
Squeeze a pea-sized amount of gel onto the fingertip, then apply the gel pointwise to the forehead,
chin, nose, and cheeks, and gently spread it evenly over the entire facial skin.
Do not use more medicine than prescribed by your doctor or use it more often than recommended.
Using too much of the medicine may cause skin irritation and will not provide better results or make
them appear faster.
Duration of treatment
For optimal treatment results, use Acnatac correctly and do not stop treatment immediately after
noticing improvement in acne lesions. Usually, the optimal treatment effect may become 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's appropriateness may be necessary.
Use of more than the recommended dose of Acnatac
Using Acnatac in amounts greater than recommended will not produce better results or make them
appear faster. Applying too much of the medicine may lead to strong redness and skin peeling, or
cause 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 result in adverse effects involving gastrointestinal disturbances, such as stomach pain,
nausea, vomiting, and diarrhea. In such cases, discontinue use of this medicine and consult your doctor.
Acnatac is intended for topical use only. In case of accidental ingestion, seek immediate medical
attention at a doctor's office or the nearest hospital emergency department.
Missed dose of Acnatac
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If a dose of Acnatac is missed before bedtime, apply the next dose at the previously scheduled time.
Do not use a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.

Uncommon: 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, dry 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 sore), macular rash (presence of small, flat, red spotted lesions), 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 pigmentation, itching, skin peeling
Feeling of warmth, pain.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps to provide more information on the safety of the 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 packaging. The expiry date refers to the last day of the stated month.
Shelf life after first opening the tube: 3 months.
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.
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6. Contents of the packaging and other information

What Acnatac contains

The active substances in Acnatac are clindamycin and tretinoin. One 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), tromethamine.

What Acnatac looks like and contents of the pack
Acnatac is a yellow, semi-transparent gel.
The medicine is available in an aluminum tube containing 30 g of gel.
For further information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Greece, 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
Marketing Authorisation Number in Greece, country of export: 41202/17/13-08-2019
Parallel Import Authorisation Number: 314/24
This medicinal product is authorised for sale in 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
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