Acnatac

Package leaflet: Information for the user

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

• Keep this leaflet for future reference.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm others, even if their symptoms are the same.
• If any adverse reactions occur, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Acnatac is and what it is used for
2. What you need to 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 the growth of cells in the outer layer of the skin and promotes proper desquamation of cells blocking the hair follicle openings in acne-affected areas. This prevents the accumulation of sebaceous material 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 a topical medicine used 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 plans to become pregnant;
• 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 colitis after antibiotic treatment, characterised by prolonged or significant diarrhoea or cramping abdominal pain;
• if the patient or a family member has ever been diagnosed with skin cancer;
• if the patient has acute acne characterised by inflammatory, red, dry and scaly skin lesions;
• if the patient has rosacea, a skin condition of the face characterised by redness, skin 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 characterised by the presence of 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
the patient should consult a doctor.
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 medicine accidentally gets into the eye, rinse thoroughly with plenty of lukewarm water.
• If prolonged or significant diarrhoea or cramping abdominal pain occurs, discontinue use of this medicine and consult a doctor immediately.
• If the patient has atopic dermatitis (chronic inflammatory skin condition with itching), consult a doctor before using the medicine.
• Avoid exposure to natural or artificial light (e.g. sunbeds), as this medicine may increase susceptibility to sunburn and other adverse effects of solar radiation. When outdoors, always use effective sunscreen products with a sun protection factor (SPF) of at least 30, as well as 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 at the same time as other topical preparations, 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, recently used, or planned to be used, including those available without a prescription and herbal preparations. Acnatac may affect the action of certain other medicines, and some other medicines may affect the action of Acnatac.
If the patient has used any preparations 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.
During treatment with Acnatac, avoid using medicated soaps, skin-cleansing preparations, 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: there may be an increased risk of bleeding. Your doctor may recommend regular blood tests to monitor blood clotting.

Pregnancy, breastfeeding and fertility
DO NOT use Acnatac during pregnancy or when planning to become pregnant. Your 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, propyl parahydroxybenzoate,
butylated hydroxytoluene 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 (E 433) may cause allergic reactions.

3. How to use Acnatac

This medicine should always be used as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

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

Instructions for use:
Wash your face gently with mild soap and warm water, then pat the skin dry with a towel.
Squeeze a pea-sized amount of gel onto the fingertip. Apply the gel spot-wise to the forehead, chin, nose, and cheeks, and gently spread it evenly over the entire face.

Do not use more medicine than prescribed by your doctor or apply 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 more quickly.

Duration of treatment:
For optimal treatment results, use Acnatac correctly and do not stop treatment immediately after acne lesions begin to improve. The full effect of treatment may take several days to become noticeable, and in some cases 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 more Acnatac than recommended will not improve or speed up results. Applying too much may cause intense redness, skin peeling, or discomfort. In such cases, gently wash the face with mild soap and lukewarm water and discontinue use until all symptoms have resolved.

Overdose may lead to adverse effects such as gastrointestinal disturbances, including stomach pain, nausea, vomiting, and diarrhoea. In such cases, stop using this medicine and consult your doctor.

Acnatac is for external use on the skin only. In case of accidental ingestion, seek immediate medical attention from a doctor or the nearest hospital emergency department.

Missed dose:
If you forget to apply Acnatac before bedtime, apply the next dose at the usual scheduled 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, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone 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
• skin inflammation, herpes virus (cold sore), 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 symptoms occur, including any adverse effects not listed
in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: + 48 22 49 21 301,
fax: + 48 22 49 21 309, 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 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.
Period of use 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Acnatac contains

• The active substances in this medicinal product 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: 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
The medicinal product is a yellow, semi-transparent gel.
It is available in an aluminium tube containing 30 g of gel.
For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Portugal, the country of export:
Viatris Healthcare, Lda.
Av. D. João II, Edifício Atlantis, nº 44C - 7.3 and 7.4
1990-095 Lisbon, Portugal

Manufacturers:
Meda Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg, Germany
Madaus GmbH
Lütticher Straße 5
53842 Troisdorf, Germany

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing authorisation number in Portugal, the country of export: 5585823
Parallel import authorisation number: 246/25

This medicinal product is authorised for sale 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