Meda

Gel 10 mg / g + 0.25 mg / g 
(Semi-transparent yellow gel)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Acnatac is and what it is used for 
2. What you need to know before you use 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 Acnatac is and what it is used for

Acnatac contains the active substances clindamycin and tretinoin.

Clindamycin is an antibiotic. It reduces bacterial growth in acne and inflammation caused by these bacteria.

Tretinoin normalizes the growth of superficial skin cells and causes normal rejection of the cells that clog the hair follicle in areas with acne. It prevents the buildup of sebum and the development of early forms of acne (blackheads).

These active substances are more effective when combined than when used separately.

Acnatac is used on the skin to treat acne in patients 12 years of age and older.

2. What you need to know before you use Acnatac

Do not use Acnatac:

  • if you are pregnant
  • if you are planning to become pregnant
  • if you are allergic to clindamycin, tretinoin, or any of the other ingredients of this medicine (listed in section 6).
  • if you are allergic to lincomycin.
  • if you have a chronic inflammatory bowel disease (eg Crohn’s disease or ulcerative colitis ).
  • if you have previously had colitis in connection with antibiotic treatment which is characterized by prolonged, severe diarrhea or stomach cramps.
  • if you or a family member have ever had skin cancer.
  • if you suffer from acute eczema characterized by inflamed, red, dry, and scaly skin.
  • if you suffer from rosacea, a skin disease that affects the face and is characterized by redness, pimples, and skin peeling.
  • if you suffer from other acute inflammatory skin conditions (eg hair follicle inflammation), especially around the mouth (perioral dermatitis ).
  • if you suffer from certain special forms of acne vulgaris that are characterized by blisters and deep, nodulocystic acne (acne conglobata and acne fulminans).

Do not use this medicine without consulting your doctor, if any of the above apply to you.

Warnings and cautions

  • Avoid getting the medicine in the mouth, eyes, mucous membranes, and on the skin that is damaged or has eczema. Be careful when applying gel to sensitive skin areas. If you accidentally get the gel in your eyes, rinse with plenty of lukewarm water.
  • If you are a woman of childbearing potential, do not use Acnatac unless you are taking contraceptives at the same time (see also section “Pregnancy, breast-feeding and fertility”).
  • If you get long-term or severe diarrhea or stomach cramps, stop using the medicine and talk to your doctor immediately.
  • If you have atopic eczema ( chronic, itchy inflammation of the skin), talk to your doctor before using this medicine.
  • Exposure to the sun or artificial light (such as sunlight) should be avoided. This is because the drug can make your skin more susceptible to sun damage and other adverse effects of the sun. An effective sunscreen with a sun protection factor (SPF) of at least 30 and protective clothing (such as a sun hat) should always be used when you are outdoors. 
    If your facial skin still burns, stop using the medicine until the skin has healed.
  • Talk to your doctor if you get acute dermatitis when using this medicine.
  • Acnatac should not be applied concomitantly with other preparations used on the skin. This also applies to cosmetics (see also the section “Other medicines and Acnatac”).

Other medicines and Acnatac

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. The reason is that Acnatac may affect the effectiveness of other medicines. Other medicines may also affect the way Acnatac works

If you have used any skin preparation that contains sulfur, salicylic acid, benzoyl peroxide, or resorcinol, or other chemical abrasives, then you must wait until the effect of these has subsided before you start using Acnatac. Your doctor may tell you when you can start treatment with Acnatac.

Do not use medicinal soap/cleanser or scrubbing solutions with a strong dehydrating effect during ongoing treatment with Acnatac. You should be careful when using the following which may have a dehydrating effect; soaps with abrasives, soaps and cosmetics and products with a high concentration of alcohol, skin tightening agents, spices, or lime.

Talk to your doctor before using this medicine with other medicines that contain:

  • erythromycin
  • metronidazole
  • aminoglycoside is
  • other antibiotics
  • corticosteroid is
  • neuromuscular blocking drugs e.g. muscle relaxants used in anesthesia.

Warfarin or similar blood thinners. You may have an easier time getting a hemorrhage. Your doctor may need to take regular blood tests to check how well your blood is coagulating.

Pregnancy, breastfeeding, and fertility

DO NOT use Acnatac if you are pregnant or planning to become pregnant. Your doctor can give you more information.

You should not use this medicine if you are breast-feeding. It is not known if Acnatac passes into breast milk and harms the baby.

If you are a woman of childbearing potential, you should use contraception while you are being treated with this medicine and for another month after stopping treatment.

Driving and using machines

Acnatac is unlikely to have any effect on the ability to drive or use machines.

Acnatac contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and butylhydroxytoluene

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause an allergic reaction (possibly delayed).

Butylhydroxytoluene (E321) may cause local skin reactions (eg contact dermatitis) or be irritating to eyes and mucous membranes.

3. How to use Acnatac

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

An amount of Acnatac as large as a pea should be applied once a day at bedtime.

Method of administration

Wash your face gently with mild soap and warm water and wipe your face dry with a towel. Press a lot of gel, as big as a pea, on your fingertip. Gently dab one gel on your forehead, chin, nose, and both cheeks, and then gently smear it all over your face.

Do not use more medicines than your doctor advised. Also, do not treat more often than your doctor has instructed you to. Too much gel can irritate the skin and does not give a faster or better result.

Treatment time

To get the best results with Acnatac, it is necessary to use it properly and not stop using it as soon as your acne starts to get better. It can usually take several weeks for the optimal effect to be achieved. In some cases, it can take up to 12 weeks. Contact your doctor if the symptoms persist for more than 12 weeks, as it may be necessary for your doctor to re-evaluate your treatment.

If you use more Acnatac than you should

You will not get a faster or better result if you use more Acnatac than recommended. If you use too much, redness, scaling or discomfort may occur. If this happens, wash your face gently with mild soap and lukewarm water. Discontinue use of the drug until all these symptoms have disappeared.

Overdose can also result in side effects from your stomach and intestines; such as stomach pain, nausea, vomiting, and diarrhea. If this happens, stop using the medicine and contact your doctor.

If you forget to use Acnatac

If you forget to use Acnatac at bedtime, skip the next dose at the usual time. You should not double the dose to compensate for the missed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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, photosensitivity reaction, itching, rash, scaly rash, sunburn.
  • The reaction at the application site such as burning sensation, inflamed skin, dryness, reddening of the skin.

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

  • Hypersensitivity
  • Hypothyroidism (symptoms such as fatigue, weakness, weight gain, dry hair, coarse pale skin, hair loss, increased sensitivity to cold).
  • Headache
  • Eye irritation
  • Gastroenteritis ( inflammation of any part of the gastrointestinal tract), nausea.
  • Inflamed skin, herpes simplex (cold sores), spotty rash (small, flat red spots), bleeding in the skin, burning sensation in the skin, pigment loss in the skin, skin irritation.
  • The reaction at the application site such as irritation, swelling, superficial skin damage, discoloration, itching, flaking.
  • Feeling of heat, pain.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Acnatac

Keep this medicine out of the sight and reach of children.

Do not store above 25 ° C. Do not freeze.

Close the tube tightly.

Do not use this medicine after the expiry date which is stated on the carton and tube after “EXP”. The expiration date is the last day of the specified month.

Shelf life after first opening: 3 months

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are clindamycin and tretinoin. 1 g 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, carbomer, methyl parahydroxybenzoate (E218), polysorbate 80, disodium edetate, anhydrous citric acid, propyl parahydroxybenzoate (E216), butylhydroxytoluene (E321), trometamol.

What the medicine looks like and the contents of the pack

This medicine is a clear, yellow gel.

Medicines are available in aluminum tubes containing 30 g of gel and 60 g of gel, respectively.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Meda AB

Box 906

SE-170 09 Solna

Manufacturer

Meda Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Germany

Madaus GmbH

Lütticher Straße 5

53842 Troisdorf

Germany

This medicinal product is authorized under the European Economic Area under the names:

Cyprus, Greece: Acnatac, 10 mg / g + 0.25 mg / g γελη

Hungary: Annex

Bulgaria, Denmark, Finland, Iceland, Italy, Poland, Portugal, Romania, Slovakia, Sweden, Czech Republic, Germany, Austria: Acnatac

Ireland, Malta, UK: Treclin

Estonia, Latvia, Lithuania, Netherlands, Spain: Treclinac

Belgium, Luxembourg: Treclinax

Norway, Slovenia: Zalna

France: Zane

Muhammad Nadeem

Leave a Reply