Normaclin

Package Leaflet: Information for the Patient

Normaclin

10 mg/g, gel

Clindamycin

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

• Keep this 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.

Table of Contents of the Leaflet

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

1. What is Normaclin and what is it used for

Normaclin is a gel for topical use on the skin, intended for the local treatment of common acne. It contains the active substance clindamycin phosphate, which, when applied to the skin, is converted into an antibiotic with antibacterial action - clindamycin. Clindamycin acts on Propionibacterium acnesbacteria, which are one of the causes of common acne. Allantoin, an excipient contained in the medicine, soothes irritations.

2. Important information before using Normaclin

When not to use Normaclin

• if you are allergic to clindamycin or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to lincosamide antibiotics (lincomycin);
• in children under 12 years of age.

Warnings and precautions

Before starting to use Normaclin, discuss it with your doctor:

• if you have had any of the following gastrointestinal diseases: enteritis, Crohn's disease, ulcerative colitis, antibiotic-associated colitis;
• if you have myasthenia gravis (a disease characterized by excessive muscle weakness).

While using Normaclin, follow these warnings:

• Avoid contact with the eyes, mucous membranes, and damaged skin. In case of contact with the medicine, rinse these areas with cold water.

Topically applied clindamycin phosphate may be absorbed through the skin into the body, so in very rare cases, during the use of Normaclin, a severe gastrointestinal disease, pseudomembranous colitis, may occur.

Children

Do not use the medicine in children under 12 years of age.

Normaclin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Tell your doctor if you are taking:

• muscle relaxants;
• lincomycin, erythromycin, and other macrolide antibiotics (medicines used to treat infections).

Do not use Normaclin at the same time as the above-mentioned medicines. When using another topical medicine, do not use it at the same time.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There is no data on the safety of using the medicine during pregnancy and breastfeeding. The medicine may be used during pregnancy only if, in the doctor's opinion, it is absolutely necessary. Do not breastfeed while using the medicine. Fertility: There is no data on the effect of clindamycin on fertility.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

Normaclin contains propylene glycol and methyl parahydroxybenzoate (E 218)

Propylene glycol: The medicine contains 100 mg of propylene glycol in each 1 gram of gel. Propylene glycol may cause skin irritation. Methyl parahydroxybenzoate (E 218): The medicine contains 1 mg of methyl parahydroxybenzoate in each 1 gram of gel. Methyl parahydroxybenzoate may cause allergic reactions (possible late-type reactions).

3. How to use Normaclin

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

Method of administration

Medicine intended for topical use on the skin.

Adults and adolescents over 12 years of age:

Apply the medicine pointwise or in a thin layer, or spray it on the affected skin, twice a day (do not rub). Wash your hands thoroughly after using the medicine. The duration of treatment is decided by the doctor. The optimal treatment result occurs after 8-12 weeks of use.

Children

Do not use the medicine in children under 12 years of age.

Instructions for using the polyethylene bottle with a spray pump

When using it for the first time, remove the cap, then direct the pump outlet in a safe direction and press the pump button several times until the first spray occurs. If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using more than the recommended dose of Normaclin

If you use more than the recommended amount of medicine, contact your doctor immediately. The medicine used topically may be absorbed in amounts that cause general side effects of clindamycin (see section 4. Possible side effects).

Missing a dose of Normaclin

Continue using the medicine, do not increase the next dose. Do not use a double dose to make up for a missed dose. If you have any further questions about using the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

• excessive dryness of the skin, burning, itching, redness, contact dermatitis, skin oiliness, folliculitis, allergic reactions (possible late-type reactions), skin irritation, skin irritation around the eyes;
• gastrointestinal disorders (e.g., loose stools, abdominal pain, bloating, indigestion).

Topically applied clindamycin phosphate may be absorbed through the skin into the body, so in very rare cases, during the use of Normaclin, severe pseudomembranous colitis may occur, with symptoms such as diarrhea, including persistent, severe diarrhea with mucus and blood, abdominal cramps, and colitis. The likelihood of such side effects occurring, in the case of using clindamycin-containing medicines on the skin, is low. If diarrhea occurs, stop using Normaclin immediately and consult your doctor to determine the cause and receive appropriate treatment.

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 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Normaclin

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label or carton. The expiry date refers to the last day of the month. Store below 25°C. 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 Normaclin contains

• The active substance is clindamycin in the form of clindamycin phosphate. 1 g of gel contains 10 mg of clindamycin in the form of clindamycin phosphate.
• The other ingredients are: carbomer, allantoin, propylene glycol, macrogol 400, methyl parahydroxybenzoate (E 218), sodium hydroxide, purified water.

What Normaclin looks like and contents of the pack

The medicine is a gel. The pack contains: tubes containing 15 g or 30 g of gel or a polyethylene HDPE bottle with a spray pump and cap (made of polypropylene, silicone, LDPE polyethylene, and stainless steel) containing 15 g or 30 g of gel, placed in a cardboard box.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151, 95-200 Pabianice, tel. (42) 22-53-100

Date of last revision of the leaflet