Clindalin

Package Leaflet: Information for the Patient

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

1. What is Clindalin and what is it used for

Clindalin is a medicinal product in the form of a gel for topical use on the skin. The active substance is clindamycin phosphate, which is converted into clindamycin, an antibiotic with antibacterial action, after application to the skin. Clindamycin acts on Propionibacterium acnesbacteria, one of the causes of common acne.

Indications:

Local treatment of common acne.

2. Important information before using Clindalin

When not to use Clindalin

• If you are allergic to clindamycin, lincomycin (people allergic to one of these substances may also be allergic to the other, so-called cross-reaction) or any of the other ingredients of this medicine (listed in section 6).
• If you have had colitis during antibiotic therapy.

Warnings and precautions

Before starting to use Clindalin, discuss it with your doctor or pharmacist: if you have had or currently have colitis associated with antibiotic therapy, enteritis, Crohn's disease, or ulcerative colitis. The medicine is intended for use on the skin only. Avoid contact with the eyes, mucous membranes, and damaged skin. In case of accidental contact with the medicine, rinse the area with cold water. Clindalin should be used with caution in patients with a tendency to allergies. Tell your doctor immediately: if you experience diarrhea, especially severe and persistent, or abdominal pain during or within a few weeks after treatment, as these may be symptoms of pseudomembranous colitis (mostly caused by Clostridium difficile). This disease, a complication of antibiotic therapy, can be life-threatening. As soon as pseudomembranous colitis is diagnosed, the doctor should recommend discontinuing Clindalin and starting appropriate treatment. Do not take anti-peristaltic or constipating medications. Prolonged use of Clindalin should be done under close medical supervision.

Children

The safety and efficacy of Clindalin in children under 12 years of age have not been established.

Clindalin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. Clindamycin inhibits neuromuscular transmission, so the medicine should be used with caution in patients taking muscle relaxants. An antagonistic effect has been observed between clindamycin and erythromycin. Cross-resistance (resistance to drugs from the same group) has been demonstrated between clindamycin and lincomycin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice. Pregnancy There are no data on the safety of Clindalin in pregnant women. The medicine should only be used during pregnancy if, in the doctor's opinion, it is absolutely necessary. Breastfeeding Do not use the medicine during breastfeeding. Fertility Studies on fertility in rats given oral clindamycin did not show any effect on fertility or reproductive ability.

Driving and using machines

No studies have been conducted on the effect of Clindalin on the ability to drive or operate machinery.

Clindalin contains:

• 49 mg of propylene glycol (E 1520) per gram of gel, so the medicine may cause skin irritation;
• methyl parahydroxybenzoate (E 218), so the medicine may cause allergic reactions (possible late reactions).

3. How to use Clindalin

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Clindalin is intended for topical use on the skin.

Use in adults and adolescents

Apply a thin layer to the affected areas of the skin twice a day. Do not rub the gel into the skin. The gel should be applied to clean skin. Wash your hands after using the medicine.

Using more than the recommended dose of Clindalin

The medicine used topically may be absorbed in amounts that cause general side effects of clindamycin (see sections 2 and 4).

Missing a dose of Clindalin

Do not use a double dose to make up for a missed dose. If you miss a dose, use the medicine as soon as possible, unless it is almost time for the next dose.

Stopping use of Clindalin

If you have any further questions about using this medicine, ask your doctor or pharmacist. Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, Clindalin can cause side effects, although not everybody gets them. After using Clindalin, the following side effects may occur: Very common (affecting more than 1 in 10 people):

• skin irritation, skin oiliness, excessive skin dryness.

Common (affecting more than 1 in 100 people, but less than 1 in 10):

• urticaria.

Uncommon (affecting more than 1 in 1,000 people, but less than 1 in 100):

• gastrointestinal disorders.

Frequency not known (cannot be estimated from the available data):

• bacterial folliculitis;
• eye pain;
• abdominal pain, pseudomembranous colitis;
• contact dermatitis.

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 Post-Marketing Surveillance 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 Clindalin

Keep the medicine out of the sight and reach of children. Store below 25°C. Do not freeze. Shelf life after first opening the tube: 3 months. Do not use this medicine after the expiry date stated on the packaging after: "EXP". The expiry date refers to the last day of the month stated. 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 Clindalin contains

• The active substance is clindamycin in the form of clindamycin phosphate. 1 g of gel contains 10 mg of clindamycin.
• The other ingredients are: allantoin, methyl parahydroxybenzoate (E 218), propylene glycol (E 1520), macrogol 400, carbomer 974, sodium hydroxide (to adjust pH), purified water.

What Clindalin looks like and contents of the pack

Clindalin is a colorless, transparent gel with a uniform consistency. Packaging: aluminum tube with a membrane, internally coated with epoxy-phenolic lacquer, with a polyethylene (HDPE) screw cap with a piercer, placed together with the leaflet in a cardboard box. Pack size: 15 g or 30 g. Not all pack sizes may be marketed.

Marketing authorization holder

ZIAJA Ltd Pharmaceutical Works sp. z o.o., ul. Jesienna 9, 80-298 Gdańsk, Tel.: +48 58 521 34 00

Manufacturer

ZIAJA Ltd Pharmaceutical Works sp. z o.o., ul. Przemysłowa 12, 83-050 Kolbudy, Date of last revision of the leaflet:06/2025