Klindacin t

Package leaflet: Information for the patient

KLINDACIN T, 10 mg/g, gel
Clindamycinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• 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. The medicine may harm someone else, even if their symptoms are similar.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Klindacin T is and what it is used for

Klindacin T contains as the active substance the antibiotic clindamycin. The medicine is in the form of a gel.
It is applied to the skin in the treatment of acne vulgaris.

2. Important information before using Klindacin T

When not to use Klindacin T
Do not use this medicine if the patient is allergic to clindamycin, lincomycin, or any of the other ingredients
of this medicine (listed in section 6).

Warnings and precautions

• This medicine is intended for topical use only.
• Avoid contact with eyes, mucous membranes, and broken skin. In case of accidental contact, wash thoroughly with plenty of cool water.
• If signs of skin irritation or allergic reaction to Klindacin T occur (such as itching, rash), discontinue use and consult a doctor.

Inform your doctor:

• if persistent, severe diarrhoea develops during or after treatment, which may be a symptom of pseudomembranous colitis. Discontinuation of the medicine may be necessary. Your doctor will determine the cause and recommend appropriate treatment.
• if the patient has had or currently has intestinal inflammation, Crohn's disease, or antibiotic-associated colitis.

Klindacin T and other medicines
Tell your doctor about all medicines currently used, recently used, or planned for use.
Do not apply two topical medicines simultaneously. Concurrent topical use of other medicines may lead to cumulative irritant effects.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Avoid using Klindacin T during pregnancy unless the doctor considers it necessary.
Klindacin T should not be used in breastfeeding women.

Driving and operating machinery
There is no data available on the influence of this medicine on the ability to drive or operate machinery.

Klindacin T contains propylene glycol
The medicine contains 50 mg of propylene glycol per gram of gel.
Propylene glycol may cause skin irritation.
Do not use this medicine in infants under 4 weeks of age on open wounds or large areas of injured or damaged skin (e.g. burned skin) without consulting a doctor or pharmacist.

3. How to use Klindacin T

This medicine should always be used exactly as recommended by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
This medicine is intended for topical application to the skin.
Recommended dose
Adults and children over 12 years of age
Apply Klindacin T as a thin layer to the affected skin area twice daily – in the morning and
evening.
The average treatment duration is approximately 4 to 8 weeks.
After each application of the gel, hands should be washed thoroughly.
Children under 12 years of age
The safety of using Klindacin T gel in children has not been established.
Use of a higher than recommended dose of Klindacin T
Overdosing may lead to systemic adverse effects of clindamycin (see section 2. Before using Klindacin T).
If a higher than recommended dose has been used, seek medical advice immediately.
Missed dose of Klindacin T
If a dose is missed at the usual scheduled time, apply the medicine as soon as possible, provided that
there is sufficient time before the next scheduled dose. Otherwise, skip the missed dose and apply the
next dose at the regular time. Continue regular use as directed.
Do not use a double dose to make up for a missed dose.
Stopping treatment with Klindacin T
It is important to use the medicine according to the recommended treatment cycle. Do not stop
treatment just because the patient feels better. If treatment is stopped too early, the infection may return.
If the patient feels worse during treatment or does not feel better after completing the recommended
treatment cycle, they should consult the doctor overseeing the treatment.

4. Possible adverse effects

Like all medicines, Klindacin T can cause adverse effects, although they do not occur in everyone.
Adverse effects following the use of Klindacin T gel are rare. They are usually reactions related to skin irritation such as:

• folliculitis;
• burning, itching, redness, excessive drying or greasiness of the skin, allergic contact dermatitis;
• abdominal pain, bloating, diarrhoea.

If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a physician.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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
Tel.: + 48 22 49 21 301; fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Klindacin T
Keep the medicine out of sight and reach of children.
Store below 25 °C. Keep the tube tightly closed to protect from light and moisture.
Do not use the medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Klindacin T contains
The active substance is clindamycin.
1 g of gel contains 10 mg clindamycin as clindamycin phosphate.
Other ingredients are: propylene glycol, isopropyl alcohol, purified water, hydroxypropyl cellulose, sodium hydroxide.

What Klindacin T looks like and contents of the pack
Colourless, transparent gel.
Pack: tube with 30 g.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Phone number: 22 811-18-14

For further information, please contact the Marketing Authorisation Holder's representative.