Klindacin T

Package Leaflet: Information for the Patient

KLINDACIN T, 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 Klindacin T and what is it 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 is Klindacin T and what is it used for

Klindacin T contains the active substance clindamycin, an antibiotic. The medicine is in the form of a gel.
It is used on the skin to treat common acne.

2. Important information before using Klindacin T

When not to use Klindacin T

If you are allergic to clindamycin, lincomycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• The medicine is for use on the skin only.
• Avoid contact with the eyes, mucous membranes, and damaged skin. If the medicine comes into contact with these areas, rinse them thoroughly with a large amount of cool water.
• If skin irritation or signs of allergy to Klindacin T occur (itching, rash), stop using the medicine and consult a doctor.

Tell your doctor:

• if you experience persistent, severe diarrhea during or after treatment with the medicine. It may be necessary to stop the medicine. Your doctor will determine the cause and recommend appropriate treatment.
• if you have had or currently have intestinal inflammation, Crohn's disease, or colitis after antibiotic therapy.

Klindacin T and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Do not use two topical medicines at the same time. Using other topical medicines at the same time may cause cumulative irritation.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Avoid using Klindacin T during pregnancy, unless your doctor considers it necessary.
Klindacin T should not be used in breastfeeding women.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.

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 children under 4 weeks of age on open wounds or large areas of damaged or broken skin (e.g., burned skin) without consulting a doctor or pharmacist.

3. How to use Klindacin T

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The medicine is for use on the skin only.
Recommended dose

Adults and children over 12 years

Apply Klindacin T thinly to the affected skin area twice a day, in the morning and evening.
The average treatment period is about 4 to 8 weeks.
Wash your hands thoroughly after each application of the gel.

Children under 12 years

The safety of using Klindacin T gel in children has not been established.

Using more Klindacin T than recommended

Overdose of the medicine may cause general side effects of clindamycin (see section 2. Before using Klindacin T).
If you use more Klindacin T than recommended, seek medical attention immediately.

Missing a dose of Klindacin T

If you miss a dose of the medicine at the usual time, apply it as soon as possible, unless the time to the next application is too short, or skip the missed dose and apply the next dose at the usual time and continue using the medicine as usual.
Do not use a double dose to make up for a missed dose.

Stopping Klindacin T treatment

It is important to use the medicine as recommended for the entire treatment cycle. Do not stop treatment because you feel better. If the treatment cycle is stopped too early, the infection may return.
If you feel worse during treatment or do not feel well after completing the recommended treatment cycle, consult your doctor.

4. Possible side effects

Like all medicines, Klindacin T can cause side effects, although not everybody gets them.
Side effects of Klindacin T gel are rare. They are usually skin irritation reactions such as:

• folliculitis;
• burning, itching, redness, excessive drying or oiliness of the skin, contact allergic dermatitis.
• Abdominal pain, bloating, diarrhea.

If you experience any side effects, including any not listed in this leaflet, please tell your doctor.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Klindacin T

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 month.
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 Klindacin T contains

The active substance is clindamycin.
1 g of gel contains 10 mg of clindamycin in the form of clindamycin phosphate.
The other ingredients are: propylene glycol, isopropyl alcohol, purified water, hydroxypropyl cellulose, sodium hydroxide.

What Klindacin T looks like and contents of the pack

Colorless, transparent gel.
Packaging:tube of 30 g.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14

Date of last revision of the leaflet: