Dalacin T

Package Leaflet: Information for the Patient

DALACIN T, 10 mg/g (1%), 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

Dalacin T gel contains the active substance clindamycin in the form of clindamycin phosphate.
After application to the skin, clindamycin phosphate is converted into clindamycin, an antibiotic
with antibacterial action. Clindamycin acts on bacteria Propionibacterium acnes, which are
one of the causes of common acne.

Indications:

Local treatment of common acne.

2. Important information before using Dalacin T

When not to use Dalacin T:

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

Warnings and precautions

This medicine is for use on the skin only.
Avoid contact with the eyes, mucous membranes, and damaged skin. In case of accidental
contact, rinse your eyes, mucous membranes, or damaged skin with cold water.
Seek medical attention immediately if you experience diarrhea, especially severe and persistent, or abdominal pain during or 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.
After diagnosing pseudomembranous colitis, your doctor should discontinue the use of Dalacin T and initiate appropriate treatment. Do not take anti-peristaltic medications or other constipating agents.
Tell your doctor if you have had colitis associated with antibiotic treatment, Crohn's disease, or ulcerative colitis.
Dalacin T should be used with caution in patients with a tendency to allergies.
Prolonged use of Dalacin T should be done under strict medical supervision.

Children

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

Dalacin T and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Clindamycin inhibits neuromuscular transmission, so it 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 and breastfeeding

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.
Pregnancy
There are no studies on the safety of using Dalacin T in pregnant women. The medicine should only be used during pregnancy if your doctor considers it absolutely necessary.
Breastfeeding
Do not use this medicine while breastfeeding.

Driving and using machines

No studies have been conducted on the effects of Dalacin T on the ability to drive and use machines.

Dalacin T contains propylene glycol (E 1520) and methyl parahydroxybenzoate (E 218)

This medicine contains 50 mg of propylene glycol and 3 mg of methyl parahydroxybenzoate per gram of gel.
Methyl parahydroxybenzoate may cause allergic reactions (possible late reactions).

3. How to use Dalacin T

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

Use in adults and adolescents

Apply a thin layer to the affected areas of the skin twice a day. Do not massage the gel into the skin. Wash your hands after using the medicine.

Using more than the recommended dose of Dalacin T

Topically applied medicine may be absorbed in amounts that cause systemic side effects of clindamycin (see sections 2 and 4).

Missing a dose of Dalacin T

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 the use of Dalacin T

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After using Dalacin T, the following side effects may occur:

Very common side effects (occurring in more than 1 in 10 patients):

• skin irritation, oily skin, excessive dryness of the skin.

Common side effects (occurring in more than 1 in 100, but less than 1 in 10 patients):

• hives.

Uncommon side effects (occurring in more than 1 in 1,000, but less than 1 in 100 patients):

• 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 those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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 or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dalacin T

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
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 Dalacin T 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) [see section 2 "Dalacin T contains propylene glycol (E 1520) and methyl parahydroxybenzoate (E 218)"], polyethylene glycol, carbomer 934 P, sodium hydroxide (40%), purified water.

What Dalacin T looks like and contents of the pack

Dalacin T is a gel.
The pack contains a laminated tube (LMDPE) with a polypropylene cap, containing 30 g of gel, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer:

Pfizer Service Company BV, Hoge Wei 10, 1930 Zaventem, Belgium

For more information, contact your local representative of the marketing authorization holder:

Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of last revision of the leaflet: 02/2025

Other sources of information

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://urpl.gov.pl