Dalacin T

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

DALACIN T (DALACIN C), 10 mg/g (1%), Gel

Clindamycin
DALACIN T and DALACIN C are different trade names for the same drug.

Read the Leaflet Carefully Before Using the Medication, 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, tell 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 Propionibacteriumacnes, which is 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 colitis during antibiotic use.

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.
Immediately consult a doctor 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 Clostridiumdifficile). This disease, a complication of antibiotic therapy, can be life-threatening.
After diagnosing pseudomembranous colitis, the doctor should discontinue the use of Dalacin T and initiate appropriate treatment. Do not take anti-peristaltic agents or other constipating medications.
Tell your doctor if you have had colitis associated with antibiotic use, 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 close medical supervision.

Children

The safety and efficacy of using 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 medicines you are taking, or have recently taken, and any you plan to take.
Clindamycin inhibits neuromuscular transmission, so use this medicine with caution in patients who are 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. This medicine should only be used during pregnancy if your doctor considers it essential.
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 and methyl parahydroxybenzoate (E 218)

This medicine contains 50 mg of propylene glycol and 3 mg of methyl parahydroxybenzoate (E 218) per gram of gel.
Methyl parahydroxybenzoate (E 218) 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 rub 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 general side effects of clindamycin (see sections 2 and 4).

Missing a dose of Dalacin T

Do not take a double dose to make up for a forgotten dose. If you forget a dose, use the medicine as soon as you remember, unless it is almost time for your 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 using this medicine 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 any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects 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.
By reporting side effects, you can help provide 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.
Do not store above 25°C.
Do not use this medicine after the expiry date 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 Dalacin T contains

• The active substance is clindamycin in the form of clindamycin phosphate. 1 g of gel contains 10 mg (1%) of clindamycin.
• The other ingredients are: allantoin, methyl parahydroxybenzoate (E 218), propylene glycol [see section 2 "Dalacin T contains propylene glycol and methyl parahydroxybenzoate (E 218)"], macrogol 400, carbomer 934P, sodium hydroxide, purified water.

What Dalacin T looks like and contents of the pack

Dalacin T is a gel.
The pack contains a laminated tube with a polypropylene cap, containing 30 g of gel, placed in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Pfizer Hellas A.E.

• L. Mesogeion 243 154 51 Neo Psychiko Greece

Manufacturer:

Pfizer Service Company BV
Hoge Wei 10
1930 Zaventem, Belgium

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Greece, the country of export:22894/9-5-2003
Parallel import authorization number:464/21

Date of revision of the leaflet: 28.12.2023

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