Package leaflet: Information for the patient

Warning! Keep this leaflet! Foreign language information on the immediate packaging.
DALACIN T (DALACIN C), 10 mg/g (1%), gel
Clindamycinum
DALACIN T and DALACIN C are different trade names for the same medicinal product.
Please read carefully all the information in this leaflet before using the 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 doubts, 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 other people, even if their symptoms are the same.
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:

What Dalacin T is and what it is used for
Important information before using Dalacin T
How to use Dalacin T
Possible adverse reactions
How to store Dalacin T
Contents of the pack and other information

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

Dalacin T gel contains the active substance clindamycin in the form of clindamycin phosphate.
After topical application, clindamycin phosphate is converted into clindamycin, a bacteriostatic
antibiotic. Clindamycin acts against Propionibacterium acnes, one of the causative agents of acne vulgaris.
Indications:
Topical treatment of acne vulgaris.

2. Information before using Dalacin T

When not to use Dalacin T:

If the patient is allergic to clindamycin or lincomycin (patients 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 the patient has previously experienced colitis during antibiotic treatment.

Warnings and precautions
Dalacin T is intended for topical use only.
Avoid contact with eyes, mucous membranes, and broken skin. In case of accidental contact, rinse the eyes, mucous membranes, or injured skin thoroughly with cool water.
Immediately consult a doctor if diarrhoea occurs during or within a few weeks after treatment, especially if it is severe and persistent, or if abdominal pain develops, as these may be symptoms of pseudomembranous colitis (usually caused by Clostridium difficile). This condition, a complication of antibiotic therapy, may be life-threatening. Once pseudomembranous colitis is diagnosed, the physician should immediately discontinue treatment with Dalacin T and initiate appropriate therapy. Do not use agents that inhibit intestinal peristalsis or have constipating effects.
Inform your doctor if you have previously experienced antibiotic-associated colitis, Crohn's disease, or ulcerative colitis.
Dalacin T should be used with caution in patients with a history of allergies.
Prolonged use of Dalacin T should be carried out under strict medical supervision.

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

Dalacin T and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Clindamycin inhibits neuromuscular transmission; therefore, caution is advised when using this medicine in patients receiving neuromuscular blocking agents.
An antagonistic effect has been observed between clindamycin and erythromycin.
Cross-resistance (resistance within the same drug class) has been demonstrated between clindamycin and lincomycin.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist.

Pregnancy
There are no studies on the safety of Dalacin T in pregnant women. This medicine should be used during pregnancy only if clearly needed and considered essential by the physician.

Breastfeeding
Dalacin T should not be used during breastfeeding.

Driving and operating machinery
The effect of Dalacin T on the ability to drive and operate machinery has not been studied.

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) in each gram of gel.
Methyl parahydroxybenzoate (E 218) may cause allergic reactions (including delayed-type reactions).

3. How to use Dalacin T

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist.
Use in adults and adolescents
Apply a thin layer to the affected areas of skin twice daily. It is not recommended to
rub the gel into the skin. Hands should be washed after applying the medicine.
Use of a larger than recommended dose of Dalacin T
When applied topically, the medicine may be absorbed in amounts sufficient to cause
systemic adverse effects of clindamycin (see sections 2. and 4.).
Missed dose of Dalacin T
Do not use a double dose to make up for a missed dose. If a dose is missed, apply the medicine as soon as possible, unless it is almost time for the next dose.
Stopping treatment with Dalacin T
If you have any further questions about the use of this medicine, consult your doctor or pharmacist. Do not stop treatment without consulting your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur after using Dalacin T:
Very common adverse reactions (occurring in more than 1 in 10 patients):

skin irritation, skin oiliness, excessive skin dryness.

Common adverse reactions (occurring in more than 1 in 100 but less than 1 in 10 patients):

urticaria.

Uncommon adverse reactions (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):

Gram-negative bacterial folliculitis;
eye pain;
abdominal pain, pseudomembranous colitis;
contact dermatitis.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 .
Reporting adverse reactions enables the collection of more information on the safety of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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.
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 medicinal product is packed in a laminated tube with a polypropylene cap containing 30 g of gel, placed in a cardboard box.
For further information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Greece, 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation number in Greece, country of export: 22894/9-5-2003
Parallel import licence number: 464/21