Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Dalacin T (Dalacin C)
10 mg/g (1%) gel
Clindamycinum
Dalacin T and Dalacin C are different trade names of the same medicine.
Please read the entire leaflet carefully 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 another person, even if their symptoms are the same.
If you experience any adverse effects, including any 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 side effects
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.
When applied to the skin, clindamycin phosphate is converted into clindamycin, an antibiotic with antibacterial activity. Clindamycin acts against Propionibacterium acnes, one of the bacteria involved in the development 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, known as cross-reactivity), 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
This medicine is for topical use only.
Avoid contact with the eyes, mucous membranes, and broken skin. In case of accidental contact, rinse the eyes, mucous membranes, or damaged skin thoroughly with cool water.
Immediately consult a doctor if diarrhoea develops during or within a few weeks after treatment, especially if it is severe and persistent, or if abdominal pain occurs, 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 doctor should immediately discontinue treatment with Dalacin T and initiate appropriate therapy. Do not use agents that inhibit intestinal peristalsis or other antidiarrhoeal drugs.
Inform the doctor if the patient has 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 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 the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Clindamycin may interfere with 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 antibiotic group) has been demonstrated between clindamycin and lincomycin.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her 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 necessary and as judged by the physician.

Breastfeeding
Dalacin T should not be used during breastfeeding.

Driving and operating machinery
No studies on the effects of Dalacin T on the ability to drive vehicles or operate machinery have been conducted.

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 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 doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Use in adults and adolescents
Apply a thin layer to the affected skin areas 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
Topically applied medicine may be absorbed in amounts leading to 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 doubts regarding 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 product may cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur after using Dalacin T:

Very common adverse reactions (occur in more than 1 in 10 patients):

skin irritation, increased skin oiliness, excessive skin dryness.

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

urticaria.

Uncommon adverse reactions (occur in more than 1 in 1,000 but less than 1 in 100 patients):

gastrointestinal disorders.

Frequency not known (cannot be estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dalacin T

Keep this medicine out of sight and reach of children.
Store below 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. 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.
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)"], macrogol 400, carbomer 934P, sodium hydroxide (40%), purified water.

What Dalacin T looks like and contents of the pack
Dalacin T is a gel.
The pack consists of a laminated tube with a white polypropylene cap containing 30 g of gel, packed in a cardboard box.

For further information, please contact the responsible party or the parallel importer:
Marketing Authorisation 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, Vlaams-Brabant, 1930 Zaventem, Belgium
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Greece, the country of export: 22894/9-5-2003
Parallel Import Licence number: 147/23