DALACIN T

Package leaflet: Information for the user

Warning! Keep the 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 for the same medicinal product.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Dalacin T is and what it is 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 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, known as cross-reactivity), or to any of the other ingredients of this medicine (listed in section 6).
• If pseudomembranous colitis has occurred during antibiotic treatment.

Warnings and precautions
This medicine is intended for topical use only.
Avoid contact with eyes, mucous membranes, and broken skin. In case of accidental contact, rinse eyes, mucous membranes, or damaged skin thoroughly with cool water.
Immediately consult a doctor if diarrhoea occurs during or within several weeks after treatment, especially if severe and persistent, or if abdominal pain develops, as these may be symptoms of pseudomembranous colitis (in most cases 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 take medications 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 tendency to 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 your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan 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 a 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 necessary and as judged by the physician.

Breastfeeding
Do not use this medicine during breastfeeding.

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

Dalacin T contains propylene glycol and methyl parahydroxybenzoate
This medicine contains 50 mg of propylene glycol and 3 mg of methyl parahydroxybenzoate per gram of gel.
Methyl parahydroxybenzoate 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 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 more than the 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 Dalacin T treatment
If you have any further questions about the use of this medicine, consult a 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 experiences them.
The following adverse reactions may occur after using Dalacin T:
Very common adverse reactions (occur in more than 1 in 10 users):

• skin irritation, oily skin, excessive skin dryness.

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

• urticaria.

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

• 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 any possible adverse reactions not listed in this leaflet, consult 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
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 this 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.
• The other ingredients are: allantoin, methyl parahydroxybenzoate, propylene glycol [see section 2 "Dalacin T contains propylene glycol and methyl parahydroxybenzoate"], polyethylene glycol 400, carbomer 934 P, sodium hydroxide (40%), 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, placed 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.
Messoghion Ave 243
154 51 Neo Psychiko, Athens
Greece
Manufacturer:
Pfizer Service Company BV
Hoge Wei 10
Vlaams-Brabant
1930 Zaventem
Belgium
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged by:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
Greece Marketing Authorisation Number: 22894/9-5-2003
Parallel Import Licence Number: 199/23