Dalacin t

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
DALACIN T (Dalacin)
10 mg/ml, emulsion for the skin
Clindamycinum
DALACIN T and Dalacin are different trade names for the same medicine.
Please read this 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 someone else, 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, pharmacist, or nurse. 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 emulsion 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 against Propionibacterium acnes
bacteria, which are one of the causes 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
Dalacin T is 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 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 (in most cases caused by Clostridium difficile). This condition, a complication of antibiotic therapy, may be life-threatening.
As soon as pseudomembranous colitis is diagnosed, the doctor should discontinue treatment with Dalacin T and initiate appropriate therapy. Do not use agents that inhibit intestinal peristalsis or have constipating effects.
Inform the doctor if the patient has previously experienced antibiotic-associated colitis, Crohn's disease, or ulcerative colitis.
Dalacin T has an unpleasant taste; therefore, extra caution should be taken when applying it around the mouth.
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 impair neuromuscular transmission; therefore, caution is advised when using it in patients receiving neuromuscular blocking agents. An antagonistic effect has been observed between clindamycin and erythromycin.
Cross-resistance (resistance within a class of antibiotics) has been demonstrated between clindamycin and lincomycin.

Pregnancy and breastfeeding
If the patient is pregnant or 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. The medicine may 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
The effect of Dalacin T on the ability to drive and operate machinery has not been studied.

Dalacin T contains methyl parahydroxybenzoate (E 218) and cetostearyl alcohol
Dalacin T contains methyl parahydroxybenzoate, which may cause allergic reactions, including delayed-type hypersensitivity reactions, and cetostearyl alcohol, which may cause local skin reactions, including contact dermatitis.

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.
This medicine is intended for topical application to the skin.
Shake well before use.
Use in adults and adolescents
Apply a thin layer to affected areas of the skin twice daily. Wash hands 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 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 everybody will experience 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, urticaria, excessive skin dryness.

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

• skin oiliness.

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

• Gram-negative bacterial folliculitis;
• eye pain;
• abdominal pain, gastrointestinal disorders, 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, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 at room temperature. Keep in the original packaging.
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 packaging and other information

What Dalacin T contains

• The active substance is clindamycin in the form of clindamycin phosphate. 1 ml of emulsion contains 10 mg of clindamycin.
• Other ingredients: sodium lauroyl sarcosinate, glycerol, glycerol monostearate, stearic acid, cetostearyl alcohol, isostearyl alcohol, methyl parahydroxybenzoate (E 218), purified water.

What Dalacin T looks like and contents of the pack
Dalacin T is an emulsion.
The pack consists of an HDPE bottle with a PP dosing cap containing 30 ml of emulsion,
housed in a cardboard carton.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
Pfizer, S.L.
Avda. de Europa 20-B
Parque Empresarial La Moraleja, 28108 Alcobendas (Madrid), Spain
Manufacturer:
Pfizer Service Company BVBA
Hoge Wei, 10, 1930 Zaventem, Belgium
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Spanish marketing authorisation number (country of export): 765875.7
Parallel import authorisation number: 262/23