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 medicine.

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those 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. Package contents 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 to clindamycin, an antibiotic with antibacterial action. Clindamycin acts on Propionibacteriumacnesbacteria, which are 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.
Seek medical attention immediately if you experience diarrhea, especially severe and persistent, or abdominal pain during or after treatment, as these may be symptoms of pseudomembranous colitis (usually caused by Clostridiumdifficile). This disease, a complication of antibiotic therapy, can be life-threatening.
After diagnosing pseudomembranous colitis, your doctor should discontinue the use of Dalacin T and initiate appropriate treatment. Do not take anti-peristaltic or 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 the medicines you are taking or have recently taken, as well as any medicines 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 in the same group) has been demonstrated between clindamycin and lincomycin.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist.
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 absolutely necessary.
Breastfeeding
Do not use this medicine while breastfeeding.

Driving and using machines

No studies have been conducted on the effect of Dalacin T on the ability to drive and use machines.

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 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

Topical use may lead to systemic absorption, causing general side effects of clindamycin (see sections 2 and 4).

Missing a dose of Dalacin T

Do not use a double dose to make up for a missed dose. If you miss a dose, use the medicine as soon as possible, unless it is almost time for the next dose.

Stopping the use of Dalacin T

If you have any further questions about the use of this medicine, ask your doctor or pharmacist. Do not stop treatment 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 available data):

• bacterial folliculitis;
• eye pain;
• abdominal pain, pseudomembranous colitis;
• contact dermatitis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dalacin T

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 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. Package contents 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 (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 packaging of the medicine is a laminated tube with a white polypropylene cap, containing 30 g of gel, in a cardboard box.
For more detailed information, contact the marketing authorization holder or 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, Vlaams-Brabant, 1930 Zaventem, Belgium

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Greece, the country of export: 22894/9-5-2003

Parallel import authorization number: 147/23

Date of leaflet approval:19.07.2023
[Information about the trademark]