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

Clindamycin
Dalacin T and Dalacin C are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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. Contents of the pack 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 into clindamycin, an antibiotic with antibacterial action. Clindamycin acts on bacteria Propionibacteriumacnes, 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.
You should avoid contact of the medicine with your eyes, mucous membranes, and damaged skin. If accidental contact occurs, you should rinse your eyes, mucous membranes, or damaged skin with cold water.
You should immediately consult a doctor if, during or within a few weeks after treatment, you experience diarrhea, especially severe or persistent, or abdominal pain, as these may be symptoms of pseudomembranous colitis (mostly caused by Clostridiumdifficile). This disease, which is a complication of antibiotic therapy, can be life-threatening.
As soon as pseudomembranous colitis is diagnosed, the doctor should advise you to stop using Dalacin T and start appropriate treatment. You should not take anti-peristaltic medicines or other constipating agents.
You should inform your doctor if you have had colitis associated with antibiotic use, Crohn's disease, or ulcerative colitis in the past.
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

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Clindamycin inhibits neuromuscular transmission, so you should use this medicine with caution if you are taking muscle relaxants.
An antagonistic effect has been observed between clindamycin and erythromycin. Cross-resistance (resistance to drugs from the same group) has been demonstrated between clindamycin and lincomycin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice.

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

You should 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 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 (possible late reactions).

3. How to use Dalacin T

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.

Use in adults and adolescents

Apply a thin layer to the affected areas of the skin twice a day. It is not recommended to massage the gel into the skin. You should wash your hands after using the medicine.

Using more than the recommended dose of Dalacin T

Medicine used locally may be absorbed in amounts that cause general side effects of clindamycin (see sections 2 and 4).

Missing a dose of Dalacin T

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

Stopping use of Dalacin T

If you have any further questions about using this medicine, you should ask your doctor or pharmacist. You should 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, oiliness of the skin, excessive dryness of the skin.

Common side effects (occurring in more than 1 in 100 but less than 1 in 10 patients):

• urticaria.

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 the available data):

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

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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
Phone: +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 this 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 stated.
Medicines should not be disposed of via wastewater or household waste. You should 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"], macrogol 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 pack consists of a laminated tube with a polypropylene cap in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Greece, the country of export: 22894/9-5-2003

Parallel import authorization number: 199/23

Date of revision of the leaflet: 18.09.2023

[Information about the trademark]