Dalacin

Package Leaflet: Information for the Patient

DALACIN, 20 mg/g (2%), Vaginal Cream

Clindamycin

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Dalacin and what is it used for
• 2. Important information before using Dalacin
• 3. How to use Dalacin
• 4. Possible side effects
• 5. How to store Dalacin
• 6. Contents of the pack and other information

1. What is Dalacin and what is it used for

Dalacin cream contains clindamycin - an antibiotic with antibacterial action.
The vaginal cream Dalacin is used to treat bacterial vaginosis caused by sensitive microorganisms.

2. Important information before using Dalacin

When not to use Dalacin

If you are allergic to clindamycin, lincomycin or any of the other ingredients of this medicine (listed in section 6).
If you have had colitis after taking antibiotics.

Warnings and precautions

Before starting treatment with Dalacin, discuss it with your doctor.
Using the vaginal cream Dalacin may cause the growth of non-sensitive microorganisms in the vagina, especially yeast.
Clindamycin, like other antibiotics, is associated with the risk of diarrhea and pseudomembranous colitis, even though the antibiotic is absorbed from the cream only to a minimal extent. You should consult a doctor if you experience diarrhea, especially severe and persistent, during or after treatment. This may be a sign of pseudomembranous colitis (usually caused by Clostridium difficile), a complication of antibiotic therapy. Do not take anti-diarrheal medicines or laxatives.
It is recommended that during treatment with Dalacin vaginal cream, you should not have sexual intercourse or use vaginal tampons or douches.
Dalacin vaginal cream contains ingredients that may damage rubber or latex products, such as vaginal diaphragms or condoms, reducing their effectiveness in preventing pregnancy or protecting against sexually transmitted diseases, including AIDS. Therefore, it is not recommended to use condoms or vaginal diaphragms during treatment with this medicine.

Children and adolescents

The safety and efficacy of Dalacin vaginal cream in children have not been established.

Dalacin and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.
Dalacin vaginal cream may interact with other medicines taken at the same time.
If you are going to have surgery, tell your doctor that you are using Dalacin vaginal cream. Clindamycin may enhance the effect of muscle relaxants used during surgery.
If you are taking erythromycin (an antibiotic), tell your doctor before starting treatment with Dalacin vaginal cream.
Due to the lack of data, it is recommended not to use Dalacin vaginal cream at the same time as other vaginal medicines.

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 before taking this medicine. Dalacin vaginal cream can be used during pregnancy only under medical supervision.
Pregnancy
Dalacin vaginal cream should only be used during the first trimester of pregnancy if it is clearly necessary, as the data on the safety of use during the first three months of pregnancy are limited.
Breastfeeding
There are insufficient data on the passage of clindamycin into breast milk.
In breastfed infants, it is not possible to exclude the occurrence of severe side effects.
Therefore, your doctor will decide whether you can take clindamycin and breastfeed at the same time.

Driving and using machines

No studies have been conducted on the effects of the medicine on the ability to drive and use machines.

Dalacin contains propylene glycol, cetylstearyl alcohol, and benzyl alcohol

This medicine contains 250 mg of propylene glycol in each 5 g of cream (applicator content), which corresponds to 50 mg/g.
This medicine contains 160.5 mg of cetylstearyl alcohol in each 5 g of cream (applicator content), which corresponds to 32.1 mg/g. Cetylstearyl alcohol may cause local skin reactions (e.g., contact dermatitis).
This medicine contains 50 mg of benzyl alcohol in each 5 g of cream (applicator content), which corresponds to 10 mg/g. Benzyl alcohol may cause allergic reactions and mild local irritation.

3. How to use Dalacin

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is 5 g of cream (100 mg of clindamycin), i.e., the contents of one applicator, administered vaginally, once a day, preferably before bedtime, for 7 consecutive days.
Depending on the symptoms, your doctor may recommend a shorter, 3-day treatment period.
Method of administration
Always wash your hands before using the cream.

Remove the cap from the tube.
Attach one of the single-use applicators to the tube in place of the removed cap.
Holding the tube upright, gently press the cream into the applicator until it stops moving, which means the applicator is filled.
Remove the applicator from the tube and replace the cap.
Lying on your back, hold the applicator firmly and insert it into the vagina as far as possible without discomfort. Holding the applicator, slowly press the plunger until it stops, and the entire contents of the cream are administered.

Gently remove the applicator, wrap it in paper, and dispose of it in the trash. Do not flush the applicator down the toilet.
After using the cream, wash your hands thoroughly.

Using more than the recommended dose of Dalacin

If you have taken more than the recommended dose, contact your doctor immediately.
Do not take a higher dose without consulting your doctor.
Clindamycin phosphate used vaginally may be absorbed in amounts that cause systemic side effects (see sections 2 and 4). In case of overdose, contact your doctor, who will recommend the appropriate treatment.

Missing a dose of Dalacin

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

Stopping treatment with Dalacin

If you have any doubts about using the 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.
The safety of using clindamycin in the form of vaginal cream has been evaluated in clinical trials in non-pregnant women and pregnant women in the second and third trimesters of pregnancy. The following side effects have been observed in less than 10% of patients.
Very common(may affect more than 1 in 10 people):

• vaginal and vulvar candidiasis

Common(may affect up to 1 in 10 people):

• fungal infections, yeast infections
• headache, dizziness, taste disturbances
• upper respiratory tract infections
• abdominal pain, constipation, diarrhea, nausea, vomiting
• itching (in places other than the application site), rash
• back pain
• urinary tract infections, glycosuria, proteinuria
• abnormal labor
• vaginitis and vulvitis, vaginal and vulvar disorders, menstrual disorders, vaginal and vulvar pain, metrorrhagia, discharge

Uncommon(may affect up to 1 in 100 people):

• bacterial infections
• allergic reactions
• vertigo of labyrinthine origin
• epistaxis
• abdominal pain, bloating with gas, unpleasant breath odor
• urticaria, erythema
• painful or difficult urination
• trichomoniasis, vaginitis, vulvitis, pelvic pain
• abnormal microbiological test results

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

• skin candidiasis
• hyperthyroidism
• pseudomembranous colitis, gastrointestinal disorders, dyspepsia
• maculopapular rash
• endometriosis
• inflammatory swelling, pain at the application site

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder or its representative.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dalacin

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use the medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated.
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. Contents of the pack and other information

What Dalacin contains

The active substance is clindamycin. 5 g of cream (applicator content) contains 100 mg of clindamycin in the form of clindamycin phosphate.
The other ingredients are: sorbitan monostearate, polysorbate 60, propylene glycol (E1520), stearic acid, cetylstearyl alcohol, cetyl palmitate (Cutina CPV), liquid paraffin, benzyl alcohol (E1519), purified water (see section 2 "Dalacin contains propylene glycol, cetylstearyl alcohol, and benzyl alcohol").

What Dalacin looks like and contents of the pack

Laminated tube (LMDPE) sealed with a cap, containing 40 g of cream, placed in a cardboard box with 7 applicators.
Each applicator, when filled (one dose), contains approximately 5 g of cream (100 mg of clindamycin).
Marketing authorization holder:
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer:
Pfizer Service Company BV
Hoge Wei 10, 1930 Zaventem
Belgium

For more information, contact your local representative of the marketing authorization holder:

Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of last revision of the leaflet: 02/2025

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://urpl.gov.pl