Dalacin

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
DALACIN
20 mg/g (2%) vaginal cream
Clindamycinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Dalacin is and what it is 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 Dalacin is and what it is used for

Dalacin vaginal cream contains clindamycin, an antibiotic with antibacterial activity.
Dalacin vaginal cream is used in the treatment of bacterial vaginosis caused by susceptible microorganisms.

2. Important Information Before Using Dalacin

When not to use Dalacin

• If the patient is allergic to clindamycin, lincomycin, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has previously experienced colitis after taking antibiotics.

Warnings and precautions
Before starting treatment with Dalacin, discuss this with your doctor.
Use of Dalacin vaginal cream may lead to overgrowth of microorganisms resistant to this medicine, especially yeasts, within the vagina.
Administration of clindamycin, as with other antibiotics, carries the risk of diarrhea and pseudomembranous colitis, even though the antibiotic is absorbed only to a minimal extent from the cream. The patient should contact her doctor if diarrhea develops during or within several weeks after treatment, especially if it is severe and persistent. This may be a symptom of pseudomembranous colitis (in most cases caused by Clostridium difficile), a condition that is a complication of antibiotic therapy. Do not take medications that inhibit intestinal peristalsis or have constipating effects.
It is recommended not to have sexual intercourse or use vaginal tampons or vaginal douching during treatment with Dalacin vaginal cream.
Dalacin vaginal cream contains ingredients that may damage rubber and latex products, such as vaginal diaphragms or condoms, reducing their effectiveness in preventing pregnancy or protecting against sexually transmitted diseases, including AIDS. Therefore, use of condoms or vaginal diaphragms is not recommended during treatment with this medicine.

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

Dalacin with other medicines
Inform your doctor about all medicines currently taken or recently used, as well as any medicines you plan to take. Dalacin vaginal cream may affect other medicines used concurrently.
If the patient is to undergo surgery, she should inform the medical team about the use of Dalacin vaginal cream. Clindamycin may enhance the effect of muscle relaxants used during surgery.
If the patient is taking erythromycin (an antibiotic), she should inform her doctor before starting treatment with Dalacin vaginal cream.
Due to lack of data, it is recommended not to use Dalacin vaginal cream simultaneously with other medicines administered vaginally.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. Dalacin vaginal cream should be used during pregnancy only under medical supervision.

Pregnancy
Dalacin vaginal cream may be used during the first trimester of pregnancy only if clearly necessary, as data on safety during the first three months of pregnancy are limited.

Breastfeeding
There are insufficient data on the passage of clindamycin into human milk. Serious adverse effects in breastfed infants cannot be excluded. Therefore, the doctor will decide whether the patient may take clindamycin and breastfeed at the same time.

Driving and operating machinery
No studies have been conducted on the effects of the medicine on the ability to drive vehicles or operate machinery.

Dalacin contains propylene glycol, cetostearyl alcohol, and benzyl alcohol
This medicine contains 250 mg of propylene glycol in each 5 g of cream (applicator content), equivalent to 50 mg/g.
This medicine contains 160.5 mg of cetostearyl alcohol in each 5 g of cream (applicator content), equivalent to 32.1 mg/g. Cetostearyl 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), equivalent to 10 mg/g. Benzyl alcohol may cause allergic reactions and mild local irritation.

3. How to use Dalacin

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
The recommended dose is 5 g of cream (100 mg of clindamycin), equivalent to the contents of one applicator, administered
intravaginally once daily, preferably before going to bed, for 7 consecutive days. Depending on symptoms,
the physician 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.
• At the site where the cap was removed, screw one of the single-use applicators onto the tube.
• Holding the tube at the bottom, gently squeeze the cream into the applicator.
• When the plunger stops moving, this indicates that the applicator is filled.
• Unscrew the applicator from the tube and replace the cap on the tube.
• Lie on your back, firmly grasp the applicator and insert it into the vagina as deeply as possible without causing discomfort. While holding the applicator in place, slowly press the plunger until it stops, ensuring the entire cream content is delivered.

• Gently remove the applicator, wrap it in paper and dispose of it in the waste container. Do not dispose of the applicator in the toilet.
• After applying the cream, wash your hands thoroughly.

Use of a higher than recommended dose of Dalacin
If more than the recommended dose is used, consult a doctor immediately.
Do not use a higher dose without consulting a doctor.
Clindamycin phosphate administered intravaginally may be absorbed in amounts sufficient to cause systemic adverse effects (see sections 2 and 4). In case of overdose, contact a doctor who will recommend appropriate treatment.
Missed dose of Dalacin
Do not use a double dose to make up for a missed dose. If a dose is missed, take the medicine as soon as possible, unless it is almost time for the next dose.
Stopping the use of Dalacin
If in doubt about using the medicine, consult your 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 safety of clindamycin used as a vaginal cream has been evaluated in clinical studies conducted in non-pregnant women and in pregnant women during the second and third trimester of pregnancy. The adverse reactions listed below were observed in less than 10% of patients.

Very common (may occur in more than 1 in 10 people):

• vaginal and vulval candidiasis

Common (may occur in no more than 1 in 10 people):

• fungal infections, yeast infections
• headache, dizziness, taste disturbances
• upper respiratory tract infections
• abdominal pain, constipation, diarrhoea, nausea, vomiting
• itching (at sites other than the application site), rash
• back pain
• urinary tract infections, glycosuria, proteinuria
• abnormal delivery
• vulvovaginitis, vulval and vaginal disorders, menstrual disorders, vaginal and vulval pain, uterine haemorrhage, vaginal discharge

Uncommon (may occur in no more than 1 in 100 people):

• bacterial infections
• allergic reactions
• labyrinthine dizziness
• epistaxis (nosebleed)
• localized abdominal pain, flatulence with gas release, unpleasant odour from mouth
• urticaria, erythema
• painful or difficult urination
• trichomonal vulvovaginitis, vaginitis, pelvic pain
• abnormal results of microbiological tests

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any possible 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, tel.: +48 22 4921301, fax: +48 22 4921309, 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

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Do not freeze.
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. Such measures help protect the environment.

6. Contents of the package and other information

What Dalacin contains

• The active substance is clindamycin. 5 g of cream (the content of one applicator) contains 100 mg clindamycin as clindamycin phosphate.
• Other ingredients are: sorbitan stearate, polysorbate 60, propylene glycol, stearic acid, cetostearyl alcohol, cetyl palmitate, liquid paraffin, benzyl alcohol, purified water.

What Dalacin looks like and contents of the pack
Laminated tube with PE layer (LMDPE), secured with a PP cap, together with 7 disposable applicators made of PE, in a cardboard box.
Each applicator when filled (one dose) contains approximately 5 g of cream (100 mg clindamycin).
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Hungary, country of export:
Pfizer Kft.
1123 Budapest
Alkotás u. 53.
Hungary
Manufacturer:
Pfizer Service Company BVBA
Hoge Wei, 1930 Zaventem
Belgium
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Hungarian, country of export, marketing authorisation number: OGYI-T-958/10
Parallel import authorisation number: 297/23