Dalacin

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
DALACIN (DALACIN C)
20 mg/g (2%) vaginal cream
Clindamycin
DALACIN and DALACIN C are different brand names for the same medicine.
Please read the following information 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. 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 cream contains clindamycin, an antibiotic with antibacterial action.
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.
The use of Dalacin vaginal cream may lead to overgrowth of microorganisms in the vagina that are resistant to this medicine, particularly yeasts.
Administration of clindamycin, as with other antibiotics, carries the risk of diarrhea and pseudomembranous colitis, even though the antibiotic is absorbed from the cream only to a minimal extent. The patient should contact her doctor if diarrhea develops during treatment or within several weeks after its completion, 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, the 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
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines she plans to take. Dalacin vaginal cream may affect other medicines used concurrently.
If the patient is to undergo surgery, she should inform the doctor 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 may be used during pregnancy only under the advice of a doctor.

Pregnancy
Dalacin vaginal cream may be used during the first trimester of pregnancy only if, in the doctor's opinion, it is 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.
The occurrence of severe adverse reactions in a breastfed infant 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 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 exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The recommended dose is 5 g of cream (100 mg clindamycin), i.e. the contents of one applicator,
administered intravaginally once daily, preferably before going to bed, for 7 consecutive days.
Depending on symptoms, your doctor may recommend a shorter treatment period of 3 days.
Method of administration
Always wash your hands before using the cream.

• Remove the cap from the tube.
• At the place 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, the applicator is filled.
• Unscrew the applicator from the tube and replace the cap on the tube.
• Lie on your back, firmly hold the applicator and insert it into the vagina as deeply as possible without causing discomfort. While holding the applicator, slowly press the plunger until it stops and the entire cream content is administered.

cervix
vagina
anus

• Gently remove the applicator, wrap it in paper and dispose of it in a waste container. Do not
  discard 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 your doctor immediately.
Do not use a higher dose without consulting your doctor.
Phosphate clindamycin administered intravaginally may be absorbed in amounts sufficient to
cause systemic adverse effects (see sections 2 and 4). In case of overdose, contact your 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, use the medicine as
soon as possible, unless it is almost time for the next dose.
Stopping treatment with 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 any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The safety of using clindamycin as a vaginal cream has been evaluated in clinical studies conducted in non-pregnant women and in pregnant women during the second and third trimesters of pregnancy. The following adverse reactions 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 up to 1 in 10 people):

• Fungal infections, yeast infections
• Headache, dizziness, taste disturbances
• Upper respiratory tract infections
• Abdominal pain, constipation, diarrhoea, nausea, vomiting
• Itching (in areas other than the application site), rash
• Back pain
• Urinary tract infections, glycosuria, proteinuria
• Abnormal labour
• Vulvovaginitis, vaginal and vulval disorders, menstrual disorders, vaginal and vulval pain, uterine haemorrhage, vaginal discharge

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

• Bacterial infections
• Allergic reactions
• Vestibular dizziness
• Epistaxis (nosebleed)
• Localised abdominal pain, flatulence with gas release, unpleasant breath odour
• Urticaria, erythema
• Painful or difficult urination
• Trichomonal vulvovaginitis, vaginitis, pelvic pain
• Abnormal microbiological test results

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

• Cutaneous candidiasis
• Hyperthyroidism
• Pseudomembranous colitis, gastric and intestinal disorders, dyspepsia
• Maculopapular rash
• Endometriosis
• Inflammatory swelling, pain at the application site

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Reporting adverse reactions helps 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 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 pack and other information

What Dalacin contains

• The active substance is clindamycin. 5 g of cream (the content of the applicator) contains 100 mg clindamycin as clindamycin phosphate.
• The other ingredients of the medicine are: sorbitan stearate, polysorbate 60, propylene glycol, stearic acid, cetyl alcohol, cetyl palmitate, liquid paraffin, benzyl alcohol, purified water (see section 2 "Dalacin contains propylene glycol, cetyl alcohol and benzyl alcohol").

What Dalacin looks like and contents of the pack
A tube with a child-resistant cap containing 40 g of cream, packaged in a cardboard box together with 7 applicators.
Each applicator when filled (one dose) contains approximately 5 g of cream (100 mg clindamycin).
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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
1930 Zaventem
Belgium
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Greece, the country of export: 21162/2-5-03
Parallel Import Licence Number: 194/23