Dalacin
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
DALACIN (DALACIN C)
20 mg/g (2%) vaginal cream
Clindamycin
DALACIN and DALACIN C are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet so that you can read it again if necessary.
- 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. The medicine may harm someone else, even if their symptoms are the same.
- If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet
- What Dalacin is and what it is used for
- Important information before using Dalacin
- How to use Dalacin
- Possible side effects
- How to store Dalacin
- 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 vaginal cream, discuss this with your doctor.
Use of Dalacin vaginal cream may lead to overgrowth of microorganisms resistant to this medicine, particularly yeasts, in the vagina.
Administration of clindamycin, as with other antibiotics, carries a risk of diarrhea and pseudomembranous colitis, even though the antibiotic is absorbed only minimally from the cream. The patient should consult a 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. Medicinal products that inhibit intestinal peristalsis or have constipating effects should not be used.
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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 infections, 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 and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take. Dalacin vaginal cream may affect other medicines used concomitantly.
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 using erythromycin (an antibiotic), she should inform the 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 become pregnant, she should consult a 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, in the opinion of the doctor, 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. Serious adverse reactions in breastfed infants cannot be excluded. Therefore, the doctor will decide whether the patient may receive clindamycin and breastfeed simultaneously.
Driving and operating machinery
No studies on the effect of the medicine on the ability to drive vehicles or operate machinery have been conducted.
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).
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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, your doctor may recommend a shorter 3-day treatment course.
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 opening of the tube where the cap was removed.
- 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 delivered.
- Gently remove the applicator, wrap it in paper and dispose of it in a waste container. Do not dispose of the applicator in the toilet.
- After applying the cream, wash your hands thoroughly.
Use of more than the recommended dose of Dalacin
If more than the recommended dose is used, seek medical advice immediately.
Do not use more than the prescribed dose without consulting your 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 your doctor who will advise 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 Dalacin treatment
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If you have any doubts regarding the use of this 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 will experience them.
The safety of using clindamycin as a vaginal cream has been evaluated in clinical trials 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 vulvar 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 (in areas other than the application site), rash
- back pain
- urinary tract infections, glycosuria, proteinuria
- abnormal delivery
- vulvovaginitis, vulvar and vaginal disorders, menstrual disorders, vaginal and vulvar 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, halitosis (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 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 a 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 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected.
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5. How to store Dalacin
Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use the 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 in use. 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 are: sorbitan monostearate, 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
A laminated tube secured with a cap, and 7 single-use applicators made of plastic,
in a cardboard box.
Each applicator when filled (one dose) contains approximately 5 g of cream (100 mg clindamycin).
For more detailed information, please contact the marketing authorisation holder 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 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
Marketing authorisation number in Greece, the country of export: 21162/2-5-03
Parallel import authorisation number: 136/22
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