How to use DALACIN 20 mg/g VAGINAL CREAM
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Prospect:patient information
Dalacin 20 mg/g vaginal cream
clindamycin
Read the entire prospectus carefully before starting to use this medication because it contains important information for you.
- Keep this prospectus, as you may need to read it again.
- If you have any doubts, consult your doctor or pharmacist.
- This medication has been prescribed to you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
- If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this prospectus. See section 4.
Contents of the prospectus:
- What Dalacin vaginal cream is and what it is used for
- What you need to know before starting to use Dalacin vaginal cream
- How to use Dalacin vaginal cream
- Possible side effects
- Storage of Dalacin vaginal cream
- Package contents and additional information
1. What Dalacin vaginal cream is and what it is used for
This medication is an antibiotic that belongs to a group called lincosamides.
Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.
It is essential that you follow the instructions regarding dosage, administration, and treatment duration indicated by your doctor.
Do not store or reuse this medication. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.
This medication is used to treat bacterial vaginosis or vaginal infection caused by bacteria in women over 16 years of age and in pregnant women during the second and third trimester of pregnancy.
2. What you need to know before starting to use Dalacin vaginal cream
Do not use Dalacin cream:
- If you are allergic to clindamycin, lincomycin, or any other component of this medication (listed in section 6).
- If you have previously suffered from antibiotic-associated colitis
Warnings and precautions
- Your doctor will investigate through laboratory tests for the presence of other infections (such as those caused by Trichomonas, Candida, Chlamydia, and gonococcal infections).
- Prolonged administration of this medication may cause the growth of other germs, especially fungi.
- During treatment with Dalacin or after it, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If this occurs, treatment should be discontinued, and your doctor will provide the necessary treatment.
- If you have an inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, inform your doctor to confirm whether you should use this medication.
- As with all vaginal infections, you should not have sexual intercourse while being treated with this medication.
- Do not use latex condoms or diaphragms within 72 hours after treatment with this medication, as their use may be associated with a decrease in contraceptive efficacy and protection against sexually transmitted diseases.
- Do not use tampons or vaginal douches during treatment with this medication.
- If you are being treated with neuromuscular blockers, inform your doctor, as clindamycin may enhance the effect of these medications.
Your doctor will regularly monitor your condition to check if this medication is having the expected effect.
Children and adolescents
This medication is indicated for use in individuals over 16 years of age. Its safety and efficacy have not been established in patients under 16 years of age.
Using Dalacin vaginal cream with other medications
Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.
If you are receiving a neuromuscular blocking agent, inform your doctor and be aware that its effect may be enhanced with the use of this medication.
Pregnancy, breastfeeding
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
In clinical trials, the vaginal administration of clindamycin phosphate cream in pregnant women during the second trimester of pregnancy was not associated with an increased frequency of congenital anomalies.
This medication may be used during the second and third trimesters of pregnancy if the woman's clinical situation clearly requires treatment.
Breastfeeding
It is unknown whether clindamycin is excreted in breast milk after vaginal administration, although it is known to be excreted in breast milk after oral and parenteral administration. Your doctor will decide whether it is necessary to interrupt breastfeeding or treatment after considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Driving and using machines
The influence of this medication on the ability to drive or use machines is negligible or nonexistent.
Dalacin vaginal cream contains propylene glycol, cetyl alcohol, and benzyl alcohol
This medication may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.
This medication contains 250 mg of propylene glycol in each applicator.
This medication contains 50 mg of benzyl alcohol in each applicator.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol may cause moderate local irritation.
3. How to use Dalacin vaginal cream
Follow the administration instructions for the medication contained in this prospectus or as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.
Your doctor will determine the most suitable dosage and treatment duration for you, according to your condition and response to treatment.
Adults and individuals over 16 years of age
The recommended dose is one full applicator of cream (approximately 5 grams) vaginally at bedtime for 3 to 7 consecutive days.
Instructions for handling the applicator are found in section 6.
If you use more Dalacin than you should
No cases of overdose have been reported with the use of this medication.
Accidental oral ingestion of the product may produce effects comparable to those produced by oral administration of therapeutic concentrations of clindamycin.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.
Information for healthcare professionals
In the event of an overdose, symptomatic and supportive measures should be implemented.
If you forget to use Dalacin
Do not use a double dose to make up for the forgotten dose.
If you interrupt treatment with Dalacin
If you stop treatment with Dalacin before your doctor recommends, your symptoms may worsen or reappear.
If you have any other doubts about using this medication, ask your doctor or pharmacist.
4. Possible side effects
Like all medications, this medication can have side effects, although not everyone experiences them.
In clinical trials, the safety of clindamycin vaginal cream has been evaluated in both non-pregnant and pregnant women in the second and third trimester of pregnancy.
The following side effects have been reported in relation to treatment:
Very common side effects (may affect more than 1 in 10 people):
- Infection of the vulva and/or vagina caused by Candida(a type of fungus).
Common side effects (may affect up to 1 in 10 people):
- Fungal infection (including Candida, a type of fungus).
- Headache, dizziness, altered taste.
- Upper respiratory tract infection.
- Abdominal pain, constipation, diarrhea, nausea, vomiting.
- Itching (at a site other than the application site), skin rash.
- Back pain.
- Urinary tract infection, presence of glucose and protein in the urine.
- Abnormal labor.
- Infection of the vulva and/or vagina, alteration of the vulva and/or vagina, menstrual disorder, pain in the vulva or vagina, vaginal bleeding (not due to menstruation), vaginal discharge.
Uncommon side effects (may affect up to 1 in 1,000 people):
- Bacterial infection.
- Allergic reaction.
- Dizziness.
- Nosebleed.
- Abdominal distension, gas, bad breath.
- Redness of the skin, urticaria (skin rash with red spots and itching).
- Painful urination.
- Infection of the vagina by a microorganism known as Trichomonas, vaginal infection, pelvic pain.
- Altered results of microbiological tests (diagnostic tests to detect microorganism infections).
Side effects with unknown frequency (cannot be estimated from available data):
- Skin infection by a type of fungus (Candida).
- Increased thyroid hormones.
- Pseudomembranous colitis, gastrointestinal disorders, stomach pain and discomfort during digestion (dyspepsia).
- Maculopapular rash (skin redness with spots and small bumps).
- Endometrial growth outside the uterus (endometriosis).
- Pain, inflammation.
Reporting side effects
If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es.
By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Dalacin vaginal cream
Do not store above 25°C.
Do not freeze.
Keep in the original packaging.
Keep out of sight and reach of children.
Do not use Dalacin after the expiration date shown on the tube and outer carton. The expiration date is the last day of the month indicated.
Do not use any packaging that is damaged or open.
Medications should not be thrown away down the drain or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Package contents and additional information
Dalacin composition
- The active ingredient is clindamycin (as phosphate). Each gram of cream contains 20 mg of clindamycin (as phosphate). Each 5 grams of cream (1 applicator) contains 100 mg of clindamycin (as phosphate).
- The other components are: sorbitan stearate, polysorbate 60, propylene glycol (E-1520), stearic acid, cetyl alcohol, cetyle palmitate, mineral oil, purified water, and benzyl alcohol.
Product appearance and packaging contents
This medication consists of a semi-solid white cream that comes in a cardboard box containing a tube with a laminated structure consisting of a polyethylene and aluminum layer with a polypropylene cap that contains 40 grams of cream.
Seven disposable polyethylene applicators are included to measure the dose and facilitate application.
Instructions for using this medication
-Remove the cap from the cream tube and screw a plastic applicator onto the tube thread.
-Press the tube from the base until the applicator is filled and the plunger reaches its stop.
-Unscrew the applicator and replace the tube cap.
-Lie on your back, insert the applicator into the vagina as deeply as possible without discomfort. Slowly push the plunger to the end and carefully remove the applicator from the vagina to discard it.
Marketing authorization holder and manufacturer
Marketing authorization holder
Pfizer, S.L.
Avda. de Europa, 20 B. Parque Empresarial La Moraleja.
28108, Alcobendas (Madrid),
Spain.
Manufacturer
Pfizer Service Company BV
Hoge Wei 10.
1930, Zaventem.
Belgium.
Date of last revision of this prospectus: February 2022
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/
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- Country of registration
- Dosage formVAGINAL SEMISOLID, 5 g
- ATC codeG01AA10
- Average pharmacy price12.96 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to DALACIN 20 mg/g VAGINAL CREAMDosage form: VAGINAL SUPPOSITORY/CAPSULE/TABLET, 100 mgActive substance: clindamycinManufacturer: Aristo Pharma GmbhPrescription requiredDosage form: VAGINAL SUPPOSITORY/CAPSULE/TABLET, 100 mgActive substance: clindamycinManufacturer: Pfizer S.L.Prescription requiredDosage form: VAGINAL LIQUID, 10% povidone iodineActive substance: povidone-iodineManufacturer: Cooper Consumer Health B.V.Prescription not required
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Frequently Asked Questions
DALACIN 20 mg/g VAGINAL CREAM requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in DALACIN 20 mg/g VAGINAL CREAM is clindamycin. This information helps identify medicines with the same composition but different brand names.
The average pharmacy price for DALACIN 20 mg/g VAGINAL CREAM is around 12.96 EUR. Prices may vary depending on the manufacturer and dosage form.
DALACIN 20 mg/g VAGINAL CREAM is manufactured by Pfizer S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether DALACIN 20 mg/g VAGINAL CREAM is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy DALACIN 20 mg/g VAGINAL CREAM in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (clindamycin) include CLINDAMYCIN ARISTO 100 mg VAGINAL SUPPOSITORIES, DALACIN 100 mg VAGINAL SUPPOSITORIES, BETADINE VAGINAL 100 mg/ml VAGINAL SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
