DALACIN 20 mg/g VAGINAL CREAM

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/