Prospect:Information for the Patient

Dalacin 20 mg/g Vaginal Cream

clindamicina

Read this entire prospect carefully before starting to use this medication because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to use Dalacin Vaginal Cream

3.How to use Dalacin Vaginal Cream

4.Possible adverse effects

5.Storage of Dalacin Vaginal Cream

6.Contents of the package and additional information

This medication is an antibiotic belonging to a group called lincosamides.

This medication is used for the treatment of bacterial vaginosis or vaginal infection caused by bacteria in women over 16 years old and in pregnant women during the second and third trimester of pregnancy.

Do not use Dalacin cream:

• If you are allergic to clindamycin, lincomycin, or any of the other components of this medication (listed in section 6).
• If in the past you have suffered from antibiotic-associated colitis.

Warnings and precautions

• Your doctor will investigate through laboratory tests the existence of other infections (such as those caused byTrichomonas, Candida, Chlamydiaand gonococcal infections).
• The prolonged administration of this medication may cause the growth of other microorganisms, especially fungi.
• During treatment with Dalacin or after it, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If so, treatment should be suspended and your doctor will put you on the treatment they consider most suitable.
• If you have an inflammatory intestinal disease, such as Crohn's disease or ulcerative colitis, inform your doctor so they can confirm whether you should use this medication.
• Like all vaginal infections, you should not have sex while on treatment with this medication.
• Do not use latex condoms or diaphragms within 72 hours after treatment with this medication, as their use could be associated with a decrease in the effectiveness of your contraceptive and protection against sexually transmitted diseases.
• Do not use tampons or vaginal irrigations during treatment with this medication.
• If you are being treated with neuromuscular blockers, inform your doctor, as clindamycin may potentiate the action 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 from the age of 16 years. Its safety and efficacy have not been established in patients under 16 years.

Use of Dalacin cream vaginal 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 blocker, inform your doctor and note that its effect may be potentiated with the use of this medication.

Pregnancy, breastfeeding

Pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

In clinical trials, the vaginal administration of the cream with clindamycin (as phosphate) in pregnant women during the second trimester of pregnancy was not associated with an increase in the 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

The excretion of clindamycin in milk after vaginal administration is unknown, although it is known to pass into milk after oral and parenteral administration. Your doctor should decide whether to interrupt breastfeeding or interrupt treatment after considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machines

The influence of this medication on the ability to drive or operate machines is negligible or insignificant.

Dalacin cream vaginal contains propylene glycol, cetyl alcohol, and benzyl alcohol

This medicationmay cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.

This medication contains250 mgofpropylene glycolin each applicator.

This medication contains50 mgof benzyl alcohol in each applicator.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Your doctor will establish the most suitable dose and treatment duration for you, based on your condition and response to treatment.

Adults and individuals over 16 years

The recommended dose is a full applicator of cream (approximately 5 grams) applied vaginally at bedtime for 3 to 7 consecutive days.

The instructions for handling the applicator can be found in section 6.

If you use more Dalacin than you should

No cases of overdose have been described with the use of this medication.

Accidental oral ingestion of the product may produce effects comparable to those produced by the oral administration of therapeutic concentrations of clindamycin.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Information for healthcare professionals

In the event of an overdose, the necessary symptomatic and supportive measures should be implemented.

If you forgot to use Dalacin

Do not use a double dose to compensate for the missed dose.

If you interrupt treatment with Dalacin

If you discontinue treatment with Dalacin before your doctor recommends, symptoms may worsen or reappear.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

In clinical studies, the safety of clindamycin vaginal cream has been evaluated in both non-pregnant patients and patients in the second and third trimesters 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):

• Vulvovaginal infection caused byCandida(a type of fungus).

Common side effects (may affect up to 1 in 10 people):

• Infection caused by fungi (includingCandida, a type of fungus).
• Headache, dizziness, altered taste.
• Upper respiratory tract infection.
• Abdominal pain, constipation, diarrhea, nausea, vomiting.
• Itching (at a different site from the application site), skin rash.
• Back pain.
• Urinary tract infection, presence of glucose and proteins in the urine.
• Alteration in labor.
• Vulvovaginal infection, vulvar and vaginal alteration, menstrual disorder, vulvar or vaginal pain, non-menstrual vaginal bleeding, vaginal discharge.

Rare side effects (may affect up to 1 in 1,000 people):

• Bacterial infection.
• Allergic reaction.
• Dizziness.
• Nasal bleeding.
• Abdominal distension, gas, bad breath.
• Redness of the skin, urticaria (skin rash with red patches and itching).
• Difficulty urinating.
• Vaginal infection caused by a microorganism known asTrichomonas, vaginal infection, pelvic pain.
• Altered results of microbiological tests (diagnostic tests for detecting infections by microorganisms).

Side effects whose frequency is unknown (cannot be estimated from available data):

• Skin infection caused by a type of fungus (Candida).
• Increased thyroid hormones.
• Colitis pseudomembranosa. gastrointestinal disorders, stomach pain and discomfort during digestion (dyspepsia).
• Maculopapular rash (redness of the skin with patches and small bumps).
• Endometrial growth outside the uterus (endometriosis).
• Pain, inflammation.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store above 25°C.

Do not freeze.

Store in the original packaging.

Keep out of sight and reach of children.

Do not use Dalacin after the expiration date appearing on the tube and the outer carton. The expiration date is the last day of the month indicated.

Do not use any damaged or open packaging.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Dalacin

• 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, polisorbate 60, propylene glycol (E-1520), stearic acid, cetoestearic alcohol, cetyl palmitate, mineral oil, purified water, and benzyl alcohol.

Appearance of the product and contents of the packaging

This medication consists of a semi-solid cream of white color that is presented in a cardboard box containing a tube with a laminated structure consisting of a layer of polyethylene and aluminum with a polypropylene plug containing 40 grams of cream.

Seven disposable polyethylene natural applicators are included to measure the dose and facilitate application.

Instructions for the use of this medication

-Remove the plug from the cream tube and screw on a plastic applicator to the tube's thread.

-Press the tube from the base until the applicator is filled and the piston reaches its top.

-Unscrew the applicator and replace the tube plug.

-Sit on your back, insert the applicator into the vagina as deeply as possible without causing discomfort. Push the piston slowly to the end and carefully remove the applicator from the vagina to dispose of it.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Pfizer, S.L.

Avda. de Europa, 20 B. Parque Empresarial La Moraleja.

28108, Alcobendas (Madrid),

Spain.

Responsible for manufacturing

Pfizer Service Company BV

Hoge Wei 10.

1930, Zaventem.

Belgium.

Last review date of this leaflet: February 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (AEMPS) http://www.aemps.es/