Leaflet: information for the user

Dalacin 10 mg topical emulsion

Clindamicina

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist.
• This medicine has been prescribed for 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 any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

1. What you need to know before you start using Dalacin topical emulsion.
2. How to use Dalacin topical emulsion.
3. Possible side effects.
4. Storage of Dalacin topical emulsion.
5. Contents of the pack and additional information.

This medication belongs to a group of antibiotics called lincosamides.

It is indicated for the treatment of mild to moderate acne vulgaris, particularly in the inflammatory lesion phase, in adults and adolescents over 12 years old.

Do not use Dalacin emulsion on the skin

• 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

• During treatment with this medication or after it, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If this is the case, 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 that they can confirm whether you should use this medication.
• During application, avoid contact with the eyes, mucous membranes, or eroded skin areas. This medication contains an alcoholic base that may cause stinging and irritation in these areas. In the event of accidental contact, wash the area with plenty of cold water and consult an ophthalmologist if necessary.
• Do not ingest.
• Improvement with Dalacin treatment is observed between 6-8 weeks of treatment. The safety and efficacy of Dalacin have not been proven in treatments exceeding 12 weeks.
• If you have been diagnosed with papulopustular acne (a type of acne), your doctor will indicate the most suitable treatment.

Children and adolescents

This medication is indicated for adolescents over 12 years old. For administration instructions, see further onHow to use Dalacin emulsion on the skin

Use of Dalacin emulsion on the skin 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 being treated with neuromuscular blockers (used to produce paralysis in the muscle, such as pancuronium, tubocurarine), inform your doctor, as clindamycin may potentiate the action of these medications.

Pregnancy and 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 studies with pregnant women, systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities.

There are no adequate and well-controlled studies with pregnant women during the first trimester with this medication.

This medication should not be used during the first trimester of pregnancy unless the woman's clinical situation requires treatment.

Lactation

The excretion of clindamycin in breast milk after topical administration is unknown. However, it is excreted in breast milk after oral or intravenous administration.

Decide whether to interrupt breastfeeding or interrupt treatment after considering the benefit of breastfeeding for the child and the benefit 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 emulsion on the skin contains phenoxyethanol and cetearyl alcohol

This medication may cause skin allergic reactions (possibly delayed) because it contains phenoxyethanol (E218).

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetearyl alcohol.

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

This medication is administered topically.For external use only.

Shake before use.

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

Adults and children over 12 years old

Dalacin is applied to the skin, applying a thin layer of the emulsion to the affected area 2 times a day. Your doctor will assess the clinical evolution after 6-8 weeks of treatment. This medication should be used for a maximum of 12 weeks, seeWarnings and precautions.

Apply it with caution to avoid contact of the medication with the eyes, nose, or mouth. If the emulsion comes into contact with the eyes, they must be washed immediately with abundant water. If you continue to feel a burning or painful sensation in the eyes, consult your doctor or pharmacist.

Consult your pharmacist if you have any doubts about these instructions.

If you use more Dalacin emulsion than you should

No cases of intoxication have been described, although topical clindamycin may be absorbed in sufficient quantities to produce adverse effects. Symptoms in case of overdose are: nausea, vomiting, or diarrhea.

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

Information for healthcare professionals

In case of overdose, peritoneal dialysis or hemodialysis are not effective for eliminating clindamycin from the serum. Gastric lavage may be performed. Activated charcoal treatment and appropriate symptomatic treatment are recommended.

In case of an allergic reaction, standard emergency treatment should be applied, including corticosteroids, adrenaline, and antihistamines.

If you forgot to use Dalacin emulsion

In case of forgotten dose, use the medication as soon as possible and continue treatment as prescribed. However, if the next dose is near, it is better not to use the missed dose and wait for the next one. Do not use a double dose to compensate for the missed dose. Continue using Dalacin as your doctor has instructed.

If you interrupt treatment with Dalacin emulsion

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

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

Like all medications, Dalacin emulsion can produce adverse effects, although not all people may experience them.

The adverse effects observed with this medication are listed below, classified by their frequency:

Very frequent: may affect more than 1 in 10 people

• Skin irritation, red, elevated, and itchy skin lesions (urticaria).

Frequent: may affect up to 1 in 10 people

• Oily skin.

Unknown frequency (cannot be estimated from available data):

• Folliculitis (inflammation of hair follicles), eye pain, abdominal pain, a special type of colitis (pseudomembranous), contact dermatitis.

Reporting Adverse Effects

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

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Store at room temperature. Store in the original packaging.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging..The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy.If in 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 ofDalacin skin emulsion

• The active ingredient is clindamicin. Each ml contains 10 mg of clindamicin (as phosphate).
• The other components (excipients) are: stearic acid, cetoestearic alcohol, monoestearate of glycerol, methyl parahydroxybenzoate (E218), sodium laurilsarcosinate, glycerol, isoestearic alcohol, and purified water.

Appearance of the product and contents of the packaging:

Dalacin is presented as a white or almost white emulsion.

The emulsion is packaged in 30 ml high-density polyethylene bottles with a white polypropylene screw-top cap.

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/2017

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