DALACIN 10 MG SKIN EMULSION

Introduction

Package Leaflet: Information for the User

Dalacin 10 mg Cutaneous Emulsion

Clindamycin

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only and you should not give it 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 package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Dalacin cutaneous emulsion is and what it is used for.

1. What you need to know before starting to use Dalacin cutaneous emulsion.
2. How to use Dalacin cutaneous emulsion.
3. Possible side effects.
4. Storage of Dalacin cutaneous emulsion.
5. Package contents and additional information.

1. What Dalacin Cutaneous Emulsion is and What it is Used for

This medication belongs to a group of antibiotics 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 treatment, return it to the pharmacy for proper disposal. Do not dispose of medications down the drain or in the trash.

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

2. What You Need to Know Before Starting to Use Dalacin Cutaneous Emulsion

Do not use Dalacin cutaneous emulsion

• 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

• During treatment with this medication or after treatment, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. 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 determine if 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 can cause stinging and irritation in these areas. In case 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 established for 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 of age. For administration instructions, see "How to use Dalacin cutaneous emulsion" below.

Using Dalacin Cutaneous Emulsion 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 muscle paralysis, such as pancuronium or tubocurarine), inform your doctor, as clindamycin may enhance the effect of these medications.

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

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 clinical situation of the woman requires treatment.

Breastfeeding

It is unknown whether clindamycin is excreted in breast milk after topical administration. However, it is excreted in breast milk after oral or intravenous administration.

A decision should be made to either discontinue breastfeeding or discontinue treatment, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and Using Machines

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

Dalacin Cutaneous Emulsion Contains Methyl Parahydroxybenzoate and Cetostearyl Alcohol

This medication may cause allergic reactions (possibly delayed) on the skin because it contains methyl parahydroxybenzoate (E218).

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

3. How to Use Dalacin Cutaneous Emulsion

Follow the administration instructions in this package leaflet or as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist.

This medication is administered topically. For external use only.

Shake before use.

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

Adults and Children Over 12 Years

Dalacin is applied to the skin, gently applying a thin layer of the emulsion to the affected area twice 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; see "Warnings and Precautions" above.

Apply with caution to avoid contact between the medication and the eyes, nose, or mouth. If the emulsion comes into contact with the eyes, they should be rinsed immediately with plenty of water. If you continue to feel a burning sensation or pain in the eyes, consult your doctor or pharmacist.

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

If You Use More Dalacin Cutaneous Emulsion Than You Should

No cases of overdose have been reported, although topically administered clindamycin may be absorbed in sufficient quantities to produce side effects. The 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 Toxicology 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 is not effective in removing clindamycin from the serum. Gastric lavage may be performed. Treatment with activated charcoal and symptomatic treatment is recommended.

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

If You Forget to Use Dalacin Cutaneous Emulsion

In case of a missed dose, use the medication as soon as possible and continue with the 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 make up for the missed dose. Continue using Dalacin as indicated by your doctor.

If You Interrupt Treatment with Dalacin Cutaneous Emulsion

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

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

4. Possible Side Effects

Like all medications, Dalacin cutaneous emulsion may cause side effects, although not everyone will experience them.

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

Very Common: May Affect More Than 1 in 10 People

• Skin irritation, skin lesions that are red, raised, and itchy (urticaria).

Common: May Affect Up to 1 in 10 People

• Oily skin.

Frequency Not Known (Cannot be Estimated from Available Data):

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dalacin Cutaneous Emulsion

Store at room temperature. Keep in the original packaging.

Keep out of sight and reach of children.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the pharmacy's SIGRE collection point. If you have any doubts, 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

Composition of Dalacin Cutaneous Emulsion

• The active ingredient is clindamycin. Each ml contains 10 mg of clindamycin (as phosphate).
• The other components (excipients) are: stearic acid, cetostearyl alcohol, glycerol monostearate, methyl parahydroxybenzoate (E218), sodium laurylsarcosinate, glycerol, isostearyl alcohol, and purified water.

Appearance of the Product and Package Contents:

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 dosing cap.

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 the Last Revision of this Package Leaflet: February/2017

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/