CLINWAS 10 mg/g GEL

Introduction

Package Leaflet: Information for the User

Clinwas 10 mg/g gel

clindamycin

Read the package leaflet carefully before starting to use this medication, as 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 not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Clinwas gel and what is it used for
2. What you need to know before using Clinwas gel
3. How to use Clinwas gel
4. Possible side effects
5. Storage of Clinwas gel
6. Package contents and additional information

1. What is Clinwas gel and what is it used for

Clinwas gel is an antibiotic medication that belongs to a group of drugs called topical anti-acne preparations. It works by slowing the growth of bacteria that cause acne.

Clinwas gel is indicated for the treatment of mild to moderate acne vulgaris in adults and adolescents over 12 years of age.

2. What you need to know before using Clinwas

Do not use Clinwas gel

• If you are allergic to clindamycin or any other component of this medication, including those listed in section 6.
• If you have demonstrated sensitivity to lincomycin (an antibiotic).
• If you are pregnant or breastfeeding.

Warnings and precautions

• If you have atopic dermatitis (especially sensitive and dry skin).
• If you have a history of inflammatory gastrointestinal diseases (Crohn's disease, ulcerative colitis).
• If you experience diarrhea associated with the antibiotic.

Consult your doctor or pharmacist before starting to use Clinwas gel.

Children and adolescents

This medication is indicated for adolescents over 12 years of age.

Other medications and Clinwas gel

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Due to its topical administration, Clinwas gel is unlikely to interact with other medications.

Inform your doctor if you are taking or using any of the following medications:

• Antibiotic medications: lincomycin, metronidazole, gentamicin, aminoglycosides, erythromycin, chloramphenicol.
• Anti-inflammatory medications: acetylsalicylic acid
• Sulfur
• Acne treatments: tretinoin, benzoyl peroxide
• Muscle relaxants used as neuromuscular blockers.
• Soaps and cosmetics with a strong drying effect, or cosmetic products with high concentrations of alcohol (e.g., after-shave lotions).

Pregnancy and breastfeeding

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

Clinwas gel should not be used if you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, as its safety has not been established.

Driving and using machines

Clinwas gel has no significant influence on the ability to drive and use machines.

Clinwas gel contains propylene glycol, methylparaben, and propylparaben

Clinwas gel contains 50 mg of propylene glycol per gram of gel.

Clinwas gel may cause allergic reactions (possibly delayed) because it contains methylparaben and propylparaben.

3. How to use Clinwas gel

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Apply a thin layer of gel to the affected area twice a day, gently rubbing it in to facilitate absorption. It is recommended to apply it using a cotton swab or with your fingertips on clean, dry skin.

The treatment duration should not exceed 12 weeks.

If you use more Clinwas gel than you should

If excessive amounts of Clinwas gel are applied, skin irritation may occur. In these cases, using a moisturizing cream may be beneficial.

If you accidentally get it in your eyes and/or mucous membranes, rinse immediately with plenty of cold water.

In case of overdose or accidental ingestion, consult the Toxicology Information Service (telephone: 91 562 04 20).

If you forget to use Clinwas gel

Do not use a double dose to make up for forgotten doses.

If you have any further questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

These side effects include, in order of frequency:

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

• Dry skin, skin irritation, redness of the skin, scaling, burning sensation, irritation of the skin around the eye.

Uncommon side effects (may affect up to 1 in 100 people)

• Abnormal tingling sensation, skin pain, rash, oily skin, abdominal pain, gastrointestinal discomfort (diarrhea, nausea, and vomiting).

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

• Folliculitis, burning sensation, exacerbation of acne.

Very rare side effects (may affect up to 1 in 10,000 people)

• Colitis.

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: https://www.notificaram.es

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

5. Storage of Clinwas gel

This medication does not require special storage conditions.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. 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 at the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6.

Composition of Clinwas gel

• The active ingredient is clindamycin. Each gram of gel contains 10 mg of clindamycin.
• The other ingredients are carbomers, disodium edetate, propylene glycol, methylparaben, propylparaben, triethanolamine, and purified water.

Appearance and packaging of the product

Clinwas gel is a compressible aluminum tube containing 30 grams or 50 grams of transparent gel.

Marketing authorization holder and manufacturer

Marketing authorization holder

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, Planta 10

08908 L'Hospitalet de Llobregat

Barcelona (Spain)

Manufacturer

• BRAUN MEDICAL, S.A.

c/ Huelma, 5 Polig. Industrial Los Olivares

23009 Jaén, Spain

Date of the last revision of this package leaflet:December 2024.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es).

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