Clinwas 10 mg/g gel

Label: information for the user

Clinwas 10 mg/g gel

clindamicina

Read this label carefully before starting to use this medication, as it contains important information for you.

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

Clinwas gel is an antibiotic medication that belongs to a group of drugs known as 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 common acne in adults and adolescents over 12 years old.

Do not use Clinwas gel

• If you are allergic to clindamycin or any of the other ingredients in this medication listed in section 6.
• If you have demonstrated sensitivity to lincomycin (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 diarrhea associated with the antibiotic appears.

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

Children and adolescents

This medication is indicated for adolescents over 12 years old.

Other medications and Clinwas gel

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

Due to its topical administration, Clinwas gel usually does not present interactions with other medications.

Inform your doctor if you take or use any of the following medications:

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

Pregnancy and lactation

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

The safety of Clinwas gel has not been established, so it should not be used if you are pregnant or think you may be pregnant, if you plan to become pregnant, or if you are breastfeeding.

Driving and operating machines

The influence of Clinwas gel on the ability to drive and operate machinery is negligible or insignificant.

Clinwas gel contains propylene glycol, methyl parahydroxybenzoate, and propyl parahydroxybenzoate

Clinwas gel contains 50 mg of propylene glycol in each gram of gel.

Clinwas gel may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Apply twice a day to the affected area a thin layer of gel, gently rubbing it in to promote absorption. It is recommended to apply with cotton or the tip of your fingers on clean and dry skin.

The treatment duration should not exceed 12 weeks.

If you use more Clinwas gel than you should

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

If contact with the eyes and/or mucous membranes occurs accidentally, wash immediately with plenty of cold water.

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

If you forgot to use Clinwas gel

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Among these adverse effects, listed in order from most frequent to least frequent:

Frequent Adverse Effects (may affect up to 1 in 10 people)

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

Less Frequent Adverse Effects (may affect up to 1 in 100 people)

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

Rare Adverse Effects(may affect up to 1 in 1,000 people)

• Folliculitis, burning sensation, acne exacerbation.

Very Rare Adverse Effects(may affect up to 1 in 10,000 people)

• Colitis.

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 Medicines for Human Use: https://www.notificaram.es

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

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 that appears on the packaging after CAD. 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 packaging and unused medicines at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Clinwas gel

• The active ingredient is clindamicina. Each gram of gel contains 10 mg of clindamicina.
• The other components are carbomers, edetate of disodium, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, triethanolamine, and purified water.

Appearance of the product and contents of the package

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L'Hospitalet de Llobregat

Barcelona (Spain)

Responsible for manufacturing

B. BRAUN MEDICAL, S.A.

c/ Huelma, 5 Industrial Park Los Olivares

23009 Jaén, Spain

Last review date of this leaflet:December 2024.

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

PR_02_04a