Clinwas 10 mg/ml soluciÓn para pulverizaciÓn cutÁnea

Label: information for the user

Clinwas 10 mg/ml topical solution for skin spray

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 solution for skin powderization is an antibiotic medication that belongs to a group of drugs called topical anti-acne preparations. It acts by slowing the growth of bacteria that cause acne.

Clinwas solution for skin powderization is indicated for the treatment of mild to moderate acne vulgaris in adults and adolescents over 12 years old.

No use Clinwas solution for topical application

• If you are allergic to clindamycin or any of the other components of 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 solution for topical application.

Children and adolescents

This medication is indicated for adolescents over 12 years old.

Other medications and Clinwas solution for topical application

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 Solution for topical application 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 think you may be pregnant, consult your doctor or pharmacist before using this medication.

Its safety has not been established, so Clinwas solution for topical application should not be used if you are pregnant or think you may be, if you plan to become pregnant, or if you are breastfeeding.

Driving and operating machinery

Clinwas solution for topical application has no or insignificant influence on the ability to drive and operate machinery.

Clinwas solution for topical application contains propylene glycol

Clinwas solution for topical application contains 50 mg of propylene glycol in each milliliter of solution.

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 light layer of solution, gently rubbing it in to facilitate absorption. Press the nebulizer container at an approximate distance of 10 cm over the skin surface being treated, with the skin clean and dry.

The treatment duration should not exceed 12 weeks.

If you use more Clinwas solution for topical spray 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 accidental contact with the eyes and/or mucous membranes occurs, immediately rinse 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 solution for topical spray

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

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 Medicinal Products 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 conservation 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 thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Composition of Clinwas solution for topical application

• The active ingredient is clindamicina. Each milliliter of solution contains 10 mg of clindamicina.
• The other components are isopropyl alcohol, propylene glycol, sodium hydroxide, and purified water.

Appearance of the product and contents of the container

Clinwas solution for topical application is presented in a glass bottle with a nebulizing valve containing 30 milliliters or 50 milliliters of transparent solution.

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

ITALFÁRMACO, S.A.

San Rafael, 3

Alcobendas

28108 Madrid

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