CLINWAS 10 mg/ml CUTANEOUS SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

Clinwas 10 mg/ml Cutaneous Spray Solution

clindamycin

Read the entire 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 doubts, 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 Clinwas Cutaneous Spray Solution is and what it is used for
2. What you need to know before starting to use Clinwas Cutaneous Spray Solution
3. How to use Clinwas Cutaneous Spray Solution
4. Possible side effects
5. Storage of Clinwas Cutaneous Spray Solution
6. Package Contents and Additional Information

1. What Clinwas Cutaneous Spray Solution is and what it is used for

Clinwas Cutaneous Spray Solution 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 Cutaneous Spray Solution 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 starting to use

Do not use Clinwas Cutaneous Spray Solution

• 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 antibiotic-associated diarrhea.

Consult your doctor or pharmacist before starting to use Clinwas Cutaneous Spray Solution.

Children and Adolescents

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

Other Medications and Clinwas Cutaneous Spray Solution

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 Cutaneous Spray Solution 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

It has not been established as safe, and Clinwas Cutaneous Spray Solution should not be used if you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding.

Driving and Using Machines

The influence of Clinwas Cutaneous Spray Solution on the ability to drive and use machines is negligible or non-existent.

Clinwas Cutaneous Spray Solution contains Propylene Glycol

Clinwas Cutaneous Spray Solution contains 50 mg of propylene glycol per milliliter of solution.

3. How to use Clinwas Cutaneous Spray Solution

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

Apply a thin layer of the solution to the affected area twice a day, gently rubbing to facilitate absorption. Press the spray container at a distance of approximately 10 cm from the skin surface to be treated, with the skin clean and dry.

The treatment duration should not exceed 12 weeks.

If you use more Clinwas Cutaneous Spray Solution 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 you accidentally come into contact with the 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 Cutaneous Spray Solution

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

If you have any further questions about the use of 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 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 Cutaneous Spray Solution

This medication does not require special storage conditions.

Keep this medication out of 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 Cutaneous Spray Solution

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

Appearance of the Product and Package Contents

Clinwas Cutaneous Spray Solution is presented in a glass bottle with a spray valve containing 30 milliliters or 50 milliliters of a clear solution.

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

ITALFÁRMACO, S.A.

San Rafael, 3

Alcobendas

28108 Madrid

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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