CLINWAS 10 MG/ML SOLUTION FOR CUTANEOUS SPRAY

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clinwas 10 mg/ml solution for cutaneous spray

clindamycin

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Clinwas cutaneous spray solution is and what it is used for
2. What you need to know before using Clinwas cutaneous spray solution
3. How to use Clinwas cutaneous spray solution
4. Possible side effects
5. How to store Clinwas cutaneous spray solution
6. Contents of the pack and other information

1. What Clinwas cutaneous spray solution is and what it is used for

Clinwas cutaneous spray solution is an antibiotic medicine that belongs to a group of drugs known as topical anti-acne preparations. It works by inhibiting the growth of bacteria that cause acne.

Clinwas cutaneous spray solution is indicated for the treatment of mild to moderate vulgar acne 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 to any of the other ingredients of this medicine listed in section 6.
• If you have demonstrated sensitivity to lincomycin (an antibiotic).
• If you are pregnant or breastfeeding.

Warnings and precautions

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

Consult your doctor or pharmacist before starting to use Clinwas cutaneous spray solution.

Children and adolescents

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

Other medicines and Clinwas cutaneous spray solution

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

Due to its topical administration, Clinwas Cutaneous Spray Solution is unlikely to interact with other medicines.

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

• Antibiotic medicines: lincomycin, metronidazole, gentamicin, aminoglycosides, erythromycin, chloramphenicol.
• Anti-inflammatory medicines: acetylsalicylic acid.
• Sulfur.
• Medicines for treating acne: tretinoin, benzoyl peroxide.
• Neuromuscular blocking agents used as muscle relaxants.
• Soaps and cosmetics with a strong drying effect, or cosmetic products with high alcohol concentrations (e.g., after-shave lotions).

Pregnancy and breastfeeding

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

Safety has not been established; therefore, Clinwas cutaneous spray solution should not be used if you are pregnant or think you might be, if you plan to become pregnant, or if you are breastfeeding.

Driving and using machines

The effect of Clinwas cutaneous spray solution on the ability to drive and operate machinery is none or negligible.

Clinwas cutaneous spray solution contains propylene glycol

Clinwas cutaneous spray solution contains 50 mg of propylene glycol in each milliliter of solution.

3. How to use Clinwas cutaneous spray solution

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Apply a thin layer of the solution twice daily to the affected area, gently rubbing to promote absorption. Press the spray container from a distance of approximately 10 cm over the skin surface to be treated, ensuring that the skin is clean and dry.

The duration of treatment 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 such cases, using a moisturizing cream may be beneficial.

If accidental contact with the eyes and/or mucous membranes occurs, immediately rinse thoroughly with plenty of cold water.

In case of overdose or accidental ingestion, contact 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 missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

These adverse effects include, in order from most to least frequent:

Frequent adverse effects (may affect up to 1 in 10 people)

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

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

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

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

• Inflammation of hair follicles, burning sensation, exacerbation of acne.

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

• Inflammation of the colon.

Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es

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

5. Storage of Clinwas cutaneous spray solution

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6.

Composition of Clinwas cutaneous spray solution

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

Appearance of the product and contents of the container

Clinwas cutaneous spray solution is supplied in a glass bottle with a spray pump containing 30 millilitres or 50 millilitres of clear solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: December 2024.

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

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