Clorxil 5 mg/g cream

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clorxil 5 mg/g cream

Chlorhexidine digluconate

Package leaflet contents:

1. What Clorxil 5 mg/g cream is and what it is used for.
2. What you need to know before using Clorxil 5 mg/g cream.
3. How to use Clorxil 5 mg/g cream.
4. Possible side effects.
5. How to store Clorxil 5 mg/g cream.
6. Contents of the pack and other information.

1. What Clorxil 5 mg/ml cream is and what it is used for

Clorxil 5 mg/g contains chlorhexidine digluconate, which is a topical antiseptic.

It is indicated as a skin antiseptic for erosions, minor superficial wounds, mild burns, and abrasions.

2. What you need to know before using Clorxil 5 mg/ml cream

Do not use Clorxil 5 mg/g

If you are allergic (hypersensitive) to chlorhexidine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Clorxil 5 mg/g cream.

• This medicine is for external use only on the skin. Do not ingest or inhale.
• It must not be applied near the eyes, inside the ear, or inside the mouth; in case of accidental contact, rinse immediately with plenty of water.
• Should not be used on deep or extensive wounds without consulting a doctor.
• Do not use on large areas of skin, or under occlusive dressings (non-breathable bandages).

Clothing that has been in contact with Clorxil 5 mg/g should not be washed with bleach or other hypochlorites, as this may cause dark staining of fabrics. Instead, wash with household detergents based on sodium perborate.

Use with caution in neonates, especially in premature infants. Clorxil 5 mg/g may cause chemical burns on the skin.

Use in children

• Do not use in children under 30 months of age without consulting a doctor.

Use of Clorxil with other medicines

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

The simultaneous or sequential use of other disinfectants should be avoided.

The product is incompatible with anionic derivatives (soaps); therefore, the skin should be thoroughly rinsed after cleansing.

Pregnancy and breastfeeding

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

Taking medicines during pregnancy can be harmful to the embryo or fetus and should be monitored by your doctor.

Driving and use of machines

Effects of this type are not expected under the recommended conditions of use.

Important information about some of the components of Clorxil 5 mg/g

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.

This medicine may cause skin irritation because it contains propylene glycol.

3. How to use Clorxil 5 mg/ml cream

Follow exactly the administration instructions provided in this leaflet or those given by your doctor or nurse. If in doubt, consult your doctor or pharmacist.

This medicine should be applied directly to wounds or affected areas after cleaning and drying the wound.

It is recommended not to use more than two applications of the product per day.

If symptoms worsen or persist after 7 days, consult your doctor.

Do not use for more than 7 consecutive days.

If you use more Clorxil 5 mg/g than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 5620420, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The most characteristic adverse effects are:

• Risk of systemic effects
• Isolated cases of hypersensitivity (allergy) to chlorhexidine have been observed.
• Possibility of allergic eczema and photosensitization (sensitivity to sunlight in the treated area).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 may also report them directly through 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 Clorxil 5 mg/ml cream

Keep the tube tightly closed to protect it from light.

Store below 25°C.

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 refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to a pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clorxil 5 mg/g

The active substance is: Chlorhexidine digluconate.

The other components (excipients) are:

Glyceryl monostearate, cetostearyl alcohol, polysorbate 80, polysorbate 60, propylene glycol, liquid paraffin, preservative containing butylene glycol, ethyl parahydroxybenzoate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, distilled water.

Appearance of the product and contents of the container

White cream.

It is presented in tubes of 50 g, 100 g and 200 g.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

LABORATORIOS BOHM, S.A.

C/ Molinaseca, 23-25. Polígono Industrial Cobo Calleja.

28947 Fuenlabrada. (Madrid).

91 642 18 18

Date of the most recent review of this leaflet: June 2015

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http:// www.aemps.es