PATIENT INFORMATION LEAFLET

Clorxil 5mg/g cream

Clorhexidina digluconate

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

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

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.
• Do not apply near the eyes, in the ear, or in the interior of the mouth; in case of accidental contact, wash immediately with plenty of water.
• Do not use on deep and extensive wounds without consulting a doctor.
• Do not use on large areas, or with occlusive dressings (non-breathable).

Clothes that have been in contact with Clorxil 5 mg/g should not be washed with bleach or other hypochlorites, as this would cause a dark discoloration of the fabric, but with domestic detergents based on sodium perborate.

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

Use in children

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

Use of Clorxil with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or might have to use any other medicine.

Avoid simultaneous or successive use of other disinfectants.

The product is incompatible with anionic derivatives (soaps) so the skin should be thoroughly rinsed after cleaning.

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.

The consumption of medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

Driving and operating machinery

No effects are expected in this sense under the indicated 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 cetomacrogol.

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

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or nurse. In case of doubt, ask your doctor or pharmacist.

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

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

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

This product should not be used 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 Toxicological Information Service. Telephone 91 5620420, indicating the medication and the amount ingested.

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

The most characteristic adverse effects are:

• Risk of systemic effects
• Some 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 that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects not appearing 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 about the safety of this medication.

Keep the tube perfectly closed to protect it from light.

Store below 25°C.

Keep this medication out of 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.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Clorxil 5 mg/g

The active ingredient is: Chlorhexidine digluconate

The other components (excipients) are:

Monoestearate of glycerol, cetyl alcohol, polisorbate 80, polisorbate 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 packaging

White cream.

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS BOHM, S.A.

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

28947 Fuenlabrada. (Madrid).

91 642 18 18

Last review date of this leaflet: June 2015

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