CLORXIL 5 mg/g CREAM

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

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

Use with caution in neonates, especially in premature babies. Clorxil 5mg/g can cause chemical burns to the skin.

Use in children

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

Using Clorxil with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

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

Pregnancy and Breastfeeding

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

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

Driving and using machines

No effects are expected in this regard under the indicated conditions of use.

Important information about some of the ingredients 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 instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or nurse. In case of doubt, ask your doctor or pharmacist.

This medicine should be administered directly to the 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. Phone 91 5620420, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most characteristic side 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 of the treated area).

If you think any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side 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 which is stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Clorxil 5 mg/g

The active ingredient is: Chlorhexidine digluconate

The other ingredients (excipients) are:

Glycerol monostearate, cetyl 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 pack

White cream.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

LABORATORIOS BOHM, S.A.

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

28947 Fuenlabrada. (Madrid).

91 642 18 18

Date of last revision of this leaflet: June 2015

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es