Furaseptic 10 mg/ml solucion cutanea

Leaflet: information for the patient

Furaseptic 10 mg/ml topical solution

Chlorhexidine digluconate

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 5 days.

1. What is Furaseptic 10 mg/ml and what it is used for

2. What you need to know before starting to use Furaseptic 10 mg/ml

3. How to use Furaseptic 10 mg/ml

4. Possible side effects

5. Storage of Furaseptic 10 mg/ml

6. Contents of the pack and additional information

Furasepticcontains as its active ingredient chlorhexidine. Chlorhexidine is an antiseptic that is administered to the skin.

It is indicated as a wound antiseptic and for light skin burns, and as an umbilical antiseptic in newborns.

Consult a doctor if it worsens or does not improve after 5 days.

Do not useFuraseptic

- If you are allergic to chlorhexidine or any of the other components of this medication (listed in section 6).

- Do not use in eyes or ears, or in the interior of the mouth or other mucous membranes.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication.

- This medication is exclusively for external use on the skin. DO NOT INGEST.

- Avoid contact with the brain, meninges (the membranes surrounding the brain and spinal cord) and the middle ear.

- Furaseptic should not come into contact with the eyes due to the risk of visual injury. If it comes into contact with the eyes, wash immediately and abundantly with water. In case of irritation, redness, or pain in the eyes, or visual disturbances, consult a doctor immediately.

Severe cases of persistent corneal injury (injury to the surface of the eye) have been reported, which could require a corneal transplant when similar products have accidentally come into contact with the eyes during surgical procedures, in patients under general anesthesia (deep, painless sleep).

- Do not use in case of deep and extensive wounds without consulting a doctor.

- Do not apply repeatedly, or use on large surfaces, with occlusive dressing (non-breathable), on injured skin and in mucous membranes.

- Do not use for the asepsis of puncture or injection sites, or for the disinfection of surgical materials.

-Remove any soaked material, gauze, or pajamas before starting the procedure.

-Do not use large quantities and avoid allowing the solution to accumulate in skin folds, under the patient, or soak the sheets or other wet material in direct contact with the patient.

-When applying occlusive dressing to areas previously exposed to this medication, be sure to take special care that there is no excess product before placing the dressing.

Children and adolescents

- Consult with your doctor before using in children under 30 months.

- Use with caution in newborns, especially in premature babies born before 32 weeks of gestation and during the first two weeks of life. This medication may cause chemical burns on the skin.

Use ofFurasepticwith other medications

- Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication.

- Avoid using multiple antiseptics at the same time or in succession, except with other cationic compounds (e.g. benzalkonium chloride).

- Do not use in combination with or after the application of anionic soaps (soaps), acids, heavy metal salts, and iodine, so the skin should be thoroughly rinsed after cleaning.

Pregnancy, breastfeeding, and fertility

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

No data or limited data are available regarding the use of chlorhexidine in pregnant women.

The excretion of chlorhexidine in breast milk is unknown, so the possible risk of systemic effects should be taken into account.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Cutaneous use. DO NOT INGEST

Follow exactly the administration instructions of the medication contained in this

leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor

or pharmacist.

Administer undiluted. It is recommended to clean and dry the wound before applyingFuraseptic. Apply directly to the affected area, or on a gauze, one or two times a day. Leave to act and dry.

Do not perform more than two applications per day of the product.

If you use moreFurasepticthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately

or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Information for the healthcare professional

In case of accidental ingestion, proceed with gastric lavage and protection of the digestive mucosa. Cases of hemolysis have been described after ingestion of chlorhexidine.

In case of hemolysis, blood transfusion may be necessary.

Like all medications, this medication may produce adverse effects,

although not all people may experience them.

The following adverse effects may occur (unknown frequency: cannot be estimated from available data):

• Dermatological allergic reactions such as dermatitis (skin inflammation), pruritus (itching), erythema (skin redness), eczema, rash, urticaria (hives), skin irritation, and chemical burns in neonates.
• Corneal injury (injury to the eye surface) and permanent eye injury, including permanent visual impairment (following accidental ocular exposure during surgical procedures on the head, face, and neck) in patients under general anesthesia (deep, painless sleep).

Reporting 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 prospectus. You can also

report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of

this medication.

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

Store below 30°C.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after

the abbreviation CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and

medicines you no longer need at a SIGRE collection point at the pharmacy. If in doubt, ask your

pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you

will help protect the environment.

Composition ofFuraseptic10 mg/ml

• The active ingredient is chlorhexidine digluconate. Each ml contains 10 mg of chlorhexidine digluconate.
• The other components (excipients) are: purified water.

Appearance of the product and contents of the packaging

Transparent solution that is presented in a 30 ml white plastic bottle with a dropper or in a 30 ml white plastic bottle with a sprayer.

Additional information

Clothing that has been in contact with this medication should not be washed with bleach or other hypochlorites, as this would cause a brownish discoloration of the tissues, but rather with domestic detergents based on sodium perborate.

Holder of the marketing authorization and responsible for manufacturing

SEID, S.A.

Carretera de Sabadell a Granollers Km 15

08185 Lliçà de Vall – Barcelona

Spain

Last review date of this leaflet:June 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/.