FURASEPTIC 10 MG/ML CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the Patient

Furaseptic 10 mg/ml Cutaneous Solution

Chlorhexidine Digluconate

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

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

Contents of the Package Leaflet

1. What is Furaseptic 10 mg/ml and what is it 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 packaging and additional information

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

Furaseptic contains chlorhexidine as the active ingredient. Chlorhexidine is an antiseptic that is administered on the skin.

It is indicated as an antiseptic for wounds and minor skin burns, and as an antiseptic for the umbilical cord in newborns.

You should consult a doctor if it worsens or does not improve after 5 days.

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

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 inside the mouth or other mucous membranes.

• Do not use on eyes or ears, or inside the mouth or other mucous membranes.

Warnings and Precautions

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

• This medication is for external use on the skin only. 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 damage. 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) that may require a corneal transplant have been reported when similar products have accidentally come into contact with the eyes during surgical interventions, 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, nor use on large surfaces, with occlusive dressing (non-permeable), on damaged skin, and on mucous membranes.

Do not use for the asepsis of puncture or injection areas, nor for the disinfection of surgical equipment.

• Remove any soaked material, gauze, or clothing before starting the intervention.

Do not use large quantities and avoid accumulating the solution in skin folds, under the patient, or soaking bedding or other moist materials in direct contact with the patient.

When applying an occlusive dressing to areas previously exposed to this medication, be especially careful not to have excess product before placing the dressing.

Children and Adolescents

• Consult with a doctor before using in children under 30 months.
• Use with caution in neonates, especially in premature babies born before the 32nd week of gestation and during the first two weeks of life. This medication can cause chemical burns to the skin.

Using Furaseptic with Other Medications

• Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Avoid using several antiseptics at the same time or successively, except with other cationic compounds (e.g., benzalkonium chloride).

• Do not use in combination or after applying anionic soaps (soaps), acids, heavy metal salts, and iodine, so the skin should be rinsed well after cleaning.

Pregnancy, Breastfeeding, and Fertility

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

There are no data or limited data on the use of chlorhexidine in pregnant women.

It is unknown whether chlorhexidine is excreted in breast milk, so the possible risk of systemic effects should be considered.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is zero or insignificant.

3. How to Use Furaseptic 10 mg/ml

Cutaneous use. DO NOT INGEST

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

Administer undiluted. It is recommended to clean and dry the wound before applying Furaseptic. Apply directly to the affected area, or to a gauze, one or two times a day. Let it act and dry.

Do not perform more than two daily applications of the product.

If You Use More Furaseptic Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Information for Healthcare Professionals

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.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The following side effects may occur (frequency not known: cannot be estimated from available data):

• Skin allergic disorders such as dermatitis (skin inflammation), pruritus (itching), erythema (skin redness), eczema, eruption, urticaria (hives), skin irritation, and blisters, and chemical burns in neonates.
• Corneal injury (injury to the surface of the eye) and permanent eye injury, including permanent visual impairment (after accidental eye exposure during surgical interventions in the head, face, and neck) in patients under general anesthesia (deep, painless sleep).

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Furaseptic 10 mg/ml

Keep this medication out of 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 shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE Point. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Contents of the Packaging and Additional Information

Composition of Furaseptic 10 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 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 come into contact with this medication should not be washed with bleach or other hypochlorites, as it may cause a brownish discoloration of the tissues, but with domestic detergents based on sodium perborate.

Marketing Authorization Holder and Manufacturer

SEID, S.A.

Carretera de Sabadell a Granollers Km 15

08185 Lliçà de Vall – Barcelona

Spain

Date of the Last Revision of this Package Leaflet: June 2024

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