Biafineact emulsion tube of 139.5g

- Avoid the hottest part of the day.

In this leaflet :

1. WHAT IS BIAFINEACT, emulsion for cutaneous application AND WHAT IS IT USED FOR?

2. WHAT YOU SHOULD KNOW BEFORE USING BIAFINEACT, emulsion for cutaneous application

3. HOW DO I USE BIAFINEACT, emulsion for cutaneous application?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE BIAFINEACT, emulsion for cutaneous application?

6. ADDITIONAL INFORMATION

1. WHAT IS BIAFINEACT, emulsion for cutaneous application AND WHAT IS IT USED FOR?

This medicine is a skin protector. It belongs to the class of dermatological drugs.

BIAFINEACT, emulsion for cutaneous application, is indicated in the treatment of:

- Superficial and not very extensive burns, including localised sunburn,

- Non-infected skin wounds.

2. WHAT DO YOU KNOW BEFORE USING BIAFINEACT, emulsion for cutaneous application?

BIAFINEACT, emulsion for cutaneous application, is not a sunscreen.

BIAFINEACT, emulsion for cutaneous application, should not be used as a skin care cream on healthy skin

Never use BIAFINEACT, emulsion for cutaneous application in the following cases:

- Known allergy to any of the components of the preparation,

- Wound with bleeding,

- Infected lesion.

Take care with BIAFINEACT, emulsion for cutaneous application in the following cases:

Take the advice of your pharmacist or doctor if you are in doubt about the severity of your lesion.

If you have a blistering burn or a large burn, or a deep or large wound, you should seek medical advice before applying any medication to the wound.

Taking or using other medicines

Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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Important information on the ingredients of BIAFINEACT, emulsion for dermal application:

The following excipients are components of which knowledge is necessary for safe use in certain patients:

- Propylene glycol

- Potassium sorbate

- Sodium methyl parahydroxybenzoate (E 219)

- Sodium propyl parahydroxybenzoate (E 217)

3. HOW TO USE BIAFINEACT, emulsion for skin application

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Dosage

- Treatment of superficial and small burns, including localized sunburns: apply in a thick layer until the skin refuses. Apply a thick layer until the skin does not accept it. Massage gently to make it penetrate the skin. Repeat 2 to 4 times a day. Any burn that is infected or not healed after one week should be referred to a doctor.

- Non-infected skin wounds: after cleaning the wound, apply a thick layer of emulsion over the surface of the lesion and repeat the applications to maintain an excess of emulsion on the lesion. Any infected or unhealed skin wound after one week should be referred to a doctor.

For the pressurized bottle: in case of blockage, run the diffuser under warm water. Slight resistance of the diffuser when first used indicates that the product has never been used.

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4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, BIAFINEACT, emulsion for cutaneous application, is likely to have undesirable effects, although not everyone is subject to them.

- Occasionally, moderate and transient (15 to 30 minutes) pain (tingling) may occur after application.

- Rarely, a contact allergy has been observed.

- Very rare cases of contact eczema requiring immediate discontinuation of treatment have been observed.

- The presence of certain excipients may cause skin irritation, or local skin reactions (e.g. contact dermatitis) or allergic reactions (possibly delayed).

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.

5. HOW TO STORE BIAFINEACT, emulsion for cutaneous application

Keep out of the reach and sight of children.

Do not use BIAFINEACT, emulsion for dermal application after the expiry date stated on the box, tube or bottle. The expiry date refers to the last day of the month.

Do not freeze.

For the pressurized bottle:

Pressurized container. Protect from sunlight, do not expose to temperatures exceeding 50°C. Do not pierce, do not throw into fire even if empty

Do not use if you notice any visible signs of deterioration of the product.

Do not dispose of medicines in the sewage system or with household waste. Ask your pharmacist what to do with unused medication. This will help protect the environment.

6. ADDITIONAL INFORMATION

What does BIAFINEACT, emulsion for cutaneous application, contain?

The active substance is:

Trolamine ........................................................................................................................................ 0.670 g

For 100 g of emulsion for dermal application.

The other components are:

Ethylene glycol stearate, stearic acid, cetyl palmitate, solid paraffin, liquid paraffin, perhydrosqualene, propylene glycol, avocado oil, sodium trolamine alginate, potassium sorbate, sodium methyl parahydroxybenzoate (E 219), sodium propyl parahydroxybenzoate (E 217), Yerbatone flavour, purified water.

What is BIAFINEACT, emulsion for cutaneous application and what does it contain?

BIAFINEACT, emulsion for cutaneous application, is available as an emulsion for cutaneous application in tubes of 139.5 g or 186 g and in pressurised bottles of 50 ml or 150 ml.

Not all presentations may be marketed.

Holder

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1, rue Camille Desmoulins

92130 ISSY-LES-MOULINEAUX

Operator

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1, rue Camille Desmoulins

92130 ISSY-LES-MOULINEAUX

Manufacturer

JANSSEN CILAG

DOMAINE DE MAIGREMONT

27100 VAL DE REUIL

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The last date on which this package insert was approved was {date}.

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Detailed information on this medicinal product is available on the website of Afssaps (France).

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Ask your pharmacist or doctor:

- · If you need further information or advice.

- · If you are not sure whether this medicine is right for you, especially

o If you are pregnant or breastfeeding,

o If you have any other disease besides the one you want to treat with this medicine,

o If you are taking other medicines at the same time, even if they are sold without a prescription,

o If you have ever been allergic to any medication,

o If you experience any discomfort while using this medication.

HEALTH ADVICE/EDUCATION

ONLY LIMITED AND SHORT-LIMITED BURNS NOT IN RISK AREAS (eyes, face, genitals, flexures, hands, feet) CAN BE MANAGED BY YOURSELF.

In all cases, the lesions must be cooled immediately by running water at 15°C (cold tap water), 15 cm from the burn, for about 15 minutes.

The lesion should then be carefully cleaned with an antiseptic solution before applying BIAFINEACT emulsion.

In the case of "sunburn", the relief provided by the application of BIAFINEACT emulsion should not lead to further exposure to the sun.

MEDICAL ADVICE SHOULD BE SOUGHT IN THE FOLLOWING CASES:

- Extent of the burn greater than 2% of the body surface: in children and elderly people the risk of dehydration in case of extensive burn requires medical advice,

- burning in the eyes, face, genitals, flexion creases, hands, feet,

- fever which may be a sign of infection,

- lack of healing after 7 days.

SIMPLE PRECAUTIONS CAN AVOID DOMESTIC ACCIDENTS OR SUNBURNS.

Preventing home burns

Most burns occur at home and during leisure time.

A few precautions can help prevent them:

- Set hot water taps so that the temperature does not exceed 50°C,

- Always turn the handles of pots and pans towards the inside of the stove,

- Keep children away from the kitchen,

- Never leave a child under 10 years old alone in the house,

- Keep children away from the fireplace and any unprotected flames.

Prevention of sunburn

BIAFINEACT, emulsion is not a sunscreen. You must use adequate protection when exposed to the sun.

A few precautions can help prevent sunburn:

- Keep light clothing on,

- Regularly apply a sun cream that guarantees an adequate level of protection,

- Reapply sunscreen after bathing,