Biafine Emuls Tb 186g

What is Biafine and when is it used?

Biafine is an emulsion that is applied to the skin to treat small, first-degree skin burns, minor wounds and non-infected injuries such as abrasions or ulcers (sores) of the legs, and to protect and heal sensitive skin.

With a doctor's prescription, Biafine can be used alternately with other dermatological medicines containing active ingredients .

What should be considered?

Biafine is not a care or sun protection cream. It should not be used in the area of ​​the mucous membranes or near the eyes.

In the case of extensive burns, you must consult your doctor.

Large, heavily soiled and deep wounds, as well as wounds from bites or stings, must be treated by a doctor (risk of tetanus).

If the extent of an injury does not decrease after a certain time or if the wound heals within If it does not improve after a week, it is advisable to see a doctor. This is also the case if the edges of the wound are very red, if the wound suddenly swells, is very painful or is accompanied by fever (risk of infection).

When must Biafine not be used?

Biafine must not be used if you are allergic to any of the ingredients (see «What does Biafine contain?»). It should also not be applied to wounds that are infected or bleeding profusely.

When should caution be taken when using Biafine?

Biafine should not be used 3 hours before radiotherapy. Avoid using this emulsion for a long time and on large areas without first talking to your doctor, pharmacist or druggist.

The use and safety of Biafine Emulsion in children and adolescents have not been studied to date.

This medicinal product contains 23 mg propylene glycol per g of cream. Propylene glycol may cause skin irritation.

This medicinal product contains 1 mg of benzoate per g of cream, as sodium methyl p-hydroxybenzoate (E 219) and sodium propyl p-hydroxybenzoate (E 217) and may cause allergic reactions, including delayed reactions.

Contains potassium sorbate (E 202): May cause localized skin irritation (e.g. contact dermatitis).

This medicinal product contains a Fragrance with 3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one, benzyl benzoate, citral, citronellol, D-limonene, eugenol, geraniol, 2-benzylideneoctanal, hydroxycitronellal, hydroxymethylpentyl-cyclohexenecarboxaldehyde, isoeugenol and linalool.

3-Methyl-4-(2,6, 6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one, benzyl benzoate, citral, citronellol, D-limonene, eugenol, geraniol, 2-benzylideneoctanal, hydroxycitronellal, hydroxymethylpentyl-cyclohexenecarboxaldehyde, isoeugenol and linalool can cause allergic reactions.

Inform your doctor, pharmacist or druggist , pharmacist or druggist, if you

• suffer from other diseases,
• have allergies or
• take other medicines (including those you bought yourself!) or use them externally!

Can Biafine be used during pregnancy or breastfeeding?

Based on previous experience, there is no known risk for the child if used as intended. However, systematic scientific investigations have never been carried out. As a precaution, you should avoid taking medicines during pregnancy and breastfeeding or ask your doctor, pharmacist or druggist for advice.

How do you use Biafine?

Adults

First degree burns

Apply a thick layer until the skin can no longer absorb the emulsion. Allow the emulsion to soak in by gently massaging it in. Repeat 2 to 4 times a day.

Skin injuries

After cleaning the wound, apply a thick layer of emulsion well beyond the edges of the wound. Repeat the application regularly so that the wound is generously covered with Biafine the whole time. Cover with a damp compress if necessary.

Do not use absorbent bandages.

Protection and healing of sensitive skin

Massage gently 2 to 3 times a day at regular intervals

The use and safety of Biafine in children and adolescents has not yet been tested.

Respect the dosage given in the package leaflet or prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Biafine have?

Uncommon (affects 1 to 10 users in 1000) transient moderate pain like a tingling sensation has been observed after using Biafine.

Very rarely (affects less than Local skin reactions (including local hypersensitivity reactions such as mild skin changes, swelling, rashes or redness) have been reported in approximately 1 in 10,000 users.

If hypersensitivity reactions occur (itching, severe burning, skin rash), please tell your doctor and stop treatment.

If you notice any side effects, contact your doctor, pharmacist or druggist doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What else needs to be taken into account?

The medicinal product may only be used up to the date marked «EXP» on the container.

Storage instructions

Store at room temperature (15-25°C). Do not store in the freezer.

Keep out of the reach of children.

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed technical information.

What does Biafine contain?

Active substances

None.

1 g oil in water emulsion contains approx. 6% (m/m) fat.

Excipients

Trolamine; ethylene glycol monopalmitostearates; stearic acid; cetyl palmitate; hard paraffin; thin liquid paraffin; squalane; avocado oil; propylene glycol (E1520); trolamine and sodium alginate; potassium sorbate (E202); sodium methyl p-hydroxybenzoate (E219); sodium methyl p-hydroxybenzoate (E217); Aroma (contains 3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one, benzyl benzoate, citral, citronellol, D-limonene, eugenol, geraniol, 2-benzylideneoctanal, hydroxycitronellal, hydroxymethylpentyl-cyclohexenecarboxaldehyde, isoeugenol and linalool); purified water.

Approval number

55470 (Swissmedic)

Where can you get Biafine? Which packs are available?

In pharmacies and drugstores, without a doctor's prescription.

Tubes of 93 g and 186 g.

Authorization holder

Janssen-Cilag AG, Zug, ZG

This package leaflet was last checked by the drug authority (Swissmedic) in June 2020.