Trolamine Biogaran emulsion 93g tube

1. WHAT IS TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application AND WHAT IS IT USED FOR?

Pharmacotherapeutic class

CUTANE PROTECTOR (D. Dermatology).

Therapeutic indications

• - Erythema secondary to radiotherapy treatments.
• - First and second degree burns and all other non-infected skin wounds.

2. WHAT YOU SHOULD KNOW BEFORE USING TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application

List of information needed before taking the medicine

Not applicable.

Contraindications

Never use TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application in the following cases:

• - Known allergy to any of the components of the preparation.
• - Bleeding wound (with bleeding).
• - Infected lesion.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Precautions for use; special warnings

Take care with TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application

Special Warnings

In case of blistering or extensive burns, or in case of deep or extensive wounds, medical advice should be sought before applying any medication to the lesion.

IN CASE OF DOUBT, IT IS ESSENTIAL TO SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.

Precautions for use

This medicine is not a sunscreen.

This medicine must not be used as a skin care cream on healthy skin.

IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Interactions with other medicines

Taking or using other medications

If you are taking or have recently taken any other medication, including medication obtained without a prescription, talk to your doctor or pharmacist.

Interactions with food and drink

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medication.

Sportsmen

Not applicable.

Effects on ability to drive and use machines

Not applicable.

List of excipients with a known effect

Not applicable.

3. HOW TO USE TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application

Instructions for proper use

Not applicable.

Dosage, Method and/or route of administration, Frequency of administration and Duration of treatment

Dosage

• - Erythema secondary to radiotherapy treatments: follow your doctor's recommendations. In general, 2 to 3 applications daily, regularly spaced, by making penetrate by a light massage.
• - Second degree burns and other skin wounds: consultation with your doctor is necessary (see Be careful with TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application). After cleansing the wound, apply a thick layer well above the surface of the lesion and repeat applications to maintain an excess of emulsion on the lesion. If necessary, cover with a moistened compress and finish the dressing. Do not use a dry absorbent dressing.
• - First degree burns: in case of extensive burns, consultation with your doctor is essential (see Take care with TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application). Apply in a thick layer until the skin does not accept it. Gently massage into skin. Repeat 2 to 4 times daily.

Method of administration

Apply to the skin.

Symptoms and instructions in case of overdose

Not applicable.

Instructions in case of missed dose(s)

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application is likely to have undesirable effects, although not everyone is subject to them.

• - Moderate, transient (15 to 30 minutes) pain (tingling) may occur after application.
• - Rare contact allergy.
• - Very rare cases of contact eczema requiring immediate discontinuation of treatment.

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

5. HOW TO USE TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application

Keep out of the reach and sight of children.

Expiry date

Do not use TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application after the expiry date stated on the box.

Conditions of storage

No special storage conditions.

If necessary, warnings against certain visible signs of deterioration

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

Not applicable.

6. ADDITIONAL INFORMATION

Complete list of active ingredients and excipients

What does TROLAMINE BIOGARAN 0.67%, emulsion for dermal application, contain?

The active substance is:

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

Per 100 g of emulsion for dermal application.

The other components are:

Ethylene glycol stearate, stearic acid, cetyl palmitate, solid paraffin, light liquid paraffin, perhydorsqualene, avocado oil, propylene glycol, sodium trolamine alginate, potassium sorbate, sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217), Campania flavour, purified water.

Pharmaceutical form and content

What is TROLAMINE BIOGARAN 0.67%, emulsion for cutaneous application and what does it contain?

This medicinal product is in the form of an emulsion for cutaneous application. Tube of 46.5 g, 93 g, 139.5 g or 186 g.

Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different

Holder

Societe ALEPT

42, avenue la Bruyere

38100 Grenoble

Operator

LABORATOIRES BIOGARAN

15 BOULEVARD CHARLES DE GAULLE

92707 COLOMBES CEDEX