BEXIDERMIL 100 mg/g GEL

Introduction

Package Leaflet: Information for the User

BEXIDERMIL 100 mg/g gel

Triethanolamine salicylate

Read all of this leaflet carefully before you start using thismedicinebecause it contains important information for you.

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

• Keep this leaflet, 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 it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the package leaflet:

1. What is Bexidermil and what is it used for
2. What you need to know before you start using Bexidermil
3. How to use Bexidermil
4. Possible side effects
5. Storage of Bexidermil 100 mg/g gel
6. Contents of the pack and further information

1. What is Bexidermil 100 mg/g gel and what is it used for

Bexidermil is a cutaneous gel.

Triethanolamine salicylate, the active ingredient of this medicine, belongs to the group of cutaneous preparations for joint and muscle pain.

This medicine is indicated in adults and adolescents from 12 years of age for the local symptomatic relief of muscle and joint pains such as:

• contractures
• lumbago
• torticollis
• small bruises, blows, sprains
• mild sprains and twists;

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

2. What you need to know before you start using Bexidermil 100 mg/g gel

Do not use Bexidermil

• if you are allergic (hypersensitive) to triethanolamine salicylate or to any of the other components of this medicine
• on open wounds, eroded skin, mucous membranes, or burns
• if you have suffered allergic reactions (rhinitis, asthma, itching, difficulty breathing, urticaria, shock or others) caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (such as ibuprofen).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Bexidermil 100 mg/g gel

Before applying Bexidermil, you should consider:

• This medicine is for external use only. Do not ingest.
• Apply only to intact skin. Avoid contact with eyes and mucous membranes
• Do not use occlusive dressings or apply heat to the area where it is used
• Do not use on large areas
• Do not apply Bexidermil to the same area where other medicines containing topical analgesics have been applied

Children

This medicine should not be used in children under 12 years of age.

• Bexidermil contains propylene glycol (E1520) and methyl parahydroxybenzoate (E218)
• This medicine contains 100 mg of propylene glycol equivalent to 10.8 mg/kg. Propylene glycol may cause skin irritation.
• This medicine may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218)

Use of other medicines

Inform your doctor or pharmacist if you are taking, or have recently taken, or may need to take any other medicine.

Do not apply to the same area other similar products.

Inform your doctor if you are being treated with oral anticoagulants (such as acenocoumarol and warfarin). Your doctor will decide if you can use the medicine.

Pregnancy and breastfeeding

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

Pregnant or breastfeeding women should not use this medicine unless their doctor prescribes it and no safer alternative is available, and treatment is strictly necessary. In case of use, limit the dose and duration of treatment to a minimum.

Driving and using machines

The use of this medicine does not affect the ability to drive and use machines.

3. How to use Bexidermil 100 mg/g gel

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Bexidermil is a medicine for external use only (on the skin).

The recommended dose is:

Apply a thin layer of the product to the painful or inflamed area 3 to 4 times a day.

It is advisable to perform the last application of the day before going to bed.

This medicine is for cutaneous use, exclusively on intact skin. Do not ingest.

Wash your hands after each application.

Do not exceed the recommended dose of 3-4 applications per day.

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

Use in children

This medicine is for use in adolescents over 12 years of age.

If you use more Bexidermil than you should

If you have applied more Bexidermil than you should, skin problems may occur.

Due to its external use (on the skin), it is unlikely to cause intoxication.

Accidental ingestion may cause nausea, vomiting, abdominal pain, restlessness, drowsiness, and dizziness. Patients intoxicated with severe gastrointestinal or neurological symptoms should be observed and treated symptomatically. Do not induce vomiting.

In case of accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, Telephone: 915 620 420, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the period of use of triethanolamine salicylate, the following side effects have been reported, whose frequency could not be established with precision: cutaneous sensitization or allergic reactions in the application area that disappear when treatment is interrupted.

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bexidermil 100 mg/g gel

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Bexidermil after the expiry date stated on the packaging.

The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Bexidermil 100mg/g gel

The active ingredient is triethanolamine salicylate.

Each gram of Bexidermil contains 100 mg of triethanolamine salicylate.

The other components (excipients) are: triethanolamine, carbomer, propylene glycol (E1520), menthol, camphor, methyl parahydroxybenzoate (E218), and purified water.

Appearance of the product and packaging contents

Colorless to yellowish translucent gel with a refreshing menthol smell

Bexidermil 100 mg/g gel is packaged in a 50g aluminum tube.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Isdin SA

Provençals, 33

08019 Barcelona

Spain

Manufacturer:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Date of the last revision of this leaflet: February 2016

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