Leaflet: information for the user

BEXIDERMIL 100 mg/g gel

Triethanolamine salicylate

Read this leaflet carefully before you start using thismedicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, or pharmacist,even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improveafter 7 days.

1.What is Bexidermil and what it is used for

2.What you need to know before starting to use Bexidermil

3.How to use Bexidermil

4.Possible side effects

5.Storage of Bexidermil 100 mg/g gel

6.Contents of the pack and additional information

Bexidermi is a topical gel.

The triethanolamine salicylate, active ingredient of this medication, belongs to the group of topical preparations for joint and muscle pain.

This medication is indicated in adults and adolescents 12 years and older for local symptomatic relief of muscle and joint pain such as:

• muscle spasms
• lower back pain
• neck stiffness
• small bruises, blows, strains
• minor sprains and strains

Consult a doctor if symptoms worsen or do not improve after 7 days of treatment.

Do not use Bexidermil

• if you are allergic (hypersensitive) to triethanolamine salicylate or any of the other components of this medication
• on open wounds, eroded skin, mucous membranes, or burns
• if you have had allergic reactions (rhinitis, asthma, itching, difficulty breathing, urticaria, shock, or others) caused by acetylsalicylic acid or other nonsteroidal 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, take into account:

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

Children

This medication should not be used in children under 12 years old.

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

Use of other medications

Inform your doctor or pharmacist if you are taking, have taken, or may take any other medication.

Do not apply other similar products to the same area.

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 medication.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

The use of this medication does not affect your ability to drive and operate machinery.

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

Bexidermil is a medication for external use on the skin only.

The recommended dose is:

Apply a thin layer of the product to the affected area 3 to 4 times a day.

It is recommended to apply the last dose of the day before going to bed.

This medication is for external use on intact skin only. 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 medication is for use in adolescents over 12 years old.

If you use more Bexidermil than you should

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

Since its use is external (on the skin), poisoning is unlikely.

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

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

Like all medications,this medicationmay cause adverse effects, although not everyone will experience them.

During the period of use of triethanolamine salicylate, the following adverse effects have been reported, whose frequency has not been established with precision: skin sensitization or cutaneous allergic reactions in the application area that resolve upon interrupting treatment.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it ispossibleadverse effects that do not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use Bexidermil after the expiration date shown on the packaging.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

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 (E320) and purified water.

Appearance of the product and contents of the packaging

Transparent, colorless to yellowish gel with a refreshing menthol odor.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the Marketing Authorization:

Isdin SA

Provençals, 33

08019 Barcelona

Spain

Responsible for Manufacturing:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Last review date of this leaflet: February 2016

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es