Bexidermil 100 mg/g gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

BEXIDERMIL 100 mg/g gel

Triethanolamine salicylate

Read the entire leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Leaflet contents:

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

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

Bexidermil is a cutaneous gel.

The active substance in this medicine, triethanolamine salicylate, belongs to the group of topical preparations used for joint and muscle pain.

This medicine is indicated for adults and adolescents aged 12 years and older for local symptomatic relief of muscular and joint pain, such as:

• muscle spasms
• lumbago
• torticollis
• minor contusions, blows, strains
• mild sprains and twists;

You should consult a doctor if symptoms worsen or do not improve after 7 days of treatment.

2. What you need to know before starting to use 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 in cases of burns
• if you have previously experienced allergic reactions (rhinitis, asthma, itching, breathing difficulties, urticaria, shock, or other reactions) 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 the following:

• This medicine is for external use only. Do not swallow.
• Apply only to intact skin. Avoid contact with eyes and mucous membranes.
• Do not use occlusive dressings or apply heat to the area where this medicine is applied.
• Do not use over large areas of skin.
• Do not apply Bexidermil to areas where other topical analgesic medications have been applied.

Children

This medicine must 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, have recently taken, or might need to take any other medicines.

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 whether you can use this medicine.

Pregnancy and breastfeeding

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

Pregnant or breastfeeding women should not use this medicine unless prescribed by a doctor, when no safer alternative has been found and treatment is strictly necessary. If used, the dose and duration of treatment should be kept to a minimum.

Driving and operating machinery

The use of this medicine does not affect your ability to drive or operate machinery.

3. How to use Bexidermil 100 mg/g gel

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Bexidermil is a topical medication intended 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 daily.

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

This medicine is for topical use only and must be applied 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.

Consult a doctor if your condition worsens or does not improve after 7 days of treatment.

Use in children

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

If you use more Bexidermil than you should

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

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

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

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

The following adverse effects have been reported during the use of triethanolamine salicylate, although their frequency could not be accurately determined: cutaneous sensitization or allergic skin reactions at the site of application, which resolve upon discontinuation of treatment.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 container.

The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bexidermil 100 mg/g gel

The active substance 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, methylparaben (E320), and purified water.

Appearance of the product and contents of the container

Translucent gel, colorless to slightly yellow, with a refreshing menthol odor.

Bexidermil 100 mg/g gel is supplied in a 50 g 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 most recent revision of this leaflet: February 2016

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es