BEXIDERMIL 100 mg/g CREAM

Introduction

Package Leaflet: Information for the User

BEXIDERMIL 100 mg/g cream

Triethanolamine salicylate

Read the entire package leaflet carefully before starting to use thismedicationbecause it contains important information for you.

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

• Keep this package leaflet, as 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 they are side effects not listed in this package 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 using Bexidermil
3. How to use Bexidermil
4. Possible side effects
5. Storage of Bexidermil 100 mg/g cream
6. Package contents and additional information

1. What is Bexidermil and what is it used for

Bexidermil is a cream for cutaneous use.

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

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

• contractures
• lumbago
• torticollis
• minor bruises, bumps, 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 using Bexidermil 100mg/g cream

Do not use Bexidermil 100 mg/g cream

• if you are allergic (hypersensitive) to triethanolamine salicylate or any of the other components of this medication (listed in section 6)
• 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 cream.

Before applying Bexidermil, you should consider:

• This medication 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 extensive areas
• Do not apply Bexidermil to the same area where other medications containing topical analgesics have been applied
• Bexidermil contains sorbic acid, cetyl alcohol, stearyl alcohol, propylene glycol, and butylhydroxyanisole
• This medication may cause local skin reactions (such as contact dermatitis) because it contains sorbic acid, cetyl alcohol, and stearyl alcohol.
• This medication contains 200 mg of propylene glycol, equivalent to 21.6 mg/kg.
• This medication may cause skin irritation because it contains propylene glycol
• This medication may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butylhydroxyanisole (E320).

Children

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

Use of other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnant or breastfeeding women should not use this medication 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 medication does not affect the ability to drive and operate machines.

3. How to use Bexidermil 100 mg/g cream

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

Bexidermil is a medication for exclusive external cutaneous use (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 bedtime.

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

If you use more Bexidermil 100 mg/g cream than you should

If you have applied more Bexidermil than you should, 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 vertigo. Patients 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 medication and the amount ingested.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Bexidermil 100 mg/g cream

Keep out of sight and reach 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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Bexidermil 100mg/g cream

The active ingredient is triethanolamine salicylate. Each gram of Bexidermil contains 100 mg of triethanolamine salicylate.

The other components (excipients) are: sorbic acid (E-200), propylene glycol (E-1520), stearyl alcohol, cetyl alcohol, sorbitan monooleate (E-491), polysorbate 60 (E-435), polysorbate 80, isopropyl myristate, butylhydroxyanisole (E-320), sodium edetate, camphor, menthol, and deionized water

Appearance of the product and package contents

Bexidermil 100 mg/g cream is a homogeneous white cream. It is presented 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 package leaflet: February 2022

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