Bexidermil 100 Mg/ml Spray Topico 200 ml

1. What is Bexidermil and what it is used for

Bexidermil is a solution for skin spraying.

Triethanolamine salicylate, the active substance in this medicine, belongs to the group of preparations

skin for joint and muscle pain.

This medicine is indicated in adults and adolescents from 12 years of age for local relief

symptomatic muscle and joint pains such as:

- contractures

- lumbago

- torticolis

- small bruises, bumps, strains

- mild sprains and sprains;

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

2. What you need to know before you start using Bexidermil

Don't use Bexidermil

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- if you are allergic (hypersensitive) to triethanolamine salicylate or any of the other components of

this medicine (listed in section 6)

- on open wounds, mucous eroded skin, or burns

- if you have had allergic reactions (rhinitis, asthma, itching, shortness of breath, hives, shock or others),

caused by aspirin or other nonsteroidal anti-inflammatory drugs (such as ibuprofen).

Warnings and precautions

Talk to your doctor or pharmacist before using Bexidermil 100 mg/ml solution for

skin spray.

Before applying Bexidermil you should consider:

- This medicine is for external use. Do not ingest.

- Apply only to intact skin. avoid contact with eyes and mucous membranes

- do not use occlusive bandages or apply heat to the area where you use it

- do not use in large areas

- you should not apply Bexidermil in the same area where other medicines have been applied that

contain topical painkillers

- because of its ethanol content, frequent application of the medicinal product may cause irritation and

dry skin

Children

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

Use of other medicines

Tell your doctor or pharmacist if you are taking, or have recently taken or might take

any other medication.

Other similar products should not be applied in the same area.

Tell your doctor if you are being treated with oral anticoagulants (such as acenocumarol and

warfarin). Your doctor will decide if you can use the medicine.

Pregnancy and lactation

If you are pregnant or breast-feeding, think you may be pregnant or intend to

becoming pregnant, talk to your doctor or pharmacist before using this medicine.

Pregnant or lactating women may not use this medicine unless their

prescribe it for not having found another safer drug and being strictly necessary

Treatment. 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 operate machines.

3. How to use Bexidermil

Always take the medicine exactly as contained in this leaflet or the

indicated by your doctor or pharmacist. If in doubt, talk to your doctor or pharmacist.

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The recommended dose is: 1 spray of the solution in the sore or inflamed area 3 to 4 times

day if necessary.

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

Spraying should be performed from a distance of about 10 cm from the affected area. Your application

can produce a feeling of cold.

Wash your hands after each application.

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

You should see a doctor if it gets worse or if it 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.

Because its use is external (on the skin), poisoning is not likely.

Accidental ingestion can cause nausea, vomiting, abdominal pain, restlessness, drowsiness and

Vertigo. Patients intoxicated with severe gastrointestinal or neurological symptoms should be

observed and treated symptomatically. Do not induce vomiting.

In case of accidental ingestion, go to a medical center immediately or call the Medical

Toxicological Information, Phone: 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 all

people suffer from them.

During the period of use of triethanolamine salicylate, the following effects have been reported

adverse diseases whose frequency has not been accurately established: skin sensitization or reactions

skin allergic diseases in the application area that they refer when stopping treatment.

Adverse effects communication

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is

possible side effects not listed in this leaflet. You can also communicate them directly to

through the Spanish Pharmacovigilance System for Medicinal Products for Human Use: www.notificaRAM.es.

By reporting side effects you can help provide more information

about the safety of this medicine.

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5. Conservation of Bexidermil 100 mg/ml Skin spray solution

Keep out of reach and sight of children.

Highly flammable liquid and vapours.

Keep away from heat, hot surfaces, sparks, open flames and any other

source of ignition. No smoking.

Do not use Bexidermil after the expiry date which is stated on the carton.

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

Medicines should not be flushed down drains or into trash. Deposit containers and containers

medicines you don't need at the SIGRE Point of the pharmacy. If in doubt, ask your

how to get rid of medicines you don't need. In this way,

will help protect the environment.

6. Packaging contents and additional information

Composition of Bexidermil 100mg/ml skin spray solution

The active substance is triethanolamine salicylate. Each milliliter of Bexidermil contains 100 mg of

triethanolamine salicylate.

The other components (excipients) are: macrogolglycerides of caprilocaproil, macrogol, menthol and ethanol

99,5%.

Product appearance and packaging content

It is a clear, colourless or slightly yellowish liquid with a mild menthol smell.

It is available as a gas-free polyethylene spray bottle with diffuser valve and polystyrene stopper. Each

bottle contains 200 ml of skin spray solution.

Marketing authorisation holder and manufacturing manager

Marketing authorisation holder:

Isdin SA

Provencals, 33

08019 Barcelona

Spain

Responsible for manufacturing:

Laboratorios Dr. Esteve, S.A.

C/ San Martí, s/n Pol. Ind. The Rock

Martorelles (Barcelona)

Spain