Leaflet: information for the user

ArnicaMed, arnica gel

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

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 your condition worsens or does not improve after 7 days.

1. What is ArnicaMed and what it is used for

2. What you need to know before using ArnicaMed

3. How to use ArnicaMed

4. Possible side effects

5. Storage of ArnicaMed

6. Contents of the pack and additional information

ArnicaMed is a traditional herbal medicine and is used for the symptomatic relief of localized muscular conditions, such as pain and stiffness, sprains, bruises, and swelling as a result of a blow.

These indications are based exclusively on its traditional use.

Do not use ArnicaMed

If you are allergic to the extract ofArnica montanaor to any of the other components of this medication (listed in section 6) or to any plant of the Asteraceae family (Compositae).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication.

Do not use a dose higher than recommended.

Do not use this gel in areas close to the eyes, nose, mouth, or other sensitive areas, as it may cause irritation.

Do not use this gel on open wounds or on irritated skin.

If your symptoms worsen, consult your doctor or pharmacist.

If you do not experience improvement within 1 week, consult your doctor or pharmacist.

Due to its ethanol content, this gel should not be used near open flames, lit cigarettes, or heat-producing devices (such as hair dryers).

In newborns (premature babies and newborns at term), high concentrations of ethanol maycause severe local reactions and systemic toxicitydue to significant absorption through the immature skin (especially in cases of occlusion).

Other medications and ArnicaMed

No interactions with other medications have been described.

Pregnancy and Breastfeeding

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

Driving and operating machinery

This gel does not affect your ability to drive and operate machinery.

This medication contains 550 mg of alcohol (ethanol) per gram.

It may cause a burning sensation on injured skin.

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

The recommended dose is:

Adults: apply a strip of 2 to 10 cm of gel gently to the affected area. Use 2 to 4 times a day.

Children over 6 years and elderly people: use the same dose as for adults.

For external use only.

This medication can be used on the skin, but not in the area close to the eyes, nose, mouth, or other sensitive areas. Do not apply the gel if your skin is open or irritated.

Close the tube after each use for proper conservation.

Before opening the tube for the first time, check that the seal is intact. Remove the seal before using the medication.

If you use more ArnicaMed than you should

Your skin may become red or irritated. If this happens, stop using the medication.

Accidental ingestion

In case of accidental ingestion, due to the irritating effect of arnica, symptoms of poisoning may include gastrointestinal and nervous system discomfort; dizziness, diarrhea, tremors, and palpitations. At very high doses, respiratory difficulty may occur.

In case of accidental ingestion, consult your doctor or the Toxicological Information Service immediately, phone 91 562 04 20, indicating the product and the amount ingested.

If you forgot to apply ArnicaMed

Do not worry and continue applying it as before.

If you stop applying ArnicaMed

You can stop applying the medication at any time.

There is additional information in section 6 at the end of this leaflet.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Adverse effects observed with ArnicaMed:

Contact dermatitis

Rash

Itching

Dry skin

If adverse effects occur, discontinue use of this medication.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

No special storage conditions are required.

After opening, store below 25 °C.

Discard 6 months after opening.

Do not usethis medicationafter the expiration date appearing on the packaging (box and tube)after Cad:/Exp: The expiration date is the last day of the month indicated..

Do not usethis medication, if you notice a change in color. It should be a translucent gel, golden brown to greenish yellow..

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of ArnicaMed

The active principle is the ethanolic extract obtained from the fresh flowers ofArnica montana. 1 g of gel contains 500 mg of extract equivalent to 25 mg of dried flowers.

The other excipients are: ethanol, purified water, vegetable-derived glycerol, and copolymer of acryloidimethyltaurato of ammonium / VP.

Appearance of ArnicaMed and content of the container

Transparent gel, brown-gold to greenish-yellow in color.

Available in 100 ml tubes.

Holder of the marketing authorization

Bioforce España A.Vogel, S.A.

Platón 6

08021 Barcelona

Spain

Responsible for manufacturing

A.VOGEL B.V.

J.P. Broeekhovenstraat 16, Elburg

Netherlands

Date of the last review of this prospectus: July 2022

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