ARNICAMED GEL DE ARNICA - Arnica Gel

Introduction

Package Leaflet: Information for the User

ArnicaMed, arnica gel

Read the entire package leaflet carefully before starting to use this medicine, as it contains important information for you.

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 not listed in this package leaflet. See section 4.

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

Contents of the Package Leaflet

1. What is ArnicaMed and what is it 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. Package Contents and Additional Information

1. What is ArnicaMed and what is it used for

ArnicaMed is a traditional herbal medicinal product used for the symptomatic relief of localized muscle complaints, such as pain and stiffness, sprains, bruises, and swelling resulting from a blow.

These indications are based exclusively on traditional use.

2. What you need to know before using ArnicaMed

Do not use ArnicaMed

If you are allergic to Arnica montanaextract or to any of the other components of this medicine (listed in section 6) or to any plant of the Asteraceae (Compositae) family.

Warnings and Precautions

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

Do not use a higher dose than recommended.

Do not use this gel on 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 irritated skin.

If your symptoms worsen, consult your doctor or pharmacist.

If you do not feel better within a week, consult your doctor or pharmacist.

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

In newborns (premature and full-term babies), high concentrations of ethanol can cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially in the case of occlusion).

Other Medicines and ArnicaMed

No interactions with other medicines have been reported.

Pregnancy and Breastfeeding

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

Driving and Using Machines

This gel does not affect the ability to drive or use machines.

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

It may cause a burning sensation on damaged skin.

3. How to Use ArnicaMed

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is:

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

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

For external use only.

This medicine can be used on the skin, but not on areas 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 preservation.

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

If you use more ArnicaMed than you should

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

Accidental Ingestion

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

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

If you forget to apply ArnicaMed

Do not worry and continue applying it as before.

If you stop using ArnicaMed

You can stop using the medicine at any time.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects that have been observed with ArnicaMed:

Contact dermatitis

Rash

Itching

Dry skin

If side effects occur, discontinue use of this medicine.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting Side Effects:

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of ArnicaMed

Keep this medicine out 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 use this medicine after the expiry date stated on the packaging (box and tube) after Cad/Exp: The expiry date is the last day of the month indicated.

Do not use this medicine if you notice a change in color. It should be a translucent, golden brown to yellowish gel.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of ArnicaMed

The active ingredient is the ethanol extract obtained from fresh Arnica montanaflowers. 1 g of gel contains 500 mg of extract, equivalent to 25 mg of dried flowers.

The other excipients are: ethanol, purified water, glycerol (vegetable origin), and ammonium acryloyldimethyltaurate/VP copolymer.

Appearance of ArnicaMed and Package Contents

Translucent gel, golden brown to yellowish in color.

Available in 100 ml tubes.

Marketing Authorization Holder

Bioforce España A.Vogel, S.A.

Platón 6

08021 Barcelona

Spain

Manufacturer

A.VOGEL B.V.

J.P. Broeekhovenstraat 16, Elburg

Netherlands

Date of the Last Revision of this Package Leaflet: July 2022

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