ArnicaMed arnica gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
ArnicaMed, arnica gel
Read the entire 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 adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
You should consult a doctor if you worsen or do not improve after 7 days.
Leaflet contents
- What ArnicaMed is and what it is used for
- What you need to know before using ArnicaMed
- How to use ArnicaMed
- Possible adverse effects
- How to store ArnicaMed
- Contents of the pack and other information
1. What ArnicaMed is and what it is used for
ArnicaMed is a traditional herbal medicinal product used for the symptomatic relief of localized muscular conditions such as pain and stiffness, sprains, bruises, and swelling following injury.
These indications are based solely on its traditional use.
2. What you need to know before using ArnicaMed
Do not use ArnicaMed
If you are allergic to the extract of Arnica montana 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 dose higher than recommended.
Do not apply this gel to areas near 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 feel improvement within 1 week, consult your doctor or pharmacist.
Due to its ethanol content, this gel must not be used near open flames, lit cigarettes, or devices that generate heat (such as hair dryers).
In newborns (premature infants and full-term newborns), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially in 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 operating machinery
This gel does not affect the ability to drive or operate machinery.
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 exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
The recommended dose is:
Adults: Gently apply a strip of 2 to 10 cm of gel to the affected area. Use 2 to 4 times daily.
Children over 6 years of age and elderly patients: Use the same dose as for adults.
For external use only.
This medicine may be used on the skin, but not near the eyes, nose, mouth, or other sensitive areas. Do not apply the gel if your skin is broken or irritated.
Close the tube after each use to ensure proper storage.
Before first opening, 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 occurs, 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 disturbances; dizziness, diarrhea, tremor, and palpitations. At very high doses, respiratory difficulty may occur.
In case of accidental ingestion, contact your doctor or the Toxicology Information Service immediately, telephone number 91 562 04 20, indicating the product and the amount ingested.
If you forget to apply ArnicaMed
Do not worry; continue applying it as before.
If you stop using ArnicaMed
You may stop applying the medicine at any time.
Additional information is provided in section 6 at the end of this leaflet.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Adverse effects observed with ArnicaMed:
Contact dermatitis
Rash
Itching
Dry skin
If any adverse effects occur, discontinue use of this medicine.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es
By reporting adverse 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 (carton and tube) after "Exp:". The expiry date refers to the last day of the month indicated.
Do not use this medicine if you observe any change in colour. It should be a translucent gel, golden brown to greenish yellow.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of ArnicaMed
The active substance is ethanolic extract obtained from fresh flowers of Arnica montana. 1 g of gel contains 500 mg of extract equivalent to 25 mg of dried flowers.
The other excipients are: ethanol, purified water, glycerol (of vegetable origin) and ammonium acryloyldimethyltaurate/VP copolymer.
Appearance of ArnicaMed and contents of the pack
Translucent gel, golden brown to greenish yellow in colour.
Available in 100 ml tubes.
Marketing Authorisation Holder
Bioforce España A.Vogel, S.A.
Platón 6
08021 Barcelona
Spain
Manufacturer
A.VOGEL B.V.
J.P. Broeekhovenstraat 16, Elburg
The Netherlands
Date of the most recent revision of this leaflet: July 2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/