Arnithei

PACKAGE LEAFLET

Package leaflet: information for the user

Arnithei

Arnica tincture
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 3–4 days.

Contents of this leaflet:

1. What Arnithei is and what it is used for
2. What you need to know before using Arnithei
3. How to use Arnithei
4. Possible side effects
5. How to store Arnithei
6. Contents of the pack and other information

1. What Arnithei is and what it is used for

Arnithei is a traditional herbal medicinal product used to relieve pain from bruises,
sprains and localized muscle pain.
The use of this traditional herbal medicinal product for the indicated therapeutic indications
is based solely on long-standing usage experience.
Arnithei is indicated for adults and adolescents aged 12 years and older.
Consult a doctor if you do not feel better or if you feel worse after 3–4 days of treatment.

2. What you need to know before using Arnithei

Do not use Arnithei:

• if you are allergic to arnica and to other plants belonging to the Asteraceae (Compositae) family or to any of the ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Arnithei.
Avoid contact with damaged skin.
If symptoms worsen during use of the medicine, consult a doctor or qualified healthcare professional.
Children

PATIENT LEAFLET

Use is not recommended in children under 12 years of age due to lack of adequate data.
Other medicines and Arnithei
Inform your doctor or pharmacist if you are taking, have recently taken, or might take/use any other medicines.
No interactions are currently known. Interaction studies have not been conducted.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Due to insufficient data, use during pregnancy and breastfeeding is not recommended.
Driving and using machines
No studies have been performed to evaluate the effect on the ability to drive vehicles and operate machinery.
Arnithei contains macrogol glycerol hydroxystearate and ethanol
100 g of Arnithei contain 3 g of macrogol glycerol hydroxystearate, which may cause local skin reactions.
Arnithei contains approximately 24% m/m ethanol. It may cause a burning sensation on damaged skin.

3. How to use Arnithei

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents aged 12 years and older
Unless otherwise directed by a doctor, apply a thin layer of Arnithei to the affected area two or three times a day.
Duration of use
Do not use the product for prolonged periods and in any case not for longer than 2 weeks.
If symptoms persist after 3 or 4 days of using the medicine, consult a doctor or qualified healthcare professional.
Method of administration
For topical use only.
Use in children
Use is not recommended in children under 12 years of age.
If you use more Arnithei than you should
No cases of overdose have been reported.
If you forget to use Arnithei
Do not use a double dose to make up for the missed dose.

PATIENT INFORMATION LEAFLET

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Allergic reactions may occur, such as itching, skin redness and eczema. Frequency is unknown (frequency cannot be estimated from the available data).
If you experience any adverse reactions, consult your doctor or another qualified healthcare professional.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Arnithei

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of that month.
Do not store above 25 °C.
The medicinal product may be used up to 6 months after first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Arnithei contains

• The active substance is: arnica tincture. 100 g of gel contain 24 g of tincture of Arnica montana L., flos (arnica flower) (DER 1:10), extraction solvent: 70% ethanol (V/V).
• The other excipients are: 96% ethanol (V/V), macrogol glycerol hydroxystearate (40), carbomer, 10% ammonia solution, medium-chain triglycerides, purified water.

Description of the appearance of Arnithei and pack contents
Opaque yellow-brown gel.
Arnithei is available in packs of 50 g or 100 g of gel in an aluminium tube with white screw cap in HDPE.
Not all pack sizes may be marketed.

PACKAGE LEAFLET

Marketing Authorization Holder and Manufacturer
Dr. Theiss Naturwaren GmbH
Michelinstraße 10
66424 Homburg
Germany
Distributed in Italy by:
Naturwaren Italia Srl, Via della Mostra 2 – Bolzano.
This medicinal product is authorized in the European Economic Area Member States under the
following names: