WEISSDORN KRÄUTERTROPFEN

HAWTHORN HERBAL DROPS Salus

Important notes (mandatory information)

Salus Hawthorn Herbal Drops Indications: Traditional herbal medicinal product to support cardiovascular function. Warning: Contains 25% alcohol by volume!

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Salus Hawthorn Herbal Drops
Liquid for use in adults
Active ingredient: Extract of hawthorn leaves with flowers and hawthorn fruits

Read the entire package leaflet carefully because it contains important information for you about what to consider when using this medicine. This medicine is available without a prescription. However, to achieve the best possible treatment results, Salus Hawthorn Herbal Drops must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 2 weeks, you must see a doctor.
• If any of the side effects listed significantly affect you or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. INDICATION GROUP AND AREAS OF APPLICATION
2. IMPORTANT NOTES BEFORE USE
3. INSTRUCTIONS FOR TAKING/USING
4. SIDE EFFECTS
5. STORAGE INSTRUCTIONS AND SHELF LIFE
6. COMPOSITION AND CONTENTS OF THE PACK
7. FURTHER INFORMATION

1. INDICATION GROUP AND AREAS OF APPLICATION

Traditional herbal medicinal product to support cardiovascular function. The medicinal product is a traditional medicinal product that is registered exclusively on the basis of many years of use for the area of application.

2. IMPORTANT NOTES BEFORE USE

2.1 Contraindications

When should you not take Salus Hawthorn Herbal Drops?
You should not take Salus Hawthorn Herbal Drops:

• If you are an alcoholic.
• if you are hypersensitive (allergic) to hawthorn, sulfur dioxide (E220) or any of the other ingredients of Salus Hawthorn Herbal Drops.

2.2 Warnings and precautions for use

When should you only take Salus Hawthorn Herbal Drops after consulting a doctor?
Due to the alcohol content, the medicinal product should only be taken by people with liver disease, epileptics and patients with organic brain diseases after consulting a doctor. If signs of illness such as accumulation of water in the legs or unclear symptoms occur, a doctor should be consulted. In the case of pain in the heart area, which can radiate into the arms, the upper abdomen or the neck area, or in the case of shortness of breath, immediate medical clarification is essential. In the case of persistent symptoms of illness or the occurrence of side effects other than those mentioned in the package leaflet, the user should consult a doctor or other qualified person in a medical profession.

2.3 Children

What do you need to consider in children and adolescents?
Salus Hawthorn Herbal Drops should not be used in children and adolescents under 18 years of age, as there are no sufficient studies. The alcohol content in Salus Hawthorn Herbal Drops also speaks against its use.

2.4 Pregnancy and breastfeeding

What do you need to consider during pregnancy and breastfeeding?
Safety during pregnancy and breastfeeding has not been adequately studied. Therefore, and because of the alcohol content, Salus Hawthorn Herbal Drops should not be taken during pregnancy and breastfeeding. Ask your doctor or pharmacist for advice before taking/using any medicines.

2.5 Driving and using machines

Salus Hawthorn Herbal Drops have only a negligible influence on the ability to drive and use machines when taken according to the dosage instructions. However, in the event of an overdose, the ability to drive and operate machinery is impaired. Please note the information under "3.2 Overdose and misuse".

2.6 Important information about certain other ingredients of Salus Hawthorn Herbal Drops

This medicinal product contains 25% alcohol by volume.

2.7 Interactions with other medicines

Interactions with other medicinal products have not yet been investigated for Salus Hawthorn Herbal Drops. An increase or decrease in the effect of other medicinal products cannot therefore be ruled out. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if these are non-prescription medicines.

3. INSTRUCTIONS FOR TAKING/USING

3.1 Dosage, type and duration of use

Please follow the dosage instructions, otherwise Salus Hawthorn Herbal Drops may not work properly!

Dosage

Adults take 2 ml of Salus Hawthorn Herbal Drops 3 times a day. Use in children or adolescents under 18 years of age is not intended.

Type of use

For oral use. The pack contains a graduated measuring cup. This can be used to measure the dose (2 ml). Make sure to empty the measuring cup completely. If necessary, you can rinse with liquid, preferably drinking water.

Duration of use

The duration of use is not limited. In the case of complaints of unclear origin, self-medication should be discontinued after two weeks. Please also note the information under "2.2 Warnings and precautions for use".

Note for diabetics

2 ml of drops correspond to less than 0.1 BE

3.2 Overdose and misuse

If you have taken more Salus Hawthorn Herbal Drops than you should

An overdose (double or triple single dose corresponds to 4 ml to 6 ml of this medicinal product) usually has no adverse effects. However, please note that in the event of an overdose, the ability to actively participate in road traffic and to operate machinery is significantly impaired due to the alcohol in Salus Hawthorn Herbal Drops.

If you have taken a significantly larger amount of Salus Hawthorn Herbal Drops than you should

Please notify your doctor. He can decide on any necessary measures. The side effects listed below may occur more frequently.

If you have forgotten to take Salus Hawthorn Herbal Drops or have taken too little

Do not take double the amount next time, but continue using as described in the dosage instructions.

4. SIDE EFFECTS

Like all medicines, Salus Hawthorn Herbal Drops can have side effects, although not everybody gets them.

Possible side effects

Gastrointestinal complaints and allergic reactions (e.g. skin rash) may occur. The frequency of these side effects is not known.

Other possible side effects

Sulfur dioxide (E 220) can rarely cause hypersensitivity reactions and bronchial spasms (bronchospasms).

What countermeasures should be taken in the event of side effects?
At the first signs of a hypersensitivity reaction, Salus Hawthorn Herbal Drops must not be taken again.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices Dept. Pharmacovigilance Kurt-Georg-Kiesinger Allee 3 D-53175 Bonn Website: www.bfarm.de by reporting side effects, you can help provide more information about the safety of this medicine.

5. STORAGE INSTRUCTIONS AND SHELF LIFE

Do not use the medicinal product after the expiry date (date after "use by:") stated on the folding box (outer carton) and the container (label). The expiry date refers to the last day of the month.

Shelf life after opening

3 months.

Keep medicines out of the reach of children.

Do not store above 25 °C.

6. COMPOSITION AND CONTENTS OF THE PACK

100 ml (103 g) of liquid contain as active ingredient: 100 ml extract (1:4.5 – 5.5) from hawthorn leaves with flowers and hawthorn fruits (1:1). Extractant: liqueur wine: ethanol 96% (V/V) (10:1) (liqueur wine produced with the addition of sulfur dioxide (E220))

Content and dosage form

Pack of 50 ml or 100 ml liquid.

7. FURTHER INFORMATION

7.1 Pharmaceutical entrepreneur and manufacturer

SALUS Haus GmbH & Co. KG
Bahnhofstraße 24
D-83052 Bruckmühl
info@salus.de

7.2 Note

Liqueur wine and sulphuring

The sulphuring of wine is a preservation method that has been used since ancient times. The added sulfur dioxide or the sulfites formed from it in aqueous solution have a preservative effect. In addition to the preservative effect, the sulfur also binds undesirable fermentation by-products and stabilizes other, desirable ingredients in the wine. Sulfites are also naturally formed in small concentrations during the fermentation process. The sulfur requirement in wine production depends on the grape variety and the time of harvest. For example, white wines usually require more sulfur than red wines. Since 2005, sulfur in wine must be declared on the label if a certain value is exceeded. Liqueur wine, which is used for the production of Salus Hawthorn Herbal Drops, is sulfured. This sulfuring must be declared. Therefore, Salus Hawthorn Herbal Drops contain references to sulfur dioxide (E220).

This package leaflet was last revised in June 2014.

Source: Information from the package leaflet
Status: 03/2016
Areas of application: Traditional herbal medicinal product to support cardiovascular function. Warning: Contains 25% alcohol by volume!