DREIERLEI

THREE DROPS

Important notes (mandatory information)

Dreierlei-Tropfen. Areas of application: to support digestive function. Warning: Contains 62% alcohol by volume!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Dreierlei-Tropfen, liquid for oral use for adults and adolescents aged 12 and over
Active ingredients: tincture of valerian root (1:5), extraction agent ethanol 70% (VA/), ether, peppermint oil
Traditional medicinal product

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you. This medicine is available without a prescription. Always take this medicine exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• Keep the package leaflet. You may need to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If your symptoms worsen or do not improve, see your doctor.

What this package leaflet contains

1. WHAT ARE DREIERLEI-TROPFEN AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING DREIERLEI-TROPFEN?
3. HOW TO TAKE DREIERLEI-TROPFEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE DREIERLEI-TROPFEN?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE DREIERLEI-TROPFEN AND WHAT ARE THEY USED FOR?

Dreierlei-Tropfen is a traditional medicinal product to support digestive function. This information is based solely on tradition and long-standing experience. If symptoms of illness occur, a doctor should be consulted.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING DREIERLEI-TROPFEN?

Dreierlei-Tropfen must not be taken:

• if you are hypersensitive (allergic) to valerian, ether, peppermint oil or any of the other ingredients of Dreierlei-Tropfen.
• by pregnant or breastfeeding women.
• by infants and children under 12 years of age.

Warnings and precautions

This medicine contains 62% alcohol by volume. If the dosage instructions are followed, up to 0.55 g of alcohol is consumed with each dose of 25 drops. A health risk exists, among others, for people with liver disease, alcoholics, epileptics, brain disease and brain damage, pregnant women and children.

Dreierlei-Tropfen should not be taken in the case of:

• stomach and intestinal ulcers,
• obstruction of the bile ducts,
• inflammation of the gallbladder,
• severe liver disease.

Use in gallstone disease should only be after consultation with a doctor or pharmacist. If symptoms of illness occur, persistent or unclear complaints, a doctor should be consulted. The effect of other medicines may be impaired or enhanced.

Children

Dreierlei-Tropfen must not be taken by children under 12 years of age.

Taking Dreierlei-Tropfen with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. Alcohol can increase the undesirable effects of other medicines, so you should consult your doctor or pharmacist before taking it.

Pregnancy and breastfeeding

Dreierlei-Tropfen must not be used during pregnancy and breastfeeding.

Driving and using machines

No special precautions are required if taken as directed in this package leaflet.

3. HOW TO TAKE DREIERLEI-TROPFEN?

Always take Dreierlei-Tropfen exactly as described in this package leaflet or as agreed with your doctor or pharmacist. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed, adolescents aged 12 and over and adults should take 25 drops (equivalent to 1.0 g) three times a day on sugar or diluted with a little water.

Duration of use

The duration of use is not limited in principle.

If symptoms of illness occur, a doctor should be consulted. Please talk to your doctor or pharmacist if you have the impression that the effect of Dreierlei-Tropfen is too strong or too weak.

If you have taken more Dreierlei-Tropfen than you should

If you accidentally take a double dose of Dreierlei-Tropfen, this will have no effect. However, please note that alcohol impairs your ability to drive.

If you forget to take Dreierlei-Tropfen

Do not take a double dose to make up for a forgotten dose.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Dreierlei-Tropfen can have side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated patients
Common:	1 to 10 in 100 treated patients
Uncommon:	1 to 10 in 1,000 treated patients
Rare:	1 to 10 in 10,000 treated patients
Very rare:	less than 1 in 10,000 treated patients
Not known:	frequency cannot be estimated from the available data.

Very rarely, sensitive patients may experience stomach upset.

Reporting of side effects

If you experience 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. of 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. HOW TO STORE DREIERLEI-TROPFEN?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after "use by". The expiry date refers to the last day of the month indicated. Storage conditions: Do not store above 25°C. Highly flammable. Keep away from naked flames. Keep tightly closed! Note on shelf life after opening: The medicine can be stored for 12 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dreierlei-Tropfen contains

The active ingredients are: 100 g (equivalent to 113 ml) of liquid contain: 33.3 g tincture of valerian root (1:5), extraction agent ethanol 70% (V/V), ether 8.0 g, peppermint oil 0.7 g. The other ingredients are: ethanol 96%, purified water.

What Dreierlei-Tropfen looks like and contents of the pack

Dreierlei-Tropfen is a light brown to brown liquid and is available in 50 ml dropper bottles.

Pharmaceutical entrepreneur and manufacturer
Hofmann & Sommer GmbH und Co. KG
Chemisch-pharmazeutische Fabrik
Lindenstraße 11
07426 Königsee-Rottenbach
Phone: 03 67 38 / 65 9-0
Fax: 03 67 38 / 65 9-119

This package leaflet was last revised in March 2017.

Source: Package leaflet information
Version: 10/2017
Areas of application: to support digestive function. Warning: Contains 62% alcohol by volume!