GASTEO

GASTEO oral liquid

Important notes (mandatory information)

Gasteo, liquid. Active ingredient: Ibuprofen. Areas of application: for the relief of mild digestive problems (e.g. feeling of fullness, flatulence), as well as mild cramp-like symptoms in the gastrointestinal tract. Warning: Contains 40% alcohol by volume!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Gasteo, liquid for oral use for adults
Traditional herbal medicinal product

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, Gasteo must be taken 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 here affect you significantly or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS GASTEO AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE TAKING GASTEO?
3. HOW TO TAKE GASTEO?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE GASTEO?
6. FURTHER INFORMATION

1. WHAT IS GASTEO AND WHAT IS IT USED FOR?

Traditional herbal medicinal product, used in adults to relieve mild digestive problems (e.g. feeling of fullness, flatulence), as well as mild cramp-like symptoms in the gastrointestinal tract. The medicine is a traditional medicinal product that is registered exclusively on the basis of many years of use for the area of application.

2. WHAT YOU NEED TO KNOW BEFORE TAKING GASTEO?

When should you not use Gasteo?
You should not use Gasteo:

• if you know that you are hypersensitive (allergic) to any of the active ingredients, to members of the daisy family, or to any of the other ingredients of Gasteo,
• in the case of obstruction of the bile duct, inflammation of the bile ducts and liver diseases,
• if you are breastfeeding or pregnant (see also Precautions for use),
• in children and adolescents under 18 years of age.

What do you need to consider before taking Gasteo?
If you suffer from gallstones and other diseases of the biliary tract, you should consult a doctor before using the medicine. Please avoid sunbathing because of the angelica root component.

When taking Gasteo with other medicines

Studies with Gasteo on interactions with other medicines have not been carried out. Taking Gasteo can affect other medicines that act via the GABA receptor. These medicines include, for example, certain sedatives (benzodiazepines) or medicines for seizures (e.g. carbamazepine). Please do not take Gasteo if you have to take such medicines and ask your doctor or pharmacist for advice. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

What should be considered during pregnancy and breastfeeding?
The safety during pregnancy and breastfeeding has not been sufficiently investigated, especially with regard to the angelica root component. Pregnant and breastfeeding women should not take Gasteo (see Contraindications). Please note that use in women of childbearing age who are not using contraception must be carefully considered, as a possible pregnancy may not yet be known.

Driving and operating machinery

No special precautions are required.

Important information about certain other ingredients of Gasteo

This medicine contains 40% alcohol by volume.

3. HOW TO TAKE GASTEO?

Always take Gasteo exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Adults take 30 drops 3 times a day with or after meals in a little liquid. 30 drops of Gasteo correspond to 1.3 ml.

Impaired renal function

There is insufficient data for specific dosage recommendations in the case of impaired renal function.

Duration of use

Gasteo should not be taken for longer than 2 weeks. In the case of persistent symptoms of illness or if side effects other than those mentioned in the package leaflet occur, the user should consult a doctor or another qualified person in a medical profession. Please talk to your doctor or pharmacist if you have the impression that the effect of Gasteo is too strong or too weak.

If you have taken more Gasteo than you should

If you have accidentally taken twice or three times the single dose, this will generally not have any adverse effects. In this case, continue taking the medicine as described in the dosage instructions.

If you have taken a significantly larger amount of Gasteo than you should

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

If you forget to take Gasteo

Do not take a double dose if you have forgotten to take the previous dose. Continue taking the medicine as described in the dosage instructions.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Hypersensitivity reactions may occur. The medicine should then no longer be taken. An increased tendency to sunburn with redness and blistering is possible. The frequency of these side effects cannot be estimated on the basis of the available data. Please inform your doctor or pharmacist if any of the side effects listed here affect you significantly or if you notice any side effects not listed in this package leaflet.

Reporting of 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, Department of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the safety of this medicine.

5. HOW TO STORE GASTEO?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date stated on the carton or container. Storage conditions: Do not store above 25°C. Store in the original packaging to protect the contents from light. Note on shelf life after opening: Shelf life after opening: 3 months. Natural products may occasionally show slight cloudiness or flocculation.

6. FURTHER INFORMATION

What Gasteo contains

The active ingredients are: 10 ml (approx. 9.7 g) Gasteo contains: Extracts from: cinquefoil (1:1.7-2.2) 3.5 ml extracting agent: ethanol 40% (V/V), chamomile flowers (1:1.7-2.2) 2.0 ml extracting agent: ethanol 45% (V/V), liquorice root (1:1.7-2.2) 1.5 ml, angelica root (1:1.7-2.2) 0.5 ml, blessed thistle (1:1.7-2.2) 0.5 ml, wormwood (1: 1.7-2.2) 0.5 ml extracting agent: each ethanol 40% (V/V). The other ingredients are: ethanol 96% (V/V), purified water.

What Gasteo looks like and contents of the pack

Gasteo is a brown liquid. Gasteo is available in packs of 20 and 50 ml liquid for oral use.

Pharmaceutical entrepreneur

Niehaus Pharma GmbH & Co. KG
55218 Ingelheim
E-mail: info@niehaus-pharma.de

Manufacturer

Dr. Gustav Klein GmbH & Co. KG
Steinenfeld 3
D-77736 Zell a. H.

This package leaflet was last revised in July 2014.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Ibuprofen. Areas of application: for the relief of mild digestive problems (e.g. feeling of fullness, flatulence), as well as mild cramp-like symptoms in the gastrointestinal tract. Warning: Contains 40% alcohol by volume!