BITTERSALZ

Epsom Salt Powder

Important notes (mandatory information)

Bittersalz, powder. Active ingredient: magnesium sulfate heptahydrate. Areas of application: suitable for short-term use in case of constipation (obstipation) and for bowel evacuation before diagnostic and therapeutic measures.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Bittersalz, powder for oral use after dissolving in water for use in children over 6 years of age and adults
Active ingredient: magnesium sulfate heptahydrate

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, this medicine 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 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, you must see a doctor in any case.

This package leaflet contains

1. WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING THIS MEDICINE?
3. HOW TO USE THIS MEDICINE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE THIS MEDICINE?
6. FURTHER INFORMATION

1. WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?

Bittersalz is a saline laxative. This powder is suitable for short-term use in case of constipation (obstipation) and for bowel evacuation before diagnostic and therapeutic measures.

2. WHAT DO YOU NEED TO KNOW BEFORE USING THIS MEDICINE?

This medicine must not be used:

• if you are hypersensitive (allergic) to magnesium sulfate heptahydrate,
• in case of intestinal obstruction,
• in case of impaired renal function.

It should not be used in case of:

• inflammatory gastrointestinal diseases and
• disorders of the water and electrolyte balance.

Special care must be taken when using this medicine if the symptoms described in section 1 become more severe. In this case, consult your doctor or pharmacist.

Children

Bittersalz must not be used in children under 6 years of age.

When using this medicine with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even if they are non-prescription medicines. Bittersalz can form poorly absorbable complexes with tetracyclines, so that only an insufficient active ingredient level is achieved. The sensitivity to cardiac glycosides can be increased due to increased potassium losses. Potassium loss can be increased when taken together with diuretics.

Pregnancy and breast-feeding

No harmful effects of Bittersalz during pregnancy and breast-feeding are known. Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

There is no experience regarding impairment of the ability to drive and operate machinery.

3. HOW TO USE THIS MEDICINE?

Always take Bittersalz exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Dosage and type of use

Unless otherwise prescribed, adults drink 2 to 3 teaspoons (10 to 15 g) of Bittersalz dissolved in approx. 250 ml of water. For rapid bowel evacuation, 1 to 2 tablespoons (20 to 30 g) of Bittersalz are dissolved in approx. 500 ml of water and drunk. Children over 6 years of age receive half the dose.

Duration of use

Bittersalz should only be used for a short period of time. Long-term use leads to increased intestinal sluggishness. Please talk to your doctor or pharmacist if you have the impression that the effect of Bittersalz is too strong or too weak.

If you have used a larger amount of the medicine than you should and experience symptoms due to the higher dose, please notify your doctor. He/she can decide on any necessary measures. The side effects listed under side effects may occur more frequently. In case of overdose of Bittersalz, water can be withdrawn with electrolyte disturbances and magnesium poisoning. The therapy must be based on the symptoms.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Bittersalz can have side effects, although not everybody gets them.

Possible side effects

When using very high doses or chronic use of Bittersalz, magnesium poisoning can occur - especially in case of impaired renal function - which is characterized by central nervous disorders, muscle weakness, loss of reflexes, fatigue, partial paralysis, coma and cardiac arrhythmias. As with other laxatives, prolonged use of Bittersalz can lead to increased loss of water, potassium and other salts. This can lead to disorders of the heart function and to muscle weakness, especially when taken together with diuretics and adrenal corticosteroids.

Special notes

If you experience the above side effects, stop using Bittersalz and notify your doctor. He/she will decide whether further measures are necessary.

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 THIS MEDICINE?

General notes: Keep medicines out of the reach of children. Do not use the medicine after the expiry date which is stated on the can and the outer carton after "Use by". The expiry date refers to the last day of the month. Storage conditions: Store tightly closed in the original container.

6. FURTHER INFORMATION

What this medicine contains

100 g of powder contain the active ingredient: 100 g of magnesium sulfate heptahydrate. No other ingredients are included.

What the medicine looks like and contents of the pack

Bittersalz is available in the following pack sizes: 100 g powder in a can with outer carton, 250 g powder in a can with outer carton.

Pharmaceutical entrepreneur/manufacturer

Bombastus-Werke AG
Wilsdruffer Straße 170
01705 Freital
Germany
Phone: +49 351 65803-0
Fax: +49 351 65803-99
E-mail: info@bombastus-werke.de

This package leaflet was last revised in January 2015.

Source: Information from the package leaflet
Status: 04/2018
Active ingredient: magnesium sulfate heptahydrate. Areas of application: suitable for short-term use in case of constipation (obstipation) and for bowel evacuation before diagnostic and therapeutic measures.