RIOPAN

RIOPAN Stomach Tablets Chewable Tablets

Important notes (mandatory information)

Riopan Magen Tabletten 800 mg Chewable Tablets. Active ingredient: Magaldrate. Areas of application: for heartburn and acid-related stomach complaints and for the symptomatic treatment of stomach and duodenal ulcers.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Riopan Magen Tabletten 800 mg Chewable Tablets
Active ingredient: Magaldrate

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• 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 you do not feel better or if you feel worse after 14 days, contact your doctor.

What this package leaflet contains

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

1. WHAT ARE RIOPAN MAGEN TABLETS AND WHAT ARE THEY USED FOR?

Riopan Magen Tablets contain magaldrate and belong to the group of medicines known as antacids, which are used to neutralise excess stomach acid. Riopan Magen Tablets are used for heartburn and acid-related stomach complaints and for the symptomatic treatment of stomach and duodenal ulcers.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING RIOPAN MAGEN TABLETS?

Riopan Magen Tablets must not be taken if you are allergic to magaldrate or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Riopan Magen Tablets. Special care should be taken when taking Riopan Magen Tablets:

• if you suffer from kidney problems or are dialysis-dependent.
• if you have Alzheimer's disease or another form of dementia.
• if you are on a phosphate diet.
• if your doctor has told you that you have a bone metabolism disorder.

Children

Riopan Magen Tablets should not be used to treat children under 12 years of age, as there is insufficient experience in this age group.

If symptoms persist or recur

If symptoms persist for more than 2 weeks, you should consult your doctor for advice. Persistent and/or recurring symptoms could be an indication of a serious illness. Inform your doctor immediately if you notice any of the following symptoms:

• You have blood in your stool. This may appear black and tarry.
• You vomit blood or dark particles that look like coffee grounds.

Taking Riopan Magen Tablets with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Since antacids such as Riopan Magen Tablets can impair the absorption of other medicines taken at the same time, a gap of 2 hours should generally be observed between taking Riopan Magen Tablets and other medicines. Inform your doctor or pharmacist, especially before taking Riopan Magen Tablets, if you are taking any of the following medicines:

• Antibiotics such as ciprofloxacin, ofloxacin and norfloxacin or another tetracycline or quinolone antibiotic,
• Digoxin (for the treatment of many heart conditions),
• Isoniazid (for the treatment of tuberculosis),
• Iron compounds,
• Chlorpromazine (for the treatment of schizophrenia and anxiety),
• Anticoagulants such as warfarin, which contains coumarin (for thinning the blood).

Taking Riopan Magen Tablets with food, drink and alcohol

The simultaneous intake of Riopan Magen Tablets and acidic drinks such as fruit juices, wine, etc. as well as effervescent tablets containing fruit acids (e.g. citric acid, tartaric acid) should be avoided.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. The benefit-risk ratio should be carefully weighed before taking aluminium-containing medicines to bind excess stomach acid during pregnancy. If you are pregnant, you should only use the medicine (the active ingredient contains aluminium) for a short period of time to avoid aluminium exposure to your unborn child. Aluminium compounds pass into breast milk. A risk to the newborn is not to be assumed, as only very small amounts are absorbed.

Driving and using machines

Riopan Magen Tablets have a negligible or no effect on the ability to drive and use machines.

Riopan Magen Tablets contain sorbitol

Do not take Riopan Magen Tablets until you have spoken to your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE RIOPAN MAGEN TABLETS?

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How many Riopan Magen Tablets should you take daily?
Adults and children over 12 years of age:

• the recommended dose is 1 -- 2 chewable tablets several times a day as needed,
• do not take more than 8 chewable tablets (6400 mg magaldrate) per day.

How should you take Riopan Magen Tablets?
The chewable tablets should be chewed well and then swallowed with a little liquid or can also be sucked.

How long should you take Riopan Magen Tablets?
Riopan Magen Tablets should only be taken for short-term treatment of your symptoms. If symptoms persist for more than 2 weeks during treatment, a doctor should be consulted. Persistent and/or recurring symptoms could be an indication of a serious illness. Inform your doctor immediately if you notice any of the following symptoms:

• You have blood in your stool. This may appear black and tarry.
• You vomit blood or dark particles that look like coffee grounds.

If you have taken more Riopan Magen Tablets than you should

If you have taken too many Riopan Magen Tablets, you should consult your doctor for advice. Overdosage may cause changes in bowel movements such as stool softening and increased stool frequency.

If you forget to take Riopan Magen Tablets

If you forget to take Riopan Magen Tablets, simply take your normal dose at the next time you are due to take it. Do not take a double dose to make up for a forgotten dose.

If you stop taking Riopan Magen Tablets

If you interrupt or prematurely terminate treatment with Riopan Magen Tablets on your own due to side effects, you should talk to your doctor.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

• Soft stools.

Very rare (may affect less than 1 in 10,000 people):

• Diarrhoea.
• Softening of the bones (only after long-term use of high doses).

In renal insufficiency or long-term use of high doses, taking Riopan Magen Tablets can cause increased aluminium and magnesium levels in the blood. Aluminium can be stored primarily in the nervous and bone tissue and phosphate depletion can occur.

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, 53175 Bonn, website: www. bfarm.de, by reporting side effects you can help to provide more information on the safety of this medicine.

5. HOW TO STORE RIOPAN MAGEN TABLETS?

Keep this medicine out of the reach of children. Do not store above 30°C. Do not use this medicine after the expiry date which is stated on the carton and container. The expiry date refers to the last day of the month indicated. Do not dispose of this medicine in wastewater. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Riopan Magen Tablets contain

The active ingredient is magaldrate. 1 chewable tablet contains 800 mg magaldrate. The other ingredients are: sorbitol, macrogol 4000, calcium behenate, maltol, caramel flavour and cream flavour.

What Riopan Magen Tablets look like and contents of the pack

Riopan Magen Tablets are white, round chewable tablets with one-sided inscription "800". Riopan is available in blister packs of 10, 20, 40, 50 and 100 chewable tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Dr. Kade Pharmazeutische Fabrik GmbH
Rigistraße 2
12277 Berlin
Tel.: 030/7 20 82-0
Fax: 030/7 20 82-200
E-mail: info@kade.de
www.kade.de

Manufacturer

Dr. Kade Pharmazeutische Fabrik GmbH
Opelstraße 2
78467 Konstanz

This package leaflet was last revised in December 2014.

Source: Information from the package leaflet
Status: 04/2018
Active ingredient: Magaldrate. Areas of application: for heartburn and acid-related stomach complaints and for the symptomatic treatment of stomach and duodenal ulcers.