RIOPAN

RIOPAN Stomach Gel Stick Pack

Important notes (mandatory information)

Riopan Magen Gel. Active ingredient: Magaldrate. Areas of application: for heartburn and acid-related stomach complaints and for the symptomatic treatment of stomach or 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 Gel 1600 mg, gel for oral use
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 notice 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 IS RIOPAN MAGEN GEL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING RIOPAN MAGEN GEL?
3. HOW TO TAKE RIOPAN MAGEN GEL?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE RIOPAN MAGEN GEL?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS RIOPAN MAGEN GEL AND WHAT IS IT USED FOR?

Riopan Magen Gel contains magaldrate and belongs to the group of medicines known as antacids, which are used to neutralise excess stomach acid. Riopan Magen Gel is used: for heartburn and acid-related stomach complaints and for the symptomatic treatment of stomach or duodenal ulcers.

2. What should you consider before taking Riopan Magen Gel?

Riopan Magen Gel 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 Gel. Special care should be taken when taking Riopan Magen Gel:

• if you suffer from kidney problems or are on dialysis,
• 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 Gel 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. Persistent and recurring stomach complaints can be a sign of a serious illness. Inform your doctor immediately if you notice any of the following symptoms:

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

Taking Riopan Magen Gel 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. Do not take any other medicines 2 hours before or after taking Riopan Magen Gel, as the absorption of other medicines by antacids such as Riopan Magen Gel may be reduced. Tell your doctor or pharmacist, especially before taking Riopan Magen Gel, if you are taking any of the following medicines:

• Antibiotics such as ciprofloxacin, ofloxacin and norfloxacin or another tetracycline and quinolone antibiotics
• 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 Gel with food, drink and alcohol

The simultaneous intake of Riopan Magen Gel and acidic drinks such as fruit juices, wine and 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The benefit-risk ratio should be carefully weighed before taking aluminium-containing medicines for binding 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 Gel has a negligible or no effect on the ability to drive and use machines.

3. HOW TO TAKE RIOPAN MAGEN GEL?

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 much Riopan Magen Gel should you take daily?
Adults and children over 12 years of age:

• the recommended dose is 1 sachet several times a day as needed,
• do not take more than 4 sachets (6400 mg magaldrate) per day.

How should you take Riopan Magen Gel?
Shake the sachet before use. The gel can be taken undiluted or with liquid.

How long should you take Riopan Magen Gel?
Riopan Magen Gel should only be taken for short-term treatment of your symptoms. If the symptoms persist for more than 2 weeks during treatment, you should consult your doctor. 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 look black and tarry.
• You vomit blood or dark particles that look like coffee grounds.

If you have taken more Riopan Magen Gel than you should

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

If you forget to take Riopan Magen Gel

If you forget to take Riopan Magen Gel, 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 Gel

If you interrupt or prematurely terminate treatment with Riopan Magen Gel 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)

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 in the case of long-term use of high doses, taking Riopan Magen Gel can cause increased aluminium and magnesium levels in the blood. Aluminium storage, especially in the nervous and bone tissue, and phosphate depletion can occur.

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, 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 GEL?

Keep this medicine out of the reach of children. Riopan Magen Gel should be stored protected from frost. Do not use this medicine after the expiry date which is stated on the sachet and the folding box. 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 have finished using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Riopan Magen Gel contains

The active ingredient is magaldrate. 1 sachet with 10 ml contains 1600 mg anhydrous magaldrate. The other ingredients are: silver sulphate; chlorhexidine digluconate; sodium hypochlorite; gum arabic; hypromellose; sodium cyclamate; simethicone emulsion; caramel flavouring; cream flavouring; 3-hydroxy-2-methyl-4-pyranone (maltol) and purified water.

What Riopan Magen Gel looks like and contents of the pack

Riopan Magen Gel is a white to cream-coloured gel with caramel and cream flavour.

Pack sizes

Riopan is available in packs of 10, 20, 30, 40 and 50 sachets each containing 10 ml of gel. Hospital packs of 500 (10 x 50) sachets each containing 10 ml of gel are also available. 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: 11/2017
Active ingredient: Magaldrate. Areas of application: for heartburn and acid-related stomach complaints and for the symptomatic treatment of stomach or duodenal ulcers.