MAGALDRAT-

MAGALDRAT-ratiopharm 800 mg tablets

Important notes (mandatory information)

Magaldrat-ratiopharm 800 mg chewable tablets. Areas of application: for the treatment of symptoms of conditions in which stomach acid should be bound: heartburn and acid-related stomach complaints and stomach or duodenal ulcers. Warning: Contains sorbitol!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Magaldrat-ratiopharm 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 directed by your doctor or pharmacist.

• 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 IS MAGALDRAT-RATIOPHARM 800 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MAGALDRAT-RATIOPHARM 800 MG?
3. HOW SHOULD MAGALDRAT-RATIOPHARM 800 MG BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD MAGALDRAT-RATIOPHARM 800 MG BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MAGALDRAT-RATIOPHARM 800 MG AND WHAT IS IT USED FOR?

Magaldrat-ratiopharm 800 mg contains magaldrate and belongs to the group of medicines known as antacids, which are used to bind (neutralise) excess stomach acid. Magaldrat-ratiopharm 800 mg is used to treat symptoms of conditions in which stomach acid should be bound: heartburn and acid-related stomach complaints and stomach or duodenal ulcers.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MAGALDRAT-RATIOPHARM 800 MG?

Magaldrat-ratiopharm 800 mg 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 Magaldrat-ratiopharm 800 mg:

• if you have kidney problems or are on dialysis
• if you have Alzheimer's 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
• in case of long-term use.

In these cases, you may only take Magaldrat-ratiopharm 800 mg under regular medical supervision of certain blood values (aluminium). 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. It may look black and tarry.
• You vomit blood or dark particles that look like coffee grounds.

Children

Do not give this medicine to children under 12 years of age, as there is insufficient experience in this age group.

Taking Magaldrat-ratiopharm 800 mg 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 Magaldrat-ratiopharm 800 mg can impair the absorption and thus the effect of medicines taken at the same time, a general interval of 2 hours should be observed between taking Magaldrat-ratiopharm 800 mg and other medicines. Inform your doctor or pharmacist before taking Magaldrat-ratiopharm 800 mg 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 Magaldrat-ratiopharm 800 mg with food and drink

The simultaneous intake of Magaldrat-ratiopharm 800 mg 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 antacids 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 exposing your unborn child to aluminium. 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

Magaldrat-ratiopharm 800 mg has a negligible or no influence on the ability to drive and use machines.

Magaldrat-ratiopharm 800 mg contains sorbitol

Please only take Magaldrat-ratiopharm 800 mg after consulting your doctor if you are known to suffer from an intolerance to certain sugars. Note for diabetics: This medicine contains 1 g of sorbitol in one tablet. When the dosage instructions are followed, up to 1 g of sorbitol, corresponding to 0.08 BE, is administered with each use.

3. HOW SHOULD MAGALDRAT-RATIOPHARM 800 MG BE TAKEN?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults and children over 12 years: Take 1 chewable tablet (equivalent to 800 mg magaldrate) several times a day as needed. The daily dose should not exceed 8 chewable tablets (equivalent to 6400 mg magaldrate).

Method of administration

Take the chewable tablets by sucking or chewing them thoroughly.

Duration of use

Do not take Magaldrat-ratiopharm 800 mg for more than 14 days without medical advice. Please talk to your doctor or pharmacist if you have the impression that the effect of Magaldrat-ratiopharm 800 mg is too strong or too weak.

If you have taken more Magaldrat-ratiopharm 800 mg than you should

If you have taken too many Magaldrat-ratiopharm 800 mg chewable tablets, you should consult your doctor for advice. Poisoning by Magaldrat-ratiopharm 800 mg is unlikely due to the low absorption of the drug into the blood. Overdosage may cause changes in bowel movements such as stool softening and increased stool frequency.

If you forget to take Magaldrat-ratiopharm 800 mg

If you forget to take Magaldrat-ratiopharm 800 mg, 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 Magaldrat-ratiopharm 800 mg

If you interrupt or prematurely terminate treatment with Magaldrat-ratiopharm 800 mg on your own initiative due to side effects, you should talk to your doctor.

If you have any further questions on the use of 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 up to 1 in 10,000 people):

• diarrhoea
• constipation
• osteomalacia (only after long-term use of high doses)

In case of insufficient kidney function or long-term use of high doses, taking Magaldrat-ratiopharm 800 mg can cause increased magnesium and aluminium levels in the blood. Aluminium can be stored mainly 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, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD MAGALDRAT-RATIOPHARM 800 MG BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the blister packs. The expiry date refers to the last day of the month indicated. Do not store above 30°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Magaldrat-ratiopharm 800 mg contains

The active ingredient is magaldrate. Each chewable tablet contains 800 mg magaldrate. The other ingredients are: sorbitol, magnesium stearate (Ph.Eur.), highly dispersed silicon dioxide, caramel flavouring.

What Magaldrat-ratiopharm 800 mg looks like and contents of the pack

White, round chewable tablet with a break notch on one side. The break notch is only to make it easier to divide the chewable tablet for easier swallowing and not to divide it into equal doses. Magaldrat-ratiopharm 800 mg is available in packs of 20, 50 and 100 chewable tablets.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This package leaflet was last revised in June 2014.

Source: Information from the package leaflet
Status: 12/2017
Areas of application: for the treatment of symptoms of conditions in which stomach acid should be bound: heartburn and acid-related stomach complaints and stomach or duodenal ulcers. Warning: Contains sorbitol!