Riopan 1600 mg - StomachGel

Riopan contains the active ingredient magaldrate and binds excess stomach acid.

Application

What is Riopan and what is it used for?

Riopan contains the active ingredient magaldrate and binds excess stomach acid. Excessive acid binding, which would lead to increased acid excretion into the stomach, is avoided. The natural digestive function is maintained, and the bile acids that in some cases flow back into the stomach are bound. The
effect of Riopan usually lasts for several hours.

Riopan is used for heartburn and acid regurgitation.

Children and adolescents under 18 years of age should only take Riopan if prescribed by a doctor.

If you do not feel better or even worse after 14 days, consult your doctor.

How is it applied?

What is Riopan and what is it used for?

Riopan contains the active ingredient magaldrate and binds excess stomach acid. Excessive acid binding, which would lead to increased acid excretion into the stomach, is avoided. The natural digestive function is maintained, and the bile acids that in some cases flow back into the stomach are bound. The
effect of Riopan usually lasts for several hours.

Riopan is used for heartburn and acid regurgitation.

Children and adolescents under 18 years of age should only take Riopan if prescribed by a doctor.

If you do not feel better or even worse after 14 days, consult your doctor.

What should you pay attention to before taking it?

What should you be aware of before taking Riopan?
Riopan must not be taken
- if you are allergic to magaldrate or any of the other ingredients of this medicine listed in section 6,
- if you have abnormal muscle weakness (myasthenia gravis,
.br>- in pathological muscle weakness (myasthenia gravis),
- in reduced phosphate levels in the blood (hypophosphataemia).

Warnings and precautions
You must only take Riopan under regular medical supervision of certain blood levels (aluminium, magnesium) if:
- your kidney function is severely reduced, especially if you need dialysis,
Riopan 1600 mg - StomachGEL 1-19160 GI.- you have Alzheimer's disease or other forms of dementia (reduction in mental capacity),
- you need to follow a low phosphate diet or have impaired bone metabolism,
- or for long-term use.

If your symptoms persist for more than 2 weeks or only partially subside
and/or recur at more frequent intervals, further investigations should be carried out to rule out a serious condition.

If you do not feel better or even worse after 14 days, contact your doctor.

Talk to your doctor
- if you lose weight unintentionally, if you feel tired and weak as this may be a sign of anaemia, if there is bleeding in the gastrointestinal tract, difficulty swallowing, persistent vomiting or vomiting of blood as these may be signs of a serious illness.
- if you have had a stomach ulcer or surgery on the stomach or intestines in the past.
- if you have jaundice, impaired liver function or liver disease.
- if you have any other serious condition that affects your general wellbeing.
- if you are over 55 years of age and suffer from new or recently changed signs of illness.

Visit a doctor if you repeatedly suffer from indigestion or heartburn over a long period of time. Inform him that you are taking non-prescription medicines for indigestion or heartburn.

Do not take Riopan permanently, there is a risk of increased aluminium storage.

Riopan contains no sugar and is permitted for diabetics.

Do not take Riopan as a preventive medicine.

Taking Riopan with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken or are planning to take any other medicines.

Because Riopan may interfere with the absorption of medicines given at the same time, an interval of 2 hours should always be observed between taking Riopan and other medicines.

Take Riopan only after consulting your doctor or pharmacist if you are taking any of the following medicines:
- certain antibiotics (medicines for infectious diseases, e.g. tetracyclines,
quinolones such as ciprofloxacin, ofloxacin, norfloxacin)
- iron preparations
- isoniazid (a medicine for tuberculosis)
- chlorpromazine (used for psychoses)
- certain tranquillisers (benzodiazepines)
- Digoxin (heart medicine)
- Bile acids (cheno and ursodeoxycholic acid)
Riopan 1600 mg - StomachGEL 1-19160 GI- Certain painkillers with indometazine as the active ingredient
.- Cimetidine (another medicine to neutralise stomach acid)
- Coumarin derivatives (certain blood thinners)
- Salicylates
- Calcium carbonate when used as a medicine to treat high levels of phosphate in the blood (hyperphosphataemia) in dialysis patients.Riopan with food and drink
Avoid taking acidic drinks (fruit juices, wine, etc.) at the same time as Riopan.These increase the absorption of aluminium salts in the intestine. Effervescent tablets also contain fruit acids which may increase aluminium absorption.

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.

Pregnancy:
Use only for a short time and at the lowest possible dose to avoid exposure of the baby to aluminium.

Lactation:
Aluminium compounds pass into breast milk. There is no presumed risk to the newborn as only very small amounts are absorbed.

Driving and ability to operate machinery
There are no known effects on driving and operating machinery.

Riopan contains sodium cyclamate
This medicinal product contains less than 1 mmol sodium (23 mg) per dosage unit, i.e. it is almost "sodium-free".

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How should the medicine be taken?

How to take Riopan?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are not sure.

The recommended dose is:
Take 1 sachet (= 10 ml) as needed for mild stomach complaints (e.g. heartburn, acid regurgitation).

The complaints usually occur after eating or at night (when lying down), so the usual dose is 1 sachet (= 10 ml) one hour after each of the main meals or before going to bed (= 4 times a day).

You should not take more than 4 sachets daily (equivalent to 6400 mg Magaldrate).

In some cases, taking one dose can bring freedom from symptoms. Stop taking the pouch when you are free of symptoms.

Instructions for taking

You can find the exact handling of the sachet in the drawing:
Riopan 1600 mg - StomachGEL 1-19160 GI
Riopan can be taken undiluted or with liquid.

Duration of treatment:
You can stop taking it when you are free of symptoms.
Riopan must not be taken for more than 14 days in a row. Consult your doctor if your symptoms do not subside within this period, last longer than 14 days or get worse, or if you experience additional symptoms. He will arrange for a diagnostic work-up to rule out other diseases.

Maximum daily dose:
You should not take more than 4 sachets daily (equivalent to 6400 mg of magaldrate).

Use in cases of renal dysfunction:
In cases of severely impaired renal function, due to the risk of chronic aluminium poisoning, long-term and higher-dose use should only take place under medical supervision with regular aluminium and magnesium blood level determinations.

Use in children and adolescents:
No sufficient information is available for children under 12 years of age, so they should not take Riopan. In adolescents aged 12 to 18 years, Riopan should only be used on the express prescription of a doctor.

If you have taken a larger amount of Riopan than you should
Acute symptoms of poisoning with Riopan are not known.

If you forget to take Riopan
Do not take a double dose if you have forgotten to take it before. Take the next dose as needed.

If you stop taking Riopan
You can stop taking it at any time if you are free of symptoms.

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

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What are the possible side effects?

How to store Riopan?

Do not freeze.

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 sachet after "EXP" and "EXP:" respectively. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special instructions for storage

How to store Riopan?

Do not freeze.

Keep this medicine out of the reach of children.

Do not use this medicinal product after the expiry date which is stated on the carton and sachet after ,,Use by" and ,,Use by:" respectively. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information

What Riopan contains
- The active substance is: magaldrate. 1 sachet of 10 ml contains 1600 mg magaldrate, anhydrous.
- The other ingredients are: Sodium cyclamate, silver sulphate, chlorhexidine digluconate solution, gum arabic, hypromellose, simethicone, maltol, caramel flavour, cream flavour, purified water.
Riopan 1600 mg - StomachGEL 1-19160 GIWhat Riopan looks like and contents of the pack
White to off-white gel in plastic sachets in an outer carton.

Pack sizes of 10, 20 and 50 sachets of 10 ml.
Not all pack sizes may be marketed.

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