Active ingredients: Magaldrato
RIOPAN 800 mg chewable tablets
Riopan package inserts are available for pack sizes:- RIOPAN 800 mg chewable tablets
- RIOPAN 80 mg / ml oral gel
Why is Riopan used? What is it for?
Pharmacotherapeutic group
RIOPAN is an antacid.
The action of its active ingredient magaldrate is carried out through the neutralization of gastric acid.
Therapeutic indications
RIOPAN is used for the treatment of duodenal and gastric ulcer and reflux oesophagitis.
It is also used in the symptomatic treatment of gastritis and gastro-duodenitis of various kinds characterized by hyperacidity.
Contraindications When Riopan should not be used
- Hypersensitivity to the active substance and / or to one of the excipients
- Porphyria
- Hypophosphatemia
- Severe kidney failure
- Contraindicated in pediatric age
- State of cachexia
Precautions for use What you need to know before taking Riopan
RIOPAN should not be used in children under 12 years of age as treatment experience is limited in this age group.
In patients with impaired renal function (creatinine clearance <30 ml / min) RIOPAN should only be used under regular monitoring of serum magnesium and aluminum levels. Serum aluminum levels should not exceed 40 ng / mL.
Particular caution should be exercised in patients undergoing dialysis due to a possible link between elevated serum aluminum levels and the development of encephalopathies.
Moderately elevated levels of serum aluminum have occasionally been observed in subjects with normal renal function.
Prolonged use of aluminum-containing antacids may reduce the absorption of phosphates.
Interactions Which drugs or foods may change the effect of Riopan
Since antacids can affect the absorption of other drugs taken at the same time, 1-2 hours should elapse between taking RIOPAN and taking other drugs.
In particular, during the use of antacids, a substantial reduction in the absorption of tetracyclines and quinolone derivatives such as ciprofloxacin, ofloxacin and norfloxacin was observed.
Modest reductions in absorption of digoxin, isoniazid, iron preparations and chlorpromazine may be observed when administered concomitantly with RIOPAN.
A possible enhancement of the anticoagulant effect of coumarin derivatives could be detected.
The intake of aluminum-containing antacids with acidic drinks (fruit juice, wine, etc.) or with effervescent tablets containing citric or tartaric acid increases intestinal absorption of aluminum. RIOPAN can influence the absorption of benzodiazepines, indomethacin and cheno and ursodeoxycholic acid.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those without a prescription.
Warnings It is important to know that:
In children, the possibility of unrecognized hereditary fructose intolerance should be considered.
Each chewable tablet contains 0.774 g of sorbitol. Following the recommended dosage can therefore be taken up to 6.2 g of sorbitol per day. In case of ascertained intolerance to some sugars, consult your doctor before taking this medicine.
Since chewable tablets have a low sodium content, they can also be used by patients with high blood pressure.
Warning for diabetic patients: One chewable tablet contains 0.07 bread units.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine
Use in pregnancy is not recommended.
There are insufficient data on the use of RIOPAN in pregnancy.
In animal studies, the administration of aluminum salts had a detrimental effect on the offspring. The potential risk for humans is unknown.
Aluminum compounds pass into breast milk. Due to the low absorption, it is believed that there is no risk to the newborn.
Important information about some of the ingredients
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Driving and using machines
There are no known effects of RIOPAN on the ability to drive and use machines. However, the medicine is unlikely to interfere with your ability to drive and / or use machines.
Dosage and method of use How to use Riopan: Dosage
Unless otherwise prescribed, one RIOPAN 800 mg tablet will be taken four times a day, one hour after the main meals and immediately before bedtime. The tablets should be chewed or sucked.
Higher dosages as needed can be used on prescription and under strict medical supervision; in all cases, as soon as possible, the dosage should be reduced to that sufficient to control the symptoms.
A daily dose of 6400 mg should not be exceeded.
Duration of treatment
Treatment should be continued for at least 4 weeks even if symptoms have disappeared.
If symptoms persist for more than 2 weeks during treatment, a clinical examination should be done to rule out any malignant disease.
Specific groups of patients
Pediatric Patients: Do not use in children under 12 years of age as treatment experience is limited in this age group.
Overdose What to do if you have taken too much Riopan
Actions to be taken in case of overdose
No acute intoxication phenomena are known. Experience with deliberate overdose is very limited. Cases of overdose with aluminum salts are more likely to occur in patients with severe chronic renal failure with the following symptoms: encephalopathy, seizures and dementia. As with all overdose cases, treatment should be symptomatic, taking generic supportive measures.
In case of accidental ingestion / intake of an excessive dose of RIOPAN, notify your doctor immediately or go to the nearest hospital.
Conduct to be followed in the event that one or more doses have been omitted
Do not administer a double dose to make up for a forgotten dose of RIOPAN. If you have any further questions on the use of RIOPAN, ask your doctor or pharmacist.
Side Effects What are the side effects of Riopan
Like all medicines, Riopan can cause side effects, although not everybody gets them.
Very common (≥ 1/10), common (≥ 1/100 - <1/10), uncommon (≥ 1/1000 - <1/100), rare (≥ 1/10000 - <1/1000), very rare including isolated cases (≤ 1/10000), not known (frequency cannot be estimated from the available data).
Disorders of the immune system
Frequency not known: hypersensitivity reactions.
Gastrointestinal disorders
Very common: loose stools
Very rare: diarrhea
Frequency not known: nausea and vomiting
Sorbitol, a component of RIOPAN chewable tablets, can cause stomach upset and diarrhea.
In patients with renal insufficiency and during prolonged use at high doses, aluminum may be deposited, particularly in nervous and bone tissue, and phosphate depletion may occur.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package
The expiry date refers to the product in intact and correctly stored packaging. Warning: Do not use the medicine after the expiry date stated on the package
Store at a temperature below 30 ° C
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the reach and sight of children
Composition and pharmaceutical form
Composition
One chewable tablet contains:
Active ingredient: anhydrous magaldrate 800 mg
Excipients: macrogol 4000, caramel flavor, peanut calcium, cream flavor, maltol, sorbitol.
Pharmaceutical form and content
Chewable tablets or to dissolve in the mouth. Box of 40 tablets
The product is also available in oral gel, 250 ml bottle and 10 ml sachets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
RIOPAN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
RIOPAN 800 mg chewable tablets
One tablet contains: anhydrous magaldrate 800.0 mg
Excipients: sorbitol
For the full list of excipients see section 6.1
RIOPAN 80 mg / ml oral gel
1 ml of gel contains: anhydrous magaldrate 80.0 mg
Excipients: maltol
For the full list of excipients see section 6.1
03.0 PHARMACEUTICAL FORM
Tablets to chew or dissolve in the mouth.
Oral gel
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of duodenal and gastric ulcer and reflux oesophagitis; symptomatic treatment of gastritis and gastro-duodenitis of various etiologies characterized by hyperacidity.
04.2 Posology and method of administration
RIOPAN 800 mg chewable tablets
Unless otherwise prescribed, one tablet of RIOPAN 800 mg will be taken four times a day, one hour after the main meals and immediately before bedtime.
The tablets must be chewed or dissolved in the mouth.
RIOPAN 80 mg / ml oral gel
Unless otherwise prescribed, 10 ml (corresponding to two teaspoons) or the content of a sachet of RIOPAN gel, four times a day, one "hour after the main meals and immediately before bedtime.
For use: shake the bottle vigorously or homogenize the contents of the sachet, manipulating it before opening it.
Higher dosages, as needed, of both tablets and gels, can be used on prescription or under strict medical supervision: in all cases, as soon as possible, the dosage will be reduced to that sufficient to control the symptoms.
A daily dose of 6400 mg should not be exceeded.
Treatment should be continued for at least 4 weeks even if symptoms have disappeared. If symptoms persist for more than 2 weeks during treatment, a clinical examination should be done to rule out any malignant disease.
Pediatric Patients: Do not use in children under 12 years of age as treatment experience is limited in this age group.
04.3 Contraindications
• Hypersensitivity to the active substance and / or to one of the excipients
• Porphyria
• Hypophosphataemia
• Severe renal insufficiency (see section 4.4)
• Contraindicated in pediatric age
• State of cachexia
04.4 Special warnings and appropriate precautions for use
RIOPAN should not be used in children under 12 years of age as treatment experience is limited in this age group.
In patients with impaired renal function (serum creatinine clearance of magnesium and aluminum. Serum levels of aluminum should not exceed 40 ng / ml.
Particular caution should be exercised in patients undergoing dialysis due to a possible link between elevated serum aluminum levels and the development of encephalopathies.
Moderately elevated levels of serum aluminum have occasionally been observed in subjects with normal renal function (see section 5.2 Pharmacokinetic properties).
Prolonged use of aluminum-containing antacids may reduce the absorption of phosphates.
For RIOPAN chewable tablets:
In children, the possibility of unrecognized hereditary fructose intolerance should be considered.
Each chewable tablet contains 0.774 g of sorbitol. Following the recommended dosage can therefore be taken up to 6.2 g of sorbitol per day. Patients with rare hereditary problems of sorbitol intolerance should not take this medicine.
Since chewable tablets have a low sodium content, they can also be used by patients with high blood pressure.
Warning for diabetic patients: One chewable tablet contains 0.07 bread units.
RIOPAN 80 mg / ml oral gel
Shake the bottle vigorously before use.
Homogenize the contents of the sachet by manipulating it before opening it.
04.5 Interactions with other medicinal products and other forms of interaction
Since antacids can affect the absorption of other drugs taken at the same time, 1-2 hours should elapse between taking RIOPAN and taking other drugs.
In particular, during the use of antacids, a substantial reduction in the absorption of tetracyclines and quinolone derivatives, such as ciprofloxacin, ofloxacin and norfloxacin, was observed.
Modest reductions in absorption of digoxin, isoniazid, iron preparations and chlorpromazine may be observed when administered concomitantly with RIOPAN.
A possible enhancement of the anticoagulant effect of coumarin derivatives could be detected.
The intake of antacids containing aluminum with acidic drinks (fruit juice, wine etc.) or with effervescent tablets containing citric or tartaric acid increases intestinal absorption of aluminum. RIOPAN can influence the absorption of benzodiazepines, indomethacin and cheno and ursodeoxycholic acid.
04.6 Pregnancy and lactation
Use in pregnancy is not recommended.
There are insufficient data on the use of RIOPAN in pregnancy.
In animal studies, the administration of aluminum salts had a detrimental effect on the offspring. The potential risk for humans is unknown.
Aluminum compounds pass into breast milk. Due to the low absorption, it is believed that there is no risk to the newborn.
04.7 Effects on ability to drive and use machines
There are no known effects of RIOPAN on the ability to drive and use machines. However, the medicine is unlikely to interfere with your ability to drive and / or use machines.
04.8 Undesirable effects
Very common (≥1 / 10),
common (≥1 / 100 -
uncommon (≥1 / 1000 -
rare (≥1 / 10,000 -
very rare including isolated cases (≤1 / 10,000),
not known (frequency cannot be estimated from the available data).
Disorders of the immune system
Frequency not known: hypersensitivity reactions
Gastrointestinal disorders
Very common: Loose stools
Very rare: Diarrhea
Frequency not known: nausea and vomiting
Sorbitol, a component of RIOPAN chewable tablets, can cause stomach upset and diarrhea. In patients with renal insufficiency and during prolonged use at high doses, aluminum may be deposited, particularly in nervous and bone tissue, and phosphate depletion may occur.
04.9 Overdose
No acute intoxication phenomena are known. Experience with deliberate overdose is very limited. Cases of overdose with aluminum salts are more likely to occur in patients with severe chronic renal failure with the following symptoms: encephalopathy, seizures and dementia.As in all cases of overdose, treatment should be symptomatic with generic supportive measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ATC: A02AD02: antacids
The action of the magaldrate is carried out through the neutralization of the gastric acid. It also has a dose-dependent and pH-dependent bond with bile acids and lysolecithin. The antacid activity is to be attributed to the binding of the protons with the sulphate and hydroxide ions of the interstitial layer, so that the lattice structure splits during neutralization.
800 mg of magaldrate neutralizes about 18-25 mEq of hydrochloric acid.
05.2 Pharmacokinetic properties
- General
Magaldrato is not absorbed from the gastrointestinal tract. During the neutralization process, small quantities of magnesium and aluminum ions are released which, during intestinal transit, are converted into limited soluble phosphates and as such excreted in the faeces. A portion of the cations is absorbed. Moderately elevated levels of serum aluminum have occasionally been observed in subjects with normal renal function. Prolonged use of aluminum-containing antacids may reduce the absorption of phosphates.
- Characteristics in patients / special groups of subjects
Due to a possible correlation between elevated serum aluminum levels and the development of encephalopathies, particular caution should be exercised in patients undergoing dialysis.
In long-term treatments, aluminum concentrations in the blood should be monitored regularly and should not exceed 40 ng / ml.
In patients with impaired renal function, plasma and tissue accumulations may occur (as aluminum accumulates mainly in the nervous and bone tissue) and overdose phenomena.
05.3 Preclinical safety data
Acute toxicity has not been determined due to low absorption (10% for magnesium and approximately 1% for aluminum) and relatively fast renal excretion.
The mutagenic potential of magaldrate has not been sufficiently investigated. For aluminum compounds there is no relevant evidence of mutagenic potential.
There are no carcinogenic studies with magaldrate.
There are no embryotoxicity studies in animals. There is no evidence of any risk of malformations in humans. Embryotoxic and foetotoxic effects have been observed in studies with other aluminum compounds. Studies in the rat have shown an increase in postnatal mortality and delayed neuromotor development of the fetus.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
RIOPAN 800 mg chewable tablets
Macrogol 4000, caramel flavor, peanut calcium, cream flavor, maltol, sorbitol
RIOPAN 80 mg / ml oral gel
Gum arabic, hypromellose, maltol, caramel essence, cream essence, simethicone emulsion, sodium cyclamate, 20% chlorhexidine digluconate, silver sulphate, purified water.
06.2 Incompatibility
None
06.3 Period of validity
RIOPAN 800 mg chewable tablets: 3 years
RIOPAN 80 mg / ml oral gel: 5 years
Riopan oral gel bottle 250 ml: chemical and physical stability during use has been demonstrated for 6 months. From a microbiological point of view, once opened, the product can be stored for up to 6 months.
06.4 Special precautions for storage
RIOPAN 800 mg chewable tablets: store below 30 ° C.
RIOPAN 80 mg / ml oral gel: do not refrigerate or freeze.
06.5 Nature of the immediate packaging and contents of the package
RIOPAN 800 mg chewable tablets: PVC-PVDC-aluminum blisters of 10 tablets each.
RIOPAN 80 mg / ml oral gel:
a) bottles of 250 ml of white polypropylene with white polyethylene cap and guarantee collar
b) 10 ml sachets in aluminum-polythene laminate.
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
Takeda Italia SpA - Via Elio Vittorini 129 - 00144 Rome
08.0 MARKETING AUTHORIZATION NUMBER
RIOPAN 800 mg chewable tablets, 40 tablets: A.I.C. n. 027103023
RIOPAN 80 mg / ml oral gel, 250 ml bottle: A.I.C. n. 027103047
RIOPAN 80 mg / ml oral gel, 40 sachets 10 ml: A.I.C. n. 027103035
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal: June 2010.
10.0 DATE OF REVISION OF THE TEXT
September 2013
