Active ingredients: Magaldrato
MAGALTOP 800 mg chewable tablets
MAGALTOP 800 mg / 10 ml oral suspension
Why is Magaltop used? What is it for?
MAGALTOP contains the active ingredient magaldrate which belongs to a group of medicines called antacids and ulcers used to protect the stomach wall from the action of acids and prevent damage caused by stress or by certain medicines used to relieve pain and inflammation (medicines non-steroidal anti-inflammatory drugs).
This medicine is indicated in the treatment of:
- lesions of the stomach or intestines (duodenal and gastric ulcer);
- inflammation of the esophagus caused by the contents of the stomach moving up the esophagus (reflux esophagitis);
- inflammation of the stomach and intestines (gastritis and gastroduodenitis) of various kinds, characterized by an increase in acidity (hyperacidity).
Contraindications When Magaltop should not be used
Do not take MAGALTOP
- if you are allergic to magaldrate or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Magaltop
Talk to your doctor or pharmacist before taking MAGALTOP.
Take MAGALTOP with caution and only under close medical supervision if you suffer from kidney problems (kidney failure). If you have severe kidney problems (severe kidney failure), avoid taking this medicine.
Interactions Which drugs or foods can modify the effect of Magaltop
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Avoid taking MAGALTOP together with any of the following medicines as magaldrate can affect their absorption:
- medicines used to treat infections (tetracyclines);
- digoxin, a medicine used to treat heart problems;
- medicines used to treat anxiety and sleep disorders (benzodiazepines);
- dicumarol, a medicine used to thin the blood;
- indomethacin, a medicine used to treat inflammation;
- medicines used to treat biliary disorders (keto- and ursodeoxycholic acid);
- medicines used to treat iron deficiencies in the body (iron derivatives).
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
There are no known effects on the ability to drive and use machines.
MAGALTOP contains sorbitol
This medicine contains sorbitol, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
MAGALTOP 800 mg / 10 ml oral suspension contains para-hydroxybenzoates
This medicinal product contains para-hydroxybenzoates (methylhydroxybenzoate, propylhydroxybenzoate) which can cause allergic reactions (including delayed).
Dose, Method and Time of Administration How to use Magaltop: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
MAGALTOP 800 mg chewable tablets
The recommended dose is 1 tablet, 4 times a day, one "hour after meals and one" hour before bedtime. The tablets must be chewed or sucked.
MAGALTOP 800 mg / 10 ml oral suspension
Bottle: The recommended dose is 10 ml of suspension (2 teaspoons), 4 times a day, one "hour after meals and one" hour before bedtime. Shake the bottle vigorously before use.
Sachets: The recommended dose is 1 sachet, 4 times a day, one "hour after meals and one" hour before bedtime.
Before opening the sachet, handle it so that its contents become homogeneous.
You can take higher doses than recommended only if prescribed by your doctor and under his close supervision. In any case, as soon as possible, reduce the dose to that sufficient to control symptoms.
Overdose What to do if you have taken too much Magaltop
There are no known cases of overdose. After taking too much of this medicine, bowel problems may occur (See "Possible side effects" section).
In case of accidental intake / ingestion of an overdose of MAGALTOP, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Magaltop
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Frequency not known (the frequency of which cannot be estimated from the available data)
- alterations of the intestine (changes in the alvo), such as increased frequency of stool expulsion (defecation) and / or soft stools (reduced stool consistency) following the intake of very high doses of MAGALTOP;
- stomach and intestinal disorders (changes in gastrointestinal transit) such as mild and temporary diarrhea or constipation (constipation).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after "EXP". The expiry date refers to the last day of that month and to the product in intact packaging, correctly stored.
This medicine does not require any special storage conditions.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What MAGALTOP contains
MAGALTOP 800 mg chewable tablets
- The active ingredient is magaldrate. Each tablet contains 800 mg of magaldrate.
- The other ingredients are: sorbitol, mannitol, corn starch, magnesium stearate, sodium saccharinate, caramel flavor.
MAGALTOP 800 mg / 10 ml oral suspension
- The active ingredient is magaldrate. 10 ml of suspension contain 800 mg of magaldrate.
- The other ingredients are: 70% sorbitol, hydroxyethylcellulose, citric acid, sodium cyclamate, sodium saccharinate, simethicone, methylhydroxybenzoate, propylhydroxybenzoate, cream flavor, passion fruit flavor, purified water.
Description of what MAGALTOP looks like and contents of the pack
MAGALTOP 800 mg chewable tablets
Box of 40 chewable tablets.
MAGALTOP 800 mg / 10 ml oral suspension
250 ml bottle. Pack of 40 sachets of 10 ml.
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 -
MAGALTOP
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Chewable tablets:
Each tablet contains: Active ingredient Magaldrato mg 800.
Oral Suspension (Sachets and Bottle):
100 ml of suspension contain: Active ingredient Magaldrate 8 g.
03.0 PHARMACEUTICAL FORM -
Chewable tablets, oral suspension.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Treatment of duodenal and gastric ulcer and reflux oesophagitis; symptomatic treatment of gastritis and gastroduodenitis of various etiologies characterized by hyperacidity.
04.2 Posology and method of administration -
Chewable tablets:
Unless otherwise prescribed, one MAGALTOP tablet four times a day, one "hour after main meals and one" hour before bedtime.
The tablets must be chewed or sucked.
Oral suspension:
Unless otherwise prescribed by a doctor, 10 ml (corresponding to two teaspoons) or the content of a sachet of MAGALTOP, four times a day, one "hour after main meals and one" hour before bedtime.
Higher dosages of both tablets and suspension can be used on prescription or under strict medical supervision: in all cases, as soon as possible, the dosage should be reduced to that sufficient to control the symptoms.
04.3 Contraindications -
Known individual hypersensitivity to the components of the product.
04.4 Special warnings and appropriate precautions for use -
In states of renal insufficiency use with caution and only under medical supervision, avoiding however the use in case of severe renal insufficiency.
For Suspension:
Shake the bottle vigorously before use.
Homogenize the contents of the bag by handling it before opening it.
Keep out of reach of children.
04.5 Interactions with other medicinal products and other forms of interaction -
MAGALTOP Chewable tablets and MAGALTOP Oral suspension may influence the absorption of some drugs (tetracyclines, digoxin, benzodiazepines, dicumarol, indomethacin, cheno- and urso-deoxycholic acid, iron derivatives), the simultaneous administration of which must therefore be avoided.
04.6 Pregnancy and breastfeeding -
No contraindications.
04.7 Effects on ability to drive and use machines -
There are no known effects on the ability to drive and use machines.
04.8 Undesirable effects -
At very high dosages, changes in the alvo may occur (an increase in the frequency of defecation and / or a reduction in stool consistency). Alterations in gastrointestinal transit (diarrhea or mild and transient constipation) occur very rarely at the recommended dosages.
04.9 Overdose -
There are no known cases of accidental or intentional overdose in humans with onset of toxic symptoms.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
MAGALTOP Chewable Tablets and MAGALTOP Oral Suspension contain, as an active ingredient, Magaldrate, an anti-ulcer drug that possesses the requirements of a real buffer antacid (not simply those of a neutralizing agent). The results of the pharmacodynamic tests have in fact shown that Magaldrato:
a) has a rapid and persistent ability to maintain gastric pH in a range of values between 3 and 5, optimal for therapeutic purposes, thanks to a buffering effect proportional to the acidity of the gastric juice and therefore self-limiting;
b) has cytoprotective activity. Evidence in this favor was obtained both in the experimental animal (in which MAGALTOP proved to be very active in preventing gastric damage induced by non-steroidal anti-inflammatory drugs and ulcers from pyloric ligation or stress and in protecting the gastroduodenal mucosa. from lesions, induced by necrotizing agents), both in man (prevention of gastric irritation induced by methylxanthines and gastroduodenal damage induced by non-steroidal anti-inflammatory drugs or by stress);
c) it possesses a strong ability to adsorb lysolecithin and bile acids and therefore to prevent the epithelial effect operated by these components of bile reflux on the gastric mucosa;
d) has a marked antipepsin action.
05.2 "Pharmacokinetic properties -
Studies in humans have shown that the intake of MAGALTOP Chewable Tablets and MAGALTOP Oral Suspension is not followed by any significant absorption of aluminum and magnesium and does not cause alterations in the metabolism of calcium and phosphorus. Magaldrato carries out its action only at the gastrointestinal level and is devoid of toxicity and systemic pharmacological effects.
05.3 Preclinical safety data -
The pharmacological actions of Magaldrate are not accompanied by increases in plasma gastrin levels. Magaldrate, in toxicity tests for single or repeated oral administration, proved to be practically non-toxic in experimental animals.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Chewable tablets:
Sorbitol, Mannitol, Corn starch, Magnesium Stearate, Sodium saccharinate, Caramel flavor.
Oral suspension (Sachets and Bottle):
Sorbitol 70%, Hydroxyethylcellulose, Citric acid, Sodium cyclamate, Sodium saccharinate, Simethicone, Methylhydroxybenzoate, Propylhydroxybenzoate, Cream flavor, Maracuia flavor, Purified water.
06.2 Incompatibility "-
Not ascertained to date.
06.3 Period of validity "-
For all packages: 60 months in unopened packaging.
06.4 Special precautions for storage -
No particular precautions.
06.5 Nature of the immediate packaging and contents of the package -
Chewable tablets
blisters of coupled PVC-PVDC / aluminum of 10 tablets each.
Oral suspension
250 ml amber glass bottles with colored polyethylene / polypropylene cap.
10 ml double laminated envelopes consisting of paper / polyethylene and aluminum / polyethylene.
06.6 Instructions for use and handling -
For MAGALTOP Oral suspension:
shake the bottle vigorously before use;
homogenize the contents of the sachet by manipulating it before opening it.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Therabel GiEnne Pharma S.p.A. Via Lorenteggio 270 / A - Milan.
08.0 MARKETING AUTHORIZATION NUMBER -
Magaltop 800 mg Chewable Tablets - 40 Tablets - AIC n. 033231010
Magaltop 800 mg / 10 ml Oral suspension - 250 ml bottle - AIC n. 033231034
Magaltop 800 mg / 10ml Oral suspension - 40 Sachets - AIC n. 033231022
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
June 1999 / June 2004
10.0 DATE OF REVISION OF THE TEXT -
01/11/2005
