Active ingredients: Magnesium carbonate, Sodium bicarbonate, Calcium carbonate
Magnesia Bisurata Aromatic tablets
Why is Magnesia bisurata aromatic used? What is it for?
Magnesia Bisurata Aromatic is an antacid medicine that contains the active ingredients magnesium carbonate, sodium bicarbonate and calcium carbonate.
Magnesia Bisurata Aromatic is used to treat disorders caused by excessive acidity in the upper part of the digestive tract (mouth, esophagus, stomach).
Contraindications When Magnesia bisurata aromatic should not be used
DO NOT take Magnesia Bisurata Aromatic
- if you are allergic to magnesium carbonate, sodium bicarbonate, calcium carbonate or any of the other ingredients of this medicine;
- if you have "kidney failure;
- if you are taking tetracyclines (antibiotics);
- if you have taken or will need to take other medicines within 1-2 hours of using Magnesia Bisurata Aromatic;
- if the patient is a child.
Precautions for use What you need to know before taking Magnesia bisurata aromatic
Talk to your pharmacist before taking Magnesia Bisurata Aromatic.
Pay particular attention:
- if you have severe kidney failure, because using Magnesia Bisurata Aromatic for a long time can increase magnesium levels in your blood and cause brain disease or worsening of bone fragility following dialysis (dialysis osteomalacia);
- if you are following a low sodium diet, as Magnesia Bisurata Aromatic contains sodium salts.
Consult your doctor before taking this medicine:
- if your kidney function is impaired or in the past. Your doctor will have tests regularly to check the levels of magnesium and calcium in your blood.
Children
Magnesia Bisurata Aromatic is contraindicated in the pediatric age.
Interactions Which drugs or foods can modify the effect of Magnesia bisurata aromatic
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Do not take any other medicines 1-2 hours before or after using Magnesia Bisurata Aromatic.
Do not take Magnesia Bisurata Aromatic with the following medicines:
- tetracyclines (antibiotics), because Magnesia Bisurata Aromatic can reduce their absorption and their action;
- quinidine (for the treatment of cardiac arrhythmias), because its elimination rate from the body may be reduced.
Take special care when taking Magnesia Bisurata Aromatic with the following medicines:
- indomethacin (anti-inflammatory)
- phosphorus
- dexamethasone (to reduce inflammation)
- digitalis (heart medicines)
- iron salts
- nitrofurantoin (antibiotic)
- lincomycin (antibiotic)
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.
During pregnancy and breastfeeding, Magnesia Bisurata Aromatic must be taken under direct medical supervision.
Driving and using machines
Magnesia Bisurata Aromatic does not affect the ability to drive and use machines.
Magnesia Bisurata Aromatic contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Sucrose can be bad for your teeth.
Dose, Method and Time of Administration How to use Magnesia bisurata aromatic: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
- Magnesia Bisurata Aromatic tablets should be dissolved slowly in the mouth.
- The recommended dose is one tablet after meals and whenever you feel pain.
- If necessary, take another "tablet after a quarter of an hour".
- Take this medicine for short periods of time only.
- Do not exceed the recommended doses without first consulting your doctor.
Talk to your doctor if you do not feel better or if you feel worse after a short period of treatment, or if the disorder occurs repeatedly, or if you have noticed any recent changes in your characteristics.
If you forget to take Magnesia Bisurata Aromatic
Do not take a double dose to make up for a forgotten dose.
If you stop taking Magnesia Bisurata Aromatic
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken an overdose of Magnesia bisurata aromatic
In case of accidental ingestion of an overdose of Magnesia Bisurata Aromatic, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Magnesia bisurata aromatic
Like all medicines, this medicine can cause side effects, although not everybody gets them.
To date, there are no known side effects caused by this medicine.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
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.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Store at room temperature, in its original packaging.
Keep this medicine out of the sight and reach of children.
Do not take Magnesia Bisurata Aromatic if the pack is visibly damaged.
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.
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.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
Other Information
What Magnesia Bisurata Aromatic contains
- The active ingredients are magnesium carbonate, sodium bicarbonate, calcium carbonate. Each tablet contains 71.0 mg of magnesium carbonate, 64.2 mg of sodium bicarbonate and 525.0 mg of calcium carbonate.
- The other ingredients are sodium saccharin, sucrose, corn starch, calcium stearate, essential oil of mint.
Description of the appearance of Magnesia Bisurata Aromatic and contents of the package
Each pack of Magnesia Bisurata Aromatic contains a blister of 40 or 80 tablets.
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
MAGNESIA BISURATA AROMATIC PADS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active ingredients: Magnesium carbonate 71.0 mg, Sodium bicarbonate 64.2 mg, Calcium carbonate 525.0 mg.
For the full list of excipients, see 6.1
03.0 PHARMACEUTICAL FORM
Pads
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of diseases of the upper digestive tract characterized by hyperacidity.
04.2 Posology and method of administration
A lozenge to dissolve slowly in the mouth after meals and whenever pain is felt. If necessary, repeat it after a quarter of an hour.
DO NOT EXCEED THE RECOMMENDED DOSE
Use only for short periods of treatment.
Patients with renal insufficiency: The reduced ability to eliminate urine exogenous saline supplement provided by antacids can affect potentially severe electrolyte imbalances. Treatment with magnesium and calcium salts requires periodic checks of magnesium and calcium.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
Kidney failure.
Do not administer simultaneously with tetracyclines (see Section 4.5).
Do not administer other drugs within 1 or 2 hours of using the product (see Section 4.5).
Pediatric administration of the drug is not recommended.
04.4 Special warnings and appropriate precautions for use
In patients with severe renal insufficiency the plasma levels of magnesium tend to increase. In these patients, long exposure to high doses of magnesium can lead to encephalopathies or worsening of dialysis osteomalacia.
Generally, caution should be exercised in patients with impaired renal function. In these patients, plasma levels of calcium and magnesium should be monitored regularly.
In the case of low-sodium diets, it must be borne in mind that the product contains sodium salts.
The product contains sucrose: this should be taken into account in case of diabetes. Patients with rare hereditary problems of fructose intolerance, glucose malabsorption, galactose malabsorption, sucrase insufficiency and isomaltase insufficiency should not take this medicinal product.
04.5 Interactions with other medicinal products and other forms of interaction
It should be noted that antacids can, by several mechanisms, interfere with the oral administration of other drugs. In particular, the simultaneous administration of Tetracyclines can give rise to insoluble complexes, with a reduction in the absorption of these antibiotics. It is however advisable not to administer other drugs within 1 or 2 hours of using the product.
Associations to be avoided :
- tetracyclines: formation of insoluble complexes with a reduction in the absorption and activity of these antibiotics.
Association not recommended:
- quinidine: increased plasma rates of quinidine and risk of overdose due to decreased excretion.
Associations requiring precautions for use:
- indomethacin, phosphorus, dexamethasone, digitatic, iron salts, nitrofurantoin, lincomycin.
04.6 Pregnancy and breastfeeding
Although no adverse reactions are known, in pregnant and lactating women the product should be used under direct medical supervision.
04.7 Effects on ability to drive and use machines
The product does not affect the ability to drive or use machines.
04.8 Undesirable effects
Based on the available bibliographic data, no side effects related to the specialty are known.
04.9 Overdose
Experience with deliberate overdose is very limited. As in all cases of overdose, treatment should be symptomatic with general supportive measures.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antacids; ATC code: A02AH.
The active ingredients characterizing the activity of the specialty are Magnesium carbonate, Sodium bicarbonate and Calcium carbonate: they are basic substances that exert an antacid action on the gastro-intestinal level with a high neutralizing capacity.
05.2 Pharmacokinetic properties
Given the nature of the active ingredients which are devoid of any real pharmacological activity, pharmacokinetic investigation was deemed superfluous. The excretion of the fraction of absorbed salts occurs mainly via the urine.
05.3 Preclinical safety data
Data from animal studies reveal no risk for humans based on conventional studies of pharmacology, safety, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Saccharin sodium, Sucrose, Corn starch, Calcium stearate, Mint essential oil.
06.2 Incompatibility
There are no known incompatibilities with other substances.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
Store at room temperature, in its original packaging.
06.5 Nature of the immediate packaging and contents of the package
Box of 40 and 80 tablets in blister packs.
06.6 Instructions for use and handling
None.
07.0 MARKETING AUTHORIZATION HOLDER
Pfizer Italia S.r.l. - Consumer Healthcare Division, Via Isonzo n. 71 -
04100 Latina.
08.0 MARKETING AUTHORIZATION NUMBER
Box of 10 tablets: 005781063 (non-commercial packaging)
Box of 40 tablets: 005781036
Box of 80 tablets: 005781048
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Box of 10 tablets: 30.9.1991 / 31.5.2010
Box of 40 tablets: 03-10-1983 / 31.5.2010
Box of 80 tablets: 03-10-1983 / 31.5.2010
10.0 DATE OF REVISION OF THE TEXT
30 October 2012
