Magion 450 mg chewable tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Magión 450 mg Chewable Tablets
Magaldrate
Read the entire leaflet carefully as it contains important information for you.
Follow exactly the instructions for use of this medicine provided in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Leaflet Contents
- What Magión is and what it is used for
- What you need to know before taking Magión
- How to take Magión
- Possible side effects
- How to store Magión
- Contents of the pack and other information
1. What Magión is and what it is used for
Magión belongs to a group of medicines called antacids. The active substance, magaldrate, is converted into aluminum and magnesium salts in the stomach, regulating gastric acidity.
It is indicated for the relief and symptomatic treatment of acid reflux and heartburn in adults and children over 12 years of age.
2. What you need to know before taking Magión
Do not take Magión
- if you are allergic (hypersensitive) to Magaldrate or to any of the other components of Magión,
- if you have intestinal obstruction,
- if you have severe renal insufficiency,
- if you have gastrointestinal tract obstruction,
- if you have high levels of magnesium in the blood (hypermagnesemia) or low levels of phosphate in the blood (hypophosphatemia).
Warnings and precautions
Consult your doctor before starting treatment with Magión if you suffer or have suffered from any of the following conditions:
- Impaired renal function: with very prolonged treatment and high doses, signs of chronic intoxication by aluminum and/or magnesium may occur.
- Osteoporosis (loss of bone density) and osteomalacia (softening of the bones): prolonged use and high doses of aluminum-containing antacids may worsen certain bone diseases due to decreased absorption of phosphorus and calcium from food.
- Dementia (progressive deterioration of brain function): prolonged use and high doses of aluminum-containing antacids may worsen dementia in patients with this condition, since aluminum may accumulate in brain tissue.
Magión may mask the symptoms of a more serious gastric condition. If your symptoms worsen or persist for more than 7 days, consult your doctor.
Use of Magión with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Magión alters the absorption and excretion of other medicines; therefore, administration should be separated by at least 1 to 2 hours to avoid possible interactions.
Concomitant administration of Magión with the following medicines should be avoided, as Magión may reduce their absorption:
- Tetracyclines (a group of antibiotics).
- Digoxin (used to treat heart problems).
- Benzodiazepines (used as sedatives and for sleep disorders).
- Dicoumarol, acenocoumarol, warfarin (oral anticoagulants).
- Indomethacin (anti-inflammatory).
- Cimetidine (antacid).
- Chenodeoxycholic and ursodeoxycholic acid (used for liver problems).
- Iron supplements (used for anemia).
Therefore, administration of the above-mentioned medicines should occur at least 2–3 hours before or after taking Magión.
Taking Magión with food and drinks
Take this medicine 1 to 2 hours after main meals.
Pregnancy, breastfeeding, and fertility
There are no data indicating that occasional administration of magaldrate during pregnancy may cause fetal harm. However, one should consider the possibility of problems related to decreased absorption of iron, fluorides, and phosphates during prolonged treatment and/or high doses.
Therefore, administration of this medicine during pregnancy is not recommended unless potential benefits outweigh the risks.
Breastfeeding:
Small amounts of aluminum and magnesium may be excreted in breast milk, but the concentrations reached are not high enough to cause adverse effects in newborns/infants. Therefore, its use during breastfeeding is considered acceptable, provided chronic and/or excessive use is avoided.
Consult your doctor or pharmacist before using any medicine.
Important information about some of the components of Magión
This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore considered essentially “sodium-free”.
Driving and using machines
The effect of Magión on the ability to drive and use machines is none or negligible.
3. How to take Magión
Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and children over 12 years of age:
The usual dose is 450 mg to 900 mg (1 to 2 tablets of 450 mg) taken orally, depending on the intensity of symptoms, one to two hours after main meals.
In certain cases, an additional tablet may be taken before going to bed.
Do not exceed 8 g of magaldrate (18 tablets) per day unless otherwise directed by a physician.
Children under 12 years of age:
Magión is not recommended for children under 12 years of age.
Instructions for proper administration:
The tablets should be swallowed whole, dissolved in the mouth, or chewed. It is recommended to drink some liquid afterwards.
If you take more Magión than you should
If you have taken more than the prescribed amount, consult your doctor or pharmacist immediately.
It is recommended not to exceed the total daily amount of 8 grams of magaldrate.
Excessive doses or even usual doses in patients on a phosphate-poor diet may lead to phosphorus loss, resulting in bone loss and calcium excretion in urine, with a risk of osteomalacia (softening of the bones).
Cases of overdose have not been reported. In case of overdose or accidental ingestion, consult your doctor and/or go to the hospital.
If you forget to take Magión
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this product, consult your doctor or pharmacist.
In case of overdose or accidental ingestion, contact the Toxicology Information Service: 91 562 04 20.
4. Possible adverse effects
Like all medicines, Magión may cause adverse effects, although not everyone experiences them.
The adverse effects of Magión are generally mild and transient. Especially at high doses, it may cause constipation and diarrhoea. However, at the recommended dose, these are very rare (affecting fewer than 1 in every 10,000 patients):
- Metabolism and nutrition disorders: hypophosphataemia (phosphorus deficiency in the blood).
- Gastrointestinal disorders: constipation or diarrhoea.
- Musculoskeletal and connective tissue disorders: osteomalacia (softening of the bones).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish System of Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Magión
Keep out of sight and reach of children.
No special storage conditions are required.
Do not use Magión if you notice any signs of deterioration in the packaging or its contents.
Do not use Magión after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Magión
- The active substance is magaldrate. One tablet of Magión contains 450 mg of magaldrate.
- The other components are: mannitol, sodium carboxymethylstarch (type A), menthol, anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate, talc and sodium saccharin.
Appearance of the medicinal product and contents of the pack
Magión is available as round, white tablets with a slight mint flavour, packed in aluminum-PVC blisters, contained in cartons of 40 or 1,000 tablets.
Marketing Authorization Holder:
Laboratorios ERN, S.A.
Perú, 228
08020 - Barcelona
Spain
Manufacturers:
Laboratorios ERN, S.A.
Gorcs i Lladó, 188
08210 - Barberà del Vallès
Barcelona
Spain
Date of the most recent review of this leaflet: November 2013.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/