MAGION 450 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Magión 450 mg Chewable Tablets

Magaldrate

Read this package leaflet carefully because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

1. What is Magión and what is it used for
2. What you need to know before taking Magión
3. How to take Magión
4. Possible side effects
5. Storage of Magión
6. Package Contents and Additional Information

1. What is Magión and what is it used for

Magión belongs to a group of medicines called antacids. The active ingredient, magaldrate, is transformed into aluminum and magnesium salts in the stomach, regulating stomach acidity.

It is indicated for the relief and symptomatic treatment of heartburn and stomach acid in adults and children over 12 years old.

2. What you need to know before taking Magión

Do not take Magión

• if you are allergic (hypersensitive) to Magaldrate or any of the other components of Magión,
• if you have intestinal obstruction,
• if you have severe kidney failure,
• if you have a digestive tract obstruction,
• if you have high levels of magnesium in the blood (hypermagnesemia) or low levels of phosphorus in the blood (hypophosphatemia).

Warnings and Precautions

Consult your doctor before starting treatment with Magión if you have or have had any of the following disorders:

• Kidney function impairment: in very prolonged treatments and at high doses, there may be signs of chronic aluminum and/or magnesium poisoning.
• Osteoporosis (bone density loss) and osteomalacia (bone softening): prolonged use and at high doses of antacids containing aluminum may worsen some bone diseases due to decreased absorption of phosphorus and calcium from food.
• Dementia (progressive brain function impairment): prolonged use and at high doses of antacids containing aluminum may aggravate dementia in patients with this disease, as aluminum can accumulate in brain tissue.

Magión may mask the symptoms of a major gastric condition. If your symptoms worsen or persist for more than 7 days, consult your doctor.

Using Magión with other Medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Magión alters the absorption and excretion of other medicines, so you should take them at least 1 to 2 hours apart to avoid possible interactions.

You should avoid taking Magión simultaneously with the following medicines, as Magión may reduce their absorption:

• Tetracyclines (a group of antibiotics).
• Digoxin (used to treat heart problems).
• Benzodiazepines (used as sedatives and for sleep problems).
• Dicumarol, acenocoumarol, warfarin (oral anticoagulants).
• Indomethacin (anti-inflammatory).
• Cimetidine (antacid).
• Chenodeoxycholic and ursodeoxycholic acid (used in liver problems).
• Iron supplements (used in anemia problems).

For this reason, the intake of the mentioned medicines should be done at least 2-3 hours before or after the administration of Magión.

Taking Magión with Food and Drinks

Take this medicine 1 to 2 hours after main meals.

Pregnancy, Breastfeeding, and Fertility

There is no data to suggest that occasional administration of magaldrate in pregnant women may cause fetal harm. However, it is worth considering the possibility of problems related to decreased absorption of iron, fluorides, and phosphates in prolonged and/or high-dose treatments.

Therefore, it is not recommended to administer this medicine during pregnancy unless the potential benefits outweigh the risks.

Breastfeeding:

Small amounts of aluminum and magnesium can be excreted in breast milk, but the concentrations reached are not high enough to cause adverse effects in newborns/breastfed children. Therefore, its use is accepted during breastfeeding, recommending avoiding chronic and/or excessive use.

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, so it is considered essentially "sodium-free".

Driving and Using Machines

The influence of Magión on the ability to drive and use machines is nil or insignificant.

3. How to Take Magión

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Adults and Children over 12 years old:

The normal dose is 450 mg to 900 mg (1 to 2 tablets of 450 mg) orally, depending on the intensity of the symptoms, 1 to 2 hours after main meals.

In certain cases, another additional tablet can be taken before bedtime.

Do not exceed 8 g of magaldrate (18 tablets) per day unless deemed necessary by a doctor.

Children under 12 years old:

Magión is not recommended for children under 12 years old.

Guidelines for correct administration:

The tablets should be swallowed, 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 you should, consult your doctor or pharmacist immediately.

It is recommended not to exceed the total daily amount of 8 grams of magaldrate.

Excessive doses or usual doses in patients with a phosphate-poor diet may lead to phosphorus loss, which can cause bone and calcium loss in the urine, with a risk of osteomalacia (bone softening).

No cases of overdose have been reported. In case of overdose or accidental ingestion, consult your doctor and/or hospital.

If you forget to take Magión

Do not take a double dose to make up for forgotten doses.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

In case of overdose or accidental ingestion, consult the Toxicology Information Service: 91 562 04 20.

4. Possible Side Effects

Like all medicines, Magión can cause side effects, although not everyone gets them.

The side effects of Magión are generally mild and transient. Especially at high doses, it can cause constipation and diarrhea. However, at the recommended dose, they are very rare (affect less than 1 in 10,000 patients):

• Metabolism and nutrition disorders: hypophosphatemia (phosphorus deficiency in the blood).
• Gastrointestinal disorders: constipation or diarrhea.
• Musculoskeletal and connective tissue disorders: osteomalacia (bone softening).

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can contribute to providing 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 signs of deterioration of the packaging or its contents.

Do not use Magión after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Magión

• The active ingredient is magaldrate. One Magión tablet contains 450 mg of magaldrate.
• The other ingredients are: mannitol, sodium carboxymethylcellulose (type A), menthol, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, talc, and sodium saccharin.

Appearance of the Product and Package Contents

Magión is presented in the form of round, white tablets with a slight menthol flavor in aluminum-PVC blisters, inside boxes containing 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 - Barberá del Vallés

Barcelona

Spain

Date of the Last Revision of this Package Leaflet: November 2013.

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/