Package Insert: Information for the User

Magión 450 mg Chewable Tablets

Magaldrate

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

Follow exactly the administration instructions of the medication contained in this package insert or those indicated by your doctor or pharmacist.

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

Magión belongs to a group of medications known as antacids. The active ingredient, magaldrate, is converted into aluminum and magnesium salts in the stomach, regulating stomach acidity.

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

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 blockage of the digestive tract,
• 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 suffer or have suffered from any of the following conditions:

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

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

Use of Magión with other medications

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

Magión modifies the absorption and excretion of other medications, so you should separate your intake by at least1 to2 hours to avoid possible interactions.

You should avoid simultaneous administration of Magión with the following medications, 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).
• Ursodeoxycholic acid (used in liver problems).
• Iron supplements (used in anemia).

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

Taking Magión with food and drinks

Take this medication1 to2 hours after main meals.

Pregnancy, breastfeeding, and fertility

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

Therefore, it is not recommended to administer this medication during pregnancy unless the 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/breastfed infants. Therefore, its use is accepted during breastfeeding, recommending avoiding chronic and/or excessive use.

Consult your doctor or pharmacist before using any medication.

Important information about some of the components of Magión

This medication contains less than 23 mg (1 mmol) of sodium per tablet, making it essentially "sodium-free".

Driving and operating machinery

The influence of Magión on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults and children over 12 years old:

The usual dose is 450 mg to 900 mg (1 to2 tablets of 450 mg) taken orally, depending on the severity of symptoms, one to two hours after main meals.

In certain cases, another tablet may be taken before bedtime.

Do not exceed 8 g of magaldrate (18 tablets) per day unless medically necessary.

Children under 12 years old:

Magiónis not recommended for children under 12 years old.

Guidelines for correct administration:

Tablets should be swallowed, dissolved in the mouth, or chewed. It is recommended to drink something 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 dose of8 gramsof magaldrate.

Excessive doses or regular doses in patients with a low-phosphate diet may lead to phosphate loss, which results in bone and calcium loss in urine, with a risk of osteomalacia (softening of the bones).

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

If you forgot to take Magión

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

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

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

Like all medications, Magión may produce adverse effects, although not all people will experience them.

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

• Metabolic and nutritional disorders: hypophosphatemia (phosphate deficiency in the blood).
• Gastrointestinal disorders: constipation or diarrhea.
• Musculoskeletal and connective tissue disorders: osteomalacia (bone softening).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Magión if you observe signs of deterioration of the container or its contents.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Magión

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

Appearance of the product and content of the packaging

Magión is presented in the form of round, white tablets with a light menthol flavor in aluminum-PVC blisters, inside boxes containing 40 or 1,000 tablets.

Holder of the marketing authorization:

Laboratorios ERN, S.A.

Perú, 228

08020 - Barcelona

Spain

Manufacturers responsible:

Laboratorios ERN, S.A.

GorcsiLladó, 188

08210 - Barberá del Vallés

Barcelona

Spain

Last review date of this leaflet: November 2013.

Detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/