PRODUCT INFORMATION FOR THE USER

magnogene 53 mg coated tablets

Magnesium

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

This medicine can be obtained without a prescription. However, for the best results, it should be used properly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 15 days, you should consult a doctor.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contains magnesium as the active ingredient. It belongs to the group of medications known as "mineral supplements".

It is used for the prevention of magnesium deficiency states due to diets poor in vegetables, whole grains, and legumes that manifest with weakness and muscle cramps that may occur in adults and children over 12 years of age.

Do not take Magnogene if:

• You are allergic (hypersensitive) to magnesium salts or any of the other components of Magnogene.
• You have a kidney disorder.
• You have or have had heart diseases such as heart block or have been diagnosed with ischemic heart disease (angina pectoris, myocardial infarction, … caused by poor blood flow to the heart).
• You have or have had diabetic coma (loss of consciousness due to excessively high or low blood sugar levels).
• You have been diagnosed with myasthenia gravis (autoimmune neuromuscular disease).
• You suffer from chronic diarrhea or have been diagnosed with ulcerative colitis (inflammatory bowel disease).
• You have had an ileostomy (intestinal intervention).
• You have symptoms of appendicitis: abdominal pain (pain around the navel) that increases in intensity and shifts to the lower right abdomen with the progression of the process. This pain may be accompanied by decreased appetite, nausea, vomiting, and low fever.

Be especially careful with Magnogene:

• Prolonged use of this medication may cause hypermagnesemia (high magnesium levels in the blood) characterized by nausea, vomiting, respiratory depression (weak breathing), and central nervous system depression (symptoms may range from numbness to coma), hyperreflexia (exaggeration of reflexes), muscle weakness, and certain cardiovascular effects such as low blood pressure, decreased heart rate, and cardiac arrest.
• Taking this medication on an empty stomach may cause diarrhea.
• Patients with kidney disease should consult their doctor before taking this medication.

Use in children:

Do not administer to children under 12 years old unless medically indicated.

Use in people over 65 years:

In patients over 65 years with kidney function impairment, the dose and frequency of magnesium salt administration should be adjusted by the doctor according to the degree of renal function impairment.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Interactions may occur with the following medications:

Azole antifungals such as itraconazole and fluconazole.

Tetracyclines (doxycycline, minocycline, oxytetracycline, tetracycline) and quinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), which may reduce the effectiveness of the antibiotic.

Bisphosphonates (medications used in the treatment of osteoporosis).

Delavirdine, an antiretroviral agent used to treat HIV/AIDS.

Digitals, used to treat congestive heart failure. The main digitalis is digoxin.

Polystyrene sulfonate of sodium, used to treat hyperkalemia, may cause metabolic alkalosis.

Quinidine, used to treat cardiac arrhythmias.

Be aware that these instructions may also apply to medications taken before or after, so in general, it is recommended to leave at least 2 hours between the administration of Magnogene and any other oral medication, as it may reduce or increase the absorption of other drugs.

Taking magnesium with food and drinks:

Excessive and prolonged consumption of products containing magnesium and calcium may cause elevated calcium levels in the blood. In these situations, calcium intake and calcium-rich foods such as dairy products should be controlled.

Alcohol and glucose increase magnesium excretion.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

It is recommended to cover magnesium needs with a diet rich in vegetables, whole grains to prevent the consequences of magnesium deficiency during pregnancy.

Lactation:

Consult your doctor or pharmacist before using any medication.

No problems have been described in breastfed infants whose mothers take Magnogene tablets at the recommended doses.

Driving and operating machinery:

No effects are expected on the ability to drive or operate tools and machines.

Important information about some components of Magnogene:

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow these instructions exactly unless your doctor has given you different instructions. Consult your doctor or pharmacist if you have any doubts.

This medication is administered orally.

Do not take on an empty stomach, as it may cause diarrhea.

Each coated tablet should be swallowed whole, with water or another liquid, without breaking or chewing. The recommended dose for adults and children over 12 years old is 2 coated tablets, 2 times a day after meals, taken with a liquid (212 mg of magnesium per day).

Individuals over 65 years, children under 12 years, and patients with kidney disease should consult their doctor.

If symptoms worsen or do not improve in 15 days, consult your doctor.

If you take more Magnogene than you should:

Consult your doctor or pharmacist immediately.

The symptoms of hypermagnesemia are: hot flashes, slowed heart rate, depression of the central nervous system, muscle weakness, fatigue, drowsiness or hyperexcitability, nausea, hypotension, confusion, respiratory depression, arrhythmias, coma, and cardiac arrest.

Hypermagnesemia-associated muscle blockade is reversible by administering calcium salts.

If renal function is normal, fluids should be administered to eliminate magnesium from the body. If renal function is impaired or hypermagnesemia is severe, dialysis may be necessary.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, tel.: 91-5620420, indicating the medication and the amount ingested.

If you forgot to take Magnogene

Do not take a double dose to make up for the missed dose. Take your dose as soon as you remember and continue treatment as before.

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

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

During the period of use of this medication, the following adverse effects have been reported, whose frequency could not be established with precision. The most characteristic have been gastrointestinal alterations such as diarrhea and vomiting, and less frequently, an increase in blood magnesium, which manifests with: drowsiness, double vision, dizziness, muscle weakness, decreased blood pressure.

If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging 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. Ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Composition of Magnogene:

Each coated tablet contains 53 mg of magnesium provided by 125.06 mg of magnesium hydroxide; 7.17 mg of magnesium bromide and 0.34 mg of magnesium fluoride.

The other components (excipients) are: sodium chloride, sodium iodide, lactose, cornstarch, povidone, macrogol 4000/10000, talc, magnesium stearate, 30% dispersion of ethyl acrylate-methacrylic acid copolymer (1:1), calcium carbonate, saccharose, gum arabic, titanium dioxide (E-171), macrogol 6000.

Appearance of the product and contents of the package

Magnogene is an oral medication in the form of coated tablets, presented in a package of 45 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

URIACH CONSUMER HEALTHCARE, S.L.

Av. Generalitat 163-167

08174 Sant Cugat del Vallès

(Barcelona – Spain)

Responsible for manufacturing

Laboratorio ALCALA FARMA S.L.

Avenida de Madrid, 82

28802 – Alcalá de Henares

(Madrid - Spain)

or

NOUCOR HEALTH, S.A.

Av. Camí Reial, 51-57

08184 Palau-solità i Plegamans

(Barcelona – Spain)

This leaflet has been reviewed in December 2010