MAGNESIOBOI 48.62 mg TABLETS

2. What you need to know before taking Magnesioboi

Do not take Magnesioboi:

• if you are allergic to magnesium lactate or any of the other components of this medication (listed in section 6),
• if you have severe renal insufficiency (reduced kidney function),
• if you have or have had heart diseases such as angina pectoris or myocardial infarction,
• if you have or have had a diabetic coma (loss of consciousness due to excessively high or low blood sugar levels),
• if you have been diagnosed with myasthenia gravis (an autoimmune neuromuscular disease),
• if you suffer from chronic diarrhea or have been diagnosed with inflammatory bowel disease (ulcerative colitis),
• if you have had an intestinal intervention (ileostomy),
• if you have symptoms of appendicitis: abdominal pain (pain around the navel) that increases in intensity and moves to the lower right part of the abdomen as the process evolves. This pain may be accompanied by loss of appetite, nausea, vomiting, and low-grade fever.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Magnesioboi.

• The continued 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 can range from numbness to coma), hyperreflexia (exaggerated 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.

Children and adolescents

Do not administer to children under 12 years old unless advised by a doctor.

Elderly patients

In patients over 65 years old who suffer from reduced kidney function, the dose and frequency of magnesium salt administration should be adjusted by the doctor according to the degree of renal function reduction.

Using Magnesioboi with other medications

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

This medication reduces the absorption of

• Antibiotics such as tetracyclines (doxycycline, minocycline, oxytetracycline, tetracycline) and quinolones (ciprofloxacin, levofloxacino, norfloxacin, ofloxacin).
• Bisphosphonates (medications used in the treatment of osteoporosis).

The intake of Magnesioboi and these medications should be spaced at least 2 hours apart to avoid unwanted interactions.

Taking Magnesioboi with food and drinks

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

This medication should be taken after meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

No problems have been described in breastfed children whose mothers take magnesium at the recommended doses.

Driving and using machines

The influence of magnesium on driving and machine safety is nil or insignificant.

Magnesioboi contains lactose

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

3. How to take Magnesioboi

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

The recommended dose for adults and children over 12 years old is 1 to 2 tablets (48.62 mg to 97.24 mg of magnesium), after each of the three meals (146 mg to 292 mg of magnesium per day). The tablets should be taken with a sufficient amount of liquid.

Do not exceed the maximum recommended dose (6 tablets per day).

Elderly patients, children under 12 years old, and patients with kidney disease should consult their doctor.

This medication is administered orally.

If your symptoms worsen or do not improve within 7 days of treatment, consult your doctor.

If you take more Magnesioboi than you should

If you have taken more medication than you should, consult your doctor or pharmacist immediately.

In cases of poisoning caused by ingestion of high doses, or in patients with renal insufficiency with decreased urine production, an increase in magnesium levels in the blood may occur. In this case, the following manifestations may appear: nausea, vomiting, drowsiness, double vision, dizziness, speech problems, swallowing difficulties, muscle weakness, skin redness, low blood pressure, cardiac rhythm disorders, and cardiac arrest.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (Telephone 91.562.04.20), indicating the medication and the amount ingested.

If you forget to take Magnesioboi

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

During the use of this medication, the following side effects have been reported, whose frequency cannot be established with precision. The most common ones are gastrointestinal disorders, such as diarrhea and vomiting, and less frequently, increased magnesium levels in the blood, which may be associated with the following discomforts: drowsiness, double vision, dizziness, muscle weakness, and low blood pressure.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Magnesioboi

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Magnesioboi composition

The active ingredient is magnesium lactate. Each tablet contains 48.62 mg of magnesium, provided by 404.85 mg of magnesium lactate.

The other components (excipients) are: lactose monohydrate, macrogol 6000, sodium croscarmellose, magnesium stearate, and talc.

Product appearance and package contents

Magnesioboi is presented in the form of white-bone colored, round, biconvex tablets. Each package contains 50 tablets.

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

P&G Health Austria GmbH & Co. OG

Hösslgasse 20

9800 Spittal an der Drau

Austria

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this leaflet: January 2011

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