Leaflet: information for the user

Magnesioboi 48.62 mg tablets

Magnesium

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

-Keep this leaflet, as you may need to read it again.

-If you need advice or more information, consult your pharmacist.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

-You should consult a doctor if you get worse or do not improve after 7 days.

1.What is Magnesioboi and what it is used for

2.What you need to know before starting to take Magnesioboi

3.How to take Magnesioboi

4.Possible side effects

5.Storage of Magnesioboi

6. Contents of the pack and additional information

This medication contains magnesium lactate. It belongs to a group of medications called “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 andchildren over 12 years old.

You should consult a doctor if it worsens or does not improve after 7 days.

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 kidney impairment (reduced kidney function),
• if you have or have had heart conditions such as angina or myocardial infarction,
• if you have or have had diabetic coma (loss of consciousness due to excessively high or low blood sugar levels),
• if you have been diagnosed with myasthenia gravis (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 shifts to the lower right abdomen as the process progresses. 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.

• 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 (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 medically indicated.

Older patients

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

Use of Magnesioboi with other medications

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

This medicationreduces the absorptionof

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

The taking ofMagnesioboiand these medications should be spaced, at least, 2 hours to avoid unwanted interactions.

Taking Magnesioboi 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.

This medication should be taken after meals.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be 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 adverse effects have been described in breastfed infants whose mothers take magnesium at the recommended doses.

Driving and operating machinery

The influence of magnesium on safety for driving and operating machinery is negligible or insignificant.

Magnesioboi contains lactose

This medication contains lactose.Consult your doctor if you have beenindicated that you have an intolerance to certain sugars before taking this medication.

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.

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).

Patients with advanced age, children under 12 years old, and patients with kidney disease should consult a doctor.

This medication is administered orally.

If symptoms worsen or do not improve within 7 days of treatment, consult a 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 intoxication caused by the ingestion of high doses, or in patients with renal insufficiency with decreased urine production, an increase in blood magnesium levels may occur. In this case, the following manifestations may occur: nausea, vomiting, drowsiness, double vision, dizziness, speech alteration, difficulty swallowing, muscle weakness, skin redness, decreased blood pressure, cardiac rhythm alterations, and cardiac arrest.

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

If you forgot to take Magnesioboi

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

During the period of use of this medication, the following adverse effects have been reported, whose frequency has not been established with precision. The most frequent are gastrointestinal disturbances, such as diarrhea and vomiting, and less frequently, an increase in blood magnesium levels, which may be associated with the following discomforts: drowsiness, double vision, dizziness, muscle weakness, and decreased blood pressure.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about 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 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 that appears on the box after CAD. The expiration date is the last day of the month indicated.

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

Composition of Magnesioboi

The active ingredient is magnesium lactate. Each tablet contains48.62 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.

Appearance of the product and content of the container

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

Holder of the marketing authorization

Laboratorios Vicks, S.L.

Avda. Bruselas, 24

28108 Alcobendas (Madrid) Spain

Responsible for manufacturing

P&G Health Austria GmbH & Co. OG

Hösslgasse 20

9800 Spittal an der Drau

Austria

Local representative

Procter & Gamble España, S.A.

Avda. Bruselas, 24

28108 Alcobendas (Madrid) Spain

Last review date of this leaflet: January 2011

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