Magnogene 53 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
magnogene 53 mg coated tablets
Magnesium
Read the entire leaflet carefully because it contains important information for you.
This medicine can be purchased without a prescription. However, to achieve the best results, it must be used correctly.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If symptoms worsen or persist beyond 15 days, you should consult a doctor.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Contents of the leaflet:
- What Magnogene is and what it is used for
- Before taking Magnogene
- How to take Magnogene
- Possible side effects
- How to store Magnogene
- Further information
1. What MAGNOGENE is and what it is used for
It contains magnesium as the active substance. It belongs to the group of medicines called "mineral supplements".
It is used for the prevention of magnesium deficiency states due to diets poor in vegetables, whole grains, and legumes, which may manifest as weakness and muscle cramps that could occur in adults and children over 12 years of age.
2. BEFORE TAKING MAGNOGENE
Do not take Magnogene if:
- you are allergic (hypersensitive) to magnesium salts or to any of the other components of Magnogene.
- you have kidney impairment.
- you currently have or have had heart conditions such as heart block, or have been diagnosed with ischemic heart disease (angina pectoris, myocardial infarction, etc.), which is caused by insufficient blood supply to the heart.
- you currently 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 (an autoimmune neuromuscular disease).
- you suffer from chronic diarrhea or have been diagnosed with ulcerative colitis (an inflammatory bowel disease).
- you have undergone ileostomy surgery (an intestinal procedure).
- you are experiencing symptoms of appendicitis: abdominal pain (pain around the navel) that increases in intensity and shifts to the lower right side of the abdomen as the condition progresses. This pain may be accompanied by loss of appetite, nausea, vomiting, and low-grade fever.
Take special care with Magnogene:
- Prolonged use of this medicine may cause hypermagnesemia (high levels of magnesium in the blood), characterized by nausea, vomiting, respiratory depression (weak breathing), and depression of the Central Nervous System (symptoms may range from drowsiness to coma), hyperreflexia (exaggerated reflexes), muscle weakness, and certain cardiovascular effects such as low blood pressure, decreased heart rate, and cardiac arrest.
- Taking this medicine on an empty stomach may cause diarrhea.
- Patients with kidney disease should consult their doctor before taking this medicine.
Use in children:
Do not administer to children under 12 years of age unless otherwise directed by a physician.
Use in patients over 65 years of age:
In patients over 65 years of age who have reduced kidney function, the dose and frequency of administration of magnesium salts should be adjusted by the physician according to the degree of renal impairment.
Use of other medicines:
Inform your doctor or pharmacist if you are currently taking, or have recently taken, any other medicines, including those obtained without a prescription.
Interactions may occur with the following medicines:
- Azole antifungal agents (for fungal infections), such as itraconazole and fluconazole.
- Antibiotics such as tetracyclines (doxycycline, minocycline, oxytetracycline, tetracycline) and quinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), which may result in reduced antibiotic efficacy.
- Bisphosphonates (medicines used in the treatment of osteoporosis).
- Delavirdine, an antiretroviral agent used in the treatment of HIV/AIDS infection.
- Digitalis glycosides, used in the treatment of congestive heart failure. The main digitalis compound is digoxin.
- Sodium polystyrene sulfonate, used in the treatment of hyperkalemia, which may lead to metabolic alkalosis.
- Quinidine, used to treat cardiac rhythm disorders.
Please note that these instructions may also apply to medicines taken before or after Magnogene. Therefore, in general, at least 2 hours should elapse between the administration of Magnogene and any other oral medication, as it may decrease or increase the absorption of other drugs.
Taking magnesium with food and drinks:
Excessive and prolonged consumption of products containing magnesium and calcium may lead to elevated levels of calcium in the blood. In such cases, calcium intake and calcium-rich foods such as dairy products should be monitored.
Alcohol and glucose increase magnesium excretion.
Pregnancy and breastfeeding:
Consult your doctor or pharmacist before using any medicine.
It is recommended to meet magnesium requirements through a diet rich in vegetables and whole grains to prevent the consequences of magnesium deficiency during pregnancy.
Important for women: If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medications during pregnancy can be harmful to the embryo or fetus and must be monitored by your doctor. |
Breast-feeding:
Consult your doctor or pharmacist before using any medicine.
No problems have been reported in breast-fed infants whose mothers take Magnogene tablets at the recommended doses.
Driving and use of machines:
Effects on the ability to drive or operate tools and machinery are not expected.
Important information about some of the components of Magnogene
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
3. HOW TO TAKE MAGNOGENE
Follow these instructions exactly unless your doctor has given you different advice. Consult your doctor or pharmacist if you have any doubts.
This medicine is administered orally.
Do not take on an empty stomach, as it may cause diarrhea.
Each coated tablet must be swallowed whole with water or another liquid, without breaking or chewing. The recommended average dose for adults and children over 12 years of age is 2 coated tablets, twice daily after meals, taken with liquid (212 mg of magnesium per day).
Patients over 65 years of age, children under 12 years of age, and patients with kidney disease should consult their doctor.
If symptoms worsen or do not improve within 15 days, consult your doctor.
If you take more Magnogene than you should:
Contact your doctor or pharmacist immediately.
Symptoms of hypermagnesemia include: flushing, slowed heart rate, central nervous system depression, muscle weakness, fatigue, somnolence or hyperexcitability, nausea, hypotension, confusion, respiratory depression, arrhythmias, coma, and cardiac arrest.
The neuromuscular blockade associated with hypermagnesemia 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 the hypermagnesemia is severe, dialysis may be required.
In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at 91-5620420, indicating the medicine and the amount ingested.
If you forget to take Magnogene:
Do not take a double dose to make up for missed doses. Take your dose as soon as you remember, and then continue your treatment as before.
If you have any doubts about how to use this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Magnogene may produce adverse effects, although not everyone will experience them.
During the period of use of this medicine, the following adverse effects have been reported, although their frequency could not be precisely established. The most common have been gastrointestinal disturbances such as diarrhea and vomiting, and, less frequently, increased magnesium levels in blood, manifested by: drowsiness, double vision, dizziness, muscle weakness, and decreased blood pressure.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
5. Storage of MAGNOGENE
Keep out of the reach and sight of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the container after "EXP:". The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. ADDITIONAL INFORMATION
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, corn starch, povidone, macrogol 4000/10000, talc, magnesium stearate, 30% dispersion of methacrylic acid-ethyl acrylate copolymer (1:1), calcium carbonate, sucrose, arabic gum, titanium dioxide (E-171), macrogol 6000.
Product appearance and packaging contents
Magnogene is a medicinal product in the form of coated tablets for oral use, available in a pack containing 45 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
URIACH CONSUMER HEALTHCARE, S.L.
Av. Generalitat 163-167
08174 Sant Cugat del Vallès
(Barcelona – Spain)
Manufacturer
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 was last reviewed in December 2010