MAGNESIUM NM 200 MG ORAL SOLUTION POWDER IN SACHET

Introduction

Package Leaflet: Information for the Patient

Magnesio NM 200 mg Powder for Oral Solution in Sachet

Magnesium

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not mentioned in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Magnesio NM and what is it used for
2. What you need to know before taking Magnesio NM
3. How to take Magnesio NM
4. Possible side effects
5. Storage of Magnesio NM

1. Contents of the Pack and Further Information

1. What is Magnesio NM and what is it used for

This medicine contains magnesium. It belongs to the group of medicines called "mineral supplements".

Magnesio NM 200 mg is used to increase the amount of magnesium in the body when the deficiency is mild or moderate, and your doctor considers it relevant, in cases caused by congenital or acquired causes.

2. What you need to know before taking Magnesio NM

Do not take Magnesio NM if:

• You are allergic (hypersensitive) to magnesium salts or any of the other components of Magnesio NM.
• You have or have had heart diseases such as cardiac block, arrhythmias, or have been diagnosed with ischemic heart disease (heart conditions such as angina pectoris and myocardial infarction caused by lack of blood flow to the heart).
• You have or have had a 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 undergone an ileostomy (intestinal surgery).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Magnesio NM.

Patients with kidney disease should consult their doctor before taking this medicine.

Continuous use of this medicine and use in patients with impaired renal function, especially those with severe renal insufficiency, and geriatric patients with renal insufficiency, 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.

Treatment should be continued until magnesium levels are normalized and in any case until your doctor considers it necessary.

Taking this medicine on an empty stomach may cause diarrhea.

Children and Adolescents

It is recommended to consult a doctor before administering it to children under 2 years of age.

Other Medicines and Magnesio NM

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

In particular, if you are using medicines that contain any of the following active ingredients, it may be necessary to modify the dose or interrupt treatment of any of them:

• Some medicines for hypertension such as captopril, enalapril, and fosinopril, and diuretics (furosemide or thiazides).
• Antifungal agents (for fungi) such as itraconazole, fluconazole, ketoconazole.
• Antibiotics such as tetracyclines (doxycycline, minocycline, oxytetracycline, tetracycline) and quinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), cephalosporins (cefpodoxime), isoniazid, rifampicin, and cefaclor, as it may reduce the effectiveness of the antibiotic. Aminoglycoside antibiotics may decrease magnesium absorption.
• Bisphosphonates (medicines used in the treatment of osteoporosis).
• Antiretrovirals such as atazanavir, tipranavir, and delavirdine, used in the treatment of HIV/AIDS.
• Digitalis, used in the treatment of congestive heart failure. The main digitalis is digoxin.
• Corticosteroids such as deflazacort.
• Sodium polystyrene sulfonate, used in the treatment of hyperkalemia, may cause metabolic alkalosis.
• Fexofenadine, an antihistamine used to relieve symptoms associated with allergic reactions.
• Antiepileptics such as gabapentin and phenytoin.
• Antipsychotics such as sulpiride and phenothiazines.
• Lansoprazole, a proton pump inhibitor, used to decrease the amount of acid produced by the stomach.
• Antimalarials: chloroquine, hydroxychloroquine, and penicillamine.
• Other types of medicines such as dipyridamole, cisplatin, levothyroxine, mycophenolate, hypolipidemics such as rosuvastatin, foscarnet, pentamidine, amphotericin B, cyclosporin A, epidermal growth factor receptor agonists (cetuximab or erlotinib), eltrombopag, and nilotinib.
• The administration of magnesium may potentiate the effects of competitive neuromuscular blocking agents, such as tubocurarine.

Note that these instructions may also apply to medicines that have been taken before or may be taken after, so at least 2 hours should elapse between the administration of Magnesio NM and any other oral medication, as it may decrease or increase the absorption of other medicines.

Pregnancy, Breastfeeding, and Fertility

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

Driving and Using Machines

No problems have been described regarding driving and using machines.

3. How to Take Magnesio NM

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults

1-2 sachets per day (200-400 mg of magnesium)

Children and Adolescents

The dose of Magnesio NM in pediatric patients should be established individually, according to age, body weight, magnesium deficit, and clinical response.

Use in Patients Over 65 Years:

Dose adjustment of Magnesio NM based on age is not recommended. In elderly patients, possible renal function impairment should be considered.

Use in Patients with Renal Insufficiency:

It should be used with caution in this group of patients, modifying the dose according to renal function.

Method of Administration

Magnesio NM should be dissolved in half a glass of water, stirring until complete dissolution, and taken immediately after.

The solution should be taken immediately after preparation. Discard any remaining contents of the sachet.

If You Take More Magnesio NM Than You Should

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

In cases of intoxication caused by ingestion of high doses, or in patients with renal insufficiency who have oliguria (decreased urine production), an increase in magnesium levels in the blood may occur. In this case, the following manifestations may appear: hot flashes, slowing of heart rate, central nervous system depression, muscle weakness, fatigue, somnolence, or hyperexcitability, nausea, vomiting, dizziness, hypotension due to vasodilation, confusion, respiratory depression, arrhythmias, coma, and cardiac arrest.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service (Tel. 91 562 04 20), indicating the medicine and the amount ingested.

If You Forget to Take Magnesio NM

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

If You Interrupt Treatment with Magnesio NM

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the period of use of this medicine, the following side effects have been reported, whose frequency could not be established with precision. The most characteristic have been gastrointestinal disorders (diarrhea, nausea, vomiting, and abdominal pain) and metabolic and nutritional disorders (low phosphate and calcium levels in the blood or high magnesium levels in the blood in patients with severe renal insufficiency).

If you consider that any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting of Side Effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not mentioned in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System (website: www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Magnesio NM

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

Do not use this medicine after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Magnesio NM

The active ingredient is magnesium 200 mg, provided by 274.85 mg of magnesium hydroxide and 834.7 mg of magnesium lactate.

Appearance of the Product and Contents of the Pack

Magnesio NM is presented in sachets of polyethylene/Aluminum/RT, in packs containing 30 sachets or 100 sachets.

Marketing Authorization Holder

Nutrición Médica, S.L.

C/ Arequipa, 1

28043 - Madrid, Spain.

Manufacturer

Industrial Farmacéutica Cantabria, S.A. (IFC)

Pirita, 9.

28850 - Torrejón de Ardoz, Spain

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

Date of the Last Revision of this Package Leaflet:April 2021