Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Magnesium
Kora Corporation Limited trading as Kora Healthcare
A12CC04
Magnesium
97 milligram(s)
Tablet
magnesium citrate
Marketed
2021-03-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER MAGMEDI 97 MG TABLETS magnesium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. 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. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Magmedi is and what it is used for 2. What you need to know before you take Magmedi 3. How to take Magmedi 4. Possible side effects 5. How to store Magmedi 6. Contents of the pack and other information 1. WHAT MAGMEDI IS AND WHAT IT IS USED FOR Magmedi contains the active ingredient magnesium citrate nonahydrate equivalent to 97.2 mg (4 mmol) of magnesium. Magmedi is intended for the treatment and prevention of magnesium deficiency in adults, adolescents and children aged from 12 years. Magnesium is an essential mineral which is particularly important in nerve and muscle function in addition to other activities within the body. You must talk to a doctor if you do not feel better or if you feel worse after taking this medicine. Magmedi is not intended for the treatment of either severe magnesium loss (blood magnesium level is less than 0.4mmol/L) or severe symptoms. Treatment with oral magnesium can begin when blood magnesium levels rise above 0.4mmol/L or when the severe symptoms are no longer present. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAGMEDI DO NOT TAKE MAGMEDI • if you are allergic to magnesium citrate nonahydrate or any of the other ingredients of this medicine (listed in section 6). • if you have severe kidney problems WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Magmedi: • if you suffer from kidney problems. • if you suf Read the complete document
Health Products Regulatory Authority 15 February 2023 CRN00D9F0 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Magmedi 97 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains magnesium citrate nonahydrate equivalent to 97.2 mg (4 mmol) of magnesium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, oblong tablet, marked with "Mg" and "97" on either side of a score line on one side. Dimensions: 18 mm x 8.7 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Magmedi is indicated for the treatment and prevention of magnesium deficiency in adults, adolescents and children aged from 12 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The duration of magnesium treatment required will depend on the clinical circumstances of each patient It is recommended that serum magnesium levels should be monitored at regular intervals e.g. every 3-6 months, particularly in children and in patients with renal impairment. Posology ADULTS (> 18 YEARS) The recommended daily dose for an adult (> 18 years) is 12-24 mmol magnesium, e.g. 1 – 2 tablets administered 3 times a day (equivalent to 291.6– 583.2 mg magnesium or 12-24 mmol magnesium daily). CHILDREN AND ADOLESCENTS (12 TO 18 YEARS) The recommended daily dose for children (12 to 18 years) and adolescents is 12 mmol magnesium, e.g. 1 tablet administered 3 times a day (equivalent to 291.6 mg magnesium or 12 mmol magnesium daily). Special populations CHILDREN LESS THAN 12 YEARS: Magmedi is not recommended for children less than 12 years as the safety and efficacy of Magmedi in children less than 12 years has not yet been established. Other pharmaceutical forms/strengths may be more appropriate for administration to this population. ELDERLY: As older patients may have diminished renal function, dose adjustments may be required according to their renal function status (see Renal impairmen Read the complete document