Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Magnesium aspartate dihydrate
Kora Corporation Limited trading as Kora Healthcare
A12CC; A12CC05
Magnesium aspartate dihydrate
243 milligram(s)
Powder for oral solution
Oral use
Packs of 10 sachets.
Product subject to prescription which may be renewed (B)
Lusomedicamenta Sociedade Tecnica Farmaceutica, S.A.
Magnesium; magnesium aspartate
Treatment and prevention of magnesium deficiency
Marketed
2015-05-15
1 PACKAGE LEAFLET: INFORMATION FOR THE USER MAGNASPARTATE 243 MG POWDER FOR ORAL SOLUTION 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 MAGNASPARTATE is and what it is used for 2. What you need to know before you take MAGNASPARTATE 3. How to take MAGNASPARTATE 4. Possible side effects 5. How to store MAGNASPARTATE 6. Contents of the pack and other information 1. WHAT MAGNASPARTATE IS AND WHAT IT IS USED FOR Magnaspartate is a mineral preparation and contains the active ingredient magnesium aspartate dihydrate equivalent to 243 mg (10 mmol) of magnesium. Magnaspartate is used in the treatment and prevention of magnesium deficiency in adults and children aged 2 years and above. You must talk to a doctor if you do not feel better or if you feel worse after taking this medicine. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAGNASPARTATE DO NOT TAKE MAGNASPARTATE: • if you are allergic to magnesium aspartate dihydrate or any of the other ingredients of this medicine (listed in section 6). • if you have severe kidney problems • if you have a very slow heart rhythm (called ‘bradycardia’) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Magnaspartate: If you have switched from another magnesium medicine to ensure that treatment with Magnaspartate does not make you feel unwell and that you can continue to receive the correct dose of magnesium. OTHER MEDICINES AND MAGNASPARTATE Tell your doctor or pharmacist if you are taking, have recently taken or might Izlasiet visu dokumentu
Health Products Regulatory Authority 08 November 2022 CRN00D3WQ Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Magnaspartate 243 mg powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 6.5 g sachet of powder contains magnesium aspartate dihydrate equivalent to 243 mg (10 mmol) of magnesium. Excipient(s) with known effect: Each sachet contains 2.706g sucrose and 2mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution White powder with a peach/apricot-like flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Magnaspartate is indicated for the treatment and prevention of magnesium deficiency in adults and children aged 2 years and above. 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) 1-2 sachets daily (243-486 mg magnesium or 10-20 mmol magnesium) CHILDREN AND ADOLESCENTS: 10 TO 18 YEARS One sachet daily (equal to 243 mg magnesium) dissolved in 50-200ml of water, tea, or orange juice. CHILDREN: 4-10 YEARS One sachet daily (equal to 243 mg magnesium) dissolved in 50-200ml of water, tea, or orange juice. Alternatively, for a half dosage, use half the volume of 1 sachet dissolved in 50-200ml of water (equal to 121.5 mg magnesium). CHILDREN: 2 TO 4 YEARS Half the volume of 1 sachet dissolved in 50-200ml water (equal to 121.5 mg magnesium). The safety and efficacy of Magnaspartate in children below 2 years has not been established RENAL PATIENTS: Magnaspartate 243 mg is contraindicated in patients with severe renal impairment (see section 4.3). There is no dose adjustment necessary in patients with mild to moderate renal impairment. ELDERLY: No dose adjustment is necessary. Method of administration Health Products Izlasiet visu dokumentu