Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
WHAT NEOMAG IS AND WHATITISUSEDFOR —*_- Penieillamine, a medicine used to treat severe NEOMAG contains magnesium in the form of rheumatoid arthritis and used in Wilson 's disease magnesium glycerophosphate. Magnesium is an * Iron, a medicine used to treat anaemia essential mineral which is important in many activities * Bisphosphonates, medicines used to treat within the body, especially nerve and muscle function. osteoporosis, such as alendronate and risedronate NEOMAG is given to you to supplement magnesium . Eirombopeg, a medicine used to correct bleeding levels when the level of magnesium in your body is too Oney: low. The following medicines may cause magnesium ; bo fake Nese ——w your daily dose of NEOMAG. ; = . * Aminoglycosides, antibiotics used to treat * ifyou are allergic to magnesium glycerophosphate infections, such as gentamicin, streptomycin and or any of the other ingredients of this medicine neomycin (listed in section 6) . . + Certain medicines used to treat cancer such as * ifyou have phenylketonuria (see "Important cisplatin and EGF-receptor antagonists such as information about one of the ingredients" below) cetuximab and erlotinib * if you have hyperphosphataemia (high levels of * Ciclosporins, medicines used to suppress the phosphate in your blood) body's immune system for example following an * if you have kidney disease organ transplant Warnings and precautions - Water tablets (Diuretics), medicines used to treat Talk to your doctor, pharmacists or nurse before taking blood pressure or heart failure such as thiazide, NEOMAG: furosemide or bumetanide ; °. 5 rr * if you have ever had an operation on your bowel. high acid in the stomach on oesophagus such as Children and adolescents omeprazole and pantoprazole Do not give this medicine to children under the age of 4 * +~Amphotericin B, an antibiotic that fights fungal years because there is not enough information about infections in the body the use of NEOMAG in this age group. * Rapamycin, a ee en to suppress the Other medicines and NEOMAG i tcl mamas or example following an Tell your doctor, pharmacist or nurse if you are taking, + Pentamidine, a medicine used to treat infections have recently taken or might take any other medicines. such as pneumonia This is because NEOMAG can affect the way some + Foscarnet, an antiviral medication. other medicines work. Also, some other medicines can * Digoxin, a medicine used to treat heart rhythm
affect the way NEOMAG works. disturbance and heart failure
ou m Pregnancy, breast feeding and fertility If you are pregnant or breast-feeding, think you may be
1k Walt <-) NOUFS Detween taking N
Cellulose sodium phosphate, used to prevent pregnant or are planning to have a baby, ask your
petatg mea ee doctor or nurse for advice before taking this medicine. ' \, used in hospital for hig! um 1eveIs The effectiveness and safety of Neomag has not been * Fluorides, including toothpastes and mouthwashes, properly studied in pregnant women although
used for preventing tooth decay magnesium salts are routinely used to treat * Tetracyclines, antibiotics to treat infections pre-eclampsia (a rise in blood pressure, and protein in
Continued overleaf
the urine during pregnancy). Neomag should only be used in pregnancy if your doctor has decided that the benefits of treatment outweigh any potential risks. Neomag can be used during breast-feeding.
Based on long-term experience, no effects on male and female fertility are expected.
NEOMAG contains Aspartame (E951)
This medicine contains 10 mg aspartame in each tablet which is equivalent to 6.3 mg/g.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Always take NEOMAG exactly as your doctor or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
The amount of Neomag that you will be prescribed will depend on your particular needs. Neomag tablets can be divided into quarters and chewed or swallowed with water.
Adults, including the elderly The recommended dose is 1-2 tablets three times a
day. Your doctor may decide to monitor your magnesium levels at regular intervals.
Children and Adolescents
NEOMAG should only be used if a doctor has decided that the benefit of treatment outweighs any potential tisk. Children need to be monitored regularly and have their dose adjusted.
The recommended doses for children and adolescents aged 4 years to 18 years are shown below:
Age range Recommended dose 12 to 18 years 1 tablet three times daily 4 to 12 years 1 tablet twice daily
NEOMAG is not recommended for children under 4 years of age because there is not enough information about the use of NEOMAG in this age group.
Patients with poor kidney function may need to be monitored regularly and have their dose adjusted
If you take more NEOMAG than you should
If you take too many NEOMAG tablets, you may have symptoms of having taken too much magnesium. These include:
flushing, thirst, feeling sick, being sick
drowsiness, confusion
muscle weakness
low blood pressure (you may feel faint when standing from a seated or lying position), abnormal heart beats
* breathing problems
Contact a doctor or nurse immediately.
If you forget to take NEOMAG Take one as soon as you remember and continue to take the remainder of the doses as directed.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking NEOMAG
It is important to continue to take this medicine until your doctor tells you that you no longer need to. If you stop taking it, talk to your doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
NEOMAG may cause diarrhoea.
It is possible that you may receive too much
magnesium.
Teil your doctor, pharmacist or nurse immediately
if you have any of the following symptoms, which
may indicate that you have had too much magnesium:
* flushing, thirst, feeling sick, being sick
+ drowsiness, confusion
* muscle weakness
* low blood pressure (you may feel faint when standing from a seated or lying position), abnormal heart beats
* breathing problems
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
Reporting side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov. uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store. By
reporting side effects you can help provide more
information on the safety of this medicine.
Do not store above 25°C. Do not freeze. Store in the
original package.
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date on the
label or carton after (EXP). The expiry date refers to the
last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.
6. FURTHER INFORMATION
What NEOMAG contains
* The active substance is magnesium glycerophosphate.
+ Each tablet contains 4 mmol (97.2 mg) of the active substance magnesium (as magnesium glycerophosphate)
+ The other ingredients are maize starch, microcrystalline cellulose, talc, aspartame (E951),
magnesium stearate, colloidal anhydrous silica, povidone. What NEOMAG looks like and contents of the pack NEOMAG tablets are white, round with a cross-scored line on one side. The tablets are packed in polypropylene plastic bottles with a mixed low and high density polypropylene cap, in a pack size of 50 tablets. Marketing Authorisation Holder Neoceuticals Limited The Innovation Centre, Innovation Way, Heslington, York YO10 5DG, UK Manufacturer Surepharm Services Limited Unit 2H, Bretby Business Park Ashby Road East, Bretby, Burton-on-Trent, DE15 OYZ, UK
This leaflet was last revised in March 2021 NMLF01-12
Neomag comes as medicine. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Neomag is magnesium glycerophosphate.
Medicines with the same active substance include: Magnesium 4mmol Chewable Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Neomag, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Neomag 4mmol Chewable Tablets are indicated as oral magnesium supplements for the treatment of patients with chronic magnesium loss or hypomagnesaemia as diagnosed by a doctor.
Neomag 4mmol Chewable Tablets are also indicated for adult patients with hypomagnesaemia due to the concomitant administration of loop and thiazide diuretics or other drugs which cause hypomagnesaemia.
Posology
Patients with severe, symptomatic hypomagnesaemia should receive intravenous magnesium repletion for acute recovery of magnesium levels prior to receiving Neomag.
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.
Adults (> 18 years): The dosage regimen should be adjusted according to the serum total magnesium level of the individual patient. Starting doses for adult patients are recommended as 4-8 mmol (1-2 tablets) administered 3 times a day. This equates to a total dose of 12 to 24 mmol per day taken in divided doses.
Elderly: No dose adjustment is necessary.
Paediatric population: Neomag tablets should only be used if the benefits of treatment outweigh any potential risks and under the supervision of physicians experienced in the management of children with hypomagnesaemia.
Children: below 4 years: Not recommended as there is insufficient information regarding the use of Neomag tablets in this age group.
Children: 4 to 12 years: The dosage regimen should be adjusted according to the serum total magnesium level of the individual patient. A starting dose for children 4 to 12 years is recommended as 4 mmol (1 tablet) administered 2 times a day. This equates to a total dose of 8 mmol per day taken in divided doses.
Children: 12 to 18 years: The dosage regimen should be adjusted according to the serum total magnesium level of the individual patient. A starting dose for children 12 to 18 years is recommended as 4 mmol (1 tablet) administered 3 times a day. This equates to a total dose of 12 mmol per day taken in divided doses.
Patients with Renal Impairment: Neomag 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.
Method of administration
The tablet may be broken into quarters and chewed or swallowed with water.
Co-Administration of Potassium and Calcium Supplements: Administration of potassium and calcium together with magnesium may be necessary since associated loss of these cations is common in severe magnesium deficiency.
Do not administer Neomag tablets if there is evidence of hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Neomag is contraindicated in patients with severe renal impairment (glomerularfiltration rate < 30 ml/min).
Neomag should not be administered to patients with phenylketonuria as Neomag tablets contain Aspartame.
Neomag should not be administered to patients with hyperphosphataemia as Neomag tablets contain phosphate.
Cardiovascular drugs: Digoxin and loop diuretics are magnesiuretic drugs and may affect magnesium balance. Magnesium deficiency may enhance digoxin toxicity.
As magnesium and other medicinal products may mutually influence each other's absorption, a time interval of 2 to 3 hours should generally be respected if possible.
This specifically applies to:
• Cellulose sodium phosphate; edetate disodium: concurrent use with magnesium supplements may result in binding of magnesium; patients should be advised not to take magnesium supplements within 1 hour of cellulose sodium phosphate or edentate disodium.
• Fluorides and tetracycline: if they must be used, the doses must be separated by 2 to 3 hours or more to prevent their admixture in the gut.
• Aminoquinolines, quinidine and quinidine derivatives, nitrofurantoin, penicillamine, iron, bisphosphonates (such as alendronate and risedronate), eltrombopag, nitroxoline: to avoid impairment of absorption, magnesium preparations should be taken 3 to 4 hours before or after the administration of those drugs.
Because of increased magnesium losses, a dose adjustment of magnesium may be necessary when taking the following substances:
• Aminoglycoside antibiotics, cisplatin and ciclosporin A
• Diuretics (such as thiazide and furosemide),
• EGF-receptor antagonists (such as cetuximab and erlotinib),
• proton pump inhibitors (such as omeprazole and pantoprazole) and
• viral DNA polymerases-inhibiting foscarnet, pentamidine, rapamycin and amphotericin B
In addition, other electrolyte disturbances, such as hypokalaemia and hypocalcaemia, should be looked for in these patients with hypomagnesaemia.
For further information on mechanisms of drug interactions see section 5.2.
Fertility
Based on long-term experience, no effects of magnesium on male and female fertility are anticipated.
Pregnancy
The effectiveness and safety of Neomag has not been established in pregnant women. Neomag tablets should only be used in pregnancy if the benefits of the treatment outweigh any potential risks. However, long-term data available from treatment of pre-eclampsia do not indicate malformative or feto/neonatal toxicity of magnesium.
Administration of aminoglycoside antibiotics should be avoided during this period, as there are indications of interactions (see Section 4.5).
Lactation
Neomag can be used during breast-feeding. Magnesium glycerophosphate /its metabolites are excreted in human milk, but at therapeutic doses of Neomag no effects on the breastfed newborns/infants are anticipated.
Neomag has no or negligible influence on the ability to drive and use machines.
Symptoms: Hypermagnesaemia characterised by flushing, thirst, hypotension, drowsiness, nausea, vomiting, confusion, loss of tendon reflexes due to neuromuscular blockade, muscle weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest.
Treatment of Iatrogenic Hypermagnesaemia and Overdose: When hypermagnesaemia is found, magnesium therapy should be withdrawn and this is all that is needed in most patients with mild to moderate hypermagnesaemia. In patients with symptomatic hypermagnesaemia, serum magnesium should be lowered and the effects of hypermagnesaemia antagonised. Calcium antagonises the toxic effects of magnesium and therefore patients with severe magnesium intoxication should be given intravenous calcium gluconate as a bolus followed by an infusion. Administration of glucose and insulin may also help to promote magnesium entry into cells. If renal function is normal adequate fluids should be given to assist removal of magnesium from the body. If the patient is in renal failure, peritoneal or haemodialysis against a low magnesium dialysis fluid will rapidly and effectively lower the serum magnesium concentration.
Ask anything about Neomag. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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