NEOMAG 4MMOL CHEWABLE TABLETS - patient leaflet, side effects, dosage

1. what neomag is and what it is used for

Neomag contains magnesium in the form of magnesium glycerophosphate. Magnesium is an essential mineral which is important in many activities within the body, especially nerve and muscle function. Neomag is given to supplement magnesium levels when the level of magnesium in the body is too low. ____

2. before you use neomag

Do not use Neomag and tell your doctor if you:

• are allergic or intolerant to any of the ingredients (listed in section 6)
• have phenylketonuria (see ‘Important information about one of the ingredients’ below)
• have hyperphosphataemia (high levels of phosphate in your blood)
• have kidney disease

You should also tell your doctor if you have ever had an operation on your bowel.

Taking other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Neomag can affect the way some other medicines work. Also some other medicines can affect the way Neomag works.

In particular, you must allow a time interval of 2–3 hours between taking Neomag and the following medicines.

• Cellulose sodium phosphate, used to prevent kidney stones

» EDTA, used in hospital for high calcium levels ______

• Fluorides, used for preventing tooth decay
• Tetracyclines, antibiotics to treat infections

You must allow a time interval of 3–4 hours between taking Noomag and the following modicinos:---------

• Aminoquinolines, medicines to treat malaria
• Quinidine and quinidine derivatives, medicines to treat heart rhythm disorders
• Nitrofurantoin, Nitroxoline, antibiotics to treat infections
• Penicillamine, medicine used to treat severe rheumatoid arthritis and used in Wilson’s disease
• Iron, to treat anaemia
• Bisphosphonates, to treat osteoporosis e.g alendronate, risedronate

• * Eltrombopag, to correct bleeding deficiency

The following medicines may cause magnesium deficiency. Your doctor may decide to adjust your daily dose of magnesium.

• Aminoglycosides, antibiotics used to treat infections e.g. gentamicin, streptomycin and neomycin
• Certain medicines used to treat cancer, such as cisplatin and EGF-receptor antagonists such as cetuximab and erlotinib
• Ciclosporins, medicines used to suppress the body’s immune system e.g. following an organ transplant___________­________________________­_______
• Water tablets (Diuretics), medicines used to treat blood pressure or heart failure e.g. thiazide, furosemide, bumetanide
• Proton Pump Inhibitors, medicines used to treat high acid in the stomach or oesophagus, e.g. omeprazole, pantoprazole
• Amphotericin B, antibiotic that fights fungal infections in the body
• Rapamycin, medicine used to suppress the body’s immune system e.g. following an organ transplant

• * Pentamidine, medicine to treat infections such as pneumonia

• Foscarnet, an antiviral medication
• Digoxin, a medicine to treat heart rhythm disturbance and heart failure

Continued overleaf

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Pregnancy and breast feeding

The effectiveness and safety of Neomag has not been properly studied in pregnant women although magnesium salts are routinely used to treat preeclampsia (a rise in blood pressure, and protein in 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 from magnesium on male and female fertility are expected.

Important information about one of the ingredients This medicine contains aspartame (E951) which contains a source of phenylalanine. This may be harmful to people with phenylketonuria.

3. how to use neomag

Always use Neomag exactly as your doctor has told you. You should check with your doctor or healthcare professional if you are not sure.

The amount of Neomag that you will be prescribed will depend on your particular condition and needs.

• Adults, including the elderly. The usual dose is

• 1 –2 tablets three times a day.

Your doctor may decide to monitor your magnesium at regular intervals.

• Patients with poor kidney function may need to be monitored at regular intervals and dose adjusted

• ■ Children: Neomag should only be used if a doctor has decided that the benefit of treatment outweigh any potential risk. Children need to be monitored regularly and have their dose adjusted.

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): 1 tablet twice per day

Children (12 to 18 years): 1 tablet three times a day

Neomag tablets may be broken into quarters and chewecfor swallowed with water.

If you forget to take a dose. 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 take too many tablets. Contact a doctor or healthcare professional immediately. Symptoms are given in section 4.

If you have any further questions on the use of this product, ask your doctor or healthcare professional.

4. possible side effects

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

Neomag may cause diarrhoea.

It is possible that you may receive too much magnesium.

Tell your doctor or healthcare professional immediately if you have any of the following symptoms:

• 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 please tell your doctor or healthcare professional.

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 the Yellow Card Scheme at:. By reporting side effects you can help provide more information on the safety of this medicine.

• 5. HOWTO STORE NEOMAG

Do not store above 25°C. Do not freeze. Store in the original package.

Keep out of the sight and reach of children.

Do not use Neomag after the expiry date which is stated on the bottle (EXP). The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your healthcare professional how to dispose of medicines no longer required. These measures will help to protect the environment.

• 6. FURTHER INFORMATION

What Neomag contains

• Each tablet contains 4mmol of the active substance magnesium
• The other ingredients are maize starch, microcrystalline cellulose, talc (purified), aspartame (E951), magnesium stearate, colloidal anhydrous silica, povidone

What Neomag looks like and contents of the pack

Neomag comes as a white, round tablet, which is cross-scored on one side. It is packed in polypropylene plastic bottles with caps made from a blend of low and high density polypropylene or high density polypropylene only. It is available in a pack size of 50 tablets.

Marketing Authorisation Holder

Neoceuticals Ltd, The Innovation Centre, Innovation Way, Heslington, York Y010 5DG

Manufacturer

Surepharm Services Limited, Unit 2H, Bretby Business Park, Ashby Road, Bretby, Burton-on-Trent, DE15 0YZ

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or healthcare professional.

If you notice any side effects not listed in this leaflet, please tell your doctor or healthcare professional.