Magnesium Hydroxide Mixture BP

1. Name Of The Medicinal Product

Magnesium Hydroxide Mixture BP.

2. Qualitative And Quantitative Composition

Magnesium Hydroxide Paste Concentrated 1.325g/5ml

3. Pharmaceutical Form

Suspension

4. Clinical Particulars

4.1 Therapeutic Indications

1. For relief of the symptoms of flatulence, heartburn, dyspepsia and indigestion.

2. As a laxative for relief of occasional constipation.

4.2 Posology And Method Of Administration

Oral.

Recommended doses and dosage schedule

1. As an antacid

Adults, the elderly and children over 12 years: one to two 5ml spoonfuls in a little water when required.

Children under 12 years: not suitable.

2. As a laxative:

Adults, the elderly and children over 12 years: 25 – 50ml (five to ten 5ml spoonfuls) in a glass of water at bedtime.

Children under 12 years: not suitable.

Directions for use: Shake the bottle.

4.3 Contraindications

Contraindicated in severe renal failure, acute gastrointestinal conditions and in hypersensitivity to magnesium salts or any of the other ingredients.

4.4 Special Warnings And Precautions For Use

Use with caution in the elderly and debilitated and in patients with impaired liver function. Also in patients with impaired kidney function as hypermagnesaemia may result.

Keep all medicines away from children.

If constipation persists consult your doctor.

Not suitable for children under 12.

Discard any unused mixture 3 months after opening.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

As a precaution for antacids, in order to minimise the risk of interactions affecting pharmacokinetics of concomitantly administered products, drug administrations should be separated by approximately 2 to 3 hours.

Magnesium salts reduce the absorption of a number of other drugs taken concomitantly. These include ACE inhibitors (captopril, enalapril, and fosinapril), antibacterials and antifungals (azithromycin, cefaclor, cefpodoxime, isoniazid, itraconazole, nitrofurantoin, rifampicin, tetracyclines, ketoconazole and the quinolone group of antibacterials); antivirals (atazanavir, fosamprenavir, tipranavir); antihistamines (fexofenadine); bisphosponates, corticosteroids (deflazacort); digoxin, dipyridamole, diflunisal, antiepileptics (gabapentin and phenytoin), ulcer healing drugs (lansoprazole); levothyroxine, mycophenolate, iron preparations, lipid regulating drugs (rosuvastatin); antipsychotics (sulpiride, phenothiazines), chloroquine, hydrochloroquine, proguanil, and penicillamine. Concomitant use with sodium polystyrene sulphonate may produce metabolic alkalosis. Alkaline urine due to some antacids increases excretion of aspirin. Antacids should be avoided with nilotinib.

Antacids possibly reduce absorption of bile acids.

4.6 Pregnancy And Lactation

As with all other medicines, use of this product should be avoided in the above conditions unless recommended by a doctor.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Magnesium hydroxide may cause diarrhoea (a dose-dependent effect) and colic in some patients.

4.9 Overdose

Excessive use of magnesium containing antacids has rarely resulted in hypermagnesaemia, symptoms of which include flushing of the skin, thirst, respiratory depression, cardiac arrhythmias, coma and cardiac arrest.

Treatment should consist of the administration of calcium gluconate injection 10% intravenously at a dose of 10 – 20ml, to counteract respiratory depression or heart block. If renal function is normal, sufficient fluids should be given to aid removal of magnesium from the body. Dialysis may be necessary in patients with impaired renal function or severe hypermagnesaemia.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Magnesium hydroxide is an antacid with slow neutralising action and a mild laxative action.

5.2 Pharmacokinetic Properties

Magnesium salts are poorly absorbed following oral administration. Approximately one third of magnesium is absorbed from the small intestine, and excreted mainly in the urine with small amounts in breast milk and saliva.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Chloroform BP, purified water BP.

6.2 Incompatibilities

None known.

6.3 Shelf Life

200ml: 12 months unopened, 3 months after first opening.

500ml: 12 months unopened, 3 months after first opening.

6.4 Special Precautions For Storage

Do not freeze.

Do not store above 25°C.

6.5 Nature And Contents Of Container

200ml: Glass bottle with plastic cap or white plastic child resistant cap with EPE/Saranex liner.

500ml: Glass bottle with plastic cap or white plastic child resistant cap with EPE/Saranex liner.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing Authorisation Number(S)

PL 00240/6500R

9. Date Of First Authorisation/Renewal Of The Authorisation

27/09/88

10. Date Of Revision Of The Text

22.01.2010