Magnesium Hydroxide Mixture Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Magnesium Hydroxide Mixture BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Magnesium Hydroxide Paste Concentrated l.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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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
Sodium Benzoate Purified Water
6.2 Incompatibilities
None known
6.3 Shelf life 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 500ml: Glass bottle with white plastic child resistant cap with EPE/Saranex liner.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd Linthwaite Laboratories Huddersfield HD7 5QH
8 MARKETING AUTHORISATION NUMBER
PL 00240/6500R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
27/09/88 / 24/09/2001
10 DATE OF REVISION OF THE TEXT
17/06/2015