Impilo Milk Of Magnesia 425 mg/5 ml Suspension

Where the use of an antacid is indicated. For the relief of occasional constipation.

Posology

SHAKE BOTTLE BEFORE USE

ANTACID

Adults: 5 u2013 10 ml (one or two medicine measures)

Children 3 u2013 10 years: 2,5 ml (half a medicine measure)

Not more than three to four times per 24 hour period.

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LAXATIVE

When used as a laxative, the medicine should be followed with sufficient water to prevent nett loss of body water. Take as a single dose, or as directed by a doctor. This product generally produces bowel movement in half to six hours.

Adults: 20 u2013 40 ml (four to eight medicine measures)

Children 2 u2013 6 years: 5 u2013 10 ml (one to two medicine measures)

6 u2013 12 years: 10 u2013 20 ml (two to four medicine measures)

The dosage recommended above should not be exceeded in a 24 hour period. Do not use the maximum daily dosage of this product for more than one week except under the advice and supervision of a doctor.

Method of administration

Oral administration only.

• Not to be taken by patients with severe renal failure or dehydration.
• Must not be given to patients who are sensitive to any of the ingredients.

Use with caution in patients with impaired renal function and debility. Not to be taken by persons suffering from diarrhoea, abdominal pain, nausea or vomiting, unless directed by a doctor. If a sudden change in bowel habits is noticed, that persists over a period of 2 weeks, consult a doctor before using the laxative. Rectal bleeding or failure to have a bowel movement after the use of a laxative may indicate a serious condition. Discontinue use and consult a doctor.

This preparation may interfere with the absorption of other medicines if taken concomitantly by increasing gastric pH. This can be avoided by giving other medicines 2-3 hours before the administration of magnesium hydroxide. Magnesium salts reduce the absorption of a number of other medicines taken concomitantly. These include:

• ACE inhibitors (captopril, enalapril, fosinapril);
• beta-blockers (propranolol, atenolol);
• antibacterials and antifungals (azithromycin, cefaclor, cefpodoxime, isoniazid, itraconazole, nitrofurantoin, rifampicin, tetracyclines, ketoconazole capsules and the quinolone group of antibacterials);
• antivirals (atazanavir, fosamprenavir, tipranavir, delavirdine, rilpivirine);
• antihistamines (fexofenadine);
• bisphosphonates (alendronate, tiludronate, clodronate, risedronate, etidronate);
• corticosteroids (prednisone, prednisolone, dexamethasone);
• digoxin;
• dipyridamole;
• antiepileptics (gabapentin and phenytoin);
• ulcer healing drugs (lansoprazole);
• levothyroxine;
• mycophenolate;
• iron preparations;
• lipid regulating drugs (rosuvastatin);
• antipsychotics (sulpiride, phenothiazines, chlorpromazine);
• antimalarials (chloroquine, hydrochloroquine, proguanil);
• penicillamine.

Magnesium hydroxide may increase the absorption of ibuprofen. Urine alkalinisation secondary to administration of magnesium hydroxide may modify excretion of some drugs; thus, increased excretion of salicylates has been seen.

The safety of this preparation in pregnancy and lactation has not been established. No fertility data available.

No effects are expected on the ability to drive or use machines.

MedDRA system organ class

Frequency

Adverse reactions

Metabolism and nutrition disorders

Less frequent

Hypermagnesaemia. Observed after prolonged administration of magnesium hydroxide to patients with renal impairment.

Gastrointestinal disorders

Frequency unknown

Abdominal pain, diarrhoea (a dose-dependent effect), colic.

Overdosage may be characterised by excessive purging. If symptoms of hypermagnesaemia (such as flushing of the skin, thirst, hypotension, drowsiness, confusion, loss of tendon reflexes, muscle weakness, respiratory depression, cardiac dysrhythmias, coma and cardiac arrest) are observed, consult a doctor. Respiratory depression or heart block can be counteracted with intravenous administration of calcium gluconate injection 10 % in a dose of 10 - 20 ml. If renal function is normal, adequate fluids should be given to assist removal of magnesium from the body. Dialysis may be necessary in patients with renal impairment or severe hypermagnesaemia.