When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
4.1 Therapeutic Indications
Milk of Magnesia is indicated as an antacid for the symptomatic relief of stomach upset and indigestion.
Milk of Magnesia is indicated as an antacid for the symptomatic relief of stomach discomfort, indigestion, hyperacidity, heartburn and flatulence.
As a laxative in occasional constipation.
4.2. Posology and Method of Administration
Use a 5 ml spoon or the dosing cup provided.
Shake well before use.
Take doses with water if required.
Do not exceed the stated dose.
As an antacid for stomach upsets and indigestion:
Adults (including the elderly) and children aged 12 years and over:
5-10 ml (one or two 5 ml spoonfuls or fill the dosing cup to the first or second line). Repeat as necessary to a maximum daily dose of 60 ml (12, 5ml spoonfuls) in any 24 hours.
Children aged 6-12 years: Children aged 6-11 years:
5 ml (one spoonful or first line in dosing cup). Repeat as necessary to a maximum daily dose of 30 ml in any 24 hours.
As a laxative:
Adults (including the elderly) and children aged 12 years and older:
30-45 ml at bedtime. Repeat nightly, reducing dose each night until constipation is relieved. Do not use for more than 3 consecutive days.
Children aged over 2 years 2 - 11 years:
5-10 ml at bedtime. Repeat nightly reducing the dose until constipation is relieved. Do not use for more than 3 consecutive days.
Not to be given to children except on medical advice. 4.4 Special Warnings and Precautions for Use Keep out of sight and reach of children. Adequate fluid intake should be maintained during use. If diarrhoea occurs especially in children or the elderly, discontinue use immediately. If symptoms persist or worsen, a doctor should be consulted. Prolonged continuous use is not recommended. If you suffer from kidney disease or are under a doctor’s care, consult him before using. In case of renal impairment a doctor should be consulted prior to use as hypermagnesaemia may occur. If you are taking any other medicines, consult your doctor or pharmacist before use. Users taking medications either physician or self prescribed should consult a doctor before use. If a laxative dose is needed every day or if there is a persistent abdominal pain further medical advice should be sought. Do not use as a laxative for more than three consecutive days, or as an antacid for more than fourteen consecutive days. Not to be given to children except on medical advice. 4.5 Interaction with Other Medicinal products and Other Forms of Interaction Magnesium hydroxide may interfere locally with the absorption of other drugs taken orally by increasing gastric pH. This can be avoided by giving other drugs 2-3 hours before the administration of magnesium hydroxide on the advice of a doctor. Milk of Magnesia may interact with tetracycline, digoxin, dicoumerol and cimetidine. Magnesium hydroxide may increase the absorption of ibuprofen, and decrease the absorption of penicillamine, bisphosphonates, ketaconazole and tetracycline. The excretion of salicylates will be increased by changes in urinary pH. Co-administration of sodium polystyrene sulphonate results in a relative excess of bicarbonate ions, which are absorbed, and may lead to metabolic alkalosis. 4.6 Pregnancy and Lactation For Magnesium hydroxide no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Magnesium crosses the placenta and, as with all drugs, use during pregnancy and lactation should be avoided unless on the advice of a doctor. Magnesium is excreted in small amounts into breast milk, however, use of Milk of Magnesia is considered to be compatible with breast feeding. Magnesium crosses the placenta and is excreted in small amounts in breast milk. Use during pregnancy and lactation should be avoided unless on the advice of a doctor. 4.8 Undesirable Effects Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). On this basis, no estimate is provided. The frequency of adverse events is not known and cannot be estimated from the available data. Diarrhoea may occur which is dose related. In patients with impaired renal function there may be sufficient accumulation of magnesium to produce toxic effects (see Overdose). 4.9 Overdose Overdose may cause diarrhoea and, where renal impairment exists, hypermagnesaemia may occur. Symptoms and Signs Symptoms of overdose include gastrointestinal irritation and watery diarrhoea. Magnesium poisoning may produce hypermagnesaemia, symptoms of which include nausea, vomiting, flushing, thirst, hypotension, drowsiness, confusion, loss of tendon reflexes, muscle weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest. Treatment Treatment consists of the intravenous administration of calcium gluconate injection 10% in a dose of 10-20ml to counteract respiratory depression or heart block. 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. 10 Date of revision of the text updated
Not to be given to children except on medical advice.
4.4 Special Warnings and Precautions for Use Keep out of sight and reach of children. Adequate fluid intake should be maintained during use. If diarrhoea occurs especially in children or the elderly, discontinue use immediately. If symptoms persist or worsen, a doctor should be consulted. Prolonged continuous use is not recommended. If you suffer from kidney disease or are under a doctor’s care, consult him before using. In case of renal impairment a doctor should be consulted prior to use as hypermagnesaemia may occur. If you are taking any other medicines, consult your doctor or pharmacist before use. Users taking medications either physician or self prescribed should consult a doctor before use. If a laxative dose is needed every day or if there is a persistent abdominal pain further medical advice should be sought. Do not use as a laxative for more than three consecutive days, or as an antacid for more than fourteen consecutive days. Not to be given to children except on medical advice. 4.5 Interaction with Other Medicinal products and Other Forms of Interaction Magnesium hydroxide may interfere locally with the absorption of other drugs taken orally by increasing gastric pH. This can be avoided by giving other drugs 2-3 hours before the administration of magnesium hydroxide on the advice of a doctor. Milk of Magnesia may interact with tetracycline, digoxin, dicoumerol and cimetidine. Magnesium hydroxide may increase the absorption of ibuprofen, and decrease the absorption of penicillamine, bisphosphonates, ketaconazole and tetracycline. The excretion of salicylates will be increased by changes in urinary pH. Co-administration of sodium polystyrene sulphonate results in a relative excess of bicarbonate ions, which are absorbed, and may lead to metabolic alkalosis. 4.6 Pregnancy and Lactation For Magnesium hydroxide no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Magnesium crosses the placenta and, as with all drugs, use during pregnancy and lactation should be avoided unless on the advice of a doctor. Magnesium is excreted in small amounts into breast milk, however, use of Milk of Magnesia is considered to be compatible with breast feeding. Magnesium crosses the placenta and is excreted in small amounts in breast milk. Use during pregnancy and lactation should be avoided unless on the advice of a doctor. 4.8 Undesirable Effects Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). On this basis, no estimate is provided. The frequency of adverse events is not known and cannot be estimated from the available data. Diarrhoea may occur which is dose related. In patients with impaired renal function there may be sufficient accumulation of magnesium to produce toxic effects (see Overdose). 4.9 Overdose Overdose may cause diarrhoea and, where renal impairment exists, hypermagnesaemia may occur. Symptoms and Signs Symptoms of overdose include gastrointestinal irritation and watery diarrhoea. Magnesium poisoning may produce hypermagnesaemia, symptoms of which include nausea, vomiting, flushing, thirst, hypotension, drowsiness, confusion, loss of tendon reflexes, muscle weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest. Treatment Treatment consists of the intravenous administration of calcium gluconate injection 10% in a dose of 10-20ml to counteract respiratory depression or heart block. 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. 10 Date of revision of the text updated
Keep out of sight and reach of children.
Adequate fluid intake should be maintained during use. If diarrhoea occurs especially in children or the elderly, discontinue use immediately.
If symptoms persist or worsen, a doctor should be consulted.
Prolonged continuous use is not recommended.
If you suffer from kidney disease or are under a doctor’s care, consult him before using.
In case of renal impairment a doctor should be consulted prior to use as hypermagnesaemia may occur.
If you are taking any other medicines, consult your doctor or pharmacist before use.
Users taking medications either physician or self prescribed should consult a doctor before use.
If a laxative dose is needed every day or if there is a persistent abdominal pain further medical advice should be sought.
Do not use as a laxative for more than three consecutive days, or as an antacid for more than fourteen consecutive days.
4.5 Interaction with Other Medicinal products and Other Forms of Interaction
Magnesium hydroxide may interfere locally with the absorption of other drugs taken orally by increasing gastric pH. This can be avoided by giving other drugs 2-3 hours before the administration of magnesium hydroxide on the advice of a doctor.
Milk of Magnesia may interact with tetracycline, digoxin, dicoumerol and cimetidine.
Magnesium hydroxide may increase the absorption of ibuprofen, and decrease the absorption of penicillamine, bisphosphonates, ketaconazole and tetracycline.
The excretion of salicylates will be increased by changes in urinary pH.
Co-administration of sodium polystyrene sulphonate results in a relative excess of bicarbonate ions, which are absorbed, and may lead to metabolic alkalosis.
4.6 Pregnancy and Lactation
For Magnesium hydroxide no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Magnesium crosses the placenta and, as with all drugs, use during pregnancy and lactation should be avoided unless on the advice of a doctor. Magnesium is excreted in small amounts into breast milk, however, use of Milk of Magnesia is considered to be compatible with breast feeding. Magnesium crosses the placenta and is excreted in small amounts in breast milk. Use during pregnancy and lactation should be avoided unless on the advice of a doctor. 4.8 Undesirable Effects Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). On this basis, no estimate is provided. The frequency of adverse events is not known and cannot be estimated from the available data. Diarrhoea may occur which is dose related. In patients with impaired renal function there may be sufficient accumulation of magnesium to produce toxic effects (see Overdose). 4.9 Overdose Overdose may cause diarrhoea and, where renal impairment exists, hypermagnesaemia may occur. Symptoms and Signs Symptoms of overdose include gastrointestinal irritation and watery diarrhoea. Magnesium poisoning may produce hypermagnesaemia, symptoms of which include nausea, vomiting, flushing, thirst, hypotension, drowsiness, confusion, loss of tendon reflexes, muscle weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest. Treatment Treatment consists of the intravenous administration of calcium gluconate injection 10% in a dose of 10-20ml to counteract respiratory depression or heart block. 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. 10 Date of revision of the text updated
For Magnesium hydroxide no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Magnesium crosses the placenta and, as with all drugs, use during pregnancy and lactation should be avoided unless on the advice of a doctor. Magnesium is excreted in small amounts into breast milk, however, use of Milk of Magnesia is considered to be compatible with breast feeding. Magnesium crosses the placenta and is excreted in small amounts in breast milk. Use during pregnancy and lactation should be avoided unless on the advice of a doctor. 4.8 Undesirable Effects Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). On this basis, no estimate is provided. The frequency of adverse events is not known and cannot be estimated from the available data. Diarrhoea may occur which is dose related. In patients with impaired renal function there may be sufficient accumulation of magnesium to produce toxic effects (see Overdose). 4.9 Overdose Overdose may cause diarrhoea and, where renal impairment exists, hypermagnesaemia may occur. Symptoms and Signs Symptoms of overdose include gastrointestinal irritation and watery diarrhoea. Magnesium poisoning may produce hypermagnesaemia, symptoms of which include nausea, vomiting, flushing, thirst, hypotension, drowsiness, confusion, loss of tendon reflexes, muscle weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest. Treatment Treatment consists of the intravenous administration of calcium gluconate injection 10% in a dose of 10-20ml to counteract respiratory depression or heart block. 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. 10 Date of revision of the text updated
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Magnesium crosses the placenta and, as with all drugs, use during pregnancy and lactation should be avoided unless on the advice of a doctor. Magnesium is excreted in small amounts into breast milk, however, use of Milk of Magnesia is considered to be compatible with breast feeding.
Magnesium crosses the placenta and is excreted in small amounts in breast milk. Use during pregnancy and lactation should be avoided unless on the advice of a doctor.
4.8 Undesirable Effects Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). On this basis, no estimate is provided. The frequency of adverse events is not known and cannot be estimated from the available data. Diarrhoea may occur which is dose related. In patients with impaired renal function there may be sufficient accumulation of magnesium to produce toxic effects (see Overdose). 4.9 Overdose Overdose may cause diarrhoea and, where renal impairment exists, hypermagnesaemia may occur. Symptoms and Signs Symptoms of overdose include gastrointestinal irritation and watery diarrhoea. Magnesium poisoning may produce hypermagnesaemia, symptoms of which include nausea, vomiting, flushing, thirst, hypotension, drowsiness, confusion, loss of tendon reflexes, muscle weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest. Treatment Treatment consists of the intravenous administration of calcium gluconate injection 10% in a dose of 10-20ml to counteract respiratory depression or heart block. 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. 10 Date of revision of the text updated
Specific estimation of the frequency of adverse events for OTC products is inherently difficult (particularly numerator data). On this basis, no estimate is provided.
The frequency of adverse events is not known and cannot be estimated from the available data.
Diarrhoea may occur which is dose related.
In patients with impaired renal function there may be sufficient accumulation of magnesium to produce toxic effects (see Overdose).
4.9 Overdose
Overdose may cause diarrhoea and, where renal impairment exists, hypermagnesaemia may occur.
Symptoms and Signs
Symptoms of overdose include gastrointestinal irritation and watery diarrhoea.
Magnesium poisoning may produce hypermagnesaemia, symptoms of which include nausea, vomiting, flushing, thirst, hypotension, drowsiness, confusion, loss of tendon reflexes, muscle weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest.
Treatment
Treatment consists of the intravenous administration of calcium gluconate injection 10% in a dose of 10-20ml to counteract respiratory depression or heart block. 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. 10 Date of revision of the text updated
10 Date of revision of the text updated
Section 1 Name of the Medicinal Product: Should be changed from "Milk of Magnesia, Traditional Mint Flavoured Liquid" to "Milk of Magnesia Traditional Mint Flavoured Liquid, 415 mg/5 ml, oral suspension"
- Section 2 Qualitative and Quantitative Composition: "For Excipients see section 6.1" should be changed to "For a full list of excipients, see section 6.1"
- Section 6.1 List of Excipients: "Sodium Bicarbonate" should be changed to "Sodium Hydrogen Carbonate"
- Section 6.5 Nature and Contents of Container: A last paragraph should be added, which reads "Not all pack sizes may be marketed."
- Section 9 Date of First Authorisation/Renewal of the Authorisation: Renewal of Authorisation date should be changed from "20th August 2003" to "20th August 2007"
- Section 10 Date of Revision of the Text: Should be changed from "May 2004" to "October 2007"
1. NAME OF THE MEDICINAL PRODUCT
Milk of Magnesia, Traditional Mint Flavoured Liquid
6.6 Instructions for Use/Handling
Shake bottle well before use. Use within 6 months of opening.
9. DATE OF FIRST AUTHORISATION/RENEWAL
20th August 1992/ 20th August 2003
10. DATE OF PREPARATION/REVISION OF THE TEXT
May 2004