Magnesium hydroxide oral suspension

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:

Magnesium sulfate dried; Chloroform; Magnesium oxide light; Sodium hydroxide

Available from:

The Boots Company Plc

ATC code:

A02AA04

INN (International Name):

Magnesium sulfate dried; Chloroform; Magnesium oxide light; Sodium hydroxide

Dosage:

47.5mg/1ml ; 3microlitre/1ml ; 52.5mg/1ml ; 15mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01060400

Patient Information leaflet

                                PRECAUTIONS BEFORE USE.
DO NOT USE IF:
- you have a serious digestive or stomach (gastro-intestinal)
condition.
- you have problems
with
your kidney or liver.
- you are physically fragile or weak.
AVOID USE during early pregnancy.
IF YOU ARE TAKING ANY OTHER MEDICATION, PRESCRIBED OR
OTHERWISE, TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USE.
The antacid properties of this product can reduce the effectiveness
of some other medicines including some (but not all):
- non-steroidal anti-inflammatory drugs (NSAIDs).
- antibiotics or medicines used to treat infections.
- epileptic therapy (phenytoin)
- malaria treatment (chloroquine, hydroxychloroquine).
- antipsychotic therapy (phenothiazines).
- osteoperosis therapy (biphosphonates).
- rheumatoid arthritis treatment (penicillamine).
- preventative heart attack or stroke treatments.
Store below 25°C. Do not freeze. Use within 1 month of opening.
Do not use after the expiry date shown.
DOSAGE, AS REQUIRED:
Shake bottle before use. To be taken by mouth.
5ml = 1 teaspoon.
revised date
Dec
ember 2015
Magnesium Hydroxide
Mixture 8% w/w
Oral suspension
Magnesium Hydroxide
Laxative for oral use for the
relief of mild constipation
KEEP OUT OF THE SIGHT
AND REACH OF CHILDREN
Marketing Authorisation Holder: Ayrton Saunders Ltd., 9 Arkwright
Road,
Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU.
Manufacturer: Pharmasol Ltd,. North Way, Andover, Hampshire, SP10 5AZ
PL 16431/0174
Contains the active ingredient:
magnesium oxide 275mg/5ml
Other ingredients: levomenthol, sodium saccharin,
phenoxyethanol, purified water.
Adults (12 years +) & elderly:
25 - 50 ml (max daily dose 50ml)
Children 6 - 12 years:
10 - 25 ml (max daily dose 25ml)
Children 1 - 6 years:
5 - 10 ml (max daily dose 10ml)
Not to be taken by children under 1 year old.
Only use occasionally. If your symptoms do not improve, or in
the event of an overdose, stop use and seek medical advice
IMMEDIATELY.
SIDE EFFECTS:
This medicine can cause colic (waves of pain in the s
t
omach).
Persistent over-use may result in hi
                                
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Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Magnesium Hydroxide Mixture 8%w/w Oral suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Magnesium Hydroxide 8% w/w, equivalent to Magnesium Oxide 5.5% w/v.
3
PHARMACEUTICAL FORM
Oral suspension
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For oral use for the relief of mild constipation
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For adults (including the elderly)
25
to
50ml
orally
as
required
(maximum daily dose 50ml)
For children aged 6-12 years
10
to
25ml
orally
as
required
(maximum daily dose 25ml)
For children aged 1-6 years
5
to
10ml
orally
as
required
(maximum daily dose 10ml)
Not recommended for children under 1 year of age.
Not recommended in cases of renal impairment of debilitation.
4.3
CONTRAINDICATIONS
Should not be used where there are known or suspected acute
gastro-intestinal
conditions, or renal or hepatic impairment.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Label warnings:
Store below 25°C.
Do not freeze.
Shake well before use.
Keep out of the sight and reach of children.
Chronic use may result in hypermagnesia.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The antacid properties of this preparation can lead to reduced
absorption of
diflusinal,
azithromycin,
ciprofloxacin,
isoniazid,
norfloxacin,
ofloxacin,
pivampicillin, rifampicin and most tetracyclines. Also reduces
absorption of
phenytoin,
itraconazole,
ketoconazole,
fosinopril,
chloroquine,
hydroxychloroquine, phenothiazines, biphosphonates and penicillamine.
The
use of this product is not advised during dipyridamole therapy. The
excretion
of aspirin is increased and quinidine is decreased in alkaline urine
which may
occur with use of this product.
4.6
PREGNANCY AND LACTATION
There is not or inadequate evidence of safety of use during pregnancy
and
lactation but has been used for many years without ill effect. As with
all
drugs, use during early pregnancy should be avoided. Can be used
during late
pregnancy and during lact
                                
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