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ZINC GLUCONATE TABLETS 32MG

Active substance(s): ZINC GLUCONATE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Zinc Gluconate Tablets 32 mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc Gluconate 32 mg

3

PHARMACEUTICAL FORM
Tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For diets containing inadequate zinc.

4.2

Posology and method of administration
Dose
Adults, the elderly and children over 12 years
One tablet daily.
Children under 12 years
Not recommended.
Dosage schedule
Take one hour before or two hours after food.
Route of administration
Oral.

4.3

Contraindications
Copper deficiency.

4.4

Special warnings and precautions for use
Consumption of fibre-containing foods inhibit absorption of zinc. Take the
tablets an hour before, or two hours after, food high in fibre.

4.5

Interaction with other medicinal products and other forms of interaction
Concurrent administration of zinc salts may diminish the effect of
penicillamine and the absorption of tetracycline and iron. Large doses inhibit
copper absorption.

4.6

Fertility, pregnancy and lactation
No problems have been reported but as with all drugs, caution is
recommended if the tablets are to be taken in the first three months of
pregnancy.

4.7

Effects on ability to drive and use machines
None

4.8

Undesirable effects
Side effects of zinc salts are abdominal pain and dyspepsia.

4.9

Overdose
Overdose with this preparation has not been reported. Excess intake or
accidental ingestion will cause nausea and abdominal pain. Treatment should
be symptomatic with plenty of milk or water.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Zinc gluconate provides a source of zinc.

5.2

Pharmacokinetic properties
Zinc and its salts are poorly absorbed from the gastrointestinal tract: Only a
small proportion of dietary zinc is absorbed.

Zinc is widely distributed throughout the body and is excreted in the faeces
with only traces appearing in the urine since the kidneys have only little or no
role in regulating the zinc content of the body.

5.3

Preclinical safety data
No relevant data.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Calcium Phosphate Dibasic
Calcium Sulphate Dihydrate
Starch
Vegetable Stearic Acid
Vegetable Magnesium Stearate
Ethylcellulose N100
Industrial Methylated Spirit 640P (Not detected)

6.2

Incompatibilities
None.

6.3

Shelf life
To be advised.

6.4

Special precautions for storage
Bulk tablets are stored in cardboard boxes with polythene liners.
Packed product - Store below 25oC.

6.5

Nature and contents of container
High density polyethylene containers with tamper-evident lids.
Pack size: 60 tablets

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Nutrition Warehouse Limited
Samuel Ryder House
Townsend Drive
Attleborough Fields
Nuneaton
Warwickshire
CV11 6XW
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 14010/0012

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
1st October 1999

10

DATE OF REVISION OF THE TEXT
31/10/2003

10.

DATE OF (PARTIAL) REVISION OF THE TEXT
October 2003

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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