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MINADEX TONIC

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Minadex Tonic.
Seven Seas Vitamin and Mineral Tonic.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
Vitamin A (as Palmitate)
Vitamin D3 (Colecalciferol) (Concentrate Oily Form)
Iron, as Green Ferric Ammonium Citrate
Potassium Glycerophosphate Solution
Calcium Glycerophosphate
Manganese Sulphate
Copper Sulphate

Quantity per 5 ml

650.00 IU
65.00 IU
12.00 mg
2.25 mg
11.25 mg
0.38 mg
0.50 mg

Excipients with known effect:
Refined soya bean oil
Sodium methyl parahydroxybenzoate (E219)
Glucose
Sucrose
Sodium metabisulphite (E223)

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
An oil and water emulsion intended for oral administration.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
A vitamin and mineral supplement for children and adults, particularly during
and after illness.

4.2.

Posology and Method of Administration

Children 6 months to 3 years:
5 ml twice a day.
Children 3 to 12 years and Pregnant or Lactating Women or Women Likely to
Become Pregnant:
5 ml three times a day
Adults:
10 ml three times a day

4.3

Contraindications
Do not exceed the stated dose.
Hypersensitivity to any of the ingredients.
Contains soya bean oil: may contain peanut protein. Not to be taken by patients
allergic to peanut or soya.

4.4

Special warnings and precautions for use

Contains glucose:
Patients with rare glucose-galactose malabsorption should not take this medicine.
Contains sucrose:
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption
or sucrase-isomaltase insufficiency should not take this medicine.
Contains ferric ammonium citrate which may stain teeth.
Contains sodium metabisulphite (E223) which may rarely cause severe hypersensitivity
reactions and bronchospasms.
Contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions
(possibly delayed).
No other medicine containing iron or vitamins A and D should be taken without prior medical
consultation.
Prolonged excessive ingestion of vitamin A and/or vitamin D can lead to hypervitaminoses
states which may occur if foods high in vitamin (for example liver), are ingested in
association with recommended doses of this product.

4.5

Interaction with other medicinal products and other forms of interaction

There are no recorded cases of any interactions with other medicaments.

4.6

Fertility, pregnancy and lactation

This product should only be used after consultation with a physician during pregnancy and
lactation. The recommended dosage must not be exceeded.
Large doses of vitamin A have been found to be teratogenic if administered during the first
trimester of pregnancy.
Vitamin D during the last trimester of pregnancy may cause hypercalcaemia in infants.
Ingestion of vitamin D supplements during breast-feeding may lead to the development of
hypercalcaemia in the infant.

4.7.

Effects on Ability to Drive and Use Machines
This product has no adverse effects on the ability to drive or to use machine.

4.8

Undesirable effects

Discolouration of faeces (black/green colour) may rarely occur.
Side effects to this product are rare, but may include temporary staining of the teeth, rash and
gastrointestinal disturbance.
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:
Yellow Card Scheme
Tel: Freephone 0808 100 3352 (available between 10 am – 2 pm Monday to Friday)
Website: www.mhra.gov.uk/yellowcard

4.9.

Overdose
Gross abuse of the product would be necessary to approach toxic levels. No
data available.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC-classification
A13A
Minadex Tonic is formulated as a vitamin and mineral supplement and
appetite restorative for children and adults.
Detailed Pharmacology not applicable.
For individual activities see Martindale (31st Edition) 1996.

5.2.

Pharmacokinetic Properties
Not applicable in this instance.
Pharmacokinectics of active constituents well documented in scientific
literature.
See Martindale (31st Edition) 1996.

5.3.

Pre-clinical Safety Data
Not applicable in this instance.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Acacia
Refined soya bean oil
Orange oil
Butylhydroxyanisole (E320)
Sodium methyl parahydroxybenzoate (E219)
Glucose
Sucrose
Citric acid monohydrate
Glycerophosphoric acid
Sodium metabisulphite (E223)
Purified deionised water

6.2.

Incompatibilities

There are no known major incompatibilities with this product.

6.3.

Shelf-Life
24 months.

6.4.

Special precautions for storage
Store below 25°C. Keep the bottle in the carton to protect from sunlight.

6.5

Nature and contents of container
Amber glass bottles with polyolefin screw caps, in the following sizes:
30 ml, 150 ml, 200 ml, 300 ml, 400 ml, 450 ml and 500 ml.

6.6.

Instruction for Use, Handling and Disposal
None.

7.

MARKETING AUTHORISATION HOLDER
Seven Seas Limited
Hendon Road
Kingston-Upon-Hull
HU9 5NJ.

8.

MARKETING AUTHORISATION NUMBER(S)
PL 1932/0004

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18 April 1989 / 13/06/2007

10

DATE OF REVISION OF THE TEXT
18/11/2013

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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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