Rubex Chewable 250mg tablets - Summary of Product Characteristics (SPC)

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Ricesteele Manufacturing Ltd
Unit 31, Cookstown Industrial Estate, Tallaght, Dublin 24, Telephone: +353 1 451 0144 Fax: +353 1 452 1875

Summary of Product Characteristics last updated on medicines.ie: 10/03/2011

SPC	Rubex Chewable 250mg tablets

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipient(s)
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Rubex Chewable 250mg, Tablets.

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 250mg of Ascorbic Acid.

Excipients: Also includes sucrose, 647mg per tablet and Sunset Yellow FCF (E110) 1 mg per tablet.

For a full list of excipients. see section 6.1

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3. PHARMACEUTICAL FORM

Tablet

Orange to orange/brown, flat, circular tablet with bevelled edges and scored on one face.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Rubex Chewable is used for the prophylaxis and treatment of ascorbic acid deficiency.

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4.2 Posology and method of administration

To be taken orally. Chew or suck before swallowing.

Adults	2 – 4 tablets daily
Children 9 – 12 years	1 – 2 tablets daily
Children 4 – 8 years	1 tablet daily

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4.3 Contraindications

1. Ascorbic acid in doses greater than 1g daily should not be given to patients with hyperoxaluria.

2. Use in diabetic patients.

3. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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4.4 Special warnings and precautions for use

1. Patients known to be at risk of hyperoxaluria should not ingest ascorbic acid in doses greater than 1g daily as there may be increased urinary oxalate excretion.

2. Ascorbic acid has caused haemolytic anaemia in certain individuals with a deficiency of glucose 6-phosphate dehydrogenase.

3. Increased intake of ascorbic acid over a prolonged period may result in an increase in renal clearance of ascorbic acid, and deficiency may result if it is withdrawn rapidly.

4. May be harmful to the teeth due to the presence of sucrose.

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4.5 Interaction with other medicinal products and other forms of interaction

Concurrent administration of ascorbic acid and fluphenazine reportedly resulted in decreased fluphenazine plasma concentration.

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4.6 Pregnancy and lactation

Ascorbic acid in doses greater than 1g daily should not be taken during pregnancy since the effect of large doses on the foetus is unknown.

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4.7 Effects on ability to drive and use machines

None known.

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4.8 Undesirable effects

Side effects include nausea, vomiting, abdominal cramping and headaches. Large doses of ascorbic acid may cause diarrhoea and the formation of renal calcium calculi.

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4.9 Overdose

Ascorbic acid in excess of the body's needs is rapidly eliminated in the urine and its elimination is usually accompanied by a mild diuresis. Large doses may cause diarrhoea and the formation of renal calcium calculi.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Ascorbic acid (vitamin C) is a water soluble vitamin oxidised into dehydroascorbic acid in the body, the two forms taking part in oxidation/reduction reactions. Exogenous ascorbic acid is required for collagen formation and tissue repair.

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5.2 Pharmacokinetic properties

None.

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5.3 Preclinical safety data

None.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Sucrose

Mannitol

Maize Starch

Saccharin Sodium

Povidone

Sunset Yellow FCF (E110)

Orange Flavour 212284

Sodium Cyclamate

Talc

Magnesium Stearate

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6.2 Incompatibilities

Not applicable.

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6.3 Shelf life

2 years

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6.4 Special precautions for storage

Do not store above 25°C. Store in the original package. Keep the jar tightly closed.

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6.5 Nature and contents of container

Amber-coloured polyethylene terephthalate (PET) jars sealed with a low density polyethylene (LDPE) jaycap. The jars contain 50 or 150 tablets.

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6.6 Special precautions for disposal and other handling

Tablets may be chewed or sucked before swallowing.

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7. MARKETING AUTHORISATION HOLDER

Ricesteele Manufacturing Limited

Cookstown Industrial Estate

Tallaght

Dublin 24

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8. MARKETING AUTHORISATION NUMBER(S)

PA 95/8/3

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 04 May 1987

Date of last renewal: 04 May 2007

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10. DATE OF REVISION OF THE TEXT

March 2011

Link to this document from your website:
http://www.medicines.ie/medicine/14396/SPC/Rubex+Chewable+250mg+tablets/

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Active Ingredients

Ascorbic acid

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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