RUBEX ORANGE 1000 Milligram Tablets Effervescent
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-06-2024
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Active ingredient:
ASCORBIC ACID
Available from:
Ricesteele Manufacturing Ltd
ATC code:
A11GA01
INN (International Name):
ASCORBIC ACID
Dosage:
1000 Milligram
Pharmaceutical form:
Tablets Effervescent
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Ascorbic acid (vitamin C), plain
Authorization status:
Authorised
Authorization date:
1987-05-04
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rubex Orange 1000mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1000mg of Ascorbic Acid.
Excipients: also includes glucose monohydrate 663mg per tablet, sunset yellow FCF (E110) 1.94 mg per tablet, sodium
273 mg per tablet and orange oil [containing natural orange oil and ethanol (0.00131 microlitres per tablet)].
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Effervescent tablet
Mottled orange, flat, circular, orange flavoured effervescent tablets 25mm in diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rubex is used for the prevention and treatment of ascorbic acid (vitamin C) deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To be taken orally.
One tablet to be taken dissolved in water (hot or cold) daily.
Rubex is not recommended for use in children.
4.3 CONTRAINDICATIONS
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. Increase intake of ascorbic acid over a prolonged period may result in an increase in renal clearance of ascorbic
acid, and deficiency may result if withdrawn rapidly.
4. Do not exceed the stated dose.
5. May be harmful to the teeth due to the presence of glucose.
6. Patients with rare glucose-galactose malabsorption should not take this medicine.
7. This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per tablet.
1. Ascorbic acid in doses greater than 1g daily should not be given to patients
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