Cyanocobalamin
1mg film-coated tablets
The first and only licenced pharmaceutical preparation for 1mg Cyanocobalamin tablets in the UK.
Cyanocobalamin
About Orobalin
Indications
Orobalin is a film-coated tablet containing 1mg cyanocobalamin.
Orobalin is indicated for haematological, neurological and other symptoms secondary to vitamin B12 deficiency, including:
- Nutritional B12 deficiency.
- Malabsorption of vitamin B12, e.g. absence of intrinsic factor (pernicious anaemia), stomach resection or disease of the small intestine.
It is also indicated during para-aminosalycylic acid therapy.
SmPC and PIL
Orobalin 1mg Tablets Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL).
Further information
For more information about Orobalin 1mg Tablets, please see the abbreviated prescribing information below:
Abbreviated Prescribing Information (UK)
Orobalin (Cyanocobalamin) 1mg film-coated tablets
Please consult the Summary of Product Characteristics (SmPC) for full prescribing information before prescribing.
Legal Class: POM
Active Substances: Cyanocobalamin
Marketing Authorisation Holder: Northumbria Pharma Ltd
Price: Orobalin 1mg film-coated tablets x30 = £9.99
Presentation: Cyanocobalamin 1mg film-coated tablets. Indications: Haematological, neurological and other symptoms secondary to vitamin B12 deficiency. Malabsorption of vitamin B12 e.g. due to absence of intrinsic factor (pernicious anaemia), stomach resection, small intestine disease. Para-aminosalicylic acid therapy. Dosage and Administration: Remission Treatment – usually 2 tablets twice daily until full remission, then follow maintenance dose. Maintenance treatment/prophylaxis – usually 1 tablet daily. If suspected neuropathy, use parenteral treatment. Administer Orobalin between meals.
Contraindications: Hypersensitivity to cyanocobalamin or any of the excipients. Warnings and Precautions: None. Interactions: Vitamin B12 absorption from the GI tract can be reduced by aminoglycosides, aminosalicylic acid, anticonvulsants, biguanides, chloramphenicol, cholestyramine, potassium salts, methyldopa and gastric-acid-inhibiting agents (e.g. omeprazole and cimetidine). Clinical relevance of many of these interactions is likely to be small. Pregnancy and Lactation: No known risks during pregnancy. Cyanocobalamin is excreted into human milk. No effects on breastfed infants anticipated at therapeutic doses. Effects on ability to drive/use machines: None/Negligible influence. Undesirable effects: Rare (>1/10,000 to <1/1,000): Anaphylaxis, fever, Urticaria Exanthema, Exanthematous rash, allergic reactions, skin reactions, angioedema. Pack size and Price: Orobalin 1mg x30 film-coated tablets – £9.99. Legal Category: POM. MA Number: PL 48259/0045. MA Holder: Northumbria Pharma Ltd, NetPark Incubator, Thomas Wright Way, Sedgefield, County Durham, TS21 3FD, UK. Date of Revision: November 2020.
Adverse events should be reported. Reporting forms and information can be found at MHRA Yellow Card website or click the link for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Northumbria Pharma on: 01740 618611.
