- Approval Id
- 1bbb56f7179f19fb
- Drug Approval Emc Name
- Cyanocobalamin 50 micrograms Film-coated Tablets
- Drug Name
- Cyanocobalamin 50 micrograms Film-coated Tablets
- Company Name
- Glenmark Pharmaceuticals Europe Ltd
- Company Address
- Building 2, Croxley Park, Watford, WD18 8YA
- Company Website
- //www.glenmarkpharma.com
- Company Telephone
- +44 (0)1923 202 950
- Company Medical Info Direct Line
- 0800 458 0383
- Company Stock Availability
- +44 (0)1923 202 950
- Atc Code
- B03BA01
- Legal Category
- Pharmacy
- Authorisation Holder
- Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2-B Draycott Avenue
Kenton, Middlesex, HA3 0BU
United Kingdom
- Authorisation Number
- PL 25258/0369
- Authorisation Date
- 15/12/2022
- Instruction Authorisation Holder
- Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2-B Draycott Avenue
Kenton, Middlesex, HA3 0BU
United Kingdom
- Instruction Authorisation Number
- PL 25258/0369
- Instruction Authorisation Date
- 15/12/2022
- Instruction Composition
- Each tablet contains 50 micrograms Cyanocobalamin.
Excipient(s) with known effect: Contains 116.955 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
Cyanocobalamin contains cobalt.
- Instruction Dosage Form
- Film-coated Tablet (Tablet).
Pink coloured round biconvex film-coated tablets (diameter about 7.00 mm) debossed with '45' on one side and 'G' on other side.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Cyanocobalamin is indicated for:
- Treatment of nutritional vitamin B12 deficiency
- Treatment of vitamin B12 deficiency following partial gastrectomy
- Treatment of tropical sprue, alone or with folic acid
- Treatment of pernicious anaemia when parenteral administration is not possible or not advised.4.2 Posology and method of administration
\*\*Posology\*\*
Adults: one to three tablets (50 to 150 micrograms) or more daily at the discretion of the physician.
In pernicious anaemia intramuscular therapy is preferable for initial correction of vitamin B12 deficiency. However, if necessary, the oral route may be used to follow this, in which case at least 300 micrograms should be given daily.
Elderly: The normal dose for adults is appropriate for the elderly.
Paediatric population: One tablet (50 micrograms) daily at the discretion of the physician.
\*\*Method of administration:\*\* Oral.
This medicine should be taken between meals.4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.4.4 Special warnings and precautions for use
For pernicious anaemia, an adequate dose must be used and the blood picture must be examined regularly at least every three months for 18 months until stabilised, and then annually.
Indiscriminate administration of this medicine may mask precise diagnosis.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction
Absorption may be reduced by Para-aminosalicylic acid, colchinine, biguanides, neomycin, cholestyramine, potassium chloride, methyldopa, and cimetidine.
Patients treated with chloramphenicol may respond poorly to this medicine.
Serum levels of this medicine may be lowered by oral contraceptives. These interactions are unlikely to have clinical significance.
Anti-metabolities and most antibiotics invalidate vitamins B12 assays by microbiological techniques.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
This medicine should not be used to treat megaloblastic anaemia of pregnancy because this is due to folate deficiency.4.7 Effects on ability to drive and use machines
None4.8 Undesirable effects
Sensitisation to this medicine is rare, but may present as an itching exanthema, and exceptionally as anaphylactic shock.
Acneform and bullous eruptions have been reported rarely.
Patients who have become sensitised to this medicine by injection are often able to tolerate the oral route without trouble.
\*\*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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Overdosage is unlikely to require treatment.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antianemic preparations, Vitamin B12 (cyanocobalamin).
ATC code: B03BA01
This medicine contain cyanocobalamin vitamin B 12, which is used for the treatment of pernicious anaemia, and nutritional deficiencies of vitamin B 12 which results in macrocytic anaemia.5.2 Pharmacokinetic properties
\*\*Absorption:\*\*
The absorption of cobalamins from the gut is dependent upon the glycoprotein intrinsic factor.
\*\*Distribution:\*\*
Cobalamins are transported rapidly into the blood bound to protein, known as transcobalamins.
\*\*Elimination:\*\*
Cobalamins are stored in the liver and excreted in the bile. They are known to cross the placenta.5.3 Preclinical safety data
No further relevant data
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Lactose monohydrate
Microcrystalline cellulose (pH101)
Croscarmellose sodium
Magnesium stearate
\*\*Readymade coating material pink:\*\*
Hypromellose HPMC 2910 (E464)
Titanium dioxide (E171)
Macrogol/polyethylene glycol
Carmine (E120)
Black iron oxide (E172)6.2 Incompatibilities
Not Applicable6.3 Shelf life
Unopened bottle packs with silica gel: 24 months
Unopened bottle packs: 18 months
Opened bottles: After first opening use within 100 days6.4 Special precautions for storage
Bottle packs: Store below 25°C. Store in the original package in order to protect from moisture. Keep the bottle container tightly closed.6.5 Nature and contents of container
HDPE containers with a polypropylene cap containing 50 tablets. Each container contains a silica gel desiccant pouch, which must be kept in the container to help protect your tablets, and it should not be swallowed
HDPE containers with a polypropylene cap containing 50 and 100 tablets
Not all pack sizes may be marketed6.6 Special precautions for disposal and other handling
No special requirements.
- Instruction Content
- ## Composition
Each tablet contains 50 micrograms Cyanocobalamin.
Excipient(s) with known effect: Contains 116.955 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
Cyanocobalamin contains cobalt.
## Pharmaceutical Form
Film-coated Tablet (Tablet).
Pink coloured round biconvex film-coated tablets (diameter about 7.00 mm) debossed with '45' on one side and 'G' on other side.
## Clinical Particulars
4.1 Therapeutic indications
Cyanocobalamin is indicated for:
- Treatment of nutritional vitamin B12 deficiency
- Treatment of vitamin B12 deficiency following partial gastrectomy
- Treatment of tropical sprue, alone or with folic acid
- Treatment of pernicious anaemia when parenteral administration is not possible or not advised.4.2 Posology and method of administration
\*\*Posology\*\*
Adults: one to three tablets (50 to 150 micrograms) or more daily at the discretion of the physician.
In pernicious anaemia intramuscular therapy is preferable for initial correction of vitamin B12 deficiency. However, if necessary, the oral route may be used to follow this, in which case at least 300 micrograms should be given daily.
Elderly: The normal dose for adults is appropriate for the elderly.
Paediatric population: One tablet (50 micrograms) daily at the discretion of the physician.
\*\*Method of administration:\*\* Oral.
This medicine should be taken between meals.4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.4.4 Special warnings and precautions for use
For pernicious anaemia, an adequate dose must be used and the blood picture must be examined regularly at least every three months for 18 months until stabilised, and then annually.
Indiscriminate administration of this medicine may mask precise diagnosis.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction
Absorption may be reduced by Para-aminosalicylic acid, colchinine, biguanides, neomycin, cholestyramine, potassium chloride, methyldopa, and cimetidine.
Patients treated with chloramphenicol may respond poorly to this medicine.
Serum levels of this medicine may be lowered by oral contraceptives. These interactions are unlikely to have clinical significance.
Anti-metabolities and most antibiotics invalidate vitamins B12 assays by microbiological techniques.4.6 Fertility, pregnancy and lactation
\*\*Pregnancy\*\*
This medicine should not be used to treat megaloblastic anaemia of pregnancy because this is due to folate deficiency.4.7 Effects on ability to drive and use machines
None4.8 Undesirable effects
Sensitisation to this medicine is rare, but may present as an itching exanthema, and exceptionally as anaphylactic shock.
Acneform and bullous eruptions have been reported rarely.
Patients who have become sensitised to this medicine by injection are often able to tolerate the oral route without trouble.
\*\*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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Overdosage is unlikely to require treatment.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antianemic preparations, Vitamin B12 (cyanocobalamin).
ATC code: B03BA01
This medicine contain cyanocobalamin vitamin B 12, which is used for the treatment of pernicious anaemia, and nutritional deficiencies of vitamin B 12 which results in macrocytic anaemia.5.2 Pharmacokinetic properties
\*\*Absorption:\*\*
The absorption of cobalamins from the gut is dependent upon the glycoprotein intrinsic factor.
\*\*Distribution:\*\*
Cobalamins are transported rapidly into the blood bound to protein, known as transcobalamins.
\*\*Elimination:\*\*
Cobalamins are stored in the liver and excreted in the bile. They are known to cross the placenta.5.3 Preclinical safety data
No further relevant data
## Pharmaceutical Particulars
6.1 List of excipients
Lactose monohydrate
Microcrystalline cellulose (pH101)
Croscarmellose sodium
Magnesium stearate
\*\*Readymade coating material pink:\*\*
Hypromellose HPMC 2910 (E464)
Titanium dioxide (E171)
Macrogol/polyethylene glycol
Carmine (E120)
Black iron oxide (E172)6.2 Incompatibilities
Not Applicable6.3 Shelf life
Unopened bottle packs with silica gel: 24 months
Unopened bottle packs: 18 months
Opened bottles: After first opening use within 100 days6.4 Special precautions for storage
Bottle packs: Store below 25°C. Store in the original package in order to protect from moisture. Keep the bottle container tightly closed.6.5 Nature and contents of container
HDPE containers with a polypropylene cap containing 50 tablets. Each container contains a silica gel desiccant pouch, which must be kept in the container to help protect your tablets, and it should not be swallowed
HDPE containers with a polypropylene cap containing 50 and 100 tablets
Not all pack sizes may be marketed6.6 Special precautions for disposal and other handling
No special requirements.
