1. NAME OF THE MEDICINAL PRODUCT
Cyanocobalamin Tablets USP 50mcg Taj Pharma.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains

Cyanocobalamin               50mcg
Excipients                             q.s.
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Tablet.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
Recommended Clinical Indications:
Treatment of nutritional Vitamin B12 deficiency.

Treatment of vitamin B 12 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
Elderly:
The normal dose for adults is appropriate for the elderly.

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

Paediatric population:
One tablet (50 micrograms) daily at the discretion of the physician.

When possible, This medicine doses should be taken between meals.

Method of administration: Oral.

 4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Hypersensitivity to the product or any of the excipients.

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
None.

4.8 Undesirable Effects
Sensitisation to this medicine is rare, but may present as an itching exanthema, and exceptionally as anaphylactic shock.

Acne form 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.

 4.9 Overdose
Overdosage is unlikely to require treatment.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Lactose
Maize Starch
Magnesium Stearate
Purified Water

Film coat
Hydroxypropyl Methylcellulose 2910 Ph.Eur
Ethylcellulose Ph Eur
Acetylated Monoglyceride
Speedcolour White 27120 Ansteads HSE (Titanium dioxide, talc and polysorbate)
Isopropyl Alcohol
Dichloromethane

6.2 Incompatibilities
None stated.

6.3  Shelf life
24 months in securitainers.
24 months in blisters

6.4 Special precautions for storage
Securitainer
Protect from light.
Store in well closed containers.
Blisters
Store below 25°C, protected from light.

6.5 Nature and contents of container
Polyproylene container with a tamper evident low density polyethylene lid, containing 50 or 100 Cyanocobalamin Tablets.
Tampertainer staysafe made from high density polyethylene containing 50 or 100 tablets.
PVC/PVdC /Aluminium blister packs with 28, 56 or 112 tablets.

6.6 Special precautions for disposal and other handling
None

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Cyanocobalamin Tablets USP 50mcg Taj Pharma

Package leaflet: Information for the patient

Cyanocobalamin Tablets USP 50mcg Taj Pharma

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
 – If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet
1. What  Cyanocobalamin Tablets is and what it is used for
2. Before you are given Cyanocobalamin Tablets
3. How you will be given  Cyanocobalamin Tablets
4. Possible side effects
5. How Cyanocobalamin Tablets is stored
6. Further Information

1. What Cyanocobalamin Tablets is and what it is used for
Cyanocobalamin Tablets contain cyanocobalamin, which is known as vitamin B12.

Most people get enough vitamin B12 from their food, but if you have had stomach surgery, or certain diseases of the intestines, or a restricted diet, you may not absorb enough vitamin B12.

Lack of vitamin B12 in the body causes a disease called pernicious anaemia (reduction in the number of red blood cells) which is often treated with vitamin B12 injections.

Cyanocobalamin tablets are used to treat vitamin B12 deficiency when injections cannot be used.

2. Before you are given Cyanocobalamin Tablets
DO NOT take Cyanocobalamin Tablets:

  • if you are allergic to cyanocobalamin or any of the other ingredients of this medicine (listed in section 6).

Those who have an allergic reaction to Cyanocobalamin by injection are often able to take Cyanocobalamin Tablets without problems.

Warnings and precautions:
Talk to your doctor or pharmacist before taking Cyanocobalamin Tablets

If you have any other medical conditions, speak to your doctor before you take these tablets.

Your doctor will want to monitor your response to this medicine carefully, particularly if you are young or elderly.

This will probably involve regular examination of your blood every three months for 18 months and then annually.

Other medicines and Cyanocobalamin Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The absorption of Cyanocobalamin tablets may be affected by:

  • Neomycin and chloramphenicol which are antibiotics
  • Colchicine, a treatment for gout
  • Biguanides, e.g. metformin, which are used to treat diabetes
  • Cholestyramine which is used to reduce the amount of cholesterol (fats) in the blood
  • Potassium chloride which is used to correct potassium deficiency
  • Methyldopa which is used to treat high blood pressure
  • Cimetidine which is used to treat excess acid in the stomach causing indigestion or ulcer
  • Oral contraceptives

Antibiotics (used to treat infections) and antimetabolites (used to treat some cancers) can affect the blood tests to measure vitamin B12.

Cyanocobalamin Tablets with food, drink and alcohol
Cyanocobalamin Tablets should be swallowed with water and taken between meals.

Pregnancy, breast feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

As with all drugs Cyanocobalamin Tablets should only be given in pregnancy and when breast feeding if absolutely necessary.

Cyanocobalamin Tablets contains lactose
This medicine also contains lactose (which is a sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How you will be given Cyanocobalamin Tablets
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Please read the label carefully, it will tell you how many Cyanocobalamin Tablets to take each day.

The recommended dose is:
Adults and Elderly: one to three tablets daily.

Children: one tablet daily.

Cyanocobalamin Tablets should be swallowed with water and taken between meals. Do not stop taking this medicine, except on your doctor’s advice. Your doctor may change the dose, depending on how you react to it.

If you take more Cyanocobalamin Tablets than you should:
If you accidentally take too much of this medicine, bring any remaining tablets and this leaflet with you to your doctor or pharmacist so that they know exactly what you have taken.

If you forget to take Cyanocobalamin Tablets:
If you miss a dose, take it as soon as you remember, if it is within a few hours of the normal time.

Otherwise, leave out that dose completely and take your next dose at the normal time it is due.

Do not take a double dose to make up for forgotten dose.

4. Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions to these tablets are rare but may show as an itchy rash. Very rarely, a severe allergic reaction may occur causing sudden onset of swelling of the face and neck, and shortness of breath.

Acne-like and blister rashes have been reported rarely.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How Cyanocobalamin Tablets is stored
Keep this medicine out of the sight and reach of children.

Do not use Cyanocobalamin Tablets after the expiry date which is stated on label. The expiry date refers to the last day of that month. If your medicine is out of date, take it to your pharmacist who will get rid of it safely.

Do not store above 25°C (room temperature). Store in the original container/package. Protect from light.

6. Further information

What Cyanocobalamin Tablets contains
The active substance is cyanocobalamin.
Each film coated tablet contains
Cyanocobalamin               50mcg
Excipients                             q.s.
Cyanocobalamin Tablets also contains lactose, maize starch, magnesium stearate and purified water. The film coating includes hydroxypropyl methylcellulose, ethylcellulose, acetylated monoglyceride, speed colour white 27120 anstead HSE, isopropyl alcohol and dichloromethane.

What Cyanocobalamin Tablets looks like and contents of the pack
Cyanocobalamin Tablets are available in container packs of 50 and 100 tablets and blister packs of 28, 56 and 112 tablets (Not all pack sizes may be marketed).

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com