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Cyanocobalamin 50 micrograms Film-coated Tablets

Active Ingredient:
cyanocobalamin
Company:  
Glenmark Pharmaceuticals Europe Ltd See contact details
ATC code: 
B03BA01
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About Medicine
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Pharmacy
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 27 Oct 2023
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 25258/0369.

{printer} Print patient leaflet as text only

Cyanocobalamin 50 micrograms Film-coated Tablets

Package leaflet: Information for the patient

Cyanocobalamin 50 micrograms Film-coated Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse told you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse.
  • The name of the medicine is ‘Cyanocobalamin 50 micrograms Film-coated tablets’ but will be referred to as ‘Cyanocobalamin tablets’ throughout the leaflet.

What is in this leaflet

1. What Cyanocobalamin tablets are and what they are used for
2. What you need to know before you take Cyanocobalamin tablets
3. How to take Cyanocobalamin tablets
4. Possible side effects
5. How to store Cyanocobalamin tablets
6. Contents of the pack and other information

1. What Cyanocobalamin Tablets are and what it is used for

Cyanocobalamin Tablets contain cyanocobalamin, which is known as vitamin B12.

Cyanocobalamin contains cobalt.

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. What you need to know before you take 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.
  • Talk to your doctor if you have a known cobalt allergy.
  • 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 blood tests 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 ulcers
  • 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 medicine.

3. How to take 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.

Your doctor may change the dose, depending on how you react to it.

When and how to take the tablets

Cyanocobalamin Tablets should be swallowed with water and taken between meals.

If you take more Cyanocobalamin Tablets than you should:

If you accidentally take too much of this medicine, take any remaining tablets and this leaflet 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.

If you stop taking Cyanocobalamin Tablets:

Do not stop taking this medicine, except on your doctor’s advice.

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. You can also report side effects directly 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.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cyanocobalamin Tablets
  • 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.
  • Store below 25°C. Store in the original package in order to protect from moisture. Keep the bottle container tightly closed.
  • After first opening use within 100 days.
  • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Cyanocobalamin tablets contain:
  • The active substance is cyanocobalamin and the other excipients are lactose monohydrate, microcrystalline cellulose (pH101), croscarmellose sodium, magnesium stearate, readymade coating material pink- hypromellose HPMC 2910 (E464), titanium dioxide (E171), macrogol (E151), carmine (E120), black iron oxide (E172).

What Cyanocobalamin tablet looks like and contents of the pack
  • The tablets are pink coloured round biconvex film-coated tablets (diameter about 7.00 mm) debossed with ‘45’ on one side and ‘G’ on other side.
  • Cyanocobalamin Tablets are available in:
    • 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 packs may be marketed

Marketing authorisation holder:
Glenmark Pharmaceuticals Europe Limited
Laxmi House
2-B Draycott Avenue
Kenton
Middlesex
HA3 0BU
United Kingdom

Manufacturer:
Glenmark Pharmaceuticals Europe Limited
Building 2
Croxley Green Business Park
Croxley Green
Hertfordshire
WD18 8YA
United Kingdom

Glenmark Pharmaceuticals s.r.o.

Production site address:

Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

Registered Address:

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Praha 4
Czech Republic

This leaflet was last revised in October 2023

Glenmark Pharmaceuticals Europe Ltd
Company image
Address
Building 2, Croxley Park, Watford, WD18 8YA
Telephone
+44 (0)1923 202 950
Fax
+44 (0)1923 251137
Medical Information Direct Line
0800 458 0383
E-mail
[email protected]
Stock Availability
+44 (0)1923 202 950
WWW
www.glenmarkpharma.com