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Betolvex

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Betolvex 1 mg film-coated tablets


PATIENT INFORMATION



Read the entire patient information carefully before you start the Betolvex tablets treatment. Please note that your doctor may have prescribed this medicine for other use and/or with a different dosage than stated in the patient information.


What does the medicine contain?

Active substance: Cyanocobalamin 1 mg (vitamine B12).

Exipients: Mannitol, pregelatinised starch, potato starch, microcrystalline cellulose, magnesium stearate, stearic acid. Film-coating: Hypromellose, macrogol, titanium dioxide (colouring agent E 171), erythrosine (colouring agent E 127), iron oxide (colouring agent E 172), quinolone yellow (colouring agent E 104).

The tablet is red, round with a diameter of 8 mm, marked CCO.


How does the medicine work?

Vitamin B12is a vital vitamin which is needed e.g. for normal cell division, normal production of blood and normal neurological function. Lack of Vitamin B12can e.g. result in the blood deficiency disease perncious anemia and/or symptoms from the neurological system, for example sensory disturbances. Normally vitamin B12is provided in small amounts with food. It is absorbed by the body through e.g. the gastric acid and a special protein (intrinsic factor) which is formed in the gastric mucous. If the intake of pure vitamin B12is increased 100-fold (=1 tablet of Betolvex) sufficient amounts of vitamin can be absorbed by the body despite of disturbances in the gastrointestinal function.


Marketing Authorisation Holder

Actavis Group hf.

Reykjavikurvegi 76-78

IS-220 Hafnarfjordur

Iceland


Manufacturer

Piramal Healthcare Ltd, UK

Whalton Road, Morpeth

Northumberland, NE61 3YA

United Kingdom


What is the medicine used for?

Betolvex is administrated at vitamin B12deficiency and when there is a risk for deficiency to occur. For example, vitamin B12deficiency can develop if the vitamin cannot be absorbed normally by the body from foods. This can be due to a gastrointestinal disease but can also result from a stomach ulcer operation or other intestinal surgery. Vitamin B12 deficiency can also occur due to longterm medicinal treatment of gastrointestinal inflammation.


Things to consider before and when you take the medicine

Treatment with vitamin B12must be continued throughout life if it is due to a chronic decreased uptake from the intestines. It is important that you do not stop taking the tablets even if you feel healthy. Otherwise the deficiency will eventually come back.


Stop taking Betolvex and immediately contact your doctor if you get any of the following symptoms (angioedema)


Pregnancy and breast-feeding

No harmful effects on the fetus or breast-fed children has been identified.


Dosage

The dose should be decided by your doctor, who will adjust it individually for you.

The usual dose for adults is: 1 tablet daily. In the beginning of treatment a higher dose is often prescribed. The tablet should preferably be taken on an empty stomach.


What happens if you take more tablets than you should?

If you have taken more tablets than you should, contact your doctor, hospital or the local poisons information centre.


Possible side effects

Rare (less than 1 in 1,000 patients)

Allergic reactions including itching and swealling. Fever. Rash. Hives. Swollen face, tounge and/or throat (angioedema).


If you get other symptoms, which you believe is due to the treatment, inform you doctor!


Storage and shelf life

No special storage conditions. Do not use this medicine after the expiry date that is stated on the package.


IMPORTANT:

* Always follow the instructions from your doctor and the information on the pharmacy label.

* If you have questions about the treatment or the medicine contact your doctor or pharmacist.

* The medicine is for you and should not be given to others.

* All medication should be kept out of sight and reach from children.

* Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


Last revised in: 2013-10-18