1 mg film-coated tablets 
cyanocobalamin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice. This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
  • You need to talk to a doctor if you do not feel better or if you feel worse.

In this leaflet you will find information about: 
1. What Betolvex is and what it is used for 
2. What you need to know before using Betolvex 
3. How to use Betolvex 
4. Possible side effects 
5. How to store Betolvex 
6. Contents of the packaging and other information 

1. What Betolvex is and what it is used for

Vitamin B 12 is a vital vitamin, which is needed for normal cell division, normal blood formation, and the normal function of the nervous system. Lack of vitamin B 12 can i.a. give anemia pernicious anemia and/or symptoms of the nervous system, e.g. emotional disturbances. Normally, vitamin B 12 is added in small amounts with food. It is absorbed into the body with the help of e.g. gastric hydrochloric acid and a special protein (intrinsic factor) that is formed in the gastric mucosa. If the intake of pure vitamin B 12 is increased 100-fold (= 1 tablet Betolvex) can be enough vitamin is absorbed by the body even if the gastrointestinal function is disturbed.

Betolvex is given in case of vitamin B 12 deficiency and when there is a risk that vitamin B 12 deficiency will occur.

Vitamin B 12 deficiency can, for example, develop if the vitamin cannot be absorbed by the body normally from food. This can be due to a gastrointestinal disease but can also be the result of, for example, a gastric ulcer operation or other bowel operation. Vitamin B 12 deficiency can also occur if you take certain medicines used in inflammation of the gastrointestinal tract for a long time.

You need to talk to a doctor if you do not feel better or if you feel worse.

2. What you need to know before using Betolvex

Do not use Betolvex

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

Other medicines and Betolvex

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

Vitamin B 12 uptake may be affected by:

  • aminoglycoside is ( antibiotics )
  • aminosalicylic acid ( antibiotics )
  • antiepileptics (medicines used to treat epilepsy )
  • biguanides (medicines used to treat diabetes )
  • chloramphenicol ( antibiotics )
  • cholestyramine (medicines used to reduce the amount of cholesterol (fat) in the blood)
  • potassium salts (used to correct potassium deficiency)
  • methyldopa (medicines used to treat high blood pressure )
  • gastric acid inhibitors (eg omeprazole and cimetidine)

Pregnancy and breastfeeding

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.

No adverse effects on the fetus or breast-feeding infant have been identified.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Betolvex

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one should be determined by a doctor, who will adjust it individually for you.

The recommended dose for adults is 1 tablet daily. At the beginning of treatment, a higher dose is often prescribed.

The tablet should preferably be taken on an empty stomach.

If you stop using Betolvex

Treatment with vitamin B 12 must last a lifetime if it is a result of a chronic poor uptake from the intestine. It is important that you do not stop taking the tablets, even if you feel healthy. Eventually, a B 12 deficiency develops again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing.

These side effects are rare (affects up to 1 in 1,000 people).

The following side effects have also been reported with Betolvex:

Rare side effects are (affecting up to 1 1 000)

  • Allergic reactions, including itching and swelling
  • Fever
  • Rash
  • Hives

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Betolvex

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. dat./EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

No special storage instructions.

6. Contents of the packaging and other information

Content declaration

  • The active substance is Cyanocobalamin 1 mg ( vitamin B 12 ).
  • The other ingredients are Mannitol, pregelatinized starch , potato starch, microcrystalline cellulose, magnesium stearate, stearic acid. Film coating: Hypromellose, macrogol, titanium dioxide (dye E 171), iron oxide (dye E 172).

What the medicine looks like and the contents of the pack

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

Jar: 30, 60, 100 tablets

1,000 tablets (for dose dispensing and hospital use only)

Blister: 50 x 1, 98 x 1 tablets (for hospital use only)

Marketing Authorization Holder and Manufacturer

Actavis Group hf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjordur

Iceland

Manufacturer

Piramal Healthcare Ltd, UK

Whalton Road, Morpeth

Northumberland, NE61 3YA

UK

Muhammad Nadeem

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