1 mg film-coated tablet 
Vitamin B 12 (cyanocobalamin)

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

Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse.

– Save this leaflet, you may need to read it again.

– Contact the pharmacy staff if you need more information or advice.

– If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

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

What Betolvidon is and what it is used for

Vitamin B 12 (cyanocobalamin) is a vital vitamin, which is necessary for the formation and function of the blood.

Pernicious anemia is a special type of anemia that occurs when vitamin B 12 isdeficient . Betolvidone is given in this disease and in other types of vitamin B 12deficiency that occurs when it is not possible to assimilate the vitamin E in the diet in the normal way. Vitamin B 12 deficiency can also occur during treatment with certain drugs.

The cyanocobalamin contained in Betolvidon may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before taking Betolvidon

Do not take Betolvidon

– if you are allergic to vitamin B 12 or any of the other ingredients of this medicine (listed in section 6).

Other medicines and Betolvidon

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

The treatment effect may be affected if Betolvidon is taken at the same time as certain other medicines.

The treating physician should therefore be aware of other concomitant medications.

Betolvidon with food and drink

The tablet is taken between meals.

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 have been demonstrated.

Betolvidone passes into breast milk but is unlikely to affect breast-fed infants.

Driving and using machines

No known effect.

How to take Betolvidon

Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse.

Dose one is determined by the doctor who adapts it individually for you.

The recommended dose for adults is 1 tablet daily. The tablet is taken between meals.

If you forget to take Betolvidon

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

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

4. Possible side effects

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

Rare (may affect up to 1 in 1,000 people): Hypersensitivity reactions that may manifest as hives, rash or itching . Fever and rash of the acne type.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effectsdirectly to the Medical Products Agency, see information below. By reporting side effects , you can help increase drug safety information.

Läkemedelsverket 
Box 26 
751 03 Uppsala 
www.lakemedelsverket.se

5. How to store Betolvidon

Do not store above 25 ° C.

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 label. 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.

6. Contents of the packaging and other information

Content declaration

– The active substance is vitamin B 12 (cyanocobalamin).

The other ingredients (excipients) are microcrystalline cellulose, calcium hydrogen phosphate dihydrate, maltodextrin, hypromellose, colloidal anhydrous silica, macrogol, titanium dioxide (dye E 171), sodium citrate (E 331), anhydrous citric acid (E 330), and magnesium stearate.

What the medicine looks like and the contents of the pack

White to slightly pink, slightly curved, film-coated tablets with red core, diameter 
8 mm.

100 and 1000 tablets in a plastic jar.

A jar of 1000 tablets is only intended for hospital use and dose dispensing.

Marketing Authorization Holder and Manufacturer

Abigo Medical AB

Ekonomivägen 5

436 33 Askim

Tel: 031-7484950

Fax: 031-683951

Email: pharma@abigo.se

Muhammad Nadeem

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