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Package leaflet: Information for the user

TrioBe tablet

cyanocobalamin (vitamin B₁₂)

folic acid

pyridoxine hydrochloride (vitamin B₆)

Read all of this leaflet carefully before you start using 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

TrioBe contains three B vitamins (folic acid, vitamin B₁₂ and vitamin B₆). B vitamins are important in maintaining the natural functions of the cells. TrioBe should be used for the prevention of symptom-causing deficiency of vitamin B₆, vitamin B₁₂ and folic acid caused by insufficient food intake or poor uptake of nutrients, particularly in the elderly.

Do not use TrioBe

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

Warnings and precautions

Talk to your doctor or pharmacist before taking TrioBe.

TrioBe is not intended for the treatment of symptom-causing deficiency of the vitamins included. Effective treatment of some types of anaemia (lack of red blood cells) may require treatment with vitamin B₁₂ injections.

TrioBe should not be used by patients who have had large parts of the small intestine removed by surgery.

Other medicines and TrioBe

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

The effect of treatment may be influenced if this medicine is taken with certain other medicines, for instance some medicines used in the treatment of epilepsy such as phenobarbital and phenytoin, as well as medicines that reduce the effect of folic acid such as methotrexate, trimetoprim and pyrimethamine. Your doctor should therefore be informed if you are receiving any of these medicines at the same time.

Pregnancy and breast-feeding

TrioBe can be used during pregnancy and breast-feeding.

Driving and using machines

TrioBe is not expected to affect your reaction time, for instance when driving or working with precision machinery.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will choose the dose which suits you best.

The recommended dosage is one tablet daily. The tablet can be chewed or swallowed whole.

If you take more TrioBe than you should

If you have taken more TrioBe than you should, or if children have been taking medicine by accident, please contact your doctor or hospital to get an opinion of the risk and advise on action to be taken.

If you forget to take TrioBe

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

4. Possible side effects

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

At the recommended dosage the risk of side effects is low.

Rare (occur in less than 1 in 1000 patients): Acne-like rash. Allergic skin reactions such as hives, itching and redness.

If any of the side effects gets worse, 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 you doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store TrioBe

Keep out of the sight and reach of children.

Do not store above 30 C. Store in the original package in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the package. The expiry date refers the last day of that month.

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

6. Contents of the pack and other information

What TrioBe contains

• The active substances are 0.5 mg vitamin B₁₂ , 0.8 mg folic acid, and 3 mg vitamin B₆.

• The other ingredients are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycollate, magnesium stearate, colloidal anhydrous silica.

What TrioBe looks like and contents of the pack

TrioBe tablet is a round, pale yellow, speckled tablet with a diameter of 10 mm.

Pack sizes: 30, 60, 100 and 250 tablets in plastic bottles with screw-on lids.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Recip AB, Box 906, 170 09 Solna, Sweden.

Telephone 08-630 1900

E-mail: info@recip.se

Manufacturer

Recipharm Stockholm AB

Lagervägen 7

136 50 Jordbro, Sweden

This medicinal product is authorised in the Member States of the EEA under the following names:

TrioBe (Denmark, Finland, Norway and Sweden).

TriBvit (Belgium).

This leaflet was last approved in 21 January 2016