The effectiveness and safety of Vitarubin Oral were only summarized by Swissmedic. The approval of Vitarubin Oral is based on Novavita with information from March 2017, which contains the same active ingredient and is approved in Sweden.

What is Vitarubin Oral and when is it used?

Vitarubin Oral contains the active substance cyanocobalamin, vitamin B_12. It is a vital vitamin that is needed for normal blood formation and the healthy functioning of the nervous system, among other things. Vitamin B₁₂ cannot be manufactured by the human body and must therefore be ingested through food. Vitamin B₁₂ is mainly found in animal products such as meat, fish, mussels, eggs and milk.

Vitarubin Oral is used in adults to prevent vitamin B₁₂ deficiency.

Vitarubin Oral can also be used in adults to treat a vitamin B₁₂ deficiency that has been diagnosed by a doctor. Therefore, consult your doctor before you start using Vitarubin Oral to treat vitamin B₁₂ deficiency. The success of the therapy must be checked regularly by your doctor.

A vitamin B₁₂ deficiency can develop, for example, if the body cannot absorb enough of the vitamin from food.

A vitamin B₁₂ deficiency can also occur with diseases of the small intestine or as a result of stomach surgery. Long-term use of certain medicines can also cause a vitamin B₁₂ deficiency.

Cyanocobalamin, the active substance in Vitarubin Oral, may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor or pharmacist if you have any further questions and always follow their instructions.

Seek medical advice if your condition does not improve or worsens.

When not to take Vitarubin Oral?

Vitarubin Oral should not be taken if you are allergic to cyanocobalamin or any of the substances listed in the section «What does Vitarubin Oral contain? » listed other ingredients of this medicine.

If you suffer from Leber's optic nerve atrophy, a rare hereditary disease of the optic nerve, you should also not take Vitarubin Oral.

When is caution required when taking Vitarubin Oral?

Please talk to your doctor or pharmacist before taking Vitarubin Oral. Especially if you suffer from severe kidney disease.

Other medicines and Vitarubin Oral

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This applies in particular to the following medicines:

• Aminoglycosides (for serious infections)
• Aminosalicylic acid (for tuberculosis or chronic inflammatory bowel disease with bleeding)
• Carbamazepine, valproate (for epilepsy)
• Metformin (for diabetes)
• Chloramphenicol (for eye infections)
• Cholestyramine (to lower cholesterol (fat) in the blood)
• Potassium salts (to correct Potassium deficiency)
• Methyldopa (for high blood pressure)
• Medicines to inhibit gastric acid production (such as pantoprazole, omeprazole or ranitidine)
• Colchicine (for gout)

Driving and using machines

Vitarubin Oral has no or negligible influence on the ability to drive and use machines.

You are responsible for evaluating your ability to drive or perform activities that require a high level of concentration. Your ability to do this may be reduced due to the effects and/or side effects of drugs. The description of these effects and side effects can be found in another section. Therefore, please read all the information in this leaflet carefully. Talk to your doctor or pharmacist if you are unsure.

Tell your doctor, pharmacist or druggist if you

• suffer from other diseases,
• have allergies or
• take other medicines (including those you bought yourself!)!

Can Vitarubin Oral be taken/used while pregnant or breastfeeding?

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask Ask your doctor or pharmacist for advice before taking this medicine.

Cyanocobalamin passes into breast milk. However, no effects on the breastfed newborn or infant are expected at therapeutic doses of Vitarubin Oral.

How do you use Vitarubin Oral?

If you have a confirmed vitamin B₁₂ deficiency, your doctor will determine the dose and adapt it to your individual needs at.

The recommended dose for the prevention of vitamin B₁₂ deficiency in adults is 1 tablet daily.

The recommended dosage for treating vitamin B₁₂ deficiency in adults is 1-2 tablets daily.

The tablets should be taken between meals on an empty stomach whenever possible. The duration of the treatment must be assessed by a doctor. Depending on the underlying condition, lifelong treatment may be required.

Your doctor will regularly check the appropriateness of the dosage.

The use and safety of Vitarubin Oral in children and adolescents has not yet been tested.

If you take more Vitarubin Oral than you should

In general, no signs of an overdose should be expected with Vitarubin Oral.

If you forget to take Vitarubin Oral

Skip the missed dose and take the next dose as usual. Do not take a double dose to make up for the missed dose.

If you stop taking Vitarubin Oral

The treatment with vitamin B₁₂ must be continued for life if the vitamin B₁₂ deficiency is due to chronically insufficient absorption from the intestine. It is important that you do not stop taking the tablets, even if you feel well. Otherwise, a lack of vitamin B₁₂ can gradually develop again.

Stick to the dosage given in the package leaflet or as prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Vitarubin Oral have?

Like all medicines, this medicine can have side effects, although not everyone gets them.

Serious side effects

The following side effects are very serious and require immediate treatment. If you notice any of the following side effects you must stop taking Vitarubin Oral and seek medical advice immediately as they are serious side effects:

Rare (affects 1 to 10 users in 10,000)

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

Other possible side effects:

Rare (affects 1 to 10 users in 10,000)

• Allergic reactions with itching and swelling, fever, rash, hives.
• Acneous skin changes.

Frequency not known (can be derived from the cannot be estimated from the available data)

• Nausea.

If you get any side effects, talk to your doctor, pharmacist or druggist or Your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What else needs to be considered?

The medicinal product may only be used up to the date marked «EXP» on the container.

Storage instructions

Do not store above 25°C and out of the reach of children.

Further information

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

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What does Vitarubin Oral contain?

Appearance

Pink, round, biconvex tablet, diameter 8.1 mm.

Active ingredients

1 film-coated tablet contains: 1000 μg cyanocobalamin.

Excipients

Tablet core: mannitol (E421); pregelatinized starch; Microcrystalline Cellulose (E460); magnesium stearate (E470b); stearic acid.

Tablet coating: hypromellose (E464); macrogol 400, titanium dioxide (E171); erythrosine (E127); yellow iron oxide (E172).

Approval number

68216 (Swissmedic)

Where can you get Vitarubin Oral? What packs are available?

In pharmacies and drugstores, without a doctor's prescription. Packs of 30 or 100 film-coated tablets.

Authorization holder

Streuli Pharma AG, 8730 Uznach.

This leaflet was last checked by the foreign reference authority in March 2017. With safety-related supplements from Swissmedic: February 2022

With safety-related supplements from Swissmedic: February 2022