1 mg film-coated tablets
cyanocobalamin ( vitamin B 12 )
What Novavita is and what it is used for
Novavita contains the active substance cyanocobalamin, vitamin B 12. This is a vital vitamin, which i.a. needed for normal blood formation and the normal functioning of the nervous system.
Novavita 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 e.g. develop if vitamin E can not be absorbed by the body normally from food. This can be due to a gastrointestinal disease but can also be the result of e.g. a gastric ulcer operation or other bowel operation. Vitamin B 12 deficiency can also occur if you take certain medicines that are used for inflammation in the gastrointestinal tract for a long time.
The cyanocobalamin contained in Novavita may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
You need to talk to a doctor if you do not feel better or if you feel worse.
What you need to know before using Novavita
Do not use Novavita:
- if you are allergic to cyanocobalamin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Novavita.
Other medicines and Novavita
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Special medicines used in:
- severe infection ( aminoglycosides )
- tuberculosis , chronic bleeding inflammation of the intestine (aminosalicylic acid)
- epilepsy ( antiepileptics )
- diabetes (eg metformin )
- eye infection (chloramphenicol)
- to reduce the amount of cholesterol (fat) in the blood (cholestyramine)
- to correct potassium deficiency (potassium salts)
- high blood pressure (methyldopa)
- to inhibit stomach acid (eg omeprazole and cimetidine).
Novavita with food and drink
The tablet should preferably be taken on an empty stomach, between meals.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Cyanocobalamin passes into breast milk, but no effects on breast-fed infants/infants are expected, at therapeutic doses of Novavita.
Driving and using machines
Novita does not influence the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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.
How to use Novavita
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
In case of confirmed vitamin B 12 deficiency, your doctor will determine the dose one, and adjust it individually for you.
For maintenance treatment, 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 use more Novavita than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
There are usually no signs of overdose with Novavita.
If you forget to use Novavita
Skip the missed dose one and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you stop using Novavita
Treatment with vitamin B 12 must last a lifetime if it is a result of a chronic poor uptake from the intestine. You mustn’t stop taking the tablets, even if you feel healthy. Then B 12 deficiency eventually develops again.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects The
following side effects are very serious and may require immediate treatment. If any of the following side effects occur, stop taking Novavita and contact your doctor immediately if the following serious side effects occur:
Rare side effects ( affects up to 1 in 1,000 people):
- Swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing.
Other side effects that may occur:
Rare side effects ( affects up to 1 in 1,000 people):
- Allergic reactions, with itching and swelling, fever, rash, hives.
How to store Novavita
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton after EXP. date. 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.
Contents of the pack and other information
Content declaration
- The active substance is cyanocobalamin ( vitamin B 12 ). 1 film-coated tablet contains 1 mg cyanocobalamin.
- The other ingredients are: mannitol (E421); pregelatinized starch; microcrystalline cellulose (E460); magnesium stearate (E470b), stearic acid, hypromellose (E464), macrogol, titanium dioxide (dye 171), erythrosine (dye E 127), iron oxide (dye E 172)
What the medicine looks like and contents of the pack
Appearance
Film-coated tablet: pink, round, biconvex tablet, diameter 8.1 mm.
Pack sizes
Plastic jar (HDPE): 30, 50, 60, 100, 105, 110, 120, 125, 250 tablets.
Blister (Alu-PVC / PVDC): 30, 50, 60 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Alternova A / S
Lodshusvej 11
4230 Skælskør
Denmark
Manufacturer
Orifarm Generics A / S
Energizer 15
5260 Odense S
Denmark
and
Saneca Pharmaceuticals as
Nitrianska 100
92027 Hlohovec
Slovakia
This medicinal product is authorized under the European Economic Area under the names:
Sweden, Finland: Novavita