Epaviten: detailed information

Injectable Solution
Cyanocobalamin + folic acid + nicotinamide + ascorbic acid
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What EPAVITEN is and what it is used for
What you need to know before using EPAVITEN
How to use EPAVITEN
Possible side effects
How to store EPAVITEN
Contents of the pack and other information

1. What EPAVITEN is and what it is used for

EPAVITEN contains the active substances cyanocobalamin, folic acid, nicotinamide, and ascorbic acid, and
belongs to the category of combinations of vitamins.
EPAVITEN is used in deficiency states of vitamin B12, nicotinamide, ascorbic acid, and folic acid.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using EPAVITEN

Do not use EPAVITEN

if you are allergic to cyanocobalamin, folic acid, nicotinamide, and ascorbic acid or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using EPAVITEN.
Medicinal products containing folic acid or its derivatives, especially if also containing vitamin B, should not be administered to you if you have anemia unless investigations have been carried out to determine the exact nature of the existing anemia.
Treatment should be carried out under hematological (blood) monitoring.
In case of pernicious anemia (caused by vitamin B12 deficiency), supplementation with vitamin B12 may be necessary. In any case, it is essential to verify whether the quantitative composition of the combination is suitable for individual therapeutic needs.
Unspecific administration of this product to anemic subjects may lead to misdiagnosis of the type of anemia.
This medicine may turn urine red. This phenomenon should not be considered abnormal.
Other medicines and EPAVITEN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
There are no contraindications regarding the use of this medicine during pregnancy and breastfeeding.
Driving and using machines
Does not affect the ability to drive and use machinery.
EPAVITEN contains sodium dithionite. Rarely, it may cause severe hypersensitivity reactions and bronchospasm (bronchial constriction).
EPAVITEN contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to use EPAVITEN

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
INTRAMUSCULAR AND INTRAVENOUS USE.
Adults
The recommended average dose is 2–3 doses per week; at the physician's discretion, 1 or 2 doses per day may be administered.
EPAVITEN can be administered intramuscularly, intravenously, or via slow intravenous infusion after dilution in 250–500 ml of saline or glucose solution.
At the time of use, draw up the contents of both vials into the same syringe.
If you use more EPAVITEN than you should
Symptoms of overdose are not known.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Administration of this medicine, especially by parenteral route (different from intestinal absorption, such as intravenous route), may be followed by hypersensitivity reactions, mostly systemic, including asthenia (weakness), fever, hypotension (low blood pressure), tachypnea (increased breathing rate), skin rashes, itching, and, with unknown frequency, severe allergic reaction (anaphylactic reaction).
Anaphylactic shock may occur.
At the injection site, redness, swelling and pain may appear.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EPAVITEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack.
Store in the original packaging. Keep the container in the outer packaging. The medicine is sensitive to light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EPAVITEN contains

The active substances are: cyanocobalamin, folic acid, nicotinamide and ascorbic acid.
The other components are: sodium tartrate, sodium hydroxide, sodium dithionite, sodium bicarbonate, water for injections.

Vial I (red) contains the active substances: cyanocobalamin 2.5 mg; folic acid 0.70 mg; nicotinamide 12 mg.
The other components are: sodium tartrate, sodium hydroxide, water for injections.
Vial II (colourless) contains the active substance ascorbic acid 150 mg.
The other components are: sodium dithionite, sodium bicarbonate, water for injections.

Description of the appearance of EPAVITEN and package contents
Sterile injectable solution
6 red vials (I) of 1 ml + 6 colourless vials (II) of 1.5 ml

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. Group S.r.l., Via Tiburtina 1143, 00156 Rome - Italy
Manufacturer
Esseti Farmaceutici Srl - Via Campobello, 15 – Pomezia (RM) - Italy