Disepavit: detailed information

Cyanocobalamin, folic acid, nicotinamide and ascorbic acid
Equivalent medicine
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

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

Contents of this leaflet:

What DISEPAVIT is and what it is used for
What you need to know before using DISEPAVIT
How to use DISEPAVIT
Possible side effects
How to store DISEPAVIT
Package contents and other information

1. What DISEPAVIT is and what it is used for

DISEPAVIT is a vitamin complex containing the following active substances: cyanocobalamin (vitamin B₁₂), folic acid, nicotinamide, and ascorbic acid (vitamin C).
DISEPAVIT is indicated for the treatment of deficiencies in vitamin B₁₂, nicotinamide, ascorbic acid, and folic acid.

2. What you need to know before taking DISEPAVIT

Do not take DISEPAVIT

If you are allergic (hypersensitive) to the active substances or to any of the other components of this medicinal product listed in section 6.

Warnings and precautions
Talk to your doctor or pharmacist before taking DISEPAVIT

If you suffer from anaemia. Only your doctor can advise whether or not you should take DISEPAVIT, after performing blood tests to determine the type of anaemia you have.
If you suffer from a specific type of anaemia called pernicious anaemia. Your doctor will evaluate the most appropriate treatment for you and may recommend supplementing your vitamin B intake.

While using DISEPAVIT, always keep in mind that:

Treatment with DISEPAVIT should be monitored through regular blood tests;
Undesirable effects can be minimized by using the medicine at the lowest effective dose and for the shortest duration necessary to control symptoms;
Inappropriate administration of this product to patients with anaemia may lead to diagnostic errors. The product may turn urine red. This phenomenon is not considered abnormal;
The product contains sodium dithionite; this substance may rarely cause severe allergic reactions and breathing difficulties (bronchospasm).

DISEPAVIT Injectable Solution (active substances: cyanocobalamin, folic acid, nicotinamide and ascorbic acid)
Other medicines and DISEPAVIT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other drugs are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
No negative interactions are known regarding the use of DISEPAVIT during pregnancy or breastfeeding.
Driving and using machines
DISEPAVIT does not affect the ability to drive vehicles or operate machinery.
This medicine contains sodium dithionite.
The product contains sodium dithionite. This substance may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take DISEPAVIT

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults
On average: 2-3 doses per week; according to the doctor's judgment, 1 or 2 doses
per day may be administered.
DISEPAVIT may be administered by intramuscular, intravenous injection, or by infusion
(slow intravenous perfusion) after dilution in 250-500 ml of physiological saline or glucose solution.
At the time of use, draw up the contents of both ampoules into the same syringe.
If you take more DISEPAVIT than you should
In case of accidental overdose, contact your doctor or go to the nearest hospital.
Symptoms of overdose with DISEPAVIT are not known.
If you forget to take DISEPAVIT
If you forget to take DISEPAVIT, do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop treatment with DISEPAVIT
and contact your doctor immediately:

severe allergic reaction with sudden onset (anaphylactic shock).

Hypersensitivity reactions characterized by: fatigue, fever, reduced blood pressure,
increased respiratory rate, skin rashes, itching, redness, swelling and pain.
Other side effects that may occur with DISEPAVIT are:
At the injection site, redness, swelling and pain may occur.
DISEPAVIT Injectable Solution (active substances: cyanocobalamin, folic acid, nicotinamide and ascorbic acid)
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DISEPAVIT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the product from sunlight.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What DISEPAVIT contains
The active substances are cyanocobalamin, folic acid, nicotinamide and ascorbic acid.
Vial I (red) of DISEPAVIT Injectable Solution contains 2.5 mg of cyanocobalamin, 0.70 mg of
folic acid and 12 mg of nicotinamide.
The other components are: sodium tartrate, sodium hydroxide, water for injectable preparations.
Vial II (colourless) of DISEPAVIT Injectable Solution contains 150 mg of ascorbic acid.
The other components are: sodium dithionite, sodium bicarbonate, water for injectable preparations.

Description of the appearance of DISEPAVIT and contents of the pack
DISEPAVIT is an injectable solution.
It can be administered both intramuscularly and intravenously.
The solution is contained in 2 glass vials:
Vial I, red, 1 ml, and Vial II, colourless, 1.5 ml.
Each DISEPAVIT pack contains 6 Vials I and 6 Vials II.

Marketing Authorisation Holder and Manufacturer
MARKETING AUTHORISATION HOLDER
So.Se.PHARM S.r.l.
Via dei Castelli Romani 22
Pomezia (Rome)
Italy

MANUFACTURER
ESSETI Farmaceutici S.r.l.
Via Campobello, 15
00040 Pomezia (Rome)
Italy