Package leaflet: Information for the patient

Eparmefolin adults 2 mg + 0,9 mg powder and solvent for injectable solution

Cyanocobalamin/Calcium folinate
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 or pharmacist.
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 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 Eparmefolin adults is and what it is used for
What you need to know before using Eparmefolin adults
How to use Eparmefolin adults
Possible side effects
How to store Eparmefolin adults
Contents of the pack and other information

1. What Eparmefolin adults is and what it is used for

Eparmefolin adults contains two active substances called cyanocobalamin (vitamin B12) and calcium folinate,
which belong to the group of antianaemic medicinal products.
Eparmefolin adults is indicated for the treatment of vitamin B12 and folate deficiency states.

2. What you need to know before using Eparmefolin adults

Do not use Eparmefolin adults

if you are allergic to cyanocobalamin, calcium folinate, or to any of the other ingredients of this medicine (listed in section 6);
if you are in hepatic coma or in pre-comatose conditions.

Warnings and precautions
Talk to your doctor before using Eparmefolin adults.
Parenteral administration of vitamin B12 in subjects with folate deficiency may cause a hematological response that could lead to a diagnostic error.

Other medicines and Eparmefolin adults
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Concomitant administration with a folic acid antagonist (e.g., amethopterin, an antineoplastic drug also known as methotrexate) may cancel the therapeutic effect of Eparmefolin adults.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.

3. How to use Eparmefolin adults

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is 1 vial daily by intramuscular or intravenous route (the latter, including infusion, is
particularly recommended in adults).
For initial treatment, the recommended dose is 2 vials daily.
For subsequent maintenance therapy, the recommended dose is 1 vial every other day.
For the treatment of deficiency states associated with chronic liver diseases, parenteral administration is
advised due to the frequent impairment of intestinal absorption; therapy may be prolonged for extended
periods according to medical prescription.
If you use more Eparmefolin adults than you should
No adverse events attributable to overdose have been reported to date.
In case of accidental ingestion of an excessive dose of the medicine, seek medical advice from your doctor or go
to the nearest hospital.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Rare cases of hypersensitivity reactions to vitamin B12 and folic acid have been reported.
High doses administered parenterally may cause rashes, diarrhoea, and, exceptionally, anaphylactic shock.
Redness, swelling, and pain at the injection site may also occur.
Patients are advised to inform their physician if any adverse reactions occur, even if not described in this
package leaflet.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or
pharmacist. You may also report adverse reactions directly via the national reporting system at the following
website: http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Eparmefolin adults

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Eparmefolin adulti contains

The active substances are cyanocobalamin and calcium folinate. 1 vial of powder contains 2 mg of cyanocobalamin (vit. B12) and 0.9 mg of calcium folinate.
The other components are: Powder for injectable solution: mannitol; Solvent: Water for injections.

Description of the appearance of Eparmefolin adulti and package contents
Carton containing 6 vials of powder + 6 vials of solvent
Marketing Authorization Holder
SUBSTIPHARM 24 rue Erlanger, 75016 Paris - France
Marketing Authorization Holder in Italy
SUBSTIPHARM S.r.l. Via Felice Casati, 20 – 20124 Milano
Manufacturers
FAMAR ITALIA S.p.A. Via Zambeletti, 25 – 20021 Baranzate MI