Epargriseovit

Package leaflet: Information for the patient

EPARGRISEOVIT adults 2500 mcg + 0.70 mg + 12 mg + 150 mg injectable solution, children 1250 mcg + 0.35 mg + 6 mg + 75 mg 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Epargriseovit is and what it is used for
2. What you need to know before using Epargriseovit
3. How to use Epargriseovit
4. Possible side effects
5. How to store Epargriseovit
6. Contents of the pack and other information

1. What Epargriseovit is and what it is used for

Epargriseovit contains the following active substances: cyanocobalamin (vitamin B₁₂), folic acid (vitamin B₉),
nicotinamide (vitamin PP), and ascorbic acid (vitamin C).
This medicinal product is used for the treatment of:

• vitamin deficiencies, especially of vitamin B₁₂ and folic acid, which may occur:
• in severe forms of physical weakness
• due to insufficient and inadequate nutrition during illness (undernutrition)
• during convalescence from illness
• in any other condition requiring vitamin supplementation via intravenous injection
• anemias that respond to administration of vitamin B₁₂ and folic acid, such as anemias caused by:
• inadequate diet
• poor intestinal absorption of vitamins
• chronic alcohol abuse (alcoholism)
• liver diseases
• pregnancy
• a disease causing chronic inflammation and, over time, joint deformities (rheumatoid arthritis)
• conditions in which medications used against seizures, malaria, infections, and tumors are administered
• trigeminal neuralgia
• diseases causing inflammation or degeneration of nerves (neuritis) that respond to vitamin B₁₂ and folic acid administration.

How Epargriseovit works
Epargriseovit is a combination of cyanocobalamin, folic acid, nicotinamide, and ascorbic acid.
Cyanocobalamin (vitamin B₁₂) is essential for normal growth of your body, for the formation of all blood cells (red blood cells, white blood cells, platelets), for the formation of cells lining your oral cavity, stomach, intestine (gastrointestinal tract), nasal cavities, bronchi, and lungs (respiratory tract), and for the normal development of nerve cells.
Folic acid (vitamin B₉) is necessary for the proper functioning of some important processes involving cyanocobalamin.
Nicotinamide (vitamin PP) is essential for certain metabolic functions in your body.
Ascorbic acid (vitamin C) is essential for the development of cartilage and bones, teeth, and wound healing. Furthermore, it is important for red blood cell formation and for the proper functioning of your immune system.

2. What you should know before taking Epargriseovit

Do not take Epargriseovit
If you or your child are allergic to any of the active substances: cyanocobalamin, folic acid, nicotinamide,
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 taking Epargriseovit.
Inform your doctor if you or your child have or have ever had any of the following conditions:

• Anaemia, because not all forms of anaemia benefit from or can be treated with the vitamins contained in this medicine. Your doctor will evaluate the health status and may decide to perform certain tests before prescribing this medicine. Your doctor will inform you about how often these tests should be carried out.
• Pernicious anaemia. If you or your child suffer from a type of anaemia called pernicious anaemia, your doctor may consider it necessary to add additional vitamin B to the treatment, beyond the amount contained in this medicine. The decision to add further vitamin B will be based on the results of tests you or your child have undergone.

Epargriseovit contains sodium metabisulfite
Epargriseovit contains a substance called sodium metabisulfite which may rarely cause severe hypersensitivity reactions and bronchospasm.
If you or your child have been diagnosed with asthma, an allergy, or any form of hypersensitivity, consult your doctor before taking this medicine.
Epargriseovit may turn urine red. This is normal during treatment with this medicine and should not be considered abnormal.

Other medicines and Epargriseovit
Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Currently, no medicines are known to interact in a harmful way with Epargriseovit.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Currently, no negative effects are known following administration of Epargriseovit during pregnancy or breastfeeding.

Driving and using machines
Epargriseovit does not affect the ability to drive vehicles or operate machinery. If in doubt, consult your doctor or pharmacist.

Epargriseovit contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically sodium-free.

3. How to use Epargriseovit

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor or the doctor treating your child will decide whether Epargriseovit should be administered by injection into a vein in the arm (intravenous route) or into a muscle, usually the buttock (intramuscular route).
The recommended dose in adults is 2–3 doses per week of “Epargriseovit adults”. Your doctor will decide whether you should take 1 or 2 doses per day.

Use in children
The recommended dose in children is 2–3 doses per week of “Epargriseovit children”, according to the doctor’s judgment.

Instructions for use
Epargriseovit contains two types of vials: vials containing a red liquid and vials containing a colourless liquid. At the time of use, the contents of both vials must be drawn up into the same syringe.
To open, hold the vial vertically, ensuring that the coloured mark is in the position shown in the figure.
Push the upper part of the vial backwards as shown in the figure.

If you use more Epargriseovit than you should
Currently, no toxic effects are known in case of overdose with Epargriseovit. If you have any doubts, consult your doctor or pharmacist.

If you forget to use Epargriseovit
If you have missed a dose of Epargriseovit, it can be administered to you or your child as soon as you remember. Epargriseovit can be administered at any time of day. Do not use a double dose to make up for the missed dose.

If you stop using Epargriseovit
If you wish to stop treatment with Epargriseovit, consult your doctor or pharmacist. There are no specific recommendations for discontinuing treatment with Epargriseovit.

If you have any questions 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 everyone gets them.

Contact your doctor immediately if, after administration of Epargriseovit, you experience the following side effect, as it may be serious:

• severe, rapidly occurring allergic reaction that may lead to death (anaphylactic shock).

The following side effects have been reported in patients treated with Epargriseovit. If any of these side effects worsen, or if you notice any side effect not listed in this leaflet, contact your doctor or pharmacist:

• reduction in muscle strength (asthenia);
• fever;
• low blood pressure;
• increased breathing rate (tachypnea);
• skin rashes;
• itching;
• redness, swelling and pain at the injection site.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following address: http://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 Epargriseovit

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Epargriseovit contains
The active substances in Epargriseovit are cyanocobalamin, folic acid, nicotinamide, and ascorbic acid.
Epargriseovit for adults contains:

• Vial I (red): 2500 mcg of cyanocobalamin, 0.70 mg of folic acid, 12 mg of nicotinamide;
• Vial II (colourless): 150 mg of ascorbic acid.
  Epargriseovit for children contains:
• Vial I (red): 1250 mcg of cyanocobalamin, 0.35 mg of folic acid, 6 mg of nicotinamide;
• Vial II (colourless): 75 mg of ascorbic acid.

The other components of Epargriseovit for adults are:

• Vial I (red): sodium tartrate, tartaric acid, sodium hydroxide, water for injections;
• Vial II (colourless): sodium metabisulfite, sodium bicarbonate, water for injections.

The other components of Epargriseovit for children are:

• Vial I (red): sodium tartrate, tartaric acid, sodium hydroxide, water for injections;
• Vial II (colourless): sodium metabisulfite, sodium bicarbonate, water for injections.

Description of the appearance of Epargriseovit and contents of the pack
Glass vials I (red) and II (colourless), 1 ml and 1.5 ml in volume:

• Epargriseovit adults: pack containing 6 vials I of 1 ml and 6 vials II of 1.5 ml;
• Epargriseovit children: pack containing 6 vials I of 1 ml and 6 vials II of 1 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina
Manufacturer
Actavis Italy S.p.a.
Viale Pasteur 10
20014 Nerviano (MI)