Vitacon

Package leaflet: Information for the patient

Vitacon, 10 mg/ml, solution for injection
Phytomenadionum
Please read all of this leaflet carefully before using this medicine, because it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Vitacon is and what it is used for

Vitacon contains phytomenadione (vitamin K_), which is essential for the production of blood clotting factors in the body.
This medicine is used:

• in adults for the treatment of bleeding caused by overdose of anticoagulant drugs of the coumarin derivatives group (acenocoumarol, warfarin), or for the treatment of bleeding caused by other acquired deficiencies of clotting factors, known as prothrombin complex deficiency (factors II, VII, IX, X),
• in children with diseases that impair vitamin K absorption: chronic diarrhoea, cystic fibrosis (a hereditary disease characterized by the production of excessive sticky mucus, causing serious organ dysfunction, e.g. in lungs, pancreas), biliary obstruction, hepatitis, coeliac disease (a disease caused by gluten intolerance),
• in children with liver disease and in malnourished children who have received antibiotics.

2. Important information before using Vitacon

When not to use Vitacon:

• If the patient is allergic to phytomenadione or any of the other ingredients of this medicine (listed in section 6), especially macrogolglycerol ricinoleate (Cremophor EL).

Warnings and precautions
Before starting treatment with Vitacon, discuss it with your doctor or pharmacist.

• If the patient has previously experienced unusual or allergic reactions to medicines, inform the doctor. The medicine contains macrogolglycerol ricinoleate, which may cause allergic reactions (symptoms: facial flushing, excessive sweating, shortness of breath, chest tightness and pain, and peripheral circulatory failure). Administering the medicine
  by intravenous infusion lasting about 30 minutes or by slow intravenous injection
  can help avoid these adverse effects.

• In patients with severe bleeding caused by an overdose of anticoagulant medicines, in addition to administration of Vitacon, transfusion of whole blood or administration of clotting factor concentrates may be necessary.

• In case of severe bleeding in patients with prosthetic heart valves, the doctor may recommend administration of fresh frozen plasma.

• When administered intramuscularly, especially in high doses, Vitacon may cause prolonged inhibition of the effect of oral anticoagulants (acenocoumarol and warfarin).

• Vitacon does not inhibit the action of heparin (an anticoagulant medicine).

• Elderly patients are more sensitive to the effects of Vitacon. In such patients, the doctor will use the smallest effective doses.

Children
Administration of Vitacon is not recommended in premature infants, newborns, or children under 2 years of age.
Vitacon and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Vitacon counteracts the effects of anticoagulant medicines belonging to the coumarin derivatives group (acenocoumarol and warfarin).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
There is no data available regarding the influence of the medicine on driving and operating machinery.
Vitacon contains macrogolglycerol ricinoleate (Cremophor EL) and benzyl alcohol
This medicine contains macrogolglycerol ricinoleate (Cremophor EL). This ingredient may cause severe allergic reactions.
This medicine contains 9 mg of benzyl alcohol in each ml of solution.
Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to newborns is associated with the risk of serious adverse effects, including respiratory disorders (so-called "gasping syndrome").
Due to the increased risk of accumulation of benzyl alcohol in small children, the medicine should not be administered to children under 3 years of age for longer than one week without medical advice or consultation with a pharmacist.
Pregnant or breastfeeding women, and patients with liver or kidney disease, should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (such as metabolic acidosis).
The medicine can be diluted with 0.9% sodium chloride solution. The sodium content originating from the diluent should be taken into account when calculating the total sodium content in the prepared diluted solution.
For precise information on the sodium content in the diluent solution used to dilute the medicine, please refer to the patient leaflet of the diluent used.

3. How to use Vitacon

This medicine should always be used according to the doctor's instructions. If in doubt, consult
your doctor or pharmacist.
This medicine is intended for intramuscular or intravenous administration.
The dosage will be determined by the doctor, taking into account the patient's condition.
Administration of a higher than recommended dose of Vitacon
Vitacon is administered by healthcare professionals, so it is unlikely that a patient will receive
more medicine than intended.
Symptoms of poisoning with Vitacon are unknown.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
The Vitacon preparation contains macrogol glycerol ricinoleate, which in animal studies
has caused reactions resembling allergy (so-called anaphylactoid reactions). Such reactions in humans cannot be ruled out.
If administered intravenously too rapidly, flushing, excessive sweating, shortness of breath, chest tightness and pain, cyanosis (bluish, localized discoloration of the skin and mucous membranes), and even circulatory collapse (acute circulatory failure) may occur.
Very rarely (in less than 1 in 10,000 individuals), irritation or inflammation of veins has been reported after intravenous administration of the medicine.
Following intramuscular administration of the medicine, particularly with repeated injections, skin reactions at the injection site may occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vitacon

Store the ampoules in the outer packaging to protect from light, at a temperature below 25°C. Do not freeze.
Keep the 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 ampoule. The expiry date refers to the last day of the stated month.
The marking following "EXP" on the packaging indicates the expiry date, and the marking following "Lot" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Vitacon contains

• The active substance is phytomenadione. Each ml of solution contains 10 mg of phytomenadione.
• Other components: macrogol glycerol ricinoleate (Cremophor EL), glucose, benzyl alcohol, water for injections.

What Vitacon looks like and contents of the pack
Vitacon is a clear or slightly opalescent yellow liquid.
10 amber glass ampoules with 1 ml each, packed in a cardboard box.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24, 01-207 Warszawa

Information intended exclusively for healthcare professionals:
Vitacon, 10 mg/ml, solution for injection
Phytomenadionum
The medicinal product is intended for intramuscular or intravenous administration.

Dosage
Adults: as an antidote in cases of overdose of anticoagulant drugs.
Severe bleeding, including potentially life-threatening:
Treatment with phytomenadione (vitamin K) should be accompanied by transfusion of whole blood or administration of clotting factor concentrate. Anticoagulant drugs should be discontinued and vitamin K administered by infusion (after prior dilution - see "Instructions for preparing Vitacon for infusion" below) or slowly intravenously at a dose of 10 mg to 20 mg. Three hours after administration of Vitacon, prothrombin time should be measured; if prolonged, the dose of Vitacon should be repeated. Intravenous doses exceeding 40 mg of vitamin K per day should not be administered. Coagulation parameters should be monitored once daily until appropriate values are achieved. In severe cases, more frequent monitoring is recommended, and if there is no immediate improvement, whole blood should be transfused or clotting factor concentrate administered.
Milder bleeding: oral vitamin K tablets are recommended.
Vitamin K may also be administered intramuscularly at a dose of 10 mg to 20 mg; the dose may be repeated if necessary.
Other indications: doses of 10 mg to 20 mg of vitamin K.

Elderly patients
Elderly patients are more sensitive to the effects of vitamin K (phytomenadione). In these patients, the lowest effective dose of Vitacon should be used.

Use in children
Administration of Vitacon is not recommended in premature infants, newborns, or children under 2 years of age.
In certain cases, a physician may recommend Vitacon for children over 2 years of age suffering from diseases impairing vitamin K absorption (chronic diarrhoea, cystic fibrosis, biliary atresia, hepatitis, coeliac disease), liver disease, or malnourished children receiving antibiotics.
Prior to administration of Vitacon to children over 2 years of age, consultation with a specialist haematologist is recommended to determine appropriate testing and treatment.
In children over 2 years of age, the dose should be determined according to the patient's condition; usually 1 mg to 5 mg of vitamin K is administered intravenously (after prior dilution - see instructions below).

Instructions for opening the ampoule
Before opening the ampoule, ensure that the entire solution is located in the lower part of the ampoule. Gently shake the ampoule or tap it with a finger to help the solution flow down.
Each ampoule has a coloured dot (see Figure 1) indicating the score line located beneath it.

• To open the ampoule, hold it vertically with both hands, with the coloured dot facing towards you - see Figure 2. The upper part of the ampoule should be held so that the thumb is positioned above the coloured dot.
• Press as indicated by the arrow in Figure 3. Ampoules are for single use only and should be opened immediately before use. Any unused portion of the product should be destroyed in accordance with applicable regulations.

Figure 1 Figure 2 Figure 3

Instructions for preparing Vitacon for infusion
Vitacon may be diluted prior to intravenous administration: 10 mg in 100 ml of 0.9% NaCl, administered as an infusion over 20 to 30 minutes. The prepared infusion solution may be stored for up to 6 hours protected from light. Aseptic techniques must be maintained during preparation and administration of the solution. Vitacon must not be mixed with other medicinal products in the infusion solution or in the same syringe.