Vitacon

Package Leaflet: Information for the Patient

Vitacon, 10 mg/ml, Solution for Injection

Phytomenadion

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Vitacon and what is it 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 is Vitacon and what is it used for

Vitacon contains phytomenadione (vitamin K), which is necessary for the production of blood clotting factors in the body.
Vitacon is used:

• in adults to treat bleeding caused by overdose of anticoagulant medications from the coumarin derivative group (acenocoumarol, warfarin) or to treat bleeding caused by other acquired deficiencies of clotting factors, known as prothrombin complex (factors II, VII, IX, X),
• in children with diseases that disrupt vitamin K absorption: chronic diarrhea, cystic fibrosis (a hereditary disease characterized by the production of excessive thick mucus, which causes serious disorders in organs, such as lungs, pancreas), bile duct obstruction, hepatitis, celiac disease (a disease caused by gluten intolerance),
• in children with liver disease and 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 macroglolglycerol 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 medications, inform your doctor. The medicine contains macroglolglycerol ricinoleate, which may cause allergic reactions (symptoms: facial flushing, excessive sweating, shortness of breath, chest tightness and pain, and peripheral circulatory failure). Administration of the medicine

in intravenous infusion (lasting about 30 minutes) or slow intravenous injection allows to avoid the mentioned side effects.

• In patients with severe bleeding caused by overdose of anticoagulant medications, in addition to Vitacon administration, blood transfusion or clotting factor concentrate administration may be necessary.
• In case of severe bleeding in patients with artificial heart valves, the doctor will recommend administration of fresh frozen plasma.
• The medicine administered intramuscularly, especially in high doses, may permanently reduce the effect of oral anticoagulant medications (acenocoumarol and warfarin).
• Vitacon does not inhibit the effect of heparin (an anticoagulant medication).
• Elderly patients are more sensitive to the effect of Vitacon. In these patients, the doctor will use the smallest effective doses.

Children

It is not recommended to administer Vitacon to premature infants, newborns, and children under 2 years of age.

Vitacon and other medications

Tell your doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
The medicine counteracts the effect of anticoagulant medications from the coumarin derivative group (acenocoumarol and warfarin).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines

There is no data on the effect of the medicine on driving and using machines.

Vitacon contains macroglolglycerol ricinoleate (Cremophor EL) and benzyl alcohol

The medicine contains macroglolglycerol ricinoleate (Cremophor EL). The medicine may cause severe allergic reactions.
The 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 severe side effects, including respiratory disorders (so-called "gasping syndrome").
Due to the increased risk of benzyl alcohol accumulation in small children, the medicine should not be administered to children under 3 years of age for more than a week without the doctor's or pharmacist's recommendation.
Pregnant or breastfeeding women, patients with liver or kidney diseases should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
The medicine can be diluted in 0.9% NaCl solution. The sodium content from the diluent should be taken into account when calculating the sodium content in the prepared dilution of the medicine.
To obtain accurate information about the sodium content in the solution used to dilute the medicine, refer to the patient leaflet of the diluent used.

3. How to use Vitacon

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The medicine is intended for intramuscular or intravenous administration.
The dosage will be determined by your doctor, taking into account the patient's condition.

Using a higher dose of Vitacon than recommended

Vitacon is administered by medical personnel, so it is unlikely that the patient will receive more medicine than they should.
There are no known symptoms of Vitacon overdose.

4. Possible side effects

Like all medicines, Vitacon can cause side effects, although not everybody gets them.
Vitacon contains macroglolglycerol ricinoleate, which in animal studies caused reactions similar to allergy (so-called pseudoanaphylactic reactions). It cannot be ruled out that such reactions may occur in humans.
After too rapid intravenous injection of the medicine, facial flushing, excessive sweating, shortness of breath, chest tightness and pain, cyanosis (blue 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 patients) after intravenous administration of the medicine, vein irritation or inflammation has been reported.
After intramuscular administration of the medicine, especially with repeated injections, skin reactions may occur at the injection site.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather 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 ampoule. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vitacon contains

• The active substance is phytomenadione. Each ml of solution contains 10 mg of phytomenadione.
• The other ingredients are: macroglolglycerol 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 ampoules of orange glass, each containing 1 ml, in a cardboard box.

Marketing authorization 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 Warsaw
Date of last revision of the leaflet:
Information intended for healthcare professionals only:

Vitacon, 10 mg/ml, Solution for Injection

Phytomenadion
The medicine is intended for intramuscular or intravenous administration.

Dosage

Adults:as an antidote after overdose of anticoagulant medications.
Severe bleeding, including potentially life-threatening:
Treatment with phytomenadione (vitamin K) should be accompanied by blood transfusion or administration of clotting factor concentrate. Anticoagulant medications should be discontinued and vitamin K administered in infusion (after prior dilution - see "Instructions for preparing Vitacon for infusion" below) or slowly intravenouslyin a dose of 10 mg to 20 mg. After 3 hours of Vitacon administration, prothrombin time should be measured, and if it is prolonged, the dose of Vitacon should be repeated. Do not administer intravenously more than 40 mg of vitamin K per day. It is recommended to monitor coagulation parameters once a day until the appropriate values are achieved. In severe cases, more frequent monitoring is recommended, and if there is no immediate improvement, blood transfusion or clotting factor concentrate administration should be performed.
Less severe bleeding: oral vitamin K is recommended.
It is possible to administer vitamin K intramuscularly in a dose of 10 mg to 20 mg; if necessary, the dose can be repeated.
Other indications: doses of 10 mg to 20 mg of vitamin K.

Elderly patients

Elderly patients are more sensitive to the effect of vitamin K (phytomenadione). In these patients, the smallest effective doses of Vitacon should be used.

Use in children

It is not recommended to administer Vitacon to premature infants, newborns, and children under 2 years of age.
In some cases, the doctor may recommend administering Vitacon to children over 2 years of age with diseases that disrupt vitamin K absorption (chronic diarrhea, cystic fibrosis, bile duct obstruction, hepatitis, celiac disease), with liver disease, and malnourished children who have received antibiotics.
Before administering Vitacon to children over 2 years of age, it is recommended to consult a hematologist to determine the appropriate tests and treatment.
In children over 2 years of age, the dose should be determined based on the patient's condition, usually administered intravenously (after prior dilution - see the description below) at a dose of 1 mg to 5 mg of vitamin K.

Instructions for opening the ampoule

Before opening the ampoule, make sure the entire solution is in the lower part of the ampoule.
You can gently shake the ampoule or tap it with your finger to facilitate the flow of the solution.
A colored dot is placed on each ampoule (see figure 1) as a mark indicating the break point below it.

• To open the ampoule, hold it vertically, with both hands, with the colored dot facing you - see figure 2. The upper part of the ampoule should be grasped in such a way that the thumb is above the colored dot.
• Press according to the arrow on figure 3. The ampoules are intended for single use only and should be opened immediately before use. The remaining contents of the unused product should be destroyed in accordance with applicable regulations.

Figure 1
Figure 2
Figure 3

Instructions for preparing Vitacon for infusion

Vitacon can be diluted before intravenous administration: 10 mg in 100 ml of 0.9% NaCl and administered in infusion lasting 20 to 30 minutes. The prepared infusion solution can be stored for 6 hours without exposure to light. During preparation and administration of the prepared solution, aseptic principles should be observed. Vitacon should not be mixed with other medications in the infusion solution or in the same syringe.