Vitacon

Package Leaflet: Information for the Patient

VITACON, 10 mg, effervescent tablets

all-rac-Phytonadione

Read the package leaflet carefully before taking the medicine, 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 taking Vitacon
• 3. How to take 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 phytonadione (vitamin K - fat-soluble), which participates in the formation of certain blood clotting factors. Vitacon is used:

• in coagulation disorders caused by oral anticoagulant drugs from the coumarin derivatives group (acenocoumarol, warfarin) and indandione derivatives (phenindione), antibacterial drugs that destroy the physiological bacterial flora of the intestines, antibiotics, sulfonamides, salicylates;
• in prothrombin deficiency (one of the clotting factors) in the course of mechanical jaundice or biliary fistula.

2. Important information before taking Vitacon

When not to take Vitacon

• If you are allergic to phytonadione or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• In patients treated with anticoagulant drugs, the medicine should be used with caution, as the use of vitamin K in these patients may cause a return of the risk of thrombotic changes.
• Use with caution in patients with liver diseases with coagulation disorders.
• In elderly patients, the doctor will recommend using smaller doses of the medicine.
• Particular caution should be exercised in patients with liver function disorders. It is not recommended to increase the doses of phytonadione in patients with liver diseases who have not improved after using average doses of the medicine.
• During treatment with the medicine, the prothrombin time should be periodically monitored.
• The effect of the medicine usually appears after 6-10 hours, and it may take 24-48 hours to achieve the full effect.

Vitacon and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take. The use of phytonadione may cause temporary resistance to the action of oral anticoagulant drugs (coumarin and indandione derivatives).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor or pharmacist before taking this medicine. The medicine may be used during pregnancy only in cases where the benefit to the mother outweighs the potential risk to the fetus. Caution should be exercised when using the medicine in breastfeeding women.

Driving and using machines

The medicine does not affect the ability to drive and use machines.

Vitacon contains lactose monohydrate, sucrose, quinoline yellow lake (E 104), and sodium

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine. The medicine may cause allergic reactions due to the presence of quinoline yellow. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Vitacon

This medicine should always be taken according to the doctor's recommendations. If you are unsure, consult your doctor or pharmacist. Coagulation disorders in adults caused by oral anticoagulant drugs (coumarin and indandione derivatives) The initial dose is usually 10 mg (maximum 30 mg or exceptionally 50 mg). The frequency and size of subsequent doses will be determined by the doctor based on prothrombin time measurements and the patient's clinical condition. If after 12-48 hours after administration of the medicine the prothrombin time has not improved satisfactorily, the dose can be repeated. Coagulation disorders in adults caused by other factors The initial dose is 10 to 30 mg, exceptionally 50 mg. The dose size depends on the patient's condition and response to treatment. The basic procedure should involve, if possible, correcting the dose of drugs that disrupt coagulation mechanisms (antibiotics, salicylates, sulfonamides). Phytonadione should be used when coagulation disorders are severe enough that changing the dose of the taken medicine does not ensure their rapid resolution, or when changing the dose is not possible. Note: Oral administration of vitamin K is justified only when it can be absorbed from the gastrointestinal tract. If the amount of bile secreted into the gastrointestinal tract is insufficient, the doctor will recommend additional oral administration of bile salts.

Overdose of Vitacon

No symptoms of phytonadione overdose are known.

Missed dose of Vitacon

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. After taking phytonadione in the form of oral tablets, no side effects have been observed.

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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vitacon

Store in a temperature below 25°C. Store in the original package to protect from moisture. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month stated. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/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 of the medicine is all-rac-phytonadione. Each effervescent tablet contains 10 mg of all-rac-phytonadione. The other ingredients are: colloidal hydrated silica; microcrystalline cellulose; sodium croscarmellose; lactose monohydrate; magnesium stearate; povidence K-30; sodium carmellose; sucrose; anhydrous colloidal silica; talc; polysorbate 80; titanium dioxide (E 171); quinoline yellow lake (E 104); Capol wax.

What Vitacon looks like and contents of the pack

Vitacon is a yellow, round, biconvex effervescent tablet. Vitacon is available in blisters of aluminum/PVC in a cardboard box. The package contains 30 tablets.

Marketing authorization holder

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

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A. Production Plant in Nowa Dęba ul. Metalowca 2, 39-460 Nowa Dęba Date of last revision of the leaflet:December 2024