Brand name Konakion 10 mg/ml oral solution/injection solution

Form solution, oral and injectable

Active substance / Dosage

FITOMENADIONA · 10 mg

Prescription type Prescription Only Medicine

ATC code

B02B B02BA B02BA01

Registration number 27262

Manufacturer Cheplapharm Arzneimittel Gmbh

Konakion 10 mg/ml oral solution/injection solution solution, oral and injectable

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Konakion 10 mg/ml is and what it is used for
2. What you need to know before using Konakion 10 mg/ml
3. How to use Konakion 10 mg/ml
4. Possible adverse effects
5. Storage of Konakion
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Konakion 10 mg/ml oral solution/injectable solution

Phytomenadione

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

What Konakion 10 mg/ml is and what it is used for
What you need to know before using Konakion 10 mg/ml
How to use Konakion 10 mg/ml
Possible adverse effects
How to store Konakion 10 mg/ml
Contents of the pack and other information

1. What Konakion 10 mg/ml is and what it is used for

Konakion contains phytomenadione (Vitamin K) as the active substance, which plays a role in the blood coagulation mechanism. A deficiency of vitamin K1 leads to an increased tendency to bleed.

It is used for the treatment and prevention of bleeding (haemorrhage).

Konakion 10 mg/ml is indicated for:

The prevention and treatment of hypoprothrombinemia (lack of a substance called prothrombin, which is necessary for blood to clot) due to vitamin K deficiency.

Therefore, it is indicated in haemorrhage or risk of haemorrhage due to severe hypoprothrombinemia caused by:

Overdose of coumarin-derived anticoagulant medicines in patients taking them (medicines that prevent the formation of blood clots)
Vitamin K deficiency (hypovitaminosis K) caused by factors that reduce the absorption or synthesis of vitamin K, such as obstructive jaundice (a disorder of bile secretion into the intestine), intestinal or hepatic disorders, and after prolonged treatment with antibiotics, sulfonamides (chemical substances that can be used as antibiotics), or salicylates (e.g., acetylsalicylic acid).

For the prevention and treatment of haemorrhagic disease of the newborn, Konakion 2 mg/0.2 ml paediatric formulation is used.

2. What you need to know before using Konakion 10 mg/ml

Do not use Konakion

If you are allergic to phytomenadione or to any of the other components of this medicine (listed in section 6)
It must not be administered intramuscularly if you are being treated with anticoagulants, as this route may interfere with anticoagulant therapy. In addition, intramuscular injections carry a risk of causing hematomas (bruising) if you are receiving anticoagulant treatment.

Warnings and precautions

Talk to your doctor before starting to use Konakion 10 mg/ml.

If you have severe liver disease, make sure your doctor is aware, as they may recommend blood tests to monitor certain parameters during your treatment
If you have other diseases
If you have allergies

Children

For newborns and children under 1 year of age, another product of the same brand but with a lower dose should be used: Konakion 2 mg/0.2 ml paediatric.

Use of Konakion 10 mg/ml with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

This is very important, as using several medicines at the same time may increase or decrease their effects.

The following medicines may interact with Konakion:

Anticoagulants such as warfarin or acenocoumarol (medicines that help prevent blood clots from forming)

Medicines for epilepsy.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Pregnancy
Konakion may be administered during pregnancy if the benefit to the mother outweighs the risk to the fetus.
Breastfeeding
You may be treated with Konakion while breastfeeding.

Administration of Konakion for the prevention of haemorrhagic disease of the newborn is not recommended in women who are in an advanced stage of pregnancy or who are breastfeeding.

Driving and use of machines

The influence of Konakion on the ability to drive or operate machinery is none or negligible.

Konakion 10 mg/ml contains sodium hydroxide

This medicine contains less than 23 mg (1 mmol) of sodium per ampoule and is therefore considered essentially "sodium-free".

3. How to use Konakion 10 mg/ml

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. Depending on the nature of your illness, your doctor will administer the correct dose of this medicine.

The route of administration will depend on the severity of your illness and the risks associated with each route. Konakion 10 mg/ml can be administered orally or intravenously; intravenous administration may be indicated when the oral route is not feasible or effective.

Usual dose for adults

Severe or very severe bleeding, e.g., during anticoagulant therapy:

After discontinuation of the coumarin anticoagulant treatment you are taking, a dose of 5–10 mg of Konakion will be administered slowly (over at least 30 seconds) intravenously, together with fresh frozen plasma (FFP) or prothrombin complex concentrate (PCC). The vitamin K₁ dose may be repeated as many times as necessary.

Recommended doses of vitamin K₁* for the treatment of patients with asymptomatic elevation of the International Normalized Ratio (INR, an internationally established index for monitoring patients on anticoagulant therapy), with or without mild bleeding***:

Anticoagulant	INR	Oral Vitamin K1	Intravenous Vitamin K1
Warfarin	5–9	1 to 2.5 mg for initial reversal 2 to 5 mg for rapid neutralization (additional dose of 1 to 2 mg if INR remains elevated after 24 hours)	0.5 to 1 mg 0.5 to 1 mg
>9	2.5 to 5 mg (up to 10 mg)	1 mg
Acenocoumarol	5–8	1 to 2 mg	1 to 2 mg
>8	3 to 5 mg	1 to 2 mg
Phenprocoumon	5–9	2 to 5 mg	2 to 5 mg
>9	2 to 5 mg	2 to 5 mg
>10	Not recommended	Individualized dosing for each patient

For small doses, one or more ampoules of another presentation of Konakion may be used: Konakion 2 mg/0.2 ml paediatric.

Recommended doses of vitamin K₁ for the treatment of patients with severe or very severe bleeding:

Anticoagulant	Situation	Vitamin K1 intravenous	Concomitant treatment
Warfarin	Severe bleeding	5 to 10 mg	PCC or FFP
Life-threatening bleeding	10 mg	PCC, FFP, or recombinant factor VIIa
Acenocoumarol	Severe bleeding	5 mg	PCC, FFP, or prothrombin and factor VII concentrates
Phenprocoumon	Severe bleeding with INR <5	5 mg	PCC
Severe bleeding with INR >5	10 mg	PCC

PFC, fresh frozen plasma

PCC, prothrombin complex concentrate

Hypoprothrombinemia due to other causes

In hypoprothrombinemia due to malabsorption disorders or treatment with antibiotics, salicylates, or sulfonamides, an oral dose preferably or an injectable dose of 2 mg of Konakion 10 mg/ml may be administered in adults. Konakion should be administered at the lowest effective dose.

The dose and route of administration will depend on the severity of the deficiency and the response to the medication.

Elderly patients

Elderly patients tend to be more sensitive to the effects of this medication. Therefore, the dose in this group should be at the lower end of the recommended range. Small doses of 0.5 to 1 mg of vitamin K1 administered intravenously or orally have been shown to effectively reduce INR to <5 within 24 hours after administration.

Use in children

Children over one year of age

The physician will determine the appropriate dose based on the indication and patient's weight. A single dose corresponding to one-tenth of the total intravenous adult dose of vitamin K1 has been reported to be effective in reversing asymptomatic INR elevations (>8) in clinically stable children.

Newborns and children under one year of age

For this patient group, due to the small dose required, Konakion 2 mg/0.2 ml pediatric formulation should be used.

Konakion is normally administered as a single dose; however, if the response is insufficient, additional doses may be given.

Instructions for correct administration of the preparation

The Konakion solution must be clear (clean) at the time of use. If ampoules have not been stored properly, they may appear cloudy or show phase separation. In such cases, the ampoule must be discarded.

Oral route: Konakion can be administered using a syringe as follows: Break the neck of the ampoule and withdraw the required amount using a syringe with a needle. Remove the needle from the syringe and administer the contents of the syringe directly into the patient's mouth. Rinse the syringe with liquid.

Parenteral route: Konakion must not be diluted or mixed with other parenteral medications, but it may be injected into the lower part of an infusion set.

If you use more Konakion 10 mg/ml than you should

Cases of vitamin K1 (phytomenadione) overdose are unknown. The ability to reinitiate anticoagulant therapy may be affected.

In case of overdose or accidental ingestion, contact your physician or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number 91 562.04.20, indicating the medication and the amount administered.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very rare adverse effects (may affect up to 1 in 10,000 people): severe allergic reaction (anaphylactic reaction) and inflammation at the site of administration (injection). Venous irritation or phlebitis with intravenous administration of Konakion 10mg/ml.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

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

5. Storage of Konakion

Store below 25°C.

Keep ampoules in the outer packaging to protect from light.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if the solution appears cloudy or shows phase separation.

For reasons of stability, any unused contents of opened ampoules must not be used and should be discarded.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Konakion 10 mg/ml oral solution/injectable solution

The active substance is phytomenadione (synthetic vitamin K1). Each ampoule contains 10 mg of phytomenadione (vitamin K1) in 1 ml.
The other components are glycocholic acid, sodium hydroxide, lecithin, 25% hydrochloric acid, and water for injections.

Appearance of the medicinal product and contents of the pack

Konakion is an oral and injectable solution contained in ampoules. Clear to slightly opalescent liquid.

Each pack contains 5 amber glass ampoules of 1 ml.