Leaflet: information for the user

Konakion 10mg/ml oral solution/injectable solution

Phytomenadione

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Konakion 10 mg/ml 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 side effects

5. Storage of Konakion 10 mg/ml

6. Contents of the pack and additional information

Konakion contains as active substance phytonadione Vitamin K which intervenes in the blood coagulation mechanism. A lack of vitamin K1causes an increase in the tendency to bleed.

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

Konakion10 mg/ml is indicated for:

Prevention andtreatment of hypoprothrombinemia (lack of a substance, prothrombin, needed for blood to clot) caused by vitamin K deficiency.

Therefore, it is indicated for bleeding or risk of bleeding due to severe hypoprothrombinemia caused by:

• Overdosing of anticoagulant medications derived from coumarin in patients who take them (medications that prevent the formation of clots)
• Lack of vitamin K (hypovitaminosis K) caused by factors that decrease vitamin K absorption or synthesis, such as obstructive jaundice (disorder of bile secretion into the intestine), intestinal or hepatic alterations, and prolonged treatment with antibiotics, sulfonamides (chemical substances that can be used as antibiotics) or salicylates(for example, acetylsalicylic acid).

Konakion 2 mg/0.2 ml pediatric is used for the prevention and treatment of hemorrhagic disease in newborns.

No useKonakion

-If you are allergic to phytonadione or any of the other components of this medication (listed in section 6)

-Do not administer intramuscularly if you are being treated with anticoagulants, as this route may hinder the initiation of anticoagulant therapy. Additionally, intramuscular injections carry a risk of hematoma (bruising) if you are being treated with anticoagulants.

Warnings and precautions

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

• If you have severe liver disease, ensure your doctor is aware of this because they will need to order blood tests to monitor certain parameters during your treatment.
• You have other diseases.
• You have allergies.

Children

For newborns and children under 1 year, use another medication from the same brand but with a lower dose, Konakion 2 mg/0.2 ml pediatric.

Use of Konakion 10 mg/ml with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This is very important, as the use of multiple medications at the same time may increase or decrease the effect of these medications.

The following medications may interact with Konakion:

Anticoagulants such as warfarin or acenocoumarol (medications that help prevent the formation of blood clots in blood vessels)

Medications for epilepsy.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.
• 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.

It is not recommended to administer Konakion for the prevention of neonatal hemorrhagic disease to women in advanced pregnancy or breastfeeding.

Driving and operating machinery

Konakion has no or insignificant influence on the ability to drive or operate machinery.

Konakion 10 mg/ml contains sodium hydroxide

This medication contains less than 23 mg (1 mmol) of sodium per ampoule, making it essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.Depending on the nature of your illness, your doctor will administer the correct dose of this medication.

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

Usual dose for adults

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

After withdrawal of the anticoagulant coumarin treatment you are taking, administer slowly (at least 30 seconds) intravenously a dose of 5-10 mg of Konakion together with fresh frozen plasma (PFC) or prothrombin complex concentrate (CCP). The dose of vitamin K1 can be repeated as needed.

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

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

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

PFC, fresh frozen plasma

CCP, prothrombin complex concentrate

Hypoprothrombinemia due to other causes

In hypoprothrombinemia due to absorption disorders or treatment with antibiotics, salicylates or sulfonamides, a dose of 2 mg of Konakion 10 mg/ml can be administered orally or injectable in adults. Konakion should be administered at the lowest effective dose.

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

Older patients

Older patients tend to be more sensitive to the effect of this medication. Therefore, the dose in this group should be set at the lower limits of the recommended values. It has been shown that small doses of 0.5 to 1 mg of vitamin K1 by intravenous or oral route effectively reduce INR to <5.

Use in children

Children over one year

The doctor will decide on the appropriate dose based on the indication and weight of the patient. It has been reported that a single dose corresponding to one-tenth of the total intravenous dose of vitamin K1 in adults is effective in reversing asymptomatic elevations of INR (>8) in clinically well children.

Newborns and children under one year

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

Normally, Konakion will be administered as a single dose, but if your response is not sufficient, you may be able to repeat the administrations.

Instructions for correct administration of the preparation

The Konakion solution must be clear (clean) at the time of use. If the ampoules have not been properly stored, they may be turbid or have phase separation. If this is the case, the ampoule should be discarded.

Oral route:Konakion can be administered with a syringe as follows: Break the ampoule neck and extract the necessary 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. Wash the syringe with liquid.

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

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

The cases of vitamin K1 (phytomenadione) overdose are unknown. The treatment with anticoagulants may be affected.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center or call the Toxicological Information Service. Phone 91 562.04.20 indicating the medication and the amount administered.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Store below 25°C.

Keep the ampoules in the outer packaging to protect from light.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the solution is cloudy or presents phase separation.

Due to stability reasons, the unused content of opened ampoules cannot be used and must be discarded.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you do not need. By doing so, you will help protect the environment.

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

-The active ingredient is phytonadione (vitamin K1synthesis). Each ampoule contains 10 mg of phytonadione (vitamin K1) in 1 ml.

-The other components areglycolic acid, sodium hydroxide, lecithin, hydrochloric acid 25% and water for injectable preparations.

Appearance of the product and contents of the packaging

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

Each package contains 5 amber glass ampoules of 1 ml.

Other presentations:

Konakion2 mg/0.2 ml pediatric oral solution/injectable solution

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Local Representative

Laboratorios Rubió, S.A.

C/ Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Responsible for Manufacturing

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Last review date of this leaflet:December 2015.

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/