KONAKION 2 mg/0.2 ml PEDIATRIC ORAL SOLUTION/INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Konakion 2mg/0.2ml pediatric oral solution/injectable solution

Phytomenadione

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again. If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Konakion 2 mg/0.2 ml pediatric and what is it used for
2. What you need to know before taking Konakion 2 mg/0.2 ml pediatric
3. How to take Konakion 2 mg/0.2 ml pediatric
4. Possible side effects
5. Storage of Konakion 2 mg/0.2 ml pediatric
6. Package contents and additional information

1. What is Konakion 2 mg/0.2 ml pediatric and what is it used for

Konakion pediatric contains the active substance phytomenadione, which is vitamin K1, involved in the blood coagulation mechanism. The lack of vitamin K1 causes an increased tendency to bleed; it is used for the treatment and prevention of bleeding (hemorrhages).

Konakion pediatric is indicated for: prevention and treatment of hemorrhagic disease of the newborn (bleeding due to vitamin K deficiency).

2. What you need to know before taking Konakion 2 mg/0.2 ml pediatric

Do not useKonakion pediatric

If the child is allergic to phytomenadione or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to use Konakion 2 mg/0.2 ml pediatric.

• Caution is required when administering the medication parenterally (by injection), as it is associated with a possible risk of kernicterus (severe neurological complication due to increased bilirubin levels in the blood) in premature infants with a weight below 2.5 kg.
• If the ampoules have not been stored correctly, they may appear turbid or show phase separation. In this case, the ampoule should be discarded.

Using Konakion 2 mg/0.2 ml pediatric with other medications

Tell your doctor or pharmacist if your child is using, has recently used, or may need to use any other medication, including those purchased without a prescription. This is very important, as the use of multiple medications at the same time can increase or decrease their effect.

The following medications may interact with Konakion:

• Anticoagulants of the coumarin type (medications that prevent thrombus formation), such as warfarin or acenocoumarol.
• Medications for epilepsy

Pregnancy, breastfeeding, and fertility

Not applicable.

Driving and using machines

Not applicable.

Konakion2 mg/0.2 ml pediatriccontainssodium hydroxide

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

3. How to take Konakion 2 mg/0.2 ml pediatric

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Administration can be oral or by intramuscular or intravenous injection.

The administration of Konakion pediatric will depend on its intended use and whether it is for a premature baby.

Prevention of hemorrhagic disease of the newborn

Healthy newborns born at term or near term (with normal gestational age)

It will be administered in one of the following ways:

• A single injection of 1 mg (half the contents of an ampoule) by intramuscular route at birth or shortly after, or
• An initial oral dose of 2 mg (one ampoule) at birth or shortly after. After this dose, a second dose of 2 mg will be administered at 4-7 days and a third dose of 2 mg one month after birth. In infants exclusively fed with formula milk (bottle), the third oral dose may not be necessary.

Additional oral doses:

• Babies who receive oral vitamin K and are breastfed may need additional oral vitamin K doses.
• Babies fed with formula milk who receive the two oral vitamin K doses may not need additional vitamin K doses. This is because it is included in the formula milk.

Premature newborns with a weight of 2.5 kg or more or term newborns with a special risk of hemorrhage(e.g., asphyxia during delivery, obstructive jaundice, etc.)

• These babies will receive an intramuscular or intravenous injection of 1 mg of Konakion at birth or shortly after.
• If the risk of hemorrhage continues, additional injections may be administered.

Premature newborns with a weight below 2.5 kg

Intramuscular and intravenous doses should not exceed 0.4 mg/kg of the baby's weight (equivalent to 0.04 ml/kg) in premature infants with a weight below 2.5 kg (see "Warnings and precautions" in section 2). The amount and frequency of additional doses will be adjusted according to the child's coagulation status.

Dosing information table for premature newborns at birth

Treatment of hemorrhagic disease of the newborn

• These babies will receive an injection of 1 mg (half the contents of an ampoule) by intravenous route at birth or shortly after.
• If the risk of hemorrhage continues, additional injections may be administered. Some babies may also need a blood transfusion.

Instructions for the correct administration of Konakion 2 mg/0.2 ml pediatric

The solution should be clear and transparent at the time of use.

Oral route: Use the dispenser included in the package. Break the neck of the ampoule and insert the dispenser vertically. Extract the solution from the ampoule by charging the dispenser to the mark. Administer the contents directly into the child's mouth.

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

If you use more Konakion 2 mg/0.2 ml pediatric than you should

The symptoms that may appear in case of overdose are: jaundice (yellowing of the skin), hyperbilirubinemia (increased bilirubin concentration in the blood), increased levels of GOT and GGT (liver enzymes), abdominal pain, constipation, soft stools, discomfort, agitation, and skin rashes.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Rare side effects (which may affect up to 1 in 1,000 people):

Anaphylactoid reactions have been described after injectable administration of Konakion pediatric.

Local irritation (pain, swelling, sensitivity) at the injection site may also occur after injectable administration.

If you notice anything unusual in the child, such as redness of the face or difficulty breathing, contact your doctor immediately.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es.

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

5. Storage of Konakion 2 mg/0.2 ml pediatric

Store below 25°C.

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

Keep this medication out of the sight and reach of children. Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice that the solution is turbid or shows phase separation.

For stability reasons, the unused contents of opened ampoules cannot be used and should be discarded.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Konakion 2 mg/0.2 ml pediatric

• The active ingredient is phytomenadione (vitamin K1). Each 0.2 ml ampoule contains 2 mg of phytomenadione.

• The other components are glycolic acid, sodium hydroxide, lecithin, 25% hydrochloric acid, and water for injectable preparations.

Appearance of the product and package contents

Konakion pediatric is an oral and injectable solution contained in amber glass ampoules.

Each package contains 5 ampoules of 0.2 ml and 5 dispensers for oral administration.

Other presentations:

Konakion 10 mg/ml oral solution/injectable solution (for adults).

Marketing authorization holder and manufacturer

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

Manufacturer

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Date of the last revision of this package leaflet:December 2015.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/