Leaflet: information for the user

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

Fitomenadiona

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 isKonakion 2 mg/0.2 ml pediatricand what it is used for

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

3. How to useKonakion 2 mg/0.2 ml pediatric

4. Possible side effects

5. Storage ofKonakion 2 mg/0.2 ml pediatric

6. Contents of the pack and additional information

Konakion pediatric contains the active substance phytonadione, which is vitamin K1,involved in the blood coagulation mechanism.Lack of vitamin K1causes an increase in the tendency to bleed; it is used for the treatment and prevention of bleeding (hemorrhages).

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

Do not useKonakion pediatric

If the child is allergic to phytonadione or to any of the other components of this medication (including those 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 by parenteral route (injectable), as it is associated with a possible risk of kernicterus (a severe neurological complication due to increased bilirubin levels in the blood) in premature children weighing less than2.5 kg.
• If the vials have not been stored correctly, they may present turbidity or phase separation. In this case, the vial will be discarded.

Use of Konakion 2 mg/0.2 ml pediatric with other medications

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

The following medications may interact with Konakion:

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

Pregnancy, breastfeeding, and fertility

Not applicable.

Driving and operating machinery

Not applicable.

Konakion2 mg/0.2 ml pediatriccontainssodium hydroxide

This medication contains less than 23 mg (1 mmol) of sodium per vial, so it is considered 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. The administration can be oral or intramuscular or intravenous.

The dosage of Konakion pediatric will depend on what it is used for and if it is a premature baby.

Prevention of newborn hemorrhagic disease

Healthy full-term or near-full-term newborns (with normal gestation duration)

It will be administered in any of the following ways:

• A single intramuscular injection of 1 mg (half the content of a vial) at birth or shortly after, or
• An initial oral dose of 2 mg (a vial) 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 formula-fed infants (bottle-fed), the third oral dose may not be necessary.

Additional oral doses:

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

Preterm newborns with a weight of 2.5 kg or more or full-term newborns with a special risk of hemorrhage(e.g. birth asphyxia, 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 can be administered.

Preterm newborns and with a weight of less than 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 of less than 2.5 kg (see "Warnings and precautions" in section 2). The amount and frequency of additional doses will be adjusted according to the baby's coagulation status.

Table of information on doses in preterm newborns at birth

Treatment of newborn hemorrhagic disease

• These babies will receive an intravenous injection of 1 mg (half the content of a vial) at birth or shortly after.
• If the risk of hemorrhage continues, additional injections can 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 must be clean and transparent at the time of use.

Oral route: Use the dispenser included in the package. Break the vial neck and insert the dispenser vertically. Extract the solution from the vial by loading the dispenser to the mark. Administer the contents directly into the baby'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 (yellow discoloration of the skin), hyperbilirubinemia (increase in bilirubin concentration in the blood), increased levels of GOT and GGT (liver enzymes), abdominal pain, constipation, soft stools, discomfort, agitation, and skin eruptions.

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.

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

Allergic reactions (anaphylactoid) have been described after the administration of injectable Konakion pediatric.

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

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

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 below25°C.

Keep the ampoules in the outer packaging to protect it 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 away through drains or in the trash. Dispose of the packaging and medications you do not need at the SIGRE collection pointof the pharmacy. In case of 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 2 mg/0.2 ml pediatric

-The active ingredient is phytonadione (vitamin K1).Each ampule of 0.2 ml contains 2 mg of phytonadione.

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

Appearance of the product and contents of the packaging

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

Eachpackaging contains5 ampules of 0.2 ml and 5 dispensers for oral administration.

Other presentations:

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

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 medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/