KONAKION 2 MG/0.2 ML PEDIATRIC ORAL SOLUTION/INJECTION SOLUTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Konakion 2 mg/0.2 ml paediatric 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 effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Konakion 2 mg/0.2 ml paediatric is and what it is used for
2. What you need to know before using Konakion 2 mg/0.2 ml paediatric
3. How to use Konakion 2 mg/0.2 ml paediatric
4. Possible adverse effects
5. How to store Konakion 2 mg/0.2 ml paediatric
6. Contents of the pack and other information

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

Konakion paediatric contains as the active substance phytomenadione, which is vitamin K1, involved in the blood clotting mechanism. A deficiency of vitamin K1 leads to an increased tendency to bleed; it is used for the treatment and prevention of bleeding (haemorrhages).

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

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

Do not use Konakion pediatric

If the child is allergic to phytomenadione or to any of the other components of this medicine (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 medicine by parenteral route (injectable), as it may be associated with a potential risk of kernicterus (a serious neurological complication due to increased levels of bilirubin in the blood) in premature infants weighing less than 2.5 kg.
• If the ampoules have not been properly stored, they may appear cloudy or show phase separation. In such a case, the ampoule must be discarded.

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

Inform your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines, including those obtained without a prescription. 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 of the coumarin type (medicines that prevent thrombus formation), such as warfarin or acenocumarol.
• Medicines for epilepsy

Pregnancy, breastfeeding and fertility

Not applicable.

Driving and using machines

Not applicable.

Konakion 2 mg/0.2 ml pediatric 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 2 mg/0.2 ml paediatric

Follow exactly the instructions given by your doctor for administering this medicine. If in doubt, consult your doctor or pharmacist again. Administration can be oral or by intramuscular or intravenous injection.

How to administer the dose of Konakion paediatric depends on the intended use and whether the infant is premature.

Prevention of haemorrhagic disease of the newborn

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

The medicine may be administered in either of the following ways:

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

Additional oral doses:

• Infants receiving oral vitamin K who are breastfed may require additional oral doses of vitamin K.
• Bottle-fed infants who have received the two oral doses of vitamin K may not require further vitamin K doses, as it is included in the formula milk.

Premature newborns weighing 2.5 kg or more, or full-term newborns at special risk of haemorrhage (e.g., birth asphyxia, obstructive jaundice, etc.)

• These infants will receive an intramuscular or intravenous injection of 1 mg of Konakion at birth or shortly afterwards.
• If the risk of haemorrhage persists, additional injections may be administered.

Premature newborns weighing less than 2.5 kg

Intramuscular and intravenous doses must not exceed 0.4 mg/kg of the infant's body weight (equivalent to 0.04 ml/kg) in premature infants weighing 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 child's coagulation status.

Dosing information table for premature newborns at birth

Treatment of hemorrhagic disease of the newborn

• These babies will receive an intravenous injection of 1 mg (half the content of one ampoule) at birth or shortly thereafter.
• If the risk of bleeding persists, additional injections may be administered. Some babies may also require a blood transfusion.

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

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

Oral administration: Use the dispenser provided in the package. Break the neck of the ampoule and insert the dispenser vertically. Draw the solution from the ampoule by filling the dispenser up to the mark indicated on it. Administer the contents directly into the child's mouth.

Parenteral (injectable) administration: Konakion pediatric must not be diluted or mixed with other parenteral medications, but it may be injected into the bottom of an infusion set.

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

Symptoms that may occur in case of overdose include: jaundice (yellowing of the skin), hyperbilirubinemia (increased blood bilirubin concentration), elevated levels of GOT and GGT (liver enzymes), abdominal pain, constipation, soft stools, malaise, restlessness, and skin rashes.

In case of overdose or accidental ingestion, consult your doctor 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.

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

Allergic reactions (anaphylactoid) have been reported following injectable administration of Konakion pediatric.

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

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

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 Medicines: www.notificaRAM.es.

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

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 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 you notice that the solution is cloudy or shows phase separation.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Konakion 2 mg/0.2 ml paediatric

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

• The other components are glycocholic acid, sodium hydroxide, lecithin, 25% hydrochloric acid, and water for injections.

Appearance of the product and contents of the pack

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

Each pack 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 Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent review of this leaflet: December 2015.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/