Gencebok 10 mg/ml solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Gencebok 10 mg/ml solution for infusion

caffeine citrate

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for your child.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your child's doctor.
• If your child experiences any adverse effects, consult your child's doctor, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Gencebok is and what it is used for
2. What you need to know before your child starts treatment with Gencebok
3. How to use Gencebok
4. Possible side effects
5. How to store Gencebok
6. Contents of the pack and other information

1. What Gencebok is and what it is used for

Gencebok contains caffeine citrate as the active substance, which is a central nervous system stimulant belonging to a group of medicines called methylxanthines.

Gencebok is used in the treatment of breathing interruptions in premature infants (primary apnea of prematurity).

These brief periods during which premature infants stop breathing occur because the infant's respiratory center is not fully developed.

This medicine has been shown to reduce the number of episodes of breathing interruption in premature newborns.

2. What you need to know before starting your child's treatment with Gencebok

Do not use Gencebok:

• if your newborn child is allergic to caffeine citrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your child's doctor before starting treatment with Gencebok.

Before starting treatment for apnea of prematurity with Gencebok, your child's doctor should have ruled out or appropriately treated other causes of apnea.

Gencebok must be used with caution. Inform your child's doctor:

• If your child has convulsive seizures
• If your child has any heart disease
• If your child has kidney or liver problems
• If your child has frequent regurgitation
• If your child produces more urine than normal
• If your child does not show adequate weight gain or is not feeding sufficiently
• If you (the mother) consumed caffeine before delivery

Use of Gencebok with other medicines

Tell your child's doctor if your child is taking, has recently taken, or might need to take any other medicines.

Inform your child's doctor if your child has previously been treated with theophylline.

Do not use the following medicines during treatment with Gencebok without first talking to your child's doctor. The doctor may need to adjust the dose or replace one of the medicines:

• theophylline (used to treat breathing difficulties)
• doxapram (used to treat breathing difficulties)
• cimetidine (used to treat stomach disorders)
• ketoconazole (used to treat fungal infections)
• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)

This medicine may increase the risk of a serious intestinal disease with bloody stools (necrotizing enterocolitis) when administered together with certain drugs used to treat stomach disorders (such as histamine H2-receptor antagonists or proton pump inhibitors that reduce gastric acid secretion).

Pregnancy and breastfeeding

If you (the mother) are breastfeeding while your child is receiving treatment with Gencebok, you should not drink coffee or consume other products high in caffeine, as caffeine passes into breast milk.

Gencebok contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, therefore it is considered practically sodium-free.

3. How to use Gencebok

Gencebok must only be used in a neonatal intensive care unit equipped with appropriate facilities for patient observation and monitoring. Treatment must be initiated under the supervision of a physician experienced in neonatal intensive care.

Dose

Your child's doctor will prescribe the correct amount of Gencebok based on your child's body weight. The initial dose is 20 mg per kg of body weight (equivalent to 2 ml per kg of body weight). The maintenance dose is 5 mg per kg of body weight (equivalent to 0.5 ml per kg of body weight) every 24 hours.

Route and method of administration

Gencebok must be administered by controlled intravenous infusion using a syringe pump or other volumetric infusion device. This method is also known as an "infusion".

Some doses (maintenance doses) may be administered orally.

Your child's doctor may need to monitor caffeine concentrations through periodic blood tests during treatment to avoid toxicity.

Duration of treatment

Your child's doctor will decide exactly how long your child's treatment with Gencebok should last. If your child remains free from apnea episodes for 5 to 7 days, the doctor will discontinue treatment.

If your child receives more Gencebok than they should

Your child may develop fever, rapid breathing (tachypnea), restlessness, muscle tremors, vomiting, elevated blood sugar (hyperglycemia), low blood potassium (hypokalemia), increased blood levels of certain chemicals (urea), elevated number of certain blood cells (leukocytes), and seizures if they receive more caffeine citrate than they should.

In such cases, treatment with Gencebok must be stopped immediately, and your child's doctor will need to manage the overdose.

If you have any further questions about the use of this medicine, ask your child's doctor.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. However, it may be difficult to distinguish them from the common complications occurring in premature infants or from complications inherent to the underlying disease.

Your child may experience some of the following reactions during treatment with Gencebok:

Serious adverse effects

Adverse effects whose frequency cannot be estimated from the available data.

• severe intestinal disease with bloody stools (necrotizing enterocolitis).

The following other adverse effects may also be considered serious by your child's physician within the context of the overall clinical assessment.

Other adverse effects

Adverse effects observed frequently (may affect up to 1 in 10 people)

• local inflammatory reactions at the infusion site
• cardiac disorders such as increased heart rate (tachycardia)
• changes in blood or serum glucose concentration (hyperglycemia)

Adverse effects observed uncommonly (may affect up to 1 in 100 people)

• stimulation of the central nervous system, for example seizures
• cardiac disorders such as irregular heartbeat (arrhythmia)

Adverse effects observed rarely (may affect up to 1 in 1,000 people)

• allergic reactions

Adverse effects whose frequency cannot be estimated from the available data:

blood infection (sepsis)

• changes in blood or serum sugar (hypoglycemia), growth retardation, feeding intolerance
• stimulation of the central nervous system, such as irritability, nervousness, and restlessness; brain injury
• deafness
• regurgitation, increased aspiration of stomach contents
• increased urine volume, elevation of certain urine components (sodium and calcium)
• changes in blood tests (reduction in hemoglobin after prolonged treatment and decrease in thyroid hormone at the beginning of treatment)

Reporting of adverse effects

If your newborn experiences any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gencebok

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

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

All ampoules containing parenteral solutions should be inspected visually before administration to check for the presence of particles. Once the ampoule has been opened, the medicine should be used immediately.

6. Contents of the pack and other information

Composition of Gencebok

• The active substance is caffeine citrate.

Each ml contains 10 mg of caffeine citrate (equivalent to 5 mg/ml of base caffeine).

Each 1 ml ampoule contains 10 mg of caffeine citrate (equivalent to 5 mg of base caffeine).

• The other components are citric acid, sodium citrate and water for injections.

Nature and contents of the container

Gencebok is a concentrate for solution for infusion.

Gencebok is a clear, colourless solution supplied in glass ampoules with 2 blue rings as a code. Each carton contains 50 ampoules.

Marketing Authorisation Holder

Gennisium Pharma
Swen Parc de Vitrolles
Chemin de la Bastide Blanche
13127 Vitrolles - France

Manufacturer (Batch Release Responsibility)

Cenexi
52 rue Marcel et Jacques Gaucher
94120 Fontenay Sous-Bois
France

Gennisium Pharma
Swen Parc de Vitrolles (Building E)
Chemin de la Bastide Blanche
13127 Vitrolles
France

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.euopa.eu.

This information is intended for healthcare professionals only:

For detailed information, please refer to the attached Gencebok summary of product characteristics.