GENCEBOK 10 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Gencebok 10 mg/ml solution for infusion

caffeine citrate

Read all of this leaflet carefully before your child starts using this medicine because it contains important information for them.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your child's doctor.
• If your child experiences any side effects, talk to your child's doctor, even if it is not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Gencebok and what is it 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. Storage of Gencebok
6. Contents of the pack and other information

1. What is Gencebok and what is it used for

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

Gencebok is used to treat apnea of prematurity (primary apnea of premature infants).

These brief periods during which premature infants stop breathing are due to the fact that the child's respiratory center is not fully developed.

It has been observed that this medicine reduces the number of episodes of apnea in premature infants.

2. What you need to know before your child starts treatment with Gencebok

Do not use Gencebok:

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

Warnings and precautions

Consult 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 adequately treated other causes of apnea.

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

• If your child has a history of seizures
• If your child has 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 sufficient weight gain or does not eat enough
• If you (the mother) consumed caffeine before birth

Using Gencebok with other medicines

Tell your child's doctor if they are taking, have recently taken, or might take any other medicines.

Tell your child's doctor if they have been previously treated with theophylline.

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

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

This medicine may increase the risk of severe intestinal disease with bloody stools (necrotizing enterocolitis) when given with certain medicines used to treat stomach diseases (such as 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 being treated with Gencebok, you should not drink coffee or take other products with high caffeine content, as caffeine passes into breast milk.

Gencebok contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, so it can be considered as essentially sodium-free.

3. How to use Gencebok

Gencebok should only be used in a neonatal intensive care unit with adequate facilities for patient observation and monitoring. Treatment should be initiated under the supervision of a doctor with experience in neonatal intensive care.

Dose

Your child's doctor will prescribe the correct amount of Gencebok based on your child's 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.

Method and route of administration

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

Some doses (maintenance doses) may be given orally.

It may be necessary for your child's doctor to monitor caffeine levels through periodic blood tests throughout treatment to avoid toxicity.

Duration of treatment

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

If your child receives more Gencebok than they should

Your child may experience fever, rapid breathing (tachypnea), nervousness, muscle tremors, vomiting, elevated blood sugar levels (hyperglycemia), decreased potassium levels in the blood (hypokalemia), elevated levels of certain chemicals in the blood (urea), and increased white blood cell count, as well as seizures if they receive more caffeine citrate than they should.

In these cases, treatment with Gencebok should be discontinued immediately and your child's doctor will need to treat the overdose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. However, it is difficult to distinguish them from the frequent complications that occur in premature infants and from the complications of the disease itself.

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

Serious side effects

Side effectswhose frequency cannot be estimated from the available data.

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

The following other side effects may also be considered serious by your child's doctor in the context of the overall clinical assessment.

Other side effects

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

• local inflammatory reactions at the infusion site
• heart disorders such as rapid heart rate (tachycardia)
• alterations in blood sugar or serum levels (hyperglycemia)

Side effects observed infrequently(may affect up to 1 in 100 people)

• central nervous system stimulation, such as seizures
• heart disorders such as irregular heart rhythm (arrhythmia)

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

• allergic reactions

Side effectswhose frequency cannot be estimated from the available data:

blood infection (sepsis)

• alterations in blood sugar or serum levels (hypoglycemia), growth retardation, feeding intolerance
• central nervous system stimulation, such as irritability, nervousness, and restlessness; brain injury
• hearing loss
• regurgitation, increased aspiration of stomach contents
• increased urine output, increased levels of certain components in the urine (sodium and calcium)
• alterations in blood tests (reduced hemoglobin after prolonged treatment and decreased thyroid hormone at the start of treatment)

Reporting of side effects

If your newborn experiences any side effects, talk to your child's doctor, even if it is not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side 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 is the last day of the month stated.

This medicine does not require any special storage conditions.

All parenteral solutions should be inspected visually for particulate matter before administration. Once the ampoule is 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 caffeine base).

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

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

Appearance and pack contents

Gencebok is a solution for infusion.

Gencebok is a clear and colorless solution presented in glass ampoules with 2 blue rings as a code. Each box contains 50 ampoules.

Marketing authorisation holder

Gennisium Pharma

Swen Parc de Vitrolles

Chemin de la Bastide Blanche

13127 Vitrolles - France

Manufacturer (batch release)

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

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended only for healthcare professionals:

If you want detailed information, consult the summary of product characteristics of Gencebok attached.