Leaflet: Information for the user

Gencebok 10 mg/ml infusion solution

caffeine citrate

Read this 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 side effects, consult your child's doctor, even if they are not listed in this leaflet. See section 4.

Gencebok contains citrate of caffeine as its active ingredient, which is a central nervous system stimulant belonging to a group of medications called methylxanthines.

Gencebok is used in the treatment of breathing interruption in premature babies (primary apnea of premature newborns).

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

It has been observed that this medication reduces the number of episodes of breathing interruption in premature newborns.

No use Gencebok:

• If your newborn baby is allergic to caffeine citrate or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your child's doctor before starting treatment with Gencebok.

Before starting treatment for premature apnea with Gencebok, your child's doctor must have ruled out or adequately treated other causes of apnea.

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

• If your child experiences convulsions
• If your child has any heart disease
• If your child has kidney or liver problems
• If your child experiences frequent regurgitation
• If your child produces more urine than normal
• If your child does not gain sufficient weight or does not eat enough
• If you (the mother) consumed caffeine before delivery

Use of Gencebok with other medications

Inform your child's doctor if your child is taking, has taken recently, or may need to take any other medication.

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

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

- theophylline (used to treat respiratory difficulties)

- doxapram (used to treat respiratory difficulties)

- cimetidine (used to treat stomach diseases)

- ketoconazole (used to treat fungal infections)

- phenobarbital (used to treat epilepsy)

- phenytoin (used to treat epilepsy)

This medication may increase the risk of severe intestinal disease that presents with bloody stools (necrotizing enterocolitis) when administered with certain medications used to treat stomach diseases (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 receives treatment with Gencebok, you should not drink coffee or consume other products with high caffeine content, as caffeine passes into breast milk.

Gencebok contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per dose, so it can be said to have practically no sodium.

Gencebok should only be used in a neonatal intensive care unit that has 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.

Route and form of administration

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

Some doses (maintenance doses) may be administered orally.

Your child's doctor may need to monitor the caffeine concentration through periodic blood tests throughout the treatment to avoid toxicity.

Treatment duration

Your child's doctor will decide exactly how long the treatment with Gencebok should last. If your child remains without apnea crises for 5 to 7 days, the doctor will discontinue the 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 (hyperglycemia), decreased blood potassium (hypokalemia), elevated blood concentration of certain chemicals (urea), elevated white blood cell count (leukocytosis), and seizures if they receive more caffeine citrate than they should.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. However, it is difficult to distinguish them from the frequent complications that occur in premature babies and from the complications inherent in the disease.

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

Severe side effects

Side effectswhose frequency cannot be calculated from the available data.

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

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

Other side effects

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

- local inflammatory reactions at the site of infusion

- cardiac disorders such as rapid heartbeat (tachycardia)

- alterations in blood sugar concentration or serum glucose (hyperglycemia)

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

- stimulation of the central nervous system, for example, convulsions

- cardiac disorders such as irregular heartbeat (arrhythmia)

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

- allergic reactions

Side effectswhose frequency cannot be calculated from the available data:

blood infection (sepsis)

- alterations in blood sugar or serum glucose (hypoglycemia), growth delay, feeding intolerance

- stimulation of the central nervous system, such as irritability, nervousness, and restlessness; brain injury

- hearing loss

- regurgitation, increased aspiration of stomach contents

- increased urine volume, increased levels of certain components of urine (sodium and calcium)

- alterations in blood tests (reduction of hemoglobin after prolonged treatment and decrease in thyroid hormone at the beginning of treatment)

Reporting side effects

If your newborn baby experiences any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

All parenteral solution ampoules must be visually inspected before administration to detect the presence of particles. Once the ampoule is opened, the medication must be used immediately.

Composition of Gencebok

• The active principle is citrate of caffeine.

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

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

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

Appearance of the product and contents of the package

Gencebok is a perfusion solution.

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

Holder of the marketing authorization

Gennisium Pharma

Swen Parc de Vitrolles

Chemin de la Bastide Blanche

13127 Vitrolles - France

Responsible for manufacturing(batch approval)

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 medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

The detailed information on this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

If you wish to have detailed information, please refer to the technical data sheet for Gencebok attached.