PEYONA 20 mg/ml SOLUTION FOR INFUSION AND ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Peyona 20mg/mL solution for infusion and oral solution

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

Contents of the package leaflet

1. What is Peyona and what is it used for
2. What you need to know before your child starts treatment with Peyona
3. How to use Peyona
4. Possible side effects
5. Storage of Peyona
6. Package contents and further information

1. What is Peyona and what is it used for

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

Peyona 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 apnea episodes in premature infants.

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

Do not use Peyona

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

Warnings and precautions

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

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

Peyona 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 childbirth

Other medicines and Peyona

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 Peyona without talking to your child's doctor first. The doctor may need to adjust the dose or change one of the medicines:

• 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 medicine may increase the risk of severe intestinal disease with bloody stools (necrotizing enterocolitis) when administered with certain medications 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 Peyona, you should not drink coffee or take other products with high caffeine content, as caffeine passes into breast milk.

Peyona contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose; it is essentially "sodium-free".

3. How to use Peyona

Peyona 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 Peyona based on your child's weight.

The initial dose is 20 mg per kg of body weight (equivalent to 1 mL per kg of body weight).

The maintenance dose is 5 mg per kg of body weight (equivalent to 0.25 mL per kg of body weight) every 24 hours.

Route and method of administration

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

Some doses (maintenance doses) may be administered orally.

It may be necessary for your child's doctor to monitor caffeine concentrations 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 Peyona. If your child remains apnea-free for 5 to 7 days, the doctor will discontinue treatment.

If your child receives more Peyona than they should

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

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

If you have any further 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 Peyona:

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)
• changes 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)
• changes in blood sugar or serum levels (hypoglycemia), growth delay, 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)
• changes 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, consult your doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online reporting system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Peyona

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 solution ampoules should be inspected visually for particulate matter and discoloration prior to administration. Once the ampoule is opened, the medicine should be used immediately.

6. Package contents and further information

Composition of Peyona

The active substance is caffeine citrate.

Each mL contains 20 mg of caffeine citrate (equivalent to 10 mg/mL of caffeine base).

Each 1 mL ampoule contains 20 mg of caffeine citrate (equivalent to 10 mg of caffeine base).

Each 3 mL ampoule contains 60 mg of caffeine citrate (equivalent to 30 mg of caffeine base).

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

Appearance and package contents

Peyona is a solution for infusion and oral solution.

Peyona is a clear and colorless solution presented in glass ampoules. Each carton contains 10 ampoules.

Marketing authorisation holder

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43122 Parma

Italy

Manufacturer (batch release)

Alfasigma S.p.A.

Via Enrico Fermi 1

Alanno (PE)

Italy

Chiesi Pharmaceuticals GmbH,

Gonzagagasse 16/16,

A-1010 Wien

Austria

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: December 2021

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

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This information is intended for healthcare professionals only:

If you require detailed information, consult the Summary of Product Characteristics (SPC) for PEYONA attached.