Peyona 20 mg/ml solution for infusion and oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Peyona 20 mg/mL infusion solution and oral solution

caffeine citrate

Read all of this leaflet carefully before your child starts using this medicine, because 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 side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Peyona is and what it is used for

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

Peyona is used in the treatment of breathing interruptions in premature babies (primary apnea of prematurity).

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

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

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

Do not use Peyona

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

Warnings and precautions

Talk to 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 appropriately treated other causes of apnea.

Peyona must be used with caution. Inform your child’s doctor:

• If your child has convulsive seizures
• If your child has a heart condition
• 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

Other medicines and Peyona

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

Tell your child’s doctor if your child has previously been treated with theophylline.

Do not use the following medicines during treatment with Peyona 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 Peyona, you should not drink coffee or consume other products high in caffeine, as caffeine passes into breast milk.

Peyona contains sodium

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

3. How to use Peyona

Peyona 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.

Dosage

Your child's physician will prescribe the correct amount of Peyona based on your child's body 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 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 physician may need to monitor caffeine concentrations through periodic blood tests during treatment to avoid toxicity.

Duration of treatment

Your child's physician will determine exactly how long your child's treatment with Peyona should last. If your child remains free from apnoea episodes for 5 to 7 days, the physician will discontinue treatment.

If your child receives more Peyona than prescribed

Your child may develop fever, rapid breathing (tachypnoea), restlessness, muscle tremors, vomiting, elevated blood sugar (hyperglycaemia), decreased blood potassium (hypokalaemia), increased blood levels of certain chemicals (urea), elevated number of certain blood cells (leucocytes), and seizures if given more caffeine citrate than prescribed.

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

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

4. Possible adverse effects

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

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

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 components in urine (sodium and calcium)
• Changes in blood tests (reduction of 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 Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 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 for the presence of particles before administration. Once the ampoule has been opened, the medicine should be used immediately.

6. Contents of the pack and other information

Composition of Peyona

The active substance is caffeine citrate.

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

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

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

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

Nature of the product and contents of the container

Peyona is a solution for infusion and an oral solution.

Peyona is a clear, colourless solution presented in glass ampoules. Each carton contains 10 ampoules.

Marketing Authorization Holder

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43122 Parma

Italy

Manufacturer (batch release responsibility)

Alfasigma S.p.A.

Via Enrico Fermi 1

Alanno (PE)

Italy

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

A-1010 Wien

Austria

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: December 2021

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

This information is intended for healthcare professionals only:

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