Peyona 20 mg/ml solution for infusion and oral solution

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your baby’s doctor.
• If your newborn gets any side effects, talk to your baby’s doctor. This includes any possible side effects not listed in this leaflet. See section 4.

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

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

Talk to your baby’s doctor before your newborn is given Peyona.

Prior to starting treatment for apnoea of prematurity with Peyona other causes of apnoea should have been excluded or properly treated by your baby’s doctor.

Peyona should be used with caution. Please inform your baby’s doctor:

• If your newborn suffers from seizures
• If your newborn suffers from any heart disease
• If your newborn has kidney or liver problems
• If your newborn has frequent regurgitation
• If your newborn produces more urine than usual
• If your newborn has a reduced weight gain or food intake
• If you (the mother) consumed caffeine prior to delivery

Tell your baby’s doctor if your newborn is taking, have recently taken or might take any other medicines.

Please inform your baby’s doctor if your newborn has been previously treated with theophylline.

Do not use the following medicines during the treatment with Peyona without talking to your baby’s doctor. The doctor may need to adjust the dose or change one of the medicines to something else:

• theophylline (used to treat breathing difficulties)
• doxapram (used to treat breathing difficulties)
• cimetidine (used to treat gastric disease)
• ketoconazole (used to treat fungine infections)
• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)

This medicine may increase the risk for serious intestinal disease with bloody stools (necrotising enterocolitis) when administered with medicines used to treat gastric disease (such as antihistamine H2 receptor blockers or proton-pump inhibitors that reduces gastric acid secretion).

If you (the mother) are breast-feeding while your infant is treated with Peyona, you should not drink coffee or take any other high caffeine product as caffeine passes into breast milk.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

Your baby’s doctor will prescribe the right amount of Peyona based on your baby’s weight.

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

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

Peyona will be infused by controlled intravenous infusion, using a syringe infusion pump or other metered infusion device. This method is also known as “a drip”.

Some of the doses (maintenance doses) may be given by mouth.

It may be needed that your baby’s doctor decides to check the levels of caffeine in a blood test periodically throughout treatment to avoid toxicity.

Your baby’s doctor will decide exactly how long your newborn must continue therapy with Peyona.

If your baby has 5 to 7 days without apnoea attacks, the doctor will stop the treatment.

Your newborn may experience fever, rapid breathing (tachypnoea), jitteriness, muscular tremor, vomiting, high blood levels of sugar (hyperglycemia), low blood levels of potassium (hypokalaemia), high blood levels of certain chemicals (urea), elevated number of certain cells (leukocyte) in blood and seizures if he/she receives more caffeine citrate than he/she should.

In the event of this happening treatment with Peyona should be stopped immediately and your baby’s doctor should treat the overdose.

Side effects where the frequency cannot be estimated from the available data

• serious intestinal disease with bloody stools (necrotising enterocolitis)

The following other side effects may also be considered serious by your baby’s doctor in the context of the global clinical evaluation.

Common reported side effects (may affect up to 1 in 10 people)

• local inflammatory reactions at the infusion site
• cardiac disorders such as fast heart beat (tachycardia)
• changes of sugar in blood or serum (hyperglycaemia)

Uncommon reported side effects (may affect up to 1 in 100 people)

• stimulation of central nervous system such as convulsion
• cardiac disorders such as irregular heart beat (arrhythmia)

Rare reported side effects (may affect up to 1 in 1,000 people)

• allergic reactions

Side effects where the frequency cannot be estimated from the available data

• bloodstream infection (sepsis)
• changes of sugar in blood or serum (hypoglycaemia), failure to grow, feeding intolerance
• stimulation of central nervous system such as irritability, nervousness and restlessness; brain injury
• deafness
• regurgitation, increase in stomach aspirate
• increase of urine flow, increase of certain urine components (sodium and calcium)
• changes in blood tests (reduced levels of haemoglobin after prolonged treatment and reduced thyroid hormone at the start of treatment)

If your newborn gets any side effects, talk to your baby’s doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:

United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Ireland: HPRA Pharmacovigilance Website: www.hpra.ie

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is caffeine citrate.

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

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

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

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

Peyona is a solution for infusion and oral solution.

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

Ireland:

United Kingdom: