Peyona

Package leaflet: Information for the user

Peyona 20 mg/mL solution for infusion and oral solution

caffeine citrate
Please read this leaflet carefully before your baby is given this medicine because it contains
important information for your newborn.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your child's doctor.
• If your newborn experiences any side effects, including those not listed in this leaflet, consult your child's doctor. See section 4.

Contents of this leaflet

1. What Peyona is and what it is used for
2. What you need to know before Peyona is given to your baby
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 the active substance caffeine citrate, which is a central nervous system stimulant belonging to a group of medicines called methylxanthines.
Peyona is used for the treatment of breathing pauses in premature infants (primary apnea of prematurity).
These brief breathing interruptions in premature infants are caused by the child's incomplete development of the respiratory centres.
This medicine has been shown to reduce the number of episodes of breathing pauses in premature infants.

2. What you should know before Peyona is given to your child

Do not use Peyona

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

Warnings and precautions
Talk to your child's doctor before Peyona is given to your newborn.
Before starting treatment for apnea of prematurity with Peyona, your child's doctor should have ruled out or appropriately treated any other possible causes of apnea.
Peyona must be used with caution. Inform the doctor if:

• your child suffers from seizures
• your child has any heart disorders
• your child has kidney or liver problems
• your child experiences frequent episodes of regurgitation
• your child produces more urine than usual
• your child has low body weight or inadequate food intake
• if you (the mother) took caffeine before delivery

Other medicines and Peyona
Inform your child's doctor if your newborn is taking, has recently taken, or might take any other medicines.
Inform your child's doctor if your newborn has previously been treated with theophylline.
Do not use the following medicines during treatment with Peyona without first consulting your child's doctor. The doctor may need to adjust the dose or change 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 blood in the stool (necrotizing enterocolitis) if administered together with medicines used to treat stomach disorders (such as H2-receptor blocking antihistamines 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 must not drink coffee or consume other products high in caffeine, as caffeine is excreted in breast milk.
Peyona contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. 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 monitoring and surveillance. Treatment must be initiated under the supervision of a physician experienced in neonatal intensive care.
Dose
Your baby's doctor will prescribe the correct dose of Peyona based on body weight.
The loading 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 will be administered by controlled intravenous infusion using a syringe pump or another calibrated delivery device. This method is also known as an "infusion".
Some of the maintenance doses may be administered orally.
It may be necessary for your baby's doctor to periodically monitor caffeine levels in the blood during treatment to avoid toxic effects.
Duration of treatment
Your baby's doctor will decide exactly how long the treatment with Peyona should continue. If your baby has been free from apnoea episodes for 5 to 7 days, the doctor will discontinue treatment.
If your baby is given more Peyona than he/she should receive
Your baby may develop fever, rapid breathing (tachypnea), restlessness, muscle tremors, vomiting, high blood sugar levels (hyperglycaemia), low potassium levels (hypokalaemia), elevated levels of certain chemicals (urea), an increased number of certain blood cells (white blood cells), and seizures if given too much caffeine citrate.
In such a case, treatment with Peyona must be stopped immediately and your baby's doctor will treat the overdose.
If you have any doubts about the use of this medicine, consult your baby's doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. However, it may be difficult to distinguish them from some common complications occurring in premature infants or from complications due to the underlying disease.
During treatment with Peyona, your newborn may experience some of the following reactions:

Serious side effects
Side effects whose frequency cannot be estimated from the available data

• severe intestinal disease with blood in the stool (necrotizing enterocolitis)

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

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

• local inflammatory reactions at the infusion site
• heart disorders such as increased heart rate (tachycardia)
• changes in blood or serum sugar levels (hyperglycaemia)

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

• stimulation of the central nervous system such as seizures
• heart disorders such as irregular heart rate (arrhythmia)

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

• allergic reactions

Side effects whose frequency cannot be estimated from the available data

• blood infections (sepsis)
• changes in blood or serum sugar levels (hypoglycaemia), poor growth, feeding intolerance
• stimulation of the central nervous system such as irritability, restlessness, and agitation; brain injury
• deafness
• regurgitation, increased gastric aspirate
• increased urine output, increased levels of certain components in urine (sodium and calcium)
• changes in blood tests (reduced haemoglobin levels after prolonged treatment and reduced thyroid hormone levels at the beginning of treatment)

Reporting of side effects
If your newborn experiences any side effects, including those not listed in this leaflet, please inform your child's doctor. You may also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 that month.
This medicine does not require any special storage conditions.
Before administration, parenteral solution vials must be inspected visually for the presence of particulate matter.
After opening the vial, the medicine should be used immediately.

6. Package contents and other information

What Peyona contains
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 vial contains 20 mg of caffeine citrate (equivalent to 10 mg of base caffeine).
Each 3 mL vial 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.

Description of the appearance of Peyona and contents of the pack
Peyona is a solution for infusion and an oral solution.
Peyona is a clear, colourless solution supplied in glass vials. Each carton contains 10 vials.

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Chiesi sa/nv Chiesi Pharmaceuticals GmbH
Tél/Tel: + 32 (0)2 788 42 00 Tel: + 43 1 4073919

България Luxembourg/Luxemburg
Chiesi Bulgaria EOOD Chiesi sa/nv
Тел.: +359 29201205 Tél/Tel: + 32 (0)2 788 42 00

Česká republika Magyarország
Chiesi CZ s.r.o. Chiesi Hungary Kft.
Tel: + 420 261221745 Tel.: + 36-1-429 1060

Danmark Malta
Chiesi Pharma AB Chiesi Farmaceutici S.p.A
Tlf: + 46 8 753 35 20 Tel: + 39 0521 2791

Deutschland Nederland
Chiesi GmbH Chiesi Pharmaceuticals B.V.
Tel: + 49 40 89724-0 Tel: +31 88 501 64 00

Eesti Norge
Chiesi Pharmaceuticals GmbH Chiesi Pharma AB
Tel: + 43 1 4073919 Tlf: + 46 8 753 35 20

Ελλάδα Österreich
Chiesi Hellas AEBE Chiesi Pharmaceuticals GmbH
Τηλ: + 30 210 6179763 Tel: + 43 1 4073919

España Polska
Chiesi España, S.A.U. Chiesi Poland Sp. z.o.o.
Tel: + 34 93 494 8000 Tel.: +48 22 620 1421

France Portugal
Chiesi S.A.S Chiesi Farmaceutici S.p.A.
Tél: + 33 1 47688899 Tel: + 39 0521 2791

Hrvatska România
Providens d.o.o. Chiesi Romania S.R.L.
Tel.: +385 (1) 48 74 500 Tel: + 40 212023642

Ireland Slovenija
Chiesi Farmaceutici S.p.A. Chiesi Slovenija d.o.o.
Tel: + 39 0521 2791 Tel: +386-1-43 00 901

Ísland Slovenská republika
Chiesi Pharma AB Chiesi Slovakia s.r.o.
Sími: +46 8 753 35 20 Tel: +421 259300060

Italia Suomi/Finland
Chiesi Italia S.p.A. Chiesi Pharma AB
Tel: + 39 0521 2791 Puh/Tel: +46 8 753 35 20

Κύπρος Sverige
Chiesi Farmaceutici S.p.A. Chiesi Pharma AB
T \h\l : + 39 0521 2791 Tel: +46 8 753 35 20

Latvija United Kingdom (Northern Ireland)
Chiesi Pharmaceuticals GmbH Chiesi Farmaceutici S.p.A.
Tel: + 43 1 4073919 Tel: + 39 0521 2791

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu .

The following information is intended exclusively for healthcare professionals:
For detailed information, refer to the enclosed Summary of Product Characteristics for PEYONA.