Peyona 20 mg/ml solution for infusion and oral solution

Peyona is a stimulant of the central nervous system, belonging to a group of medicines called methylxanthines.

Peyona is used in the treatment of interrupted breathing in premature babies (primary apnoea of premature neonates).
These short periods when premature babies stop breathing are due to the baby?s breathing centres not being fully developed.

Peyona must not be used:

• If your newborn is allergic (hypersensitive) to caffeine citrate or any of the other ingredients of Peyona

Take special care with 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 your newborn has been previously treated with theophylline (used to treat breathing difficulties)
• If you (the mother) consumed caffeine prior to delivery

Taking other medicines:

Do not use the following medicines during the treatment with Peyona without talking to your 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).

Please inform your baby?s doctor if your newborn is taking or has recently taken any other medicines, even those not prescribed.

Pregnancy and breast-feeding

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.

Important information about some of the ingredients of Peyona

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ?sodium-free?.

Peyona should only be used in a neonatal intensive care unit in which adequate facilities are available for patient surveillance and monitoring. Treatment should be initiated under supervision of a physician experienced in neonatal intensive care.

Dose

Your baby?s doctor will prescribe the right amount of Peyonabased 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.

Method of administration

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.

Duration of treatment

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.

If your newborn receives more Peyona than he/she should

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.
If you have any further questions on the use of this product, ask your baby?s doctor.

Like all medicines, Peyona can cause side effects, although not everybody gets side effects. However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease.
The frequency of possible side effects listed below is defined using the following convention:

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very rare affects less than 1 user in 10,000 Not known frequency cannot be estimated from the available data

While under treatment with Peyona, your newborn may experience some of the following reactions:

• Common: local inflammatory reactions at the infusion site
• Rare: allergic reactions
• Frequency not known:
• bloodstream infection (sepsis)
• changes of sugar in blood or serum (hypoglycaemia and hyperglycaemia), failure to grow,feeding intolerance
• stimulation of central nervous system such as irritability, nervousness and restlessness; braininjury, and seizures
• deafness
• cardiac disorders such as fast heart beat (tachycardia)
• regurgitation, increase in stomach aspirate, serious intestinal disease with bloody stools(necrotising enterocolitis)
• increase of urine flow, increase of certain urine components (sodium and calcium)
• changes in blood tests (reduced levels of haemoglobin after prolonged treatment and reducedthyroid hormone at the start of treatment)

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your baby?s doctor.

Keep out of the reach and sight of children.
The medicinal product must not be used after the expiry date stated on the label.
The medicinal product does not require any special storage conditions.
Ampoules of all parenteral solutions must be inspected visually for particulate matter prior to administration. After opening the ampoules, the product should be used immediately.

What Peyona contains

The active substance is caffeine citrate.
Each ml contains 20 mg caffeine citrate (equivalent to 10 mg/ml of caffeine base). Each1 ml ampoule contains 20 mg caffeine citrate (equivalent to 10 mg of caffeine base). The other ingredients are citric acid, sodium citrate and water for injections.

What Peyona looks like and content of the pack

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation HolderChiesi Farmaceutici S.p.A,
Via Palermo 26/A,
I-43100 Parma,
Italy

Manufacturer (Batch release)
Alfa Wasserman S.p.A,
Via Enrico Fermi 1,
Alanno (PE)
Italy

Torrex Chiesi Pharma GmbH,
Gonzagagasse 16/16,
A-1010 Wien
Austria

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Chiesi Farmaceutici S.p.A. Tlf 39 0521 2791 LuxembourgLuxemburg Chiesi Farmaceutici S.p.A. Tlf 39 0521 2791

Torrex Chiesi Bulgaria Ltd . 359 29201205 Magyarország Torrex Chiesi Kft. Tel.36-1-429 1060

eská republika Torrex Chiesi CZ s.r.o. Tel 420 261221745 Malta Chiesi Farmaceutici S.p.A Tel 39 0521 2791

Danmark Chiesi Farmaceutici S.p.A. Tlf 39 0521 2791 Nederland Chiesi Pharmaceuticals B.V. Tel 31 0 70 413 20 80

Deutschland Chiesi GmbH Tel 49 40 89724-0 Norge Chiesi Farmaceutici S.p.A. Tlf 39 0521 2791

Eesti Torrex Chiesi Pharma GmbH Tel 43 1 4073919 Österreich Torrex Chiesi Pharma GmbH Tel 43 1 4073919

Chiesi Hellas Pharmaceuticals S.A. 30 210 6179763 Polska Torrex Chiesi Polska Sp z.o.o. Tel. 48 22 620 1421

España Chiesi España, S.A Tel 34 93 494 8000 Portugal Chiesi Farmaceutici S.p.A. Tel 39 0521 2791

France Chiesi S.A. Tél 33 1 47688899 România Torrex Chiesi S.R.L. Tel 40 212023642

Ireland Trinity-Chiesi Pharmaceuticals Ltd Tel 44 0161 4885555 Slovenija Torrex Chiesi Slovenija d.o.o. Tel 386-1-43 00 901

Ísland Chiesi Farmaceutici S.p.A. Sími 39 0521 2791 Slovenská republika Torrex Chiesi Slovakia s.r.o. Tel 421 259300060

Italia Chiesi Farmaceutici S.p.A. Tel 39 0521 2791 SuomiFinland Chiesi Farmaceutici S.p.A. PuhTel 39 0521 2791

Chiesi Farmaceutici S.p.A. T 39 0521 2791 Sverige Chiesi Farmaceutici S.p.A. Tel 39 0521 2791

Latvija Torrex Chiesi Pharma GmbH Tel 43 1 4073919 United Kingdom Chiesi Ltd Tel 44 0161 4885555

Lietuva
Torrex Chiesi Pharma GmbH
Tel: + 43 1 4073919

This leaflet was last approved in:

------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only: For detailed information refer to the enclosed Summary of Product Characteristics of PEYONA.