Caffeine citrate Monico

Package leaflet: Information for the user

caffeina citrato Monico

10 mg/ml infusion solution and oral solution
20 mg/ml infusion solution and oral solution
caffeina citrato
Please read all of this leaflet carefully before this medicine is administered to your baby, as 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, contact your child's doctor. See section 4.

Contents of this leaflet:

1. What caffeina citrato Monico is and what it is used for

2. What you need to know before caffeina citrato Monico is given to your baby

3. How to use caffeina citrato Monico

4. Possible side effects

5. How to store caffeina citrato Monico

6. Contents of the pack and other information

7. What caffeina citrato Monico is and what it is used for
   Caffeina citrato Monico contains the active substance caffeina citrato, which is a central nervous system stimulant belonging to a group of medicines called methylxanthines. Caffeina citrato Monico is used for the treatment of breathing interruptions in premature infants (primary apnea of prematurity). These brief breathing pauses in premature infants are caused by the incomplete development of the infant's respiratory centres. This medicine has been shown to reduce the number of episodes of breathing interruption in premature infants.

2. What you need to know before caffeine citrate Monico is given to your child

Caffeine citrate Monico must not be given to your child

• if he/she is allergic to caffeine citrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your child's doctor before caffeine citrate Monico is administered.
Before starting treatment for apnea of prematurity with caffeine citrate Monico, your child's doctor should have ruled out or appropriately treated any other possible causes of apnea.
Caffeine citrate Monico 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;
• you (the mother) have consumed caffeine before delivery.

The doctor must carefully monitor your child during treatment with this medicine to ensure that he/she does not develop a serious inflammatory condition affecting the small intestine and colon (necrotizing enterocolitis).
Other medicines and caffeine citrate Monico
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 for your child during treatment with caffeine citrate Monico without first consulting your child's doctor. The doctor may need to adjust the dose or discontinue one of the following 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 concomitantly 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 caffeine citrate Monico, you must not drink coffee or consume other products high in caffeine, as caffeine is excreted in breast milk.
Caffeine citrate Monico contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to use Caffeina Citrato Monico

Caffeina citrato Monico 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.
If you have any doubts, consult your child's doctor.

Dosage
Your child's doctor will prescribe the correct dose of Caffeina citrato Monico based on body weight.
The initial dose is 20 mg per kilogram of body weight.
The maintenance dose is 5 mg per kilogram of body weight every 24 hours.

Route and method of administration
Caffeina citrato Monico will be administered via a controlled intravenous infusion, using a syringe pump or another device delivering measured amounts. This method is commonly known as an "infusion" or "drip".
Some of the maintenance doses may be administered orally.

It may be necessary for your child's doctor to periodically monitor caffeine blood levels during treatment to prevent toxic effects.

Duration of treatment
Your child's doctor will determine exactly how long treatment with Caffeina citrato Monico should continue. If your child has gone 5 to 7 days without apnea episodes, the doctor will discontinue treatment.

If your child receives more Caffeina citrato Monico than he/she should
If your child receives more Caffeina citrato Monico than required, symptoms may include fever, rapid breathing (tachypnea), restlessness, muscle tremors, vomiting, elevated blood glucose levels (hyperglycemia), low potassium levels (hypokalemia), increased levels of certain chemicals (urea), elevated white blood cell count, and seizures.
In such a case, treatment with Caffeina citrato Monico must be immediately stopped and your child's doctor will treat the overdose.

If you have any questions about the use of this medicine, consult your child's doctor.

4. Possible side effects

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

Serious side effects
Not known (frequency cannot be estimated from the available data):

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

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

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

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

Uncommon (may affect up to 1 in 100 people):

• central nervous system stimulation such as seizures;
• cardiac disorders such as irregular heart rate (arrhythmia).

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

• allergic reactions.

Not known (frequency cannot be estimated from the available data):

• blood infections (sepsis);
• decreased levels of sugar in blood or serum (hypoglycaemia), poor growth, feeding intolerance;
• central nervous system stimulation such as irritability, restlessness and agitation; brain lesions;
• deafness;
• regurgitation, increased gastric aspirate;
• increased urine flow, 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 effect, including those not listed in this leaflet, please contact your child's doctor. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store caffeine citrate Monico

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
The solution should be clear, colourless and free from visible particles. It is intended for single, uninterrupted administration, and any remaining residue must not be used.
After opening the vial, the medicine must be used immediately.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What caffeine citrate Monico contains
caffeine citrate Monico 10 mg/ml solution for infusion and oral solution – colourless glass vial of
type I with 1 ml

• The active substance is caffeine citrate. Each 1 ml vial contains 10 mg of caffeine citrate, equivalent to 5 mg of caffeine base.
• The other components are: citric acid, sodium hydroxide and water for injections.

caffeine citrate Monico 20 mg/ml solution for infusion and oral solution – colourless glass vial of
type I with 1 ml

• The active substance is caffeine citrate. Each 1 ml vial contains 20 mg of caffeine citrate, equivalent to 10 mg of caffeine base.
• The other components are: citric acid, sodium hydroxide and water for injections.

caffeine citrate Monico 20 mg/ml solution for infusion and oral solution – colourless glass vial of
type I with 2 ml

• The active substance is caffeine citrate. Each 2 ml vial contains 40 mg of caffeine citrate, equivalent to 20 mg of caffeine base.
• The other components are: citric acid, sodium hydroxide and water for injections.

Description of the appearance of caffeine citrate Monico and contents of the pack
Pack containing 10 vials of 1 or 2 ml of solution.
Marketing Authorisation Holder and Manufacturer
Monico S.p.A.
Via Ponte di Pietra 7, 30173 Venezia Mestre – Italy

The following information is intended exclusively for doctors or healthcare professionals

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