• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask the hospital doctor who is looking after your baby.
  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 Caffeine Citrate 10mg/ml Oral Solution is and what is it used for
2. What you need to know before your baby is given Caffeine Citrate 10mg/ml Oral Solution
3. How Caffeine Citrate 10mg/ml Oral Solution is used
4. Possible side effects
5. How to store Caffeine Citrate 10mg/ml Oral Solution
6. Contents of the pack and other information

• if allergic to caffeine citrate or to any of the other ingredients of this medicine listed in section 6.

Talk to your baby’s doctor before your newborn is given Caffeine Citrate 10mg/ml Oral Solution if your baby:

• has liver or kidney disease
• has had any unusual heart rhythms detected or heart disease.
• suffers from seizures
• has frequent regurgitation
• produces more urine than usual
• 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.

As with most medicines, Caffeine Citrate 10mg/ml Oral Solution may interact with other medicines given at the same time. A premature baby may need many medicines, and any problems with caffeine are likely to be minor, but tell the doctor about any other medication they may not know about, particularly any other medicine (for example theophylline) given to your baby to help it breathe.

Medications containing phenobarbitone or phenytoin, taken by the mother herself to treat epilepsy, may also have an effect on the way the baby reacts to caffeine therapy. If you have been taking treatment for epilepsy during pregnancy, please tell your baby’s doctor about it.

• Doxapram (used to treat breathing difficulties)
• Cimetidine (used to treat gastric disease)
• Ketoconazole (used to treat fungal infections)
• 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 Caffeine Citrate 10mg/ml Oral Solution, 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 ml, that is to say essentially ‘sodium-free’.

Your baby’s doctor will decide exactly how long your newborn must continue therapy with Caffeine Citrate 10mg/ml Oral Solution. If your baby has 5 to 7 days without apnoea attacks, the doctor will stop treatment.

The doctor may decide to check the levels of caffeine in a blood sample as a precaution, or if your baby is not responding to treatment as expected.

If too much caffeine solution is accidentally given to your baby, the side effects described above may become more noticeable. In cases of very high overdosage, fits can also occur. If signs of over-dosage are noticed, please tell the baby’s doctor immediately.

Treatment with Caffeine Citrate 10mg/ml Oral Solution should be stopped immediately and your baby’s doctor should treat the overdose.

• serious intestinal disease with bloody stools (necrotising enterocolitis)
• convulsion
• allergic reactions
• bloodstream infection (sepsis)

Common (may affect up to 1 in 10 people)

• cardiac disorders such as fast heart beat (tachycardia)
• increased sugar in blood or serum (hyperglycaemia)

Uncommon (may affect up to 1 in 100 people)

• cardiac disorders such as irregular heart beat (arrhythmia)

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

• reduced sugar in blood or serum (hypoglycaemia)
• failure to grow
• feeding intolerance
• stimulation of central nervous system such as irritability,nervousness, restlessness and 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)
• 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 Yellow Card Scheme.

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient is caffeine citrate 10mg/ml.

The other ingredients are:

• water for injections
• citric acid
• sodium chloride
• sodium hydroxide
• dilute hydrochloric acid

• Caffeine Citrate 10mg/ml Oral Solution is available in clear glass bottles with a rubber stopper and screw cap containing 5ml. Each 1ml of the solution contains 10mg caffeine citrate, equivalent to 5mg caffeine.