Patient Leaflet Updated 14-Sep-2018 | Martindale Pharma, an Ethypharm Group Company
Caffeine Citrate 10mg/ml Oral Solution
Caffeine Citrate 10mg/ml Oral Solution
Equivalent to Caffeine 5mg/ml
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
These short periods when premature babies stop breathing are due to the baby’s breathing centres not being fully developed. This medicine has been shown to reduce the number of episodes of interrupted breathing in premature newborns.
Talk to your baby’s doctor before your newborn is given Caffeine Citrate 10mg/ml Oral Solution if your baby:
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.
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’.
Caffeine Citrate 10mg/ml Oral Solution 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.
The doctor or nurse will administer Caffeine Citrate 10mg/ml Oral Solution by mouth or via a gastric feeding tube. The exact dose depends on each baby’s needs and response to the treatment, but will usually be:
If your baby fails to respond to the starting dose (after at least 4 hours), the doctor or nurse may give one more higher dose, before continuing to the lower maintenance doses.
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.
If you have any further questions on the use of this medicinal product, ask your baby’s doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them. However, it is difficult to distinguish them from frequent complications occurring in premature babies and complications due to the disease.
While under treatment with Caffeine Citrate 10 mg/ml Oral Solution, your newborn may experience some of the following reactions:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Not known (frequency cannot be estimated from the available data)
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.
Keep this medicine out of the sight and reach of children.
There are no other special conditions of storage.
Do not use this medicine after the expiry date which is stated on the label.
The expiry date refers to the last day of that month
Do not use if there are any signs of discolouration or clouding of the solution. Use once only and discard bottle and any remaining solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment
The active ingredient is caffeine citrate 10mg/ml.
The other ingredients are:
This leaflet was last revised in: July 2018
Marketing Authorisation Number: PL 01883/0345
D04359
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