Active ingredient
- caffeine citrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 01883/0345.
Caffeine Citrate 10mg/ml Oral Solution
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Caffeine Citrate 10mg/ml Oral Solution
Equivalent to Caffeine 5mg/ml
Please read all of this leaflet carefully before your baby is given this medicine.
What is in this leaflet:
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
1. What Caffeine Citrate 10mg/ml Oral Solution is and what it is used for
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.
2. What you need to know before your baby is given Caffeine Citrate 10mg/ml Oral Solution
Your baby should not be given Caffeine Citrate 10mg/ml Oral Solution
Warnings and precautions
Talk to your baby’s doctor before your newborn is given Caffeine Citrate 10mg/ml Oral Solution if your baby:
Other medicines and Caffeine Citrate 10mg/ml Oral Solution
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.
Pregnancy and breast-feeding
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.
Caffeine Citrate Oral 10mg/ml Solution contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.
3. How Caffeine Citrate 10mg/ml Oral Solution is used
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.
Duration of treatment
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 your baby is given more Caffeine Citrate 10mg/ml Oral Solution than they should
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.
4. Possible side effects
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:
Serious side effects
Other side effects
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)
Reporting of side effects
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.
5. How to store Caffeine Citrate 10mg/ml Oral Solution
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
6. Contents of the pack and other information
What Caffeine Citrate 10mg/ml Oral Solution contains
The active ingredient is caffeine citrate 10mg/ml.
The other ingredients are:
What Caffeine Citrate 10mg/ml Oral Solution looks like and contents of the pack
Marketing authorisation holder
Manufacturer
This leaflet was last revised in: July 2018
Marketing Authorisation Number: PL 01883/0345
D04359
Building A2, Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, UK
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