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CAFFEINE CITRATE 10MG/ML ORAL SOLUTION

Active substance(s): CAFFEINE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

D03650

Caffeine Citrate 10mg/ml Oral Solution
Equivalent to Caffeine 5mg/ml

In this leaflet:
1. What Caffeine Citrate 10mg/ml Oral
Solution is and what is it used for
2. 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. Storing Caffeine Citrate 10mg/ml Oral
Solution
6. Further information

1. What Caffeine Citrate 10mg/ml
Oral Solution is and what it is
used for
• Caffeine belongs to a group of medicines
known as methylxanthines
• It stimulates breathing, and is used to
treat apnoea of prematurity (breathing
difficulties as a result of being born
prematurely).

2. Before your baby takes
Caffeine Citrate 10mg/ml Oral
Solution
Your baby should not be given Caffeine
Citrate 10mg/ml Oral Solution if there is
known hypersensitivity (allergy) to any of the
ingredients listed in paragraph 6 overleaf.
Special care is needed with Caffeine
Citrate 10mg/ml Oral Solution when your
baby:
• has liver or kidney disease
• has had any unusual heart rhythms
detected.

Please tell the doctor looking after your baby
of any of such problems.
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.
If you, as the mother, drank a lot of coffee,
or took any other high caffeine-containing
product just before your baby was born,
some caffeine may still be present in your
baby’s circulation. Tell the doctor about this.
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.
Caffeine Citrate 10mg/ml Oral Solution
contains 3.04mg sodium per 1ml of the
solution, which the doctor will need to
consider if your baby is on a controlled
sodium diet.

3. How Caffeine Citrate 10mg/ml
Oral Solution is used
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:
• A starting dose of 20mg/kg of the baby’s
body weight calculated as caffeine citrate
(equivalent to caffeine 10mg/kg or 2ml/kg
of this solution).
Continued overleaf

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.

4. Possible side effects
Caffeine acts as a stimulant to the nervous
system. Side effects from this action may
include restlessness or jitteriness. Caffeine
may also aggravate any tendency to
vomiting.
If you think your baby is showing any of
these side effects, or you notice any other
effects after caffeine treatment, please tell
the doctor immediately.
Other side-effects are not visible, but will be
detected by the monitoring equipment used
in the special care baby unit:
• your baby may produce more urine than
usual, and as a consequence blood levels
of certain chemicals (sodium, calcium and
glucose) may be affected.
• Increased blood pressure or heart rate
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.
Accidental overdosage: 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.

5. Storing Caffeine Citrate 10mg/
ml Oral Solution
Caffeine Citrate 10mg/ml Oral Solution
needs to be kept out of the reach and sight
of children. There are no other special
conditions of storage.
Use by date: Do not use Caffeine Citrate
10mg/ml Oral Solution after the expiry
date on the label, or if there are any signs of
discolouration or clouding of the solution.

6. Further Information
The active ingredient is caffeine.
The other ingredients are:
• water for injections
• citric acid
• sodium chloride
• sodium hydroxide
• dilute hydrochloric acid
What Caffeine Citrate 10mg/ml Oral
Solution looks like and contents of the
pack
• 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.
Marketing authorisation holder
Viridian Pharma Ltd, Bampton Road,
Romford, Essex, RM3 8UG
Manufacturer
Macarthys Laboratories Limited T/A
Martindale Pharma, Bampton Road,
Harold Hill, Romford, Essex RM3 8UG
This leaflet was last revised:
January 2017
Marketing Authorisation Number:
20346/0005

D03650

Please read all of this leaflet carefully
before your baby is given this medicine.
• 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.

• Followed after 24 hours by a lower daily
maintenance dose of 5 to 10mg/kg of the
baby’s body weight calculated as caffeine
citrate (equivalent to caffeine 2.5 to 5mg/
kg or 0.5 to 1ml/kg of this solution).

100mm Measurement Verification Bar

3650-C

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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