PACKAGE LEAFLET: INFORMATION FOR THE PATIENT doctor or nurse may give one more higher • changes in blood tests (reduced levels dose, before continuing to the lower of haemoglobin after prolonged Caffeine Citrate 10mg/ml Oral Solution maintenance doses. treatment) Duration of treatment • reduced thyroid hormone at the start Equivalent to Caffeine 5mg/ml Your baby’s doctor will decide exactly of treatment with other medicines given at the same Please read all of this leaflet carefully how long your newborn must continue Reporting of side effects time. A premature baby may need many before your baby is given this therapy with Caffeine Citrate 10mg/ml If your newborn gets any side effects, medicines, and any problems with caffeine medicine. Oral Solution. If your baby has 5 to 7 days talk to your baby’s doctor. This includes are likely to be minor, but tell the doctor • Keep this leaflet. You may need to read without apnoea attacks, the doctor will any possible side effects not listed in this about any other medication they may it again. stop treatment. leaflet. You can also report side effects D04359 not know about, particularly any other • If you have further questions, please The doctor may decide to check the directly via Yellow Card Scheme. medicine (for example theophylline) given ask the hospital doctor who is looking levels of caffeine in a blood sample Website: www.mhra.gov.uk/yellowcard to your baby to help it breathe. after your baby. as a precaution, or if your baby is not or search for MHRA Yellow Card in the If your newborn gets any side effects, Medications containing phenobarbitone responding to treatment as expected. Google Play or Apple App Store. By reporting side effects you can help talk to your baby’s doctor. This includes or phenytoin, taken by the mother If your baby is given more Caffeine any possible side effects not listed in herself to treat epilepsy, may also have provide more information on the safety Citrate 10mg/ml Oral Solution than of this medicine. this leaflet. See section 4. an effect on the way the baby reacts to they should caffeine therapy. If you have been taking If too much caffeine solution is 5. How to store Caffeine Citrate What is in this leaflet: treatment for epilepsy during pregnancy, accidentally given to your baby, the side 10mg/ml Oral Solution please tell your baby’s doctor about it. 1. What Caffeine Citrate 10mg/ml Oral effects described above may become Keep this medicine out of the sight and ·Doxapram (used to treat breathing Solution is and what is it used for more noticeable. In cases of very high reach of children. difficulties) 2. What you need to know before your overdosage, fits can also occur. If signs of There are no other special conditions ·Cimetidine (used to treat gastric disease) baby is given Caffeine Citrate 10mg/ml over-dosage are noticed, please tell the of storage. Oral Solution ·Ketoconazole (used to treat fungal baby’s doctor immediately. infections) Do not use this medicine after the expiry 3. How Caffeine Citrate 10mg/ml Oral Treatment with Caffeine Citrate 10mg/ date which is stated on the label. ·This medicine may increase the risk for Solution is used ml Oral Solution should be stopped The expiry date refers to the last day of serious intestinal disease with bloody 4. Possible side effects immediately and your baby’s doctor should that month 5. How to store Caffeine Citrate 10mg/ml stools (necrotising enterocolitis) treat the overdose. Oral Solution when administered with medicines Do not use if there are any signs of 6. Contents of the pack and other information used to treat gastric disease (such as If you have any further questions on the use discolouration or clouding of the solution. antihistamine H2 receptor blockers or of this medicinal product, ask your baby’s Use once only and discard bottle and any 1. What Caffeine Citrate 10mg/ml proton-pump inhibitors that reduces doctor. remaining solution. Oral Solution is and what it is gastric acid secretion). 4. Possible side effects Do not throw away any medicines via used for wastewater or household waste. Ask your Pregnancy and breast-feeding Like all medicines, this medicine can cause pharmacist how to throw away medicines • Caffeine belongs to a group of medicines If you (the mother) are breast-feeding side effects, although not everybody gets you no longer use. These measures will known as methylxanthines while your infant is treated with Caffeine them. However, it is difficult to distinguish help protect the environment • It is used in the treatment of interrupted Citrate 10mg/ml Oral Solution, you should them from frequent complications breathing in premature babies (primary not drink coffee or take any other high occurring in premature babies and 6. Contents of the pack and apnoea of premature newborns). caffeine product as caffeine passes into complications due to the disease. other information These short periods when premature breast milk. While under treatment with Caffeine Citrate What Caffeine Citrate 10mg/ml Oral babies stop breathing are due to the Caffeine Citrate Oral 10mg/ml Solution 10 mg/ml Oral Solution, your newborn may Solution contains baby’s breathing centres not being fully experience some of the following reactions: contains sodium The active ingredient is caffeine citrate developed. This medicine has been This medicine contains less than 1 mmol Serious side effects shown to reduce the number of episodes 10mg/ml. sodium (23 mg) per ml, that is to say • serious intestinal disease with bloody The other ingredients are: of interrupted breathing in premature essentially ‘sodium-free’. stools (necrotising enterocolitis) newborns. • water for injections 3. How Caffeine Citrate 10mg/ml • convulsion • citric acid 2. What you need to know before Oral Solution is used • allergic reactions • sodium chloride your baby is given Caffeine • bloodstream infection (sepsis) • sodium hydroxide Caffeine Citrate 10mg/ml Oral Solution Other side effects • dilute hydrochloric acid Citrate 10mg/ml Oral Solution should only be used in a neonatal Your baby should not be given Caffeine intensive care unit in which adequate Common (may affect up to 1 in 10 people) What Caffeine Citrate 10mg/ml Oral Citrate 10mg/ml Oral Solution facilities are available for patient • cardiac disorders such as fast heart beat Solution looks like and contents of the • if allergic to caffeine citrate or to any of surveillance and monitoring. Treatment (tachycardia) pack the other ingredients of this medicine should be initiated under supervision • increased sugar in blood or serum • Caffeine Citrate 10mg/ml Oral Solution listed in section 6. of a physician experienced in neonatal (hyperglycaemia) is available in clear glass bottles Warnings and precautions intensive care. Uncommon (may affect up to 1 in 100 with a rubber stopper and screw The doctor or nurse will administer people) cap containing 5ml. Each 1ml of the Talk to your baby’s doctor before your Caffeine Citrate 10mg/ml Oral Solution by solution contains 10mg caffeine citrate, newborn is given Caffeine Citrate 10mg/ml • cardiac disorders such as irregular heart mouth or via a gastric feeding tube. The beat (arrhythmia) equivalent to 5mg caffeine. Oral Solution if your baby: exact dose depends on each baby’s needs • has liver or kidney disease Not known (frequency cannot be Marketing authorisation holder and response to the treatment, but will Macarthys Laboratories Limited • has had any unusual heart rhythms usually be: estimated from the available data) detected or heart disease. • reduced sugar in blood or serum T/A Martindale Pharma, Bampton Road, • A starting dose of 20mg/kg of the baby’s Romford, Essex, RM3 8UG • suffers from seizures body weight calculated as caffeine (hypoglycaemia) • has frequent regurgitation citrate (equivalent to caffeine 10mg/kg • failure to grow Manufacturer • produces more urine than usual or 2ml/kg of this solution). • feeding intolerance Macarthys Laboratories Limited T/A • has a reduced weight gain or food intake • stimulation of central nervous system Martindale Pharma, Bampton Road, • If you (the mother) consumed caffeine • Followed after 24 hours by a lower daily such as irritability,nervousness, Harold Hill, Romford, Essex RM3 8UG prior to delivery maintenance dose of 5 to 10mg/kg of restlessness and brain injury the baby’s body weight calculated as This leaflet was last revised in: Other medicines and Caffeine Citrate • deafness caffeine citrate (equivalent to caffeine July 2018 10mg/ml Oral Solution • regurgitation 2.5 to 5mg/kg or 0.5 to 1ml/kg of this Tell your baby’s doctor if your newborn is • increase in stomach aspirate Marketing Authorisation Number: solution). taking, have recently taken or might take • increase of urine flow PL 01883/0345 any other medicines. If your baby fails to respond to the • increase of certain urine components starting dose (after at least 4 hours), the (sodium and calcium) As with most medicines, Caffeine Citrate 10mg/ml Oral Solution may interact Continued overleaf D04359 100mm Measurement Verification Bar 4359-A.