When parents ask for your help calming post-immunisation fever,
there’s a name healthcare professionals have trusted for over 35 years.
Gentle enough for babies Suitable from 2 months*
Gets to work on fever in just 15 minutes
Lets Kids be Kids
CALPOL 120 mg/5 ml Sugar Free Infant Oral Suspension COMPOSITION: contains 120 mg Paracetamol in each 5 ml. INDICATIONS: for the treatment of pain (including teething pain), and as an antipyretic. CALPOL Sugar Free Infant Suspension is indicated for the relief of headache, migraine, neuralgia, toothache and teething pains, sore throat, rheumatic aches and pains, infl uenza, feverishness and feverish colds. DOSAGE: Infants aged 2-3 months: Post-vaccination fever and other causes of Pain and Fever - if your baby weighs over 4 kg and was born after 37 weeks: 2.5 ml. If necessary, after 4-6 hours, give a second 2.5 ml dose. Do not give to babies less than 2 months of age. Do not give more than 2 doses. Leave at least 4 hours between doses. If further doses are needed, talk to your doctor or pharmacist. It is important to shake the bottle for at least 10 seconds before use. Children aged 3 months – 6 years: 3 – 6 months: 2.5 ml, 4 times in 24 hours; 6 – 24 months: 5 ml, 4 times in 24 hours; 2 – 4 years: 7.5ml, 4 times in 24 hours; 4-6 years: 10ml, 4 times in 24 hours. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist. Heptatic / renal dysfunction: Caution should be exercised when administrating the product to patients with severe hepatic or renal impairment. CONTRA-INDICATIONS: Hypersensitivity to the active substance or to any of the excipients. WARNINGS AND PRECAUTIONS FOR USE: CALPOL Sugar Free Infant Suspension should be used with
IRE/CA/15-1590(1)
caution in moderate to severe renal impairment or severe hepatic impairment. Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported very rarely in patients receiving paracetamol. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the fi rst appearance of skin rash or any other sign of hypersensitivity. The following precautions should be followed when taking this medicine: Do not take with any other paracetamol-containing products. Never give more medicine than shown in the table. Do not overfi ll the syringe. Always use the syringe supplied with the pack. Do not give to babies less than 2 months of age. For infants 2-3 months no more than 2 doses should be given. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist. As with all medicines, if your child is currently taking any medicine consult your doctor or pharmacist before taking this product. Keep out of sight and reach of children. This product contains the following excipients which have recognised effects: Carmoisine which may cause allergic reactions. Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Ethyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). The sorbitol and maltitol content of this product means that this product is unsuitable for people with inherited intolerance to fructose. INTERACTIONS: Chronic alcohol intake can
*For babies weighing over 4kg and born after 37 weeks
increase the hepatotoxicity of paracetamol overdose. Acute alcohol intake may diminish an individual’s ability to metabolise large doses of paracetamol. The use of drugs that induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptives, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no signifi cant effect. UNDESIRABLE EFFECTS: Paracetamol has been widely used and, when taken at the usual recommended dosage, side effects are mild and infrequent and reports of adverse reactions are rare. Skin rash and other allergic reactions occur rarely. Most reports of adverse reactions to paracetamol relate to overdosage with the drug. Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of the disease improved after paracetamol withdrawal. Low level transaminase elevations may occur in some patients taking labelled doses of paracetamol; these are not
accompanied with liver failure and usually resolve with continued therapy or discontinuation of paracetamol. Nephrotoxic effects following therapeutic doses of paracetamol are uncommon. Papillary necrosis has been reported after prolonged administration. Adverse drug reactions identifi ed during post- marketing experience with paracetamol are included in the table below. The frequencies are provided according to the following convention: Very common 1/10, Common 1/100 and < 1/10, Uncommon 1/1,000 and <1/100, Rare 1/10,000 and <1/1,000, Very rare <1/10,000, Not known (cannot be estimated from the available data) Blood and lymphatic system disorders: Not known - Thrombocytopenic purpura, Haemolytic anaemia,
Agranulocytosis. Immune
system disorders: Not known - Anaphylactic reaction, Rare - Hypersensitivity. Hepatobilary disorders: Not known - Hepatic necrosis, Liver injury. Skin and subcutaneous tissue disorders: Rare-Rash, Not known - Urticaria, Pruritic rash. Renal and urinary disorders: Uncommon - Nephropathy toxic, Not known - Renal papillary necrosis; Investigations: Not known- Transaminases increased. OVERDOSAGE: Please refer to local guidelines for the treatment of paracetamol overdose. MARKETING AUTHORISATION HOLDER: McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland. Marketing Authorisation Number: PA 823/10/5. Date of Revision of the Text: April 2016 Legal Category: Product not subject to medical prescription. Further information available upon request from Johnson & Johnson (Ireland) Ltd.
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