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Drug Details

Calpol Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension

• Drug Class Description
  Other analgesics and antipyretics. ATC Code: NO2 BE01
• Generic Name
  Paracetamol
• Presentation
  Oral Suspension. An off-white strawberry flavoured suspension.
• Description
  CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension contains 120 mg Paracetamol in each 5 ml. Excipients: maltitol liquid (E965), sorbitol liquid (E420), methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214) and propyl parahydroxybenzoate (E216).
• Indications
  

  CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, teething, sore throat, colds and influenza, aches and pains and post-immunisation fever.

• Adult Dosage
  

  Age : 2 – 3 months	Dose
  1. Post-vaccination fever	2.5 ml (small end of spoon) If necessary, after 4-6 hours, give a second 2.5 ml dose
  2. Other causes of Pain and Fever - if your baby weighs over 4 kg and was born after 37 weeks
  • 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.

  Children aged 3 months – 6 years:

  Child's Age	How Much	How often (in 24 hours)
  3 – 6 months	One 2.5 ml spoonful (small end)	4 times
  6 – 24 months	One 5 ml spoonful (large end)	4 times
  2 – 4 years	One 5 ml spoonful (large end) and one 2.5 ml spoonful (small end)	4 times
  4 – 6 years	Two 5 ml spoonfuls (large end)	4 times
  • 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

  It is important to shake the bottle for at least 10 seconds before use.

• Child Dosage
  

  Age : 2 – 3 months	Dose
  1. Post-vaccination fever	2.5 ml (small end of spoon) If necessary, after 4-6 hours, give a second 2.5 ml dose
  2. Other causes of Pain and Fever - if your baby weighs over 4 kg and was born after 37 weeks
  • 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.

  Children aged 3 months – 6 years:

  Child's Age	How Much	How often (in 24 hours)
  3 – 6 months	One 2.5 ml spoonful (small end)	4 times
  6 – 24 months	One 5 ml spoonful (large end)	4 times
  2 – 4 years	One 5 ml spoonful (large end) and one 2.5 ml spoonful (small end)	4 times
  4 – 6 years	Two 5 ml spoonfuls (large end)	4 times
  • 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

  It is important to massage the sachet for before use.

• Elderly Dosage
  

  In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.

• Contra Indications
  

  CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension is contra-indicated in patients with known hypersensitivity to paracetamol, or any of the other components.

• Special Precautions
  

  CALPOL Infant Sugar Free Colour Free 120 mg/5 ml Oral Suspension should be used with caution in severe renal impairment or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

  Concomitant use of other paracetamol-containing products should be avoided.

  Due to the presence of maltitol liquid (E965) and sorbitol liquid (E420), patients with rare hereditary problems of fructose intolerance should not take this medicine.

  Ethyl (E214), Propyl (E216) and Methyl (E218) parahydroxybenzoate may cause allergic reactions (possibly delayed).

  The label contains the following statements:

  Contains paracetamol.

  Do not give this medicine with any other paracetamol containing products.

  For oral use only

  Never give more medicine than shown in the table.

  Do not overfill the spoon.

  Always use the spoon 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 other medicine consult your doctor or pharmacist before using this product.

  Keep out of the reach and sight of children.

  Do not store above 25°C. Keep bottle in outer carton,

  Shake the bottle for at least 10 seconds before use.

  Do not exceed the stated dose.

  If symptoms persist consult your doctor.

  Immediate advice should be sought in the event of an overdose, even if the child seems well. (label)

  Immediate advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage. (leaflet)

  Talk to your doctor: If your child has an inherited intolerance to fructose or been diagnosed with an intolerance to some other sugars. (leaflet)

  The sorbitol liquid (E420) and maltitol liquid (E965) content of this product means that this product is unsuitable for people with inherited intolerance to fructose. (leaflet).

• Interactions
  

  The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

  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 significant effect.

  Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.

  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.

• Adverse Drug Reactions
  

  Adverse effects of paracetamol are rare but hypersensitivity/anaphylactic reactions including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.

  Most reports of adverse reactions to paracetamol relate to overdose 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 their disease improved after paracetamol withdrawal.

  Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.