Care Infant Paracetamol 120mg/5ml Suspension
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Care Infant Paracetamol 120mg/5ml Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol BP 120 mg/5 ml
3 PHARMACEUTICAL FORM
Suspension for oral administration
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For relief of mild to moderate pain including teething pain, and for pyrexia.
4.2 Posology and method of administration
|
Age |
Dose |
|
For post-vaccination fever for babies aged between 2-3 months |
One 2.5 ml dose. 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 | |
|
Age |
Dose - up to 4 times in 24hrs |
|
3-6 months |
2.5 ml |
|
6-24 months |
5ml |
|
2-4 years |
7.5ml (5ml + 2.5ml) |
|
4-6 years |
10ml (5ml + 5ml) |
|
• 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.
4.3 Contraindications
Contra-indicated in patients with a known hypersensitivity to paracetamol or any of the other constituents.
4.4 Special warnings and precautions for use
Paracetamol should be used with care in patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Do not exceed the stated dose.
If symptoms persist consult your doctor.
The label should contain the following statements:
• Contains paracetamol
• Do not give with any other paracetamol-containing products.
• For oral use only.
• Never give more medicine than shown in the table
• 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.
• Do not store above 25°C. Store in the original package.
• Keep out of the reach and sight of children
• Immediate medical advice should be sought in the event of an overdose, even if the child seems well (label).
• Immediate medical 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)
4.5 Interaction with other medicinal products and other forms of interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone; and absorption reduced by cholestyramine.
The anti-coagulant 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.
4.6 Pregnancy and lactation
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contra-indicate breast feeding.
4.7 Effects on ability to drive and use machines
None
4.8 Undesirable effects
Undesirable effects with paracetamol are rare, however, hypersensitivity including skin rashes may occur. Very rare cases of serious skin reactions have been reported.
There have been a few reports of blood dyscrasias including thrombocytopenia, and agranulocytosis but these were not necessarily causally related to paracetamol.
4.9 Overdose
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk factors:-If the patient
a) Is on long term treatment with carbamazepine, phenobarbital, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
Or
b) Regularly consumes ethanol in excess of recommended amounts.
Or
c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose.
Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with
N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Paracetamol has analgesic and antipyretic actions probably due to the inhibition of prostaglandin biosynthesis.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastro-intestinal tract and peak plasma concentrations usually occur 30 minutes to 2 hours after ingestion. Paracetamol is metabolised in the liver and largely excreted in the urine as sulphate and glucuronide conjugates. Less than 5% is excreted unchanged. The elimination half life varies from about 1 to 4 hours.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerol
Dispersible Cellulose Sodium Methylparaben Sodium Propylparaben Citric Acid Anhydrous Saccharin Sodium
Strawberry Flavour (containing Propylene Glycol) Acesulphame K
Carmine Extract P4011 (containing Carmine)
Glycerine
Potassium Hydroxide Hydrogenated Glucose Syrup Xanthan Gum Purified Water
6.2 Incompatibilities
None
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Store at or below 25oC. Do not refrigerate. Protect from light.
6.5 Nature and contents of container
100ml: PET bottles with polyethylene child resistant screw closures.
A 5ml graduated syringe with a 2.5 & 5ml measure is supplied. The barrel is clear natural polypropylene. The plunger is white high density polyethylene.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Thornton and Ross Limited Linthwaite Laboratories Huddersfield HD7 5DH United Kingdom
8
MARKETING AUTHORISATION NUMBER(S)
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/06/2004
10 DATE OF REVISION OF THE TEXT
11/03/2015