Summary of medicine characteristics - INFANTS & CHILDRENS PARACETAMOL SUSPENSION, JUNIOR PARACETAMOL SUSPENSION
1 NAME OF THE MEDICINAL PRODUCT
Junior Paracetamol Suspension
Infant’s & Children’s Paracetamol Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol BP 120 mg/ 5 ml
3 PHARMACEUTICAL FORM
Oral Suspension.
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
For oral administration. It is important to shake the bottle for at least 10 seconds before use.
For children aged 3 months to 12 years:
| Child’s Age | How Much | How often (in 24 hours) |
| 3 – 6 months | 2.5 ml | 4 times |
| 6 – 24 months | 5 ml | 4 times |
| 2 – 4 years | 7.5 ml (5 ml + 2.5 ml) | 4 times |
| 4 – 8 years | 10 ml (5 ml + 5 ml) | 4 times |
| 8 – 10 years | 15 ml (5 ml + 5 ml + 5ml) | 4 times |
| 10 – 12 years | 20 ml (5 ml + 5 ml + 5 ml + 5 ml) | 4 times |
| Do not give more t Leave at least 4 hoi Do not give this m | han 4 doses in any 24 hour period urs between doses edicine to your child for more than 3 days without speaking to | |
your doctor or pharmacist
Babies over 2 months in age
For the relief of fever after vaccination at 2, 3 and 4 months
2.5ml. This dose may be given up to 4 times a day at the time of vaccination. Do not give more than 4 doses in any 24 hour period. Leave at least 4 hours between doses. If your baby still needs this medicine two days after receiving the vaccine talk to your doctor or pharmacist.
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 hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Patients should be advised not to take other paracetamol containing products concurrently.
Paracetamol should be used with care in patients with severe renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Patients should be advised not to take other paracetamol containing products concurrently.
The label should contain the following statements:
Contains paracetamol.
Do not give this medicine with any other paracetamol-containing product.
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 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).
This medicinal product contains less than 1 mmol sodium (23 mg) per 20ml, that is to say essentially ‘sodium-free’.
4.5. Interactions with other Medicaments and other forms of Interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone; and absorption reduced by colestyramine.
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.
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.
4.6 Fertility, pregnancy and lactation
This product is for children. However, other formulations of paracetamol products advise the following for paracetamol use in pregnancy and breastfeeding. A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
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.
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.
Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but apillary necrosis has been reported after prolonged administration.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseLiver damage is possible in adults and adolescents (>12 years of age) who have taken 7.5g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested) become irreversibly bound to liver tissue. 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, phenobarbitone, 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, hyperhidrosis, malaise, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. This may include hepatomegaly, liver tenderness, jaundice, acute hepatic failure and hepatic necrosis. Abnormalities of glucose metabolism and metabolic acidosis may occur. Blood bilirubin, hepatic enzymes, INR, prothrombin time, blood phosphate and blood lactate may be increased. 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.
Haemolytic anaemia (in patients with glucose-6-phosphate dehydrogenase [G6PD] deficiency): Haemolysis has been reported in patients with G6PD deficiency, with use of paracetamol in overdose.
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 h from ingestion should be discussed with the NPIS or a liver unit.
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
5.3 Preclinical safety dataConventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
6.1 List of excipients
Glycerol; Dispersible Cellulose; Sodium Methylparaben; Sodium Propylparaben; Citric Acid Anhydrous; Saccharin Sodium; Strawberry Flavour D3694 (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 25 °C. Do not refrigerate. Protect from light.
6.5 Nature and contents of container
Amber glass or PET bottles with polyethylene child resistant screw closures, containing 70, 100, 150 or 200 ml.
5ml unit dose foil laminate sachets sold individually or packed into cartons containing 4, 5, 8, 10, 12, 15, 16, 20, 24, 25, 48, 50, 70, 96 or 100.
6.6 Special precautions for disposal
7. MARKETING AUTHORISATION HOLDER
8 MARKETING AUTHORISATION NUMBER(S)
PL 16028/0119