Paracetamol 120mg/5ml Oral Suspension
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 120mg/5ml Oral Suspension
Mandanol Infant Paracetamol 120mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of the oral suspension contains Paracetamol 120mg For full list of excipients- see section 6.1
3 PHARMACEUTICAL FORM
Oral Suspension
White uniform suspension with an aroma of strawberries
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Paracetamol 120mg/5ml Oral Suspension is indicated for the treatment of mild to moderate pain (including teething pain), and as an antipyretic (including post immunisation fever).
4.2 Posology and method of administration
It is important to shake the bottle for at least 10 seconds before use
|
Age |
Dose |
|
For post-vaccination fever for babies aged between 2 - 3 months |
One 2.5 mL spoonful (small end) 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 | |
|
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 5.0 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 | ||
The Elderly:
In the elderly, the rate and extent of paracetamol absorption is normal but plasma halflife is longer and paracetamol clearance is lower than in young adults.
4.3 Contraindications
Paracetamol Oral Suspension is contra-indicated in patients with known hypersensitivity to paracetamol, or any of the other constituents.
4.4. Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with noncirrhotic alcoholic liver disease.
The label will include:
• Contains paracetamol.
• Do not give 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 product contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217). These may cause allergic reactions (possibly delayed).
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 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.
Patients who have taken barbiturates, tricyclic antidepressants and alcohol may show diminished ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.
Alcohol can increase the hepatotoxicity of paracetamol overdosage and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol.
Chronic ingestion of anticonvulsants or oral steroid contraceptives induce liver enzymes and may prevent attainment of therapeutic paracetamol levels by increasing first pass metabolism or clearance.
4.6 Pregnancy and lactation
Pregnancy
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 the doctor regarding its use.
Lactation
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causality 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.
Nephrotoxic effects following therapeutic doses of paracetamol are uncommon. Papillary necrosis has been reported after prolonged administration.
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, 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, 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 24h from ingestion should be discussed with the NPIS or a liver unit.
5.1 Pharmacodynamic properties
ATC CODE: N02B E 01 NON-OPIOID ANALGESIC
Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has weak anti-inflammatory effects.
5.2 Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma half-life is in the range of 1 to 3 hours after therapeutic doses. Drug is widely distributed throughout most body fluids. Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours almost entirely following hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected. Children have less capacity for glucuronidation of the drug than do adults. In overdosage there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.
5.3 Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
6.1 List of excipients
Glycerol
Polysorbate 80
Xanthan gum
Maltitol liquid
Saccharin sodium
Citric acid monohydrate
Sodium methyl parahydroxybenzoate
Sodium propyl parahydroxybenzoate
Strawberry flavour (containing propylene glycol)
Purified water
6.2 Incompatibilities
None Known
6.3 Shelf life
24 months.
6.4 Special precautions for storage
Do not store above 25°C. Store the container in the outer carton. Discard after 2 months of first opening.
6.5. Nature and contents of containers
Amber Type III Glass
Child Resistant Tamper Evident Cap- High density polypropylene cap with a polyethylene lining
A spoon with a 2.5 ml and 5 ml measure is supplied with all packs of this product
Pack sizes available: 100ml, 200ml 6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
Edict Consulting Ltd 49 Ivinghoe Road Bushey Herts
WD23 4SW
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
03/03/2009
10 DATE OF REVISION OF THE TEXT
06/06/2011