1. Name Of The Medicinal Product
Galpamol
Junior Paracetamol Suspension
Boots Pain Relief Paracetamol Suspension 3 Months Plus
Galpamol for Children Paracetamol 120mg/5ml Oral Suspension
Infant's & Children's Paracetamol Suspension
Boots Paracetamol Sachets 3 Months Plus 120 mg/5 ml Oral Suspension
2. Qualitative And Quantitative Composition
Paracetamol 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:
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For infants aged less than 3 months:
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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).
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 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.
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. 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, 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 24 h 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
None stated
6. Pharmaceutical Particulars
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 or 100 ml.
5ml unit dose foil laminate sachets sold individually or packed into cartons containing 4, 5, 8, 10, 12, 15, 16 or 20 sachets.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Galpharm Healthcare Limited
Hugh House
Upper Cliffe Road
Dodworth Business Park
Dodworth
South Yorkshire
S75 3SP
8. Marketing Authorisation Number(S)
PL 16028/0118
9. Date Of First Authorisation/Renewal Of The Authorisation
8/10/2011
10. Date Of Revision Of The Text
8/10/2011
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