Medinol Paediatric Paracetamol Oral Suspension BP 120mg / 5ml

1. Name Of The Medicinal Product

Medinol Paediatric Paracetamol Oral Suspension BP 120mg/5ml.

2. Qualitative And Quantitative Composition

Paracetamol 120mg/5ml.

3. Pharmaceutical Form

Oral suspension

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of pain and to relieve or reduce fever.

4.2 Posology And Method Of Administration

Route of administration: oral

To be taken four times daily.

Do not repeat dose more frequently than every four hours.

Infants under 3 months: on doctors advice only (10mg/kg).

A 2.5ml dose is suitable for babies who develop a fever following vaccination at 2 months. In all other cases use only under medical supervision.

Infants 3 months to 1 year: half to one 5ml spoonful (60-120mg).

Children 1-6 years: one or two 5ml spoonfuls (120-240mg).

Children over 6 years: two or four 5ml spoonfuls (240-480mg).

Do not give more than four doses in 24 hours.

Not to be given to infants under 3 months except on medical advice.

4.3 Contraindications

Hypersensitivity to paracetamol and/or other constituents. Impaired kidney and liver function.

4.4 Special Warnings And Precautions For Use

1. If pain or fever persists for more than 3 days consult a doctor.

2. Prolonged use without medical supervision may be harmful.

3. Do not give with other product containing paracetamol concurrently.

4. If your baby was born prematurely and is less than 3 months old consult your doctor before use.

5. In cases of accidental overdose seek medical attention immediately.

6. 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 (non-cirrhotic) alcoholic liver disease.

7. Keep out of the reach of children.

8. Do not exceed the stated dose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Cholestyramine may reduce absorption of paracetamol. Metoclopramide and domperidone may accelerate absorption of paracetamol. Alcohol, barbiturates, anticonvulsants and tricyclic antidepressants may increase the hepatoxicity of paracetamol particularly after an overdose. 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.

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 contraindicate breast-feeding. This product may, therefore, be taken during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

None stated.

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 thrombocytopaenia and agranulocytosis, but these were not necessarily causally related to paracetamol. If given in therapeutic doses side effects are rare. Haematological reactions have been reported. Most reports of adverse reactions to paracetamol relate to overdosage with the drug.

4.9 Overdose

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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol.

Treatment: 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 and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. General supportive measures must be available. After gastric lavage a suitable antidote such as acetylcysteine or methionine should be given. Acetylcysteine is given by intravenous infusion in an initial dose of 150mg/kg body weight over 15 minutes, followed by 50mg/kg over 4 hours and then by 100mg/kg over the next 16 hours. Alternatively, methionine 2.5g may be given by mouth every four hours to a total of 4 doses. The blood paracetamol levels should be monitored to determine whether further therapy is necessary.

In severe poisoning, hepatic failure may progress to encephalopathy, coma and death.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Analgesic/antipyretic.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Methylhydroxybenzoate; Propylhydroxybenzoate; Sodium Saccharin; Sodium Cyclamate 1968; Tragacanth; Lycasin; Strawberry Flavour PFW 500253E; Water.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months unopened.

6.4 Special Precautions For Storage

Avoid extremes of temperatures.

6.5 Nature And Contents Of Container

Amber glass sirop or winchester bottle with tamper evident cap with fitted polycone liner containing 50, 70, 100, 140, 150 or 200ml of product. The 70ml and 140ml size will also be cartoned. 30ml universal amber glass bottle fitted with a child-resistant cap containing 20, 25 or 30ml of product. Amber glass winchester bottle with polypropylene cap with EPE wad containing 500 or 1000ml of product.

A 2.5ml syringe measuring device may also be included with each pack of suspension.

5ml CE marked polystyrene measuring spoon supplied with product.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Cupal Ltd., Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA.

8. Marketing Authorisation Number(S)

PL 0338/0033.

9. Date Of First Authorisation/Renewal Of The Authorisation

10^th February 1977 / 12^th February 1992.

10. Date Of Revision Of The Text

19/07/06