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MEDINOL OVER 6 PARACETAMOL ORAL SUSPENSION BP

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Medinol Over 6 Paracetamol Oral Suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol BP 250mg/5ml Excipients with known effect: Lycasin (Maltitol Syrup) Propylhydroxybenzoate (E216) Methylhydroxybenzoate (E218). For the full list of excipients, see section 6.1.

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PHARMACEUTICAL FORM
Oral suspension

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4.1

CLINICAL PARTICULARS
Therapeutic indications
For the relief of mild to moderate pain including headache, migraine, neuralgia, toothache and sore throat. Symptomatic relief of rheumatic aches and pains. Symptomatic relief of influenza, feverishness and colds.

4.2

Posology and method of administration
Route of Administration: Oral Childs Age How often (in 24 hours) 6 8 years 5 mL 4 times 8 10 years 7.5 mL 4 times 10 12 years 10 mL 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 How Much

speaking to your doctor or pharmacist Do not give to children under the age of 6 years. Children aged 1210 - 15mL up to 4 times a day 16 years Adults and children 10 - 20 mL up to 4 times a day over 16 years It is important to shake the bottle for at least 10 seconds before use.

4.3

Contraindications
Should be used with caution in patients having impaired kidney or liver function. Hypersensitivity to paracetamol and/or 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 and in those with non-cirrhotic alcoholic liver disease. The hazards of overdose are greater in those with alcoholic liver disease. If pain or fever persists for more than 3 days, consult your doctor. Prolonged use without medical supervision may be harmful. Do not exceed the stated dose. Keep out of the reach of children. 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 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 25C. 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).

Patients with rare hereditary problems of fructose intolerance should not take this medicine. This product contains sodium propylhydroxybenzoate (E217) and sodium methylhydroxylbenzoate (E219) which may cause allergic reactions (possibly delayed).

4.5

Interaction with other medicinal products and other forms of interaction
Alcohol, barbiturates, anticonvulsants and tricyclic antidepressants may increase hepatotoxicity of paracetamol, particularly after an overdose. 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.

4.6

Pregnancy and lactation
Epidemiological studies in human pregnancy have shown no effects due to paracetamol used in the recommended dosage. However, paracetamol should be avoided in pregnancy unless considered essential by the physician. 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
None 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 thrombocytopaenia and agranulocytosis, but these were not necessarily causally related to paracetamol, and of acute pancreatitis.

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 Johns 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 Nacetylcysteine 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.

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5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Paracetamol has analgesic and antipyretic properties.

5.2

Pharmacokinetic properties
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. The elimination half-life varies from 1 to 4 hours.

5.3

Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Sodium methylhydroxybenzoate Sodium propylhydroxybenzoate Sodium saccharin Sodium cyclamate Tragacanth Lycasin 80/55 (maltitol syrup) Strawberry flavour PFW 500253E Purified water.

6.2

Incompatibilities
None known

6.3

Shelf life
36 months

6.4

Special precautions for storage
Store below 25C.

6.5

Nature and contents of container
100ml, 200ml: amber glass sirop bottle with tamper evident cap with fitted polycone liner. 500ml, 1000ml: amber glass Winchester bottle with plastic screw cap A 5ml/2.5ml CE marked polypropylene double-ended measuring spoon is included.

6.6

Special precautions for disposal
Not applicable.

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MARKETING AUTHORISATION HOLDER
Cupal Ltd. Venus 1 Old Park Lane Trafford Park Manchester M41 7HA

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MARKETING AUTHORISATION NUMBER(S)
PL 00338/0069

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/11/1989 / 20/09/2004

10

DATE OF REVISION OF THE TEXT
25/06/2012

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