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MEDINOL PAEDIATRIC PARACETAMOL ORAL SUSPENSION BP 120MG/5ML

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Medinol For Children 120mg/5ml Oral Suspension Medinol Paediatric Paracetamol Oral Suspension BP 120mg/5ml

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol BP 120.00mg/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
Liquid

4
4.1

CLINICAL PARTICULARS
Therapeutic indications For the relief of pain and to relieve or reduce fever.

4.2

Posology and method of administration
Route of administration: oral Age For post-vaccination fever for babies aged between 2 3 months Dose 2.5 mL. 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

Childs Age 3 6 months 6 24 months 2 4 years 4 8 years 8 10 years 10 - 12 years

How Much 2.5 mL 5 mL 7.5 mL 10 mL 15 mL 20 mL

How often (in 24 hours) 4 times 4 times 4 times 4 times 4 times 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

It is important to shake the bottle for at least 10 seconds before use.

4.3

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

4.4

Special warnings and precautions for use
1. 2. 3. 4. 5. 6. If pain or fever persists for more than 3 days consult a doctor. Prolonged use without medical supervision may be harmful. Do not give with other product containing paracetamol concurrently. If your baby was born prematurely and is less than 3 months old consult your doctor before use. In cases of accidental overdose seek medical attention immediately. 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. Keep out of the reach of children. Do not exceed the stated dose.

7. 8.

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 or syringe 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 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
Cholestyramine may reduce absorption of paracetamol. Metochlopramide and doperidone may accelerate the absorption of paracetamol. Alcohol, barbiturates, anticonvulsants and tricyclic antidepressants may increase the hepatatoxicity 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.

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 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.

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.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties Analgesic/ Antipyretic.

5.2

Pharmacokinetic properties None stated.

5.3

Preclinical safety data None stated.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Tragacanth BP

Lycasin (Maltitol Syrup) Methylhydroxybenzoate BP Propyl Parahydroxybenzoate Sodium Saccharin BP Sodium Cyclamate 1968 BP Strawberry Flavour PFW 500253E Water for injection

6.2

Incompatibilities None stated.

6.3

Shelf life 36 months

6.4

Special precautions for storage Avoid extremes of temperatures Store in the original container Do not refrigerate Do not store above 25oC

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 5ml/2.5ml CE marked polypropylene double-ended measuring spoon or a 5ml CE marked syringe is also included with each pack of suspension.

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 United Kingdom

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MARKETING AUTHORISATION NUMBER(S)
PL 00338/0033

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/02/1977

10

DATE OF REVISION OF THE TEXT
29/03/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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