Medised for Children

1. Name Of The Medicinal Product

Medised For Children

2. Qualitative And Quantitative Composition

Paracetamol 120mg/5ml

Diphenhydramine HCl 12.5mg/5ml

3. Pharmaceutical Form

Oral solution.

Clear to pale pink liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of mild to moderate pain including teething pain, headache, sore throat, aches and pains.

Symptomatic relief of influenza and feverish colds and the associated symptoms of runny nose and sneezing.

4.2 Posology And Method Of Administration

Route of Administration: Oral.

Recommended Doses and Dosage Schedules:

6 years to under 12 years: 10ml-20ml (2-4 teaspoonful) 3 times daily.

Medised is contraindicated in children under 6 years of age (see section 4.3)

Parents or carers should seek medical attention if the child's condition deteriorates during treatment.

4.3 Contraindications

Do not take if you are hypersensitive to paracetamol, and/or any other constituents.

Large doses of antihistamines may precipitate fits in epileptics.

Do not take if you are currently taking monoamine inhibitors (MAOIs) or within 14 days of stopping treatment with MAOIs.

Not to be used in children under the age of 6 years.

4.4 Special Warnings And Precautions For Use

Do not exceed the stated dose. Immediate medical advice should be sought in the event of an overdose, even if you feel well because of the risk of delayed, serious liver damage.

Do not take with any other paracetamol-containing products, or cough and cold medicines.

Dose should not be repeated more frequently than 4 hour intervals.

Not more than 4 doses should be taken in 24 hours.

Dosage should not be continued for more than three days without consulting a doctor.

This product should be administered with caution to patients with known renal or hepatic impairment, prostatic hypertrophy, urinary retention, or susceptibility to angle-closure glaucoma. The hazards of overdose are greater in those with alcoholic liver disease.

The product may cause drowsiness. This product should not be used to sedate a child.

Keep out of the reach of children.

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 daily use of paracetamol with increased risk of bleeding.

May enhance the sedative effects of CNS depressants including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics and alcohol.

May have an additive muscarinic actions with other drugs, such as atropine and some antidepressants.

Not to be used in patients taking MAOIs or within 14 days of stopping treatment as there is a risk of serotonin syndrome.

4.6 Pregnancy And Lactation

Safety in pregnancy has not been established.

Epidemiological studies in human pregnancy have shown no 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 a clinically significant amount.

Available published data does not contraindicate breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

May cause drowsiness. If affected do not drive or operate machinery.

4.8 Undesirable Effects

Common side effects

CNS effects: Drowsiness (usually diminishes within a few days), paradoxical stimulation, headache, psychomotor impairment.

Antimuscarinic effects: Urinary retention, dry mouth, blurred vision, gastrointestinal disturbances, thickened respiratory tract secretions

Rare side effects:

Hypotenstion, extrapyramidal effects, dizziness, confusion, depression, sleep disturbances, tremor, convulsions, palpitation, arrhythmia, hypersensitivity reactions (including skin rash), blood disorders and liver dysfunction.

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

The features of overdose are: sedation, pallor, nausea, vomiting, diarrhoea, anorexia, and abdominal pain; liver damage may become apparent within 12 to 48 hours. In some children overdose may cause cerebral stimulation resulting in convulsions and hyperpyrexia.

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 likely in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

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 four hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol is an antipyretic and analgesic. Diphenhydramine HCl is an antihistamine with anti-cholinergic, anti-emetic, anti-allergic and sedative effects.

5.2 Pharmacokinetic Properties

Paracetamol and diphenhydramine HCl are both readily absorbed from the gastrointestinal tract. Both are widely distributed throughout the body. Both are metabolised in the liver and excreted in the urine. As Medised Infant is a solution, absorption of actives is rapid following oral ingestion.

5.3 Preclinical Safety Data

Paracetamol and diphenhydramine HCl are well established drug substances whose preclinical profiles have been investigated and are thoroughly established.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Macrogol 4000

Glycerol

Propylene Glycol

Sorbitol Solution (non crystallising) 70%

Lycasin 80/55 (Maltitol Solution)

Sodium Cyclamate

Sodium Saccharin

Nipasept (Methylhydroxybenzoate, Ethylhydroxybenzoate and Parahydroxybenzoate)

Strawberry Flavour 513805E

Sugar Module 555049E

Water, purified

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C.

Do not refrigerate.

Keep container in outer carton.

6.5 Nature And Contents Of Container

Amber type III glass bottle and plastic clic loc cap with pulp stearan wadding. 20ml, 30ml, 70ml, 100ml, 140ml and 200ml.

All pack sizes except the 20ml have a 5ml plastic spoon.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

SSL International Plc

Venus

1 Old Park Lane

Trafford Park

Manchester

M41 7HA

UK

8. Marketing Authorisation Number(S)

PL 17905/0090

9. Date Of First Authorisation/Renewal Of The Authorisation

13/09/99

10. Date Of Revision Of The Text

September 2009