Medised Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medised Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol EP 500.0mg/tablet
Promethazine hydrochloride 10.0mg/tablet
EP
3 PHARMACEUTICAL FORM
Tablet containing paracetamol EP 500mg and promethazine hydrochloride EP 10mg per tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
In the treatment of mild to moderate pain, including headache, toothache and musculo-skeletal aches and pains. In the symptomatic relief of influenza, feverishness and feverish colds.
4.2 Posology and method of administration
Oral use.
Adults and the elderly
2 tablets usually at night. Dose not to be repeated more frequently than 4 hourly intervals, and no more than 4 does should be taken in any 24 hour period.
Children
Not recommended.
4.3 Contraindications
Hypersensitivity to paracetamol or any other constituents.
4.4 Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with severe renal and 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.
Dosage should not be continued for more than 3 days without consulting a doctor.
If symptoms persist, consult your doctor.
Do not exceed the stated dose.
Not recommended for children.
Keep out of the reach of children.
Labelling:
‘Immediate medical advice should be sought in the event of an overdose, even if you feel well’ and ‘Do not take with any other paracetamol-containing products’.
Patient information leaflet:
‘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’.
4.5 Interaction with other medicinal products and other forms of interaction
Preparations containing paracetamol or promethazine. Avoid alcoholic drinks. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption is reduced by cholestyramine. The anticoagulant effect of warfarmn and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no effect.
4.6 Pregnancy and lactation
As with all medicines, Medised should not be used during pregnancy and lactation unless it is considered essential by the physician.
Epidemiological studies in human pregnancies 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
May cause drowsiness. If affected do not drive or operate machinery.
4.8 Undesirable effects
May cause dryness of the mouth, throat and nose. Some patients may experience dizziness or abdominal pain with vomiting and diarrhoea. Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been a few reports of blood dyscarias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol.
4.9 Overdose
Immediate medical advice should be sought in the event of an overdose, even if you feel well. 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 liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible 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.
Promethazine overdosage may cause convulsions.
Treatment
In cases of promethazine overdosage, diazepam should be administered intravenously. 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 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have beneficial effect up to 48 hours after the overdose, may be required. General supportive measures must be available.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Paracetamol: has analgesic and anti-pyretic actions.
Promethazine hydrochloride: is a powerful, long acting H1 receptor antagonist. It also causes CNS depression and sedation.
5.2 Pharmacokinetic properties
Paracetamol: small doses are rapidly absorbed from the gastro-intestinal tract.
Plasma concentrations produced vary considerably between subjects. The plasma half life after therapeutic doses is 1 - 4 hours. It is widely distributed throughout most body fluids and the volume of distribution is about 1L per Kg body weight. Plasma protein binding is between 8 - 40%. About 85% of a therapeutic dose is excreted in the urine within 24 hours, 1 - 4% unchanged, 20 - 30% conjugated with sulphate and 40 - 60% conjugated with glucuronic acid.
Promethazine hydrochloride: the plasma half life is 7 - 10 hours (after an oral dose). The volume of distribution is about 170L. It is 90% plasma protein bound and about 2% is excreted unchanged in the urine.
Preclinical safety data
5.3
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Povidone, maize starch, talc, magnesium stearate, modified starch, purified water.
6.2 Incompatibilities
None stated.
6.3 Shelf life
24 months unopened.
6.4 Special precautions for storage
Not applicable.
6.5 Nature and contents of container
Strip packed in aluminium/LDPE 25/38 u 76mm printed foil in a cardboard outer Pack sizes: 4, 8, 12 16, 20 or 24 tablets
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd
9 Arkwright Road
Astmoor Industrial Estate
Runcorn
Cheshire
WA7 1NU
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0146
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/5/97
10 DATE OF REVISION OF THE TEXT
04/03/2011