INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo LENADOL TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

LENADOL TABLETS

COMPOSITION:
Each tablet contains: Paracetamol 400 mg
  Diphenhydramine HCl 5 mg
  Caffeine Anhydrous 50 mg
  Codeine Phosphate 10 mg
Preservative: Nipastat 0,02% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combinations.

PHARMACOLOGICAL ACTION:
Lenadol has analgesic, antipyretic and antihistaminic properties.

INDICATIONS:
Lenadol relieves fever and pain-tension states.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. Patients with severe liver or kidney complications. The use of Lenadol during pregnancy should be avoided, as it crosses the placenta. It must be avoided in asthma, respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, head injuries and conditions in which intracranial pressure is raised, heart failure secondary to chronic lung disease, a history of cardiac disease, epilepsy, and all convulsive states, patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment and acute alcoholism. It must not be given to comatose patients.
Do not administer to children under 12 years of age.

WARNINGS:
Lenadol contains codeine and exceeding the prescribed dose, together with prolonged and continuous use, may lead to dependence and addiction. The administration of codeine during labour may cause respiratory depression in the newborn infant. As this product contains paracetamol, doses in excess of those recommended may cause severe liver damage to occur.
Patients suffering from kidney or liver disease should take paracetamol under strict medical supervision.
Consult your doctor if no relief is obtained with the recommended dosage.
Do not use continuously for longer than 10 days without consulting your doctor.
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants agents. Patients should be warned not to drive a motor vehicle or operate dangerous machinery.
STORE IN A SAFE PLACE OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years:
One to two tablets every 3 to 4 hours, to a maximum of 8 tablets daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol: Haematological reactions e.g. thrombocytopenia, neutropenia, pancytopenia and leucopenia have been reported, skin eruptions have also occured. Sensitivity reactions including skin rash may occur. This is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions.
Doses in excess of those recommended may cause severe liver damage to occur. Not more than 4 000 mg should be taken in 24 hours and treatment should not be continued for more than 3 days.
There may be an added risk of liver damage when patients with certain pre-existing liver diseases are given paracetamol. It is recommended that patients suffering from hepatitis or who are recovering from any form of liver disease, should not take paracetamol.
Sensitivity reactions resulting in reversible skin rash or blood dyscrasia may occur following paracetamol intake.
Interactions: The risk of liver-cell toxicity of paracetamol may be somewhat greater in patients who receive concurrently medicines which induce hepatic enzymes, such as the barbiturates.
Prolonged excessive use may cause irreversible kidney damage.
Codeine phosphate: In normal doses the most common side-effects of codeine phosphate are constipation, nausea and vomiting, dizziness confusion and drowsiness but these are less common than with morphine. Dry mouth, facial flushing, vertigo, bradycardia, palpitations, faintness, sedation, restlessness, changes of mood, and miosis may also occur. These effects occur more commonly in ambulant patients than in those at rest in bed and in those without severe pain. Raised intracranial pressure occurs in some patients. Following large doses of codeine, excitement and convulsions may occur.
Due to the dose-related histamine-releasing effect allergic reactions such as urticaria and pruritus occur in some individuals as well as hypotension and flushing.
Codeine may cause respiratory depression, circulatory failure, hypotension, orthostatic hypotension, deepening coma with larger doses, confusion, euphoria, flushing, hypothermia, dry mouth, muscle rigidity, sweating, urinary retention, ureteric and biliary spasm, and an antidiuretic effect.
The most common side-effect of diphenhydramine HCl is sedation varying from slight drowsiness to deep sleep including inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and incoordination. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation, colic and epigastric pain, headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, thickened respiratory-tract secretions, tightness of the chest, tingling and paraesthesia.
It may cause hypotension, tachycardia and cardiac arrthythmias. Hypersensitivity reactions such as skin rashes, urticaria, purpura, angioedema, bronchospasm or anuria may occur. Erythema multiforme and exfoliative or bullous dermatitis may occur. Blood disorders such as agranulocytosis, eosinophilia, leucopenia, thrombocytopenia and aplastic anaemia may occur. Symptoms of porphyria may be exacerbated.
Side effects of caffeine include nausea headache and insomnia. Caffeine increases gastric secretion and my cause ulceration. Large doses may cause restlessness, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extrasystoles.
Special Precautions:
The absorption of paracetamol may be accelerated by metoclopramide. Excretion may be affected and plasma concentrations altered when administered with probenecid.
Codeine should be given with caution or in reduced doses in patients with adrenocortical insufficiency. The dosage should be reduced in the debilitated and in the elderly.
Should be used with caution or in reduced doses in patients with hypothyroidism, asthma, impaired kidney or liver function, prostatic hypertrophy, hypotension, shock, inflammatory or obstructive bowel disorders, or myasthenia gravis. Prolonged use of high doses of codeine may lead to dependence.
Codeine may affect the activity of other medicines by delaying their absorption.
The depressant effects of codeine is enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants and phenothiazines. Diphenhydramine may cause drowsiness, patients so affected should not drive or operate machinery.
Patients should avoid alcoholic drink. Diphenhydramine should be used with care in conditions such as closed-angle glaucoma, urinary retention, prostatic hyperplasia or pyloroduodenal obstruction.
It may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and neuroleptics. Monoamine oxidase inhibitors may enhance the antimuscarinic effects of diphenhydramine and have an additive antimuscarinic action with medicine such as atropine and tricyclic antidepressants.
Diphenhydramine could mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibiotics.
Caffeine should be taken with care by patients with a history of peptic ulceration or hyperacidity. With prolonged use, some degree of tolerance and psychic dependence may occur.
NOT TO BE TAKEN TOGETHER WITH SEDATIVES AAND TRANQUILISERS.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of overdosage consult your doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible.
Symptoms of overdosage are constipation, nausea, vomiting, anorexia, dizziness, drowsiness, abdominal pain, gastro-intestinal haemorrhage, potentially fatal liver damage, cerebal oedema and renal tubular necrosis, hyperglycaemia and hypoglycaemia. Central stimulation and exhilaration, followed by cardiovascular collapse, respiratory depression, and coma.
Naloxone hydrochloride 400 micrograms is given subcutaneously, intramuscularly, or intravenously, repeated at intervals of 2 to 3 minutes if necessary. Respiration may be assisted.
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 and metabolic acidosis may occur.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage.
Cardiac arrhythmias have been reported.
Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may become manifest on the second day (or later), initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and nonspecific myocardial depression have also occurred.
Prompt treatment is essential. Any patient who has ingested about 7,5 g of paracetamol in the preceeding 4 hours should undergo gastric lavage. Specific therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered IV as soon as possible.
When patients are seen in the first few hours after ingestion of an overdose of paracetamol attempts should be made immediately to limit further gastro-intestinal absorption by inducing emesis or by gastric lavage, and by subsequent administration of 30 to 50 grams of activated charcoal.
Activated charcoal should be given within 1- 2 hours of ingestion of the paracetamol.
Acetylcysteine
Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage.
IV:                An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours, and then 100 mg/kg in 1 litre over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally: 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. Acetylcysteine is effective if administered within 8 hours of overdosage.
Estimations of paracetamol levels in the plasma, when these can be carried out, are of value in managing the patient with acute paracetamol toxicity. In addition, they may give a prediction of the patients likely outcome. Kidney damage has been described in numerous cases in which liver injury has been of primary concern in acute paracetamol poisoning.

IDENTIFICATION:
Yellow, flat bisected tablets with bevelled edges.

PRESENTATION:
Securitainers with 18, 100 and 500 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
M/2.9/4

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited, 7 Fairclough Road, Korsten, PORT ELIZABETH 6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
05 February 1980.

                D508
A&S PRINTERS
Updated on this site: November 2002 - Source: Community Pharmacy

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