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

Logo SEDINOL TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

SEDINOL TABLETS

COMPOSITION:
Each Tablet contains:
       
Doxylamine Succinate        5,00 mg
       
Paracetamol        450,00 mg
       
Codeine Phosphate        10,00 mg
       
Caffeine, Anhydrous        30,00 mg

PHARMACOLOGICAL ACTION:
Sedinol tablets have analgesic, antipyretic and antihistaminic action.

INDICATIONS:
Relief of mild to moderate pain associated with tension.

CONTRA-INDICATIONS:
Sensitivity to any of the ingredients. The dosage in renal functional impairment must be reduced. Should be taken only with caution by asthmatics. Severe liver function impairment.

Sedinol should not be administered to patients with acute intermittent porphyria. The use of Sedinol during pregnancy should be avoided. 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, acute alcoholism.

WARNINGS:
Dosages in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should take Paracetamol under medical supervision.

Consult your doctor if no relief is obtained with the recommended dosage.

This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned against taking charge of vehicles or machinery performing potentially hazardous tasks where loss of concentration may lead to accidents.

Do not use continuously for longer than 10 days without consulting your doctor.
KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND DIRECTIONS FOR USE:
Adults:        One to two tablets every 4 to 6 hours. Do not exceed 8 tablets per day.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Sensitivity reactions resulting in reversible skin rash or blood disorders may occur. This rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by drug fever and mucosal lesions. The use of Paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia. Patients suffering from liver or kidney disease should take Paracetamol under medical supervision.

The commonest side-effects of therapeutic doses of Codeine are constipation, nausea and vomiting, dizziness and drowsiness. Very rarely skin rashes may occur in patients hypersensitive to Codeine.

Codeine may cause respiratory depression, bradycardia, circulatory failure, hypotension, orthostatic hypotension, palpitations, deepening coma, confusion, euphoria, mood changes, restlessness, flushing, hypothermia, increased intracranial pressure, miosis, dry mouth, muscle rigidity, pruritus, urticaria, sweating, urinary retention, uteric and biliary spasm, and an antidiuretic effect.

Side effects of antihistaminics vary in incidence and severity with each patient as much as with each drug. The most common effect is sedation. Other side-effects include gastro-intestinal disturbances, headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest, and tingling, heaviness and weakness of the hands, nausea, vomiting, diarrhoea and paraesthesia. It may cause hypotension, tachycardia and cardiac arrhythmias. 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, thombocytopenia and aplastic anaemia may occur. Symptoms of porhyria may be exacerbated.

Side-effects of Caffeine include nausea, headache and insomnia. Large doses may cause restlessness, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extrasystoles. Caffeine increases gastric secretion and may cause gastric ulceration.

PRECAUTIONS:
Codeine should be used with caution or in reduced doses in patients with adrenocortical insufficiency. Should be used with caution with patients with obstructive bowel disorders. The dosage should be reduced in the debilitated and in the elderly. Should be used with caution or reduced doses in patients with hypothyroidism, myasthenia gravis, prostatic hypertrophy and shock. Prolonged use of high doses of codeine may lead to dependence.

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.

Doxylamine succinate may lower the tolerance to alcohol and other central nervous system depressants. It may enhance the metabolism of oral contraceptives, corticosteroids, phenytoin, phenothiazines and tricyclic antidepressants.

Codeine may affect the activity of other medicines by delaying their absorption. The depressant effects are aggravated by alcohol, anaesthetics, hypnotics, sedatives, tricyclic anti-depressants and phenothiazines.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
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, 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.

In the event of overdosage consult your doctor or take the patient to the nearest hospital immediately. Specialized treatment is essential as soon as possible.

Prompt treatment is essential. Any patient who has ingested about 7,5 g of Paracetamol in the preceding 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.

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 very effective if administered within 8 hours of overdosage.

Overdosage of doxylamine succinate causes sedation. In severe overdosage of antihistamines the stomach should be emptied by aspiration and lavage. Other treatment is supportive and symptomatic and may include artificial respiration, external cooling for hyperpyrexia, and intravenous fluid.

Poisoning with Codeine produces central stimulation with exhilaration and, in children, convulsions, followed by vomiting, drowsiness, respiratory depression and cyanosis, and coma.

In view of the dosages involved the effects of overdosage of Paracetamol and Codeine are likely to predominate and dictate treatment.

IDENTIFICATION:
White bisected bevelled edged tablets, engraved "SEDINOL" on one side.

PRESENTATION:
Blister packs of 18, 54 and 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25 °C. Protect from light.
Exposure to air should be MINIMUM.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
L/2.8/335

NAME AND BUSINESS ADDRESS OF APPLICANT:
S.A.D. SELF MEDICATION [PTY] LIMITED
Co. Reg. No. 92/04769/07
Robbie de Lange Road, Wilsonia, EAST LONDON, 5201
P O Box 422, EAST LONDON, 5200

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 1981

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