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. 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. Sedinol should not be taken during pregnancy, nor whilst breast-feeding.
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 (Sedinol) are constipation, nausea and vomiting, dizziness and drowsiness. Very rarely skin rashes may occur in patients hypersensitive to Codeine (Sedinol).
Codeine (Sedinol) 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 (Sedinol) include nausea, headache and insomnia. Large doses may cause restlessness, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extrasystoles. Caffeine (Sedinol) increases gastric secretion and may cause gastric ulceration.
Moderate to severe pain of any origin: tension headache, migraine, dental pain, post-op pain, dysmenorrhoea, cancer pain, low back pain, fever & also symptomatic relief from colds and cough.
Doxylamine (Sedinol) succinate may enhance the sedative effects of central nervous system depressants including alcohol, tricyclic antidepressants, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers. Monoamine oxidase (MAO) inhibitors may enhance the antimuscarinic effects of Doxylamine (Sedinol) succinate, and it has additive effects with other antimuscarinic agents, such as atropine and tricyclic antidepressants. It has been suggested that Doxylamine (Sedinol) succinate could mask the warning signs of damage caused by ototoxic medicines such as aminoglycoside antibiotics.
Codeine (Sedinol) Phosphate
The most common side-effects are nausea, vomiting, constipation, drowsiness and confusion, tolerance usually develops with long-term use, but not to constipation. Micturition may be difficult and there may be ureteric or billiary spasm as well as an antidiuretic effect. Dry mouth, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood, hallucinations and miosis may occur. These effects are more common in ambulant patients and in those without severe pain. Raised intracranial pressure occurs in some patients. Its euphoric activity has led to abuse. A dose-related histamine-releasing effect which may be responsible in part for reactions such as urticaria, pruritis as well as hypotension and flushing may occur.
Interactions:
Monoamine oxidase (MAO) inhibitors or within 14 days of taking such a treatment. The depressant effects of Codeine (Sedinol) are enhanced by depressants such as alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines. The gastro-intestinal effects may delay absorption as with mexiletine or may be counteractive as with metoclopramide.
Caffeine (Sedinol) Anhydrous
Gastro-intestinal irritation including nausea, vomiting, abdominal pain, diarrhoea and gastro-intestinal bleeding, insomnia, headache, anxiety, restlessness, dizziness and palpitations.
Paracetamol
Haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, angranulocytosis and anaemia have been reported. Pancreatitis, skin rashes and other allergic reactions, hepatitis, renal colic, renal failure and sterile pyuria occur occasionally.
