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

Logo ADCO-SINAL CO

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ADCO-SINAL CO
Tablets

COMPOSITION:
Each tablet contains:

Paracetamol         300 mg
Phenylpropanolamine HCl         25 mg
Phenyltoloxamine Citrate         22 mg
Codeine Phosphate         15 mg

PHARMACOLOGICAL CLASSIFICATION:
A.5.8 Preparations for the common cold including nasal decongestants and antihistaminics.

PHARMACOLOGICAL ACTION:
ADCO-SINAL CO
has analgesic, antipyretic, antihistaminic and decongestant properties.

INDICATIONS:
ADCO-SINAL CO
is indicated for the symptomatic relief of symptoms associated with colds and influenza such as nasal congestion, headache, minor aches and pains.

CONTRA-INDICATIONS:
ADCO-SINAL CO is contra-indicated in patients with a known sensitivity to any of the active ingredients. It is contraindicated in patients with coronary artery disease, hypertension, hyperthyroidism or cardiovascular disease. ADCO-SINAL CO should not be given during or within fourteen days following administration of mono-amine oxidase inhibitors for depression (eg. tranylcypromine). Not recommended in pregnancy and lactating mothers.
Contra-indicated in respiratory depression, acute alcoholism, head injuries and conditions in which intracranial pressure is raised.
Should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.

WARNINGS:
Severe hypertensive episodes leading to intracranial haemorrhage have followed phenylpropanolamine ingestion. Patients should be informed of the dangers of exceeding the recommended dose; in particular the increased risk of serious adverse effects such as hypertensive crisis and haemorrhagic stroke. In addition, ADCO-SINAL COmay aggravate conditions such as diabetes, glaucoma or prostatic enlargement.
Do not use continuously for more than seven days without consulting a doctor. After 5-7 days, tachyphylaxis may occur and the product may lose effect. Consult a doctor if symptoms do not improve or are accompanied by fever.
Dosages in excess of those recommended may cause severe liver damage, nervousness, dizziness, sleeplessness, tremulousness or cadiac arrythmias. This may also occur in sensitive individuals at small doses. Use in caution in patients with phaeochromocytoma or occlusive vascular disease including arteriosclerosis and aneurysms.
Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
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 advised particularly at the initiation of therapy not to drive a motor vehicle, climb dangerous heights or operate dangerous machinery. In these situations, impaired decision making could lead to accidents.
Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependancy and addiction.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years: Take one tablet every four hours.
Do not take more than four doses per day. Do not exceed the recommended dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
SIDE-EFFECTS:
Paracetamol:
Sensitivity reactions resulting in reversible skin rash or blood disorders including neutropenia, pancytopenia and leucopenia may occur. The rash is usually erythematous or urticarial, but sometines more serious and may be accompanied by fever and mucosal lesions.
Phenylpropanolamine Hydrochloride:
Haemorrhagic stroke may occur, particularly at high doses and in high risk patients (see Warnings).
Fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness, psychotic states, reduced apetite, nausea and vomiting, vasoconstriction, hypertension, cerebral haemorrhage, pulmonary oedema, bradycardia or tachycardia, cardiac arrythmias, anginal pain, palpitations, cardiac arrest, hypotension with dizziness and fainting, flushing, difficulty in micturition, urinary retention, dyspnoea, altered metabolism including disturbance of glucose metabolism, sweating, hypersalivation, and headache may occur.
Phenyltoloxamine Citrate:
Sedation, lassitude, dizziness, inco-ordination, nausea, vomiting, diarrhoea or constipation, anorexia, epigastric pain, blurred vision, difficulty in micturition, dysuria, dryness of the mouth, tightness of the chest, hypotension, muscular weakness, tinnitus, euphoria and headache may occur. Blood disorders including agranulocytosis, leucopenia and haemolytic, anaemia have been reported less frequently.
Codeine Phosphate:
Nausea, vomiting, constipation, drowsiness, confusion, difficulty in micturition, ureteric or biliary spasm, antidiuresis, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood, miosis, raised intracranial pressure, euphoria, dependence.

SPECIAL PRECAUTIONS:
Phenylpropanolamine Hydrochloride:
Should be used in caution in patients with: hyperthyroidism; cardiovascular diseases such as ischaemic heart desease, arrythmia or tachycardia; occlusive vascular disorders, including arteriosclerosis, hypertension or aneurysms; diabetes mellitus and closed angle glaucoma.
Anginal pain may be precipitated in patients with angina pectoris.
Phenyltoloxamine Citrate:
Paradoxical central nervous stimulation may occur, especially in children, with insomnia, nervousness, tachycardia, tremors and convulsions.
May precipitate seizures in epileptics.
Caution in patients with narrow angle glaucoma, urinary retention or prostatic hypertrophy.
May lead to drowsiness, patients so affected should not drive or operate machinery. Patients should abstain from alcohol.
Codeine Phosphate:
Caution in patients with hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy, shock, patients with obstructive bowel disorders and myasthenia gravis.

INTERACTIONS:
Reversal of the action of antihypertensive agents may occur and therefore care is advisable in patients receiving antihypertensive therapy. Interaction with alpha- and beta- blocking drugs may be complex and can produce hypertensive crisis.
Interactions are possible with guanethidine, reserpine, digoxin and alpha-methyldopa.
ADCO-SINAL COshould be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics as they may induce ventricular fibrillation.
An increased risk of arrhythmias may occur when given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Paracetamol:
Symptoms of paracetamol overdosage in the first twenty four hours are pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become apparent twelve to forty-eight 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 two 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.
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.
Prompt treatment is essential. Any patient who has ingested about 7,5 g of paracetamol in the preceeding four 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 eight hours of overdosage.
IV: An initial dose of 150mg/kg in 200 mL glucose injection, given intravenously over fifteen minutes, followed by an intravenous infusion of 50mg/kg in 500 mL of glucose injection over the next four hours, and then 100mg/kg in 1000 mL over the next sixteen hours. The volume of intravenous fluids should be modified for children.
Orally: 140mg/kg as a 5% solution initially, followed by a 70mg/kg solution every four hours for seventeen doses. Acetylcysteine is effective if administered within eight hours of overdosage.

Phenyltoloxamine citrate:
Overdose may be fatal, especially in infants and children in whom the main symptoms are central nervous system stimulation and antimuscarinic effects, including ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse and death may occur within eighteen hours.
In adults, the usual symptoms are of central nervous system depression with drowsiness, coma and convulsions. Hypotension may also occur.

Codeine:
Symptoms include restlessness, excitement, respiratory depression and hypotension with circulatory failure and coma. In children convulsions may occur. The specific antagonist, naloxone hydrochloride is used to counteract the severe respiratory depression.

IDENTIFICATION:
Pink, round smooth tablets with no markings.

PRESENTATION:
Packs containing 20, 100 and 250 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C in a well closed container. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Y/5.8/264

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Bryanston
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
September 1991

New addition to this site: April 2004
Source: Pharmaceutical Industry

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