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

Logo ADCO-FLUPAIN

SCHEDULING STATUS:
S2

PROPRIETARY NAME:
(and dosage form)
ADCO-FLUPAIN
Syrup

COMPOSITION:
Each 5 mL contains:-

Triprolidine Hydrochloride         0,625 mg
Pseudoephedrine Hydrochloride         15,0 mg
Paracetamol         125,0 mg
Preserved with:-        
Methyl Hydroxybenzoate 0,12% m/v
Propyl Hydroxybenzoate 0,02% m/v
Contains Alcohol 9,6% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 5.8 Preparations for the Common Cold including Decongestants and Antihistaminics.

PHARMACOLOGICAL ACTION:
ADCO-FLUPAIN Syrup
has decongestive, antipyretic, antihistamine and analgesic properties.

INDICATIONS:
For the relief of symptoms such as nasal congestion, sniffing and headache associated with the common cold and influenza.

CONTRA-INDICATIONS:
ADCO-FLUPAIN Syrup
should not be administered to patients suffering from cardiovascular disease (especially coronary insufficiency), hypertension, thyrotoxicosis, prostatism, bladder dysfunction, narrow angle glaucoma and pheochromocytoma. Individuals who have previously exhibited intolerance to ADCO-FLUPAIN Syrup or any of its constituents and in patients with a known hypersensitivity to any of the ingredients.
ADCO-FLUPAIN Syrup is contra-indicated in patients being treated with monoamine oxidase inhibitors and within two weeks of stopping such treatment as a hypertensive response may result.
Premature infants or neonates.
During an attack of asthma.
Avoid during cyclopropane, and halothane anaesthesia (or any other halogenated anaesthetic). The safe use of ADCO-FLUPAIN Syrup in pregnancy has not been established.

WARNINGS:
ADCO-FLUPAIN Syrup
contains paracetamol. Dosages of ADCO-FLUPAIN Syrup in excess of those recommended, may cause severe liver damage. ADCO-FLUPAIN Syrup 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 not to drive a motor vehicle, climb dangerous heights or operate dangerous machinery, as impaired mental alertness could lead to accidents. Do not use continuously for longer than 10 days without consulting your doctor.

DOSAGE AND DIRECTIONS FOR USE:
May be given three times daily.
Children 6 to 12 years        5 to 10 mL
Children 2 to 5 years        5 mL
Infants 6 months up to 2 years 2,5 mL
Consult your doctor if no relief is obtained with the recommended dosage.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol
may cause skin rashes and other allergic reactions. The 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 occurrence of neutropenia, pancytopenia and leucopenia. Patients suffering from liver and kidney disease should take ADCO-FLUPAIN Syrup under medical supervision due to the paracetamol content. Alcohol may increase the hepatotoxicity of paracetamol and may contribute to pancreatitis.
Pseudoephedrine hydrochloride may cause giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficult micturition, muscular weakness and tremors, anxiety, restlessness and insomnia. Hypertension and ventricular arrhythmias may occur.
Pseudoephedrine HCl should be given with caution to patients with organic heart disease, cardiac decompensation or angina of effort. In patients with prostatic enlargement, it may increase difficulty of micturition. Fixed drug eruption due to pseudoephedrine HCl, taking the form of erythematous nummular patches has been reported. The following side-effects due to pseudoephedrine may also occur: agitation, anginal pain, especially in patients suffering from angina pectoris, loss of appetite, reflex bradycardia, cardiac arrest, confusion, dizziness, dyspnea, aneurisms, fainting, fear, flushing, disturbances of glucose metabolism, irritability, miosis, dry mouth, psychotic states and weakness.
ADCO-FLUPAIN Syrup should be used with caution in patients with diabetes mellitus, in elderly and debilitated patients, and in patients with occlusive vascular disorders (arteriosclerosis). It must be used with care in hypersusceptible individuals. Tolerance may develop when given to asthmatics for its asthmatic effects. The most common side-effects of triprolidine hydrochloride are sedation varying from slight drowsiness to deep sleep, and 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 and epigastric pain. Headache, tinnitus, elation or depression, irritability, nightmares, anorexia, difficult micturition, dryness of the mouth, tightness of the chest and tingling, heaviness and weakness of the hands may occur. Large doses may precipitate fits in epileptic patients. Allergy and anaphylaxis may occur. Blood dyscrasias, including agranulocytosis and haemolytic anaemia may occur. Lichenoid skin eruption due to triprolidine HCl has been reported. The following side-effects due to triprolidine may occur: nervousness, leucopenia, convulsions, especially in children, insomnia, tremor, photosensitisation of the skin, tachycardia and euphoria.
ADCO-FLUPAIN Syrup should be used with caution in severe liver or kidney dysfunction, cardiovascular disease, glaucoma, urinary retention and prostatic hypertrophy. Elderly patients are more susceptible to central nervous system depressants and hypotensive effects. The positive results of skin tests may be suppressed.
ADCO-FLUPAIN Syrup should be used with caution in patients taking other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psycho-stimulants, or antihypertensive agents, as this may cause a rise in blood pressure largely because of interaction with pseudoephedrine HCl. The effects of a single dose of ADCO-FLUPAIN Syrup on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment. The antibacterial agent, furazolidone, is known to cause a dose-related inhibition of monoamine oxidase. ADCO-FLUPAIN Syrup and furazolidone should not be taken together.
The effects of ADCO-FLUPAIN Syrup due to pseudoephedrine HCl, are diminished by guanethidine, reserpine, methyldopa and may be diminished by tricyclic antidrepressants. The effects of atropine and tricyclic antidepressants may be enhanced by triprolidine HCl. Triprolidine HCl may mask the warning symptoms of damage caused by ototoxic drugs and may affect the metabolism of drugs in the liver. Long term use of anticonvulsants and oral steroid contraceptives cause an increase in the first past metabolism or clearance rate and may prevent attainment of therapeutic levels. Reversal of the effect of antihypertensive agents may occur. Do not give together with cardiac glycosides, quinidine, and, tricyclic antidepressant agents. The depressant effects of triprolidine are aggravated by alcohol anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines. Monoamine oxidase inhibitors may enhance the anticholinergic effects.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
For symptoms of overdosage - see side-effects.
Symptoms of pseudoephedrine HCl overdosage may include paranoid psychosis, delusions and hallucinations.
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. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrythmias 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 manifest itself 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 non-specific myocardial depression have also occurred.
In the event of overdosage consult a 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.
An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over fifteen minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next four hours, and then 100 mg/kg in 1 000 mL over the next sixteen hours. The volume of intravenous fluid should be modified for children.
Orally:
140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution over four hours for seventeen doses. Acetylcysteine is effective if administered within eight hours of overdosage.

IDENTIFICATION:
A clear red syrup with a raspberry odour and taste.

PRESENTATION:
Amber glass bottles containing 50 mL, 100 mL, 200 mL and 500 mL

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
27/5.8/0260

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:
10 June 1993

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

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