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

Logo FLUTEX EFFERVESCENT (tablets)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

FLUTEX EFFERVESCENT (tablets)

COMPOSITION:
Each tablet contains:

Chlorpheniramine maleate         4,0 mg
Paracetamol         500,0 mg
Pseudoephedrine hydrochloride         50,0 mg
Vitamin C         330,0 mg

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

PHARMACOLOGICAL ACTION:
FLUTEX EFFERVESCENT tablets have analgesic, antipyretic, antihistaminic and decongestant properties.

INDICATIONS:
Symptomatic relief of minor aches and pains, and sinus and nasal congestion associated with colds and flu.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Coronary disease and cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia.
Safety in pregnancy and lactation has not been established.
Patients sensitive to one antihistamine may be sensitive to others.
Patients receiving monoamine oxidase inhibitor treatment, or within 14 days of stopping such treatment.
Severe liver function impairment. Flutex Effervescent tablets should not be administered to children under the age of 12 years.

WARNINGS:
Consult a doctor if no relief is obtained from the recommended dosage.
Do not use this product for more than 7 days without consulting a doctor.
Store in a safe place out of reach of children.
May lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants e.g. sedatives and tranquilizers.
Caution should be used when driving a motor vehicle or operating machinery or performing potentially dangerous tasks, where loss of concentration may lead to accidents.
Should be used with caution in patients with prostatic hypertrophy, narrow angle glaucoma, emphysema or chronic bronchitis, porphyria.
Paradoxical hyperexcitability, nervousness and insomnia may occur in children and the elderly.
Elderly patients are especially susceptible to dizziness, sedation, confusion, hypotension and anticholinergic effects such as a dry mouth and urinary retention.
After 5 to 7 days tachyphylaxis may occur and the product loses effect. If symptoms do not improve, or are accompanied by fever, consult a doctor.
Exceeding the recommended dosage may result in nervousness, dizziness, sleeplessness, tremulousness or cardiac arrhythmia. This may also occur in sensitive individuals at small doses.
Should be used with caution in patients with hypertension, hyperthyroidism, diabetes mellitus, closed-angle glaucoma, prostatic hypertrophy, phaeochromocytoma, occlusive vascular disease including arteriosclerosis, aneurysms.
Consult a doctor if pain or fever persists or gets worse, if new symptoms occur or if redness and swelling are present, as these could be signs of a serious condition.
In the event of over-dosage or suspected over-dosage, prompt medical attention is critical for adults as well as children, even if there are no obvious signs or symptoms. The nearest doctor, hospital or poisons control center must be contacted immediately.
Dosages in excess of those recommended may cause severe liver damage.
Consult a doctor if no relief is obtained from the recommended dosage.
Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take paracetamol.
Use with caution in renal disease.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years:
One tablet every 4 to 6 hours if necessary to a maximum of 4 tablets per day.
Place one tablet in a glass of warm water and allow to dissolve. Drink the contents immediately once the whole tablet has dissolved.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol
Pancreatitis, skin rashes and other allergic reactions may occur. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions.
The use of paracetamol has been associated with the occurrence of agranulocytosis, thrombocytopenia, neutropenia, pancytopenia and leucopenia, anaemia, dermatitis, hepatitis, renal colic, renal failure and sterile pyuria.
Pseudoephedrine hydrochloride
Fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states.
Appetite may be reduced and nausea and vomiting may occur.
Vasoconstriction with resultant hypertension. The rise in blood pressure may produce cerebral hemorrhage and pulmonary oedema. There may also be a reflex bradycardia, but stimulation of B
1-adrenergic receptors of the heart may produce tachycardia and cardiac arrhythmias, anginal pain, palpitations and cardiac arrest. Hypotension with dizziness and fainting and flushing may occur.
Difficulty in micturition and urinary retention, dyspnoea, altered metabolism, including disturbances of glucose metabolism, sweating and hypersalivation. Headache is also common.
Anginal pains may be precipitated in patients with angina pectoris.
Reversal of the action of antihypertensive agents may occur and therefore special care is advisable in patients receiving antihypertensive therapy. Interactions with alpha- and beta-blockers may be complex and can produce hypertensive crisis.
An increased risk of arrhythmias may occur when given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Interactions are possible with tricyclic antidepressants, guanethidine, reserpine, alpha-methyldopa and digoxin.
Should be used with caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics as they may induce ventricular fibrillation.
Aluminium hydroxide mixtures may enhance the absorption of pseudoephedrine.
Chlorpheniramine maleate
Central nervous system reactions include sedation, drowsiness, confusion, hallucinations, convulsions, headache, dizziness, tinnitus, lassitude, incoordination, fatigue, nervousness, insomnia and tremors.
Extra pyramidal effects with muscle spasms and dystonia.
Gastrointestinal disturbances such as nausea, vomiting, epigastric pain and diarrhoea have occurred.
Anticholinergic effects with ataxia, flushing, blurred vision, dryness of the mouth, throat and respiratory passages, thickening of mucous, urinary retention or frequency, dysuria, reduction in tone and motility of the gastrointestinal tract, resulting in constipation and gastric reflux.
Palpitation and arrhythmias, hypertension, hypotension, tachycardia, headache, tightness of the chest, tingling, heaviness and weakness of the hands.
Photosensitivity and skin rash, allergic dermatitis and drug fever.
Blood dyscrasia including agranulocytosis, leucopenia, haemolytic anaemia and thrombocytopenia have been reported.
Should be used with care in patients with pyloroduodenal obstruction, epilepsy and severe cardiovascular disorders.
May cause rashes and hypersensitivity reactions (including bronchospasm, angioedema and anaphylaxis).
All sedatives, including alcohol, will potentiate depressant effects on the central nervous system if taken with antihistamines. May enhance the sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics.
Antihistamines may suppress positive skin test results and should be stopped several days before the test.
Sweating, myalgia, paraesthesias, sleep disturbances, depression, hair loss.
Medications tending to cause extrapyramidal reactions and those with anticholinergic effects may be potentiated. These include tricyclic antidepressants, maprotiline and monoamine oxidase inhibitors.
Vitamin C
Large doses are reported to cause diarrhoea and other gastrointestinal disturbances and are associated with the formation of renal calcium oxalate calculi. Ascorbic acid should be given with care to patients with hyperoxaluria. Tolerance may be induced with prolonged use of large doses. Large doses of Vitamin C have resulted in haemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
May interact with desferrioxamine, hormonal contraceptives, fluphenazine and warfarin.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Chlorpheniramine maleate
Central excitatory effects constitute the greatest danger in overdose. Symptoms include drowsiness or paradoxical excitement, hallucinations, ataxia, incoordination, athetosis and convulsions.
Fixed dilated pupils with a flushed face, sinus tachycardia, dyspnoea, urinary retention, dry mouth and fever. Terminally deepening coma and cardiorespiratory collapse.
Children and the elderly are more likely to exhibit anticholinergic and central nervous system stimulant effects. The elderly are prone to hypotension.
The stomach should be emptied by emesis or lavage. There is no specific antidote and treatment is symptomatic and supportive. It may be necessary to treat extrapyramidal reactions with barbiturates or diphenhydramine.
The patient must be taken to a doctor or hospital immediately as specialized treatment may be necessary.
Pseudoephedrine hydrochloride
Pseudoephedrine overdosage produces central nervous system stimulation with excitement, restlessness, rapid speech, hallucinations, hypertonicity and hyperflexia with dilated pupils and tachycardia.
Beta-blockers may be administered for tachycardia. Potassium supplements may be required.
Paracetamol
Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person to a hospital directly. A delay in starting treatment may mean that the antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed.
Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5-10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrition, and with the use of drugs that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazapine.
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia, and abdominal pain. Mild symptoms during the first two days of acute poisoning, do not reflect the potential seriousness of the overdosage.
Liver damage may become apparent 12 to 48 hours, or later after ingestion, initially by elevation of the serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of the prothrombin time. Liver damage may lead to encephalopathy, coma and death.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac arrhythmias have been reported.
Treatment of paracetamol overdose
Prompt treatment is essential in the management of paracetamol overdosage. Any adult person who has ingested about 7,5 g or more of paracetamol (or child who has had more than 140 mg/kg) within the preceding 4 hours, should have the stomach emptied by lavage (emesis may be adequate for children) and a single dose of 50 g activated charcoal given via the lavage tube.
N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible, preferably within 8 hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken.
IV: An initial dose of 150 mg/kg N-acetylcysteine 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 1 000 mL glucose injection over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally (not the treatment of choice): 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. N-acetylcysteine is more likely to be effective if administered within 8 hours of overdosage.
A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours, unless high, may be misleading. Patients at risk of liver damage, and hence requiring continued treatment of N-acetylcysteine, can be identified according to their plasma paracetamol level. The plasma paracetamol level can be plotted against the time since ingestion in the nomogram below.
Those whose plasma paracetamol levels are above the “normal treatment line”, should continue N-acetylcysteine treatment with 100 mg/kg over sixteen hours repeatedly until recovery. Patients with increased susceptibility to liver damage as identified above, should continue treatment if concentrations are above the “high risk treatment line”. Prothrombin index correlates best with survival.
If N-acetylcysteine is not available, methionine 2,5 g may be given immediately, followed by 2,5 g every four hours for three doses. Patients should however preferably be transferred to a facility where N-acetylcysteine can be given.
Monitor all patients with significant ingestion for at least ninety six hours.

IDENTIFICATION:
Round, biplane tablets, off-white with a pink tinge and a rough surface. It produces a slightly pink, clear solution with a ginger flavour, once dissolved in + 200 mL of warm water.

PRESENTATION:
Available in aluminium tubes in packs of 12 tablets.

STORAGE INSTRUCTIONS:
Store in a cool dry place below 25°C.
Keep tube tightly closed.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
35/5.8/0152

NAME AND BUSINESS ADDRESS OF APPLICANT:
PHARMACARE LIMITED
7 Fairclough Road
Korsten
Port Elizabeth
6020
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
05 July 2001

New addition to this site: January 2006
Source: Pharmaceutical Industry

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