Flustat Capsules 5 mg Capsule

FLUSTAT u00ae CAPSULES are indicated for the relief of symptoms associated with colds and influenza such as nasal congestion, sniffing, headache, minor aches and pains.

Adults: 2 capsules three times daily. Children (6 - 12 years): 1 capsule three times daily. Not recommended for children under the age of 6 years.

FLUSTAT u00ae CAPSULES are contra-indicated in persons with:

• Hypersensitivity to any of the active ingredients, or to any of the excipients in listed in section 6.1.
• Coronary Disease
• Hypertension
• Cardiovascular disease
• Hyperthyroidism
• Epilepsy
• Pregnancy (see Section 4.6 )
• Persons being treated with monoamine oxidase inhibitors or within 10 days of stopping such treatment.
• Patients with prostatic enlargement, paralytic ileus or pyloric stenosis, closed angle glaucoma or with a narrow angle between the iris and the cornea.
• Flustat u00ae Capsules are not recommended for children under the age of 6 years.

Dosages in excess of those recommended may cause liver damage. Do not use continuously for more than 10 days without consulting your doctor. This medicine may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents.

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

Severe cutaneous adverse reactions (SCARs) such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), eosinophilia and systemic (DRESS)/Drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE) have been reported in patients treated with paracetamol containing medicines. If a patient develops SCAR, treatment with FLUSTAT CAPSULES must immediately be discontinued and appropriate treatment instituted.

Phenylephrine Administer with caution to hypersensitive patients, particularly those with Hyperthyroidism, patients with cardiovascular disease, diabetes mellitus or closed angle glaucoma.

Chlorpheniramine Chlorpheniramine may produce sedation, persons should not operate machinery, drive cars, climb dangerous heights or perform potentially dangerous tasks where impaired decision making could lead to accidents.

Caffeine This product contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or poison centre must be contacted immediately.

Caffeine should be given with care to patients with a history of peptic ulcers. Contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucosegalactose malabsorption should not take this medicine.

Pheylephrine Patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics. Patients receiving antihypertensive therapy may experience a reversal of the action of the antihypertensive medication, if phenylpropanolamine is given concomitantly. Patients taking cardiac glycosides, quinidine, tricyclic antidepressants or antihypertensive therapy are at increased risk of experiencing arrhythmias when phenylpropanolamine is given concomitantly.

Chlorpheniramine Other central nervous system depressants, such as barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers, if taken concomitantly will enhance sedation. Care should be observed when tricyclic antidepressants, guanethidine, reserpine, methyldopa or atropine are taken concomitantly.

Pregnancy Contra-indicated in pregnancy

Lactation The safety of this medicine in lactation has not been established

Patients should be warned not to drive a motor vehicle, operate dangerous machinery or climb dangerous heights, as impaired decision making could lead to accidents.

Flustat Capsules Paracetamol Phenylephrine Chlorpheniramine Caffeine Blood and the lymphatic system disorders: Frequency Unknown Neutropenia, pancytopenia and leucopenia Immune System Disorders: Frequency Unknown Reversible skin rash Endocrine Disorders Frequency Unknown Hypersalivation Metabolism and Nutrition Disorders: Frequency Unknown Altered metabolism including disturbance of glucose metabolism Anorexia Psychiatric Disorders: Frequency Unknown Psychotic states, fear, anxiety Elation or depression, nightmares, irritability Nervous System Disorders: Frequency Unknown Restlessness, tremor, insomnia, confusion, irritability, cerebral haemorrhage, Headache Sedation, headache, cerebral stimulation particularly in children, dizziness, nervousness, tremors, muscle twitching, convulsions Headache, Insomnia Eye Disorders: Frequency Unknown Blurred vision Ear and Labyrinth Disorders: Frequency Unknown Tinnitus Skin and Subcutaneous tissue disorders: Frequency Unknown Erythematous or urticarial rash which may be accompanied by fever and mucosal lesions. Risk of fixed drug eruptions and drug- induced hypersensitivity syndrome Cardiac Disorders: Frequency Unknown Vasoconstriction, hypertension, bradycardia or tachycardia, cardiac arrhythmias, anginal pain, palpitations, cardiac arrest, hypotension with dizziness and fainting Tightness of chest and tingling, hypotension, tachycardia Palpitations Respiratory, thoracic and mediastinal disorders: Frequency Unknown Pulmonary oedema, dyspnea Gastrointestinal disorders: Frequency Unknown Nausea and vomiting Nausea, vomiting, diarrhea, constipation, colic, epigastric pain Nausea Renal and Urinary disorders: Frequency Unknown Difficulty in micturition, urinary retention Difficulty in micturition General disorders and administrative site conditions: Frequency Unknown Weakness, reduced appetite, flushing, sweating Dryness of mouth, heaviness and weakness of hands, allergy and anaphylaxis, inability to concentrate, inco- ordination, lassitude Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Caffeine: Overdosage symptoms include restlessness, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia and extrasystoles.

Pheylephrine hydrochloride: Tachycardia may occur with an overdose sufficient to stimulate the heart.

Paracetamol: Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person directly to a hospital. A delay in starting treatment may mean that 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 medicine that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepme. Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, arorexia and possibly 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 lime. 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 for paracetamol overdosage: Ingestion of amounts of paracetamol smaller than 5 u2013 10 grams or more of paracetamol (or a chiId who has had more than 140 mg/kg) may require treatment in patients susceptible to paracetamol poisoning. N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible preferably within eight hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamoI was taken. An initial dose of 150 mg/kg N-acetylcysteine in 200 ml dextrose injection given intravenously over 15 minutes, followed by an infusion of 50 mg/kg in 500 ml dextrose injection over the next four hours, and then 100 mg/kg in 1 000 ml dextrose injection over the next sixteen hours. The volume of intravenous fluid should be modified for children. Although the oraI formulation is not the treatment of choice, 140 mg/kg dissolved in water may be administered Initially, followed by 70 mg/kg every tour hours for seventeen doses. A plasma paracetamol level should be determined four hours after Ingestion In all cases of suspected overdosage. Levels done before four hours may be misleading. Patients at risk of liver damage, and hence requiring continued treatment with N- acetylcysteine, can be identified according to their 4-hour plasma paracetamol level. The plasma paracetamol level can be plotted against time since ingestion In the nomogram below. Source: Martindale: The Complete Drug Reference -37th Edition.

The nomogram should be used only in relation to a single acute ingestion. Those whose plasma paracetamol levels are above the u201cnormal treatment lineu201d, should continue N-acetylcysteine treatment with 100 mg/kg IV over sixteen hours repeated until recovery. Patients with increased susceptibility lo liver damage as identified above, should continue treatment if concentrations are above the