Flustat Syrup 20 ml Syrup

FLUSTAT u00ae SYRUP is recommended for the relief of the symptoms associated with colds and influenza such as headache, minor aches and pains and coughing.

Adults and children: Over 12 years: 20 ml every four hours up to four times daily. Children 6-12 years: 10 ml every four hours up to four times daily.

DO NOT EXCEED THE RECOMMENDED DOSE. If symptoms persist, consult your doctor.

FLUSTAT u00ae SYRUP is contra-indicated in persons with:

• Hypersensitivity to any of the active ingredients, or to any of the excipients in listed in section 6.1.
• Asthma
• Sensitivity to small doses of sympathomimetic substances is manifested by sleeplessness, dizziness, light-headedness, weakness, tremulousness or cardiac arrhythmia.
• Liver damage
• Cardiovascular disease
• Hypertension
• Hyperthyroidism
• Hyperexcitability
• Phaeochromocytoma
• Closed angle glaucoma
• FLUSTAT u00ae SYRUP is not recommended for children under the age of 6 years.

PARACETAMOL: FLUSTAT u00ae SYRUP contains paracetamol, dosages of FLUSTAT u00ae SYRUP in excess of those recommended may cause severe liver damage. DO NOT use continuously for more than 10 days without consulting your doctor.

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 SYRUP must immediately be discontinued and appropriate treatment instituted.

PHENYLPROPANOLAMINE HYDROCHLORIDE: In patients with prostatic enlargement it may cause difficulty in micturition. Phenylpropanolamine hydrochloride should be given with caution to patients receiving chloroform, cyclopropane, halothane or other halogenated anaesthetics. The effect of phenylpropanolamine hydrochloride are diminished by guanethidine, reserpine, methyldopa and may be diminished or enhanced by tricyclic antidepressants. It may diminish the effect of guanethidine and may increase the possibility of arrhythmias in digitalised patients. Prolonged use may lead to rebound congestion. Use with caution in patients with diabetes.

FLUSTAT u00ae SYRUP contains sucrose 4 g, liquid sorbitol 9,4 g, propylene glycol 2 g, and alcohol (96 %) 3,08 ml, sodium saccharin 10 mg and sodium citrate 240 mg in each 20 ml.

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.

Sucrose: therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Liquid sorbitol non crystallising: patients with hereditary fructose intolerance (HFI) should not take/be given FLUSTAT u00ae SYRUP.

Small amounts of ethanol (alcohol): less than 100 mg per dose.

Sodium: This medicinal product contains 31 mg sodium per dosage unit equivalent to 1,55 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Do not take this medicine if already receiving other medicines or with alcohol. FLUSTAT u00ae SYRUP should not be given concomitantly with any monoamine-oxidase inhibitor, or within 14 days of stopping such treatment.

The safety and efficacy of use during pregnancy and lactation has not been established. Therefore FLUSTAT SYRUP is not recommended during pregnancy and lactation.

Some patients may experience side effects such as dizziness, headaches and drowsiness. 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 Syrup

Pheynlpropanolamine

Paracetamol

Dextromethorphan hydrobromide

Blood and the lymphatic system disorders: Frequency Unknown Neutropaenia, pancytopaenia, leucopaenia

Metabolism and Nutrition Disorders: Frequency Unknown Mental confusion

Psychiatric Disorders: Frequency Unknown

Nervous System Disorders: Frequency Unknown Dizziness, Headache, tremor, anxiety, restlessness, insomnia Drowsiness, dizziness, excitation

Skin and Subcutaneous tissue disorders: Frequency Unknown Skin rashes (erythematous, urticarial or mucosal lesions) Risk of fixed drug eruptions and drug-induced hypersensitivity syndrome

Musculoskeletal and connective tissue disorders: Frequency Unknown Muscular weakness

Cardiac Disorders: Frequency Unknown Tachycardia, precordial pain, palpitations, hypertension, ventricular arrhythmias

Gastrointestinal disorders: Frequency Unknown Nausea, vomiting Nausea, vomiting, diarrhoea

Renal and Urinary disorders: Frequency Unknown Sweating, thirst, difficulty micturition, prostatic enlargement

General disorders and administrative site conditions: Frequency Unknown Allergic reactions, drug fever

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

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 carbamazepime.

Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia 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 child 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 paracetamol 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 oral formulation is not the treatment of choice, 140 mg/kg dissolved in water may be administered Initially, followed by 70 mg/kg every four 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 to liver damage as identified above, should continue treatment if concentrations are above the