Betafed Syrup 5 ml Syrup

BETAFED SYRUP is indicated for the relief of symptoms associated with colds and influenza such as nasal and sinus congestion, allergic rhinitis, vasomotor rhinitis and the common cold.

Adults and children over 12 years: 2 medicine measures (10 ml) orally three times daily.
Children 6 to 12 years: 1 medicine measure (5 ml) orally three times daily.
Children 2 to 5 years: u00bd medicine measure (2,5 ml) orally three times daily.
Method of Administration: For oral use.

• Hypersensitivity to pseudoephedrine hydrochloride, triprolidine hydrochloride or to any of the excipients listed in section 6.1.
• BETAFED SYRUP is contraindicated in patients who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks as this may cause a rise in blood pressure. The antibacterial agent furazolidone is known to cause a dose-related inhibition of monoamine oxidase. For this reason, BETAFED SYRUP and furazolidone should not be taken together.
• BETAFED SYRUP is contraindicated during acute attacks of asthma.
• BETAFED SYRUP is contraindicated in children under the age of 2 years.
• BETAFED SYRUP is contraindicated in severe hypertension or uncontrolled hypertension.
• BETAFED SYRUP is contraindicated in severe acute or chronic kidney disease/renal failure.

The use of BETAFED SYRUP may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Great care is needed in patients with cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders, including arteriosclerosis, hypertension or aneurysms. Care is required when pseudoephedrine is given to patients with hyperthyroidism, diabetes mellitus, closed-angle glaucoma or prostatic enlargement. Caution should be exercised in the presence of severe renal or hepatic impairment. Symptoms of central nervous system excitation, may occur, including sleep disturbances and hallucinations. Difficulty with micturition may also be experienced. Dyspnoea; altered metabolism including disturbances of glucose metabolism, sweating and hypersalivation are possible. Fixed drug eruption to pseudoephedrine, taking the form of erythematous nummular patches and lichenoid skin eruption due to triprolidine have been reported. Paradoxical central nervous system stimulation may occur particularly in children, with insomnia, nervousness, tachycardia, tremors and convulsions. Epileptiform seizures may be precipitated in patients with focal lesions of the cerebral cortex. Allergic reactions and cross-sensitivity to related medicines are possible with systemic triprolidine administration. Blood disorders including agranulocytosis, leukopenia and haemolytic anaemia have been reported. Elderly patients are more susceptible to the central nervous system depressant and hypotensive effects of antihistamines even at therapeutic doses. Posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) Cases of PRES and RCVS have been reported with the use of pseudoephedrine-containing products (see section 4.8). The risk is increased in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease/renal failure (see section 4.3). Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances. Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment.

Concomitant use of BETAFED SYRUP with other sympathomimetic medicines, such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants, or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure largely because of interaction with pseudoephedrine. Pseudoephedrine may partially reverse the hypotensive action of medicines which interfere with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine and methyldopa. Pseudoephedrine should 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 also occur if pseudoephedrine is given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants. Triprolidine may have an additive antimuscarinic action with other antimuscarinic medicines, such as atropine and the tricyclic antidepressants. BETAFED SYRUP may enhance the sedative effects of central nervous system depressants including alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquilisers. BETAFED SYRUP could mask the warning signs of damage caused by ototoxic medicines such as aminoglycoside antibiotics, due to its triprolidine content.

The safety and efficacy of BETAFED SYRUP in pregnancy and lactation has not been established.

Patients should be warned not to drive or operate dangerous machinery.

System Organ Class (SOC) Frequent Less frequent Frequency unknown
Blood and Lymphatic System Disorders Blood disorder Immune System Disorders Hypersensitivity u2013 cross sensitivity may occur with other sympathomimetics
Psychiatric Disorders Insomnia 1, nervousness 1 Hallucination, confusional state, depression, sleep disorder Agitation, anxiety, delusion, euphoric mood, hallucination, visual irritability, restlessness
Nervous System Disorders Headache, dizziness 1, paradoxical drug reaction, psychomotor hyperactivity, somnolence Extrapyramidal disorder, seizure, tremor Cerebrovascular accident, epilepsy, paraesthesia, posterior reversible, encephalopathy syndrome (PRES) / reversible cerebral vasoconstriction syndrome (RCVS)
Eye Disorders Vision blurred Ischaemic optic neuropathy
Cardiac Disorders Dysrhythmia, palpitations Myocardal infarction / Myocardial ischaemia, tachycardia
Vascular Disorders Hypotension Hypertension
Respiratory, Thoracic and Mediastinal Disorders Increased viscosity of bronchial secretion Dry throat, epistaxis, nasal dryness
Gastrointestinal Disorders Dry mouth, gastrointestinal disorder, nausea 1 Abdominal discomfort, ischaemic colitis, vomiting
Hepatobiliary Disorders Liver disorder
Skin and Subcutaneous Tissue Disorders Angioedema, pruritus, rash, severe skin reactions, including acute generalised exanthematous pustulosis (AGEP), urticaria
Renal and Urinary Disorders Urinary retention Dysuria
General Disorders and Fatigue, hyperpyrexia

Overdosage due to triprolidine may be fatal, especially in children in whom the main symptoms are central nervous system stimulation and antimuscarinic effects: ataxia, excitement, hallucinations, muscle tremor, convulsions, dilated pupils, dry mouth, flushed face and hyperpyrexia. Deepening coma, cardiorespiratory collapse and death may occur within 18 hours. In adults, the usual symptoms of overdosage are drowsiness, coma and convulsions. Weakness, dizziness, incoordination, difficulty with micturition, respiratory depression, hypotension, agitation, irritability, hypertension, palpitations, restlessness and tachycardia, may occur. Treatment is symptomatic and supportive.