ANGILOL

Posology Adults Hypertension The starting dose of Angilol should be 80mg twice a day, to be increased by the same amount at weekly intervals, according to patient response. Usually a response is seen within the dose range 160 - 320mg per day.

A further reduction of blood pressure may be achieved when a diuretic and/or anti-hypertensive therapy is given in addition to Angilol. Angina, migraine and essential tremor The starting dose is 40mg two or three times daily, increasing by the same amount at weekly intervals, according to patient response.

An adequate response in migraine and essential tremor is usually seen in the range of 80 - l60mg daily in divided doses. In angina the dose to achieve adequate response will usually be l20 - 240mg/day (in divided doses). Situational and generalised anxiety A dose of 40 mg daily may provide short term relief of acute situational anxiety.

Generalised anxiety, requiring longer term therapy, usually responds adequately to 40 mg twice daily which, in individual cases, may be increased to 40 mg three times daily. Treatment should be continued according to response. Patients should be reviewed after 6 to 12 months treatment.

Arrhythmias, anxiety tachycardia, hypertrophic obstructive cardiomyopathy and thyrotoxicosis, Most patients respond within the dosage range of 10 - 40mg three or four times a day. Post myocardial infarction Treatment should start between days 5 and 21 after myocardial infarction, with an initial dose of 40 mg four times a day for 2 or 3 days.

In order to improve compliance the total daily dosage may thereafter be given as 80 mg twice a day. Portal hypertension Dosage should be titrated to achieve approximately 25% reduction in resting heart rate. Dosage should begin with 40 mg twice daily, increasing to 80 mg twice daily depending on heart rate response.

If necessary, the dose may be increased incrementally to a maximum of 160 mg twice daily. Phaeochromocytoma (Used only in conjunction with an alpha-receptor blocking drug) Pre-operatively: 60mg daily for three days is recommended - malignant cases (non- operable): 30mg daily.

Paediatric population:

Dysrhythmias, phaeochromocytoma, thyrotoxicosis The dose of Angilol should be determined according to the cardiac status of the patient and the circumstances necessitating treatment. 5mg/kg three or four times daily as required. Migraine Oral: under the age of 12: 20 mg two to three times daily Over the age of 12: the adult dose Fallot's Tetralogy The value of Angilol in this condition is confined mainly to the relief of the right- ventricular outflow tract shut-down.

It is also useful for treatment of associated dysrhythmias and angina. Dosage should be individually determined according to circumstances and is usually up to 1 mg/kg repeated three or four times daily as required.

Elderly:

Evidence concerning the relation between blood level and age is conflicting. Angilol should be used to treat older people with caution. It is suggested that treatment should start with the lowest dose. The optimum dose should be individually determined according to the clinical response.

Method of administration For oral administration.

Angilol is usually well tolerated. In clinical studies the undesired events reported are usually attributable to the pharmacological actions of propranolol. The following undesired events, listed by body system, have been reported.

The following definitions of frequencies are used:

Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). System Organ class Frequency Undesirable Effect Blood and lymphatic system disorders Rare Thrombocytopaenia Endocrine disorders Not known Hypoglycaemia in neonates, infants, children, elderly patients, patients on haemodialysis, patients on concomitant antidiabetic therapy, patients with prolonged fasting and patients with chronic liver disease has been reported, seizure linked to hypoglycaemia Common Sleep disturbances, nightmares Rare Hallucinations, psychoses, mood changes, confusion, memory loss, paraesthesia Nervous system disorders Very rare Isolated reports of myasthenia gravis like syndrome or exacerbation of myasthenia gravis have been reported Not known Depression Eye disorders Rare Dry eyes, visual disturbances Common Bradycardia, cold extremities, Raynaud’s phenomenon Cardiovascular disorders Rare Heart failure deterioration, precipitation of heart block, postural hypotension, which may be associated with syncope, exacerbation of intermittent claudication Respiratory, thoracic and mediastinal disorders Rare Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints, sometimes with fatal outcome Gastrointestinal disorders Uncommon Gastrointestinal disturbance, such as nausea, vomiting, diarrhoea Skin and subcutaneous tissue disorders Rare Purpura, alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes Reproductive system and breast disorders Not known Impotence Common Fatigue and/or lassitude (often transient)General disorders and administration site conditions Rare Dizziness Investigations Very rare An increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear Discontinuance of the drug should be considered if, according to clinical judgement, the well-being of the patient is adversely affected by any of the above reactions.

Cessation of therapy with a beta-blocker should be gradual. In the rare event of intolerance of Angilol manifested by bradycardia and hypotension, the drug should be withdrawn and, if necessary, treatment instituted for overdosage. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard.

3), Angilol should be given with caution to patients with less severe peripheral circulatory disturbances as these may be aggravated. 3), may be used in patients whose signs of heart failure have been controlled. Special care should be taken with patients whose cardiac reserve is poor.

Due to a negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block. Angilol may block/modify the signs and symptoms of the hypoglycaemia (especially tachycardia). g.

neonates, infants, children, elderly patients, patients on haemodialysis or patients suffering from chronic liver disease and patients suffering from overdose. Severe hypoglycaemia associated with Angilol has rarely presented with seizures and/or coma in isolated patients.

Caution must be exercised in the concurrent use of Angilol and hypoglycaemic therapy in diabetic patients. 3). Heart failure due to thyrotoxicosis often responds to Angilol alone, but if other adverse factors co-exist myocardial contractility must be maintained and signs of failure controlled with digitalis and diuretics.

Angilol may mask the important signs of thyrotoxicosis. Angilol should not be used in untreated phaeochromocytoma. However, in patients with phaeochromocytoma, an alpha-blocker may be given concomitantly. Beta-blockers may induce bradycardia as a result of its pharmacological action.

In the rare instance that a treated patient develops symptoms which may be attributable to a slow heart rate a reduction in dose may be necessary. Beta-blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions.

Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions. It is important that treatment with a beta-blocking agent is not discontinued abruptly. Either the equivalent dosage of another beta-blocker may be substituted or the withdrawal of Angilol should be gradual over a period of 7 to 14 days.

Patients should be followed during withdrawal especially those with ischaemic heart disease.

Anaesthesia:

Angilol can cause an altered response to stress and therefore it may be necessary to withdraw the drug before surgery. The risk/benefit of stopping beta blockade should be made for each patient. If it is decided to withdraw Angilol it should be done 24 hours before elective surgery.

In emergency, or when interruption of treatment might expose the patient to severe uncontrolled angina or dysrhythmia, such withdrawal may be impracticable. Anaesthesia may still proceed, however, provided that the patient is protected against vagal dominance by the intravenous administration of atropine l - 2mg and that agents such as ether, chloroform, cyclopropane and trichloroethylene are avoided.

Since the half-life may be increased in patients with significant hepatic or renal impairment, caution must be exercised when starting treatment and selecting the initial dose. 2). In patients with portal hypertension, liver function may deteriorate and hepatic encephalopathy may develop.

2). Psoriasis may be aggravated by the use of beta adrenoceptor blocking drugs. Patients with psoriasis should take beta-blockers only after careful consideration.

Interference with laboratory tests:

Angilol has been reported to interfere with the estimation of serum bilirubin by the diazo method and with the determination of catecholamines by methods using fluorescence. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. 1 2. In the presence of 2nd and 3rd degree heart block 3. Sick Sinus syndrome 4. Bradycardia 5. Untreated phaeochromocytoma 6. Uncontrolled heart failure 7. Cardiogenic shock 8. Hypotension 9. Asthma 10. Intermittent claudication 11. Severe peripheral circulatory disturbances; 12.

Prinzmetals angina; 13. If there is a history of bronchial asthma or bronchospasm. The text on the label for this product will carry this following warning. 'Do not take this medicine if you have wheezing or asthma A similar warning appears in the patient information leaflet.

Bronchospasm can usually be reversed by beta-2 agonist bronchodilators such as salbutamol. Large doses of the beta-2 agonist bronchodilator may be required to overcome the beta blockade produced by propranolol and the dose should be titrated according to the clinical response; both intravenous and inhalational administration should be considered.

The use of intravenous aminophylline and/or the use of ipratropium (given by nebuliser) may also be considered. Glucagon (1 to 2 mg given intravenously) has also been reported to produce a bronchodilator effect in asthmatic patients.

Oxygen or artificial ventilation may be required in severe cases. 14. After prolonged fasting, patients with restricted counter-regulatory reserves or in patients prone to hypoglycaemia. Patients with restricted counter regulatory reserves may have reduced autonomic and hormonal responses to hypoglycaemia which includes glycogenolysis, gluconeogenesis and /or impaired modulation of insulin secretion.

Patients at risk for an inadequate response to hypoglycaemia includes individuals with malnutrition, prolonged fasting, starvation, chronic liver disease, diabetes and concomitant use of drugs which block the full response to catecholamine 15.

g. in diabetes).