VERAPAMIL

For oral administration.

Angina Pectoris Adults:

The usual dosage is 120 mg three times daily. 80 mg three times daily may be satisfactory in some patients with angina of effort. Less than 120 mg three times daily is not likely to be effective in angina at rest and variant angina.

Children:

No data are available. Supraventricular tachycardia Adults: 40 - 120 mg three times daily according to the severity of the condition.

Children:

Up to 2 years: Half a 40 mg tablet 2 to 3 times a day. 2 years and above: One to three 40 mg tablets two to three times daily according to age and effectiveness.

Hypertension Adults:

The usual dosage is 160 mg twice a day. However, a minority of patients may be successfully controlled on 120 mg twice a day while others may require up to 480 mg daily given in divided doses.

Children:

Up to 10 mg/kg/day, in divided doses, according to the severity of the disease. 4). Elderly patients show enhanced bioavailability of verapamil and therapeutic control may be achieved with lower doses in this patient population.

Hepatic impairment:

Verapamil is extensively metabolised in the liver and for those patients with impaired liver function, the dose should be reduced and carefully titrated.

Renal impairment:

About 70% of an administered dose of verapamil is excreted as metabolites in the urine. Verapamil should be prescribed cautiously when renal function is impaired. Careful patient monitoring is recommended.

g. erythema, pruritus, urticaria) are very rarely seen. Nervous system disorders: headache, dizziness, paraesthesia, tremor and extrapyramidal syndrome. Ear and labyrinth disorders: vertigo and tinnitus. Cardiac disorders/vascular disorders: bradycardic arrhythmias such as sinus bradycardia, sinus arrest with asystole, 2nd and 3rd degree AV block, bradyarrhythmia in atrial fibrillation, peripheral oedema, palpitations, tachycardia, development or aggravation of heart failure and hypotension.

There have been rare reports of flushing. Gastrointestinal disorders: nausea, vomiting, constipation, ileus and abdominal pain/discomfort. Gingival hyperplasia may occur very rarely when the drug is administered over prolonged periods, and is fully reversible when the drug is discontinued.

Skin and subcutaneous tissue disorders: ankle oedema, Quincke's oedema, Steven- Johnson syndrome, erythema multiforme, erythromelalgia, alopecia and purpura. Musculoskeletal and connective tissue disorders: muscular weakness, myalgia and arthralgia.

Reproductive system and breast disorders: impotence (erectile dysfunction) has been rarely reported and isolated cases of galactorrhoea. On very rare occasions, gynaecomastia has been observed in elderly male patients under long-term verapamil treatment, and is fully reversible in all cases when the drug was discontinued.

General disorders and administration site conditions: fatigue.

Investigations:

A reversible impairment of liver function characterised by an increase of transaminase and/or alkaline phosphatase may occur on very rare occasions during verapamil treatment and is most probably a hypersensitivity reaction. Rises in blood prolactin levels have been reported.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

2). Although the pharmacokinetics of verapamil in patients with renal impairment are not affected, caution should be exercised and careful patient monitoring is recommended. Verapamil is not removed during dialysis. Verapamil may affect impulse conduction and should be used with caution in patients with bradycardia or first degree atrioventricular block.

The effects of verapamil and beta blockers or other drugs with a cardio-depressive action may be additive both with respect to conduction and contraction, therefore care must be exercised when these are administered concurrently or closely together.

This is especially true when either drug is administered intravenously. g. Wolff-Parkinson-White syndrome) may rarely develop increased conduction across the anomalous pathway and ventricular tachycardia may be precipitated. If there are signs of tachycardia-induced heart failure (energetic exhaustion of the myocardium) digitalisation is necessary before intravenous administration of verapamil.

Verapamil may affect left ventricular contractility; this effect is small and normally not important but cardiac failure may be precipitated or aggravated. g. digitalis. When treating hypertension with verapamil, monitoring of the patient’s blood pressure at regular intervals is required.

3), especially in acute myocardial infarction as this is a condition where atrioventricular conduction defects may develop and contractility may be impaired. g. simvastatin, atorvastatin or lovastatin) for patients taking verapamil. These patients should be started at the lowest possible dose of verapamil and titrated upwards.

g. simvastatin, atorvastatin or lovastatin), refer to advice in the respective statin product information (see section

1. • Cardiogenic shock. • Acute myocardial infarction with complications such as bradycardia. • Marked hypotension or left ventricular failure. • Porphyria. • Hypotension of less than 90 mmHg systolic. • Bradycardia (< 50 beats / min). • Uncompensated heart failure.

• Second or third degree atrioventricular (AV) block (except in patients with a functioning artificial pacemaker). • Sino-atrial block. • Sick sinus syndrome (except in patients with a functioning artificial pacemaker). • Concomitant ingestion of grapefruit juice.

g. Wolff-Parkinson-White (WPW) syndrome, Lown-Ganong-Levine syndrome) may develop increased conduction across the anomalous pathway and ventricular tachycardia may be precipitated. 5). 5).