VERAPRESS MR

Adults:

Hypertension: Most patients respond to 240 mg daily (one tablet) given as a single dose. If control is not achieved after a period of at least one week, the dosage may be increased to a maximum of two Verapress MR 240 tablets daily (one in the morning and one in the evening at an interval of about twelve hours).

A further reduction in blood pressure may be achieved by combining Verapress MR 240 with other anti- hypertensive agents, in particular diuretics.

Angina pectoris:

One tablet of Verapress MR 240 twice daily. A small number of patients respond to a lower dose and where indicated, adjustment down to one tablet of Verapress MR 240 daily could be made. 4, 'Special Warnings and Precautions for Use').

Children Verapress MR 240 is not recommended for children.

Liver impairment:

In patients with impaired liver function, metabolism of the drug is delayed to a greater or lesser extent depending on the severity of hepatic dysfunction, thus potentiating and prolonging the effects of verapamil hydrochloride. Therefore, the dosage needs to be adjusted with special caution in patients with impaired liver function and low doses should be given initially (see Special Warnings and Precautions for Use Section).

Method of administration For oral use only. The tablets should not be chewed or crushed. They should be swallowed whole with a glass of water.

g. erythema, pruritus, urticaria) are very rarely seen. Nervous system disorders: headache, dizziness, paresthesia, 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 characterized 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

Since verapamil is extensively metabolised in the liver, careful dose titration is required in patients with liver disease. 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. Heart Block/ 1st Degree AV block/Bradycardia/Asystole Verapamil hydrochloride affects the AV and SA nodes and prolongs AV conduction time. Use with caution as development of second-or third-degree AV block (contraindication) or unifascicular, bifascicular or trifascicular bundle branch block requires discontinuation in subsequent doses of verapamil hydrochloride and institution of appropriate therapy, if needed.

Verapamil hydrochloride affects the AV and SA nodes and rarely may produce second- or third- degree AV block, bradycardia, and, in extreme cases, asystole. This is more likely to occur in patients with a sick sinus syndrome (SA nodal disease), which is more common in older patients.

Asystole in patients other than those with sick sinus syndrome is usually of short duration (few seconds or less), with spontaneous return to AV nodal or normal sinus rhythm. If this does not occur promptly, appropriate treatment should be initiated immediately.

See Undesirable Effects Section. Hypotension Intravenous verapamil hydrochloride often produces a decrease in blood pressure below baseline levels that is usually transient and asymptomatic but may result in dizziness. , simvastatin, atorvastatin or lovastatin) for patients taking verapamil.

These patients should be started at the lowest possible dose of verapamil and titrated upwards. , simvastatin, atorvastatin or lovastatin), refer to advice in the respective statin product information. Use with caution in the presence of diseases in which neuromuscular transmission is affected (myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy).

1. Cardiogenic shock; acute myocardial infarction complicated by bradycardia, marked hypotension, left ventricular 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); uncompensated heart failure; bradycardia of less than 50 beats/minute; hypotension of less than 90 mm Hg systolic.

g. WPW syndrome) may develop increased conduction across the anomalous pathway and ventricular tachycardia may be precipitated. Combination with ivabradine (see section