VERAPAMIL

d. d. when necessary. In some cases, dosages of up to 480mg daily, in divided doses, have been used. A further reduction in blood pressure may be obtained by combining verapamil with other antihypertensive agents, in particular diuretics.

For concomitant administration with beta-blockers see Precautions. s. is recommended. s. can be completely satisfactory in some patients with angina of effort. s is not likely to be effective in variant angina. s. according to the severity of the condition.

Hepatic Impairment:

Verapamil is extensively metabolised in 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.

Children:

Up to 2 years: 20mg, 2-3 times a day. 2 years and above: 40-120mg, 2-3 times a day, according to age and effectiveness.

Elderly:

The adult dose is recommended unless liver or renal function is impaired (see Precautions).

Verapamil is generally well tolerated. Side effects are usually mild and transient and discontinuation of therapy is rarely necessary. g. erythema, pruritus, urticaria) are very rarely seen.

Nervous System Disorders:

Tremor and extrapyramidal syndrome. Headaches and dizziness have been reported rarely. Paraesthesia may occur.

Ear and Labyrinth Disorders:

Vertigo and tinnitus.

Cardiac Disorders:

Particularly when given in high doses or in the presence of previous myocardial damage, some cardiovascular effects of verapamil may occasionally be greater than therapeutically desired: bradycardic arrhythmias, such as sinus bradycardia, sinus arrest with asystole, second and third degree AV block, bradyarrhythmia in atrial fibrillation, palpitations, tachycardia, development or aggravation of heart failure.

Vascular Disorders:

Peripheral oedema, hypotension. Flushing is observed occasionally. Erythromelalgia may occur.

Gastrointestinal Disorders:

Constipation may occur. Nausea, vomiting, ileus, abdominal pain/discomfort have been reported rarely. Gingival hyperplasia may very rarely occur 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.

Hepatobiliary Disorders:

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

Musculoskeletal and Connective Tissue Disorders:

In very rare cases, there may be 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, which was fully reversible in all cases when the drug was discontinued.

Rises in prolactin levels have been reported.

General Disorders and Administration Site Conditions:

Fatigue and ankle oedema have been reported rarely.

Investigations:

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.

Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme. 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 of verapamil 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. 8). 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. g. simvastatin, atorvastatin or lovastatin) for patients taking verapamil. These patients should be started on the lowest possible dose of verapamil and titrated upwards.

g. simvastatin, atorvastatin or lovastatin), refer to the 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).

Excipient warnings This product contains: • Propylene glycol (E1520). This medicine contains 500mg propylene glycol in each 5ml dose. Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old.

While propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, it may reach the foetus and was found in milk. As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis.

Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.

• Liquid Maltitol (E965). Patients with rare hereditary problems of fructose intolerance should not take this medicine. • Ethanol. 1mg of alcohol (ethanol) in each 5ml dose. The amount in 5ml of this medicine is equivalent to less than 1ml beer or 1ml wine.

The small amounts of alcohol in this medicine will not have any noticeable effects. • Benzoic acid (E210). This medicine contains 5mg benzoic acid in each 5ml dose. • Sodium. This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially ‘sodium free’.

g. Wolff- Parkinson-White syndrome, Lown-Ganong-Levine syndrome) may develop increased conduction across the anomalous pathway and ventricular tachycardia may be precipitated. Porphyria Combination with ivabradine (see section Interactions with other medicinal products and other forms of interaction).

Concomitant ingestion of grapefruit juice.