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1. Verapamil 80mg Tablets
2. Verapamil 80mg Tablets

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Verapamil 80 mg Tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains verapamil hydrochloride 80 mg For excipients, see 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablet

Pale yellow, concave, film-coated tablets engraved MP69 on one side.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

1.    The prophylaxis and treatment of angina pectoris.

2.    Prophylaxis and treatment of supraventricular paroxysmal tachycardia; atrial fibrillation and premature supraventricular contractions; atrial fibrillation and flutter and supraventricular paroxysmal tachycardia of the reciprocating type, associated with the Wolff-Parkinson-White Syndrome.

3.    Treatment either alone or in conjunction with other anti-hypertensive therapy of mild to moderate hypertension (including renal hypertension).

4.2. Posology and method of administration

Angina

Adults (including the elderly):

120 mg three times a day is recommended. 80 mg three times a day can be completely satisfactory in some patients with angina of effort. Less than 120 mg three times a day is not likely to be effective in angina at rest and variant angina.

Children:

Not applicable

Supraventricular paroxysmal tachycardia

Adults:

40-120 mg three times a day according to the severity of the condition.

Children:

Up to 2 years: 20 mg 2-3 times daily.

2 years and above: 40-120 mg 2-3 times daily.

Elderly:

It is recommended to commence with lowest dose and adjust as required.

Hypertension

Adults:

The usual dose range is 80-160 mg three times a day. The dose should be increased from 80 mg three times a day at weekly intervals according to response, either alone or in conjunction with other antihypertensive therapy. A further reduction in blood pressure may be obtained by combining verapamil with other antihypertensive agents, e.g. thiazide diuretics.

Children:

Up to 10 mg per kilo bodyweight per day in divided doses, according to severity of disease. Elderly:

It is recommended to commence with the lowest dose and adjust as required.

Route of administration: Oral

4.3. Contraindications

Sick sinus syndrome, second or third degree atrioventricular block, hypotension associated with cardiogenic shock, and bradycardia (less than 50 beats/minute). Sino-atrial block, history of heart failure or significantly impaired left ventricular function, even if controlled by therapy. Atrial flutter or fibrillation complicating Wolff-Parkinson-White syndrome. Porphyria. Concomitant ingestion of grapefruit juice.

4.4. Special Warnings and Precautions for Use

Care should be exercised when beta blockers are administered either concurrently or closely together because the effects of beta blockers and verapamil may be additive with respect to both contraction and conduction. This is particularly important when either drug is administered intravenously.

Verapamil should be used with caution in patients with first degree atrioventricular block because impulse conduction may be affected. Left ventricular contractility may be affected by verapamil because of its mode of action; cardiac failure may therefore be precipitated or, if it already exists, may be aggravated by verapamil. It is therefore important that verapamil should only be administered after appropriate therapy for cardiac failure has been instituted, e.g. digoxin etc. Patients with impaired liver function exhibit reduced drug metabolism and therefore careful attention should be paid to dosage in these patients.

Verapamil should not be used in children with arrhythmias without specialist advice; some supraventricular arrhythmias in childhood can be accelerated by verapamil with dangerous consequences.

4.5. Interaction with other medicinal products and other forms of interaction

Verapamil increases the serum concentration of digoxin with increased risk of AV block and bradycardia; the awareness of the possibility of digitalis toxicity should also be borne in mind. Verapamil also increases the plasma concentration of imipramine and possibly other tricyclics, ciclosporin and theophylline. Verapamil inhibits the metabolism of midazolam; increased plasma-midazolam increases sedation. The effect of carbamazepine is enhanced by verapamil.

Verapamil enhances the effect of non-polarising muscle relaxants possibly causing hypotension, myocardial depression and hyperkalaemia.

Grapefruit juice - an increase in verapamil serum level has been reported.

Enhanced hypotensive effect has been reported with concomitant use of verapamil with the following: Alcohol, aldesleukin, alprostadil, anaesthetics with risk of AV delay, antihypertensives, antipsychotics, diuretics and moxisylyte. Concomitant use of beta-blockers and verapamil may cause severe hypotension and even heart failure and should only be given together if myocardial function is well preserved. Cimetidine may inhibit the metabolism of verapamil causing increased verapamil-plasma concentrations.

Amiodarone-induced risk of bradycardia, AV block and myocardial depression is increased by verapamil. Concomitant use of verapamil with disopyramide and flecainide increases the risk of myocardial depression and asystole. Verapamil may raise the plasma concentration of quinidine resulting in extreme hypotension.

Rifampicin increases the metabolism of verapamil thereby significantly reducing its plasma concentration. The effect of verapamil is also reduced by phenobarbital and phenytoin.

Neurotoxicity may occur without increased plasma-lithium concentrations in patients given verapamil.

4.6. Pregnancy and lactation

Verapamil is not recommended for use during pregnancy unless the benefits of the drug outweigh the possible hazards to the foetus.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

Administration of verapamil is commonly associated with constipation.

Occasionally the following side-effects may be experienced: Nausea and vomiting, flushing, headache, dizziness, fatigue, ankle oedema, myalgia, arthralgia, paraesthesia, erythromelalgia and increased prolactin concentration. On rare occasions gynaecomastia and gingival hyperplasia may occur after long-term treatment. After intravenous administration of high doses hypotension, heart failure, bradycardia, heart block, and asystole have occurred.

Sensitivity or allergy to verapamil is rare. Symptoms of allergy are erythema, pruritis, urticaria, angioedema and Stevens-Johnson syndrome.

4.9. Overdose

The classical measures for cardiovascular side effects should be instituted immediately. Cardiac arrest should be treated by heart massage and mechanical respiration, and the necessary intensive care appropriate to the condition should be instituted.

In the case of hypotension, dopamine, noradrenaline or dobutamine may be used together with appropriate positioning of the patient. Likewise, in myocardial insufficiency treatment should be either dopamine, dobutamine, cardiac glycosides or 10-20 ml of a 10% solution of calcium gluconate. Second or third degree AV block should be treated with atropine or isoprenaline and if necessary a pace maker should be used.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Verapamil is a Class 4 anti-arrhythmic agent which acts on supraventricular arrhythmias by interfering with calcium conductants.

Pharmacokinetic properties

Verapamil is almost completely absorbed from the gastro-intestinal tract but is subject to very considerable first-pass metabolism in the liver. The plasma half-life is about 7 hours following oral administration and that of its active metabolite which is norverapamil is about nine hours.

Verapamil acts within minutes of intravenous administration but its effects may only last for about half-an-hour. It may require two hours to act after oral administration with peak effect after five hours.

Verapamil is extensively bound to plasma proteins. The drug is mainly excreted by the kidneys in the form of its metabolites, but some is also excreted in the bile and in the faeces.

5.3. Preclinical safety data

No relevant information additional to that contained elsewhere in the SPC.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Tablet core:

Maize Starch Lactose monohydrate Gelatin

Silica, colloidal anhydrous Talc

Magnesium stearate

Tablet coat:

Titanium dioxide Hydroxypropyl cellulose Quinoline yellow E104 Sunset yellow E110 Hydroxypropyl methylcellulose 2910 Ethylcellulose Diethyl phthalate

6.2. Incompatibilities

Not applicable

13/03/2009

DATE OF REVISION OF THE TEXT

18/08/2009