AKILEN Film-coated tablet Ref.[28110] Active ingredients: Verapamil

The dose of verapamil hydrochloride should be adjusted individually in accordance with the severity of disease. Longstanding clinical experience shows that the average daily dose in all indications is between 240 mg and 360 mg. The daily dose should not exceed 480 mg on a long-term basis, although a higher dose may be used for a short period.

There is no limitation on the duration of use. Verapamil hydrochloride should not be discontinued abruptly after long-term use. It is recommended to taper the dosage. Akilen 40 mg film-coated tablets should be used for patients likely to display a satisfactory response to low doses (e.g. patients with hepatic dysfunction or elderly patients). For patients requiring higher dosages (e.g., 240 mg to 480 mg verapamil hydrochloride per day), formulations with a more suitable active drug content should be used.

Posology

Adults

For the treatment of angina, including Prinzmetal’s angina, the usual dose is 120 mg 3 to 4 times daily. Although 80 mg 3 times daily may be adequate in many patients with angina of effort, doses below 120 mg 3 times daily are unlikely to be effective in angina of rest and Prinzmetal’s angina.

In cases of supraventricular tachycardia the usual dose is 40 mg to 120 mg 3 to 4 times daily according to the severity of the patient’s condition.

For the treatment of essential hypertension the usual dose is 40 mg to 120 mg 3 to 4 times daily. In long-term treatment, a total daily dose of 480 mg should not be exceeded; short-term dose increases are possible only when directed by the physician.

Special Populations

Renal impairment

Currently available data are described in section 4.4. Verapamil hydrochloride should be used cautiously and with close monitoring in patients with impaired renal function.

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 section 4.4).

Method of administration

Tablets are for oral administration. The tablets should be swallowed whole with sufficient liquid, preferably with or shortly after meals.

Verapamil should not be taken with grapefruit juice (see section 4.5).

Symptoms

Hypotension, bradycardia up to high degree AV block and sinus arrest, hyperglycemia, stupor and metabolic acidosis. Fatalities have occurred as a result of overdose.

Treatment

The usual intensive care measures should be taken. Fatalities have occurred as a result of overdose. Verapamil hydrochloride cannot be removed by hemodialysis.

The specific antidote is calcium, e.g. 10-20 ml in a 10% calcium gluconate solution administered intravenously (2.25-4.5 mmol), repeated if necessary or given as a continuous drip infusion (e.g. 5 mmol/hour).

The following measures may also be necessary:

• In the case of 2 or 3 degree AV block, sinus bradycardia, asystole: Atropine, isoprenaline, orciprenaline or pacemaker therapy. Asystole should be handled by the usual measures including beta adrenergic stimulation (e.g., isoproterenol hydrochloride).
• In the case of hypotension: Dopamine, dobutamine, norepinephrine.
• If there are any signs of continuing myocardial failure: Dopamine, dobutamine, if necessary repeated calcium injections, and possibly other medication that increases cardiac contractility combined with isoprenaline.

5 years.

Store below 25°C in the original packaging in order to protect from light.

Combination polyvinylchloride film and aluminium foil blisters of ten tablets.

Blisters are placed, with a patient information leaflet, in a card carton. Packs of 50, 100, 250, 500 and 1000 tablets are available.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.