ISOPTIN 120 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

VERAPAMIL HYDROCHLORIDE

Available from:

Abbott Laboratories Ireland Ltd

INN (International Name):

VERAPAMIL HYDROCHLORIDE

Dosage:

120 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

ISOPTIN
®
 40 MG FILM-COATED TABLETS
ISOPTIN
®
 80 MG FILM-COATED TABLETS
ISOPTIN
®
 120 MG FILM-COATED TABLETS
(verapamil hydrochloride)
Leaflet contents:
1.  What is Isoptin and what is it used for?
2.  What you need to know before you take Isoptin tablets
3.  How should you take your tablets?
4.  Possible side effects.
5.  How should you store your tablets?
6.  Further information.
1. WHAT IS ISOPTIN AND WHAT IS IT USED FOR?
Isoptin tablets belong to a group of medicines called 
calcium channel blockers.
Calcium channel blockers change the amount of calcium 
getting into the muscle cells in your heart and blood 
vessels. This can change the strength and speed with 
which your heart beats. It also opens up the blood vessels 
so blood can be pumped around the body more easily. 
This helps more oxygen to get to your heart muscle and 
can lower your blood pressure. 
Isoptin tablets are used to treat hypertension (high blood 
pressure), abnormal heart rhythms and to prevent and 
treat angina (chest pain) attacks. 
The active ingredient in Isoptin tablets is verapamil 
hydrochloride.
2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOPTIN 
TABLETS
DO NOT TAKE ISOPTIN TABLETS IF:
•  your blood pressure is extremely low as a
  result of severe heart problems (such as 
    during shock)
•   you have recently had a heart attack
•  you have heart failure or second or third degree heart 
block (impaired nerve signal in the heart – causing a 
very slow heartbeat) or an electrical abnormality of the 
heart (atrial fibrillation/flutter) causing periods of very 
fast heartbeat (Wolff-Parkinson-White syndrome)
•  you have problems with your heart valves or ‘sick 
sinus syndrome’ (irregular heartbeat) 
•  you are being treated with injectable beta-blockers
•  you are sensitive (allergic) to verapamil or any of the 
ingredients in the tablets? (See Section 6) 
•  you  are pregnant or planning to become pregnant
WARNINGS A

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isoptin 120 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 120mg of Verapamil Hydrochloride
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablets
Circular, white, biconvex, film-coated tablet, embossed 'Isoptin 120' on one side and 'Knoll' above the scoreline on the
other side.
The scoreline is to allow breaking for ease of swallowing.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis and/or treatment of:-
Angina pectoris, including Prinzmetal’s angina (coronary spasm, vasospastic angina).
Supraventricular tachycardias such as paroxysmal supraventricular tachycardia, atrial fibrillation/flutter with
rapid ventricular response (except in WPW syndrome, see “Contraindications”).
Mild to moderate essential hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dose of verapamil hydrochloride should be adjusted individually in accordance with the severity of disease. Long-
standing 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.
Isoptin 120mg tablets should be used for patients likely to display a satisfactory response to low doses (e.g. patients
with hepatic dysfunction or elderly patients).
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,