ISOPTIN SR 240 MG PROLONGED-RELEASE TABLETS 240 Milligram Prolonged Release Capsules

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:

240 Milligram

Pharmaceutical form:

Prolonged Release Capsules

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

ISOPTIN
®
 SR 240 MG PROLONGED-RELEASE TABLETS
(verapamil hydrochloride)
IMPORTANT INFORMATION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet as you may need to read it again.

This leaflet provides a summary of the information currently available 
about Isoptin SR.

For further information or advice ask your doctor or pharmacist.

This medicine is for you only and should never be given to anyone else, 
even if they appear to have the same symptoms as you.

Tell your doctor or pharmacist if you experience any side effects. See 
Section 4.
Leaflet contents:
1.
What is Isoptin SR and what is it used for?
2.
What you need to know before you take Isoptin SR
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 SR AND WHAT IS IT USED FOR?
Isoptin SR 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 SR tablets are used to treat hypertension (high blood
pressure) and to prevent 
angina (chest pain) attacks.
The active ingredient in Isoptin SR tablets is verapamil
hydrochloride.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOPTIN SR
DO NOT TAKE ISOPTIN SR IF:

you are sensitive (allergic) to verapamil or any of the ingredients in the 
tablets? (See Section 6) 

your blood pressure is extremely low as a result of heart problems (such as 
during shock)

you have

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isoptin SR 240 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Isoptin SR Prolonged-Release tablet contains 240 mg Verapamil Hydrochloride.
Excipients: Each prolonged release tablet contains up to 32mg (1.39mmol) Sodium.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release film-coated tablet
The oblong tablets are film-coated and light green colour, with a breakline on both sides and the Knoll logo on one
side.The tablets can be divided into equal halves but must not be crushed or chewed.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mild to moderate hypertension and coronary heart disease, i.e. prophylaxis of myocardial ischaemia, angina pectoris.
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.
Verapamil hydrochloride 240 mg 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.
Adults _Hypertension: _The adult dose is one tablet (240 mg) in the morning, increasing if necess