Isoptin SR 240 mg Prolonged-Release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Verapamil hydrochloride

Available from:

Mylan IRE Healthcare Limited

ATC code:

C08DA; C08DA01

INN (International Name):

Verapamil hydrochloride

Dosage:

240 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Administration route:

Oral use

Units in package:

packs containing 28 tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

AbbVie Deutschland GmbH & Co. KG

Therapeutic group:

Selective calcium channel blockers with direct cardiac effects, phenylalkylamine

Therapeutic area:

Phenylalkylamine derivatives; verapamil

Therapeutic indications:

Mild to moderate hypertension and coronary heart disease, i.e. prophylaxis of myocardial ischaemia, angina pectoris.

Authorization status:

Marketed

Authorization date:

1987-05-07

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ISOPTIN SR 240MG® PROLONGED-RELEASE TABLETS
(VERAPAMIL HYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What Isoptin SR is and what it is used for
2.
What you need to know before you take Isoptin SR
3.
How to take Isoptin SR
4.
Possible side effects
5.
How to store Isoptin SR
6.
Contents of the pack and other information
1.
WHAT ISOPTIN SR IS AND WHAT IT IS 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 recently had a heart attack (within the last 7 days)

you have heart failure or second or third degree heart block (impaired
nerve signa

Summary of Product characteristics

Health Products Regulatory Authority
25 January 2021
CRN00C3TQ
Page 1 of 14
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 40mg 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 necessary after one week to 240 mg in
the morning and 240 mg in the evening, with an interval of 12 hours.
In elderly patients, the initial dose is half a tablet (120