ISOPTIN SR 240 Milligram Tablet Prolonged Release

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

VERAPAMIL HYDROCHLORIDE

MAH:

LTT Pharma Limited

INN:

VERAPAMIL HYDROCHLORIDE

dosage:

240 Milligram

pharmaceutical_form:

Tablet Prolonged Release

prescription_type:

Product subject to prescription which may be renewed (B)

authorization_status:

Authorised

authorization_date:

0000-00-00

PIL

ISOPTIN  SR 240MG PROLONGED-RELEASE TABLETS 
(verapamil hydrochloride)
PATIENT INFORMATION LEAFLET
IMPORTANT INFORMATION
*
Read all of this leaflet carefully before you start taking this
medicine
*
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
Leaflet contents:
What is Isoptin SR and what it is used for?
What you need to know before you take Isoptin SR
How should you take your tablets?
Possible side effects.
How should you store your tablets?      
Further information.
WHAT IS ISOPTIN SR 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.
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 severe 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/flut

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isoptin SR 240mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Isoptin SR 240mg Prolonged-Release Tablet contains 240 mg verapamil hydrochloride.
Excipients: Each prolonged release tablet contains up to 32mg (1.39 mmol) sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
_Product imported from Poland._
Isoptin SR tablets are light green, oblong in shape and marked with two triangles 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
Isoptin SR 240 mg Prolonged Release Tablets are indicated in the treatment of mild to moderate hypertension and
coronary heart disease, i.e. prophylaxis of myocardial ischaemia, angina pectoris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
_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 mg) in the morning, increasing by 120 mg increments at weekly intervals according to patient response.
_Angina pectoris: _The usual dose is 120-240 mg twice daily according to patient response. It is recommended that low
initial doses with upward titration are used in new patients.
Verapamil should not be taken with grapefruit juice (see interactions).
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 nee