Isoptin SR 240 mg Prolonged-Release Tablets

Страна: Малта

Език: английски

Източник: Medicines Authority

Предлага се от:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

АТС код:

C08DA01

INN (Международно Name):

VERAPAMIL HYDROCHLORIDE 240 mg

Лекарствена форма:

PROLONGED-RELEASE TABLET

Композиция:

VERAPAMIL HYDROCHLORIDE 240 mg

Вид предписание :

POM

Терапевтична област:

CALCIUM CHANNEL BLOCKERS

Статус Оторизация:

Authorised

Дата Оторизация:

2023-10-31

Листовка

1
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 is and what it is used for
2.
What you need to know before you take Isoptin
3.
How to take Isoptin
4.
Possible side effects
5.
How to store Isoptin
6.
Contents of the pack and other information
1.
WHAT ISOPTIN IS AND WHAT IT IS 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)
and to prevent angina (chest pain)
attacks.
The active ingredient in Isoptin tablets is verapamil hydrochloride.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOPTIN
DO NOT TAKE ISOPTIN 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 signal in the heart
– causing a very slow heart

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Isoptin SR 240 mg Prolonged-Release Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Isoptin Prolonged-Release Tablet contains 240 mg Verapamil
Hydrochloride.
Excipients with known effect: Each prolonged release tablet contains
37.1 mg 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 mg) in the
morning, increasing by 120 mg
increments at weekly intervals according t