Isoptin 40 mg film-coated tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Verapamil hydrochloride

Fáanlegur frá:

Mylan IRE Healthcare Limited

ATC númer:

C08DA; C08DA01

INN (Alþjóðlegt nafn):

Verapamil hydrochloride

Skammtar:

40 milligram(s)

Lyfjaform:

Film-coated tablet

Stjórnsýsluleið:

Oral use

Einingar í pakka:

Pack size: 100 tablets/carton

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Framleitt af:

AbbVie Deutschland GmbH & Co. KG

Meðferðarhópur:

Selective calcium channel blockers with direct cardiac effects, phenylalkylamine

Lækningarsvæði:

Phenylalkylamine derivatives; verapamil

Ábendingar:

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 “Contra-indications”); Mild to moderate essential hypertension.

Leyfisstaða:

Marketed

Leyfisdagur:

1980-04-01

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ISOPTIN
® 40MG FILM-COATED TABLETS
ISOPTIN
® 80MG FILM-COATED 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 tablets
3.
How to take Isoptin tablets
4.
Possible side effects
5.
How to store Isoptin tablets?
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),
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 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
fibrillat

Vara einkenni

Health Products Regulatory Authority
26 January 2022
CRN00CS2G
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isoptin 40 mg film‐coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 40mg of Verapamil Hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film‐coated tablets
Circular, biconvex, white, film‐coated tablet, embossed 40 on one
side and embossed with a triangle on the other side.
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 or LGL syndrome, see
“Contra‐indications”).
– 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 40mg 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:
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, doses
below 120 mg 3 times dail