Caveril 40mg coated tablets

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

VERAPAMIL HYDROCHLORIDE

から入手可能:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATCコード:

C08DA01

INN（国際名）:

VERAPAMIL HYDROCHLORIDE 40 mg

医薬品形態:

COATED TABLET

構図:

VERAPAMIL HYDROCHLORIDE 40 mg

処方タイプ:

POM

治療領域:

CALCIUM CHANNEL BLOCKERS

認証ステータス:

Authorised

承認日:

2007-02-15

情報リーフレット

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CAVERIL 40 MG 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 or pharmacist.
-
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 or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Caveril is and what it is used for
2.
What you need to know before you take Caveril
3.
How to take Caveril
4.
Possible side effects
5.
How to store Caveril
6.
Contents of the pack and other information
1.
WHAT CAVERIL IS AND WHAT IT IS USED FOR
Caveril contains the active substance verapamil hydrochloride. It
belongs 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.
Caveril is used to treat hypertension (high blood pressure), abnormal
heart rhythms
and to prevent and treat angina (chest pain) attacks.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CAVERIL
DO NOT TAKE CAVERIL
•
if your blood pressure is extremely low as a result of severe heart
problems
(such as during shock).
•
if 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/flutter) causing periods of very
fast heartbeat
(Wolff-Parkinson-White syndrome or L

製品の特徴

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Caveril 40 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 40 mg verapamil hydrochloride.
Excipient(s) with known effect
This product contains 10 mg lactose and 47,74 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet.
Yellow, round, coated tablets.
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 “Contraindications”).
­
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.
Caveril 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.
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Posology
_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 dai