Istin 5mg Tablets

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Amlodipine (as amlodipine besilate ph. eur.)

থেকে পাওয়া:

Pfizer Healthcare Ireland

এটিসি কোড:

C08CA; C08CA01

INN (আন্তর্জাতিক নাম):

Amlodipine (as amlodipine besilate ph. eur.)

ডোজ:

5 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Tablet

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may be renewed (B)

থেরাপিউটিক এলাকা:

Dihydropyridine derivatives; amlodipine

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

1989-08-09

তথ্য লিফলেট

mock up 6918
mock up 6918
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, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Istin is and what it is used for
2. What you need to know before you
take Istin
3. How to take Istin
4. Possible side effects
5. How to store Istin
6. Contents of the pack and other
information
1. WHAT ISTIN IS AND
WHAT IT IS USED FOR
Istin contains the active substance
amlodipine which belongs to a group of
medicines called calcium antagonists.
Istin is used to treat high blood pressure
(hypertension) or a certain type of chest
pain called angina, a rare form of which is
Prinzmetal’s or variant angina.
In patients with high blood pressure this
medicine works by relaxing blood vessels,
so that blood passes through them more
easily. In patients with angina Istin works
by improving blood supply to the heart
muscle which then receives more oxygen
and as a result chest pain is prevented.
This medicine does not provide
immediate relief of chest pain from
angina.
2. WHAT YOU NEED TO
KNOW BEFORE YOU
TAKE ISTIN
DO NOT TAKE ISTIN
•
If you are allergic (hypersensitive) to
amlodipine, or any of the other
ingredients of this medicine listed in
section 6, or to any other calcium
antagonists. This may be itching,
reddening of the skin or difficulty in
breathing.
•
If you have severe low blood
pressure (hypotension).
•
If you have narrowing of the aortic
heart valve (aortic stenosis) or
cardiogenic shock (a condition
where your heart is unable to
supply enough blood to the body).
•
If you suffer from heart failu

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
01 October 2020
CRN009P2F
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Istin 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains amlodipine besilate equivalent to 5 mg
amlodipine.
Excipients:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, emerald-shaped tablets engraved AML 5 and breaker
score on one side and Pfizer logo on the other side.
The 5 mg tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Chronic stable angina pectoris
Vasospastic (Prinzmetal’s) angina.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
For both hypertension and angina, the usual initial dose is 5 mg Istin
once daily which may be increased to a maximum dose of
10 mg depending on the individual patient’s response.
In hypertensive patients, Istin has been used in combination with a
thiazide diuretic, alpha blocker, beta blocker, or an
angiotensin converting enzyme inhibitor. For angina, Istin may be used
as monotherapy or in combination with other
antianginal medicinal products in patients with angina that is
refractory to nitrates and/or to adequate doses of beta blockers.
No dose adjustment of Istin is required upon concomitant
administration of thiazide diuretics, beta blockers and
angiotensin-converting enzyme inhibitors.
Special populations
_Elderly patients_
Istin used at similar doses in elderly or younger patients is equally
well tolerated. Normal dosage regimens are recommended
in the elderly, but increase of the dosage should take place with care
(see sections 4.4 and 5.2).
_Patients with hepatic impairment_
Dosage recommendations have not been established in patients with mild
to moderate hepatic impairment; therefore dose
selection should be cautious and should start at the lower end of the
dosing range (see sections 4.4 and 5.2). The
pharmacokinetics of amlodipine have not been studied in severe hepatic
impairment.