ISTOLDE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMLODIPINE BESILATE

Available from:

Actavis Group PTC ehf

ATC code:

C08CA01

INN (International Name):

AMLODIPINE BESILATE

Dosage:

5 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

amlodipine

Authorization status:

Marketed

Authorization date:

2008-11-28

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Istolde 5 mg tablets
Istolde10 mg tablets
Amlodipine
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.
WHAT IS IN THIS LEAFLET
1.
What Istolde is and what it is used for
2.
What you need to know before you take Istolde
3.
How to take Istolde
4.
Possible side effects
5.
How to store Istolde
6.
Contents of the pack and other information.
1.
WHAT ISTOLDE IS AND WHAT IT IS USED FOR
Istolde contains the active substance amlodipine which belongs to a
group of medicines called calcium
antagonists.
Istolde 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 Istolde 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 ISTOLDE
DO NOT TAKE ISTOLDE
-
if you are allergic 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)
-
if you are in shock (including cardiogenic shock (a condition where
your h

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Istolde 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg tablets:
Each tablet contains 5 mg amlodipine (as besilate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Istolde 5 mg tablet: White, uncoated, round, flat, tablet (8 mm) with
score line on one side and embossed with AB5 on
the other side.
The tablet can be divided into equal doses.
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
amlodipine once daily which may be increased to a
maximum dose of 10 mg depending on the individual patient's response.
In hypertensive patients, amlodipine has been used in combination with
a thiazide diuretic, alpha blocker, beta blocker,
or an angiotensin converting enzyme inhibitor. For angina, Istolde 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 Istolde is required upon concomitant
administration of thiazide diuretics, beta blockers, and
angiotensin-converting enzyme inhibitors.
_Special populations_
_Elderly_
Amlodipine 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).
_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. Amlodipine should be initiated at
the lowest dose and titrated slowly in patients with seve