Istin 5 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amlodipine

Available from:

Upjohn EESV

ATC code:

C08CA; C08CA01

INN (International Name):

Amlodipine

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Dihydropyridine derivatives; amlodipine

Authorization status:

Marketed

Authorization date:

1989-08-09

Patient Information leaflet

Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER
ISTIN™ 5 MG AND 10 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 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 supp

Summary of Product characteristics

Health Products Regulatory Authority
24 October 2023
CRN00DWNW
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Istin 5 mg 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 VLE 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. Amlodi