ISTIN 5 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMLODIPINE BESILATE

Available from:

LTT Pharma Limited

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:

Dihydropyridine derivatives

Authorization status:

Authorised

Authorization date:

2011-09-30

Patient Information leaflet

ISTIN 5MG TABLETS
ISTIN 10MG 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:
What Istin is and what it is used for
What you need to know before you take Istin
How to take Istin
Possible side effects
How to store Istin
Contents of the pack and other information
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.
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 failure after a he

Summary of Product characteristics

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
_Product imported from the UK:_
White to off white, emerald shaped tablets engraved AML-5 and breaker score on one side and “Pfizer” as logo on the
other side.
The 5mg tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
As per PA0019/045/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0019/045/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Calcium hydrogen phosphate anhydrous
Magnesium stearate
Microcrystalline cellulose
Sodium starch glycolate Type A
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 13/09/2016_
_CRN 2180231_
_page number: 1_
6.5 NATURE AND CONTENTS OF CONTAINER
Opaque PVC/PVDC blister calendar packs with aluminium foil backing containing 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused product or waste material should be disposed of in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
LTT Pharma Limited
Unit 18, Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1562/055/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 30th September 2011
10 DATE OF REVISION OF THE