Istin 10mg Tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Amlodipine besylate

Saatavilla:

Imbat Limited

ATC-koodi:

C08CA; C08CA01

INN (Kansainvälinen yleisnimi):

Amlodipine besylate

Annos:

10 milligram(s)

Lääkemuoto:

Tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Dihydropyridine derivatives; amlodipine

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2006-10-06

Pakkausseloste

_Page 1 of 2 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ISTIN™ 10MG TABLETS
amlodipine (as besilate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE.
- 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. Do not pass it on to
others. It may harm them, even if their symptoms are the
same as yours.
- If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What Istin is and what it is used for
2. Before you take Istin
3. How to take Istin
4. Possible side effects
5. How to store Istin
6. Further 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 your 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. Your medicine does not
provide immediate relief of chest pain from angina.
2. BEFORE YOU TAKE ISTIN
DO NOT TAKE ISTIN
If you are allergic (hypersensitive) to amlodipine, or any of
the other ingredients of your 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 heart attack.
TAKE SPECIAL CARE WITH ISTIN
You should inform your doctor if you have

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Istin 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg amlodipine (as besilate)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the UK:_
White, emerald shaped tablet with imprint ‘AML-10’ on one side and
Pfizer logo on the other.
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 5mg
amlodipine once daily which may be increased to a
maximum dose of 10mg 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_
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).
_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 severe hepatic
impairment.
_Renal impairment_
Changes in amlodipine plasma concentratio