Amlodipine 2.5mg Tablets

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

AMLODIPINE BESILATE

זמין מ:

Brillpharma (Ireland) Limited Inniscarra, Main Street, Rathcoole, Co. Dublin, Ireland

קוד ATC:

C08CA01

INN (שם בינלאומי):

AMLODIPINE BESILATE 2.5 mg

טופס פרצבטיות:

TABLET

הרכב:

AMLODIPINE BESILATE 2.5 mg

סוג מרשם:

POM

איזור תרפויטי:

CALCIUM CHANNEL BLOCKERS

מצב אישור:

Authorised

תאריך אישור:

2019-04-11

עלון מידע

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMLODIPINE 2.5 MG TABLETS
AMLODIPINE BESILATE
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, please ask your doctor or
pharmacist.
• The medicine has been prescribed for you only and 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 or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Amlodipine is and what it is used for
2. What you need to know before you take Amlodipine
3. How to take Amlodipine
4. Possible side effects
5. How to store Amlodipine
6. Contents of the pack and other information
1. WHAT AMLODIPINE IS AND WHAT IT IS USED FOR
•
Amlodipine belongs to a group of medicines called calcium-channel
blockers.
Amlodipine 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.
•
If you have high blood pressure amlodipine works by relaxing blood
vessels, so that
blood passes through them more easily.
•
If you have angina, you may get chest pain when your heart cannot get
enough blood.
Amlodipine helps in preventing this by increasing blood supply to the
heart.
Amlodipine Tablets do not work immediately to stop chest pain from
angina.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLODIPINE
DO NOT TAKE AMLODIPINE:
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•
If you are allergic to amlodipine or any other calcium channel
blockers or any other
ingredients of this medicine (these are listed in section 6). This may
include 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

מאפייני מוצר

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amlodipine 2.5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg Amlodipine as Amlodipine Besilate.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White to off white, round biconvex, uncoated tablets marked ‘Y2’
on one side
and plain on other side. The tablet dimensions are 6.0 mm
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
tablets 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, Amlodipine may be used as monotherapy or
in
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combination
with
other
antianginal
drugs
in
patients
with
angina
that
is
refractory to nitrates and /or adequate doses of beta blockers.
No dose adjustment of Amlodipine Tablets is required upon concomitant
administration of thiazide diuretics, beta blockers, and angiotensin-
converting
enzyme inhibitors.
SPECIAL POPULATIONS
PAEDIATRIC POPULATION
CHILDREN AND ADOLESCENTS WITH HYPERTENSION FROM 6 YEARS TO 17 YEARS OF
AGE:
The recommended antihypertensive oral dose in paediatric patients ages
6-17
years is 2.5 mg once daily as a starting dose, up-titrated to 5 mg
once daily if
blood pressure goal is not achieved after 4 weeks. Doses in excess of
5 mg
daily have not been studied in paediatric patients (see sections 5.1
and 5.2).
CHILDREN UNDER 6 YEARS OLD
_ _
No data are available.
ELDERLY PATIENTS
Amlodipine tablets, used at similar doses in elderly or younger
patients, is
equally well tolerated. Therefore normal dosage regimens are
recommended in
the elderly, but increase of the do