Amlodipine 5 mg Tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Amlodipine besilate

Tersedia dari:

Niche Generics Limited

Kode ATC:

C08CA; C08CA01

INN (Nama Internasional):

Amlodipine besilate

Dosis:

5 milligram(s)

Bentuk farmasi:

Tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Area terapi:

Dihydropyridine derivatives; amlodipine

Status otorisasi:

Marketed

Tanggal Otorisasi:

2013-02-22

Selebaran informasi

Page 2 of 7
PA 1063/051/01-02
08.01.2018
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE 5 MG TABLETS
AMLODIPINE 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 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 tablets contain the active substance amlodipine which
belongs to a group of medicines called
calcium antagonists.
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.
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 Amlodipine 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLODIPINE
DO NOT TAKE AMLODIPINE:
-
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 steno

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of amlodipine (as amlodipine besilate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat faced, bevelled edged tablets debossed
with ‘U’ and ‘L’ on either side of the breakline
on one side and breakline on the other side.
The tablets 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, Amlodipine
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 amlodipine 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).
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