AMLODIPINE

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

AMLODIPINE BESILATE

Verfügbar ab:

Chanelle Medical

ATC-Code:

C08CA01

INN (Internationale Bezeichnung):

AMLODIPINE BESILATE

Dosierung:

5 Milligram

Darreichungsform:

Capsules Hard

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

amlodipine

Berechtigungsstatus:

Not Marketed

Berechtigungsdatum:

2008-11-13

Gebrauchsinformation

ID: L 90M (IRL NATIONAL)
VERSION: 10
EFFECTIVE DATE: 02/01/2018
Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE 5 MG & 10 MG CAPSULES
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 of the side effects, talk to your doctor , pharmacist
or nurse . This includes any possible
side effects not listed in this leaflet, See section 4.
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 capsules 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 this 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. This
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 (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 h

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine 5 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains amlodipine besilate equivalent to 5 mg
amlodipine.
Excipients:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Size 3 capsule with buff opaque body and light green opaque capsule.
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 patients:_
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).
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