Amlodipine Bluefish 5 mg tablets

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Amlodipine besilate

Disponibbli minn:

Bluefish Pharmaceuticals AB

Kodiċi ATC:

C08CA; C08CA01

INN (Isem Internazzjonali):

Amlodipine besilate

Dożaġġ:

5 milligram(s)

Għamla farmaċewtika:

Tablet

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Dihydropyridine derivatives; amlodipine

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

2010-05-07

Fuljett ta 'informazzjoni

1 PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE BLUEFISH 5 MG TABLETS
AMLODIPINE BLUEFISH 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 Bluefish is and what it is used for
2.
What you need to know before you take Amlodipine Bluefish
3.
How to take Amlodipine Bluefish
4.
Possible side effects
5.
How to store Amlodipine Bluefish
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE BLUEFISH IS AND WHAT IT IS USED FOR
Amlodipine Bluefish contains the active substance amlodipine which
belongs to a group of medicines
called calcium antagonists.
Amlodipine Bluefish 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
Bluefish 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 BLUEFISH
DO NOT TAKE AMLODIPINE BLUEFISH
•
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 (hypotensio

Karatteristiċi tal-prodott

Health Products Regulatory Authority
15 September 2022
CRN00D0H0
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine Bluefish 5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of amlodipine (as amlodipine besilate)
For the full list ofexcipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White or almost white, flat, cylinder shaped tablet with bevelled
edges and approximate dimensions of 7.9 x 5.6 mm, imprinted
with “C” on one side and “58” on the other side.
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 Bluefish once daily which may be increased to a
maximum dose of 10 mg depending on the individual patient's response.
In hypertensive patients, Amlodipine Bluefish has been used in
combination with a thiazide diuretic, alpha blocker, beta blocker,
or an angiotensin converting enzyme inhibitor. For angina, Amlodipine
Bluefish 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 Bluefish is required upon concomitant
administration of thiazide diuretics, beta blockers,
and angiotensin-converting enzyme inhibitors.
Special populations
Elderly
Amlodipine Bluefish 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 hav