Amlodipine Krka 10 mg Tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Amlodipine

Beschikbaar vanaf:

KRKA, d.d., Novo mesto

ATC-code:

C08CA; C08CA01

INN (Algemene Internationale Benaming):

Amlodipine

Dosering:

10 milligram(s)

farmaceutische vorm:

Tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

Dihydropyridine derivatives; amlodipine

Autorisatie-status:

Marketed

Autorisatie datum:

2013-03-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMLODIPINE KRKA 5 MG TABLETS
AMLODIPINE KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Amlodipine Krka
3.
How to take Amlodipine Krka
4.
Possible side effects
5.
How to store Amlodipine Krka
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE KRKA IS AND WHAT IT IS USED FOR
Amlodipine Krka contains the active substance amlodipine which belongs
to a group of medicines
called calcium antagonists.
Amlodipine Krka 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
Krka 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 KRKA
DO NOT TAKE AMLODIPINE KRKA 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.
-
have severe low blood pressure (severe hypotension)
-
if you have narrowing of the aortic heart valve

Productkenmerken

Health Products Regulatory Authority
26 September 2022
CRN00D0T9
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine Krka 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg amlodipine (as amlodipine besilate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Tablets are white, round (diameter 10.5 mm), slightly biconvex with
beveled edges.
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 Krka 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 Krka 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). 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 s