Amlodipine Mylan 5 mg tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Amlodipine besilate

Tilgjengelig fra:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC-kode:

C08CA; C08CA01

INN (International Name):

Amlodipine besilate

Dosering :

5 milligram(s)

Legemiddelform:

Tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Dihydropyridine derivatives; amlodipine

Autorisasjon status:

Marketed

Autorisasjon dato:

2010-09-10

Informasjon til brukeren

PAGE 1 OF 8
PACKAGE LEAFLET
PAGE 2 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMLODIPINE MYLAN 5 MG TABLETS
AMLODIPINE MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Amlodipine Mylan
3.
How to take Amlodipine Mylan
4.
Possible side effects
5.
How to store Amlodipine Mylan
6.
Contents of the pack and other information
1.
WHAT AMLODIPINE MYLAN IS AND WHAT IT IS USED FOR
Amlodipine tablets contain 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.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLODIPINE MYLAN
DO NOT TAKE AMLODIPINE MYLAN:
•
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.
•
If you have severe low blood pressure (hypotension).
•
If the blood f

Preparatomtale

Health Products Regulatory Authority
19 September 2022
CRN00D46K
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine Mylan 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 coloured, round biconvex tablets debossed with “5” on one
side and scored on other side.
The tablet 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 Mylan 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 Mylan
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 Mylan 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).
_Patients with 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
imp