Amlode 5 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amlodipine

Available from:

Rowex Ltd

ATC code:

C08CA; C08CA01

INN (International Name):

Amlodipine

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dihydropyridine derivatives; amlodipine

Authorization status:

Marketed

Authorization date:

2007-06-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMLODE 5 MG TABLETS
AMLODE 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 Amlode is and what it is used for
2.
What you need to know before you take Amlode
3.
How to take Amlode
4.
Possible side effects
5.
How to store Amlode
6.
Contents of the pack and other information
1.
WHAT AMLODE IS AND WHAT IT IS USED FOR
Amlode belongs to a group of medicines called calcium antagonists.
Amlode is used to treat:
-
high blood pressure (hypertension)
-
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 Amlode works by improving blood supply to the
heart muscle which then receives
more oxygen and as a result chest pain is prevented. Amlode does not
provide immediate relief of chest pain
from angina.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLODE
DO NOT TAKE AMLODE
-
if you are allergic to amlodipine, to any other calcium antagonists,
or any of the other ingredients of this
medicine (listed in section 6). 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 stenosis) or
cardiogenic shock (a condition where
your heart is unable to supply enough blood to the body)
-
if you suffer from heart failure after a hear

Summary of Product characteristics

Health Products Regulatory Authority
22 September 2022
CRN00D098
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlode 5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of amlodipine (as besylate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
_Tablet_
White or almost white, oblong tablet with bevelled edges, score line
on one side and marked with a "5" on the 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 once daily which may be increased to a maximum
dose of 10 mg depending on the individual patient’s response.
In hypertensive patients, Amlodehas 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
anti-angina 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.
_Paediatric population_
_Children and adolescents with hypertension from 6 years to 17 years
of age._
The recommended antihypertensive oral dose in paediatric patients ages
6-17 years is 2.5 mg once daily as a starting dose,
up-titrated to 5 mg once daily if blood pressure goal is not achieved
after 4 weeks. Doses in excess of 5 mg daily have not
been studied in paediatric patients (see sections 5.1 and 5.2).
_Children under 6 years old_
No data are available.
Special populations
_Elderly_
Health Products Regulatory Authority
22 September 2022
CRN00D098
Page 2 of 9
Amlode used at similar doses in elderly or younger patient