Amlodipine Upjohn 10 mg tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Amlodipine

Disponível em:

Upjohn EESV

Código ATC:

C08CA; C08CA01

DCI (Denominação Comum Internacional):

Amlodipine

Dosagem:

10 milligram(s)

Forma farmacêutica:

Tablet

Área terapêutica:

Dihydropyridine derivatives; amlodipine

Status de autorização:

Not marketed

Data de autorização:

2011-12-09

Folheto informativo - Bula

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE UPJOHN® 5 MG AND 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, pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1. What Amlodipine Upjohn is and what it is used for
2. What you need to know before you take Amlodipine Upjohn
3. How to take Amlodipine Upjohn
4. Possible side effects
5. How to store Amlodipine Upjohn
6. Contents of the pack and other information
1. WHAT AMLODIPINE UPJOHN IS AND WHAT IT IS USED FOR
Amlodipine Upjohn contains the active substance amlodipine which
belongs to a group of
medicines called calcium antagonists.
Amlodipine Upjohn 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
Upjohn 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 UPJOHN
DO NOT TAKE AMLODIPINE UPJOHN
•
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

Características técnicas

Health Products Regulatory Authority
24 October 2023
CRN00DWNW
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine Upjohn 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains amlodipine besilate equivalent to 10 mg
amlodipine.
Excipients:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, emerald-shaped tablets engraved AML-10 on one side
and VLE 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 Upjohn once daily which may be increased to a
maximum dose of 10 mg depending on the individual patient's response.
In hypertensive patients, Amlodipine Upjohn has been used in
combination with a thiazide diuretic, alpha blocker, beta blocker,
or an angiotensin converting enzyme inhibitor. For angina, Amlodipine
Upjohn 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 Upjohn is required upon concomitant
administration of thiazide diuretics, beta blockers,
and angiotensin-converting enzyme inhibitors.
Special populations
_Elderly patients_
Amlodipine Upjohn 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
impairment.