AMLODIPINE PFIZER 10 Milligram Tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

AMLODIPINE BESILATE

Commercializzato da:

Pfizer Limited

Codice ATC:

C08CA01

INN (Nome Internazionale):

AMLODIPINE BESILATE

Dosaggio:

10 Milligram

Forma farmaceutica:

Tablets

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Dihydropyridine derivatives

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2011-12-09

Foglio illustrativo

Pfleet Number: 2017-0032096
Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE PFIZER® 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 Pfizer is and what it is used for
2. What you need to know before you take Amlodipine Pfizer
3. How to take Amlodipine Pfizer
4. Possible side effects
5. How to store Amlodipine Pfizer
6. Contents of the pack and other information
1. WHAT AMLODIPINE PFIZER IS AND WHAT IT IS USED FOR
Amlodipine Pfizer contains the active substance amlodipine which
belongs to a group of medicines
called calcium antagonists.
Amlodipine Pfizer 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
Pfizer 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 PFIZER
DO NOT TAKE AMLODIPINE PFIZER

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 pres

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine Pfizer 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 Pfizer logo 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 Pfizer once daily which may be increased
to a maximum dose of 10 mg depending on the individual patient’s
response.
In hypertensive patients, Amlodipine Pfizer has been used in
combination with a thiazide diuretic, alpha blocker, beta
blocker, or an angiotensin converting enzyme inhibitor. For angina,
Amlodipine Pfizer 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 Pfizer
is required upon concomitant
administration of
thiazide diuretics,
beta
blockers, and angiotensin-converting enzyme inhibitors.
Special populations
_Elderly patients_
Amlodipine Pfizer
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. Amlodipine should be initiated at
the lowest dose and titrated sl