Amlodipine Pfizer 10mg hard capsules

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

amlodipine besilate

Available from:

Pfizer Limited

ATC code:

C08CA01

INN (International Name):

amlodipine besilate

Dosage:

10mg

Pharmaceutical form:

Hard capsule

Administration route:

Oral use

Units in package:

14, 28, 30, 56, 90, 98 and 100 capsules

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Fareva Amboise

Therapeutic group:

Calcium channel blockers, selective calcium channel blockers with mainly vascular effects

Therapeutic indications:

Hypertension Chronic stable angina pectoris Vasospastic (Prinzmetal’s) angina

Authorization status:

Authorised

Authorization date:

2015-03-12

Patient Information leaflet

Ref: dd AML 2_0 
Pfleet no: 2015-0010642
Page 1 of 13
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE PFIZER 5 MG AND 10 MG HARD CAPSULES
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Amlodipine Pfizer 10 mg hard capsules 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each hard capsule contains amlodipine besilate equivalent to 10 mg 
amlodipine. 

Excipients: 
For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Hard capsule. 
Grey capsules with black imprint AML 10 on one side and
Pfizer logo on the other. 

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 th