Amlodipine Fair-Med 10mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amlodipine besilate

Available from:

Fairmed Healthcare GmbH

ATC code:

C08CA; C08CA01

INN (International Name):

Amlodipine besilate

Dosage:

10 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dihydropyridine derivatives; amlodipine

Authorization status:

Not marketed

Authorization date:

2014-02-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMLODIPINE FAIR-MED 5MG TABLETS
AMLODIPINE FAIR-MED 10MG 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, pharmacist or
nurse.
-
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 Fair-Med is and what it is used for
2. What you need to know before you take Amlodipine Fair-Med
3. How to take Amlodipine Fair-Med
4. Possible side effects
5. How to store Amlodipine Fair-Med
6. Contents of the pack and other information
1.
WHAT AMLODIPINE FAIR-MED IS AND WHAT IT IS USED FOR
Amlodipine Fair-Med contains the active substance amlodipine which
belongs to a group of
medicines called calcium antagonists.
Amlodipine Fair-Med 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
Fair-Med 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMLODIPINE FAIR-MED
DO NOT TAKE AMLODIPINE FAIR-MED

If you are allergic to the active substance, 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

Summary of Product characteristics

Health Products Regulatory Authority
29 July 2022
CRN008HHR
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlodipine Fair-Med 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains amlodipine besilate equivalent to 10mg
amlodipine.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Amlodipine 10 mg tablets are white to off white, round biconvex,
uncoated tablets with a score line on one side and plain 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 Fair-Med once daily which may be increased to a
maximum dose of 10 mg depending on the individual patient's response.
In hypertensive patients, Amlodipine Fair-Med has been used in
combination with a thiazide diuretic, alpha blocker, beta
blocker, or an angiotensin converting enzyme inhibitor. For angina,
Amlodipine Fair-Med 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 Fair-Med is required upon concomitant
administration of thiazide diuretics, beta blockers,
and angiotensin-converting enzyme inhibitors.
Special populations
Older people
Amlodipine Fair-Med 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