Amlotan 5 mg tablet

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Amlodipine (as amlodipine besilate ph. eur.)

Dostupno od:

Athlone Laboratories Ltd

ATC koda:

C08CA; C08CA01

INN (International ime):

Amlodipine (as amlodipine besilate ph. eur.)

Doziranje:

5 milligram(s)

Farmaceutski oblik:

Tablet

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

Dihydropyridine derivatives; amlodipine

Status autorizacije:

Not marketed

Datum autorizacije:

2006-08-18

Uputa o lijeku

PATIENT INFORMATION LEAFLET
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 YOUR 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 THAT ARE NOT LISTED IN THIS LEAFLET. SEE SECTION 4.
WHAT IS IN THIS LEAFLET:
1.
What Amlotan Tablets are and what they are used for
2.
What you need to know before you take Amlotan Tablets
3.
How to take Amlotan Tablets
4.
Possible side effects
5.
How to store Amlotan Tablets
6.
Contents of the pack and other information
The name of your medicine is Amlotan5mg Tablets or Amlotan10mg
Tablets. We
refer to them as Amlotan Tablets or Amlotan throughout this leaflet.
Amlotan Tablets contain the active substance amlodipine which belongs
to a group of medicines called
calcium antagonists.
Amlotan Tablets may be used to treat:

high blood pressure (hypertension); and

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, these medicines work by relaxing
blood vessels, so that blood passes
through them more easily. In patients with angina, Amlotan 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.
DO NOT TAKE AMLOTAN TABLETS:

if you have ever had an allergic reaction to amlodipine or any of the
ingredients in the tablet
listed in section 6, or to any other calcium antagonist. An allergic
reaction may include a rash,
itching, difficulty breathing or swelling of the face, lips, throat or
tongue;

if you have very low blood pressure (hypotension) so that you

Svojstava lijeka

Health Products Regulatory Authority
30 September 2019
CRN008L7Q
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amlotan 5 mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg amlodipine (as amlodipine mesilate
monohydrate).
Excipients:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
The tablets are white to off-white, round biconvex and embossed with
“5” on one 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 once daily which may be increased to a maximum
dose of 10 mg (as a single dose) depending on the individual patient's
response.
In hypertensive patients, amlodipine has 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
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 is required upon concomitant
administration of thiazide diuretics, beta blockers, and
angiotensin-converting enzyme inhibitors.
_Special populations Elderly patients_
Amlodipine 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 t