Felotens XL 5mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Felodipine

Dostupné z:

Thornton & Ross Ltd

ATC kód:

C08CA02

INN (Medzinárodný Name):

Felodipine

Dávkovanie:

5mg

Forma lieku:

Modified-release tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 02060200

Príbalový leták

IN THIS LEAFLET:
1. What
Felotens XL Tablets are and what
they
are used for
2. Before you take Felotens XL Tablets
3. How to take Felotens XL Tablets
4. Possible side-effects
5. How to store Felotens XL Tablets
6. Further information
1. WHAT FELOTENS XL TABLETS ARE AND WHAT THEY
ARE USED FOR
Felotens
XL
Tablets
belong
to
a
group
of
medicines
called dihydropyridine-type calcium
channel
blockers.
These work by relaxing the
smooth muscle in the blood vessel
walls and
opening the blood vessels.
This then lowers the
blood pressure.
FELOTENS XL TABLETS ARE USED TO:
-
treat
patients
with
high
blood
pressure
(essential
hypertension).
2. BEFORE YOU TAKE FELOTENS XL TABLETS
DO NOT TAKE FELOTENS XL TABLETS IF YOU:
-
are
allergic
(hypersensitive)
to
felodipine,
other similar compounds (dihydropyridine-type
calcium channel
blockers) or any of
the other
ingredients
in the tablets
(see section 6.
"Further information" at the end of this leaflet)
-
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal
product
-
have a very low pulse and blood pressure
(cardiogenic shock)
-
have
severe
narrowing
(stenosis)
of
the
heart valves (mitral
or aortic valve)
-
suffer
from an
enlarged
heart
muscle
(obstructive hypertrophic cardiomyopathy)
-
get chest pain (unstable angina pectoris)
-
have
suffered
a
heart
attack
within
the
last two months
-
have
untreated
and/or
decompensated
heart
failure,
causing
swelling
of
the
extremities, weakness, and shortness of breath
-
have severely reduced liver function
-
are or may be pregnant
-
suffer
from acute porphyria (a disease that
causes stomach problems and discolouration
of the urine).
TAKE SPECIAL CARE WITH FELOTENS XL TABLETS IF YOU:
-
have severely reduced kidney function
-
have
mild
to
moderate
reduced
liver
function
-
suffer with stable heart failure
-
suffer with fast heartbeat (tachycardia)
-
suffer
with
narrowing
(stenosis)
of
the
heart valves (mitral
or aortic valve)
-
have
conduction
disturbances
in
the
heart
(e.g.
2nd o

Súhrn charakteristických

OBJECT 1
FELOTENS XL 5MG PROLONGED RELEASE TABLETS
Summary of Product Characteristics Updated 04-Feb-2015 | Genus
Pharmaceuticals
1. Name of the medicinal product
Felotens XL 5 mg Prolonged Release Tablets
2. Qualitative and quantitative composition
Felotens XL 5 mg Prolonged Release Tablets contain 5mg of felodipine.
3. Pharmaceutical form
Light pink, round, biconvex, film coated prolonged-release tablets
with imprint 5.
4. Clinical particulars
4.1 Therapeutic indications
In the management of hypertension and prophylaxis of chronic stable
angina pectoris.
4.2 Posology and method of administration
For oral administration
Hypertension:
_Adults (including elderly): _The dose should be adjusted to the
individual requirements of the patient. The
recommended starting dose is 5 mg once daily. If necessary the dose
may be further increased or another
antihypertensive agent added. The usual maintenance dose is 5-10 mg
once daily. Doses higher than 20
mg daily are not usually needed. For dose titration purposes a 2.5 mg
tablet is available. In elderly
patients an initial treatment with 2.5 mg daily should be considered.
Angina pectoris:
_Adults: _The dose should be adjusted individually. Treatment should
be started with 5 mg once daily and if
needed be increased to 10 mg once daily.
_Administration: _The tablets should regularly be taken in the morning
without food or with a light meal.
Felotens XL 5 mg Prolonged Release Tablets must not be chewed or
crushed. They should be swallowed
whole with half a glass of water.
_Children: _The safety and efficacy of Felotens XL 5 mg Prolonged
Release Tablets in children has not
been established.
Felotens XL 5 mg Prolonged Release Tablets can be used in combination
with β-blockers, ACE inhibitors
or diuretics. The effects on blood pressure are likely to be additive
and combination therapy will usually
enhance the antihypertensive effect. Care should be taken to avoid
hypotension. In patients with severely
impaired liver function the dose of felodipine should be low. The
pharmacokine