Nifelat 10 mg film-coated tablets

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

NIFEDIPINE

Prieinama:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC kodas:

C01CA05

INN (Tarptautinis Pavadinimas):

NIFEDIPINE 10 mg

Vaisto forma:

FILM-COATED TABLET

Sudėtis:

NIFEDIPINE 10 mg

Recepto tipas:

POM

Gydymo sritis:

CARDIAC THERAPY

Autorizacija statusas:

Authorised

Leidimo data:

2016-05-06

Pakuotės lapelis

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NIFELAT 10 MG FILM-COATED TABLETS
NIFEDIPINE
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 not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Nifelat is and what it is used for
2.
What you need to know before you take Nifelat
3.
How to take Nifelat
4.
Possible side effects
5.
How to store Nifelat
6.
Contents of the pack and other information
1.
WHAT NIFELAT IS AND WHAT IT IS USED FOR
Nifelat contains the active substance nifedipine.
One cause of high blood pressure is when the resistance in the blood
vessels is too high.
Nifelat is a calcium channel blocker (an agent that inhibits the
influx of calcium into
certain cells). Treatment with Nifelat reduces the tension in the
muscle cells of the blood
vessels. Hereby more blood (and thus more oxygen) is delivered and the
blood vessels
dilate.
The most common type of angina occurs when the heart muscle receives
too little
oxygen. In case of angina, Nifelat dilates blood vessels, the heart
does not have to work
as hard to pump out the blood and thus less oxygen is needed.
Raynaud’s disease is due to local vasoconstriction including
fingers, which turn bluish,
white,
pulseless,
cold,
insensitive
and
clumsy.
Nifelat
counteracts
this
type
of
vasoconstriction.
Nifelat is used to treat high blood pressure, stable angina, and
Raynaud's disease
(vasoconstriction in the fingers).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NIFELAT
DO NOT TAKE NIFELAT
•
if you are allergic to nifedipine or any of the other in

Prekės savybės

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICAL PRODUCT
Nifelat 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg nifedipine.
Excipient(s) with known effect
This product contains 60,9 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round, scored, film-coated tablets with Remedica’s logo on
one side.
The tablet can be divided into equal doses using a pill cutter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Stable angina pectoris.
Hypertension.
Short-term treatment of Raynaud disease, primary as well as secondary.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose is adjusted individually. The tablets are swallowed whole
with liquid, independently
of meals. The tablets must not be split or crushed. Grapefruit juice
should be avoided in
conjunction with ingestion of the tablets (see 4.5 Interactions).
The recommended dosing interval for Nifelat is approximately 12 hours
but no less than 4
hours.
_Angina pectoris:_
The appropriate starting dose is 10 mg twice daily. Normal dosage is
1-2
tablets (10-20 mg) twice daily.
_Hypertension:_
The appropriate starting dose and usual maintenance dose is 10 mg
twice daily.
The dose may be increased gradually up to 40 mg twice daily. If a
satisfactory therapeutic
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response has not been achieved after about 4-6 weeks with the initial
dose, a dose increase or
addition of another blood pressure lowering agent is recommended.
_Raynaud disease:_
Given mainly to patients with bothersome symptoms when they are
expected to be exposed to triggers. The usual dose is 10-20 mg twice
daily. Experimentally,
the dose may be increased to 40 mg twice daily.
_Special patient groups _
_ _
_Paediatric population _
The efficacy and safety of nifedipine in children below 18 years of
age has not been established.
The information currently available