Nifelat R

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

NIFEDIPINE

Boleh didapati daripada:

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

Kod ATC:

C08CA05

INN (Nama Antarabangsa):

NIFEDIPINE 20 mg

Borang farmaseutikal:

TABLET

Komposisi:

NIFEDIPINE 20 mg

Jenis preskripsi:

POM

Kawasan terapeutik:

CALCIUM CHANNEL BLOCKERS

Status kebenaran:

Authorised

Tarikh kebenaran:

2006-11-07

Risalah maklumat

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NIFELAT R 20 MG MODIFIED-RELEASE 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 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 R is and what it is used for
2.
What you need to know before you take Nifelat R
3.
How to take Nifelat R
4.
Possible side effects
5.
How to store Nifelat R
6.
Contents of the pack and other information
1.
WHAT NIFELAT R IS AND WHAT IT IS USED FOR
Nifelat R contains nifedipine, which belongs to a group of drugs
called calcium antagonists_. _
Nifelat R is used to treat high blood pressure or angina (chest pain).
For high blood pressure: Nifelat R works by relaxing and expanding the
blood vessels. This
makes the blood flow more easily and lowers blood pressure. Lower
blood pressure reduces
the strain on your heart.
For angina: Nifelat R works by relaxing and expanding the arteries
supplying the heart. This
allows more blood and oxygen to reach the heart and decreases the
strain on it. Your angina
attacks will be less severe and less frequent if there is less strain
on the heart.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NIFELAT R
DO NOT TAKE NIFELAT R:

if you are allergic to the active ingredient (nifedipine), to any of
the other ingredients or
to any other similar medicines (known as dihydropyridines). The
ingredients of Nifelat
R are listed in section 6.

if you have been told that you have a narrowing of the aortic heart
valve (stenosis).
Page 2 of 7

if you have ever had a collapse caused by a heart problem (cardiogenic
sho

Ciri produk

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICAL PRODUCT
Nifelat R
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nifedipine BP 20 mg
3.
PHARMACEUTICAL FORM
Film-coated tablets.
4.
CLINICAL INFORMATION
4.1
THERAPEUTIC INDICATIONS
For
the
prophylaxis
of
chronic
stable
angina
pectoris
and
the
treatment
of
hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Oral use.
As a rule, tablets are swallowed whole with a little liquid, either
with or without food.
Nifelat R should not be taken with grapefruit juice (see Section 4.5).
Dosage regimen
After treatment with 20mg per day the dose may be titrated to 40 mg
every 12 hours,
to a maximum daily dose of 80 mg.
Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may
result in the
recommendation to adapt the nifedipine dose or not to use nifedipine
at all (see
Section 4.5).
Duration of treatment
Treatment may be continued indefinitely.
Additional information on special populations
Children and adolescents
The safety and efficacy of Nifelat R in children below 18 years of age
has not been
established.
Geriatric patients
The pharmacokinetics of Nifelat R are altered in the elderly so that
lower maintenance
doses of nifedipine may be required compared to younger patients.
Patients with hepatic impairment
Nifedipine is metabolised primarily by the liver and therefore
patients with liver
dysfunction should be carefully monitored and in severe cases, a dose
reduction may
be necessary.
Patients with renal impairment
Page 2 of 10
Based on pharmacokinetic data, no dosage adjustment is required in
patients with
renal impairment (see Section 5.2).
4.3
CONTRA-INDICATIONS
Nifelat R must not be administered to patients with known
hypersensitivity to
nifedipine, or to other dihydropyridines because of the theoretical
risk of cross-
reactivity, or to any of the excipients.
Nifelat R is contraindicated in pregnancy before week 20 and during
breastfeeding
(see Sections 4.4, 4.6 and 5.3).
Nifelat R must not be used in cases of c