Adipine MR 10 tablets

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Nifedipine

Tersedia dari:

Chiesi Ltd

Kode ATC:

C08CA05

INN (Nama Internasional):

Nifedipine

Dosis:

10mg

Bentuk farmasi:

Modified-release tablet

Rute administrasi :

Oral

Kelas:

No Controlled Drug Status

Jenis Resep:

Caution - AMP level prescribing advised

Ringkasan produk:

BNF: 02060200; GTIN: 5028613000939

Selebaran informasi

WHAT IS IN THIS LEAFLET
1. What Adipine™ MR is and what it is used for
2. What you need to know before you take
Adipine™ MR
3. How to take Adipine™ MR
4. Possible side effects
5. How to store Adipine™ MR
6. Contents of the pack and other information
1. WHAT ADIPINE™ MR IS AND WHAT IT IS
USED FOR
Adipine™
MR
contains
the
active
substance
nifedipine, which belongs to a group of medicines
called _calcium antagonists. _
ADIPINE™ MR IS USED TO TREAT HIGH BLOOD PRES-
SURE OR ANGINA (chest pain).
For high blood pressure: Adipine™ MR 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: Adipine™ MR 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
ADIPINE™ MR
DO NOT TAKE ADIPINE™ MR
• IF YOU ARE ALLERGIC to the active substance, to
any other similar medicines (known as dihydro
-
pyridines) or to any of the other ingredients of
this medicine (listed in section 6).
• IF YOU HAVE HAD A HEART ATTACK within the last
month.
• IF YOU GET A SUDDEN ANGINA ATTACK.
Adipine™
MR will not help relieve symptoms of angina
quickly.
• IF YOU HAVE UNSTABLE ANGINA.
• IF YOU ARE TAKING RIFAMPICIN,
an antibiotic.
• IF YOU HAVE BEEN TOLD THAT YOU HAVE A NARROW-
ING OF THE AORTIC HEART VALVE (stenosis).
• IF YOU HAVE EVER HAD A COLLAPSE caused by
a
HEART
PROBLEM (cardiogenic
shock),
during
which you became breathless, pale and had a
cold sweat and dry mouth.
• IF
YOUR
BLOOD
PRESSURE
CONTINUES
TO
RISE
despite treatment (malignant hypertension).
• If you have been told to AVOID LACTOSE,
that you
have a hereditary condition called _LAPP LACTASE_
_DEFICIENCY_ or _ GLUCOSE-GALACTOSE MALABSORP-_
_TION._
WARNINGS AND PRECAUTIONS
Talk to your doctor o

Karakteristik produk

OBJECT 1
ADIPINE MR 10MG TABLETS
Summary of Product Characteristics Updated 16-Sep-2016 | Chiesi
Limited
1. Name of the medicinal product
Adipine MR 10
Adipine MR 20
2. Qualitative and quantitative composition
_Adipine MR 10 _
One modified release tablet contains 10mg of nifedipine
Excipient(s) with known effect: lactose monohydrate 39 mg
_Adipine MR 20 _
One modified release tablet contains 20mg of nifedipine
Excipient(s) with known effect: lactose monohydrate 36.2 mg
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Modified release tablet
Round, slightly biconvex, pink coated tablets with smooth surface.
4. Clinical particulars
4.1 Therapeutic indications
• Hypertension
• Prophylaxis of chronic stable angina pectoris
4.2 Posology and method of administration
Posology
The recommended starting dose of Adipine MR is 10 mg every 12 hours
swallowed with water with
subsequent titration of dosage according to response. Adipine MR
permit titration of the initial dosage,
which may be adjusted 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).
Method of administration
Oral use.
As a rule, tablets are swallowed whole with a little liquid, either
with or without food.
Adipine MR should not be taken with grapefruit juice (see section
4.5).
Duration of treatment
Treatment may be continued indefinitely.
_Additional information on special populations_
_Older people (> 65 years)_
The pharmacokinetics of nifedipine are altered in older people 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_
Based on pharmacokinetic data, no dosage adjus