Tensipine MR 10 tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Nifedipine

Beschikbaar vanaf:

Genus Pharmaceuticals Ltd

ATC-code:

C08CA05

INN (Algemene Internationale Benaming):

Nifedipine

Dosering:

10mg

farmaceutische vorm:

Modified-release tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Caution - AMP level prescribing advised

Product samenvatting:

BNF: 02060200; GTIN: 5030451000101

Bijsluiter

WHAT IS IN THIS LEAFLET:
1.
What Tensipine MR is and what it is used for
2.
What you need to know before you take Tensipine MR
3.
How to take Tensipine MR
4.
Possible side-effects
5.
How to store Tensipine MR
6.
Contents of the pack and other information
Tensipine MR contains nifedipine, which belongs to a group of
medicines called calcium antagonists.
Tensipine MR is used to treat high blood pressure or angina (chest
pain).
For high blood pressure: Tensipine 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: Tensipine 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.
DO NOT TAKE TENSIPINE MR:
•
if you are allergic (hypersensitive) to nifedipine, any other similar
medicines (known as
_dihydropyridines_) or any of the other ingredients of Tensipine MR
(listed in Section 6).
•
if you have had a heart attack within the last month or if you suspect
that you are having a heart
attack.
•
if you get a sudden angina attack. Tensipine MR will
not help to relieve the symptoms of angina
quickly.
•
if you have unstable angina.
•
if you are pregnant, think you may be pregnant, are planning to become
pregnant or are breast-
feeding.
•
if you are taking rifampicin, an antibiotic.
•
if you have been told that you have a narrowing 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 the severity or frequency of your angina has rapidly worsened over
a matter of hours or 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

Productkenmerken

OBJECT 1
TENSIPINE MR 10
Summary of Product Characteristics Updated 15-Nov-2016 | Genus
Pharmaceuticals
1. Name of the medicinal product
Tensipine MR 10
Tensipine MR 20
2. Qualitative and quantitative composition
Tensipine MR 10
One film-coated tablet contains 10mg nifedipine.
Tensipine MR 20
One film-coated tablet contains 20mg nifedipine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Modified release tablets for oral administration.
Tensipine MR 10
Pink-grey lacquered, modified release tablets each containing 10mg
nifedipine, one side marked TMR
and the reverse side marked 10.
Tensipine MR 20
Pink-grey lacquered, modified release tablets each containing 20mg
nifedipine, one side marked TMR
and the reverse side marked 20.
4. Clinical particulars
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.
Tensipine MR should not be taken with grapefruit juice (see Section
4.5).
_Dosage regimen_
The recommended starting dose of Tensipine MR is 10mg every 12 hours
swallowed with water with
subsequent titration of dosage according to response. The dose may be
adjusted to 40mg every 12 hours,
to a maximum daily dose of 80mg.
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 nifedipine in children below 18 years of
age has not been established.
Currently available data for the use of nifedipine in hypertension are
described in section 5.1.
_Elderly patients_
The pharmacokinetics of nifedipine are altered in the elderly so that
lower maintenance doses of
nifedipine may be required com