Adalat 10mg capsules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Nifedipine

Saatavilla:

DE Pharmaceuticals

ATC-koodi:

C08CA05

INN (Kansainvälinen yleisnimi):

Nifedipine

Annos:

10mg

Lääkemuoto:

Oral capsule

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 02060200

Pakkausseloste

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADALAT
® 10MG CAPSULES
(nifedipine)
Your medicine is called Adalat 10mg Capsules but will be
referred to as Adalat Capsules throughout this leaflet.
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 Adalat Capsules are and what they are used for
2.
What you need to know
before you take Adalat Capsules
3.
How to take Adalat Capsules
4.
Possible side effects
5.
How to store Adalat Capsules
6.
Contents of the pack and other information
1.
WHAT ADALAT CAPSULES ARE AND WHAT THEY
ARE USED FOR
Adalat Capsules contain nifedipine, which belongs to a group
of medicines called _calcium antagonists_.
ADALAT CAPSULES ARE USED TO TREAT HIGH BLOOD PRESSURE,
ANGINA (_chest pain_) OR A CONDITION CALLED _RAYNAUD’S _
_PHENOMENON_ which causes discolouration (often whitening)
of the fingers and toes.
For high blood pressure: Adalat Capsules work 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: Adalat Capsules work 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.
Adalat Capsules can increase the risk of serious heart
problems in patients with high blood pressure or angina.
Because of this, Adalat Capsules are only used in these
patients

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Adalat 10 mg soft capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 10 mg nifedipine.
Excipient with known effect: Yellow orange S (E110)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft.
Orange, softgel capsule (6 minims oblong) containing a yellow viscous
fluid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the prophylaxis of chronic stable angina pectoris, the treatment
of Raynaud's
phenomenon and essential hypertension.
For patients suffering from essential hypertension or chronic stable
angina pectoris, and
treated with fast release forms of nifedipine (Adalat capsules), a
dose dependent increase
in the risk of cardiovascular complications (e.g., myocardial
infarction) and mortality
may occur. Due to this, Adalat capsules should only be used for
treatment of patients
with essential hypertension or chronic stable angina pectoris if no
other treatment is
appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
The maximum total daily dose is 60 mg. The recommended starting dose
is 5 mg
every eight hours with subsequent titration of dose according to
response permitting
an increase to a maximum of 20 mg every eight hours.
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 for special populations _
_Paediatric population _
The safety and efficacy of Adalat capsules 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
_Older people (>65 years) _
The pharmacokinetics of Adalat capsules are altered in the older
people so that lower
maintenance doses of nifedipine may be required.
_Patients with hepatic impairment _
Nifedipine is metabolised primarily by