Adalat 10mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nifedipine

Available from:

Lexon (UK) Ltd

ATC code:

C08CA05

INN (International Name):

Nifedipine

Dosage:

10mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060200

Patient Information leaflet

ADALAT 10MG SOFT CAPSULES
(nifedipine)
PATIENT INFORMATION 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.
Your medicine is called Adalat 10mg Soft Capsules but will be referred
to as
Adalat capsules throughout the rest of this leaflet.
WHAT IS IN THIS LEAFLET
WHAT ADALAT CAPSULES ARE AND WHAT THEY ARE USED FOR
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADALAT CAPSULES
HOW TO TAKE ADALAT CAPSULES
POSSIBLE SIDE EFFECTS
HOW TO STORE ADALAT CAPSULES
CONTENTS OF THE PACK AND OTHER INFORMATION
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 if no other treatments are appropriate.

Summary of Product characteristics

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