Adalat 5mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nifedipine

Available from:

Bayer Plc

ATC code:

C08CA05

INN (International Name):

Nifedipine

Dosage:

5mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060200; GTIN: 5010605321115

Patient Information leaflet

PATIENT INFORMATION LEAFLET
ADALAT
® 5MG SOFT CAPSULES
(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.

This medicine is called Adalat 5mg soft capsules but will be referred
to
as Adalat capsules throughout the remainder of this leaflet.

This product is also available in other strengths.
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. Becaus

Summary of Product characteristics

OBJECT 1
ADALAT 5
Summary of Product Characteristics Updated 12-Oct-2017 | Bayer plc
1. Name of the medicinal product
Adalat 5 mg soft capsules
2. Qualitative and quantitative composition
Each soft capsule contains 5 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 (3 minims, oval) 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 impair