Adalat retard 20mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Nifedipine

Предлага се от:

Bayer Plc

АТС код:

C08CA05

INN (Международно Name):

Nifedipine

дозиране:

20mg

Лекарствена форма:

Modified-release tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Caution - AMP level prescribing advised

Каталог на резюме:

BNF: 02060200; GTIN: 5010605005091

Листовка

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Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADALAT
 RETARD 20 MG
Modified-release tablets
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.
WHAT IS IN THIS LEAFLET
1.
What Adalat retard is and what it is used for
2.
What you need to know before you take Adalat retard
3.
How to take Adalat retard
4.
Possible side effects
5.
How to store Adalat retard
6.
Contents of the pack and other information
_ _
_ _
1.
WHAT ADALAT RETARD IS AND WHAT IT IS USED FOR
Adalat retard contains nifedipine, which belongs to a group of
medicines called _ calcium _
_antagonists. _
ADALAT RETARD IS USED TO TREAT HIGH BLOOD PRESSURE OR ANGINA (_chest
pain_).
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For high blood pressure: Adalat retard 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: Adalat retard 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

Данни за продукта

OBJECT 1
ADALAT RETARD 20 MG MODIFIED-RELEASE TABLETS
Summary of Product Characteristics Updated 09-Oct-2017 | Bayer plc
1. Name of the medicinal product
Adalat retard 20 mg modified-release tablets
2. Qualitative and quantitative composition
Each modified-release tablet contains 20 mg nifedipine.
Excipient with known effect: Lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Modified-release tablets.
Grey-pink, round, modified-release tablets marked with 1U on one side
and a Bayer cross on the reverse.
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
Posology
The recommended starting dose of Adalat retard is 10 mg every 12 hours
swallowed with water with
subsequent titration of dosage according to response. Adalat retard
tablets 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).
_Duration of treatment_
Treatment may be continued indefinitely.
_Additional information on special populations_
_Paediatric population_
The safety and efficacy of Adalat retard 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 retard 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 the liver and therefore
patients with mild, moderate or severe liver
dysfunction should be carefully monitored and a dose reduction may be
necessary. The pharmacokinetics
of nifedipine has not been investigated in patients with severe
hepatic impairment (see section 4.