Adalat LA 60mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Download 환자 정보 전단 (PIL)
07-06-2018
Download 제품 특성 요약 (SPC)
07-06-2018

유효 성분:

Nifedipine

제공처:

Bayer Plc

ATC 코드:

C08CA05

INN (국제 이름):

Nifedipine

복용량:

60mg

약제 형태:

Modified-release tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Caution - AMP level prescribing advised

제품 요약:

BNF: 02060200; GTIN: 5010605005114

환자 정보 전단

                                V 025_0
Page 1 of 8
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
 LA 60 MG
Prolonged-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 LA is and what it is used for
2.
What you need to know before you take Adalat LA
3.
How to take Adalat LA
4.
Possible side effects
5.
How to store Adalat LA
6.
Contents of the pack and other information
_ _
_ _
1. WHAT ADALAT LA IS AND WHAT IT IS USED FOR
Adalat
LA
contains
nifedipine,
which
belongs
to
a
group
of
medicines
called
_calcium _
_antagonists. _
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Page 2 of 8
ADALAT LA IS USED TO TREAT HIGH BLOOD PRESSURE OR ANGINA _(chest
pain)_.
For high blood pressure: Adalat LA 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 LA 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 NEED TO KNOW BEFORE YOU TA
                                
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제품 특성 요약

                                OBJECT 1
ADALAT LA 60 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 09-Oct-2017 | Bayer plc
1. Name of the medicinal product
Adalat LA 60 mg prolonged-release tablets
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 60 mg nifedipine.
Each tablet contains a 10% overage of nifedipine to deliver the label
claim.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet.
Pink, round, convex prolonged-release tablet with a laser hole on one
side and marked with Adalat 60.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of all grades of hypertension.
For the prophylaxis of chronic stable angina pectoris either as
monotherapy or in combination with a
beta-blocker.
4.2 Posology and method of administration
_Posology_
In mild to moderate hypertension, the recommended initial dose is one
20 mg tablet once-daily. In severe
hypertension, the recommended initial dose is one 30 mg tablet
once-daily. If necessary, the dosage can
be increased according to individual requirements up to a maximum of
90 mg once-daily.
For the prophylaxis of angina pectoris, the recommended initial dose
is one 30 mg tablet once-daily. The
dosage can be increased according to individual requirements up to a
maximum of 90 mg once-daily.
Patients in whom hypertension or anginal symptoms are controlled on
Adalat capsules or Adalat retard
may be safely switched to Adalat LA. Prophylactic anti-anginal
efficacy is maintained when patients are
switched from other calcium antagonists such as diltiazem or verapamil
to Adalat LA. Patients switched
from other calcium antagonists should initiate therapy at the
recommended initial dose of 30 mg Adalat
LA once-daily. Subsequent titration to a higher dose may be initiated
as warranted clinically.
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_
Tre
                                
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