Adalat 10mg capsules

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Nifedipine

から入手可能:

Bayer Plc

ATCコード:

C08CA05

INN（国際名）:

Nifedipine

投薬量:

10mg

医薬品形態:

Oral capsule

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 02060200; GTIN: 5010605321108

情報リーフレット

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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
 10 MG
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.
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.
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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 decrea

製品の特徴

OBJECT 1
ADALAT
Summary of Product Characteristics Updated 12-Oct-2017 | Bayer plc
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 impai