Doxazosin 1mg tablets

国: イギリス

言語: 英語

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

即購入

ダウンロード 製品の特徴 (SPC)
14-08-2018

有効成分:

Doxazosin mesilate

から入手可能:

Arrow Generics Ltd

ATCコード:

C02CA04

INN(国際名):

Doxazosin mesilate

投薬量:

1mg

医薬品形態:

Oral tablet

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: 02050400; GTIN: 5060034832126

情報リーフレット

                                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 Doxazosin is and what it is
used for
2.
What you need to know before you
take Doxazosin
3.
How to take Doxazosin
4.
Possible side effects
5.
How to store Doxazosin
6.
Contents of the pack and other
information
1.
WHAT DOXAZOSIN IS AND WHAT IT
IS USED FOR
Doxazosin belongs to the group known
as vasodilators. These substances
cause the blood vessel to widen, which
reduces the blood pressure. Doxazosin
can also reduce tension in the muscle
tissues of the prostate and the urinary
tract.
Doxazosin is used to treat:
•
high blood pressure;
•
symptoms of an enlarged prostate.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE DOXAZOSIN
DO NOT TAKE DOXAZOSIN
•
if you are allergic to doxazosin,
other types of quinazolines (such
as prazosin and terazosin) or any
of the other ingredients of this
medicine (listed in section 6). This
may have been itching, reddening
of the skin or difficulty in breathing.
•
if you are breast-feeding
•
if you are under 18 years of age
•
if you have
an enlarged
prostate gland
(benign prostatic
hyperplasia) AND
have low blood
pressure.
•
If you have
a history of a
condition known
as ‘orthostatic
hypotension’
which is a form
of low blood
pressure that
causes you to
feel dizzy or light-
headed when you
stand up from
sitting or lying
down.
•
If you have an enlarged prostate
gland with one of the following: any
kind of congestion or blockage in
your urinary tract, a longstanding
infection of the urinary tract or you
have bla
                                
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製品の特徴

                                OBJECT 1
DOXAZOSIN 1MG TABLETS
Summary of Product Characteristics Updated 15-Nov-2018 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Doxazosin 1 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 1.21 mg doxazosin mesilate equivalent to 1mg
doxazosin.
Excipients with known effect:
Each Doxazosin 1 mg tablet contains 24 mg lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
White to off- white coloured, circular biconvex shaped uncoated tablet
debossed with H on one side and
01 on other side
4. Clinical particulars
4.1 Therapeutic indications
• Essential hypertension. Doxazosin is not appropriate for
first-line treatment. It may be used as a
monotherapy in patients who have failed to respond to or have
contraindications to other agents.
Alternatively, use should be limited to second or third line treatment
in combination with other
antihypertensives.
• Symptomatic treatm
                                
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