Doxazosin 1mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Download Tờ rơi thông tin (PIL)
01-12-2016

Thành phần hoạt chất:

Doxazosin mesilate

Sẵn có từ:

Kent Pharma (UK) Ltd

Mã ATC:

C02CA04

INN (Tên quốc tế):

Doxazosin mesilate

Liều dùng:

1mg

Dạng dược phẩm:

Oral tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 02050400

Tờ rơi thông tin

                                Please take this leaflet, any remaining tablets and
the container with you to the hospital or doctor so
that they know which tablets were consumed.
IF YOU FORGET TO TAKE DOXAZOSIN
If you forget to take a tablet, leave that dose out
completely. Then go back to your usual schedule.
Do not take a double dose to make up for a
forgotten dose. Take the remaining doses at the
correct time. In case of doubt you should always
consult your pharmacist or doctor.
IF YOU STOP TAKING DOXAZOSIN
You should continue to take these tablets for as
long as your doctor tells you to. If the use of this
medication is suddenly stopped, the symptoms
that existed before the start of the treatment may
reoccur.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
STOP TAKING THE TABLETS AND TELL YOUR DOCTOR
IMMEDIATELY or go to the casualty department at
your nearest hospital if you experience any of the
following effects:
•
allergic reactions, this can be recognized by e.g.
rash and/or itch
•
swelling of the face due to fluid accumulation
(facial oedema).
These are very serious but uncommon side effects.
You may need urgent medical attention or
hospitalisation.
COMMON (may affect up to 1 in 10 people)
•
infection of the respiratory tract
•
infection of the urinary tract
•
headache
•
dizziness
•
sleepiness
•
low blood pressure (hypotension), faintness or
dizziness caused by low blood pressure when
getting up from a sitting or lying position
(postural hypotension)
•
sensation that one's self or the surroundings are
moving or spinning (vertigo)
•
palpitations, rapid heart rate (tachycardia)
•
inflammation of the airway (bronchitis), cough,
shortness of breath, runny nose (rhinitis)
•
abdominal pain, pain or discomfort in the upper
abdomen (dyspepsia), dry mouth, feeling sick
•
severe itching (pruritus)
•
back pain, muscle pain
•
bladder infection (cystitis), uri
                                
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Đặc tính sản phẩm

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Doxazosin Tablets 1mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1mg doxazosin (as mesilate).
Excipient(s) with known effect
Lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to off-white, odourless biconvex uncoated tablets with D and 1
on
either side of the score line and plain on the other.
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Doxazosin Tablets are indicated for management of hypertension, as the
sole
agent, or in combination with a thiazide diuretic, ACE inhibitor,
beta-blocker
or calcium antagonist, and for the treatment of urinary outflow
obstruction and
symptoms associated with benign prostatic hyperplasia (BPH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Doxazosin may be administered in the morning or evening.
Adults and the elderly:
_Hypertension: _Doxazosin Tablets should be taken once a day.
Initial dosage is 1mg to minimise the potential
for postural hypotension and/or syncope (see
section 4.4). This may be increased after 1-2
weeks to 2mg daily, and thereafter to 4mg
daily, if necessary. The majority of patients
who respond to doxazosin will do so at a
dose of 4mg or less. Dosage can be further
increased if necessary to 8mg or to a
maximum daily dose of 16mg.
_Benign prostatic hyperplasia: _The recommended initial dosage of
Doxazosin
is 1mg given once daily to minimise the
potential for postural hypotension and/or
syncope (see section 4.4). Depending on the
individual patient’s urodynamics and BPH
symptomatology, dosage may then be
increased to 2mg and thereafter to 4mg and up
to the maximum recommended dose of 8mg.
The recommended titration interval is 1-2
weeks. The usual recommended dose is 2-4mg
daily.
Paediatric population:
The safety and efficacy of doxazosin mesilate (Doxazosin Tablets) in
children
and adolescents have not be
                                
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