Doxadura XL 4mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Doxazosin mesilate

Sẵn có từ:

Dexcel-Pharma Ltd

Mã ATC:

C02CA04

INN (Tên quốc tế):

Doxazosin mesilate

Liều dùng:

4mg

Dạng dược phẩm:

Modified-release 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; GTIN: 5030451003614

Tờ rơi thông tin

WHAT IS IN THIS LEAFLET
1. What Doxadura XL is and what it is used for
2. What you need to know before you take
Doxadura XL
3. How to take Doxadura XL
4. Possible side-effects
5. How to store Doxadura XL
6. Contents of the pack and other information
1. WHAT DOXADURA XL IS AND WHAT IT IS USED FOR
The active substance in your tablets, doxazosin,
belongs to a group of medicines known as alpha-1
antagonists. Doxadura XL is used to treat the
following conditions:
-
High blood pressure. If left uncontrolled, high
blood pressure can increase the risk of heart
disease or stroke.
Doxadura XL works by widening your blood vessels
making it easier for your heart to pump blood through
them. This helps to lower raised blood pressure and
reduce the risk of heart disease.
-
Symptoms of benign prostatic hyperplasia (BPH).
This condition causes enlargement of the
prostate gland, which is just underneath the
bladder in men. This makes it difficult to pass
urine.
Doxadura XL works by relaxing muscle around the
bladder exit and prostate gland, making it easier to
pass urine.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DOXADURA XL
DO NOT TAKE DOXADURA XL
-
if you are allergic to doxazosin, to quinazolines
(e.g. prazosin, terazosin) which is the chemical
family of medicines to which doxazosin belongs,
or any of the other ingredients of this medicine (in
section 6). Allergic reactions may be, for example,
itching, reddening of the skin or difficulty breathing
-
if you have low blood pressure (hypotension) or
have had a fall in blood pressure on standing
up which caused dizziness, light-headedness or
fainting (orthostatic hypotension)
-
if you have or have had any form of obstruction of
the digestive tract
-
if you have benign prostatic hyperplasia (BPH)
and additionally suffer from a blockage of your
upper urinary tract, chronic urinary infections or
bladder stones
-
if you have an overflowing bladder, almost no
production of urine (anuria) or if your kidneys fail to
function properly (progressive renal insufficiency)
-
if you are breast-f

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
DoxaduraTM XL 4mg Prolonged-release Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release tablet contains 4 mg doxazosin (as mesilate).
For the full list of excipients, see section 6.1.
Excipient(s) with known effect
Each prolonged-release tablet contains 0.1mg sodium.
3
PHARMACEUTICAL FORM
Prolonged-release tablet.
White, round, biconvex tablets, with bossing “DL” on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Essential hypertension.
Symptomatic treatment of benign prostatic hyperplasia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The maximum recommended dose is 8 mg doxazosin once daily.
_ _
_Essential hypertension _
_Adults _
Most patients treated with Doxadura XL 4 mg prolonged release tablets
once
daily achieve control of blood pressure. It may take up to four weeks
to reach
optimal effect. If necessary, the dose can thereafter be increased to
8 mg once
daily depending on the clinical response.
Doxadura XL 4 mg prolonged release tablets can be used as monotherapy
or in
combination with another medicinal product e.g. a thiazide diuretic, a
beta-
adrenoceptor blocking agent, a calcium antagonist or an ACE-inhibitor
if
either of them alone does not provide sufficient effect.
_ _
_Symptomatic treatment of benign prostatic hyperplasia _
_Adults_
Recommended dose is 4 mg once daily. Depending on clinical response,
the
dosage may be increased to 8 mg doxazosin once daily.
Doxazosin may be used in benign prostatic hyperplasia patients who are
either
hypertensive or normotensive, as the blood pressure reduction in
normotensive
patients is generally slight. Patients should be closely monitored in
the initial
phase of the treatment due to the risk of postural adverse events.
_Special populations _
_Elderly_
Same dosage recommendations as for adults.
_Renal impairment_
Since there is no change in pharmacokinetics in patients with impaired
renal
function and since there are no signs that doxazosin aggravates