Doxazosin 4mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Doxazosin mesilate

Available from:

Teva UK Ltd

ATC code:

C02CA04

INN (International Name):

Doxazosin mesilate

Dosage:

4mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050400; GTIN: 5017007014713

Patient Information leaflet

IF YOU TAKE MORE DOXAZOSIN THAN YOU SHOULD
If you have taken more than the dosage prescribed or
if you think a child or someone else has swallowed
any of the tablets, contact your nearest hospital
casualty department or your doctor immediately.
An overdose is likely to cause low blood pressure,
which may make you feel dizzy or faint. In case of
serious dizziness or imminent fainting you should
lie down immediately with your head downward.
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 positio

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Doxazosin 4 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4.85 mg doxazosin mesilate equivalent to 4 mg of
doxazosin
Excipient(s) with known effect
Each tablet contains 80.0 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
4 mg: white oblong scored tablet, “D4” engraved on one side
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
Essential hypertension.
Symptomatic treatment of benign prostatic hyperplasia (BPH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The duration of therapy will be decided by the physician.
HYPERTENSION:
The usual dosage limits of doxazosin lie between 1 and 8 mg per day.
The maximum
recommended dosage is 16 mg per day. The initial dosage is 1 mg, to be
taken before retiring to
bed. This dose is maintained for 1 or 2 weeks. The dose can then be
increased to 2 mg once a day
for another 1 or 2 weeks. If necessary the daily dose can then be
gradually increased, observing
equal intervals, to 4, 8 and 16 mg once a day, depending on the
patient's response.
The maximum daily dose should not exceed 16mg
BENIGN PROSTATE HYPERPLASIA:
The initial dose of doxazosin is 1 mg (1 mg tablet) on the 1st to 8th
day once daily and 2 mg (2
mg tablet) on the 9th to 14th day. Subsequently, dose should be
titrated individually to 4 mg and
to the maximum recommended dosage of 8 mg, depending on the urodynamic
parameters and
the BPH symptomatology of the patient. The recommended titration
interval is 1 to 2 weeks. The
usual recommended dose is 2-4 mg daily. Doxazosin is administered once
a day. If the doxazosin
treatment has been stopped for a number of days, the regimen should be
determined again.
RENAL IMPAIRMENT
Because
the
pharmacokinetics
of
doxazosin
remain
unchanged
in
patients
with
renal
insufficiency,
and
no
evidence
exists
that
doxazosin
will
exacerbate