Terazosin 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Terazosin hydrochloride

Available from:

Kent Pharma (UK) Ltd

ATC code:

G04CA03

INN (International Name):

Terazosin hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050400

Patient Information leaflet

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 Terazosin Tablets are and what they are used
for
2. What you need to know before you take Terazosin
Tablets
3. How to take Terazosin Tablets
4. Possible side effects
5. How to store Terazosin Tablets
6. Contents of the pack and other information
1. WHAT TERAZOSIN TABLETS ARE AND WHAT THEY
ARE USED FOR
The name of your medicine is Terazosin 1 mg, 2 mg,
5 mg and 10 mg Tablets (called Terazosin Tablets in
this leaflet). Terazosin Tablets contain the active
ingredient terazosin.
Terazosin belongs to a group of medicines called
alpha-blockers.
Terazosin Tablets are used in adults to treat high blood
pressure.
Terazosin Tablets are also used in adults for the treatment
of a condition called benign prostatic hyperplasi
a (BPH)
which affects the prostate and is common in older men.
This condition stops the flow of urine from the bladder
and can lead to symptoms such as a weak or
interrupted urine flow, a need to pass water more
frequently and/or a sudden need to pass water.
Terazosin Tablets can relax the muscle of the prostate
gland and bladder exit to help relieve these symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TERAZOSIN TABLETS
DO NOT TAKE TERAZOSIN TABLETS IF YOU:
•
are allergic to terazosin or to any of the other
ingredients contained in this medicine listed in
section 6 (allergic reactions include mild symptoms
such as itching and/or rash. More severe symptoms
include swelling of the face, lips, tongue and/or
throat with difficulty in swa

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Terazosin 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active
mg/tablet
Terazosin
5.0
as hydrochloride dihydrate
Excipients with known effect:
Lactose
Red iron oxide (E172)
Croscarmellose Sodium
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Red, round, bevelled edged uncoated tablets debossed with the
identifying code
“S152” on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Orally administered terazosin is indicated:
(i) for the symptomatic treatment of urinary obstruction caused by
benign
prostatic hyperplasia (BPH). Terazosin is a selective post synaptic
alpha-1-
adrenoreceptor antagonist. Antagonism of alpha-1-receptors on
prostatic and
urethral smooth muscle has been shown to improve urinary tract flow
and
relieve the urinary obstruction caused by BPH.
(ii) in the treatment of mild to moderate hypertension. It may be used
in
combination with thiazide diuretics and/or other antihypertensive
drugs or as
sole
therapy
where
other
agents
are
inappropriate
or
ineffective.
The
hypotensive effect is most pronounced on the diastolic pressure.
Although the
exact mechanism of the hypotensive action of terazosin is not
established, the
relaxation of peripheral blood vessels appears to be produced mainly
by
competitive antagonism of post-synaptic alpha
1
- adrenoreceptors. Terazosin
usually produces an initial gradual decrease in blood pressure
followed by a
sustained antihypertensive action.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS ONLY:
The dose of terazosin should be adjusted according to the patient's
response. The
following is a guide to administration:
INITIAL DOSE
1 mg before bedtime is the starting dose for all patients and should
not be exceeded.
Strict compliance with this recommendation should be observed to
minimise acute
first-dose hypotensive episodes. Therefore, use of an alternative
preparation will be
necessary for initiation of therapy.
SUBSEQUENT DOSE
IN THE TREATMENT