Terazosin 5mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Terazosin

Available from:

Accord Healthcare Limited

ATC code:

G04CA; G04CA03

INN (International Name):

Terazosin

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Alpha-adrenoreceptor antagonists; terazosin

Authorization status:

Marketed

Authorization date:

2009-04-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TERAZOSIN 2 MG TABLETS
TERAZOSIN 5 MG TABLETS
Terazosin
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
Terazosin belongs to the class of drugs known as alpha-1- selective
adrenoreceptor blocking
agents.
TERAZOSIN TABLETS ARE USED TO:

treat patients suffering from high blood pressure. They help reduce
blood pressure.

treat a condition called benign prostatic hyperplasia which is common
in older men. This
condition is caused by the prostate gland growing too big and
obstructing, it can partially
block the flow of urine from the bladder. This leads to some
unpleasant 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 can relax the muscle of the prostate gland and bladder exit
to help relieve these
symptoms.
Ask your doctor or pharmacist if you need additional information.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TERAZOSIN TABLETS
DO NOT TAKE TERAZOSIN TABLETS:

If you are allergic to active substance, or any of the other
ingredients of this medicine
(listed in section 6).

If you have ever experienced a brief loss of consciousness when
passing water,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Terazosin 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg terazosin (as terazosin monohydrochloride
dihydrate).
Excipient with known effect: Each tablet contains 117.12 mg of lactose
(as lactose monohydrate).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Light pink coloured, round, flat tablets with bevelled edges and score
line on one side of the tablet.
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
Terazosin tablets are indicated for:
The treatment of mild to moderate hypertension
The symptomatic treatment of urinary obstruction caused by benign
prostatic hyperplasia (BPH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For oral use.
For the different dosage regimens suitable strengths are available.
The dose of terazosin should be adjusted according to the patient's
response.
The following is a guide to administration:
INITIAL DOSE
The lowest single dose of 1 mg before bedtime for all patients, which
should not be exceeded. Strict compliance with
this recommendation should be observed to minimise potential acute
first-dose hypotensive episodes.
SUBSEQUENT DOSES
Treatment of mild to moderate hypertension:
The single daily dosage may be increased by approximately doubling the
dosage at
weekly intervals to achieve the
desired blood pressure response.
The maintenance dose needs to be adjusted to the patient’s response.
2 mg/day may be sufficient with increases up to
10 mg if necessary (clinical studies support the use of 2 – 10 mg as
maintenance dose).
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