Terazostad 1 mg + 2 mg Tablett

Country: Շվեդիա

language: շվեդերեն

source: Läkemedelsverket (Medical Products Agency)

active_ingredient:

terazosinhydrokloriddihydrat

MAH:

STADA Arzneimittel AG

ATC_code:

G04CA03

INN:

terazosin hydrochloride dihydrate

dosage:

1 mg + 2 mg

pharmaceutical_form:

Tablett

composition:

laktosmonohydrat Hjälpämne; terazosinhydrokloriddihydrat 1,187 mg Aktiv substans; terazosinhydrokloriddihydrat 2,374 mg Aktiv substans; para-orange Hjälpämne; laktosmonohydrat Hjälpämne

prescription_type:

Receptbelagt

therapeutic_area:

Terazosin

authorization_status:

Avregistrerad

authorization_date:

2002-11-29

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TERAZOSTAD 1 MG, 2 MG, 5 MG, 10 MG AND 1 MG + 2 MG TABLETS
Terazosin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

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. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Terazostad is and what it is used for
2.
Before you take Terazostad
3.
How to take Terazostad
4.
Possible side effects
5.
How to store Terazostad
6.
Further information
1. WHAT TERAZOSTAD IS AND WHAT IT IS USED FOR
Terazostad belongs to a group of medicines called alpha blockers. It
works by
relaxing the blood vessels making it easier for the blood to flow
through. It can
also relax the muscle of the bladder and bladder exit.
TERAZOSTAD IS USED TO:

treat mild to moderate high blood pressure (hypertension).

treat urinary problems due to a condition called benign prostatic
hyperplasia
(BPH). This condition is caused by overgrowth of the prostate gland
and is
common in older men. When the prostate gland grows too big, it can
partially block the flow of urine out of the bladder. This leads to
symptoms
such as:

a weak or intermittent flow of urine

a need to pass water more frequently or at night

a sudden need to pass water.
2. BEFORE YOU TAKE TERAZOSTAD
DO NOT TAKE TERAZOSTAD

If you are allergic (hypersensitive) to terazosin, or to a
structurally similar
alpha-adrenergic antagonist, the colourant “sunset yellow” FCF (E
110) or to
any of the other ingredients of the Terazostad tablets (see section 6
“Further
information” at the end of the leaflet)
2

If you suffer or have ever suffered from micturition syncope. This is
a brief
loss of consciousness that occurs when passing w

SPC

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Terazostad 1 mg tablets
Terazostad 2 mg tablets
Terazostad 5 mg tablets
Terazostad 10 mg tablets
Terazostad 1 mg + 2 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains terazosin 1 mg, 2 mg, 5 mg or 10 mg (as terazosin
hydrochloride dihydrate).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
1 mg tablet: white, round tablet
2 mg tablet: orange, round tablet, with a break mark on one side. The
tablet can be divided into equal
halves.
5 mg tablet: red, round tablet
10 mg tablet: blue, round tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Terazostad tablets are indicated for:

the treatment of mild to moderate hypertension

symptomatic treatment of urinary obstruction caused by benign
prostatic hyperplasia (BPH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
For the treatment of hypertension:
The dose of terazosin should be managed according to each patients
response.
The starting dose for all patients is 1 mg before bedtime and this
should not be exceeded during the
first week of treatment. Patients should be advised to comply in order
to avoid first-dose hypotensive
effect. The dose can be increased by approximately doubling the dose
at weekly intervals until
effective control of blood pressure is established.
The usual maintenance dose is 2 mg daily. However, for certain
patients, an increased dose may
become necessary. A maximum dose of 20 mg should not be exceeded.
Reduction of dose should be undertaken when adding other
antihypertensive medication followed by
re-titration if required.
2
For the treatment of Benign Prostatic Hyperplasia (BPH):
The dose of terazosin should be managed according to each patients
response.
The starting dose for all patients is 1 mg at night-time for 7 days
and this should not be exceeded
during the first week of treatment. The dose can then be increased to
2 mg daily for 14 days, followed
-if necessary- by 5 mg daily for 7 days. Response t