Terazosin 10mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Terazosin hydrochloride

Prieinama:

Focus Pharmaceuticals Ltd

ATC kodas:

G04CA03

INN (Tarptautinis Pavadinimas):

Terazosin hydrochloride

Dozė:

10mg

Vaisto forma:

Oral tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 02050400

Pakuotės lapelis

BLACK
PANTONE® GREEN C
ZINC Ref:
EAS3577B LEA TERAZOSIN 2MG 5MG 10MG TAB TUK
28 MAY 2020
Version:
3
Colours Used:
Length:
Width:
Depth:
323 MM
160 MM
-
TEMPLATE
UK & Ireland Artwork Department
TERAZOSIN 2 MG, 5 MG AND 10 MG
TABLETS
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 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.
1.
WHAT TERAZOSIN IS AND WHAT IT IS USED FOR
2. BEFORE YOU TAKE TERAZOSIN
3. HOW TO TAKE TERAZOSIN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE TERAZOSIN
6. FURTHER INFORMATION
WHAT TERAZOSIN IS AND WHAT IT IS
USED FOR
Terazosin belongs to a group of medicines called
alpha-blockers.
Terazosin is used to treat:
•
high blood pressure
•
blocked urine flow caused by benign prostatic
hyperplasia (BPH), which is common in older
men
BPH is caused by the prostate gland growing
too big and obstructing the flow of urine from
the bladder. This leads to some unpleasant
symptoms such as 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.
BEFORE YOU TAKE TERAZOSIN
DO NOT TAKE TERAZOSIN IF YOU:
•
are allergic (hypersensitive) to terazosin or any
of the other ingredients of this medicine
•
are allergic (hypersensitive) to other similar
medicines such as prazosin or doxazosin
•
have ever fainted when urinating
•
have the rare hereditary problem of galactose
intolerance, Lapp lactase deficiency, or
glucose-galactose malabsorption.
TAKE SPECIAL CARE WITH TERAZOSIN
TALK TO YOUR DOCTOR BEFORE YOU START TO TAKE THIS
MEDICINE IF YOU:
•
have any liver problems
•
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Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Terazosin Teva 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 11.87mg of terazosin hydrochloride dihydrate
equivalent
to 10 mg of terazosin.
Excipient with known effect:
Each 10 mg tablet contains 109.03 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Mottled blue, round, flat tablet with bevelled edges embossed with
“93” on
one-side and “763” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Terazosin Teva 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
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).
The maximum dose is 20 mg of terazosin per day and should not be
exceeded.
Use with thiazide diuretics and other antihypertensive agents in the
treatment
of hypertension
When adding a thiazide diuretic or another antihypertensive agent to a
patient's regimen the dose of terazosin should be reduced or
discontinued and
retitration carried out if necessary. Caution should be observed when
terazo