Benph 5mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Terazosin hydrochloride

Commercializzato da:

Viatris UK Healthcare Ltd

Codice ATC:

G04CA03

INN (Nome Internazionale):

Terazosin hydrochloride

Dosaggio:

5mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 02050400

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v2/Oct 2016
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1
Myriad Pro
15 Sep 2017
17:42
10 pt
10 pt
170 x 480 mm
Terazosin Hydrochloride 5 mg,10 mg,2 mg,1 mg
28,30,84,50,20,7,14,98,100,10
Leaflet
1206831
618304
1206831
N/A
N/A
LT1858AB
202
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313718
5
United Kingdom
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Black
PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
BENPH 1 MG, 2 MG, 5 MG
AND 10 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 Benph is and what it is used for
2. What you need to know before you take
Benph
3. How to take Benph
4. Possible side effects
5. How to store Benph
6. Contents of the pack and other information
1.
WHAT BENPH IS AND WHAT IT IS USED
FOR
Your medicine contains terazosin, which
belongs to a group of medicines called
alpha-blockers. Benph is given to adult men
suffering from an enlarged prostate gland
(part of the male sexual organs found just
below the bladder, which can place pressure
on the bladder, causing problems, when
passing water (urine)), as it can relax the
muscles allowing urine to be passed more
easily.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE BENPH
DO NOT TAKE BENPH:
•
if you are allergic to terazosin or any of the
other

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Benph 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1MG:
Each tablet contains 1mg of terazosin (in the form of terazosin
hydrochloride dihydrate).
_ _
Excipient with known effect:
55mg lactose monohydrate
For the full list of excipients, see section 6.1.
2MG:
Each tablet contains 2mg of terazosin (in the form of terazosin
hydrochloride dihydrate).
_ _
Excipient with known effect:
110mg lactose monohydrate
For the full list of excipients, see section 6.1.
5MG:
Each tablet contains 5mg of terazosin (in the form of terazosin
hydrochloride dihydrate).
_ _
Excipients with known effect:
110mg lactose monohydrate
0.01mg Sunset Yellow (E110)
For the full list of excipients, see section 6.1.
10MG:
Each tablet contains 10mg of terazosin (in the form of terazosin
hydrochloride dihydrate).
_ _
Excipients with known effect:
110mg lactose monohydrate
0.1mg Sunset Yellow (E110)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
5mg:
Tablet
Light orange, round, flat, bevel edged, tablet imprinted “E” and
“453” on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Benph tablets are indicated in adults for:
-
symptomatic treatment of urinary obstruction caused by benign
prostatic hyperplasia (BPH).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults only:
The dose of terazosin should be managed according to each patient’s
response. The following is a
guide to administration.
Initial dose
An initial dose of 1.0mg daily should be given before bedtime. Strict
compliance with this
recommendation should be observed to minimise acute first-dose
hypotensive episodes.
Subsequent dose
The dose may be increased by approximately doubling the dose at weekly
or bi-weekly intervals to
achieve the desired reduction in symptoms. The maintenance dose is
usually 5 to 10mg once daily.
Improvements in symptoms have been detected as early as two weeks
after starting treatment with
terazosin.
At present there are insufficient data