Terazosin 10mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Terazosin hydrochloride

Dostopno od:

Actavis UK Ltd

Koda artikla:

G04CA03

INN (mednarodno ime):

Terazosin hydrochloride

Odmerek:

10mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 02050400

Navodilo za uporabo

CHILDREN
•
Terazosin is not recommended for use in
children.
IF YOU TAKE MORE TERAZOSIN THAN YOU SHOULD
•
If you accidentally take more than 1 tablet in a
day, you should contact your doctor
immediately.
•
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child has
swallowed any of the tablets, contact your
nearest hospital casualty department or your
doctor immediately.
An overdose is likely to cause very low blood
pressure resulting in fainting, dizziness, and
drowsiness.
Please take this leaflet, any remaining tablets,
and the container with you to the hospital or
doctor so that they know which tablets were
consumed.
IF YOU FORGET TO TAKE TERAZOSIN
•
If you have forgotten to take a tablet of a new
strength at bedtime, ask your doctor or
pharmacist for advice before continuing.
•
If you forget to take a tablet at the normal time,
take one as soon as you remember. DO NOT
take a double dose to make up for a forgotten
dose. Take the remaining doses at the correct
time.
•
If you have forgotten to take a tablet for
several days, DO NOT continue using the same
tablets. YOU MUST CONTACT YOUR DOCTOR FOR
ADVICE BEFORE YOU START TAKING TERAZOSIN TABLETS
AGAIN AS YOUR TREATMENT MAY HAVE TO BE
RESTARTED AS IF YOU ARE TAKING IT FOR THE FIRST TIME.
IF YOU STOP TAKING TERAZOSIN
•
You should continue to take your tablets
unless your doctor tells you not to. DO NOT
stop just because you feel better.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Terazosin can cause side
effects, although not everybody gets them.
If the following happens, stop taking the tablets
and tell your doctor immediately or go to the
casualty department at your nearest hospital:
•
an allergic reaction (swelling of the lips, face or
neck leading to severe difficulty in breathing;
skin rash or hives).
This is a very serious but rare side effect. You may
need urgent medical attention or hospitalisation.
THE MOST COMMON S

Lastnosti izdelka

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