HYTRIN 10 MG TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TERAZOSIN AS MONOHYDRACHLORIDE DIHYDRATE

Available from:

BIOTIS LTD

ATC code:

G04CA03

Pharmaceutical form:

TABLETS

Composition:

TERAZOSIN AS MONOHYDRACHLORIDE DIHYDRATE 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

AMDIPHARM SALES & MARKETING LTD., UK

Therapeutic group:

TERAZOSIN

Therapeutic area:

TERAZOSIN

Therapeutic indications:

For symptomatic treatment of urinary obstruction caused by benign prostatic hypertrophy (BPH). For mild to moderate hypertension.

Authorization date:

2021-12-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
HYTRIN 5 MG TABLETS
HYTRIN 10 MG TABLETS
Tablets
Each tablet contains:
Hytrin 5 mg Tablets:
Terazosin (as monohydrochloride dihydrate) 5 mg
Hytrin 10 mg Tablets:
Terazosin (as monohydrochloride dihydrate) 10 mg
Inactive and allergenic ingredients: see section 6 “Further
Information” and in section 2
“Important information about some of the ingredients of the
medicine”.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet contains concise information about the medicine. If you
have further questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to others.
It may harm them, even if it seems to you that their medical condition
is similar.
1) WHAT IS THE MEDICINE INTENDED FOR?
Hytrin Tablets is used for the symptomatic treatment of urinary tract
obstruction caused by
benign enlargement of the prostate gland (benign prostatic hyperplasia
- BPH) and for the
treatment of mild to moderate hypertension.
Therapeutic group: Selective apha-1 andrenergic receptor blocker.
2) BEFORE USING THE MEDICINE
Do not use the medicine if:

You are sensitive (allergic) to terazosin or to any of the additional
ingredients contained in
the medicine. For the list of inactive ingredients, see section 6
“Further Information”.
(Allergic reactions include mild symptoms such as itching and/or rash.
More severe
symptoms include swelling of the face, lips, tongue and/or throat with
difficulty swallowing
or breathing).

You are sensitive to any of the following medicines: alfuzosin,
indoramin, prazosin,
tamsulosin, doxazosin.

You have ever fallen or fainted while passing water.
Special warnings regarding use of the medicine
Before taking the medicine, tell your doctor if you:

Are taking other medicines for high blood pressure. If you start
taking a medicine for

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hytrin 5 mg Tablets
Hytrin 10 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hytrin 5 mg tablets contain 5 mg of terazosin as monohydrochloride
dihydrate.
Hytrin 10 mg tablets contain 10 mg of terazosin as monohydrochloride
dihydrate.
Excipients with known effect:
Hytrin 5 mg tablets: Lactose (123.07 mg).
Hytrin 10 mg tablets: Lactose (117.68 mg)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hytrin 5 mg tablets are: Tan, round, flat, bevelled edge tablets
embossed with corporate logo
and triangular facets on one face, plain on the other.
Hytrin 10 mg tablets are: Blue, round, flat, bevelled edge tablets
embossed with corporate
logo and triangular facets on one face, plain on the other.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic indications
For symptomatic treatment of urinary obstruction caused by benign
prostatic hypertrophy
(BPH).
For mild to moderate hypertension.
4.2.
Posology and method of administration
Posology
Hypertension
Adults
Initial dose
Do not start treatment with a new patient if it is not possible to
reach a dose of 1 mg and 2
mg.
1 mg before bedtime is the starting dose for all patients and should
not be exceeded.
Compliance with this initial dosage recommendation should be strictly
observed to minimise
potential for acute first-dose hypotensive episodes.
Subsequent doses
The single daily dosage may be increased by approximately doubling the
dosage at weekly
intervals to achieve the desired blood pressure response.
The usual maintenance dose is 2 mg to 10 mg once daily. Doses over 20
mg rarely improve
efficacy and doses over 40 mg have not been studied.
If 1 or 2 mg dose is not optional, the physician should consider
alternative therapies for
these patients.
BPH
Adults
The dose of terazosin should be adjusted according to the patient’s
response. The following
is a guide to administration:
Initial dose
Do not start treatment with a new patient if it is not possible to
reach a dose of 1 mg and 2
m