Hytrin 5mg Tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Terazosin

可用日期:

Amdipharm Limited

ATC代码:

G04CA; G04CA03

INN（国际名称）:

Terazosin

剂量:

5 milligram(s)

药物剂型:

Tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Alpha-adrenoreceptor antagonists; terazosin

授权状态:

Marketed

授权日期:

1989-05-25

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HYTRIN® 1 MG AND 2 MG TABLETS (STARTER PACK)
HYTRIN® 2 MG TABLETS
HYTRIN® 5 MG TABLETS
HYTRIN® 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 Hytrin Tablets are and what they are used for
2. What you need to know before you take Hytrin Tablets
3. How to take Hytrin Tablets
4. Possible side effects
5. How to store Hytrin Tablets
6. Contents of the pack and other Information
1. WHAT HYTRIN TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Hytrin Tablets. Hytrin Tablets contains
the active ingredient
terazosin. Terazosin belongs to a group of medicines called alpha
blockers.
Hytrin Tablets are used to treat high blood pressure, either on its
own or in combination with other
medicines used to treat high blood pressure. Hytrin Tablets is also
used for the treatment of a
condition called benign prostatic hyperplasia (BPH) which affects the
prostate and is common in
older men.
This condition stops the flow of urine from the bladder and can lead
to symptoms such as a weak or
interrupted urine flow, a need to pass water more frequently and/or a
sudden need to pass water.
Hytrin Tablets can relax the muscle of the prostate gland and bladder
exit to help relieve these
symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYTRIN TABLETS
DO NOT TAKE HYTRIN TABLETS:
-
if you are allergic to terazosin or any of the other ingredients of
this medicine (listed in
section 6)
-
if you have a history of syncope (fainting) duri

产品特点

Health Products Regulatory Authority
16 March 2023
CRN00DC0C
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hytrin 5mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg terazosin (as terazosin hydrochloride
dihydrate).
Excipient with known effect
Contains lactose monohydrate 123.07 mg per tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
A tan round flat, bevel edged tablet embossed with company logo '
' and triangular facets on one face and plain on the
other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hytrin is a selective blocker of post-junctional
alpha-1-adrenoreceptors.
Hytrin is indicated as:

A peripheral vasodilator for use in the management of hypertension
either alone or in conjunction with other
anti-hypertensive agents such as thiazide diuretics or
beta-adrenoreceptor blockers.

An alpha-1-adrenoreceptor blocker for use in the symptomatic treatment
of benign prostatic hyperplasia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HYPERTENSION
_Adults_
An initial dose of 1.0 mg should be given in the evening, one to two
hours before retiring. If no untoward effect has occurred a
dose of 2.0 mg daily may be given after 7 to 14 days. Subsequent
increments should be tailored to the individual patient's
response and requirements, bearing in mind the delay in complete
response.
The usual procedure thereafter is to increase the dose by gradual
increments to the level of optimum response usually 5 - 10
mg daily. Doses over 20 mg rarely improve efficacy and doses over 40
mg have not been studied.
If additional anti-hypertensive therapy is to be introduced, the dose
of terazosin should be reduced and re-titration carried out
if necessary.
_Elderly_
In the elderly dosage should be kept as low as possible and increments
made under close supervision.
Health Products Regulatory Authority
16 March 2023
CRN00DC0C
Page 2 of 7
BENIGN PROSTATIC HYPERPLASIA
_Adults_
An initial dose of 1.0 mg daily should be give