Hydralazine 25mg coated Tablets

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

HYDRALAZINE HYDROCHLORIDE

Disponible desde:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

Código ATC:

C02DB02

Designación común internacional (DCI):

HYDRALAZINE HYDROCHLORIDE 25 mg

formulario farmacéutico:

COATED TABLET

Composición:

HYDRALAZINE HYDROCHLORIDE 25 mg

tipo de receta:

POM

Área terapéutica:

ANTIHYPERTENSIVES

Estado de Autorización:

Authorised

Fecha de autorización:

2006-09-20

Información para el usuario

page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HYDRALAZINE 25 MG COATED TABLETS
Hydralazine hydrochloride
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 Hydralazine is and what it is used for
2.
What you need to know before you take Hydralazine
3.
How to take Hydralazine
4.
Possible side effects
5.
How to store Hydralazine
6.
Contents of the pack and other information
1.
WHAT HYDRALAZINE IS AND WHAT IT IS USED FOR
The name of your medicine is Hydralazine. The active ingredient is
hydralazine
hydrochloride. Hydralazine hydrochloride belongs to a group of
medicines called
antihypertensives.
Hydralazine is used to treat high blood pressure and heart failure.
It works by relaxing blood vessels and increasing the supply of blood
and oxygen to
the heart.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYDRALAZINE
DO NOT TAKE HYDRALAZINE
•
if you are allergic to hydralazine or to any other ingredients of this
medicine (listed
in section 6). 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 in swallowing or breathing).
•
if you are pregnant, or intend to get pregnant or if you are breast
feeding.
•
if you have or have ever had a condition called Systemic Lupus
Erythematosus
(SLE), an autoimmune condition which causes joint pain, skin rashes
and fever.
•
if you suffer from severe tachycardia or right sided heart failure due
to increased
pressure in the blood vessels of the lungs (

Ficha técnica

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Hydralazine 25 mg coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains hydralazine 25 mg.
Excipient(s) with known effect
This product contains lactose 25 mg and sucrose 47.68 mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Coated tablet.
Yellow, round, sugar-coated tablets.
4. CLINICAL PARTICULARS
_ _
4.1 THERAPEUTIC INDICATIONS
For the treatment of moderate to severe hypertension as an adjunct to
other anti-
hypertensive agents.
Due to the complementary mechanism of action the combination of
hydralazine with
b-blockers and diuretics may enable antihypertensive efficacy at lower
dose levels and
counteract accompanying hydralazine effects such as reflex tachycardia
and oedema.
As supplementary medication for use in combination with long-acting
nitrates in
moderate to severe chronic congestive cardiac failure in patients in
whom optimal doses
of conventional therapy have proved insufficient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Adults_
Hypertension: the dose should be adjusted to the individual
requirements of the patient.
Treatment should begin with low doses of Hydralazine which, depending
on the
patient's response should be increased stepwise to achieve optimal
therapeutic effect
whilst keeping unwanted effects to a minimum.
Page 2 of 9
Initially 25 mg bid. This can be increased gradually to a dose not
exceeding 200 mg
daily. The dose should not be increased beyond 100 mg daily without
first checking the
patient's acetylator status.
Chronic congestive heart failure: Treatment with Hydralazine should
always be
initiated in hospital, where the patient's individual haemodynamic
values can be reliably
determined with the help of invasive monitoring. It should then be
continued in hospital
until the patient has become stabilised on the requisite maintenance
dose. Doses vary
greatly between individual patients and are generally higher than
those used for treating
hype