Lisinopril/Hydrochlorothiazide Mylan 20mg/12.5mg Tablet

Country: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

HYDROCHLOROTHIAZIDE, LISINOPRIL

Доступно од:

Generics UK Limited Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

АТЦ код:

C09BA03

INN (Међународно име):

HYDROCHLOROTHIAZIDE 12.5 mg LISINOPRIL 20 mg

Фармацеутски облик:

TABLET

Састав:

HYDROCHLOROTHIAZIDE 12.5 mg LISINOPRIL 20 mg

Тип рецептора:

POM

Терапеутска област:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Статус ауторизације:

Withdrawn

Датум одобрења:

2011-11-09

Информативни летак

PAGE 1 OF 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LISINOPRIL/HYDROCHLOROTHIAZIDE MYLAN 20 MG/12.5 MG TABLETS
lisinopril and hydrochlorothiazide
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 Lisinopril/Hydrochlorothiazide Mylan is and what it is used for
2.
What you need to know before you take Lisinopril/Hydrochlorothiazide
Mylan
3.
How to take Lisinopril/Hydrochlorothiazide Mylan
4.
Possible side effects
5.
How to store Lisinopril/Hydrochlorothiazide Mylan
6.
Contents of the pack and other information
1.
WHAT LISINOPRIL/HYDROCHLOROTHIAZIDE MYLAN IS AND WHAT IT IS USED FOR
Lisinopril/Hydrochlorothiazide Mylan is used to treat high blood
pressure (hypertension). It
contains two medicines called lisinopril and hydrochlorothiazide which
act together to lower
your blood pressure.
Lisinopril belongs to a group of medicines called Angiotensin
Converting Enzyme (ACE)
inhibitors. ACE inhibitors lower blood pressure by widening your blood
vessels. This allows
the blood to flow more easily and reduces the effort needed to pump
blood around the body.
Hydrochlorothiazide belongs to the group of medicines called thiazide
diuretics (water tablets).
The medicine works by helping your body to get rid of water and salts
(like sodium) by
increasing the amount of urine made by your kidneys.
Lisinopril/Hydrochlorothiazide Mylan is used to treat patients whose
blood pressure is not
adequately controlled by lisinopril alone or hydrochlorothiazide
alone.
If high blood pressure is left untreated it can increa

Карактеристике производа

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Lisinopril/Hydrochlorothiazide Mylan 20 mg/12.5 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of lisinopril (as dihydrate) and 12.5 mg of
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Lisinopril/Hydrochlorothiazide Mylan 20 mg/12.5 mg Tablets: A white,
round, biconvex, bevelled
edge tablet, approximately 10.5 mm in diameter, marked with LH2 over M
on one side of the tablet
and a score line on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Lisinopril/Hydrochlorothiazide Tablet fixed dose combination is
indicated for the treatment of
hypertension in patients whose blood pressure is not adequately
controlled by lisinopril alone (or
hydrochlorothiazide alone).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Essential hypertension _
The selection of a suitable antihypertensive dose of lisinopril and
hydrochlorothiazide will depend
upon the clinical evaluation of the patient.
The recommended dose is one tablet administered once daily. As with
other medicines that are taken
once daily, Lisinopril/Hydrochlorothiazide Mylan should be taken at
about the same time each day.
The administration of the fixed combination lisinopril and
hydrochlorothiazide is usually
recommended after dosage titration with the individual components.
When clinically appropriate a direct change from monotherapy to fixed
combination may be
considered.
10 mg/12.5 mg tablets may be administered in patients whose blood
pressure is not adequately
controlled by 10 mg lisinopril alone.
20 mg/12.5 mg tablets may be administered in patients whose blood
pressure is not adequately
controlled by 20 mg lisinopril alone.
A maximum daily dose of 40 mg lisinopril/ 25 mg hydrochlorothiazide
should not be exceeded.
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