Coversyl Plus

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

PERINDOPRIL TERT, BUTYLAMINE SALT, INDAPAMIDE

Dostopno od:

Les Laboratoires Servier 50 Rue Carnot, 92284 Suresnes Cedex, France

Koda artikla:

C09BA04

INN (mednarodno ime):

PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg INDAPAMIDE 1.25 mg

Farmacevtska oblika:

TABLET

Sestava:

PERINDOPRIL TERT-BUTYLAMINE SALT 4 mg INDAPAMIDE 1.25 mg

Tip zastaranja:

POM

Terapevtsko območje:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2005-10-10

Navodilo za uporabo

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
COVERSYL PLUS 4MG/1.25MG TABLETS
perindopril tert-butylamine/indapamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What COVERSYL PLUS 4mg/1.25mg is and what it is used for
2.
Before you take COVERSYL PLUS 4mg/1.25mg
3.
How to take COVERSYL PLUS 4mg/1.25mg
4.
Possible side effects
5.
How to store COVERSYL PLUS 4mg/1.25mg
6.
Further information
1.
WHAT COVERSYL PLUS IS AND WHAT IT IS USED FOR
WHAT IS COVERSYL PLUS 4MG/1.25MG ?
COVERSYL PLUS 4mg/1.25mg is a
combination
of two active ingredients,
perindopril and
indapamide.
It is an
anti-hypertensive and
is
used in
the treatment
of
high
blood
pressure
(hypertension).
WHAT IS COVERSYL PLUS 4MG/1.25MG USED FOR ?
Perindopril belongs to a class of medicines called ACE inhibitors.
These work by widening the
blood vessels, which makes it easier for your heart to pump blood
through them. Indapamide is a
diuretic. Diuretics increase the amount of urine produced by the
kidneys. However, indapamide is
different from other diuretics, as it only causes a slight increase in
the amount of urine produced.
Each of the active ingredients reduces blood pressure and they work
together to control your blood
pressure.
2.
BEFORE YOU TAKE COVERSYL PLUS 4MG/1.25MG
DO NOT TAKE COVERSYL PLUS 4MG/1.25MG
-
if you are allergic to perindopril or any other ACE inhibitor, or to
indapamide or any other
sulphonamides or any of the other ingredients of COVERSYL PLUS
4mg/1.25mg,
-
if you have experienced symptoms such as wheezing, swelling of the
face or tongue, intense
itching or severe skin rashes with

Lastnosti izdelka

PAGE 1 OF 19
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 19
1.
NAME OF THE MEDICINAL PRODUCT
COVERSYL PLUS 4mg/1.25mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 3.338 mg perindopril corresponding to 4 mg
perindopril tert-butylamine and
1.25 mg indapamide.
Excipient: 61.55 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, rod-shaped tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension, COVERSYL PLUS 4mg/1.25mg is
indicated in patients whose
blood pressure is not adequately controlled on perindopril alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral route
One COVERSYL PLUS 4mg/1.25mg tablet per day as a single dose,
preferably to be taken in the
morning, and before a meal.
When possible individual dose titration with the components is
recommended. COVERSYL PLUS
4mg/1.25mg
tablet
should
be
used
when
blood
pressure
is
not
adequately
controlled
on
PRETERAX 2mg/0.625mg tablet (where available).When clinically
appropriate, direct change from
monotherapy to COVERSYL PLUS 4mg/1.25mg tablet may be considered.
_Elderly (see section 4.4) _
Treatment should be initiated after considering blood pressure
response and renal function.
_Patients with renal impairment (see section 4.4) _
In severe renal impairment (creatinine clearance below 30 ml/min),
treatment is contraindicated.
In patients with moderate renal impairment (creatinine clearance 30-60
ml/min), it is recommended
to start treatment with the adequate dosage of the free combination.
In patients with creatinine clearance greater than or equal to 60
ml/min, no dose modification is
required. Usual medical follow-up will include frequent monitoring of
creatinine and potassium.
_Patients with hepatic impairment (see sections 4.3, 4.4 and 5.2) _
In severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic impairment, no dose modification is
required.
PAGE 3 OF 19
Children and adolescents
COVERSYL PLUS 4m