Natrixam 1.5mg/5mg modified-release Tablets

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

AMLODIPINE, INDAPAMIDE

Доступна с:

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

код АТС:

C08GA02

ИНН (Международная Имя):

INDAPAMIDE 1.5 mg AMLODIPINE 5 mg

Фармацевтическая форма:

MODIFIED-RELEASE TABLET

состав:

INDAPAMIDE 1.5 mg AMLODIPINE 5 mg

Тип рецепта:

POM

Терапевтические области:

CALCIUM CHANNEL BLOCKERS

Статус Авторизация:

Authorised

Дата Авторизация:

2013-09-23

тонкая брошюра

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NATRIXAM 1.5 MG / 5 MG MODIFIED-RELEASE TABLETS
NATRIXAM 1.5 MG / 10 MG MODIFIED-RELEASE TABLETS
indapamide / amlodipine
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 Natrixam is and what it is used for
2.
What you need to know before you take Natrixam
3.
How to take Natrixam
4.
Possible side effects
5.
How to store Natrixam
6.
Contents of the pack and other information
1.
WHAT NATRIXAM IS AND WHAT IT IS USED FOR
Natrixam is prescribed as substitution treatment for high blood
pressure (hypertension) in patients already
taking indapamide and amlodipine from separate tablets in the same
strength.
Natrixam is a combination of two active ingredients, indapamide and
amlodipine.
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.
Amlodipine
is
a
calcium
antagonist
(which
belongs
to
a
class
of
medicines
called
dihydropyridines) and it works by relaxing blood vessels, so that
blood passes through them more easily.
Each of the active ingredients reduces blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NATRIXAM
DO NOT TAKE NATRIXAM
-
if you are allergic to indapamide or any other sulfonamide (class of
medicinal product for the treatment
of hypertension), or to amlodipine or any other calcium antagonist
(class of medicinal produt for the
treatment of hypertension) or to any

Характеристики продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Natrixam 1.5 mg / 5 mg modified-release tablets
Natrixam 1.5 mg / 10 mg modified-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 1.5 mg indapamide and 6.935 mg amlodipine besilate
equivalent to 5 mg amlodipine.
One tablet contains 1.5 mg indapamide and 13.87 mg amlodipine besilate
equivalent to 10 mg amlodipine.
Excipient with known effect: 104.5 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablet.
White, round, film-coated, bilayered, modified-release tablet of 9 mm
diameter engraved with
on one
face.
Pink, round, film-coated, bilayered, modified-release tablet of 9 mm
diameter engraved with
on one face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Natrixam is indicated as substitution therapy for treatment of
essential hypertension in patients already
controlled with indapamide and amlodipine given concurrently at the
same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One tablet per day as single dose, preferably to be taken in the
morning, to be swallowed whole with water
and not chewed.
The fixed dose combination is not suitable for initiation therapy.
If a change of the posology is required, titration should be done with
the individual components.
Special populations
_Paediatric population _
The safety and efficacy of Natrixam in children and adolescents have
not been established.
_ _
No data are available.
_ _
_Patients with renal impairment (see sections 4.3 and 4.4): _
In severe renal impairment (creatinine clearance below 30 ml/min),
treatment is contraindicated.
In patients with mild to moderate renal impairment, no dose adjustment
is needed.
_Older people (see section 4.4 and 5.2): _
Older people can be treated with Natrixam according to renal function.
_ _
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_Patients with hepatic impairment (see sections 4.3 and 4.4): _
In severe hepatic impairment, treatment is contraindicated.
Dosage recommendations of aml