Percarnil Indapamide 10mg/2.5mg film-coated Tablets

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

PERINDOPRIL ARGININE, INDAPAMIDE

متاح من:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC رمز:

C09BA04

INN (الاسم الدولي):

PERINDOPRIL ARGININE 10 mg INDAPAMIDE 2.5 mg

الشكل الصيدلاني:

FILM-COATED TABLET

تركيب:

PERINDOPRIL ARGININE 10 mg INDAPAMIDE 2.5 mg

نوع الوصفة الطبية :

POM

المجال العلاجي:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

الوضع إذن:

Withdrawn

تاريخ الترخيص:

2015-12-22

نشرة المعلومات

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PERCARNIL INDAPAMIDE 10 MG/2.5 MG FILM-COATED TABLETS
perindopril arginine/indapamide hemihydrate
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.
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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 Percarnil indapamide is and what it is used for
2.
What you need to know before you take Percarnil indapamide
3.
How to take Percarnil indapamide
4.
Possible side effects
5.
How to store Percarnil indapamide
6.
Contents of the pack and other information
1.
WHAT PERCARNIL INDAPAMIDE IS AND WHAT IT IS USED FOR
Percarnil indapamide is a combination of two active ingredients,
perindopril and indapamide. It is
an antihypertensive and is used in the treatment of high blood
pressure (hypertension).
Percarnil indapamide 10 mg/2.5 mg is prescribed for patients already
receiving perindopril 10 mg
and indapamide 2.5 mg from separate tablets, these patients may
instead receive one tablet of
Percarnil indapamide 10 mg/2.5 mg which contains both ingredients.
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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERCARNIL INDAPAMIDE
DO NOT

خصائص المنتج

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Percarnil indapamide 10 mg/2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg perindopril arginine
corresponding to 6.79 mg perindopril
and 2.5 mg indapamide hemidydrate.
Excipient with known effect:
Each film-coated tablet contains 167 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Percarnil indapamide 10 mg/2.5 mg film-coated tablets are white, 8.5
mm round and biconvex.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Percarnil indapamide 10 mg/2.5 mg is indicated as substitution therapy
for treatment of essential
hypertension, in patients already controlled with perindopril and
indapamide given concurrently at
the same dose level.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One Percarnil indapamide 10 mg/2.5 mg tablet per day as a single dose,
preferably to be taken in the
morning, and before a meal.
_Elderly (see section 4.4) _
In elderly, the plasma creatinine must be adjusted in relation to age,
weight and gender. Elderly
patients can be treated if renal function is normal and after
considering blood pressure response.
_Patients with renal impairment (see section 4.4) _
In severe and moderate renal impairment (creatinine clearance below 60
ml/min), treatment is
contraindicated.
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.
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In patients with moderate hepatic impairment, no dose modification is
required.
_ _
_Paediatric population _
Percarnil indapamide should not be used in children and adolescents as
the efficacy and tolerability
of perindopril in children and adolescents, alone or in combination,
have not been established.
Method of administration
Oral use.
4.3
CONTRAINDICATIONS
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Hypersensitivity to the active su