NATRIXAM 1.5/10 mg/mg Modified-release Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
INDAPAMIDE AMLODIPINE AS AMLODIPINE BESILATE
Available from:
Les Laboratoires Servier
INN (International Name):
INDAPAMIDE AMLODIPINE AS AMLODIPINE BESILATE
Dosage:
1.5/10 mg/mg
Pharmaceutical form:
Modified-release Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
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 of 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
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Natrixam 1.5mg/10mg modified release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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.
_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.
_Patients with hepatic impairment (see sections 4.3 and 4.4):_
In severe hepatic impairment, treatment is contraindicated.
Dosage recommendations of amlodipine have not been established in patients with mild to moderate hepati
Read the complete document
