Natrilix SR 1.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Indapamide

Available from:

Sigma Pharmaceuticals Plc

ATC code:

C03BA11

INN (International Name):

Indapamide

Dosage:

1.5mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020100

Patient Information leaflet

NATRILIX
® SR 1.5 MG TABLETS
(indapamide)
PATIENT INFORMATION LEAFLET
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.
This medication is available using the above name but will be referred
to as
Natrilix SR throughout the following. WHAT IS IN THIS LEAFLET:
1. What Natrilix SR is and what it is used for
2. What you need to know before you take Natrilix SR
3. How to take Natrilix SR
4. Possible side effects
5. How to store Natrilix SR
6. Contents of the pack and other information
1. WHAT NATRILIX SR IS AND WHAT IT IS USED FOR
Natrilix SR is a prolonged-release film-coated tablet containing
indapamide
as the active ingredient.
Indapamide is a diuretic. Most 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.
This medicine is intended to reduce high blood pressure (hypertension)
in
adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NATRILIX SR
DO NOT TAKE NATRILIX SR:
-
if you are allergic to indapamide or any other sulfonamide or to any
of the
other ingredients of this medicine (listed in section 6),
-
if you have severe kidney disease,
-
if you have severe liver disease or suffer from a condition called
hepatic
encephalopathy (degenerative disease of the brain),
-
if you have low potassium levels in your blood.
WARNINGS AND PRECAUTIONS:
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING NATRILIX SR:
-
if you have liver problems,
-
if you have diabetes,
-
if you suffer from gout,
-
if you have any h

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Natrilix SR 1.5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release film-coated tablet contains 1.5 mg indapamide.
Excipient with known effect: 124.5 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release tablet.
White, round, film-coated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Natrilix SR is indicated in essential hypertension in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One tablet per 24 hours, preferably in the morning, to be swallowed
whole with water
and not chewed. _ _
At higher doses the antihypertensive action of indapamide is not
enhanced but the
saluretic effect is increased.
Special populations
_Renal impairment (see sections 4.3 and 4.4): _
In severe renal failure (creatinine clearance below 30 ml/min),
treatment is
contraindicated.
Thiazide and related diuretics are fully effective only when renal
function is normal
or only minimally impaired._ _
_ _
_Hepatic impairment (see sections 4.3 and 4.4)_:
In severe hepatic impairment, treatment is contraindicated.
_Elderly (see section 4.4)_:
In the elderly, the plasma creatinine must be adjusted in relation to
age, weight and
gender. Elderly patients can be treated with Natrilix SR when renal
function is normal
or only minimally impaired.
_Paediatric population: _
The safety and efficacy of Natrilix SR in children and adolescents
have not been
established. No data are available.
Method of administration
_ _
Oral use
4.3
CONTRAINDICATIONS
- Hypersensitivity to the active substance, to other sulfonamides or
to any of the
excipients listed in section 6.1.
- Severe renal failure.
- Hepatic encephalopathy or_ _severe impairment of liver function.
- Hypokalaemia.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Special warnings _
When
liver
function
is
impaired,
thiazide-related
diuretics
may
cause
hepatic
encephalopathy, particularly in case of electrolyte imbalance.
Administration