NATRILIX SR 1.5MG SUSTAINED RELEASE TABLETS

Active substance: INDAPAMIDE

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NATRILIX® SR
1.5MG SUSTAINED RELEASE TABLETS
(indapamide)

PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Natrilix SR 1.5mg
Sustained Release Tablets but will be referred to as Natrilix SR
through out the leaflet.

Read all of this leaflet carefully before you
start using 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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:

1.
2.
3.
4.
5.
6.

What Natrilix SR is and what it is used for
Before you take Natrilix SR
How to take Natrilix SR
Possible side effects
How to store Natrilix SR
Further information

1. WHAT NATRILIX SR IS AND WHAT IT IS
USED FOR
This medicine is intended to reduce high blood pressure
(hypertension).
It 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.

2. BEFORE YOU TAKE NATRILIX SR
Do not take Natrilix SR:

if you are allergic to indapamide or any other sulphonamide
or to any of the other ingredients of Natrilix SR,
if you have severe kidney disease,
if you have severe liver disease or suffer from a condition
called hepatic encephalopathy (liver problems which affect
the brain and central nervous system),
if you have low potassium levels in your blood.

Take special care with Natrilix SR:

if you have liver problems,
if you have diabetes,
if you suffer from gout,
if you have any heart rhythm problems or problems with
your kidneys,
if you need to have a test to check how well your
parathyroid gland is working.

You should tell your doctor if you have had photosensitivity
reactions.
Your doctor may give you blood tests to check for low sodium or
potassium levels or high calcium levels.
If you think any of these situations may apply to you or you have
any questions or doubts about taking your medicine, you should
consult your doctor or pharmacist.

Pregnancy and breast-feeding:

Ask your doctor or pharmacist for advice before taking any
medicine.

Athletes should be aware that this medicine contains an active
ingredient, which may give a positive reaction in doping tests.

This medicine is not recommended during pregnancy. When a
pregnancy is planned or confirmed, the switch to an alternative
treatment should be initiated as soon as possible. Please tell your
doctor if you are pregnant or wish to become pregnant.
The active ingredient is excreted in milk. Breastfeeding is not
advisable if you are taking this medicine.

Taking other medicines:

Driving and using machines:

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
You should not take Natrilix SR with lithium (used to treat
depression) due to the risk of increased levels of lithium in the
blood.
Make sure to tell your doctor if you are taking any of the following
medicines, as special care may be required:
medicines used for heart rhythm problems (e.g. quinidine,
hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide,
dofetilide, digitalis),
medicines used to treat mental disorders such as
depression, anxiety, schizophrenia (e.g. tricyclic
antidepressants, antipsychotic drugs, neuroleptics),
bepridil (used to treat angina pectoris, a condition causing
chest pain),
cisapride (used to treat reduced movement of the gullet and
stomach),
diphemanil (used to treat gastric problems such as ulcers,
too much acid, overactive digestive system),
sparfloxacin, moxifloxacin (antibiotics used to treat
infections),
halofantrine (antiparasitic drug used to treat certain types of
malaria),
pentamidine (used to treat certain types of pneumonia),
mizolastine (used to treat allergic reactions, such as hay
fever),
non-steroidal anti-inflammatory drugs for pain relief (e.g.
ibuprofen) or high doses of acetylsalicylic acid,
angiotensin converting enzyme (ACE) inhibitors (used to
treat high blood pressure and heart failure),
oral corticosteroids used to treat various conditions including
severe asthma and rheumatoid arthritis,
stimulant laxatives,
baclofen (to treat muscle stiffness occurring in diseases such
as multiple sclerosis),
potassium-sparing diuretics (amiloride, spironolactone,
triamterene),
metformin (to treat diabetes),
iodinated contrast media (used for tests involving X-rays),
calcium tablets or other calcium supplements,
ciclosporin, tacrolimus or other medicines to depress the
immune system after organ transplantation, to treat
autoimmune diseases, or severe rheumatic or
dermatological diseases,
tetracosactide (to treat Crohn’s disease).

Page 1 of 2

This medicine can cause side effects such as dizziness or tiredness
due to lowering of the blood pressure (see section 4).
These side effects are more likely to occur after initiation of the
treatment and after dose increases. If this occurs, you should
refrain from driving and other activities requiring alertness.
However, under good control, these side effects are unlikely to
occur.

Important information about some of the
ingredients of Natrilix SR:

This medicine contains lactose monohydrate. If you have been
told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.

3. HOW TO TAKE NATRILIX SR
Instructions for proper use:

One tablet each day, preferably in the morning. The tablets can be
taken with or without food. They should be swallowed whole with
water. Do not crush or chew them.
Treatment for high blood pressure is usually life-long.

If you take more Natrilix SR than you should:

If you have taken too many tablets, contact your doctor or
pharmacist immediately.
A very large dose of Natrilix SR could cause nausea (feeling sick),
vomiting, low blood pressure, cramps, dizziness, drowsiness,
confusion and changes in the amount of urine produced by the
kidneys.

If you forget to take Natrilix SR:

If you forget to take a dose of your medicine, take the next dose
at the usual time. Do not take a double dose to make up for the
forgotten dose.

If you stop taking Natrilix SR:

As the treatment for high blood pressure is usually life-long, you
should discuss with your doctor before stopping this medicinal
product.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Natrilix SR can cause side effects, although not
everybody gets them.

Common (less than 1 patient in 10 but more than 1 in
100):

Low potassium in the blood, which may cause muscle weakness.

Uncommon (less than 1 patient in 100 but more than 1 in
1000):
Vomiting, allergic reactions, mainly dermatological, such as skin
rashes, purpura (red pinpoints on skin) in subjects with a
predisposition to allergic and asthmatic reactions.

Rare (less than 1 patient in 1000 but more than 1 in
10,000):

Feeling of tiredness, dizziness, headache, pins and needles
(paresthesia);
Nausea (feeling sick), constipation, dry mouth;
Increased risk of dehydration in the elderly and in patients
suffering from heart failure.

Very rare (less than 1 patient in 10,000):

Heart rhythm irregularities (causing palpitations, feeling of
the heart pounding), low blood pressure;
Kidney disease (causing symptoms of tiredness, increased
need to urinate, itchy skin, feeling sick, swollen
extremities);
Pancreatitis (inflammation of the pancreas which causes
upper abdominal pain), abnormal liver function (with
symptoms such as tiredness, loss of appetite, feeling or
being sick, swollen extremities, yellow skin). In cases of liver
failure, there is a possibility of getting hepatic
encephalopathy (liver problems which affect the brain and
central nervous system);
Changes in blood cells, such as thrombocytopenia (decrease
in the number of platelets which causes easy bruising and
nasal bleeding), leucopenia (decrease of white blood cells
which may cause unexplained fever, soreness of the throat
or other flu-like symptoms – if this occurs, contact your
doctor) and anaemia (decrease in red blood cells);
Angioedema and/or urticaria, severe skin manifestations.
Angioedema is characterised by swelling of the skin around
the eyes, lips, hands or feet. It may cause swelling of the
throat, tongue or airways resulting in shortness of breath or
difficulty in swallowing. If this occurs, contact your doctor
immediately.

If you suffer from systemic lupus erythematosus (a disorder of the
immune system leading to inflammation and damage to the joints,
tendons and organs with symptoms including skin rashes,
tiredness, loss of appetite, weight gain and joint pain), this might
get worse. Cases of photosensitivity reactions (change in skin
appearance) after exposure to the sun or artificial UVA have also
been reported.

Not known (frequency cannot be estimated from the
available data):

Changes may occur in your blood and your doctor may need
to give you blood tests to check your condition. The
following changes in your blood test results may occur:
low potassium in the blood,
low sodium in the blood that may lead to dehydration
and low blood pressure,
increase in uric acid, a substance which may cause or
worsen gout (painful joint(s) especially in the feet),
increase in blood glucose levels in diabetic patients,
increase of calcium in blood,
increased levels of liver enzymes,
Abnormal ECG heart tracing
Life-threatening irregular beat (Torsade de Pointes)
Hepatitis
Fainting

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

5. HOW TO STORE NATRILIX SR
Keep out of the sight and reach of children.
Do not store above 30º C.
Do not use this medicine after the expiry date which is
stated on the carton and blister. The expiry date refers to
the last day of that month.
If your doctor decides to stop your treatment, return any
tablets left over to the pharmacist. Only keep them if your
doctor tells you to.
If your tablets appear to be discoloured, or show any other
signs of deterioration, take them to your pharmacist who will
advise you.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Natrilix SR contains:

The active ingredient is indapamide. Each tablet contains 1.5mg
indapamide.
The other ingredients include:
tablet core: colloidal anhydrous silica, hypromellose,
lactose monohydrate, magnesium stearate and povidone
film-coating: glycerol, hypromellose, macrogol 6000,
magnesium stearate and titanium dioxide (E171).

What Natrilix SR looks like and the contents of the
pack:
Natrilix SR are white, round, prolonged-release film-coated
tablets.
Natrilix SR tablets are available in blister packs of 30.

Page 2 of 2

Manufacturer:

Manufactured by: Les Laboratoires Servier Industrie,
905 route de Saran, 45520 Gidy, France.
Or
Servier (Ireland) Industries Limited., Gorey Road,
Co-Wicklow - Arklow, Ireland.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0537

POM

Leaflet revision and issue date (Ref): 30.07.12
NATRILIX® is a registered trademark of Biofarma.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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