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NATRILIX SR 1.5MG PROLONGED-RELEASE TABLETS

Active substance: INDAPAMIDE

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S1286 LEAFLET Natrilix SR 20150422

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

NATRILIX SR 1.5mg PROLONGED-RELEASE TABLETS
(indapamide)
Your medicine is known as Natrilix SR 1.5mg Prolonged-release
Tablets but will be referred to as Natrilix SR throughout the
following leaflet.
Read all of this leaflet carefully before you start using this
medicine.

Taking other medicines:
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),



Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or
pharmacist.





bepridil (used to treat angina pectoris, a condition causing chest
pain),

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.



cisapride (used to treat reduced movement of the gullet and
stomach),



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.



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),

2. Before you take Natrilix SR



mizolastine (used to treat allergic reactions, such as hay fever),

3. How to take Natrilix SR



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),

6. Further information



oral corticosteroids used to treat various conditions including
severe asthma and rheumatoid arthritis,

1. WHAT NATRILIX SR IS AND WHAT IT IS USED FOR



stimulant laxatives,

This medicine is intended to reduce high blood pressure
(hypertension).



baclofen (to treat muscle stiffness occurring in diseases such as
multiple sclerosis),

It is a prolonged-release film-coated tablet containing indapamide
as 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.



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).

In this leaflet:
1. What Natrilix SR is and what it is used for

4. Possible side effects
5. How to store Natrilix SR

2. BEFORE YOU TAKE NATRILIX SR t Retard:
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,

Pregnancy and breast-feeding:



if you have severe liver disease or suffer from a condition called
hepatic encephalopathy (liver problems which affect the brain
and central nervous system),

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



if you have low potassium levels in your blood.

Take special care with Natrilix SR:

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.



if you have liver problems,



if you have diabetes,



if you suffer from gout,

Driving and using machines:



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.

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.

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

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 DO

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

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.



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.

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.



If you have taken too many tablets, contact your doctor or
pharmacist immediately.

low potassium in the blood,



Treatment for high blood pressure is usually life-long.
If you take more Natrilix SR than you should:

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:

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:

increased levels of liver enzymes.



Abnormal ECG heart tracing



Life-threatening irregular beat (Torsade de Pointes)



Hepatitis



Fainting

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on
the safety of this medicine.

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):

5. HOW TO STORE NATRILIX SR


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30° C.

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



Store in the original container.

Uncommon (less than 1 patient in 100 but more than 1 in 1000):



If your doctor stops your treatment, take any leftover tablets
back to the pharmacy for safe disposal.



Do not take your tablets after the expiry date on the container.
Take any tablets which are out of date back to the pharmacy.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

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);

What Natrilix SR contains





Each prolonged-release tablet contains 1.5mg indapamide.

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);



Natrilix SR tablets also contain the following: lactose, colloidal
anhydrous silica, magnesium stearate, glycerol,
hydroxypropylmethylcellulose, macrogol 6000, titanium dio xide
(E171) and polyvinylpyrrolidone.



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);

What Natrilix SR looks like and contents of the pack



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.

6. FURTHER INFORMATION



Natrilix SR tablets are white, round film-coated tablets with no
marking on either side.



Natrilix SR Tablets are available as blister packs of 30 and 60
tablets.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Anpharm Przedsiebiorstwo
Farmaceutyczne S.A., ul. Annopol 6B, Warsaw 03-236 Poland.
POM PL 19488/1286
Leaflet revision date: 22 April 2015
Natrilix SR is a registered trade mark of Biofarma France.
S1286 LEAFLET Natrilix SR 20150422

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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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