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NATRILIX SR 1.5MG PROLONGED-RELEASE TABLETS

Active substance(s): INDAPAMIDE / INDAPAMIDE / INDAPAMIDE

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S1286 LEAFLET Natrilix SR 20160627

PACKAGE LEAFLET: INFORMATION FOR THE USER

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),

Your medicine is known as Natrilix SR 1.5mg Prolonged-release
Tablets but will be referred to as Natrilix SR throughout the
following leaflet.



medicines used to treat mental disorders such as depression,
anxiety, schizophrenia… (e.g. tricyclic antidepressants,
antipsychotic drugs, neuroleptics),

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.



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



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





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

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



diphemanil (used to treat gastro-intestinal problems),



sparfloxacin, moxifloxacin, erythromycin by injection (antibiotics
used to treat infections),



vincamine by injection (used to treat symptomatic cognitive
disorders in elderly including memory loss),



halofantrine (antiparasitic drug used to treat certain types of
malaria),

What is in this leaflet:



pentamidine (used to treat certain types of pneumonia),

1. What Natrilix SR is and what it is used for



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

2. What you need to know before you 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. Contents of the pack and other information



amphotericine B by injection (anti-fungal medicines),

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



Natrilix SR is a prolonged-release film-coated tablet containing
indapamide as active ingredient.

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),

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



metformin (to treat diabetes),



iodinated contrast media (used for tests involving X-rays),

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NATRILIX
SR t Retard:



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,

®

NATRILIX SR 1.5mg PROLONGED-RELEASE TABLETS
(indapamide)



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.

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

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.

Do not take Natrilix SR:


if you are allergic to indapamide or any other sulphonamide 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 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.
Athletes should be aware that this medicine contains an active
ingredient, which may give a positive reaction in doping tests.
Other medicines and Natrilix SR:
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
You should not take Natrilix SR with lithium (used to treat
depression) due to the risk of increased levels of lithium in the
blood.

 tetracosactide (to treat Crohn’s disease).
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for
advice before taking any medicine.
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. Breast-feeding is not
advisable if you are taking this medicine.
Driving and using machines:
This medicine can cause side effects due to lowering of the blood
pressure such as dizziness or tiredness (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.
Natrilix SR 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
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet each day, preferably in the
morning.
The tablets can be taken irrespective of meals. They should be
swallowed whole with water. Do not crush or chew them. Treatment
for high blood pressure is usually life-long.



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.



Short sightedness (myopia).



Blurred vision.

Do not take a double dose to make up for the forgotten dose.



Visual impairment.

If you stop taking 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 laboratory parameters may occur:

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.

As the treatment for high blood pressure is usually life-long, you
should discuss with your doctor before stopping this medicinal
product.

-

low potassium in the blood,

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

-

low sodium in the blood that may lead to dehydration and
low blood pressure,

4. POSSIBLE SIDE EFFECTS

-

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,

-

increased levels of liver enzymes,

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Stop taking the medicinal product and see a doctor
immediately, if you experience any of the following side
effects:




Angioedema and/or urticarial. Angioedema is characterised by
swelling of the skin of extremities or face, swelling of the lips or
tongue, swelling of the mucous membranes of the throat or
airways resulting in shortness of breath or difficulty of
swallowing. If this occurs, contact your doctor immediately.
(Very rare) (may affect up to 1 in 10,000 people)
Severe skin reactions including intense skin rash, reddening of
the skin over your whole body, severe itching, blistering, peeling
and swelling of the skin, inflammation of mucous membranes
(Stevens Johnson Syndrome) or other allergic reactions, (Very
rare) (may affect up to 1 in 10,000 people)



Life-threatening irregular beat. (Not known)



Inflamed pancreas which may cause severe abdominal and
back pain accompanied with feeling very unwell (Very rare)
(may affect up to 1 in 10,000 people)



Disease of the brain caused by liver illness (Hepatic
encephalopathy) (Not known)



Inflammation of the liver (Hepatitis) (Not known)

In decreasing order of frequency, other side effects can include:
Common (may affect up to 1 in 10 people):


Red raised skin rash;



Allergic reactions, mainly dermatological, in subjects with a
predisposition to allergic and asthmatic reactions.

 Abnormal ECG heart tracing.
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.
5. HOW TO STORE NATRILIX SR


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30° C.



Store in the original container.



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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Uncommon (may affect up to 1 in 100 people):

What Natrilix SR contains



Vomiting;





Each prolonged-release tablet contains 1.5mg indapamide.

Red pinpoints on skin (Purpura).



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

Rare (may affect up to 1 in 1000 people):


Feeling of tiredness, headache, pins and needles (paresthesia),
vertigo;



Gastro-intestinal disorders (such as nausea, constipation), dry
mouth;

Very rare (may affect up to 1 in 10,000 people):


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


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.



High level of calcium in blood;

Manufacturer



Heart rhythm irregularities (causing palpitations, feeling of the
heart pounding), low blood pressure;

This product is manufactured by Anpharm Przedsiebiorstwo
Farmaceutyczne S.A., ul. Annopol 6B, Warsaw 03-236 Poland.



Kidney disease (causing symptoms of tiredness, increased
need to urinate, itchy skin, feeling sick, swollen extremities);



Abnormal hepatic function.

Not known:


Fainting.

POM PL 19488/1286
Leaflet revision date: 27 June 2016
Natrilix SR is a registered trade mark of Biofarma France.
S1286 LEAFLET Natrilix SR 20160627

Expand Transcript

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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