NATRILIX SR 1.5MG TABLETS

Active substance: INDAPAMIDE

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Natrilix® SR 1.5mg Tablets
(indapamide)
Your medicine is known by one of the above name, but will be referred to as
Natrilix SR throughout this:
Patient Information 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) What Natrilix SR is and what it is used for
2) Before you take Natrilix SR
3) How to take Natrilix SR
4) Possible side effects
5) How to store Natrilix SR
6) 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 para thyroid 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.
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),
 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).
Pregnancy and breast-feeding:
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. Breastfeeding is not advisable if
you are taking this medicine.
Driving and using machines:
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.

- 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
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 in 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,

 Keep all medicines out of the sight and reach of children.
 Do not use this medicine after the expiry date printed on the carton and
blister label.
 If your doctor tells you to stop taking these tablets, please take it back to
the pharmacist for safe disposal. Only keep it if your doctor tells you to.
 Do not throw them away with your normal household water or waste. This
will help to protect the environment.
 If the tablets become discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist who will tell
you what to do.

6) Further information
What Natrilix SR contains:
The active substance is indapamide. Each film-coated tablet contains 1.5
mg of indapamide in a prolonged release formulation as the active
ingredient.
In addition, the tablet contains a number of inactive ingredients. These are
necessary to add bulk and consistency to medicines. They improve the
packaging, storage and handling characteristics of the tablets and make
them easier to use.
The inactive ingredients include: lactose, hypromellose, povidone,
anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171),
glycerol and Macrogol 6000.
What Natrilix SR looks like and contents of the pack
The tablets are White, round, convex, film-coated, tablets with no markings.
Natrilix® SR 1.5mg Tablets are available in pack sizes of 30 tablets
PL 10383/1750

Natrilix® SR 1.5mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Anpharm Przedsiebiorstwo
Farmaceutyczne Spolka Akcyjna Warszawa Poland. Procured from within
the EU and repackaged by Product Licence Holder Primecrown Ltd, 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 30.08.2012

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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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