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NATRILIX SR TABLETS

Active substance: INDAPAMIDE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

000-0000D

NATRILIX® SR TABLETS
(indapamide)
Patient Information Leaflet

This medicine is known by the above name but will be referred to as Natrilix SR in this leaflet.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
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BRIDGED TO
CRESTOR 6464/2069 2070

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 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.

6464/2198D
CODE:

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.

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Important information about some of the ingredients of Natrilix SR:
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

Black

WARNING!

27/07/12
DATE OF PROOF:

UK PIL DATED NOVEMBER 2011

DT
ARTWORKER:
Natrilix SR tabs
PRODUCT:

DATE:

DATE:

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

PRE-PRESS NO.:

05-0269

WARNING!

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.

CUSTOMER: Waymade

Q.A.
APPROVED:

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

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

PROOF HISTORY:
v.2 - waymade - 27/07/12

Leaflet Flat Size = 148 x 400

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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

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.

DT

27/07/12

ARTWORKER:

DATE OF PROOF:

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

UK PIL DATED NOVEMBER 2011

6464/2198D
CODE:

PRODUCT:

Natrilix SR tabs



CUSTOMER: Waymade

WARNING!

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:
o low potassium in the blood,
o low sodium in the blood that may lead to dehydration and low blood pressure,
o increase in uric acid, a substance which may cause or worsen gout (painful joint(s) especially
in the feet),
o increase in blood glucose levels in diabetic patients,
o increase of calcium in blood.
o increased levels of liver enzymes.
• Abnormal ECG heart tracing
• Life-threatening irregular beat (Torsade de Pointes)
• Hepatitis
• Fainting







5. How to store Natrilix SR
Do not use after the expiry date printed on the carton label or blister strip. The expiry date refers to
the last day of that month.
Natrilix SR tablets should not be stored above 25°C.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should consult your
pharmacist who will advise 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. Further information
Your medicine is called Natrilix SR tablets. Each tablet contains 1.5mg of the active ingredient, indapamide
in a white round, film coated sustained-release tablet which is plain on both sides.
Natrilix SR tablets also contain the following inactive ingredients:
Lactose, magnesium stearate, glycerol, titanium dioxide (E171), anhydrous colloidal silicon dioxide,
hypromellose, macrogol 6000 and povidone.
Natrilix SR tablets are available as blister packs of 30 tablets.
POM

PL No: 6464/2198

This product is manufactured by Anpharma SA, Annopol 6, Warsaw, Poland and procured from within the
EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR.

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Leaflet Reference (revision and issue date) 27.7.2012
Natrilix is a registered trademark of Biofarma

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WARNING!

DATE:

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.

DATE:

CUSTOMER
APPROVED:
05-0269
PRE-PRESS NO.:

Q.A.
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

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

PROOF HISTORY:
v.2 - waymade - 27/07/12

Leaflet Flat Size = 148 x 400

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.

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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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