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Package leaflet: Information for the user

natrilix® 2.5 mg Tablets

indapamide

What is in this leaflet

1.    What Natrilix is and what it is used for

2.    What you need to know before you take Natrilix

3.    How to take Natrilix

4.    Possible side effects

5.    How to store Natrilix

6.    Contents of the pack and other information

1. What Natrilix is and what it is used for

Natrilix is a 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.

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

2. What you need to know before you take Natrilix

Do not take Natrilix

•    if you are allergic to indapamide or any other sulfonamide 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 (liver problems which affect the brain and central nervous system),

•    if you have low potassium levels in your blood.

Warnings and precautions

Talk to your doctor or pharmacist before taking Natrilix:

•    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

Tell your doctor or pharmacist, if you are taking, have recently taken or might take any other medicines.

You should not take Natrilix 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 gastro-intestinal 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

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 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.

Natrilix 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

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 with or without food. They should be swallowed whole with water.

Treatment for high blood pressure is usually life-long.

If you take more Natrilix than you should

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

A very large dose of Natrilix 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

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 a forgotten dose.

If you stop taking Natrilix

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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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;

•    Allergic reactions, mainly dermatological, such as skin rashes in subjects with a predisposition to allergic and asthmatic reactions.

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

•    Vomiting;

•    Purpura (red pinpoints on skin).

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

•    Feeling of tiredness, dizziness, headache, pins and needles (paraesthesia);

•    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);

•    Increase of calcium in blood;

•    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);

•    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.

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 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,

-    increased levels of liver enzymes;

•    In cases of liver failure, there is a possibility of getting hepatic encephalopathy (liver problems which affect the brain and central nervous system);

•    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;

•    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 or pharmacist. 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.aov.uk/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Natrilix

Keep this medicine out of the sight and reach of children.

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.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information What Natrilix contains

The active substance is indapamide. Each tablet contains 2.5 mg of indapamide.

The other ingredients are:

•    tablet core: lactose monohydrate, maize starch, magnesium stearate (E470B), talc (E553B), povidone

•    film-coating: glycerol (E422), white beeswax (E901), sodium lauryl sulfate (E514), hypromellose (E464), macrogol 6000, magnesium stearate (E470B), titanium dioxide (E171).

What Natrilix looks like and contents of the pack

This medicine is a white, round film-coated tablet.

The tablets are available in blisters of 30 or 60 tablets packed in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder Servier Laboratories Ltd Rowley, Wexham Springs,

Framewood Road, Wexham,

Slough, SL3 6PJ,

United Kingdom

SERVIER

Manufacturers

Les Laboratoires Servier Industrie 905 route de Saran 45520 Gidy France

and

Servier (Ireland) Industries Ltd Gorey Road Co. Wicklow - Arklow Ireland

This leaflet was last revised in 05/2014