•    halofantrine (antiparasitic drug used to treat certain types of malaria), which may cause a problem with your heart rhythm when taken together with indapamide tablets

•    vincamine IV (used to increase blood flow to the brain), which may cause a problem with your heart rhythm when taken together with indapamide tablets

•    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) which may cause a problem with your heart rhythm when taken together with indapamide tablets

•    sparfloxacin, moxifloxacin, erythromycin IV (antibiotics used to treat infections), which may cause a problem with your heart rhythm when taken together with indapamide tablets

•    other diuretics ('water tablets') such as furosemide. Your doctor may want to monitor you more closely

•    medicines to treat a heart condition e.g. digoxin

•    steroids e.g. prednisolone or hydrocortisone

•    laxatives

•    medicines used to treat mental disorders such as depression, anxiety or schizophrenia (for example tricyclic antidepressants, antipsychotic drugs, such as chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, amisulpride, sulpiride, sultopride, diapride, droperidol, haloperidol, neuroleptics) which may cause a problem with your heart rhythm when taken together with indapamide tablets

•    pentamidine (used to treat certain types of pneumonia)

•    mizolastine (used to treat allergic reactions, such as hayfever)

•    non-steroidal anti-inflammatory drugs for pain relief (e.g. ibuprofen) or high doses of acetylsalicylic acid (aspirin)

•    angiotensin converting enzyme (AcE) inhibitors (used to treat high blood pressure and high blood pressure)

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

•    baclofen (to treat muscle stiffness occurring in diseases like 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 to treat severe rheumatic or dermatological diseases

•    tetracosactide (to treat crohn's disease)

•    carbenoxolone, to treat ulcers

•    amphotericin B administered by injection into a vein (used to treat fungal infections).

pregnancy, breast-feeding and fertility -

Indapamide should not be given to pregnant mothers unless the benefits to the mother outweigh the risks to the baby. Ask your doctor or pharmacist for advice before taking any medicine.

Do not use this medicine if you are breast-feeding or planning to breast-feed.

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 this medicine.

Driving and using machines - Do not drive or operate machinery if you feel dizzy or drowsy, or you have eyesight problems while taking this medicine. These effects are more likely at the start of treatment and after the dose increases or if another medicine for the treatment of high blood pressure is added.

Indapamide 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.

3. how to take indapamide

Always take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure. Indapamide should be swallowed whole with a drink of water. It may take several months before this treatment shows its full effect. however, if there is not a steady lowering of blood pressure, your doctor may wish to add another medicine (such as a beta-blocker, AcE inhibitor, methyldopa or clonidine), to your treatment, to help lower your blood pressure. If your doctor starts you on an AcE inhibitor e.g. captopril, he may stop Indapamide treatment a few days before, to avoid a sudden fall in your blood pressure (hypotension). Some patients may need regular blood tests to check their blood salt (sodium, potassium) levels and kidney function.

The recommended dose is:

Adults (including older people): one tablet (2.5 mg) daily, taken in the morning.

use in children and adolescents: Indapamide should not be given to children or adolescents.

LT1295AE

If you take more Indapamide than you should

- Contact your doctor or go to your nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose include low blood pressure, muscle weakness and disturbances with your blood salt levels and severe dehydration which can change the amount of urine produced by your kidneys. other symptoms include cramps, dizziness, drowsiness, confusion and you may feel or be sick (nausea or vomiting).

If you forget to take Indapamide - take the next dose of Indapamide as soon as you remember unless it is almost time for your next dose.

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

If you stop taking Indapamide - If you suddenly stop taking Indapamide you may experience side effects. Speak to your doctor first before stopping this medicine.

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.

stop taking Indapamide and tell your doctor immediately or go to your nearest hospital emergency department if you think you may have any of the following side effects:

Rare (may affect up to 1 in 1,000 people): • skin rash, which may blister, and looks like small targets • central dark spots surrounded by a paler area, with dark ring around the edge (erythema multiforme).

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

•    inflammation of the pancreas (pancreatitis): severe upper stomach pain, often with nausea and vomiting • lack of white blood cells with the following symptoms; fever, severe chills, sore throat or mouth ulcers (agranulocytosis)

•    swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema) • a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens Johnson syndrome) • a widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis) • kidney failure (kidney disease with little or no urine, drowsiness, nausea, vomiting, breathlessness blood or protein loss in urine).

Not known (frequency cannot be estimated from the available data): • Heart rhythm irregularities known as torsades de pointes (causing palpitations, feeling of the heart pounding), low blood pressure; which could lead to death

•    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 experiencing a brain disease caused by severe liver problems (hepatic encephalopathy).

these are serious side effects. You may need medical attention.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

common (may affect up to 1 in 10 people):

•    skin rash.

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

•    dizziness upon standing up from a sitting or lying position • being sick (vomiting) • purple or red-brown spots visible through the

skin (purpura).

Rare (may affect up to 1 in 1,000 people):

•    spinning sensation (vertigo) • feeling tired

•    headache • numbness or tingling in the arms or legs • feeling sick • constipation • muscle cramps

•    dry mouth.

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

•    other blood disorders when the numbers of different types of cells in the blood may fall, which may cause fever, chills, sore throat, ulcers in the mouth and throat (leucopenia), unusual bleeding or you may bruise more easily than normal (thrombocytopenia) • tiredness, headaches, being short of breath when exercising, dizziness and looking pale; frequent infections such as fever, severe chills, sore throat or mouth ulcers; bleeding or bruising more easily than normal, nosebleeds (these may be signs of haemolytic

or aplastic anaemia) • raised calcium levels in the blood that can lead to a loss of appetite, nausea, vomiting, constipation, stomach pain • a fast, slow or irregular heartbeat • low blood pressure • hives (urticaria) • abnormal liver function tests.

not known (frequency cannot be estimated from the available data): • raised glucose levels in the blood that can make you feel more thirsty or pass more urine than usual • low blood potassium levels, more likely in elderly patients or those with heart problems, hyperaldosteronism or with a history of gout • low sodium levels in the blood with low blood volume • feeling dehydrated • irritability and muscle twitching. this may be due to an imbalance in your blood called metabolic alkalosis • feeling faint • weight loss

•    change in liver enzyme tests • worsening of an inflammatory disease of the connective tissues with symptoms such as fever, weakness, fatigue, joint pain and skin lesions (lupus erythematosus)

•    allergic reactions, mainly affecting the skin, more likely in patients with a history of allergy or asthma • impotence • kidney problems (causing symptoms of tiredness, increased need to urinate, itchy skin, feeling sick, swollen extremities)

•    increased sensitivity to sunlight or ultraviolet light (e.g. sun bed use) leading to excessive skin redness and sunburn • raised urate levels in the blood that can make you feel more thirsty or pass more urine than usual • dizziness.

If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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, website: 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 indapamide

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 after 'EXP', the expiry date refers to the last day of that month. Store in a cool, dry place. 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 Indapamide contains - the active substance is indapamide hemihydrate.

Each tablet contains 2.5 mg indapamide hemihydrate. the other ingredients are: lactose; cellulose, microcrystalline; sodium starch glycolate; croscarmellose sodium type A; magnesium stearate. the film-coating contains: hydroxypropylmethylcellulose; polyethylene glycol 400; titanium dioxide (E171).

What Indapamide looks like and contents of the pack - Indapamide tablets are white biconvex film coated tablet, marked 'IE 2.5' on one side and 'G' on the other side.

Indapamide is available in blisters of 28, 30, 56 or 60 tablets or in containers of 30, 60, 100, 250 or 500 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Mylan, Potters Bar, Hertfordshire, EN6 1TL,

United Kingdom.

Manufacturer:

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

this leaflet was last revised    410764

in 04/2014    Lr1295AE

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