INDAPAMIDE PIL :INDAPAMIDE PIL-00440614-02 6/21/14	-n 4:50 PM Page 1
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Patient information leaflet

INDAPAMIDE 2.5MG TABLETS

Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

•    Keep the leaflet. You may need to read it again.

•    If you have any other questions, or if there is something you do not understand, please ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Never give it to someone else. It may not be the right medicine for 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.

1. What Indapamide is and what is it used for

Indapamide belongs to a group of medicines called diuretics. Indapamide is used to treat high blood pressure (hypertension). It acts on the kidneys to remove more water from the body, thereby increasing the volume of urine. Indapamide therefore reduces blood pressure by reducing the volume of the blood and the work required by the heart.

2. What you need to know before you take Indapamide

♦    Do NOT take Indapamide if you:

•    are allergic (hypersensitive) to indapamide or any other

sulphonamide drugs (such as Co-trimoxazole) or any of the other ingredients of this medicine (listed in section 6)

•    have recently had a stroke

•    have ever had severe liver problems or suffer from a condition called hepatic encephalopathy (a liver problem which affects your brain and central nervous system)

•    suffer from porphyria (abnormalities in the chemical steps that lead to the production of heme, a component of your blood and bone marrow)

•    have low levels of potassium in your blood (hypokalaemia)

•    have low levels of sodium in your blood (hyponatraemia)

•    have high levels of calcium in your blood (hpercalcaemia)

•    have severe kidney failure

•    are suffering from failure of adrenal glands

•    are pregnant, planning to become pregnant or breast-feeding

♦    Warnings and precautions

Talk to your doctor or pharmacist before taking these tablets if you:

•    have gout

•    have heart rhythm problems

•    have liver problems

•    have diabetes

•    have very low levels of sodium in your blood, which may be caused by excessive sweating, vomiting or reaction to another drug

•    suffer from systemic lupus erythematosus, as symptoms get worse (See section 4)

•    need to have a blood test to check how well your parathyroid gland is working. Treatment should be stopped before tests for parathyroid function are performed.

Tell your doctor if you have had photosensitivity reactions (i.e. sensitive to sunlight) See section 4.

Before starting this medicine, and whilst taking these tablets, your doctor may do blood tests at intervals to check if you have low sodium or potassium levels or high calcium levels.

Athletes: These tablets may give a positive reaction in doping tests.

♦    Taking other medicines

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

Do NOT take these tablets with lithium (used to treat depression)

Tell your doctor if you are taking any of the following medicines, as special care may be required:

•    non-steroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen)

•    medicines used to treat an abnormal heartbeat e.g. quinidine, hydroquinidine, digoxin, disopyramide, amiodarone, bretylium, sotalol, digitalis, ibutilide, mexiletine

•    medicines such as sultropride, anti-depressants e.g. reboxetine, antipsychotics and neuroleptics (used to treat mental disorder)

•    vincamine (used in the treatment of brain disorders)

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

•    stimulant laxatives, which are used for constipation eg.cisapride

•    carbenoxolone, diphemanil (used in the treatment of ulcers)

•    intravenous erythromycin, sparfloxacin, clarithromycin, moxifloxacin (antibiotic medicine)

•    halofantrine (anti-malarial drug)

•    amphotericin B (used to treat fungal infections)

•    pentamidine (used in the treatment of protozoal infections e.g pneumonia)

•    atomoxetine (CNS stimulant drug)

•    anti-histamines e.g. mizolastine, astemizol, terfenadine (used to treat allergic reactions, such as hay fever)

•    angiotensin converting enzyme inhibitors (used in the treatment of high blood pressure and heart failure) e.g. captopril. Other anti-hypertensive drugs (e.g. clonidine, methyldopa, moxonidine)

•    alpha-adrenoreceptor blocking drugs (e.g.prazosin), adrenergic neurone blockers (e.g. guanethidine), beta blockers (e.g attenol), calcium channel blockers (e.g. diltiazem, nifedipine)

•    nitrates (e.g. isosorbide mononitrate)

•    minoxidil (vasodilator antihypertensive drug)

•    anxiolytic (e.g.diazepam), hypnotic (e.g. nitrazepam), monoamine oxidase inhibitor (e.g. phenelzine)

•    oral corticosteroids (used to reduce inflammation and to treat various conditions including asthma, rheumatoid arthritis)

•    baclofen (a muscle relaxant)

•    potassium sparing diuretics (e.g. amiloride, spironolactone, triamterene)

•    diuretics which are used to increase the flow of urine (e.g. bumetanide, furosemide, piretanide, thiazides or xipamide)

•    metformin (used in the treatment of diabetes)

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

•    calcium tablets or other calcium supplements

•    ciclosporin (used in patients who have had an organ transplant)

•    toremifene, vitamin-D compounds

•    tetracosactide (used to assess adrenal gland function and to treat Crohn’s disease)

•    levodopa (used to treat parkinsons disease)

•    alprostadil (used to treat impotence)

•    local anaesthetic (e.g. lidocaine), general anaesthetics

•    theophylline used to treat asthma and chronic obstructive pulmonary disease (COPD)

♦    Pregnancy and breast feeding

If you are pregnant, think you may be pregnant or planning to become pregnant, consult your doctor for advice before taking this medicine. This medicine is not recommended during pregnancy.

Do not breast-feed unless advised by your doctor as the active ingredient in these tablets passes into the breast milk to your baby.

♦    Driving and using machines

This medicine may make you feel dizzy. Do not drive or operate machinery until you know how the tablets affect you.

♦    Indapamide contains lactose

These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

3. How to take Indapamide

Always take this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The pharmacist’s label should tell you how much to take and how often. If it does not or you are not sure ask your doctor or pharmacist.

♦    Adults and the elderly

•    The usual dose is one tablet daily, taken in the morning.

•    Swallow the tablets with water.

•    Treatment for high blood pressure is usually life-long

Do not take more than the recommended dose

♦    Children

These tablets are not to be given to children or adolescents under 18 years.

♦    If you take more Indapamide than you should

If you or anyone else has taken too many tablets, contact your nearest hospital casualty department or doctor immediately. Take any remaining tablets with you to show the doctor.

A very large dose of these tablets could cause nausea (feeling sick), vomiting (being sick), low blood pressure, cramps, dizziness, drowsiness, confusion and changes in the amount of urine.

♦    If you forget to take a dose

If you forget to take a dose, take the next dose as soon as you remember, then go on as before. If you miss a day, do not take a double dose the following day but continue as prescribed by your doctor.

♦    If you stop taking Indapamide tablets

As treatment for high blood pressure is usually life long, you should consult your doctor before stopping these tablets.

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

4. Possible side effects

Like all medicines, Indapamide tablets can cause side effects, although not everybody gets them.

If you get any of these serious side effects, STOP taking this medicine immediately and contact your doctor or pharmacist:

•    swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing (an allergic reaction) You may also notice an itchy, lumpy rash or nettle rash

•    symptoms including blistering or peeling of your skin, flu like symptoms and a high temperature

•    pancreatitis (an inflammation of the pancreas, usually marked by abdominal pain, often radiating to the back, nausea and vomiting)

•    angioedema and/or skin rash with pale red, raised, itchy bumps, severe skin problems. Angioedema is seen as 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.

•    in the case of liver failure, there is a possibility of getting hepatic encephalopathy (a liver problem which affects the brain and central nervous system)

•    if you experience dizziness, fainting and or palpitations (awareness of heartbeat) these may be symptoms of a very serious irregular heart beat called Torsades de Pointes

•    hepatitis (seen as yellowing of the skin or whites of the eyes)

Tell your doctor if any of the following side effects get serious:

•    Common (may affect up to 1 in 10 people):

•    muscle weakness which is caused by low potassium in the blood

•    allergic reaction- mainly skin rashes in people who suffer from allergic and asthmatic reactions

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

•    vomiting (being sick)

•    red pinpoints on skin

•    visual disturbances

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

•    tiredness, dizziness, headache, pins and needles

•    nausea (feeling sick), constipation, dry mouth

•    increased risk of dehydration in the elderly and in patients suffering from heart failure

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

•    heart rhythm irregularities, low blood pressure (seen as fainting on standing up)

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

•    increase of calcium in blood

•    abnormal liver function (with symptoms such as tiredness, loss of appetite, weight loss, feeling or being sick, swollen extremities, yellow skin)

•    blood disorders 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)

•    abnormal renal function test values (increased blood urea, increased creatinine) have been reported in association with hypovolaemia

♦    Not known (frequency cannot be estimated from the available data):

•    changes may occur in your blood and your doctor may need to do 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

-    an increase of uric acid, a substance which may cause or worsen gout (painful joints)

-    an increase of blood glucose levels in diabetic patients

-    increased levels of liver enzymes

•    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), your symptoms might get worse

•    itching, photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA have also been reported

•    abnormal ECG heart tracing

•    fainting, weakness, fatigue, weight loss

•    impotence

•    muscle cramps

♦    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 Indapamide

Keep all medicines out of the sight and reach of children.

Do not take this medicine after the expiry date printed after “EXP” on the carton and blister pack or bottle.

Do not store above 25°C.

Keep the container tightly closed (for plastic bottles).

Store in the original package (for blister packs and bottles).

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.

♦    What Indapamide tablets contain

•    The active substance is Indapamide. Each tablet contains 2.5mg Indapamide Ph. Eur.

•    The other ingredients are: lactose, maize starch, povidone, magnesium stearate, polyvinyl acetate phthalate, stearic acid, purified talc, calcium carbonate, acacia, sucrose, yellow carnauba wax, white beeswax, shellac and colour (titanium dioxide, E171). See end of section 2 for further information on lactose.

♦    What Indapamide tablets look like and contents of the pack

Indapamide tablets are white, circular and sugar coated tablets.

Pack sizes for Indapamide are “28, 30,50,60, 100, 120 or 250

tablets in plastic bottles” and

“28, 30, 50,56, 60, 100 or 120 tablets in blister packs”.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Pharmvit Ltd, 177 Bilton Road, Perivale,

Greenford, Middlesex UB6 7HQ.

Telephone: 0208 997 5444 Fax:    0208 997 5433

To request a copy of this leaflet in large print or audio format or additional copies, please contact the licence holder at the address (or telephone, fax) above.

Date leaflet last revised: June 2014

PL 04556 / 0044    |POM|

Reference: 00440614/02