PATIENT INFORMATION LEAFLET Indapamide Hemihydrate 2.5mg Tablets

Read all of this leaflet carefully before you start taking this medicine.

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

•    If you have any further questions, ask your doctor or pharmacist.

•    Do not pass this medicine on to others. It may harm them, even if their symptoms are the same as yours. This medicine is for you.

•    Tell your doctor or pharmacist if any of the side effects gets serious, or you notice any side effects not listed in this leaflet.

In this leaflet:

1.    What Indapamide Tablets are and what they are used for

2.    Before you take Indapamide Tablets

3.    How to take Indapamide    Tablets

4.    Possible side effects

5.    How to store Indapamide Tablets

6.    Further information

1. WHAT INDAPAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR

Indapamide hemihydrate is related to a group of medicines called sulphonamides. It affects the arteries in the extremities of the body, e.g. the limbs, and has the effect of lowering blood pressure.

Indapamide Tablets are used to treat high blood pressure either alone or in combination with other medicines.

2. BEFORE YOU TAKE INDAPAMIDE TABLETS

DO NOT take Indapamide Tablets if you:

•    know that you are allergic to Indapamide hemihydrate, any other sulphonamide related medicines, or any of the other ingredients of Indapamide (see section 6 of this leaflet).

•    have a serious liver disorder or impaired liver function or suffer from a condition called hepatic encephalopathy (liver problems which affect the brain and central nervous system).

•    have recently suffered a stroke, i.e. a bleed or blood clot in the brain

•    have low blood potassium ( a condition known as hypokalaemia).

•    have kidney failure.

Take special care with Indapamide Tablets if you have:

•    A tendency to low levels of potassium in the blood. This is more likely if you are elderly, if you are receiving medication for heart problems or if you have a disease of the adrenal glands (your doctor will be able to advise you on the last two)

•    An over active parathyroid gland which is causing an excess of calcium in the blood (your doctor will be able to advise you)

•    A history of suffering from gout

•    Kidney problems

•    liver problems

•    if you have had photosensitivity reactions

•    Y ou should not take this medicine if you have rare hereditary disorder called ‘galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption’ characterized by inability to digest the lactose which is in this medicine

•    A tendency to low sodium levels or high calcium levels (your doctor will determine this after a laboratory test)

•    if you have diabetes

•    if you have any heart rhythm problems.

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

If you think any of these apply to you, discuss it with your doctor.

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. The effects of these medicines may change, especially if you are taking:

•    Lithium, used mainly to treat severe mental illness.

•    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

Indapamide should only be used in pregnancy if it is thought to be essential. This decision should be taken by your doctor.

The active ingredient is excreted in milk. Breast feeding is not advisable if you are taking this medicine.

Ask your doctor or pharmacist for advice before taking any 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 Indapamide Tablets

This medicine contains lactose and sucrose. Consult your doctor before starting these tablets if know you have an intolerance of sugars.

This medicine also contains less than 1mmol (23mg) of sodium in each tablet, i.e. it is essentially sodium-free.

Some of the other ingredients of this medicine, i.e. Ponceau 4R (E124), methyl hydroxybenzoate (E218), and propylhydroxybenzoate (E216), may cause allergic type reactions (possibly delayed), e.g. rash.

3.    HOW TO TAKE INDAPAMIDE TABLETS

Always take Indapamide Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will decide the best dose for you and may change it depending on how you respond to treatment. You may also be given other medicines.

Adults and elderly: The normal dose is one tablet a day, taken in the morning. Swallow the tablet whole with a little water.

Keep taking your medicine even if you feel well and do not stop unless your doctor tells you to. Medicines for high blood pressure are usually taken for long periods of time.

Indapamide is not recommended for children.

If you take more Indapamide Tablets than you should:

A very large dose 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 think that you, or any other person, have taken too many Tablets, contact your doctor or hospital casualty department immediately. Take any remaining Tablets and this leaflet with you so that the medical staff know exactly what you have taken.

If you forget to take your Indapamide Tablets:

If you miss taking Indapamide Tablets in the morning, then take it as soon as you remember and carry on taking the tablets as normal on the following morning. If you forget for a whole day, do not take two doses together the next day.

4.    POSSIBLE SIDE EFFECTS

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

All medicines can cause allergic reactions although serious allergic reactions are rare. If you notice any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) STOP TAKING your medicine and go to a doctor immediately.

"Side effects include:

Commonly (less than 1 patient in 10 but more than 1 in 100):

•    low potassium in the blood, which may cause muscle weakness.

•    Feeling of tiredness, headache

•    Loss of appetite, nausea, diarrhoea, constipation, indigestion characterized by stomach pain and fullness

•    Skin rash

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

•    vomiting, allergic reactions, purpura (red pinpoints on skin) in subjects with a predisposition to allergic and asthmatic reactions.

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

•    dizziness, , pins and needles (paresthesia);

•    dry mouth;

•    increased blood pH levels (a condition called metabolic acidosis), increase in blood sugar and uric acid levels.

•    Reversible short sightedness

•    Inadequate Kidney function as    detected by laboratory tests

•    Impotence which is the inability to have an erection

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

•    A condition of the skin called erythema multiforme characterized by red blotched on skin

Very rarely (less than 1 patient in 10,000):

•    Heart rhythm irregularities (causing palpitations, feeling of the heart pounding), low blood pressure; Kidney failure (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).;

•    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 of 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.

•    A skin condition called Steven Johnson syndrome which is life threatening.

Not Known:

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

Some 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,

•    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."

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,

please tell your doctor or pharmacist.

5. HOW TO STORE INDAPAMIDE TABLETS

Keep out of the reach and sight of children.

Do not use Indapamide after the expiry date which is stated on the box. If your Tablets are out of date, take them to your pharmacist who will get rid of them safely.

Do not store above 25°C. Store in the original package. Protect from light.

Each Indapamide Tablet contains 2.5mg of Indapamide hemihydrate. Other ingredients are lactose, di-basic calcium phosphate, maize starch, magnesium stearate, croscarmellose sodium, shellac, castor oil, titanium dioxide (E171), talc, sucrose, acacia, polyethylene glycol-6000, methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), and a colourant which contains sucrose, sodium benzoate, polyvinylpyrrolidone, talc, Ponceau 4R (E124), and erythrosine E127 and Opalux AS-F-1312.

What Indapamide Tablets look like and contents of the pack:

Indapamide Tablets are round, pink sugar coated tablets. They are supplied in blister packs of 28, 30, 56 or 60 tablets.

Marketing Authorisation Holder and Manufacturer:

Crescent Pharma Limited, Units 3 & 4 Quidhampton Business Units, Polhampton Lane, Overton, Hampshire, RG25 3ED, UK.

This leaflet was last revised in November 2014.

5