Indapamide 2.5mg Tablets

• 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 only. Do not pass it on to others. It may harm 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 Tablets are and what they are used for
2. What you need to know before you take Indapamide Tablets
3. How to take Indapamide Tablets
4. Possible side effects
5. How to store Indapamide Tablets
6. Contents of the pack and other information

• If you are allergic (hypersensitive) to Indapamide or any other sulfonamide or to any of the other ingredients of Indapamide Tablets. See section 6
• If you have or ever had severe kidney failure and/or liver problems
• 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 the blood

Talk to your doctor or pharmacist before taking Indapamide tablets

• If you have or ever had liver and/or kidney problems
• If you have or ever had heart rhythm problems
• If you have diabetes
• If you have gout (severe swelling and painful joints)
• If you have or ever had thyroid or parathyroid disease (which causes too low/high calcium levels in the bloodstream)
• If you have been told by your doctor that you have low levels of potassium in your blood (hypokalaemia)
• If you have photosensitivity reactions
• If you have been told by your doctor that you have low levels of sodium in the blood (hyponatraemia)
• If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking Indapamide Tablets. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developing this.

Indapamide Tablets may lower potassium levels and your doctor may monitor this by means of blood tests. Blood calcium levels may need to be monitored in those patients suffering from overactivity of the parathyroid gland. Blood glucose levels may need to be monitored as this medicine may affect them.

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly, and blood tests should be done occasionally.

Athletes – This drug contains the active ingredient that may give a positive reaction in doping tests.

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

You should not take Indapamide if you are taking Lithium due to the risk of increased lithium levels in the body.

Examples of medicines that can affect Indapamide Tablets are:

• Carbenoxolone, which is used in the treatment of ulcers
• Diuretics or “water tablets”, such as bumetanide, furosemide, thiazides and xipamide
• Diuretics or “water tablets” such as amiloride, spironolactone and triamterene which increase the flow of urine without excessive loss of potassium
• Quinidine or cardioglycosides, such as digoxin, disopyramide, amiodarone and sotalol, ibutilide, dofetilite, digitalis which are used to treat abnormal heart beat
• Lidocaine, flecainide and mexiletine (to treat irregular heart beat)
• Intravenous erythromycin, an antibiotic
• Pentamidine (used in the treatment of protozoal infections)
• Prazosin, which is used to treat high blood pressure
• Antiepileptics such as oxcarbazepine
• Anti-psychotics such as pimozide and sertindole, which are used to treat some mental disorders
• Baclofen, which is a muscle relaxant (to treat muscle stiffness occurring in disease such as multiple sclerosis)
• Allopurinol (for the treatment of gout)
• ACE inhibitors (angiotensin converting enzyme inhibitors) such as e.g. captopril (to treat high blood pressure)
• NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin and Ibuprofen (used in the management of arthritis)
• Amphotericin B (used to treat fungal infections)
• Tetracosactide (to assess adrenal gland function to treat Crohn's disease)
• Stimulant laxatives (to treat constipation)
• Metformin, which is used in the treatment of diabetes
• Anti-depressants and neuroleptics (to treat mental disorders)
• Ciclosporin and tacrolimus or other medicines to depress the immune system after organ transplantation, to treat autoimmune diseases, or severe rheumatic or dermatological diseases, which are used in patients who have had an organ transplant
• Tetracosactide or corticosteroids, which are used to reduce inflammation including severe asthma and rheumatoid arthritis
• Bepridil (to treat angina pectoris, a condition causing chest pain)
• Cisapride (to treat reduced movement of the gullet and stomach)
• Dephemanil (used to treat gastro-intestinal problems such as ulcers, too much acid, overactive digestive system)
• Sparfloxacin, moxiflaxacin (antibiotics used to treat infections)
• Halofantrine (to treat certain types of malaria)
• Pentamidine (used to treat certain types of pneumonia)
• Mizolastine (used to treat allergic reactions, such as hay fever)
• Iodinated contrast media (used for test involving X-rays)
• Calcium tablets or other calcium supplements

Follow your doctor's directions. They may include a daily exercise program and a low-sodium or low-salt diet, potassium supplements, and increased amounts of potassium-rich foods (e.g., bananas, prunes, raisins and orange juice) in your diet.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

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. 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.

Indapamide tablets may cause dizziness due to lowering of blood pressure (see section 4). Do not drive a car or operate machinery in such a case. 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.

This medicinal product contains Lactose and Sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you take more Indapamide Tablets than you should, contact your doctor or nearest hospital emergency department immediately. Take the pack and remaining tablets with you. A very large dose of Indapamide 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 a dose, take it 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 tablet.

Do not stop taking Indapamide Tablets without talking to your doctor, even if you feel better. It is important that you take the full course of Indapamide prescribed by your doctor.

• Angioedema and/or urticaria. Angioedema is characterised by swelling of the skin of extremities or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or airways resulting in shortness of breath or difficulty of swallowing. If this occurs, contact your doctor immediately
• Severe skin reactions including intense skin rash, reddening of skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions
• Life-threatening irregular beat
• Inflamed pancreas which may cause severe pain in the abdomen and back accompanied with feeling very unwell
• Disease of the brain caused by liver illness (Hepatic encephalopathy)
• Inflammation of liver (Hepatitis)
• Allergic reactions, mainly dermatological, such as skin rashes in subjects with a predisposition to allergic and asthmatic reactions

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

• Maculopapular rashes (red raised skin rash)
• Low potassium in the blood

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

• Vomiting (being sick)
• Purpura (red pinpoints on skin)
• Low sodium in the blood that may lead to dehydration and low blood pressure
• Impotence (inability to obtain or maintain an erection).

Rare (may affect up to 1 in 1000 people):

• Feeling of tiredness, headache, pins and needles (paraesthesia), vertigo
• Gastrointestinal disorders such as nausea (feeling sick) or constipation, dry mouth
• Low chloride in the blood
• Low magnesium in the blood

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

• 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)
• High level of calcium in blood (Hypercalcaemia)
• 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)
• Problems which affect how the liver works normally (abnormal hepatic function)

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

• Fainting
• If you suffer from systemic lupus erythematosus (a type of collagen disease), this might get worse
• Cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA have also been reported
• Short sightedness (myopia)
• Blurred vision
• Visual impairment
• 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:
  • increase in uric acid, a substance which may cause or worsen gout (painful joint(s) especially in the feet)
  • increase in blood glucose level in diabetic patients
  • increase levels of liver enzymes
• Abnormal ECG heart trace
• Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)

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.gov.uk./yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is Indapamide as Indapamide Hemihydrate. The other ingredients are Lactose Monohydrate, Maize Starch, Povidone, Magnesium Stearate, Purified Talc, Calcium Carbonate, Acacia, Titanium Dioxide (E171), Sucrose, Opaseal (Titanium Dioxide (E171), Polyvinyl Acetate Phthalate, Stearic Acid) and Opaglos 6000P (Shellac, White Beeswax, Carnuba Wax).

Indapamide 2.5 mg tablets are white, biconvex, sugar-coated tablet.

Pack sizes:

28, 30, 50, 56, 60 and 100 tablets in blisters and 30, 50, 60, 100 and 250 in containers.

Not all pack sizes may be marketed.