PACKAGE LEAFLET Page 1 of 8 Package leaflet: Information for the patient Indapamide hemihydrate 2.5 mg film-coated tablets (indapamide hemihydrate) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - 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. What is in this leaflet 1. What Indapamide is and what it is used for 2. What you need to know before you take Indapamide 3. How to take Indapamide 4. Possible side effects 5. How to store Indapamide 6. Contents of the pack and other information 1. What Indapamide is and what it is used for Indapamide belongs to a group of medicines called diuretics (or ‘water tablets’). Your doctor will prescribe indapamide to help treat high blood pressure (essential hypertension). When used at the normal recommended dose indapamide does not normally substantially increase urine production but does lower blood pressure. The exact way in which indapamide lowers blood pressure is not known but treatment with indapamide may take several months to reach full effect. It may be used on its own or in combination with other medicines for the treatment of high blood pressure. 2. What you need to know before you take Indapamide Do not take Indapamide: if you are allergic to indapamide or a sulfonamide-type medicine (e.g. certain antibiotics or other diuretics), or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, tongue or throat if you have ever had severe liver failure or problems or suffer from liver problems which affect your brain and central nervous system (hepatic encephalopathy) if you have recently suffered from a stroke or bleeding within the brain if you have low levels of potassium in your blood (hypokalaemia) if you have experienced severe kidney failure. Warnings and precautions Talk to your doctor or pharmacist before taking Indapamide: if you have had low levels of potassium in your blood in the past. Low levels of potassium can occur, for example, in someone with heart disease or high blood pressure if you have other kidney problems if you suffer from an overactive adrenal gland causing symptoms such as muscle weakness, spasms and high blood pressure if you suffer from gout Page 2 of 8 if you are diabetic if you suffer from an overactive parathyroid gland (leading to too much calcium in the blood), which can cause soft bones if you have heart rhythm problems, heart failure (a weakness of the heart muscle) or reduced blood flow to the heart (such as angina) if you have other liver problems, especially that causing fluid accumulation in the stomach and abdomen (ascites) If you are not able to eat normally, or can only manage limited food intake and are malnourished if you have had photosensitivity reactions e.g. symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal. This medicine may increase the risk of this occurring and you may need to use sunscreen or avoid sunlight or artificial UV light e.g. sunbeds. Whilst taking this medicine, if you notice reddening of the skin or other sunburn like symptoms, stop taking and talk to your doctor if you are an athlete and play competitive sports. This medicine contains an active ingredient which may give a positive reaction in doping tests During treatment Talk to your doctor or pharmacist: if you get swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioneurotic oedema) Your doctor may do blood tests to check for low sodium or potassium levels, high calcium levels and kidney function. If you need to have a test to check how well your parathyroid gland is working, tell the doctor or hospital staff that you are taking this medicine. Other medicines and Indapamide Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because indapamide can affect the way that some medicines work and some medicines can affect the way that indapamide works. You should not take indapamide tablets 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 they may cause a problem with your heart rhythm when taken together with indapamide, and special care may be required: medicines for heart rhythm problems such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide or digoxin (which may also be used for other problems e.g. heart failure) halofantrine (antiparasitic drug used to treat certain types of malaria) vincamine IV (used to increase blood flow to the brain) 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, erythromycin IV (antibiotics used to treat infections) medicines used to treat mental health conditions such as depression, anxiety or schizophrenia (for example tricyclic antidepressants, or antipsychotics (which may also be known as ‘neuroleptics’) such as chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, amisulpride, sulpiride, sultopride, tiapride, droperidol, or haloperidol) pentamidine (used to treat certain types of pneumonia) mizolastine (used to treat allergic reactions, such as hay fever) If you are taking any of the following medicines, special care may also be required: Page 3 of 8 non-steroidal anti-inflammatory drugs for pain relief (e.g. ibuprofen), similar medicines known as COX-2 inhibitors (e.g. celecoxib) or high doses of acetylsalicylic acid (aspirin) angiotensin converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure) oral steroids (e.g. prednisolone or hydrocortisone), used to treat various conditions including severe asthma and rheumatoid arthritis baclofen (to treat muscle stiffness occurring in diseases like multiple sclerosis) other diuretics (‘water tablets’) such as furosemide, or 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). laxatives (e.g. senna, bisacodyl) Pregnancy and breast-feeding 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 as this medicine may pass into the milk. 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 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 medicine. 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, they may stop indapamide treatment a few days before, to avoid a sudden fall in your blood pressure (hypotension). Page 4 of 8 Some patients may need regular blood tests to check their blood salt (sodium, potassium, calcium) 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. 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.