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.
If you stop taking Indapamide If you suddenly stop taking indapamide you may experience side effects. Talk 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 or leucopenia) lack of certain blood cells, or damage to the red blood cells, with the following symptoms; tiredness, headaches, being short of breath when exercising, dizziness, looking pale, nosebleeds (haemolytic or aplastic anaemia) 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)
Page 5 of 8 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. Changes in heart rhythm may be seen on a recording of the electrical activity of the heart (‘ECG) 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. allergic reactions, mainly affecting the skin, more likely in patients with a history of allergy or asthma
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 platelets in the blood may fall, which may cause unusual bleeding or you may bruise more easily than normal (thrombocytopenia) 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, an overactive adrenal gland (hyperaldosteronism) or with a history of gout low sodium levels in the blood with low blood volume
Page 6 of 8 fainting weight loss short-sightedness (myopia), blurred or decreased vision change in liver enzymes, which may be seen in blood tests worsening of an inflammatory disease of the connective tissues with symptoms such as fever, weakness, fatigue, joint pain and skin lesions (lupus erythematosus) 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. If this occurs, stop taking this medicine and talk to your doctor. raised urate levels in the blood that can make you feel more thirsty or pass more urine than usual dizziness.
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 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: hypromellose; macrogol 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 with a plastic spacer at the top of the pack 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.
Page 7 of 8 Manufacturer: Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
This leaflet was last revised in 12/2016
Page 8 of 8