Indapamide 2.5mg Tablets
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Indapamide 2.5mg Tablets
Indapamide Ph. Eur. 2.5mg
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 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
1. What Indapamide Tablets are and what they are used for
This medicine is intended to reduce high blood pressure (hypertension).
It is a film-coated tablet containing indapamide as active ingredient. Indapamide is a diuretic. Most diuretics increase the amount of urine produced by the kidneys. However, Indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced.
2. What you need to know before you take Indapamide Tablets
Do not take Indapamide 2.5mg Tablets:
■ if you are allergic to indapamide or any other sulphonamide drugs or any of the other ingredients of this medicine (listed in section 6),
■ if you have severe kidney disease,
■ 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 your blood.
Warning and precautions
Talk to your doctor or pharmacist before taking Indapamide Tablets.
Take special care if you have:
■ liver problems,
■ if you have any heart rhythm problems or problems with your kidneys,
■ gout (painful inflammation of the joints),
■ diabetes,
■ if you need to have a test to check how well your parathyroid gland is working.
You should tell your doctor if you have had photosensitivity reactions.
Your doctor may give you blood tests to check for low sodium or potassium levels or high calcium levels.
If you think any of these situations may apply to you or you have any questions or doubts about taking your medicine, you should consult your doctor or pharmacist. Athletes should be aware that this medicine contains an active ingredient, which may give a positive reaction in doping tests.
Other medicines and Indapamide Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
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 special care may be required:
■ medicines used for heart rhythm problems (e.g. quinidine, hyd roquinidine, 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 gastrointestinal 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 corticosteroidsused 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-sparring 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, breast-feeding and fertility 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.
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.
Indapamide Tablets contains Lactose
This medicine contains lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Indapamide Tablets
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is one tablet each day, preferably in the morning. The tablets can be taken with or without food. They should be swallowed whole with water.
Treatment for high blood pressure is usually life-long.
If you take more Indapamide Tablets than you should
If you have taken too many tablets, contact your doctor or pharmacist immediately.
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 Indapamide Tablets
If you forget to take a dose of your medicine, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.
If you stop taking Indapamide Tablets
As the treatment for high blood pressure is usually life-long, you should discuss with your doctor before stopping this medicinal product.
If you have any further question on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (less than 1 patient in 10 but more than 1 in 100):
■ Low potassium in the blood, which may cause muscle weakness;
■ Allergic reactions, mainly dermatological, such as skin rashes in subjects with a predisposition to allergic and asthmatic reactions.
Uncommon (less than 1 patient in 100 but more than 1 in 1000):
■ Vomiting;
■ Purpura (red pinpoints on skin).
Rare (less than 1 patient in 1000 but more than 1 in 10,000):
■ Feeling of tiredness, dizziness, headache, pins and needles (paresthesia);
■ Nausea (feeling sick), constipation, dry mouth;
■ Increased risk of dehydration in the older people and in patients suffering from heart failure.
Very rare (less than 1 patient in 10,000):
■ 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);
■ Increase of calcium in the blood;
■ 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.
Not known (frequency cannot be estimated from the available data):
■ 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 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,
□ increased levels of liver enzymes.
■ In cases of liver failure, there is a possibility of getting hepatic encephalopathy (liver problems which affect the brain and central nervous system);
■ 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.
■ Cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA have also been reported.
■ Abnormal ECG heart tracing
■ Life-threatening irregular beat (Torsade de Pointes)
■ Hepatitis
■ Fainting
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. u k/ye llowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Indapamide Tablets
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 box. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package to protect from light.
Do not throw away any medicines via the wastewater or household waste. Ask you pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Indapamide Tablets contain
Each tablet contains 2.5mg of Indapamide Ph. Eur.
Indapamide Tablets also contain lactose, sodium starch glycollate, magnesium stearate.
What Indapamide Tablets look like and contents of the pack
Indapamide Tablets are round, white, flat bevelled edged tablet; embossed with I and 2.5 on one side, plain on the other side.
They are supplied in blister packs containing 20, 28, 30, 56, 60, 84 or 120 tablets.
Marketing Authorisation Holder
Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Hertfordshire, SG4 0TW, United Kingdom
Manufacturer
Niche Generics Limited, Unit 5, 151 Baldoyle Industrial Estate, Dublin 13,
Ireland
This leaflet was last revised in October 2014.