Indapamide-Teva

Indapamide-Teva

indapamide

Manufacturer:

Teva

Distributor:

KLN Pharma
Full Prescribing Info
Contents
Indapamide.
Description
Each Indapamide-Teva Tablet contains 1.5 mg of indapamide.
Excipients/Inactive Ingredients: The other ingredients are lactose monohydrate, hypromellose (Methocel K4M Premium), silica colloidal anhydrous and magnesium stearate.
The tablet coating (Opadry II white 33G28707) contains: hypromellose 6cP (E464), titanium dioxide (E171), lactose monohydrate, macrogol 3000 and triacetin.
Action
Indapamide-Teva belongs to a class of medicines known as diuretics which increase urine production by the kidneys.
Indications/Uses
Indapamide-Teva is used to treat high blood pressure (hypertension).
Dosage/Direction for Use
Adults: The usual dose is 1.5 mg (one tablet) preferably in the morning swallowed whole with water and not chewed.
Patients with kidney problems: Indapamide-Teva is not recommended for patients with kidney problems.
Patients with liver problems: Indapamide-Teva is not recommended for patients with liver problems.
Elderly patients: Elderly patients can be treated with Indapamide-Teva providing he/she has no problems with the kidneys.
Children and adolescents (less than 18 years of age): Indapamide-Teva is not recommended for use in children and adolescents.
Taking Indapamide-Teva with food and drink: Indapamide-Teva can be taken with meals.
If patient forgets to take Indapamide-Teva: If patient forgets to take a tablet, just carry on with the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If patient stops taking Indapamide-Teva: Treatment for high blood pressure is normally life-long and therefore patient should not stop taking Indapamide-Teva without talking to the doctor. If patient has any further questions on the use of this product, ask the doctor or pharmacist.
Overdosage
If patient (or someone else) swallows a lot of the tablets all together or if a child has swallowed any of the tablets, contact the nearest hospital casualty department or the doctor immediately. Patient may experience the following if he/she has taken too many tablets: nausea, vomiting, low blood pressure, cramps, feeling dizzy, drowsiness, confusion, an increase or decrease in urination. Please take the product leaflet, any remaining tablets and the container to the hospital or doctor so that they know which tablets were consumed.
Contraindications
Do not take Indapamide-Teva: if allergic (hypersensitive) to indapamide or any other sulphonamide or to any of the other ingredients of this medicine (listed in Description); if suffering from severe kidney disease; if patient has severe liver disease; if suffering from a brain and central nervous system disorder caused by liver disease (hepatic encephalopathy); if patient has a low potassium level in the blood.
Special Precautions
Tell the doctor: if patient has any heart rhythm problems; if patient has problems with the liver or kidneys; if diabetic; if a test is needed to check how well the parathyroid gland is working; if suffering from gout; if patient gets any skin problems such as a rash, change in skin colour, swelling or if the skin becomes sensitive to sunlight (photosensitive) while taking this medication.
Before patient starts taking Indapamide-Teva and during the treatment the doctor may give blood tests to check the levels of sodium, potassium and calcium in the blood. This is especially important for the elderly or patients who suffer from liver disease, heart disease or have an overactive parathyroid gland.
Athletes: Athletes should be aware that this medicinal product contains an active ingredient that could give a positive result during doping tests.
Ophthalmologic: Choroidal effusion, Secondary Acute Angle-Closure Glaucoma and/or Acute Myopia: Sulfonamide or sulfonamide derivative drugs can cause an idiosyncratic reaction, which may result in choroidal effusion, secondary acute angle-closure glaucoma and/or acute transient myopia. Symptoms include acute onset of decreased visual acuity, blurred vision or ocular pain and typically occur within hours to weeks of drug initiation.
Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue Indapamide-Teva as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Important information about some of the ingredients of Indapamide-Teva: Patients who are intolerant to lactose should note that Indapamide-Teva contains a small amount of lactose.
In case of intolerance to some sugars, contact the doctor before taking this medicine.
Driving and using machines: This medicine can cause side effects due to lowering of the blood pressure such as dizziness or tiredness (see Side Effects). These side effects are more likely to occur after initiation of the treatment and after dose increases. If this occurs, refrain from driving and other activities requiring alertness. However, under good control, these side effects are unlikely to occur.
Use In Pregnancy & Lactation
Pregnancy and breast-feeding and fertility: Indapamide-Teva should not be taken during pregnancy or while breast-feeding. If patient finds out she is pregnant while taking Indapamide-Teva, tell the doctor immediately. Ask the doctor or pharmacist for advice before taking any medicine.
Side Effects
Like all medicines, Indapamide-Teva can cause side effects, although not everybody gets them.
The following side effects have been reported at the approximate frequencies shown: Common (may affect up to 1 in 10 people): maculopapular rashes (allergic reaction on the skin that creates large areas of redness with small bumps).
Uncommon (may affect up to 1 in 100 people): vomiting; allergic reactions mainly in people prone to allergic and asthmatic reactions and mainly affecting the skin causing purpura (red pinpoints on skin).
Rare (may affect up to 1 in 1000 people): vertigo (a feeling of dizziness); tiredness; headache; paresthesia (pins and needles); nausea; constipation; dry mouth.
Very Rare (may affect up to 1 in 10000 people): increased calcium levels in the blood; irregular heart beat; low blood pressure; reduction in blood platelets, which may increase the risk of bleeding or bruising; reduction in the number of white blood cells, which may make infections more likely; bone marrow failure (causing a reduction of all blood cell types) or anaemia (decrease in red blood cells); inflammation or infection of the pancreas; kidney failure; allergic reactions such as angioedema and/or urticaria, severe skin manifestations. (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 the doctor immediately); severe allergic reactions such as toxic epidermic necrolysis and Stevens Johnson syndrome which may cause flu like symptoms and blistering or peeling of the skin. (If this occurs, contact the doctor immediately); liver problems.
Not known (frequency cannot be estimated from the available data): worsening of a condition called hepatic encephalopathy in patients with liver problems which could cause damage to the brain and nerves; patients suffering from acute disseminated lupus erythematosus (a rare inflammatory disease) may find their condition is worsened while taking this medicine; a reduction in potassium levels in the blood, which may cause muscle weakness; a reduction in sodium levels in the blood and decreased blood volume which may lead to dehydration or dizziness and light-headedness upon standing due to low blood pressure; an increase in uric acid levels in the blood which may cause or worsen cases of gout (a condition which causes pain, inflammation and swelling in one, or more, of the joints); an increase in blood glucose levels in diabetic patients; photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial Ultraviolet A (UVA) light; ophthalmologic: eye disorders (secondary acute angle-closure glaucoma, acute myopia and choroidal effusion).
If any of the side effects gets serious, or if patient notices any side effects not listed, please tell the doctor or pharmacist.
Drug Interactions
Tell the doctor or pharmacist if patient is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Do not take Indapamide-Teva in combination with: Lithium (used to treat depression) due to the risk of increased levels of lithium in the blood.
Tell the doctor if patient is taking any of the following as the dose may need to be adjusted: chlorpromazine, thioridazine, amisulpride, sulpiride, haloperidol (used to treat schizophrenia and other psychotic disorders); quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide and ibutilide (used to treat abnormal heart rhythms); bepridil (used to treat high blood pressure and chest pain); cisapride and diphemanil (used to treat gastric problems); antibiotics such as erythromycin injection, pentamidine, sparfloxacin and moxifloxacin; halofantrine (used to treat malaria); mizolastine (used to treat allergic reactions); vincamine injection (used to increase the blood flow to the brain); non-steroidal anti-inflammatory drugs (NSAIDs) used for pain relief and to treat inflammation such as ibuprofen, cyclooxygenase-2 (COX-2) specific inhibitors such as celecoxib or high doses of acetylsalicylic acid; angiotensin converting enzyme (ACE) inhibitors used to treat hypertension and congestive heart failure such as captopril, enalapril or perindopril; amphotericin B injection (use to treat fungal infections); steroids such as hydrocortisone, prednisolone (used to treat severe asthma and rheumatoid arthritis), and tetracosactide (used to in the diagnosis of some illnesses and in the treatment of Crohn's disease); stimulant laxatives such as senna and glycerol suppositories (used to relieve constipation); baclofen (a muscle relaxant); medicines used to treat heart failure such as digoxin and digitoxin; potassium-sparing diuretics such as amiloride, spironolactone and triamterene; metformin (used to treat diabetes); antidepressants such as imipramine and neuroleptics (used to treat mental disorders); medicines containing calcium; medicines that reduce the body's natural immunity (immunosuppressive agents) such as ciclosporin and tacrolimus.
If patient is going for an X-ray, tell the doctor that he/she is taking indapamide as additional precautions need to be taken.
Storage
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
MIMS Class
Diuretics
ATC Classification
C03BA11 - indapamide ; Belongs to the class of low-ceiling sulfonamide diuretics.
Presentation/Packing
Form
Indapamide-Teva PR tab 1.5 mg
Packing/Price
30's
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