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الرسالة

تنشط مؤسسة رفيق الحريري في ميادين التربية والتعليم والثقافة والرعاية الصحية والاجتماعية، بغية اعداد مواطنين مؤهلين معرفيا، مسلحين بقيم المواطنة ومبادئ حقوق الانسان لكي ينخرطوا لاحقاً في العملية التنموية على الصعيدين الوطني والعالمي، متكئين لهذه الغاية على ما يحصلونه من عمق المعرفة في شتى الاختصاصات ومختلف الثقافات، وما يكتسبونه من مهارات العمل

Indapamide Taj SR 1.5 mg Sustained-release Tablets

PATIENT INFORMATION LEAFLET

Indapamide Taj SR 1.5mg Sustained-Release Tablets

Indapamide

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 Taj SR 1.5mg Sustained-Release Tablets are and what they are used for
2. What you need to know before you take Indapamide Taj SR 1.5mg Sustained-Release Tablets
3. How to take Indapamide Taj SR 1.5mg Sustained-Release Tablets
4. Possible side effects
5. How to store Indapamide Taj SR 1.5mg Sustained-Release Tablets
6. Contents of the pack and other information

1. What Indapamide Taj SR 1.5mg Sustained-Release Tablets are and what they are used for

The active substance in Indapamide Taj SR 1.5mg Sustained-Release Tablets is indapamide. Indapamide belongs to a class of medicines called “diuretics” which increase urine production by the kidneys.

It is used to treat high blood pressure (essential hypertension).

2. What you need to know before you take Indapamide Taj SR 1.5mg Sustained-Release Tablets

Do not take Indapamide Taj SR 1.5mg Sustained-Release Tablets if you:

· are allergic to indapamide or any of the other ingredients of this medicine

· are allergic to other medicines in the same chemical class as Indapamide (“Sulfonamides”), such as trimethoprim or Co-trimoxazole

· have severe liver disease or a condition called Hepatic Encephalopathy (damage to the brain and nerves which can occur as a complication of liver problems)

· have severe kidney disease

· have been told by your doctor that you have low levels of potassium in your blood

Warnings and precautions

Talk to your doctor or pharmacist before taking Indapamide Taj SR 1.5mg Sustained-Release Tablets if you suffer from or have previously suffered from any of the following:

· Heart disease, heart failure or heart rhythm problems

· Diabetes (please check your blood sugar levels regularly)

· Gout

· Kidney problems

· Liver problems

Indapamide affects the levels of potassium and sodium in the blood. Your doctor may conduct blood tests to monitor levels of potassium and sodium in your blood before and during your treatment. This is especially important in patients, who are at high risk to develop electrolyte disturbances (such as elderly, patients who are taking many medicines or malnourished patients).

Indapamide may increase the sensitivity of your skin to sunlight. If this happens you should tell your doctor as he/she may decide to stop your treatment. In case of an administration of Indapamide, it is recommended to protect exposed areas to the sun or to artificial UVA.

If the function of your parathyroid gland is to be examined: tell your doctor, who will suspend your treatment with Indapamide.

Athletes should be aware that Indapamide may give a positive reaction in drug tests.

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.

Other medicines and Indapamide Taj SR 1.5mg Sustained-Release Tablets

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

The effects of Indapamide may be altered or undesirable effects may occur if you are also taking the following medicines. Talk to your doctor if you are taking any of the following:

Combinations that are not recommended:

· Lithium (used in the treatment of depression): you should not take Indapamide with lithium due to the risk of increased levels of lithium in the blood with signs of overdose.

Combinations requiring precautions for use:

Torsade des pointes (special form of heart rhythm disorders) may be induced by taking:

· Medicines used in the treatment of irregular heart beat such as Quinidine, Hydroquinidine, Disopyrimide, Amiodarone, Sotalol, Dofetilide or Ibutilide

· Medicines used in the treatment of Psychoses such as Chlorpromazine, Cyamemazine, Levomepromazine, Thioridazine, Trifluoperazine, Amisulpride, Sulpiride, Sultopride, Tiapride, Droperidol or Haloperidol

· Various other drugs such as Bepridil (used for the treatment of Angina), Cisapride and Diphemanil (used for the treatment of gastro-intestinal problems), Intravenous Erythromycin, Pentamidine, Moxifloxacin, sparfloxacin (used for treatment of infection), Halofantrine (used for the treatment of Malaria), Mizolastine (used in the treatment of allergy), intravenous Vincamine (used to treat circulatory problems in the brain)

Non-Steroidal anti-inflammatory drugs (sometimes called N.S.A.I.D’s) used in the treatment of pain and inflammation (e.g. Ibuprofen, Diclofenac and Indometacin), including selective Cyclooxygenase-2 (COX-2) inhibitors (such as Celecoxib, Etoricoxib) and high doses of Aspirin (3g or more a day):

· Possible reduction in the blood pressure lowering effect of indapamide. Risk of acute kidney failure in patients with decreased body water (dehydration). Adequate fluid intake is essential.

ACE inhibitors used to treat high blood pressure and heart failure (e.g. Captopril, Enalapril, Perindopril):

Risk of a severe reduction in blood pressure and/or acute kidney failure when treatment with an ACE inhibitor is started in patients with pre-existing sodium depletions (particularly in patients with Renal Artery Stenosis)

The effect of indapamide may be altered or undesirable effects may occur if you are also taking any of the following:

· Metformin (used in the treatment of diabetes)

· Baclofen (used in the treatment of muscle spasm)

· Ciclosporin and Tacrolimus (used for the treatment of auto-immune disorders or to suppress the immune system following a transplant)

· Steroids (e.g. Prednisolone, Hydrocortisone or Fludrocortisone) used to treat various conditions including severe Asthma and Rheumatoid Arthritis

· stimulant laxatives (e.g. Senna)

· some medicines used to treat heart failure and some heart rhythm disorders (e.g. Digoxin, Digitoxin)

· Some potassium-sparing diuretics (water tablets) such as Amiloride, Spironolactone, Triamterene

· certain water tablets which may cause a decrease of blood potassium levels such as Bendroflumethiazide, Furosemide, Piretanide, Bumetanide and Xipamide

· Some Antidepressants (e.g. Imipramine), Neuroleptics (used to treat mental disorders)

· Some Iodine containing medicines (used in the diagnosis of some illnesses)

· Tetracosactide (used in the diagnosis of some illnesses and treatment of gastro-intestinal problems)

· Medicines containing calcium

Indapamide Taj SR 1.5mg Sustained-Release Tablets with food and drink

Food and drink have no impact on the way that your medicine works. You may take it with or after food or on an empty stomach.

Pregnancy and breast-feeding

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.

Pregnancy

This medicine is not recommended during pregnancy. Please tell your doctor if you are pregnant or wish to become pregnant.

Breast-feeding

The active ingredient is excreted in milk. Breastfeeding is not advisable if you are taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Indapamide lowers blood pressure which may make you feel light-headed and dizzy in relation to the decrease in blood pressure, especially at the start of the treatment or when another antihypertensive is added. If affected do not drive or operate heavy machinery.

Indapamide Taj SR 1.5mg Sustained-Release Tablets contain lactose

Your medicine contains the sugar lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Indapamide Taj SR 1.5mg Sustained-Release Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 1 tablet per day which should preferably be taken in the morning.

Method of administration

Your tablets should be swallowed whole with a sufficient amount of water (such as a glass of water). Do not crush or chew the tablets. Indapamide can be taken without regard to meals.

Patients with impaired renal function

Patients with severe renal failure (creatinin-clearance below 30 ml/min) must not be treated with Indapamide (see section 2. “Do not take Indapamide Taj SR 1.5mg Sustained-Release Tablets if you:”). Thiazide and related diuretics are fully effective only when renal function is normal or only minimally impaired.

Patients with impaired liver function

Patients with severe hepatic impairment must not be treated with Indapamide (see section 2. “Do not take Indapamide Taj SR 1.5mg Sustained-Release Tablets if you:”).

Elderly

Elderly patients can be treated with Indapamide when renal function is normal or only minimally impaired.

Use in children and adolescents

Indapamide is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.

Duration of treatment:

The duration of treatment will be decided by the treating doctor. If you have the impression that the effect of Indapamide is too strong or too weak, talk to your doctor or pharmacist.

If you take more Indapamide Taj SR 1.5mg Sustained-Release Tablets than you should

In case of an overdose, there will be an increased rate of side effects, an increased diuretic effect with a risk of blood pressure drop and disturbances of the water and electrolyte balance. If you have accidentally taken more Indapamide than you should, contact your doctor immediately for advice. Symptoms of an overdose may include nausea, vomiting, low blood pressure (leading to lightheadedness), cramps, dizziness, drowsiness, confusion, excessive production of urine or low production of urine.

If you forget to take Indapamide Taj SR 1.5mg Sustained-Release Tablets

If you forget to take a tablet then take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking Indapamide Taj SR 1.5mg Sustained-Release Tablets

Treatment for high blood pressure is normally life-long. You should not stop taking your medicine without discussing it with your doctor first.

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.

The following side effects can occur:

Common (may affect up to 1 in 10 people)

· Allergic reaction (especially in people who tend to have allergic or Asthmatic reactions) leading to skin rashes with macules and papules

Uncommon (may affect up to 1 in 100 people)

· Vomiting

· Allergic reaction (especially in people who tend to have allergic or Asthmatic reactions) leading to purple spots or patches on the skin

Rare (may affect up to 1 in 1,000 people)

· Dizziness (vertigo)

· Tiredness

· Headache

· Pins and needles (paraesthesiae)

· Nausea (feeling sick)

· Constipation (infrequent bowel movements; hard, dry stools)

· Dry mouth

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

· Reduction in blood platelets, which increases risk of bleeding or bruising

· Reduction in the number of white blood cells, which makes infections more likely; which may be severe (agranulocytosis)

· Reduction in levels of certain blood cells which can cause weakness, bruising or make infections more likely (Haemolytic Anaemia); Aplastic Anaemia (a bone marrow depression)

· Inflammation of the pancreas, which causes severe pain in the abdomen and back (Pancreatitis)

· Irregular heart beat

· Low blood pressure, which may cause lightheadedness

· Kidney problems

· Liver problems (detected by blood tests)

· Increases in the levels of calcium in your blood

· Serious allergic reactions (Angioedema, especially in people who tend to have allergic or Asthmatic reactions) with swelling of the face, lips or tongue and nettle rash, 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.

· Serious allergic reaction with flu like symptoms, blistering of the skin, mouth, eyes and genital organs (Toxic Epidermic Necrolysis, Stevens Johnson Syndrome). If this occurs, contact your doctor immediately.

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

· Indapamide may cause low levels of sodium and potassium in your blood. Your doctor may monitor these levels via blood tests (see above – “Warnings and precautions”).

· Indapamide may cause decreased blood volume (Hypovolaemia) with dehydration and fall in the blood pressure on standing up (Orthostatic Hypotension).

· Indapamide may cause low levels of chloride in the blood, which may lead to Metabolic Alkalosis (low acidity of the blood).

· Indapamide may cause increased blood sugar levels.

· If you have existing liver problems, taking Indapamide may cause a condition called Hepatic Encephalopathy (damage to the brain and nerves which can occur as a complication of liver disease).

· If you suffer from a condition called “Acute Disseminated Lupus Erythmatosus” (rare, widespread inflammatory disease), taking Indapamide may worsen the disease.

· Taking Indapamide may make your skin more sensitive to UV light (see “Warnings and precautions” above).

· Indapamide may cause high levels of uric acid in the blood leading to gout attacks.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Indapamide Taj SR 1.5mg Sustained-Release Tablets

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton and container. The expiry date refers to the last day of that month.

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 Taj SR 1.5mg Sustained-Release Tablets contain

· The active substance is indapamide. Each Sustained-release tablet contains 1.5mg of indapamide.

· The other ingredients are:
Tablet core: lactose monohydrate, starch, pregelatinised; hypromellose, silica, colloidal anhydrous magnesium stearate (vegetable).
Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E171).

What Indapamide Taj SR 1.5mg Sustained-Release Tablets look like and contents of the pack

Indapamide Taj SR 1.5mg Sustained-Release Tablets are white to off white, round, biconvex Sustained-release, film-coated tablets.

Indapamide Taj SR 1.5mg Sustained-Release Tablets are available in packs containing 30 Sustained-release tablets in blister packs (PVC / aluminium).

Manufacturer

TAJ PHARMACEUTICALS LTD.

Mumbai, India

This leaflet was last revised in October 2016

Rafik Hariri Foundation operates in the domains of Education, Culture and Social & Health Care Services in order to qualify the Lebanese youth with multidisciplinary and multicultural knowledge, work skills, civic education, principles of human rights and equal opportunities; all being requisites to contribute to the viability of the national and global development processes.