Indipam XL 1.5mg Prolonged-Release Tablets
Indapamide
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your Doctor or Pharmacist.
In this leaflet:
- 1. What Indipam XL 1.5mg Prolonged-Release Tablets are and what they are used for
- 2. Before you take Indipam XL 1.5mg Prolonged-Release Tablets
- 3. How to take Indipam XL 1.5mg Prolonged-Release Tablets
- 4. Possible side effects
- 5. How to store Indipam XL 1.5mg Prolonged-Release Tablets
- 6. Further information
What Indipam Xl 1.5Mg Prolonged-Release Tablets Are And What They Are Used For
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).
Before You Take Indipam Xl 1.5Mg Prolonged-Release Tablets
Do not take Indipam XL 1.5mg Prolonged-Release Tablets if you:
- Are allergic (hypersensitive) to Indapamide or any of the other ingredients of this medicine
- Are allergic (hypersensitive) to other medicines in the same chemical class as Indapamide (“Sulphonamides”), 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
Take special care with Indipam XL 1.5mg Prolonged-Release Tablets:
Tell your Doctor before you start to take this medicine 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 regulary)
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 of doubts about taking your medicine, you should consult your Doctor or Pharmacist.
Taking other medicines
Please tell your Doctor or Pharmacist if you are taking or have recently taken any other medicines, including medicines obtained withour a prescription.
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 (particulary 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 gastrointestinal problems)
- Medicines containing calcium
Taking Indapamide 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
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.
Important information about some of the ingredients of Indipam XL 1.5mg Prolonged-Release Tablets
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.
How To Take Indipam Xl 1.5Mg Prolonged-Release Tablets
Always take Indapamide exactly as your Doctor has told you. You should check with your Doctor or Pharmacist if you are
not sure.
The usual dose is 1 tablet per day which should preferably be taken in the morning.
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 INDIPAM XL 1.5MG PROLONGED-RELEASE TABLETS”). 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 INDIPAM XL 1.5MG PROLONGED-RELEASE TABLETS”).
Elderly
Elderly patients can be treated with Indapamide when renal function is normal or only minimally impaired.
Children and adolescents
Indapamide is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
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.
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 Indipam XL 1.5mg Prolonged-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 Indipam XL 1.5mg Prolonged-Release Tablets
If you forget to take a tablet then take it as soon as you remember. However, do not take a double dose to make up for a
forgotten dose.
If you stop taking Indipam XL 1.5mg Prolonged-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 product, ask your doctor or Pharmacist.
Possible Side Effects
Like all medicines, Indapamide can cause side effects, although not everybody gets them. The following side effects can occur:
Common (affecting fewer than one person in 10 but more than one person in 100):
- Allergic reaction (especially in people who tend to have allergic or Asthmatic reactions) leading to skin rashes with macules and papules
Uncommon (affecting fewer than one person in 100 but more than one person in 1,000):
- Vomiting
- Allergic reaction (especially in people who tend to have allergic or Asthmatic reactions) leading to purple spots or patches on the skin
Rare (affecting fewer than one person in 1,000 but more than one person in 10,000):
- Dizziness (vertigo)
- Tiredness
- Headache
- Pins and needles (paresthesia)
- Nausea (feeling sick)
- Constipation (infrequent bowel movements; hard, dry stools)
- Dry mouth
Very rare (affecting fewer than one person in 10,000):
- 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 flue like symptoms, blistering of the skin, mouth, eyes and genital organs (Toxic Epidermic Necrolysis, Steven Johnson Syndrome). If this occurs, contact your Doctor immediately.
The following side-effects may also occur. However, based on available data it is not possible to give an indication of how common these are:
- Indapamide may cause low levels of sodium and potassium in your blood. Your doctor may monitor these levels via blood tests (see above – “Take special care with Indipam XL 1.5mg Prolonged-Release Tablets”).
- 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 “Take special care with Indipam XL 1.5mg Prolonged-Release Tablets” above).
- Indapamide may cause high levels of uric acid in the blood leading to gout attacks.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your Doctor.
How To Store Indipam Xl 1.5Mg Prolonged-Release Tablets
Keep out of the reach and sight 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.
Medicines should not be disposed of via wastewater or household waste. Ask your Pharmacist how to dispose of medicines. These measures will help to protect the environment.
Further Information
What Indipam XL 1.5mg Prolonged-Release Tablets contain:
The active substance is: indapamide
Each prolonged-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 Indipam XL 1.5mg Prolonged-Release Tablets look like and contents of the pack:
White, round, prolonged-release, film-coated tablet.
28 prolonged-release tablets in blister packs (PVC / aluminium).
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
CMS : Product name
DE (RMS): Indapamid-Actavis 1,5 mg Retardtabletten
AT : Indapamid Actavis 1,5 mg Retardtabletten
DK : Indapamid Actavis
EE : Indapamide Actavis
HU : SERENID 1.5 mg SR tabletta
IT : Indapamide Actavis
LT : Indapamide Actavis 1,5 mg pailginto atpalaidavi mo tabletės
LV : Indapamide Actavis
PL : Indipam SR
PT : Indapamida Actavis
RO : Indapamidă Actavis 1.5 mg Comprimate Cu Eliberare Prelungită
SK : ACTAPAM 1, 5 mg
UK : Indipam XL 1.5mg Prolonged-Release Tablets
This leaflet was last revised in May 2008
If you would like a leaflet with larger text, please contact 01271 311257.
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