Indapamide Sandoz

Patient Information Leaflet

INDAPAMIDE SANDOZ 2.5 mg film-coated tablets

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What INDAPAMIDE SANDOZ is and what it is used for
2. What you need to know before taking INDAPAMIDE SANDOZ
3. How to take INDAPAMIDE SANDOZ
4. Possible side effects
5. How to store INDAPAMIDE SANDOZ
6. Contents of the pack and other information

1. What INDAPAMIDE SANDOZ is and what it is used for

INDAPAMIDE SANDOZ contains the active substance indapamide, a medicine belonging to a group of drugs called "thiazide diuretics", which work by promoting the elimination of fluid from the body, thereby lowering blood pressure.
INDAPAMIDE SANDOZ is used for the treatment of high blood pressure (essential arterial hypertension).

2. What you should know before taking INDAPAMIDE SANDOZ

Do not take INDAPAMIDE SANDOZ

• if you are allergic to indapamide or to other similar medicines (sulfonamide-derived drugs) or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems (severe renal failure) or if you have little or no urge to urinate (anuria);
• if you have severe liver problems or a condition called hepatic encephalopathy (brain disturbances caused by the release into the bloodstream of "toxic" substances related to liver failure);
• if you have low levels of potassium in your blood (hypokalaemia);
• if you have recently had a stroke (cerebral vascular infarction);
• if you have been diagnosed with a tumour called phaeochromocytoma (a tumour of the adrenal glands causing high blood pressure);
• if you have been diagnosed with overactivity of the adrenal gland leading to excessive production of the hormone aldosterone, causing high blood pressure (Conn's syndrome).

Warnings and precautions
Talk to your doctor or pharmacist before taking INDAPAMIDE SANDOZ.
Pay particular attention:

• if you have had or currently suffer from low levels of sodium in your blood (hyponatraemia);
• if you have had or currently suffer from low levels of potassium in your blood; low potassium levels may occur in elderly patients, debilitated patients or those taking multiple medications (polypharmacy), in patients with liver cirrhosis, a liver disease causing fluid accumulation in the abdominal cavity, in patients with heart diseases (coronary artery disease or heart failure, long QT syndrome), and in patients suffering from heart rhythm disorders (particularly torsades de pointes).
• if you have been found to have elevated levels of calcium in your blood (hypercalcaemia): thiazide diuretics may reduce calcium excretion in urine and cause a mild and transient increase in blood calcium levels. Your doctor may perform blood tests to check whether you have low levels of sodium or potassium or high levels of calcium in your blood.
• If you have liver problems (impaired liver function), you may develop a disorder called hepatic encephalopathy, characterised by mental confusion and drowsiness, especially if there are disturbances in blood electrolyte levels (sodium, potassium). Immediately discontinue treatment with this medicine if you experience these symptoms.

During treatment with this medicine, a reduction in thyroid gland activity without symptoms may occur.
Be especially careful when using this medicine and inform your doctor:

• if you have high levels of uric acid in your blood (hyperuricaemia) and are prone to joint inflammation (gout);
• if you have diabetes;
• if you are elderly and have kidney problems (persistent renal insufficiency), as INDAPAMIDE SANDOZ may not work properly in patients with even slightly impaired kidney function;
• if you have liver problems, as INDAPAMIDE SANDOZ could trigger hepatic encephalopathy (see section Do not take INDAPAMIDE SANDOZ). if you experience decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur within hours or weeks after taking INDAPAMIDE SANDOZ. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing an allergic reaction. if you suffer from muscle disorders including muscle pain, tenderness, weakness or cramps.

Photosensitivity
Cases of photosensitivity reactions (skin reaction to light causing redness and burning sensations; an abnormal and exaggerated reaction even after brief exposure to sunlight) have been reported with the use of indapamide. If such reactions occur, discontinue treatment and consult your doctor.
If resuming treatment with indapamide becomes necessary, it is recommended to protect sun-exposed areas or areas exposed to artificial UVA rays.
During treatment with this medicine, a mild decrease in blood acidity (hypochloraemic alkalosis) may occur, which requires specific treatment if you have liver or kidney disorders.
While using this medicine, your doctor may periodically prescribe blood tests to monitor the levels of:

• sodium, both before starting and during treatment. If you are elderly or have liver problems (cirrhosis), these checks should be even more frequent;
• potassium, especially if you are elderly or malnourished, if you have liver problems (cirrhosis with oedema and ascites), or if you have heart problems (heart failure and coronary diseases, prolonged QT interval). The first check should be performed during the first week of treatment.
• glucose (blood sugar), particularly if you have diabetes and low potassium levels in your blood (hypokalaemia);
• calcium, because an increase in calcium levels (hypercalcaemia) may indicate altered parathyroid gland function (hyperparathyroidism). Before assessing parathyroid function, discontinue treatment;
• uric acid, because gout attacks may increase.

This medicine is more effective when kidney function is normal or only slightly impaired.
In elderly patients, serum creatinine levels should be monitored according to age, weight and sex. This medicine may cause a reduction in blood volume (hypovolaemia), leading to reduced kidney function and increased blood urea and creatinine levels.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
The use of this medicine is not recommended in children and adolescents.
Other medicines and INDAPAMIDE SANDOZ
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Be especially careful and inform your doctor if you are taking:

• lithium-containing medicines, used to treat depression. Concomitant use with this medicine, if necessary, requires monitoring of lithium blood levels and dose adjustment;
• non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. ibuprofen), including selective COX-2 inhibitors or high doses of salicylic acid, used to treat pain, especially if you are dehydrated;
• other medicines used to treat high blood pressure, such as ACE inhibitors, particularly if you have low sodium levels in your blood;
• baclofen, a medicine used to treat muscle stiffness in conditions such as multiple sclerosis. Increase fluid intake and monitor kidney function before starting treatment;
• digitalis medicines, used to treat heart rhythm disorders;
• allopurinol, used in gout; concomitant treatment with indapamide may increase the incidence of hypersensitivity reactions to allopurinol;
• intravenous amphotericin B, a medicine used to treat fungal infections;
• systemic glucocorticoids and mineralocorticoids, used for various disorders such as severe asthma and rheumatoid arthritis;
• tetracosactide, a medicine used to treat various conditions (rheumatoid arthritis, terminal stages of certain cancers, Crohn's disease and other autoimmune diseases);
• stimulant laxatives, used to promote intestinal motility, which may cause potassium loss (hypokalaemia);
• potassium-sparing diuretics, such as amiloride, spironolactone, triamterene;
• metformin, a medicine used to treat diabetes;
• iodine-containing medicines used in radiological investigations (iodinated contrast media);
• calcium tablets or other calcium supplements;
• cyclosporine and tacrolimus, medicines used in transplant patients.

Inform your doctor and avoid taking INDAPAMIDE SANDOZ if you have low potassium levels in your blood (hypokalaemia) and are taking the following medicines:

• medicines used to treat heart rhythm disorders such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, bretylium;
• medicines used to treat mental disorders such as depression, anxiety or schizophrenia (e.g. tricyclic antidepressants (such as imipramine), antipsychotics, neuroleptics (such as chlorpromazine, chlordiazepoxide, levomepromazine, thioridazine, trifluoperazine, amisulpride, sulpiride, sultopride, tiapride, droperidol, haloperidol));
• bepridil (used to treat angina pectoris, a condition causing chest pain);
• cisapride and difemanil, used for stomach and intestinal problems;
• halofantrine (an antiparasitic drug used to treat gastrointestinal disorders);
• antihistamines used to treat allergic reactions, such as hay fever (e.g. mizolastine, astemizole, terfenadine);
• pentamidine, used to treat certain protozoan infections;
• sparfloxacin, moxifloxacin and intravenous erythromycin, antibiotics used to treat bacterial infections;
• intravenous vincamine, used to treat certain nervous system disorders;
• methadone (used to treat addiction).

Combining this medicine with those listed above may increase the risk of heart problems (torsades de pointes), especially if you have low potassium levels in your blood. Before starting treatment with this medicine, your doctor will prescribe tests to check your blood electrolyte levels and heart function (electrocardiogram).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Avoid using this medicine during pregnancy. Do not use this medicine during pregnancy to treat physiological swelling (physiological oedema). Diuretic medicines can cause serious harm to fetal growth.
Use of this medicine during breastfeeding is not recommended, as a risk to newborns/infants cannot be excluded.
Driving and using machines
This medicine does not affect concentration, but individual reactions due to blood pressure reduction may occur, especially at the beginning of treatment or when this medicine is combined with another antihypertensive agent. In such cases, your ability to drive vehicles or operate machinery may be impaired.
INDAPAMIDE SANDOZ contains lactose and sodium
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take INDAPAMIDE SANDOZ

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
The recommended dose is 1 tablet daily, taken in the morning.

Use in patients with kidney problems (renal impairment)
Your doctor will adjust the dose according to your kidney function.
This medicine is effective only if your kidneys are functioning properly or if their function is only slightly reduced. (See section 2).
Do not use this medicine if you suffer from severe renal impairment (See section 2 Do not take Indapamide Sandoz).

Use in patients with liver problems (hepatic impairment)
If you suffer from hepatic impairment, a dose reduction is required.
Do not use this medicine if you have severe hepatic impairment (See section 2 Do not take Indapamide Sandoz).

Use in elderly patients
Take this medicine only if you have normal kidney function or if it is only slightly impaired (See section 2 Warnings and precautions). Therefore, before starting treatment with INDAPAMIDE SANDOZ, kidney function parameters (serum creatinine) should be evaluated in relation to age, weight, and sex.

Children and adolescents
The use of this medicine is not recommended in children and adolescents.

If you take more INDAPAMIDE SANDOZ than you should
This medicine has not shown toxicity even at doses much higher than the therapeutic dose. Signs of overdose mainly involve disturbances in blood levels of sodium and potassium.
Symptoms may include:

• nausea and vomiting;
• low blood pressure (hypotension);
• involuntary muscle contractions associated with pain (cramps);
• dizziness;
• drowsiness, confusion;
• increased or decreased urine output (polyuria and oliguria), up to possible absence of urine production (anuria).

If you have taken or ingested an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take INDAPAMIDE SANDOZ
Do not take a double dose to make up for the missed tablet.
If you have any doubts about how to use this medicine, consult 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 may occur:

Common (may affect up to 1 in 10 people)

• skin irritation (maculopapular rash)
• low levels of potassium in the blood

Uncommon (may affect up to 1 in 100 people)

• vomiting
• small red spots on the skin (purpura) in patients predisposed to allergic reactions
• low levels of sodium in the blood, which may lead to dehydration and reduced blood pressure
• impotence (inability to achieve or maintain an erection)

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

• dizziness
• feeling of fatigue and drowsiness
• headache
• tingling in the hands and feet (paraesthesiae)
• stomach and intestinal disturbances (gastrointestinal intolerance), nausea, and constipation
• dry mouth
• muscle pain (cramps)
• low levels of chloride in the blood
• low levels of magnesium in the blood

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

• decrease in platelet count (thrombocytopenia), decrease in white blood cell count (leucopenia, agranulocytosis), decrease in all blood components (aplastic anaemia), and decrease in red blood cells (haemolytic anaemia)
• changes in heart rhythm (arrhythmias)
• low blood pressure (hypotension)
• inflammation of the pancreas (pancreatitis)
• liver disorders
• swelling around the eyes and mouth (angioneurotic oedema)
• skin irritation (urticaria), severe skin reactions, serious skin disease (toxic epidermal necrolysis), and allergic-type reactions (Stevens-Johnson syndrome)
• kidney problems (renal failure)
• increased levels of calcium in the blood (hypercalcaemia)

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

• loss of consciousness (syncope)
• mental confusion
• vision disturbances (myopia, blurred vision, visual impairment)
• heart problems such as torsade de pointes, potentially fatal (See section 2 “Warnings and precautions” and “Other medicines and INDAPAMIDE SANDOZ”)
• dizziness upon standing due to a rapid drop in blood pressure (orthostatic hypotension)
• onset of a serious liver disease called hepatic encephalopathy (brain disturbances due to circulating “toxic” substances related to liver failure), characterised by mental confusion and drowsiness (see section 2 “Do not take INDAPAMIDE SANDOZ” and “Warnings and precautions”)
• inflammation of the liver (hepatitis)
• skin disorders such as itching, irritation (transient skin redness (rash))
• cases of photosensitivity reactions (see section “Warnings and precautions”)
• worsening of a skin disease called systemic lupus erythematosus (an autoimmune disease causing inflammation and damage to joints, tendons, and organs, skin redness, fatigue, loss of appetite, weight gain, and joint pain)
• kidney problems (acute renal failure)
• excessive tiredness (asthenia)
• sudden falls
• changes in heart rhythm (prolongation of the QT interval – see section 2 “Warnings and precautions” and “Other medicines and INDAPAMIDE SANDOZ”)
• increased levels of uric acid and blood sugar (glycaemia), and slight increase in nitrogen in urine; pay particular attention if you have diabetes or gout
• slight increase in blood urea nitrogen
• slight increase in liver enzymes
• decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• excessive loss of chlorides in urine (which may lead to mild metabolic alkalosis)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store INDAPAMIDE SANDOZ

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What INDAPAMIDE SANDOZ contains

• The active substance is indapamide. Each tablet contains 2.5 mg of indapamide.
• The other ingredients are maize starch; glycerol; monohydrate lactose; hypromellose; magnesium stearate; polyethylene glycol 6000; povidone; sodium lauryl sulfate; talc; titanium dioxide.

Description of the appearance of INDAPAMIDE SANDOZ and pack contents
Pack containing 30 coated tablets.
Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy
Manufacturer
Edmond Pharma S.r.l. – Strada Statale Dei Giovi, 131 - 20037 Paderno Dugnano (MI), Italy