Indapamide Mylan Generics

Package leaflet: Information for the patient

INDAPAMIDE MYLAN GENERICS 2.5 mg film-coated tablets

Indapamide
Generic medicine
Please read all of this leaflet carefully before 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What INDAPAMIDE MYLAN GENERICS is and what it is used for

This medicinal product contains the active substance indapamide, which belongs to a group of medicines called
diuretics. These work by promoting the elimination of fluids from the body, thereby lowering blood
pressure.
INDAPAMIDE MYLAN GENERICS is used for the treatment of high blood pressure
(arterial hypertension).

2. What you need to know before taking INDAPAMIDE MYLAN GENERICS

Do not take INDAPAMIDE MYLAN GENERICS

• 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 urine production (anuria);
• if you have liver problems (hepatic encephalopathy or severe impairment of liver function);
• if you have low levels of potassium in your blood (hypokalaemia);
• if you have recently had problems with blood circulation in the brain (cerebrovascular accidents);
• if you have been diagnosed with a tumour called phaeochromocytoma;
• if you have been diagnosed with overactivity of the adrenal gland (Conn's syndrome).

Warnings and precautions
Talk to your doctor or pharmacist before taking INDAPAMIDE MYLAN GENERICS.
If you have liver problems (impaired liver function), you may develop a condition called hepatic encephalopathy, characterised by mental confusion and drowsiness, especially if levels of salts in your blood (sodium, potassium) are altered. Stop treatment with this medicine immediately if you experience these symptoms.
Stop treatment with this medicine if you develop skin irritation associated with itching in areas exposed to sunlight (photosensitivity reactions). If treatment needs to be restarted, protect the affected areas from light.
If you are pregnant.
During treatment with this medicine, your thyroid activity may decrease without symptoms.
Pay special attention 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 are elderly and have kidney problems (persistent renal failure).

While using this medicine, your doctor may periodically request blood tests to monitor 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), if you have heart problems (heart failure and coronary diseases, prolonged QT interval). The first check should be performed during the first week after starting treatment. If potassium levels in your blood decrease (hypokalaemia), a dose adjustment will be necessary.
• glucose (blood sugar), particularly if you have diabetes and if your blood potassium levels are low (hypokalaemia);
• calcium, because increased calcium levels (hypercalcaemia) may indicate altered function of the parathyroid gland (hyperparathyroidism). Stop treatment before checking parathyroid function.
• uric acid, because gout attacks may increase.

For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children and adolescents
This medicine is not recommended for use in children and adolescents.
Other medicines and INDAPAMIDE MYLAN GENERICS
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pay particular attention and inform your doctor if you are taking:

• medicines containing lithium, used to treat depression. Combination with this medicine, if necessary, requires monitoring of lithium blood levels and dose adjustment.
• non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain, especially if you are dehydrated;
• other medicines used to treat high blood pressure, such as ACE inhibitors, if you have low sodium levels in your blood;
• baclofen, used to treat muscle disorders. Increase fluid intake and check kidney function before starting treatment.
• digitalis medicines, used to treat heart rhythm disorders;
• amphotericin B (if administered intravenously), a medicine used to treat fungal infections;
• systemic glucocorticoids and mineralocorticoids, used for various disorders such as 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;
• potassium-sparing diuretics, such as amiloride, spironolactone, triamterene;
• metformin, a medicine used to treat diabetes;
• allopurinol, a medicine used to reduce uric acid levels in the blood;
• iodinated contrast media;
• calcium salts;
• cyclosporine and tacrolimus, medicines used in transplant cases;
• imipramine-like antidepressants, used to treat depression;
• neuroleptics, used to treat mental disorders (psychosis).

Inform your doctor and avoid taking INDAPAMIDE MYLAN GENERICS 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;
• medicines used to treat mental disorders (antipsychotics) such as chlorpromazine, ciamemazine, levomepromazine, thioridazine, trifluoperazine, amisulpride, sulpiride, sultopride, tiapride, droperidol, haloperidol;
• bepridil, used to treat heart problems;
• cisapride and difemanil, used for stomach and intestinal problems;
• intravenous erythromycin;
• halofantrine, used to treat a type of malaria;
• mizolastine, used to treat allergies;
• pentamidine, used to treat certain types of pneumonia;
• sparfloxacin, moxifloxacin and intravenous erythromycin, antibiotics used to treat bacterial infections;
• intravenous vincamine, used to treat certain nervous system disorders. The combination of this medicine with those listed above may increase the risk of heart problems (torsade de pointes), especially if you have low potassium levels in your blood. Before starting treatment with this medicine, it is necessary to check electrolyte levels and heart function (electrocardiogram). If you have low potassium levels in your blood, they must be corrected to normal levels before taking INDAPAMIDE MYLAN GENERICS.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Avoid using this medicine if you are pregnant. 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 is not recommended if you are breastfeeding.
In men, effects on fertility are not expected.
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 or operate machinery may be impaired.
INDAPAMIDE MYLAN GENERICS contains lactose and sucrose
This medicine contains lactose and sucrose, two types of sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take INDAPAMIDE MYLAN GENERICS

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 kidney function.
This medicine is effective only if your kidneys are functioning properly or only slightly impaired (see section 2).
Do not use this medicine if you have severe renal impairment (see section 2).

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).

Use in elderly people
Your doctor will adjust the dosage based on age, weight, and sex.
Take this medicine only if your kidney function is normal or only slightly reduced (see section 2).

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

• nausea and vomiting;
• low blood pressure (hypotension);
• involuntary muscle contractions associated with pain (cramps);
• dizziness;
• drowsiness, confusion;
• increased or decreased urine production (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 MYLAN GENERICS
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:

• maculopapular rash

Uncommon (may affect up to 1 in 100 people)

• vomiting;
• skin disorder associated with bleeding (purpura).

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

• dizziness;
• feeling of fatigue and drowsiness;
• headache;
• tingling in hands and feet (paraesthesiae);
• stomach and intestinal disorders (gastrointestinal intolerance), nausea and constipation;
• dry mouth;
• muscle pain (cramps).

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

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

Not known (frequency cannot be estimated from available data)

• loss of consciousness (syncope);
• confusion;
• visual disturbances (myopia, blurred vision, visual impairment);
• heart problems such as torsade de pointes (see section 2);
• rapid heartbeat (palpitations);
• dizziness upon standing due to a sudden drop in blood pressure (orthostatic hypotension);
• hepatic encephalopathy, characterized by mental confusion and drowsiness, if you have liver problems (hepatic insufficiency);
• liver problems (hepatitis);
• skin disorders such as itching, irritation (erythema, rash, photosensitivity);
• worsening of a skin disease called systemic lupus erythematosus;
• kidney problems (acute renal failure);
• asthenia;
• falls;
• changes in heart rhythm (prolongation of QT interval);
• decrease in potassium and sodium levels in the blood (see section 2). If there is also a simultaneous decrease in chloride ions, a condition called metabolic alkalosis may occur;
• increased levels of uric acid and blood sugar (glycaemia). Pay particular attention if you have diabetes or gout;
• slight increase in blood urea nitrogen;
• increased liver enzymes.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store INDAPAMIDE MYLAN GENERICS

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 packaging after “Exp.”.
The expiry date refers to the last day of that month.
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 MYLAN GENERICS contains

• The active substance is indapamide. Each tablet contains 2.5 mg of indapamide.
• The other components are lactose, sucrose, maize starch, talc, acacia gum, magnesium carbonate, magnesium stearate, titanium dioxide, eryrosine red (E127).

Description of the appearance of INDAPAMIDE MYLAN GENERICS and package contents
Pack containing 50 coated tablets.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan
Manufacturer
Mipharm S.p.A., Via B. Quaranta 12, 20141 Milan
ABC Farmaceutici S.p.A., Canton Moretti 29, Località San Bernardo, 10090 Ivrea (TO)