INDAPAMIDE 1.5 MG Coated tablet

Зміст інструкції

1. INDAPAMIDE DOC Generici 1,5 mg prolonged-release film-coated tablets
   1. What is INDAPAMIDE DOC Generici and what is it used for?
   2. What you need to know before you take INDAPAMIDE DOC Generici
   3. How to take INDAPAMIDE DOC Generici
   4. Possible side effects
   5. How to store INDAPAMIDE DOC Generici
   6. Contents of the pack and other information

INDAPAMIDE DOC Generici 1,5 mg prolonged-release film-coated tablets

Equivalent Medicinal Product

Read this leaflet carefully before you start to take this medicinebecause 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is INDAPAMIDE DOC Generici and what is it used for?

INDAPAMIDE DOC Generici belongs to a class of medicines called “diuretics”, which
increase urine production by the kidneys.
It is used for the treatment of high blood pressure (essential hypertension).

2. What you need to know before you take INDAPAMIDE DOC Generici

Do not take INDAPAMIDE DOC Generici

• If you are allergicto indapamide or to any of the other ingredients of this medicine (listed in section 6)
• If you are allergicto other drugs belonging to the same chemical class as indapamide (“sulphonamides”), such as trimethoprim or cotrimoxazole
• If you suffer from a severe liver disease or a disorder called hepatic encephalopathy (brain and nerve damage, which can manifest as a complication of liver problems)
• If you suffer from a severe kidney disease
• If your doctor has told you that you have low levels of potassium in your blood.

Warnings and precautions
Talk to your doctor before taking INDAPAMIDE DOC Generici.
Tell your doctor before starting to take this medicine if you suffer or have suffered in the past from
any of the following conditions:

• Heart disease, heart failure or heart rhythm problems
• Diabetes (check your blood sugar levels regularly)
• Gout
• Kidney disorders
• Liver disorders.

Indapamide affects the levels of potassium and sodium in the blood. Your doctor may subject you to blood
tests to monitor the levels of potassium and sodium in the blood, both before and during
therapy. This is particularly important for patients at high risk of developing electrolyte imbalances (such as the elderly, patients taking many medications, or malnourished patients).
INDAPAMIDE DOC Generici can increase the skin's sensitivity to sunlight. If this happens,
consult your doctor, as it may be necessary to stop the therapy. If you are taking indapamide, it is recommended to protect the areas exposed to the sun or artificial UVA rays.
If it is necessary to check the function of the parathyroid gland, contact your doctor, who
will suspend the therapy with INDAPAMIDE DOC Generici.

For those who play sports:the use of the medicine without a therapeutic need constitutes doping and
can still lead to positive doping tests.
Athletes should be aware that INDAPAMIDE DOC Generici can lead to a
positive doping test.
If you believe that any of the situations described applies to your case or if you have questions
or doubts about taking this medicine, consult your doctor or pharmacist.

Other medicines and INDAPAMIDE DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
If you are taking one or more of the following medicines at the same time, the effect of
INDAPAMIDE DOC Generici may be altered or side effects may occur.
Tell your doctor if you are taking one or more of the following medicines:
Combinations not recommended:

• Lithium (used in the treatment of depression): you should not take INDAPAMIDE DOC Generici together with lithium, due to the risk of increased lithium levels in the blood, with signs of overdose.

Combinations that require precautions for use:

Torsades de pointes(a particular form of heart rhythm disorders) can be induced
by taking:

• Medicines used to treat irregular heartbeat, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide.
• Medicines used to treat psychoses, such as chlorpromazine, ciamemazine, levomepromazine, thioridazine, trifluoperazine, amisulpride, sulpiride, sultopride, tiapride, droperidol, haloperidol.
• Other drugs of various types such as bepridil (used for the treatment of angina), cisapride and difemanil (used for the treatment of gastrointestinal disorders), erythromycin intravenously, pentamidine, moxifloxacin, sparfloxacin (used for the treatment of infections), halofantrine (used for the treatment of malaria), mizolastine (used for the treatment of allergies), vincamine intravenously (used for the treatment of circulatory problems in the brain).

Non-steroidal anti-inflammatory drugs (sometimes called NSAIDs) used to treat pain and
inflammation (for example ibuprofen, diclofenac and indometacin), including selective
cyclooxygenase-2 (COX-2) inhibitors (such as Celecoxib, Etoricoxib) and aspirin at high doses (3 g or more per
day):

• Possible reduction of the blood pressure lowering effect of INDAPAMIDE DOC Generici. Risk of acute renal failure in patients with a reduced amount of fluid in the body (dehydration). Adequate fluid intake is essential.

ACE inhibitors, used to treat high blood pressure and heart failure (for example
captopril, enalapril, perindopril):

• Risk of severe lowering of blood pressure and/or acute renal failure when treatment with ACE inhibitors is started in patients with pre-existing sodium depletion (particularly in patients with renal artery stenosis).

If you are taking one or more of the medicines listed at the same time, the effect of indapamide may
be altered or side effects may occur:

• Metformin (used in the treatment of diabetes)
• Baclofen (used in the treatment of muscle spasms)
• Cyclosporine and tacrolimus (used to treat autoimmune diseases or to suppress the immune system response after a transplant)
• Steroids (for example prednisolone, hydrocortisone or fludrocortisone) used to treat various disorders, including severe asthma and rheumatoid arthritis
• Stimulant laxatives (for example senna)
• Some medicines used to treat heart failure and some heart rhythm disorders (for example digoxin, digitoxin)
• Some potassium-sparing diuretics, such as amiloride, spironolactone, triamterene
• Some diuretics that can cause a lowering of potassium levels, such as bendroflumethiazide, furosemide, piretanide, bumetanide and xipamide
• Some antidepressants (for example imipramine) and neuroleptics (used to treat mental disorders)
• Some medicines containing iodine (used for the diagnosis of some diseases)
• Tetracosactide (used for the diagnosis of some diseases and for the treatment of gastrointestinal disorders)
• Medicines containing calcium.

INDAPAMIDE DOC Generici with food and drink
Food and drink have no influence on the way the medicine works. You can therefore
take it regardless of meals, after meals or on an empty stomach.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Pregnancy:
The use of this medicine is not recommended during pregnancy. Tell your doctor if you are pregnant or
if you wish to become pregnant.
Breastfeeding:
The active ingredient is excreted in breast milk. Breastfeeding is therefore not recommended if you are
taking this medicine. Ask your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines
INDAPAMIDE DOC Generici lowers blood pressure and may therefore cause a feeling of
faintness or dizziness, related to the decrease in blood pressure, especially at the beginning
of therapy or when another antihypertensive is added. If you experience these symptoms, do not drive
vehicles and do not use machinery.

INDAPAMIDE DOC Generici contains lactose monohydrate
This medicine contains a sugar called lactose. If you have been diagnosed with
intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take INDAPAMIDE DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor.
The recommended dose is 1 tablet a day, preferably taken in the morning.

Patients with impaired renal function
Patients with severe renal insufficiency (creatinine clearance below 30 ml/min) should not be treated with
INDAPAMIDE DOC Generici (see section 2 “Do not take INDAPAMIDE DOC Generici”). Thiazides and
related diuretics are fully effective only when renal function is normal or only slightly impaired.

Patients with impaired hepatic function
Patients with severe hepatic insufficiency should not be treated with INDAPAMIDE DOC
Generici (see section 2 “Do not take INDAPAMIDE DOC Generici”).

Elderly
Elderly patients may be treated with INDAPAMIDE DOC Generici when renal function is normal or only
slightly impaired.

Use in children and adolescents
The use of INDAPAMIDE DOC Generici in children and adolescents is not recommended, due to the
lack of data regarding efficacy and safety.
Method of administration
The tablets should be swallowed whole with a sufficient amount of water (a glass). Do not
crush or chew the tablets. INDAPAMIDE DOC Generici can be taken
independently of meals.
Duration of treatment
The duration of treatment will be established by the treating doctor.
If you feel that the effect of INDAPAMIDE DOC Generici is too strong or too weak,
consult your doctor.

If you take more INDAPAMIDE DOC Generici than you should
In case of overdose, there will be a high rate of occurrence of undesirable effects, a
potentiation of the diuretic effect with risk of lowering blood pressure and disturbances
of water and electrolyte balance. If you have accidentally taken more INDAPAMIDE DOC Generici than
you should have, contact your doctor immediately for instructions. Symptoms of
overdose may include nausea, vomiting, low blood pressure (which
causes dizziness), cramps, dizziness, drowsiness, confusion, excessive or reduced
urine production.

If you forget to take INDAPAMIDE DOC Generici
If you forget to take a tablet at the scheduled time, take it as soon as you remember. However,
do not take a double dose to make up for the forgotten tablet.

If you stop taking INDAPAMIDE DOC Generici
Treatment for high blood pressure usually lasts for life. Do not stop
taking the medicine without first discussing it with your doctor.
If you have any doubts about 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 may occur:
Common (may affect up to 1 in 10 people):

• Decreased potassium levels in the blood, which can cause muscle weakness. The doctor may monitor these levels through specific blood tests (see “Warnings and precautions”)
• Allergic reaction (especially in individuals who tend to have allergic or asthmatic reactions) causing skin rashes with macules (light-colored flat spots) and papules (small bumps).

Uncommon (may affect up to 1 in 100 people):

• Vomiting
• Allergic reaction (especially in individuals who tend to have allergic or asthmatic reactions) causing the appearance of purple spots or patches on the skin.

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

• Dizziness/vertigo
• Fatigue
• Headache
• Tingling (paresthesia)
• Nausea (feeling of sickness)
• Constipation (infrequent bowel movements; hard and dry stools)
• Dry mouth.

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

• Reduced number of platelets in the blood, which increases the risk of bleeding or bruising
• Reduced number of white blood cells (leukopenia), which facilitates the occurrence of infections and can be severe (agranulocytosis), or suppression of the bone marrow (aplastic anemia). If you experience unexplained fever, sore throat or other flu-like symptoms, contact your doctor immediately, as these symptoms may indicate that the levels of white blood cells in the blood are too low
• Reduced levels of red blood cells (anemia), which can cause weakness, paleness, rapid heartbeat and shortness of breath
• Inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis)
• Irregular heartbeat
• Low blood pressure, which can cause dizziness
• Kidney problems
• Liver problems (detectable through blood tests)
• Increased calcium levels in the blood
• Severe allergic reactions (angioedema, especially in individuals who tend to have allergic reactions or asthma), with swelling of the face, lips or tongue, hives, swelling of the mucous membranes of the throat or airways, causing difficulty breathing or swallowing. If this occurs, contact your doctor immediately.
• Severe allergic reactions with symptoms similar to those of the flu, blistering on skin, mouth, eyes and genitals (toxic epidermal necrolysis or Stevens-Johnson syndrome). If this occurs, contact your doctor immediately.

The following side effects may also occur. However, based on the available data, it is not
possible to provide details regarding their frequency:

• INDAPAMIDE DOC Generici can cause a decrease in sodium levels in the blood.
• The doctor may monitor these levels through specific blood tests (see “Warnings and precautions”).
• INDAPAMIDE DOC Generici can cause a reduction in blood volume (hypovolemia), with loss of fluids and a drop in blood pressure when getting up (orthostatic hypotension).
• INDAPAMIDE DOC Generici can reduce chloride levels in the blood, causing metabolic alkalosis (low blood acidity).
• INDAPAMIDE DOC Generici can increase blood sugar levels.
• If you suffer from liver problems, taking INDAPAMIDE DOC Generici can cause a condition called hepatic encephalopathy (brain and nerve damage, which can manifest as a complication of liver disease).
• If you suffer from a condition called acute disseminated lupus erythematosus (a rare widespread inflammatory disease), taking INDAPAMIDE DOC Generici may worsen the disease.
• Taking INDAPAMIDE DOC Generici may make the skin more sensitive to UV rays (see “Warnings and precautions”).
• INDAPAMIDE DOC Generici may cause an increase in uric acid levels in the blood, causing gout attacks (painful and red swelling of the joints, often located in the big toe).
• Torsades de pointes (a particular form of cardiac rhythm disturbance, potentially fatal).
• Syncope.
• Hepatitis.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store INDAPAMIDE DOC Generici

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What INDAPAMIDE DOC Generici contains

• The active ingredient is indapamide. One prolonged-release film-coated tablet contains 1.5 mg of indapamide.
• The other ingredients are lactose monohydrate, carbomer, hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica, talc and hypromellose, titanium dioxide (E171), macrogol 3000, triacetin, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Description of the appearance of INDAPAMIDE DOC Generici and contents of the pack
INDAPAMIDE DOC Generici prolonged-release film-coated tablets are available in
the form of pale pink, round and biconvex tablets.
1 pack contains 28, 30, 56 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano

Manufacturer
Pharmaceutical Works POLPHARMA SA
19 Pelplińska Street
83-200 Starogard Gdanski
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany: Indapamid bioeq pharma 1.5 mg Retardtabletten
France: INDAPAMIDE Zydus LP 1.5 mg, prolonged-release film-coated tablets
Italy: INDAPAMIDE DOC Generici