Indapamide Doc Generici

Italy
Brand name Indapamide Doc Generici
Form tablets, prolonged-release
Active substance / Dosage
INDAPAMIDE
Prescription type Prescription only
ATC code
C03BA11
Registration number 039505
Manufacturer DOC GENERICI SRL

Table of Contents

Patient Information Leaflet

INDAPAMIDE DOC Generici 1.5 mg prolonged-release film-coated tablets

Generic Medicine
Read this entire 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, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 INDAPAMIDE DOC Generici is and what it is 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 should know before taking INDAPAMIDE DOC Generics

Do not take INDAPAMIDE DOC Generics

  • If you are allergic to indapamide or to any of the other ingredients of this medicine (listed in section 6)
  • If you are allergic to other medicines belonging to the same chemical class as indapamide ("sulfonamides"), such as trimethoprim or cotrimoxazole
  • If you have severe liver disease or a condition called hepatic encephalopathy (a brain and nerve disorder that may occur as a complication of liver problems)
  • If you have 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 Generics.
Inform your doctor before starting this medicine if you have or have previously had any of the following conditions:

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

Indapamide affects blood levels of potassium and sodium. Your doctor may perform blood tests to monitor potassium and sodium levels both before and during treatment. This is particularly important for patients at high risk of developing electrolyte imbalances (such as elderly patients, those taking multiple medications, or malnourished patients).
INDAPAMIDE DOC Generics may increase skin sensitivity to sunlight. If this occurs, consult your doctor, as treatment interruption may be necessary. When taking indapamide, it is advisable to protect skin areas exposed to sunlight or artificial UVA radiation.
If parathyroid function testing is required, contact your doctor, who will discontinue treatment with INDAPAMIDE DOC Generics.
For athletes: Use of this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Athletes should be aware that INDAPAMIDE DOC Generics may result in a positive anti-doping test.
If you believe any of the situations described apply to you, or if you have questions or doubts about taking this medicine, consult your doctor or pharmacist.
Other medicines and INDAPAMIDE DOC Generics
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
If you are taking one or more of the following medicines concurrently, the effect of INDAPAMIDE DOC Generics may be altered or undesirable effects may occur. Inform your doctor if you are taking any of the following medicines:
Combinations not recommended:

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

Combinations requiring precautions during use:
Torsades de pointes (a specific type of heart rhythm disorder) may be induced by taking:

  • Medicines used to treat irregular heartbeat, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide.
  • Medicines used to treat psychosis, such as chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine, amisulpride, sulpiride, sultopride, tiapride, droperidol, haloperidol.
  • Other various medicines such as bepridil (used to treat angina), cisapride and difemethil (used to treat gastrointestinal disorders), intravenous erythromycin, pentamidine, moxifloxacin, sparfloxacin (used to treat infections), halofantrine (used to treat malaria), mizolastine (used to treat allergies), intravenous vincamine (used to treat cerebral circulatory disorders).

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

  • Possible reduction in the blood pressure-lowering effect of INDAPAMIDE DOC Generics. Risk of acute kidney failure in patients with reduced body fluid volume (dehydration). Adequate fluid intake is essential.

ACE inhibitors, used to treat high blood pressure and heart failure (e.g., captopril, enalapril, perindopril):

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

If you are taking one or more of the following medicines concurrently, the effect of indapamide may be altered or undesirable effects may occur:

  • Metformin (used to treat diabetes)
  • Baclofen (used to treat muscle spasms)
  • Cyclosporine and tacrolimus (used to treat autoimmune diseases or to suppress the immune response after organ transplantation)
  • Steroids (e.g., prednisolone, hydrocortisone, or fludrocortisone) used to treat various disorders, including severe asthma and rheumatoid arthritis
  • Stimulant laxatives (e.g., senna)
  • Some medicines used to treat heart failure and certain heart rhythm disorders (e.g., digoxin, digitoxin)
  • Some potassium-sparing diuretics, such as amiloride, spironolactone, triamterene
  • Some diuretics that may cause low potassium levels, such as bendroflumethiazide, furosemide, piretanide, bumetanide, and xipamide
  • Some antidepressants (e.g., imipramine) and neuroleptics (used to treat mental disorders)
  • Some iodine-containing medicines (used in diagnosing certain diseases)
  • Tetracosactide (used in diagnosing certain diseases and treating gastrointestinal disorders)
  • Medicines containing calcium.

INDAPAMIDE DOC Generics with food and drink
Food and beverages do not affect how this medicine works. Therefore, you may take it during meals, after meals, or on an empty stomach.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Pregnancy:
Use of this medicine is not recommended during pregnancy. Inform your doctor if you are pregnant or intend to become pregnant.
Breastfeeding:
The active ingredient is excreted in breast milk. Breastfeeding is therefore not recommended while taking this medicine. Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
INDAPAMIDE DOC Generics lowers blood pressure and may therefore cause dizziness or fainting due to reduced blood pressure, especially at the beginning of treatment or when another antihypertensive is added. If you experience these symptoms, do not drive or operate machinery.
INDAPAMIDE DOC Generics contains lactose monohydrate
This medicine contains a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take INDAPAMIDE DOC Generici

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
The recommended dose is 1 tablet daily, to be taken preferably in the morning.

Patients with impaired renal function
Patients with severe renal impairment (creatinine clearance below 30 ml/min) must 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 minimally impaired.

Patients with impaired hepatic function
Patients with severe hepatic impairment must not be treated with INDAPAMIDE DOC Generici (see section 2 "Do not take INDAPAMIDE DOC Generici").

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

Use in children and adolescents
The use of INDAPAMIDE DOC Generici in children and adolescents is not recommended due to lack of data on efficacy and safety.

Instructions for administration
The tablets should be swallowed whole with a sufficient amount of water (a glassful). Do not crush or chew the tablets. INDAPAMIDE DOC Generici may be taken independently of meals.

Duration of treatment
The duration of treatment will be determined by your physician.
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 an increased occurrence of adverse reactions, enhanced diuretic effect with risk of low blood pressure and disturbances in fluid and electrolyte balance. If you have accidentally taken more INDAPAMIDE DOC Generici than you should, contact your doctor immediately for advice. Symptoms of overdose may include nausea, vomiting, low blood pressure (causing fainting), cramps, dizziness, drowsiness, confusion, and 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 continues for life. Do not stop taking this medicine without first discussing it with your doctor.

If you have any questions about the use of 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):

  • Decrease in blood potassium levels, which may cause muscle weakness. Your doctor can monitor these levels with specific blood tests (see "Warnings and precautions")
  • Allergic reaction (especially in individuals who tend to have allergic or asthmatic reactions) causing skin eruptions with macules (flat, pale spots) and papules (small raised 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 sensations (paraesthesia)
  • Nausea (feeling of nausea)
  • Constipation (infrequent bowel movements; hard, dry stools)
  • Dry mouth

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

  • Reduction in the number of platelets in the blood, increasing the risk of bleeding or bruising
  • Reduction in the number of white blood cells (leucopenia), which increases the risk of infections and may be serious (agranulocytosis), or bone marrow suppression (aplastic anaemia). If you experience unexplained fever, sore throat, or other flu-like symptoms, contact your doctor immediately, as these may indicate that your white blood cell levels are too low
  • Reduction in red blood cell levels (anaemia), which may cause weakness, paleness, rapid heartbeat, and shortness of breath
  • Inflammation of the pancreas causing severe abdominal and back pain (pancreatitis)
  • Irregular heartbeat
  • Low blood pressure, which may cause fainting
  • Kidney problems
  • Liver problems (detectable by blood tests)
  • Increased levels of calcium 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 flu-like symptoms, blistering of the 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 available data, it is not possible to estimate their frequency:

  • INDAPAMIDE DOC Generici may cause a decrease in blood sodium levels.
  • Your doctor can monitor these levels with specific blood tests (see "Warnings and precautions").
  • INDAPAMIDE DOC Generici may reduce blood volume (hypovolaemia), with fluid loss and drop in blood pressure upon standing (orthostatic hypotension).
  • INDAPAMIDE DOC Generici may reduce chloride levels in the blood, leading to metabolic alkalosis (reduced blood acidity).
  • INDAPAMIDE DOC Generici may increase blood sugar levels.
  • If you have liver problems, taking INDAPAMIDE DOC Generici may cause a condition called hepatic encephalopathy (a brain and nerve disorder, which may occur as a complication of liver disease).
  • If you have a condition called acute disseminated lupus erythematosus (a rare systemic inflammatory disease), taking INDAPAMIDE DOC Generici may worsen the disease.
  • Taking INDAPAMIDE DOC Generici may make your skin more sensitive to UV rays (see "Warnings and precautions").
  • INDAPAMIDE DOC Generici may increase blood uric acid levels, causing gout attacks (painful, red swelling of the joints, often affecting the big toe).
  • Torsades de pointes (a specific type of potentially life-threatening cardiac arrhythmia).
  • Syncope.
  • Hepatitis.

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.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 temperatures above 30°C.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 DOC Generici contains

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

Description of the appearance of INDAPAMIDE DOC Generici and package contents
INDAPAMIDE DOC Generici prolonged-release film-coated tablets are available as pale pink, round, biconvex tablets.
1 package contains 28, 30, 56 or 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorization 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 authorized in the European Economic Area Member States under the following names:
Germany: Indapamid bioeq pharma 1.5 mg Retardtabletten
France: INDAPAMIDE Zydus LP 1.5 mg, comprimés pelliculés à libération prolongée
Italy: INDAPAMIDE DOC Generici