INDAPAMIDE 1.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Indapamide SR Genoptim, 1.5 mg, Prolonged-Release Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents
3. What is Indapamide SR Genoptim and what is it used for
4. Important information before taking Indapamide SR Genoptim
   1. When Not to Take Indapamide SR Genoptim
   2. Warnings and Precautions
   3. Indapamide SR Genoptim and Other Medications
   4. Make Sure Your Doctor is Informed About the Use of Any of the Following Medications, as Special Precautions May be Necessary:
   5. Pregnancy and Breastfeeding
   6. Driving and Using Machines
   7. Indapamide SR Genoptim Contains Lactose
5. How to Take Indapamide SR Genoptim
   1. What to Do if You Take More Indapamide SR Genoptim Than You Should
   2. What to Do if You Forget to Take Indapamide SR Genoptim
   3. What to Do if You Want to Stop Taking Indapamide SR Genoptim
6. Possible Side Effects
   1. If You Experience Any of the Following Serious Side Effects, Stop Taking the Medication and Contact Your Doctor Immediately:
   2. Common (may occur in up to 1 in 10 patients):
   3. Uncommon (may occur in up to 1 in 100 patients):
   4. Rare (may occur in up to 1 in 1,000 patients):
   5. Very Rare (may occur in up to 1 in 10,000 patients):
   6. Frequency Not Known (frequency cannot be estimated from available data):
   7. Reporting Side Effects
7. How to Store Indapamide SR Genoptim
8. Contents of the Pack and Other Information
   1. What Indapamide SR Genoptim Contains
   2. What Indapamide SR Genoptim Looks Like and Contents of the Pack
   3. Marketing Authorization Holder and Manufacturer
   4. Marketing Authorization Holder
   5. Manufacturer

Package Leaflet: Information for the Patient

Indapamide SR Genoptim, 1.5 mg, Prolonged-Release Tablets

Indapamide

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 1. What is Indapamide SR Genoptim and what is it used for
• 2. Important information before taking Indapamide SR Genoptim
• 3. How to take Indapamide SR Genoptim
• 4. Possible side effects
• 5. How to store Indapamide SR Genoptim
• 6. Contents of the pack and other information

1. What is Indapamide SR Genoptim and what is it used for

Indapamide SR Genoptim is a prolonged-release tablet containing indapamide as the active substance. This medication is used to lower high blood pressure (hypertension) in adults. Indapamide is a diuretic. Most diuretics increase urine production by the kidneys. However, indapamide differs from other diuretics, causing only a slight increase in the amount of urine produced. Additionally, indapamide dilates blood vessels, making it easier for blood to flow. This helps lower blood pressure.

2. Important information before taking Indapamide SR Genoptim

When Not to Take Indapamide SR Genoptim

• if you are allergic to indapamide, sulfonamides, or any of the other ingredients of this medication (listed in section 6);
• if you have severe kidney disease;
• if you have severe liver disease or liver dysfunction (encephalopathy);
• if you have low potassium levels in your blood.

Warnings and Precautions

Before starting treatment with Indapamide SR Genoptim, discuss with your doctor or pharmacist:

• if you have liver problems;
• if you have diabetes;
• if you have gout;
• if you have any heart rhythm disorders or kidney problems;
• if you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure - they may occur within a few hours to weeks after taking Indapamide SR Genoptim. If left untreated, they can lead to permanent vision loss. The risk of these symptoms is higher in patients who have previously been allergic to penicillin or sulfonamides.

If you have muscle disorders, including pain, tenderness, weakness, or cramps;

• if you are scheduled for a test to assess parathyroid function.

Tell your doctor if you experience a light sensitivity reaction. Your doctor may order blood tests to check for low sodium or potassium levels, or high calcium levels in your blood. If you think you may be affected by any of the above or have questions or concerns about taking this medication, consult your doctor or pharmacist. Athletesshould be aware that this medication contains an active substance that can cause positive doping test results.

Indapamide SR Genoptim and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take. Do nottake Indapamide SR Genoptim with lithium (used to treat depression) due to the risk of increased lithium levels in your blood.

Make Sure Your Doctor is Informed About the Use of Any of the Following Medications, as Special Precautions May be Necessary:

• medications used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis preparations, bretylium);
• medications used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, neuroleptics (e.g., amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol));
• bepridil (used to treat coronary artery disease, which causes chest pain);
• cisapride, difemanil (used to treat gastrointestinal disorders);
• antibiotics used to treat bacterial infections (e.g., sparfloxacin, moxifloxacin, erythromycin in injectable form);
• vincamine in injectable form (used to treat cognitive disorders in the elderly, including memory loss);
• halofantrine (an antiparasitic medication used to treat various types of malaria);
• pentamidine (used to treat certain types of pneumonia);
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, acemetazine, terfenadine);
• non-steroidal anti-inflammatory medications used to relieve pain (e.g., ibuprofen) and acetylsalicylic acid in high doses;
• angiotensin-converting enzyme (ACE) inhibitors (used to treat hypertension and heart failure);
• amphotericin B in injectable form (used to treat fungal infections);
• oral corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis;
• laxatives that stimulate peristalsis;
• baclofen (used to treat muscle stiffness, such as in multiple sclerosis);
• allopurinol (used to treat gout);
• potassium-sparing diuretics (e.g., amiloride, spironolactone, and triamterene);
• metformin (used to treat diabetes);
• contrast agents containing iodine (used in X-ray tests);
• medications containing calcium or other calcium-containing products;
• cyclosporine, tacrolimus, or other immunosuppressive medications used after organ transplantation, to treat autoimmune diseases, severe rheumatic diseases, or dermatological diseases;
• tetracosactide (used to treat Crohn's disease);
• methadone (used to treat addiction).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication. This medication is not recommended during pregnancy. If pregnancy is planned or confirmed, alternative treatment should be started as soon as possible. Inform your doctor that you are pregnant or plan to become pregnant. The active substance is excreted into breast milk. This medication is not recommended during breastfeeding.

Driving and Using Machines

This medication can cause side effects related to lowering blood pressure, such as dizziness or fatigue (see section 4). These side effects can occur especially at the beginning of treatment and after dose increase. If these side effects occur, avoid driving and operating machinery. However, with proper blood pressure control, the occurrence of these side effects is unlikely.

Indapamide SR Genoptim Contains Lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medication.

3. How to Take Indapamide SR Genoptim

Always take this medication exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is one tablet per day, taken preferably in the morning. The tablets can be taken with or without food. Swallow the tablet whole with water. Do not break or chew it. Treatment of hypertension is usually lifelong.

What to Do if You Take More Indapamide SR Genoptim Than You Should

If you have taken more tablets than you should, contact your doctor or pharmacist immediately. Very high doses of Indapamide SR Genoptim can cause nausea, vomiting, low blood pressure, muscle cramps, dizziness, drowsiness, confusion, and changes in urine production by the kidneys.

What to Do if You Forget to Take Indapamide SR Genoptim

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

What to Do if You Want to Stop Taking Indapamide SR Genoptim

Treatment of hypertension usually lasts for the rest of your life, so consult your doctor before stopping this medication. If you have any further questions about taking this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Indapamide SR Genoptim can cause side effects, although not everybody gets them.

If You Experience Any of the Following Serious Side Effects, Stop Taking the Medication and Contact Your Doctor Immediately:

• angioedema and/or urticaria. Angioedema is characterized by swelling of the skin of the limbs or face, lips, or tongue, mucous membranes of the throat or respiratory tract, which can cause difficulty breathing or swallowing. If you experience these symptoms, contact your doctor immediately (very rare - may occur in up to 1 in 10,000 patients);
• severe skin reactions, including severe rash, redness of the skin, severe itching, blistering, peeling, and swelling of the skin, or other allergic reactions (very rare - may occur in up to 1 in 10,000 patients);
• life-threatening heart rhythm disorders (frequency not known);
• pancreatitis, which can cause severe abdominal and back pain with very poor general condition (very rare - may occur in up to 1 in 10,000 patients);
• liver disease caused by liver dysfunction (encephalopathy) (frequency not known);
• hepatitis (frequency not known);
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high temperature, which can be caused by abnormal muscle breakdown (frequency not known).

Other side effects may include:

Common (may occur in up to 1 in 10 patients):

• red, raised rash;
• allergic reactions, mainly affecting the skin, in people prone to allergies and asthma;
• low potassium levels in the blood.

Uncommon (may occur in up to 1 in 100 patients):

• vomiting;
• red spots on the skin (petechiae);
• low sodium levels in the blood, which can cause dehydration and low blood pressure;
• impotence (inability to achieve or maintain an erection).

Rare (may occur in up to 1 in 1,000 patients):

• feeling tired, headache; tingling or numbness (paresthesia), dizziness;
• gastrointestinal disorders (such as nausea, constipation), dry mouth;
• low chloride levels in the blood;
• low magnesium levels in the blood.

Very Rare (may occur in up to 1 in 10,000 patients):

• changes in blood cell count, such as thrombocytopenia (reduced platelet count, which can cause easy bruising and nosebleeds), leukopenia (reduced white blood cell count, which can cause unexplained fever, sore throat, or other flu-like symptoms - if you experience these symptoms, contact your doctor), and anemia (reduced red blood cell count);
• high calcium levels in the blood;
• heart rhythm disorders, low blood pressure;
• kidney failure;
• liver function disorders.

Frequency Not Known (frequency cannot be estimated from available data):

• fainting;
• in patients with acute systemic lupus erythematosus (a rare inflammatory disease), taking this medication may worsen the symptoms of the disease;
• light sensitivity reactions (skin changes) after exposure to sunlight or UVA radiation;
• myopia;
• blurred vision;
• vision disturbances;
• vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma).
• changes in laboratory test results (blood tests) may occur, and your doctor may order blood tests. The following changes in laboratory test results may occur:
• increased uric acid levels, which can cause or worsen gout (joint pain or stiffness, especially in the feet);
• increased glucose levels in the blood in patients with diabetes;
• high calcium levels in the blood;
• increased liver enzyme activity.
• abnormal electrocardiogram (ECG) tracing.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Indapamide SR Genoptim

Keep this medication out of the sight and reach of children. Do not use this medication after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Indapamide SR Genoptim Contains

• The active substance is indapamide. Each Indapamide SR Genoptim tablet contains 1.5 mg of indapamide.
• The other ingredients are lactose monohydrate, hypromellose (Methocel K4M Premium), colloidal anhydrous silica, and magnesium stearate.
• The tablet coating (Opadry II white 33G28707) contains hypromellose 6cP (E464), titanium dioxide (E171), lactose monohydrate, macrogol 3000, and triacetin.

What Indapamide SR Genoptim Looks Like and Contents of the Pack

Indapamide SR Genoptim is a white, biconvex, round tablet with the inscription "1.5" on one side and a smooth surface on the other. Indapamide SR Genoptim is available in packs containing 10, 14, 15, 20, 28, 30, 50, 60, 90, 98, and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Synoptis Pharma Sp. z o.o., ul. Krakowiaków 65, 02-255 Warsaw

Manufacturer

Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, Netherlands; TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary; Date of last revision of the package leaflet:July 2022