PERINDOPRIL 8 mg + 2.5 Mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Perindopril + Indapamide Krka, 8 mg + 2.5 mg, Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
3. What is Perindopril + Indapamide Krka and what is it used for
   1. What is Perindopril + Indapamide Krka
   2. What is Perindopril + Indapamide Krka used for
4. Important information before taking Perindopril + Indapamide Krka
   1. When not to take Perindopril + Indapamide Krka:
   2. Warnings and precautions
   3. Children and Adolescents
   4. Perindopril + Indapamide Krka with other medications
   5. Perindopril + Indapamide Krka with food and drink
   6. Pregnancy and Breastfeeding
   7. Driving and using machines
   8. Perindopril + Indapamide Krka contains lactose and sodium
5. How to take Perindopril + Indapamide Krka
   1. Overdose of Perindopril + Indapamide Krka
   2. Missing a dose of Perindopril + Indapamide Krka
   3. Stopping treatment with Perindopril + Indapamide Krka
6. Possible side effects
   1. If you experience any of the following serious side effects, stop taking this medication and consult your doctor immediately:
   2. Reporting side effects
7. How to store Perindopril + Indapamide Krka
8. Contents of the pack and other information
   1. What Perindopril + Indapamide Krka contains
   2. What Perindopril + Indapamide Krka looks like and contents of the pack
   3. Marketing authorization holder and manufacturer

Package Leaflet: Information for the Patient

Perindopril + Indapamide Krka, 8 mg + 2.5 mg, Tablets

tert-Butylamine Perindopril + Indapamide

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult your doctor or pharmacist.
• This medication has been prescribed specifically for you. 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 leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Perindopril + Indapamide Krka and what is it used for

What is Perindopril + Indapamide Krka

Perindopril + Indapamide Krka is a combination of two active substances, perindopril and indapamide. Perindopril + Indapamide Krka is an antihypertensive medication used to treat high blood pressure (hypertension).

What is Perindopril + Indapamide Krka used for

Perindopril belongs to a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors). The mechanism of action of these medications involves dilating blood vessels, making it easier for the heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine excreted by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in urine production. Each active substance lowers blood pressure, and their combined effect improves blood pressure control.

2. Important information before taking Perindopril + Indapamide Krka

When not to take Perindopril + Indapamide Krka:

• If you are allergic to perindopril or any other ACE inhibitor; or to indapamide or any other sulfonamide or to any of the other ingredients of this medication (listed in section 6);
• If you have experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rash while taking ACE inhibitors in the past;

or if you have experienced such symptoms in any other circumstances (a condition known as angioedema);

• In patients with severe liver disease or hepatic encephalopathy (liver dysfunction);
• If you have severe kidney disease that reduces blood flow to the kidneys (renal artery stenosis);
• If you are undergoing dialysis or blood filtration using a different method. Depending on the device used, Perindopril + Indapamide Krka may not be suitable for you;
• In case of increased or decreased potassium levels in the blood;
• In patients with suspected untreated or uncontrolled heart failure (symptoms may include water retention and breathing difficulties);
• Above 3 months of pregnancy (it is also recommended to avoid taking Perindopril + Indapamide Krka in early pregnancy - see "Pregnancy and Breastfeeding");
• If you have diabetes and are taking a blood pressure-lowering medication containing aliskiren,
• If you have taken or are currently taking sacubitril with valsartan, a medication used to treat a certain type of chronic heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases.

Warnings and precautions

Before starting treatment with Perindopril + Indapamide Krka, discuss it with your doctor or pharmacist:

• if you have aortic stenosis (narrowing of the main heart valve) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney);
• if you have heart failure or any other heart disease;
• if you have kidney disease or are undergoing dialysis;
• if you have an abnormal increase in a hormone called aldosterone in your blood (primary aldosteronism);
• if you have liver disease;
• if you have connective tissue diseases (skin diseases), such as systemic lupus erythematosus or systemic scleroderma;
• if you have atherosclerosis (hardening of the arteries);
• if you have hyperparathyroidism (overactive parathyroid glands);
• if you have gout;
• if you have diabetes;
• if you are on a low-salt diet or using salt substitutes containing potassium;
• if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene) - you should avoid taking them with Perindopril + Indapamide Krka (see "Perindopril + Indapamide Krka with other medications");
• if you are elderly;
• if you have had allergic reactions to sunlight;
• if you have had a severe allergic reaction with facial, lip, mouth, tongue, or throat swelling, which can cause difficulty swallowing or breathing (angioedema) - swelling can occur at any time during treatment. If such symptoms occur, discontinue treatment and consult your doctor immediately;
• if you are taking any of the following medications used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g., valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes,
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood.

See also the subsection "When not to take Perindopril + Indapamide Krka".

• if you are black - in this case, there may be a higher risk of angioedema and the medication may be less effective in lowering blood pressure than in patients of other races;
• if you are undergoing dialysis using high-flux membranes;
• if you are taking any of the following medications, which increase the risk of angioedema (rapid swelling of tissues under the skin, such as the throat):
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus, and other medications belonging to the so-called mTOR inhibitors (used to prevent organ rejection and treat cancer),
• linagliptin, saxagliptin, sitagliptin, wildagliptin, and other medications belonging to the group of medications called gliptins (used to treat diabetes).

Angioedema

In patients treated with ACE inhibitors, including Perindopril + Indapamide Krka, angioedema (severe allergic reaction with facial, lip, tongue, or throat swelling, and difficulty swallowing or breathing) has been reported. This reaction can occur at any time during treatment. If such symptoms occur, discontinue Perindopril + Indapamide Krka and consult your doctor immediately. See also section 4.

You must inform your doctor about pregnancy, suspected pregnancy, or planning pregnancy. Do not take Perindopril + Indapamide Krka during pregnancy and breastfeeding, or if you are planning to become pregnant, consult your doctor or pharmacist before taking this medication.

• planned anesthesia and/or surgery,
• recent diarrhea, vomiting, or dehydration,
• planned dialysis or LDL cholesterol apheresis (a procedure to remove cholesterol from the blood using a special device),
• planned desensitization to bee or wasp venom,
• planned diagnostic procedure involving intravenous administration of iodine-containing contrast agents (a substance that allows organs such as the kidneys or stomach to be visible on X-ray images),
• if you experience vision disturbances or eye pain while taking Perindopril + Indapamide Krka. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or glaucoma, increased pressure in one or both eyes - they can occur within a few hours to weeks after taking Perindopril + Indapamide Krka. Patients with a history of sulfonamide or penicillin allergy may be more prone to developing this condition. Discontinue Perindopril + Indapamide Krka and consult your doctor.

The medication contains the active substance indapamide, which may give a positive result in anti-doping tests.

Children and Adolescents

Perindopril + Indapamide Krka should not be used in children and adolescents.

Perindopril + Indapamide Krka with 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.

Avoid taking Perindopril + Indapamide Krka with:

• lithium (used to treat depression),
• aliskiren (a medication used to treat high blood pressure) in patients who do not have diabetes or kidney problems;
• potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium salts, or other medications that may increase potassium levels in the body (such as heparin, a medication used to thin blood to prevent clots; trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections, cyclosporine, an immunosuppressive medication used to prevent organ rejection),
• estramustine (used to treat cancer),
• other medications used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.

Other medications may affect treatment with Perindopril + Indapamide Krka. Inform your doctor if you are taking any of the following medications, as special care may be necessary:

• other medications used to treat high blood pressure; including angiotensin II receptor antagonists (AIIRA) or aliskiren (see also subsections "When not to take Perindopril + Indapamide Krka" and "Warnings and precautions"), or diuretics (medications that increase urine production);
• potassium-sparing medications used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• a combination medication containing sacubitril and valsartan (used to treat chronic heart failure). See subsections "When not to take Perindopril + Indapamide Krka" and "Warnings and precautions".
• anesthetics;
• iodine-containing contrast agents;
• procainamide (used to treat heart rhythm disorders),
• allopurinol (used to treat gout),
• terfenadine or astemizole, mizolastine (antihistamines used to treat hay fever or allergies),
• corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis,
• immunosuppressive medications used to treat autoimmune diseases or prevent organ rejection (e.g., cyclosporine, tacrolimus),
• anticancer medications,
• intravenous erythromycin, moxifloxacin, sparfloxacin (antibiotics),
• halofantrine (used to treat certain types of malaria),
• pentamidine (used to treat pneumonia),
• vincamine (used to treat cognitive disorders in the elderly, including memory loss),
• bepridil (used to treat angina pectoris),
• medications used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, bretylium),
• cisapride, difemanil (used to treat gastrointestinal disorders),
• digoxin or other cardiac glycosides (used to treat heart conditions),
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
• antidiabetic medications, such as insulin, metformin, or gliptins,
• calcium, including calcium supplements,
• laxatives that stimulate peristalsis (e.g., senna),
• nonsteroidal anti-inflammatory medications (e.g., ibuprofen) or salicylates in high doses (e.g., acetylsalicylic acid),
• amphotericin B administered intravenously (used to treat severe fungal infections),
• medications used to treat mental disorders, such as depression, anxiety, schizophrenia [e.g., tricyclic antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)],
• tetracosactide (used to treat Crohn's disease),
• vasodilators, including nitrates,
• gold administered intravenously (used to treat arthritis), e.g., aurothioglycan sodium,
• a medication commonly used to treat diarrhea (racecadotril),
• medications commonly used to prevent organ rejection (sirolimus, everolimus, temsirolimus, or other medications belonging to the so-called mTOR inhibitors). See subsection "Warnings and precautions",
• medications used to treat low blood pressure, shock, or asthma (e.g., ephedrine, norepinephrine, or epinephrine).

Your doctor may recommend changing the dose and/or taking other precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also subsections "When not to take Perindopril + Indapamide Krka" and "Warnings and precautions").

Perindopril + Indapamide Krka with food and drink

It is recommended to take Perindopril + Indapamide Krka before a meal.

Pregnancy and Breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy

Inform your doctor about pregnancy, suspected pregnancy, or planning pregnancy. Your doctor will usually recommend discontinuing Perindopril + Indapamide Krka before planned pregnancy or as soon as possible after pregnancy is confirmed, and will recommend taking a different medication instead of Perindopril + Indapamide Krka. It is not recommended to take Perindopril + Indapamide Krka in early pregnancy and it should not be taken after 3 months of pregnancy, as it may have a very harmful effect on the development of the fetus if taken during this period.

Breastfeeding

Inform your doctor about breastfeeding or intending to breastfeed. Perindopril + Indapamide Krka is not recommended during breastfeeding, and your doctor may prescribe a different medication if you want to breastfeed.

Driving and using machines

Perindopril + Indapamide Krka usually does not affect alertness, but in some patients, it may cause individual reactions such as dizziness or weakness due to lowered blood pressure. If such symptoms occur, the ability to drive or operate machinery may be impaired.

Perindopril + Indapamide Krka contains lactose and sodium

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

This medication contains less than 1 mmol of sodium (23 mg) per tablet, so it can be considered "essentially sodium-free".

3. How to take Perindopril + Indapamide Krka

Always take this medication exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

The recommended dose is one tablet once a day.

Your doctor may decide to change the dose in case of concurrent kidney function disorders.

It is recommended to take one tablet in the morning, before a meal.

Swallow the tablet with a glass of water.

Overdose of Perindopril + Indapamide Krka

If you have taken too many tablets, contact your doctor or go to the emergency department of the nearest hospital immediately. The most likely symptom of overdose is low blood pressure.

If you experience a significant drop in blood pressure (with accompanying nausea, vomiting, cramps, dizziness, drowsiness, disorientation, or changes in urine production), lie down with your legs elevated above the level of your torso.

Missing a dose of Perindopril + Indapamide Krka

It is important to take the medication daily, as the effectiveness of hypertension treatment depends on regular medication intake. However, if you miss a dose of Perindopril + Indapamide Krka, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Perindopril + Indapamide Krka

Since hypertension treatment usually lasts a lifetime, consult your doctor before stopping treatment.

If you have any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Perindopril + Indapamide Krka can cause side effects, although not everyone gets them.

If you experience any of the following serious side effects, stop taking this medication and consult your doctor immediately:

• severe dizziness or fainting due to low blood pressure (common - may occur in less than 1 in 10 patients);
• bronchospasm (feeling of chest tightness, wheezing, and shortness of breath; uncommon - may occur in less than 1 in 100 patients);
• facial, lip, mouth, tongue, or throat swelling, difficulty breathing - sudden allergic reaction with shortness of breath, rash (angioedema, see subsection "Warnings and precautions" in section 2); uncommon - may occur in less than 1 in 100 patients;
• severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, or other allergic reactions (very rare - may occur in less than 1 in 10,000 patients);
• cardiovascular disorders (heart rhythm disorders, angina pectoris, heart attack; very rare - may occur in less than 1 in 10,000 patients);
• weakness or paralysis of the arms or legs, or speech disorders, which may be symptoms of a stroke (very rare - may occur in less than 1 in 10,000 patients);
• pancreatitis, which can cause severe abdominal pain and general malaise (very rare - may occur in less than 1 in 10,000 patients);
• jaundice (yellowing of the skin or eyes), which can be a symptom of liver inflammation (very rare - may occur in less than 1 in 10,000 patients);
• life-threatening heart rhythm disorders (frequency not known);
• liver disease caused by liver dysfunction (encephalopathy; frequency not known);
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high fever, which may be caused by abnormal muscle breakdown (frequency not known).

The following side effects have been reported:

Common (may occur in less than 1 in 10 patients):

• skin reactions in patients prone to allergic and asthmatic reactions, headache, vision disturbances, dizziness, weakness (asthenia), tinnitus, vertigo, paresthesia, dyspnea, cough, gastrointestinal disorders (nausea, abdominal pain, loss of appetite, vomiting), abdominal pain, taste disturbances, dry mouth, dyspepsia, diarrhea, constipation), muscle cramps, allergic reactions (such as skin rashes, itching), fatigue, low potassium levels in the blood.

Uncommon (may occur in less than 1 in 100 patients):

• mood changes, sleep disturbances, depression, urticaria, purpura, changes in kidney function, excessive sweating, impotence (erectile dysfunction), sexual dysfunction, increased eosinophil count, changes in laboratory test results: high potassium levels in the blood, which may be transient after discontinuation of treatment, low sodium levels in the blood, which may cause dehydration and low blood pressure; drowsiness, fainting, palpitations, tachycardia, hypoglycemia, vasculitis, photosensitivity reactions, arthralgia, myalgia, chest pain, malaise, peripheral edema, fever, increased urea levels in the blood, increased creatinine levels in the blood, falls
• if you have systemic lupus erythematosus, your disease symptoms may worsen.

Rare (may occur in less than 1 in 1,000 patients):

• worsening of psoriasis, changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in serum, high calcium levels in blood serum, low chloride levels in the blood, low magnesium levels in the blood, decreased or absent urine production, sudden reddening of the face and neck, acute kidney failure,
• dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion).

Very rare (may occur in less than 1 in 10,000 patients):

• confusion, eosinophilic pneumonia (a rare form of pneumonia), nasal congestion or rhinitis (inflammation of the nasal mucosa), changes in blood parameters, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin levels, decreased hematocrit, decreased platelet count, liver dysfunction.

Unknown (frequency cannot be estimated from available data):

• abnormal heart rhythm detected on an ECG, changes in laboratory test results: high uric acid levels and high blood sugar levels, myopia, blurred vision, visual impairment, 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 glaucoma),

• cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon).

There may be blood, kidney, liver, or pancreas disorders, as well as changes in laboratory test results (blood tests). Your doctor may recommend blood tests to monitor your health.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 Perindopril + Indapamide Krka

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the month.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

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 Perindopril + Indapamide Krka contains

• The active substances of the medication are perindopril tert-butylamine and indapamide. Each tablet contains 8 mg of perindopril tert-butylamine, equivalent to 6.68 mg of perindopril, and 2.5 mg of indapamide.
• Other ingredients are: calcium chloride hexahydrate, lactose monohydrate, crospovidone, microcrystalline cellulose, sodium bicarbonate, colloidal silicon dioxide, magnesium stearate. See section 2, "Perindopril + Indapamide Krka contains lactose and sodium".

What Perindopril + Indapamide Krka looks like and contents of the pack

White to almost white, round, slightly convex tablets with a dividing line on one side. The dividing line on the tablet is only to facilitate breaking and does not divide the tablet into equal doses.

Packaging: 14, 20, 28, 30, 50, 56, 60, 90, or 100 tablets in blisters in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

To obtain more detailed information on the names of medicinal products in other EU member states, contact the local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warsaw

Tel. 22 57 37 500

Date of last revision of the leaflet:13.01.2022