PERINDOPRIL 4 mg /1.25 Mg Coated Tablet

Зміст інструкції

1. Perindopril and Indapamide Zentiva 4 mg+1.25 mg tablets
   1. What is Perindopril and Indapamide Zentiva 4 mg+1.25 mg and what is it used for
   2. What you need to know before taking Perindopril and Indapamide Zentiva 4 mg+1.25 mg
   3. How to take Perindopril and Indapamide Zentiva 4 mg+1.25 mg
   4. Possible side effects
   5. How to store Perindopril e Indapamide Zentiva 4 mg+1,25 mg
   6. Contents of the pack and other information
2. Perindopril and Indapamide Zentiva 8 mg+2.5 mg tablets
   1. What is Perindopril and Indapamide Zentiva 8 mg+2.5 mg and what is it used for
   2. What you need to know before taking Perindopril and Indapamide Zentiva 8 mg+2.5 mg
   3. How to take Perindopril and Indapamide Zentiva 8 mg+2.5 mg
   4. Possible side effects
   5. How to store Perindopril e Indapamide Zentiva 8 mg+2,5 mg
   6. Contents of the pack and other information

Perindopril and Indapamide Zentiva 4 mg+1.25 mg tablets

Generic medicine
Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Never give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Perindopril and Indapamide Zentiva 4 mg+1.25 mg is and what it is used for
• 2. What you need to know before you take Perindopril and Indapamide Zentiva 4 mg+1.25 mg
• 3. How to take Perindopril and Indapamide Zentiva 4 mg+1.25 mg
• 4. Possible side effects
• 5. How to store Perindopril and Indapamide Zentiva 4 mg+1.25 mg
• 6. Contents of the pack and other information

1. What is Perindopril and Indapamide Zentiva 4 mg+1.25 mg and what is it used for

Perindopril and Indapamide Zentiva 4 mg+1.25 mg is a combination of two active ingredients, perindopril and
indapamide.
It is an antihypertensive and is used in the treatment of high blood pressure (hypertension).
Perindopril belongs to a class of medicines called ACE inhibitors. These drugs work by dilating the
blood vessels, which makes it easier for the heart to pump blood through.
Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, Indapamide
differs from other diuretics in that it causes only a slight increase in the amount of urine produced.
Each active ingredient reduces blood pressure and, together, they work to control blood
pressure.

2. What you need to know before taking Perindopril and Indapamide Zentiva 4 mg+1.25 mg

Do not take Perindopril and Indapamide Zentiva 4 mg+1.25 mg

• if you are allergic to perindopril or to any other ACE inhibitor;
• if you are allergic to indapamide or to any other sulfonamide;
• if you are allergic to any of the other ingredients of this medicine (listed in section 6);
• if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes related to a previous treatment with ACE inhibitors or if you or a family member has experienced such symptoms in any other circumstance (a condition called angioedema);
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren;
• if you have a severe liver disease or if you suffer from a disease called hepatic encephalopathy (a degenerative brain disease),
• if you suffer from a severe kidney disease, where the blood flow to the kidneys is reduced (renal artery stenosis),
• if you are undergoing dialysis or any type of blood filtration. Depending on the machinery used, the

therapy with Perindopril and Indapamide Zentiva may not be suitable for you,

• if you have a decrease in plasma potassium,
• if you suspect you have decompensated heart failure (severe fluid retention, difficulty breathing),
• if you are pregnant for more than 3 months. (It is best to avoid Perindopril and Indapamide Zentiva 4 mg+1.25 mg even in the early stages of pregnancy - see section “Pregnancy and Breastfeeding”),
• if you are breastfeeding,
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a long-term (chronic) type of heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) may increase. Warnings and precautionsTalk to your doctor, pharmacist or nurse before using Perindopril and Indapamide Zentiva 4 mg+1.25 mg:
• if you have aortic stenosis (narrowing of the main artery leaving the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
• if you suffer from heart failure or other heart problems,
• if you suffer from kidney problems or are on dialysis,
• if you have an abnormally high level of an hormone in the blood called aldosterone (primary aldosteronism),
• if you have liver problems,
• if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus (special chronic inflammation) or scleroderma,
• if you suffer from atherosclerosis (hardening of the arteries),
• if you suffer from hyperparathyroidism (overactivity of the parathyroid glands),
• if you suffer from gout,
• if you have diabetes,
• if you are following a diet that restricts salt intake or use potassium-containing salt substitutes,
• if you are taking lithium or potassium-sparing medicines (spironolactone, triamterene) or potassium supplements, as their use with Perindopril and Indapamide Zentiva 4 mg+1.25 mg should be avoided (see “Taking Perindopril and Indapamide Zentiva 4 mg+1.25 mg with other medicines”),
• if you are elderly,
• if you have experienced photosensitivity reactions,
• if you experience decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within hours or weeks of taking Perindopril and Indapamide Zentiva. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamides, you may be at greater risk of developing it.
• if you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor blocker" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section "Do not take Perindopril and Indapamide Zentiva".
• if you are of Black origin as you may have a higher risk of angioedema and this medicine may be less effective in reducing your blood pressure compared to patients who are not Black,
• if you are a patient undergoing hemodialysis with high-flux membranes,
• if you are taking any of the following medicines, increases the risk of angioedema:
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used in preventing rejection after organ transplantation and for cancer),
• vildagliptin, a medicine used to treat diabetes.

Angioedema
Angioedema (a serious allergic reaction with swelling of the face, lips, tongue or throat with
difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril +
indapamide. This can happen at any time during treatment. If you develop such symptoms,
stop taking Perindopril and Indapamide Zentiva and call your doctor immediately. See also
section 4.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Perindopril and Indapamide Zentiva 4 mg+1.25 mg is not recommended in the early stages of pregnancy,
and must not be taken if you are pregnant for more than 3 months, as it can cause serious harm to
the baby if taken during this period (see “Pregnancy and breastfeeding”).
If you are taking Perindopril and Indapamide Zentiva 4 mg+1.25 mg, tell your doctor or healthcare staff:

• if you need to undergo anesthesia and/or surgery,
• if you have recently had diarrhea or vomiting, or if you are dehydrated,
• if you need to undergo dialysis or LDL apheresis (blood purification from cholesterol by means of a machine),
• if you need to undergo a medical examination that requires the injection of an iodine-containing contrast agent (a substance that makes organs such as kidneys or stomach visible on X-rays),
• if you have experienced changes in vision or eye pain during taking Perindopril and Indapamide Zentiva. This could be a sign that glaucoma, increased pressure in an eye(s) is developing. Stop taking Perindopril and Indapamide Zentiva and consult a doctor.

Athletes should be aware that Perindopril and Indapamide Zentiva 4 mg+1.25 mg contains an
active ingredient (indapamide) that can induce a positive result in doping tests.

Children and adolescents
Perindopril and Indapamide Zentiva 4 mg+1.25 mg should not be given to children and adolescents.

Other medicines and Perindopril and Indapamide Zentiva 4 mg+1.25 mg
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines.
You must not take Perindopril and Indapamide Zentiva 4 mg+1.25 mg with:

• lithium (used to treat manic disorder and depression),
• aliskiren (a medicine used to treat hypertension) unless you have diabetes or kidney problems,
• potassium-sparing diuretics (such as triamterene, amiloride), potassium salts (including salt substitutes) and other drugs that can increase potassium levels in the blood (such as heparin, a medicine used to thin the blood to prevent blood clots; trimethoprim and co- trimoxazole, also known as trimethoprim/sulfamethoxazole for infections caused by bacteria),
• estramustine (used in cancer therapy),
• other medicines used to treat high blood pressure: angiotensin-converting enzyme inhibitors and angiotensin receptor blockers.

The treatment with Perindopril and Indapamide Zentiva 4 mg+1.25 mg may be affected by other medicines.
Your doctor may need to change the dose and/or take other precautions. Make sure to tell
your doctor if you are taking any of these medicines, as special
attention may be needed:

• other medicines for the treatment of high blood pressure, including an angiotensin II receptor blocker (AIIRA) or aliskiren (see also the sections "Do not take Perindopril and Indapamide Zentiva 4 mg+1.25 mg" and "Warnings and precautions") or diuretics (medicines that increase the amount of urine produced by the kidneys),
• potassium-sparing diuretics, used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• medicines used mainly for the treatment of diarrhea (racecadotril) or for the prevention of rejection after organ transplantation (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”,
• sacubitril/valsartan (used for the long-term treatment of heart failure). See the sections "Do not take Perindopril and Indapamide Zentiva 4 mg/1.25mg” and “Warnings and precautions”,
• anesthetics,
• iodine-containing contrast agents,
• moxifloxacin, sparfloxacin (antibiotics: medicines used to treat infections),
• methadone (used to treat addictions),
• procainamide (for the treatment of irregular heartbeat),
• allopurinol (for the treatment of gout),
• mizolastine, terfenadine or astemizole (antihistamines for hay fever or allergies),
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune diseases or following transplants to prevent rejection (e.g. cyclosporine, tacrolimus),
• injectable erythromycin (an antibiotic),
• halofantrine (used to treat certain types of malaria),
• pentamidine (used to treat pneumonia),
• gold by injection (used to treat rheumatoid polyarthritis),
• vincamine (used to treat symptomatic cognitive disorders in the elderly including memory loss),
• bepridil (used to treat angina pectoris),
• sultopride (for the treatment of psychosis),
• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol),
• cisapride, difemanil (used to treat stomach and digestive problems)
• digoxin or other cardiac glycosides (for the treatment of heart problems),
• baclofen (for the treatment of muscle stiffness in conditions such as multiple sclerosis),
• medicines to treat diabetes such as insulin, metformin or gliptins,
• calcium, including calcium supplements,
• stimulant laxatives (e.g. senna),
• Non-Steroidal Anti-Inflammatory Drugs (e.g. ibuprofen) or high doses of salicylates (e.g. aspirin),
• injectable amphotericin B (for the treatment of severe fungal infections),
• medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics),
• tetracosactide (for the treatment of Crohn's disease),
• trimethoprim (for the treatment of infections),
• vasodilators, including nitrates (products that widen blood vessels),
• medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, norepinephrine or adrenaline).

Perindopril and Indapamide Zentiva 4 mg+1.25 mg with food and drink
It is preferable to take Perindopril and Indapamide Zentiva 4 mg+1.25 mg before a meal.

Pregnancy and breastfeeding
If you are pregnant, if you suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist before using this medicine .

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking Perindopril and Indapamide
Zentiva 4 mg+1.25 mg before starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Perindopril and Indapamide Zentiva 4
mg+1.25 mg. Perindopril and Indapamide Zentiva 4 mg+1.25 mg is not recommended in the early stages of pregnancy,
and must not be taken if you are pregnant for more than 3 months, as it can cause serious harm to
the baby if taken after the third month of pregnancy.

Breastfeeding
Immediately inform your doctor if you are breastfeeding or if you are about to start breastfeeding. You must not take
Perindopril and Indapamide Zentiva 4 mg+1.25 mg if you are breastfeeding and your doctor may choose another
treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.
Warn your doctor immediately.

Driving and using machines
Perindopril and Indapamide Zentiva 4 mg+1.25 mg normally does not affect alertness but in some patients
different reactions such as dizziness or fatigue may occur due to the reduction of blood
pressure. If you experience such symptoms, your ability to drive vehicles or operate machinery may be
reduced.

Perindopril and Indapamide Zentiva 4 mg+1.25 mg contains lactose monohydrate
If your doctor has diagnosed you with intolerance to some sugars, contact them before taking this
medicine.

3. How to take Perindopril and Indapamide Zentiva 4 mg+1.25 mg

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
The recommended dose is one tablet a day.
Your doctor may decide to modify the dosage if you suffer from renal impairment. Take the
tablet preferably in the morning and before a meal.
The tablet must be swallowed with a glass of water.
The tablet can be divided into equal doses.

If you take more Perindopril and Indapamide Zentiva 4 mg+1.25 mg than you should
If you have taken an excessive amount of tablets, consult your doctor immediately or go
immediately to the nearest emergency room. The most likely effect in case of overdose is a
lowering of blood pressure. In case a marked drop in blood pressure occurs (associated with
nausea, vomiting, cramps, dizziness, drowsiness, mental confusion, changes in the amount of urine produced
by the kidneys), it may be helpful to lie down with your legs raised.

If you forget to take Perindopril and Indapamide Zentiva 4 mg+1.25 mg
It is important to take the medicine every day as regular treatment is more effective. However, if you
forget to take a dose of Perindopril and Indapamide Zentiva 4 mg+1.25 mg, take the next dose
at the usual time.
Do not take a double dose to compensate for forgetting the previous dose.

If you stop taking Perindopril and Indapamide Zentiva 4 mg+1.25 mg
Since the treatment of high blood pressure is usually lifelong, you should talk to your doctor before
stopping taking this medicine.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
manifest.

Stop taking the medicine immediately and contact your doctor immediately if you experience any of the
following effects:

• Severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people),
• Bronchospasm (chest tightness, wheezing and shortness of breath) (uncommon - may affect up to 1 in 100 people),
• Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (see section 2 “Warnings and precautions”) (uncommon - may affect up to 1 in 100 people),
• Severe skin reactions, including erythema multiforme (a skin rash that often starts with itchy red patches on the face, arms or legs) or severe rash, hives, redness all over the skin, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome) or other allergic reactions (very rare - may affect up to 1 in 10,000),
• Cardiovascular disorders [irregular heartbeat, angina pectoris (chest, jaw and back pain caused by exertion), heart attack] (very rare - may affect up to 1 in
• 10,000),
• Weakness of arms or legs, or speech problems which could be a sign of a possible stroke (very rare - may affect up to 1 in 10,000),
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of unwellness (very rare - may affect up to 1 in 10,000),
• Jaundice (yellowing of the skin or eyes) which may be a sign of hepatitis (very rare - may affect up to 1 in 10,000),
• Life-threatening irregular heartbeat (frequency not known - cannot be estimated on the basis of available data),
• Brain disease caused by liver disease (hepatic encephalopathy) (frequency not known - cannot be estimated on the basis of available data).

In decreasing order of frequency, side effects may include:
Common (may affect up to 1 in 10 people):

• skin reactions in subjects predisposed to allergies and asthmatic reactions,
• headache,
• dizziness,
• vertigo,
• tingling,
• impaired vision,
• tinnitus (sensation of noise in the ears),
• cough,
• shortness of breath (dyspnea),
• gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or indigestion, diarrhea, constipation),
• allergic reactions (such as skin rashes, itching),
• muscle cramps,
• feeling tired.

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

• mood changes,
• sleep disturbances,
• urticaria,
• purpura (small red spots on the skin),
• clustered blisters,
• kidney disorders,
• impotence,
• sweating, excess of eosinophils (a type of white blood cells),
• alteration of laboratory parameters: high level in the blood of potassium reversible upon discontinuation, low level of sodium in the blood,
• drowsiness,
• fainting,
• palpitations (awareness of heartbeat),
• tachycardia (fast heartbeat),
• hypoglycemia (low blood sugar) in diabetic patients,
• vasculitis (inflammation of blood vessels),
• dry mouth,
• photosensitivity reactions (increased sensitivity of the skin to the sun),
• arthralgia (joint pain),
• myalgia (muscle pain),
• chest pain,
• feeling unwell,
• peripheral edema,
• fever,
• increased urea in the blood,
• increased creatinine in the blood,
• fall.

Rare (may affect up to 1 in 1000):

• worsening of psoriasis,
• change in laboratory parameters: increased levels of liver enzymes, high levels of serum bilirubin,
• fatigue.

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

• confusion,
• eosinophilic pneumonia (a rare type of pneumonia),
• highly concentrated urine (dark in color), feeling or state of unwellness, muscle cramps, confusion and convulsions, probably due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, see your doctor immediately.
• rhinitis (stuffy or runny nose),
• severe kidney problems,
• change in blood parameters, such as lowering of the number of white blood cells and red blood cells, lower hemoglobin, lower number of platelets, high blood levels of calcium, abnormal liver function.

Frequency not known (frequency cannot be estimated on the basis of available data):

• abnormal ECG tracing,
• change in laboratory parameters: low levels of potassium, high levels of uric acid and high levels of sugar in the blood,
• decreased vision (myopia),
• blurred vision,
• abnormal color vision,
• numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon),
• decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma),
• If you suffer from systemic lupus erythematosus (a connective tissue disease), this may worsen.

Hematological, renal, hepatic or pancreatic disorders and changes in laboratory parameters (blood tests) may occur. Your doctor may prescribe you laboratory tests to check your condition.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Perindopril e Indapamide Zentiva 4 mg+1,25 mg

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30ºC.
Do not use this medicine after the expiry date which is stated on the box and on the blister after the word
“EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 contains Perindopril and Indapamide Zentiva 4 mg+1,25 mg

• The active ingredients are perindopril tert-butylamine and indapamide. One tablet contains 4 mg of perindopril tert-butylamine equivalent to 3.338 mg of perindopril and 1.25 mg of indapamide.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Perindopril and Indapamide Zentiva 4 mg+1,25 mg and pack contents
Perindopril and Indapamide Zentiva 4 mg+1,25 mg tablets are white, capsule-shaped tablets, with
a fracture line on both sides, with a “+” imprinted on both sides of the fracture line and smooth on the
back, with a length of 8.0±0.2 mm and 4.0 ±0.2 mm in width.
The tablet can be divided into equal doses.
The tablets are available in blisters of 10, 20, 30 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Viale L. Bodio n. 37/B
20158 Milano
Italy

Manufacturer:
Atlantic Pharma – Produções Farmacêuticas SA
Rua da Tapada Grande, 2
Abrunheira, 2710 – 089 Sintra
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:

Perindopril and Indapamide Zentiva 8 mg+2.5 mg tablets

Generic medicine
Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Never give it to others, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Perindopril and Indapamide Zentiva 8 mg+2.5 mg is and what it is used for
• 2. What you need to know before you take Perindopril and Indapamide Zentiva 8 mg+2.5 mg
• 3. How to take Perindopril and Indapamide Zentiva 8 mg+2.5 mg
• 4. Possible side effects
• 5. How to store Perindopril and Indapamide Zentiva 8 mg+2.5 mg
• 6. Contents of the pack and other information

1. What is Perindopril and Indapamide Zentiva 8 mg+2.5 mg and what is it used for

Perindopril and Indapamide Zentiva 8 mg+2.5 mg is a combination of two active ingredients, perindopril and
indapamide. It is an antihypertensive and is used in the treatment of high blood pressure (hypertension).
Perindopril and Indapamide Zentiva 8 mg+2.5 mg is prescribed for patients who are already receiving perindopril 8 mg and
indapamide 2.5 mg in separate tablets; these patients may instead receive a tablet of
Perindopril and Indapamide Zentiva 8 mg+2.5 mg which contains both active ingredients.
Perindopril belongs to a class of medicines called ACE inhibitors. These drugs work by dilating the
blood vessels, which makes it easier for the heart to pump blood through them.
Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide
differs from other diuretics in that it causes only a slight increase in the amount of urine produced.
Each active ingredient reduces blood pressure and, together, they work to control blood
pressure.

2. What you need to know before taking Perindopril and Indapamide Zentiva 8 mg+2.5 mg

Do not take Perindopril and Indapamide Zentiva 8 mg+2.5 mg

• if you are allergic to perindopril or to any other ACE inhibitor,
• if you are allergic to indapamide or to any other sulfonamide,
• if you are allergic to any of the other ingredients of this medicine (listed in section 6),
• if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes related to a previous treatment with ACE inhibitors or if you or a family member has experienced such symptoms in any other circumstance (a condition called angioedema),
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren,
• if you have a severe liver disease or if you suffer from a disease called hepatic encephalopathy (a degenerative brain disease),
• if you have a severe kidney disease, where the blood flow to the kidneys is reduced (renal artery stenosis),
• if you are undergoing dialysis or any type of blood filtration. Depending on the machinery used, therapy with Perindopril and Indapamide Zentiva may not be suitable for you,
• if you have a decrease in plasma potassium,
• if you suspect you have decompensated heart failure (severe fluid retention, difficulty breathing),
• if you are pregnant for more than 3 months. (It is best to avoid Perindopril and Indapamide Zentiva 8 mg+2.5 mg even in the early stages of pregnancy - see section “Pregnancy and Breastfeeding”),
• if you are breastfeeding,
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) may increase. Warnings and precautionsTalk to your doctor, pharmacist or nurse before using Perindopril and Indapamide Zentiva 8 mg+2.5 mg:
• if you have aortic stenosis (narrowing of the main artery leaving the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
• if you suffer from heart failure or other heart problems,
• if you suffer from kidney problems or are on dialysis,
• if you have an abnormally high level of an hormone in the blood called aldosterone (primary aldosteronism),
• if you have liver problems,
• if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus (special chronic inflammation) or scleroderma,
• if you suffer from atherosclerosis (hardening of the arteries),
• if you suffer from hyperparathyroidism (overactivity of the parathyroid glands),
• if you suffer from gout,
• if you have diabetes,
• if you are following a diet that limits salt intake or use potassium-containing salt substitutes,
• if you are taking lithium or potassium-sparing medicines (spironolactone, triamterene) or potassium supplements, as their use with Perindopril and Indapamide Zentiva 8 mg+2.5 mg should be avoided (see “Taking Perindopril and Indapamide Zentiva 8 mg+2.5 mg with other medicines”),
• if you are elderly,
• if you have experienced photosensitivity reactions,
• if you experience blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and can occur within hours or weeks of taking Perindopril and Indapamide Zentiva. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamides, you may be at greater risk of developing it.
• if you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor blocker" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section "Do not take Perindopril and Indapamide Zentiva".
• if you are of black origin as you may have a higher risk of angioedema and this medicine may be less effective in reducing your blood pressure compared to non-black patients,
• if you are a patient undergoing hemodialysis with high-flux membranes,
• if you are taking any of the following medicines, increases the risk of angioedema:
• racecadotril (used for the treatment of diarrhea),
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used in preventing rejection following organ transplantation and for cancer),
• vildagliptin, a medicine used to treat diabetes.

Angioedema
Angioedema (a serious allergic reaction with swelling of the face, lips, tongue or throat with
difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril +
indapamide. This can happen at any time during treatment. If you develop such symptoms,
stop taking Perindopril and Indapamide Zentiva and call a doctor immediately. See also
section 4.
You should inform your doctor if you think you may be pregnant (or if there is a possibility of starting a
pregnancy). Perindopril and Indapamide Zentiva 8 mg+2.5 mg is not recommended in the early stages of pregnancy, and
should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the
baby if taken during this period (see “Pregnancy and breastfeeding”).
If you are taking Perindopril and Indapamide Zentiva 8 mg+2.5 mg, tell your doctor or healthcare
staff:

• if you need to undergo anesthesia and/or surgery,
• if you have recently had diarrhea or vomiting, or if you are dehydrated,
• if you need to undergo dialysis or LDL apheresis (blood purification from cholesterol by means of a machine),
• if you need to undergo a medical examination that requires the injection of an iodine-containing contrast agent (a substance that makes organs such as kidneys or stomach visible on X-rays),
• if you have experienced changes in vision or pain in one or both eyes while taking Perindopril and Indapamide Zentiva. This could be a sign that glaucoma is developing, increased pressure in an eye(s). Stop taking Perindopril and Indapamide Zentiva and consult a doctor.

Athletes should be aware that Perindopril and Indapamide Zentiva 8 mg+2.5 mg contains an
active ingredient (indapamide) that may cause a positive result in doping tests.

Children and adolescents
Perindopril and Indapamide Zentiva 8 mg+2.5 mg should not be given to children and adolescents.

Other medicines and Perindopril and Indapamide Zentiva 8 mg+2.5 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
You must not take Perindopril and Indapamide Zentiva 8 mg+2.5 mg with:

• lithium (used for the treatment of manic disorder and depression),
• aliskiren (a medicine used to treat hypertension) if you do not have diabetes or kidney problems,
• potassium-sparing diuretics (such as triamterene, amiloride), potassium salts (including salt substitutes) and other drugs that can increase potassium levels in the blood (such as heparin, a medicine used to thin the blood to prevent blood clots; trimethoprim and co- trimoxazole, also known as trimethoprim/sulfamethoxazole for infections),
• estramustine (used in cancer therapy),
• other medicines used to treat high blood pressure: angiotensin converting enzyme inhibitors and angiotensin receptor blockers.

The treatment with Perindopril and Indapamide Zentiva 8 mg+2.5 mg may be affected by other medicines. Your
doctor may need to adjust the dose and/or take other precautions. Make sure to tell your
doctor if you are taking any of these medicines, as special attention may be needed:

• other medicines for the treatment of high blood pressure, including an angiotensin II receptor blocker (AIIRA) or aliskiren (see also the section "Do not take Perindopril and Indapamide

Zentiva 8 mg+2.5 mg" and "Warnings and precautions") or diuretics (medicines that increase the amount of
urine produced by the kidneys),

• potassium-sparing diuretics used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• medicines used mainly for the treatment of diarrhea (racecadotril) or to prevent rejection following organ transplantation (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”,
• sacubitril/valsartan (used for the long-term treatment of heart failure). See the sections "Do not take Perindopril and Indapamide Zentiva 8 mg/2.5mg" and "Warnings and precautions”,
• anesthetics,
• iodine contrast agents,
• moxifloxacin, sparfloxacin (antibiotics: medicines used to treat infections),
• methadone (used for the treatment of dependencies),
• procainamide (for the treatment of irregular heartbeat),
• allopurinol (for the treatment of gout),
• mizolastine, terfenadine or astemizole (antihistamines for hay fever or allergies),
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune diseases or following transplants to prevent rejection (e.g. cyclosporine, tacrolimus),
• injectable erythromycin (an antibiotic),
• alofantrine (used to treat certain types of malaria),
• pentamidine (used to treat pneumonia),
• gold by injection (used to treat rheumatoid polyarthritis),
• vincamine (used to treat symptomatic cognitive disorders in the elderly including memory loss),
• bepridil (used to treat angina pectoris),
• sultopride (for the treatment of psychoses),
• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol),
• cisapride, difemanil (used to treat stomach and digestive problems)
• digoxin or other cardiac glycosides (for the treatment of heart problems),
• baclofen (for the treatment of muscle stiffness in conditions such as multiple sclerosis),
• medicines for the treatment of diabetes such as insulin, metformin or gliptins,
• calcium including calcium supplements,
• stimulant laxatives (e.g. senna),
• Non-Steroidal Anti-Inflammatory Drugs (e.g. ibuprofen) or high doses of salicylates (e.g. aspirin),
• injectable amphotericin B (for the treatment of severe fungal infections),
• medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics),
• tetracosactide (for the treatment of Crohn's disease),
• trimethoprim (for the treatment of infections),
• vasodilators including nitrates (products that make blood vessels wider),
• medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, norepinephrine or adrenaline).

Perindopril and Indapamide Zentiva 8 mg+2.5 mg with food and drink
It is preferable to take Perindopril and Indapamide Zentiva 8 mg+2.5 mg before a meal.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You should tell your doctor if you think you may be pregnant (or if there is a possibility of starting a
pregnancy). As a rule, your doctor will advise you to stop taking Perindopril and Indapamide
Zentiva 8 mg+2.5 mg before starting pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Perindopril and Indapamide Zentiva 8
mg+2.5 mg. Perindopril and Indapamide Zentiva 8 mg+2.5 mg is not recommended in the early stages of pregnancy, and
should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the
baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor immediately if you are breastfeeding or are about to start breastfeeding. You should not take
Perindopril and Indapamide Zentiva 8 mg+2.5 mg if you are breastfeeding and your doctor may choose another
treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.
Inform your doctor immediately.

Driving and operating machinery
Perindopril and Indapamide Zentiva 8 mg+2.5 mg normally does not affect alertness but in some patients
different reactions such as dizziness or fatigue may occur due to reduced blood pressure. If you experience such symptoms, your ability to drive vehicles or operate machinery may be
reduced.

Perindopril and Indapamide Zentiva 8 mg+2.5 mg contains lactose monohydrate
If your doctor has diagnosed you with intolerance to some sugars, contact them before taking this
medicine.

3. How to take Perindopril and Indapamide Zentiva 8 mg+2.5 mg

Take this medicine exactly as your doctor or pharmacist has instructed. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is one tablet a day.
Take the tablet preferably in the morning and before a meal.
The tablet must be swallowed with a glass of water.
The tablet can be divided into equal doses.

If you take more Perindopril and Indapamide Zentiva 8 mg+2.5 mg than you should
If you have taken an excessive amount of tablets, consult your doctor immediately or go
immediately to the nearest emergency room. The most likely effect in case of overdose is a
lowering of blood pressure. In case a marked drop in blood pressure occurs (associated with
nausea, vomiting, cramps, dizziness, drowsiness, mental confusion, changes in the amount of urine produced
by the kidneys), it may be helpful to lie down with your legs raised.

If you forget to take Perindopril and Indapamide Zentiva 8 mg+2.5 mg
It is important to take the medicine every day as regular treatment is more effective. However, if you
forget to take a dose of Perindopril and Indapamide Zentiva 8 mg+2.5 mg, take the next dose
at the usual time.
Do not take a double dose to make up for a missed dose.

If you stop taking Perindopril and Indapamide Zentiva 8 mg+2.5 mg
Because treatment for high blood pressure is usually lifelong, you should talk to your doctor before
stopping taking this medicine.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking the medicine immediately and contact your doctor immediately if you experience any of the following effects:

• Severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people),
• Bronchospasm (chest tightness, wheezing and shortness of breath) (uncommon - may affect up to 1 in 100 people),
• Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (see section 2 “Warnings and precautions”) (uncommon - may affect up to 1 in 100 people),
• Severe skin reactions including erythema multiforme (a skin rash that often starts with itchy red patches on the face, arms or legs) or severe rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome) or other allergic reactions (very rare - may affect up to 1 in 10,000 people),
• Cardiovascular disorders [irregular heartbeat, angina pectoris (chest, jaw and back pain caused by physical exertion), heart attack] (very rare - may affect up to 1 in 10,000 people),
• Weakness of arms or legs, or speech problems which could be a sign of a possible stroke (very rare - may affect up to 1 in 10,000 people),
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of unwellness (very rare - may affect up to 1 in 10,000 people),
• Yellowing of the skin or eyes (jaundice) which may be a sign of hepatitis (very rare - may affect up to 1 in 10,000 people),
• Life-threatening irregular heartbeat (frequency not known - cannot be estimated based on available data),
• Brain disease caused by liver disease (hepatic encephalopathy) (frequency not known - cannot be estimated based on available data). Decreasing in frequency, side effects may include: Common (may affect up to 1 in 10 people):
• skin reactions in subjects predisposed to allergy and asthmatic reactions,
• headache,
• dizziness,
• vertigo,
• tingling,
• impaired vision,
• tinnitus (sensation of noises in the ears),
• cough,
• shortness of breath (dyspnea),
• gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty digesting food, diarrhea, constipation),
• allergic reactions (such as skin rashes, itching),
• muscle cramps,
• feeling of fatigue.

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

• mood changes,
• sleep disturbances,
• urticaria,
• purpura (small red spots on the skin),
• clustered blisters,
• kidney disorders,
• impotence,
• sweating, excess of eosinophils (a type of white blood cells),
• alteration of laboratory parameters: high level in the blood of potassium reversible upon discontinuation, low level of sodium in the blood,
• drowsiness,
• fainting,
• palpitations (awareness of heartbeat),
• tachycardia (fast heartbeat),
• hypoglycemia (low blood sugar) in diabetic patients,
• vasculitis (inflammation of blood vessels),
• dry mouth,
• photosensitivity reactions (increased sensitivity of the skin to the sun),
• arthralgia (joint pain),
• myalgia (muscle pain),
• chest pain,
• malaise,
• peripheral edema,
• fever,
• increased urea in the blood,
• increased creatinine in the blood,
• falls.

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

• worsening of psoriasis,
• change in laboratory parameters: increase in liver enzyme levels, high levels of serum bilirubin,
• fatigue.

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

• confusion,
• eosinophilic pneumonia (a rare type of pneumonia),
• highly concentrated urine (dark in color), feeling or state of unwellness, muscle cramps, confusion and convulsions probably due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, seek immediate medical attention.
• rhinitis (stuffy or runny nose),
• severe kidney problems,
• change in blood parameters such as lowering of white and red blood cells, lower hemoglobin, lower number of blood platelets, high blood calcium levels, abnormal liver function.

Frequency not known (the frequency cannot be estimated based on available data):

• abnormal ECG tracing,
• change in laboratory parameters: low levels of potassium, high levels of uric acid and high levels of sugar in the blood,
• impaired vision (myopia),
• blurred vision,
• abnormal color vision,
• numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon),
• decreased vision or eye pain due to high blood pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma),
• If you suffer from systemic lupus erythematosus (a connective tissue disease), this may worsen.

Hematological, renal, hepatic or pancreatic disorders and changes in laboratory parameters (blood tests) may occur. Your doctor may prescribe laboratory tests to monitor your condition.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Perindopril e Indapamide Zentiva 8 mg+2,5 mg

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack and on the blister after the word
“EXP”. The expiry date refers to the last day of the month.
Do not dispose of any medicine in waste water 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 Perindopril and Indapamide Zentiva 8 mg+2.5 mg contains

• The active ingredients are perindopril tert-butylamine and indapamide. One tablet contains 8 mg of perindopril tert-butylamine equivalent to 6.676 mg of perindopril and 2.5 mg of indapamide.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Perindopril and Indapamide Zentiva 8 mg+2.5 mg and pack contents
Perindopril and Indapamide Zentiva 8 mg+2.5 mg are circular tablets from white to almost white with a
break line on one side, with a length of 8.0±0.2 mm.
The tablets are available in blisters in packs of 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Viale L. Bodio n. 37/B
20158 Milano
Italy

Manufacturer:
Atlantic Pharma – Produções Farmacêuticas SA
Rua da Tapada Grande, 2
Abrunheira, 2710 – 089 Sintra
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following
names: