Perindopril Teva

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Perindopril Teva (Perindopril Tosilate Teva)

10 mg, coated tablets

Perindopril tosilate
Perindopril Teva and Perindopril Tosilate Teva are different trade names for the same medicine.

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if their symptoms are the same.
• If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Perindopril Teva and what is it used for

Perindopril Teva belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). The action of these medicines is to widen the blood vessels, making it easier for the heart to pump blood.
Perindopril Teva is used:

• to treat high blood pressure(hypertension);
• to reduce the risk of certain heart events, such as heart attack in patients with stable coronary artery disease(a disease where the heart does not get enough blood and oxygen), who have had a heart attack and/or a procedure to improve blood flow to the heart.

2. Important information before taking Perindopril Teva

When not to take Perindopril Teva

• if the patient is allergic to perindopril, another ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has had symptoms such as wheezing, swelling of the face or tongue, intense itching, or severe skin rash when taking an ACE inhibitor in the past, or if such symptoms have occurred in a family member in any other circumstances (a condition called angioedema).
• after the third month of pregnancy. (It is also recommended to avoid taking Perindopril Teva during early pregnancy - see the section "Pregnancy, breastfeeding, and fertility").
• if the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine containing aliskiren.

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• if the patient is undergoing dialysis or blood filtration by another method. Depending on the device used, Perindopril Teva may not be suitable for the patient.
• if the patient has kidney problems that reduce blood flow to the kidneys (renal artery stenosis).
• if the patient has taken or is currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases (see sections "Warnings and precautions" and "Perindopril Teva with other medicines").

Warnings and precautions

Before starting to take Perindopril Teva, the patient should discuss it with their doctor or pharmacist:

• if the patient has a narrowing of the aortic valve (narrowing of the main blood vessel carrying blood from the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the blood vessel supplying the kidney),
• if the patient has any other heart disease,
• if the patient has liver disease,
• if the patient has kidney disease or is undergoing dialysis,
• if the patient has an abnormally high level of a hormone called aldosterone in the blood (primary aldosteronism),
• if the patient has a collagen vascular disease (a disease of the skin), such as systemic lupus erythematosus or scleroderma,
• if the patient has diabetes,
• in case of a low-salt diet or the use of salt substitutes containing potassium;
• if the patient is to undergo anesthesia and/or surgery,
• if the patient is to undergo LDL apheresis (removal of cholesterol from the blood using a special device),
• if the patient is to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings,
• if the patient has recently had diarrhea or vomiting, or is dehydrated,
• in black patients, there is a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure than in patients of other races,
• if the patient is taking any of the following medicines for high blood pressure:
• an angiotensin receptor blocker (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes.
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under the heading "When not to take Perindopril Teva".
• if the patient is taking any of the following medicines, the risk of angioedema may increase:
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors (used to prevent the rejection of transplanted organs and to treat cancer);
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes).

Angioedema
In patients treated with ACE inhibitors, including Perindopril Teva, angioedema (a severe allergic reaction; symptoms include swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing) has been reported. This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Perindopril Teva and contact their doctor immediately. See also section "Possible side effects".
The patient must inform their doctor if they think they are (or might be) pregnant. Perindopril Teva is not recommended during early pregnancy and should not be taken if the patient is pregnant over 3 months, as it may cause serious harm to the baby (see section "Pregnancy, breastfeeding, and fertility").

Children and adolescents

Perindopril Teva should not be used in children and adolescents under 18 years of age.

Perindopril Teva with other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Taking other medicines may affect the treatment with Perindopril Teva. The doctor may need to change the dose and/or take other precautions when taking such medicines as:

• other medicines used to treat high blood pressure, including an angiotensin receptor blocker (ARB), aliskiren (see also the information under the headings "When not to take Perindopril Teva" and "Warnings and precautions"), or diuretics (medicines that increase the amount of urine produced by the kidneys);
• potassium-sparing medicines (e.g., triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent blood clots; trimethoprim and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses of 12.5 mg to 50 mg per day;
• lithium salts used to treat mania or depression;
• non-steroidal anti-inflammatory medicines (NSAIDs) (e.g., ibuprofen) used as painkillers or high doses of aspirin or large doses of acetylsalicylic acid, a substance found in many medicines, used as a painkiller and anti-inflammatory, as well as to prevent blood clots;
• medicines used to treat diabetes (such as insulin or metformin);
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, neuroleptics);
• immunosuppressive medicines (medicines that suppress the body's immune system) used to treat immune system disorders or after organ transplantation (e.g., cyclosporine, tacrolimus);
• estramustine (used to treat cancer);
• medicines commonly used to treat diarrhea (racecadotril) or to prevent the rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See section "Warnings and precautions";
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Perindopril Teva" and "Warnings and precautions";
• allopurinol (used to treat gout);
• procainamide (used to treat irregular heart rhythms);
• vasodilators, including nitrates;
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline);

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• gold salts, especially when given intravenously (used to treat symptoms of rheumatoid arthritis).

Perindopril Teva with food and drink

Perindopril Teva should be taken in the morning before breakfast.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

The patient must inform their doctor if they think they are pregnant (or plan to become pregnant). In general, the doctor will recommend taking a different medicine instead of Perindopril Teva, as taking Perindopril Teva during early pregnancy is not recommended. However, it should not be taken after the third month of pregnancy, as it may cause serious harm to the baby.

Breastfeeding

The patient should inform their doctor if they are breastfeeding or plan to breastfeed. It is not recommended to take Perindopril Teva while breastfeeding. For breastfeeding women, the doctor may recommend other medicines, especially if the breastfed baby is a newborn or premature.

Fertility

The effect of perindopril on human fertility is not known.

Driving and using machines

While taking Perindopril Teva, some patients may experience dizziness or fatigue related to low blood pressure. In such cases, the ability to drive or operate machines may be impaired.

Perindopril Teva contains lactose

If the patient has been told they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

Perindopril Teva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Perindopril Teva

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The tablets should be taken with a glass of water, preferably at the same time each day, in the morning, before breakfast. The doctor will decide on the appropriate dose for the patient.
The usual doses of Perindopril Teva are:
Hypertension:the recommended initial and maintenance dose is 5 mg per day. After one month, the doctor may increase the dose to 10 mg per day if necessary. The dose of 10 mg per day is the maximum recommended dose for the treatment of hypertension.
In patients over 65 years of age, the recommended initial dose is 2.5 mg per day. After one month, the doctor may increase the dose to 5 mg per day or, if necessary, to 10 mg per day.
Stable coronary artery disease:the recommended initial dose is 5 mg per day. After two weeks, the doctor may increase the dose to 10 mg per day, which is the maximum recommended dose for this indication.
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In patients over 65 years of age, the recommended initial dose is 2.5 mg per day. After one week, the doctor may increase the dose to 5 mg per day, and after another week to 10 mg per day.

Use in children and adolescents

Perindopril Teva should not be used in children and adolescents.

Overdose of Perindopril Teva

In case of taking too many tablets, the patient should immediately contact their doctor or go to the nearest emergency department. The most common symptom of overdose is low blood pressure with symptoms such as dizziness or fainting. If this occurs, it may be helpful to lie down with the legs elevated.

Missed dose of Perindopril Teva

It is essential to take the medicine regularly for it to work best. However, if a dose of Perindopril Teva is missed, the next dose should be taken at the usual time. A double dose should not be taken to make up for the missed dose.

Stopping Perindopril Teva treatment

Perindopril Teva treatment is long-term, so before stopping the treatment, the patient should consult their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Perindopril Teva can cause side effects, although not everybody gets them.

The patient should stop taking this medicine and contact their doctor immediately if they experience any of the following serious side effects:

• 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 dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people),
• very fast or irregular heartbeat, chest pain (angina pectoris), or heart attack (very rare - may affect up to 1 in 10,000 people);
• weakness of the arms or legs or difficulty speaking, which may be a sign of a stroke (very rare - may affect up to 1 in 10,000 people);
• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm; uncommon - may affect up to 1 in 100 people);
• pancreatitis, which may cause severe abdominal pain radiating to the back and very severe illness (very rare - may affect up to 1 in 10,000 people), yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare - may affect up to 1 in 10,000 people);
• rash, often starting with the appearance of red, itchy patches on the face, arms, or legs (erythema multiforme; very rare - may affect up to 1 in 10,000 people).

The patient should inform their doctor if they experience any of the following side effects:

Side effects, grouped by frequency of occurrence:
Common (may affect up to 1 in 10 people):

• headache,
• dizziness,
• vertigo,

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• tingling or numbness,
• visual disturbances,
• ringing in the ears (tinnitus),
• cough,
• shortness of breath,
• gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion, or difficulty digesting, diarrhea, constipation),
• allergic reactions (such as rash, itching),
• muscle cramps,
• feeling of weakness.

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

• mood changes,
• sleep disturbances,
• depression,
• dry mouth,
• intense itching or severe skin rash,
• kidney problems,
• impotence,
• excessive sweating,
• increased eosinophil count (a type of white blood cell),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis,
• photosensitivity reaction (increased skin sensitivity to sunlight),
• joint pain,
• muscle pain,
• chest pain,
• general feeling of being unwell,
• peripheral edema,
• fever,
• falls,
• abnormal laboratory test results: high potassium levels in the blood, transient after stopping treatment, low sodium levels, hypoglycemia (very low blood sugar) in diabetic patients, increased urea levels in the blood, increased creatinine levels in the blood.

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

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

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

• disorientation,
• eosinophilic pneumonia (a rare type of pneumonia),
• nasal congestion (stuffy nose or runny nose),
• blood test changes, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin level, decreased platelet count.

Unknown (frequency cannot be estimated from the available data):

• blue discoloration, numbness, and pain in the fingers or toes (Raynaud's phenomenon).

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Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, 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, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Perindopril Teva

The medicine should be stored out of sight and reach of children.
After opening, it should be used within 100 days.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The medicine should be stored in a tightly closed container to protect it from moisture and light. There are no special storage temperature recommendations.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Perindopril Teva contains

• The active substance of the medicine is perindopril tosilate. Each coated tablet contains 6.816 mg of perindopril (which corresponds to 10 mg of perindopril tosilate).
• The other ingredients are: lactose monohydrate, cornstarch, sodium hydrogen carbonate, maize starch, povidone K 30, magnesium stearate. Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, and indigo carmine, aluminum lake (E 132), brilliant blue, aluminum lake (E 133), yellow iron oxide (E 172), quinoline yellow, aluminum lake (E 104).

What Perindopril Teva looks like and contents of the pack

Perindopril Teva 10 mg, coated tablets are green, round, biconvex, coated tablets with a diameter of approximately 8 mm, with the number "10" embossed on one side and the letter "T" on the other side.
The tablets are available in packs containing 30 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Ireland, the country of export:

Teva Pharma B.V., Swensweg 5, 2031GA Haarlem, Netherlands

Manufacturer:

Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Teva Operations Poland Sp. z o.o., Mogilska 80, 31-546 Kraków, Poland

Parallel importer:

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Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Ireland export license number: PA0749/168/003

Parallel import license number: 417/19

This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Belgium:
Perindopril Teva
Bulgaria:
Zaprinel
Estonia:
Perindopril Teva
Greece:
Perindopril Teva Pharma
France:
Perindopril Tosilate Teva
Hungary:
Perindopril-tozilát Teva
Ireland:
Perindopril Tosilate Teva
Italy:
Perindopril Teva Italia
Lithuania:
Perindopril Teva
Latvia:
Perindopril Teva
Netherlands:
Perindopril tosilaat 10mg Teva
Poland:
Perindopril Teva
Portugal: Perindopril Rytulop
Romania:
Perindopril tosilat Teva
Slovenia:
Perivol 10 mg filmsko obložene tablete

Date of leaflet approval: 06.11.2024

[Information about trademark]
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