Perindanor

Package Leaflet: Information for the User

Perindanor, 4 mg, Tablets

tert-Butylamine Perindopril

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of Contents of the Package Leaflet:

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

1. What is Perindanor and what is it used for

Perindopril belongs to a group of medicines called ACE inhibitors. The action of these medicines is to widen the blood vessels, making it easier for the heart to pump blood. Perindanor is used to treat:

• high blood pressure;
• heart failure(a condition where the heart is not able to pump enough blood to meet the body's needs) [only Perindanor 4 mg];
• to reduce the risk of certain heart events, such as heart attack in patients with stable coronary artery disease(a disease where the blood supply to the heart is reduced or blocked), who have had a heart attack and/or have had a procedure to improve blood supply to the heart muscle.

2. Important information before taking Perindanor

When not to take Perindanor

• if you are allergic to perindopril or any of the other ingredients of this medicine (listed in section 6) or to any other ACE inhibitor.
• above the third month of pregnancy. It is also not recommended to take perindopril during early pregnancy, see section "Pregnancy, breastfeeding and fertility".
• if you have ever had symptoms such as difficulty breathing, swelling of the face or tongue, intense itching or severe skin rash associated with treatment with an angiotensin-converting enzyme inhibitor, or if such symptoms have occurred in other circumstances (a condition called angioedema).
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term heart failure (chronic), as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases.
• if you are undergoing dialysis or blood filtration by another method. Depending on the device used, perindopril may not be suitable for you.
• if you have kidney disease that reduces blood flow to the kidneys (renal artery stenosis).

Warnings and precautions

Before taking Perindanor, discuss with your doctor or pharmacist if any of the following conditions apply to you:

• if you have narrowing of the aortic valve (narrowing of the main blood vessel leading from the heart), hypertrophic cardiomyopathy (a disease of the heart muscle) or narrowing of the renal arteries (arteries that supply the kidneys with blood),
• if you have any other heart disease,
• if you have liver disease,
• if you have kidney disease or are on dialysis,
• if you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism),
• if you have collagen disease (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma,
• if you have diabetes,
• if you are on a low-salt diet or using salt substitutes that contain potassium,
• if you are scheduled for anesthesia and/or major surgery,
• if you are undergoing LDL apheresis (removal of cholesterol from the blood using a special device),
• if you are undergoing desensitization treatment for bee or wasp stings,
• if you have recently had diarrhea or vomiting or are dehydrated,
• if you are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonists (also known as ARBs - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals. See also the information under the heading "When not to take Perindanor".

• if you are black, as there is a higher risk of angioedema (rapid swelling of tissues under the skin, such as the throat), and this medicine may be less effective in lowering blood pressure than in patients of other races.
• if you are taking any of the following medicines, as the risk of angioedema increases:
• racecadotril (a medicine used to treat diarrhea);
• medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes;
• sacubitril (available in a combination product containing sacubitril and valsartan), used to treat chronic heart failure. See sections "When not to take Perindanor" and "Warnings and precautions".

Children and adolescents

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

Perindanor and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Other medicines may affect the action of Perindanor. Your doctor may need to change the dose and/or take other precautions. These medicines include:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (also known as ARBs) or aliskiren (see also the information under the headings "When not to take Perindanor" and "Warnings and precautions"), diuretics (medicines that increase urine production),
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent transplant rejection; and heparin, a medicine used to thin the blood),
• lithium, used to treat mental illnesses or depression,
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen) used for pain relief or high doses of aspirin,
• 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, etc. (e.g., tricyclic antidepressants, antipsychotics),
• immunosuppressants (medicines that reduce the body's immune response) used to treat autoimmune disorders or after transplants (e.g., cyclosporine, tacrolimus),
• trimethoprim (used to treat infections),
• estr Mustine (used to treat cancer),
• medicines commonly used to treat diarrhea (racecadotril) or to prevent transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See section "Warnings and precautions",
• a combination product containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Perindanor" and "Warnings and precautions",
• allopurinol (used to treat gout),
• procainamide (used to treat heart rhythm disorders),
• vasodilators, including nitrates,
• heparin (a medicine used to thin the blood),
• medicines used to treat low blood pressure, shock, or asthma (e.g., epinephrine, norepinephrine, or adrenaline),
• gold salts, especially when given intravenously (used to treat rheumatoid arthritis).

Taking Perindanor with food and drink

It is recommended to take Perindanor before a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must tell your doctor if you think you may be pregnant or are planning to become pregnant. Your doctor will usually recommend a different medicine instead of Perindanor, as taking Perindanor during early pregnancy is not recommended. It must not be taken after the third month of pregnancy (in the second and third trimesters), as it may cause serious harm to the baby.

Breastfeeding

Tell your doctor if you are breastfeeding or planning to breastfeed. Perindanor is not recommended during breastfeeding. For breastfeeding women, your doctor may recommend other medicines, especially if the baby is a newborn or premature.

Driving and using machines

Perindanor usually does not affect alertness, but some patients may experience dizziness or weakness due to low blood pressure. If you experience these symptoms, your ability to drive or operate machinery may be impaired.

Perindanor contains lactose.

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Perindanor

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The tablet should be swallowed with a glass of water, preferably at the same time each day, in the morning before breakfast. The dose will be decided by your doctor. The recommended doses of Perindanor are:

Hypertension:the usual starting dose is 4 mg, taken once a day, in the morning. After one month of treatment, your doctor may increase the dose to 8 mg, taken once a day. The dose of 8 mg is the maximum recommended dose for hypertension.

In patients over 65 years of age, treatment should be started with a dose of 2 mg once a day. After one month of treatment, your doctor may increase the dose to 4 mg, and if necessary to 8 mg once a day.

Heart failure:the usual starting dose is 2 mg per day. After two weeks, your doctor may increase the dose to 4 mg per day, which is the maximum dose used for this indication.

Stable coronary artery disease:the usual starting dose is 4 mg, taken once a day, in the morning. After two weeks of treatment, the dose may be increased to 8 mg, taken once a day, which is the maximum dose used for this indication.

In patients over 65 years of age, treatment usually starts with 2 mg once a day. After one week of treatment, the dose can be increased to 4 mg once a day, and after another week to 8 mg once a day.

Use in children and adolescents

Perindanor should not be used in children and adolescents.

Overdose of Perindanor

If you have taken too many tablets, contact your doctor or go to the hospital immediately. The most likely symptom of overdose is low blood pressure, which can cause dizziness and fainting. In such cases, it is helpful to lay the patient down with their legs elevated.

Missing a dose of Perindanor

It is important to take the medicine regularly for it to work best. If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Perindanor

Treatment with Perindanor is long-term. Before stopping treatment, consult your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking the medicine and contact your doctor immediately if you experience any of the following side effects, as they can be serious:

Common (may affect up to 1 in 10 people):

• severe dizziness or fainting due to low blood pressure.

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"),
• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm).

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

• very fast or irregular heartbeat, chest pain (angina pectoris), or heart attack,
• weakness of the arms or legs, or difficulty speaking, which may be a sign of a stroke,
• pancreatitis, which can cause severe abdominal pain and very poor health,
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation,
• a rash that often starts with red, itchy patches on the face, arms, or legs (erythema multiforme).

Tell your doctor if you experience any of the following side effects:

Common (may affect up to 1 in 10 people):

• headache
• dizziness
• vertigo
• tingling or numbness
• vision disturbances
• tinnitus (a feeling of hearing sounds in the ears)
• cough
• shortness of breath (dyspnea)
• gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion, or difficulty digesting, diarrhea, constipation)
• allergic reactions (such as rashes, itching)
• muscle cramps
• feeling weak

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

• mood changes
• sleep disturbances
• dry mouth
• increased itching or severe rashes
• formation of blisters on the skin
• kidney problems
• impotence
• sweating
• increased levels of a type of white blood cell called eosinophils
• drowsiness
• fainting
• palpitations
• rapid heartbeat
• inflammation of blood vessels
• reactions to sunlight (increased sensitivity of the skin to the sun)
• joint pain
• muscle pain
• chest pain
• feeling unwell
• peripheral edema
• fever
• falls
• abnormal laboratory test results: high levels of potassium in the blood, which may return to normal after stopping treatment, low levels of sodium, hypoglycemia (very low blood sugar levels) in patients with diabetes, increased levels of urea in the blood, increased levels of creatinine in the blood

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

• worsening of psoriasis
• abnormal laboratory test results: increased liver enzyme activity, high levels of bilirubin in the blood

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

• disorientation
• eosinophilic pneumonia (a rare type of pneumonia)
• inflammation of the nasal mucosa (swelling or discharge from the nose)
• acute kidney failure
• blood cell count changes, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin levels, decreased platelet count

After taking ACE inhibitors, the following may occur: concentrated urine (dark urine), nausea, or vomiting, muscle cramps, disorientation, and convulsions, which may be caused by inappropriate secretion of antidiuretic hormone. If you experience these symptoms, contact your doctor as soon as possible.

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

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl

You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Perindanor

Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store in the original package to protect from light and moisture. Use within 60 days of opening the aluminum pouch. The aluminum pouch contains a desiccant. Do not swallow the desiccant. Do not use this medicine after the expiry date stated on the carton, label, and blister after EXP. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Perindanor contains

• The active substance is perindopril tert-butylamine. One tablet contains 4 mg of perindopril tert-butylamine, which corresponds to 3.338 mg of perindopril.
• The other ingredients are lactose anhydrous, colloidal anhydrous silica, microcrystalline cellulose, and magnesium stearate.

What Perindanor looks like and contents of the pack

Tablet

Perindanor 4 mg

White or almost white, oval tablets with a symbol "D" embossed on one side and "5" and "8" on either side of the score line on the other side. The tablet can be divided into two equal doses.

Perindanor tablets are available in blisters of 28, 30, 56, 60, 84, 90, 112, and 120 tablets.

The blisters are packaged in an aluminum pouch with a desiccant. Do not swallow the desiccant. Not all pack sizes may be marketed.

Marketing authorization holder

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana FRN 1913

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

For more information on this medicine, contact the local representative of the marketing authorization holder:

Orion Pharma Poland Sp. z o.o.

[email protected]

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

France

Perindopril Arrow Lab 2 mg, comprimé

Perindopril Arrow Lab 4 mg, comprimé sécable

Malta

Perindopril Aurobindo 2 mg/ 4 mg Tablets

Netherlands

Perindopril tert-butylamine Aurobindo 2 mg/ 4 mg, tabletten

Poland

Perindanor

Spain

Perindopril Aurovitas 4 mg comprimidos EFG

United Kingdom

Perindopril 2 mg/ 4 mg tablets

Date of last revision of the package leaflet: