Perindanor

Package Leaflet: Information for the User

Perindanor, 8 mg, Tablets

tert-Butylamine perindopril

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This 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.

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;
• 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 by widening the heart's blood vessels.

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.
• if you are more than 3 months pregnant. It is also not recommended to take perindopril during early pregnancy - see the section "Pregnancy, breast-feeding and fertility".
• if you have had symptoms such as difficulty breathing, swelling of the face or tongue, intense itching or severe skin rash associated with previous treatment with an ACE inhibitor, or if you have had these symptoms 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, as the risk of angioedema (rapid swelling of the tissues under the skin, e.g. in the throat) is increased.
• if you are undergoing dialysis or blood filtration using a method other than haemodialysis. 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, tell your doctor or pharmacist if any of the following apply to you:

• if you have narrowing of the aortic valve (narrowing of the main blood vessel leading out of the heart), hypertrophic cardiomyopathy (a disease of the heart muscle) or narrowing of the renal arteries (the arteries that supply the kidneys with blood),
• if you have any other heart disease or liver or kidney disease, or if you 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 are on a low-salt diet or using salt substitutes that contain potassium,
• if you have uncontrolled diabetes,
• if you are scheduled for anaesthesia and/or major surgery,
• if you have recently had diarrhoea or vomiting, or are dehydrated,
• if you are undergoing desensitization treatment for bee or wasp stings,
• if you are undergoing LDL apheresis (a procedure to remove cholesterol from the blood using a special device),
• if you are taking any of the following medicines to treat high blood pressure:
• angiotensin receptor blockers (ARBs) (also known as sartans - 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 (e.g. potassium) at regular intervals. See also the information under the headings "When not to take Perindanor" and "Warnings and precautions".

• if you are black, as there is a higher risk of angioedema (rapid swelling of the tissues under the skin, e.g. in the throat) and this medicine may be less effective in lowering your blood pressure than in patients of other races.
• if you are taking any of the following medicines, as the risk of angioedema is increased:
• racecadotril (a medicine used to treat diarrhoea);
• medicines used to prevent transplant rejection and to treat cancer (e.g. sirolimus, everolimus, temsirolimus);
• 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 the medicines you are taking, have recently taken, or might take, including those obtained without a prescription. 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 receptor blockers (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; cyclosporin, an immunosuppressant used to prevent transplant rejection; and heparin, a medicine used to thin the blood to prevent clots),
• medicines used to treat diabetes (such as insulin or metformin) to lower blood sugar levels,
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
• lithium (used to treat mental illnesses or depression),
• medicines used to treat mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics),
• allopurinol (used to treat gout),
• immunosuppressants (medicines that reduce the body's immune response) used to treat autoimmune disorders or after transplants (e.g. cyclosporin, tacrolimus),
• trimethoprim (used to treat infections),
• estr Mustine (used to treat cancer),
• medicines commonly used to treat diarrhoea (racecadotril) or to prevent transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of medicines known as 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",
• procainamide (used to treat irregular heart rhythms),
• non-steroidal anti-inflammatory medicines (e.g. ibuprofen) used for pain relief or high doses of aspirin,
• medicines used to treat low blood pressure, shock, or asthma (e.g. adrenaline, noradrenaline, or adrenaline),
• vasodilators, including nitrates,
• heparin (a medicine used to thin the blood),
• 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, breast-feeding, and fertility

If you are pregnant or breast-feeding, 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 it is not recommended to take Perindanor during early pregnancy. Do not take Perindanor after the third month of pregnancy (in the second and third trimesters), as it may cause serious harm to the baby.

Breast-feeding

Tell your doctor if you are breast-feeding or plan to breast-feed. It is not recommended to take Perindanor while breast-feeding. Your doctor may recommend a different medicine, especially if your 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 in adults 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.

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. This is the maximum recommended dose for this indication.

In patients over 65 years of age, treatment should usually be started with a dose of 2 mg once a day. After one week of treatment, the dose may 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

If you have taken more tablets than you should, contact your doctor or go to the hospital emergency department immediately. The most likely symptom of overdose is low blood pressure, which can cause dizziness and fainting. In this case, it is helpful to lay the patient down with their legs raised.

Missed dose

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 forgotten 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 rapid 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 may cause severe abdominal pain and very severe illness,
• 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
• visual disturbances
• tinnitus (a feeling of hearing sounds in the ears)
• cough
• shortness of breath (dyspnoea)
• gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion, or difficulty digesting, diarrhoea, constipation)
• allergic reactions (such as rashes, itching)
• muscle cramps
• feeling weak.

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

• mood changes
• sleep disturbances
• dryness of the mucous membranes of the mouth
• increased itching or severe rashes
• formation of blisters on the skin
• kidney problems
• impotence
• sweating
• increased levels of eosinophils (a type of white blood cell)
• drowsiness
• fainting
• palpitations
• tachycardia
• vasculitis
• photosensitivity reactions (increased sensitivity of the skin to sunlight)
• joint pain
• muscle pain
• chest pain
• feeling unwell
• peripheral oedema
• fever
• falls
• abnormal laboratory test results: high levels of potassium in the blood, transient after stopping treatment, low levels of sodium, hypoglycaemia (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)
• nasal congestion (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 haemoglobin, 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 inadequate 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 national reporting system via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme at https://www.mhra.gov.uk/yellowcard. 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 aluminium pouch. The aluminium pouch contains a desiccant. Do not swallow the desiccant. Do not use this medicine after the expiry date which is stated on the carton, label, and blister after EXP. The expiry date refers to the last day of that month. 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 8 mg of perindopril tert-butylamine, equivalent to 6.676 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

Perindanor 8 mg tablets are white or almost white, round, biconvex tablets with a symbol "D" engraved on one side and "5" and "9" 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 aluminium pouch with a desiccant. Do not swallow the desiccant. Not all pack sizes may be marketed.

Marketing authorisation 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 further information on this medicine, contact the local representative of the marketing authorisation holder: Orion Pharma Poland Sp. z o. o., [email protected]

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

France: Perindopril Arrow Lab 8 mg, comprimé sécable

Malta: Perindopril Aurobindo 8 mg Tablets

Netherlands: Perindopril tert-butylamine Aurobindo 8 mg, tabletten

Poland: Perindanor

United Kingdom: Perindopril 8 mg tablets

Date of last revision of the package leaflet: