Perindopril Aurovitas 4 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Perindopril Aurovitas 4 mg tablets EFG

perindopril terbutylamine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Perindopril Aurovitas

3. How to take Perindopril Aurovitas

4. Possible adverse effects

5. How to store Perindopril Aurovitas

6. Contents of the pack and other information

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

Perindopril tert-butylamine belongs to a group of medicines called ACE inhibitors. These work by widening blood vessels, making it easier for the heart to pump blood throughout the body.

Perindopril Aurovitas is used for:

• Treating high blood pressure (hypertension).
• Treating heart failure (a condition in which the heart cannot pump enough blood to meet the body's needs).
• Reducing the risk of certain heart problems, such as heart attack, in patients with stable coronary artery disease (a condition in which blood supply to the heart is reduced or blocked), who have already had a heart attack and/or undergone a procedure to improve blood flow to the heart by widening the supplying blood vessels.

2. What you need to know before taking Perindopril Aurovitas

Do not take Perindopril Aurovitas

• If you are allergic to perindopril or to any of the other ingredients of this medicine (listed in section 6), or to any other ACE inhibitor.
• If you are more than three months pregnant. (It is also advisable to avoid perindopril in early pregnancy – see pregnancy section).
• If you have previously experienced symptoms such as wheezing, swelling of the face, tongue or throat, severe itching or serious skin rashes when taking an ACE inhibitor, or if you or a family member have ever had these symptoms under any circumstances (a condition called angioedema).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, for example in the throat) is high.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, perindopril may not be suitable for you.
• If you have kidney problems causing reduced blood flow to your kidneys (renal artery stenosis).

Warnings and precautions

If any of the following apply, consult your doctor or pharmacist before starting to take Perindopril Aurovitas:

• if you have aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidney),

• if you have any other heart problems,

• if you have liver problems,

• if you have kidney problems, or if you are on dialysis,

• if you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism),

• if you suffer from a vascular collagen disease such as systemic lupus erythematosus or scleroderma,

• if you have diabetes,

• if you are on a low-salt diet or use a salt substitute containing potassium,

• if you are due to undergo general anaesthesia and/or major surgery,

• if you are scheduled to undergo LDL apheresis (removal of cholesterol from the blood using a machine),

• if you are to receive treatment to reduce sensitivity to bee or wasp sting allergies,

• if you have recently had diarrhoea or vomiting, or are dehydrated,

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as "sartans" – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

• aliskiren.

Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Perindopril Aurovitas”.

• If you are of Black origin, as you may have a higher risk of angioedema (rapid swelling under the skin, for example in the throat), and this medicine may be less effective in lowering your blood pressure compared to non-Black patients.

• If you are taking any of the following medicines, the risk of angioedema increases:

• racecadotril (a medicine used to treat diarrhoea),

• medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus and everolimus),

• vildagliptin, a medicine used to treat diabetes,

• sacubitril (available in fixed-dose combination with valsartan), used to treat chronic heart failure.

Children and adolescents

The use of perindopril in children and adolescents up to 18 years of age is not recommended.

Other medicines and Perindopril Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Treatment with Perindopril Aurovitas may be affected by other medicines. Your doctor may need to adjust your dose and/or take other precautions. These include:

• other medicines to treat high blood pressure, including angiotensin II receptor antagonists (ARA), aliskiren (see also information under the headings “Do not take Perindopril Aurovitas” and “Warnings and precautions”), or diuretics (medicines that increase the amount of urine produced by the kidneys),
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots),
• lithium (a medicine for mania or depression),
• non-steroidal anti-inflammatory drugs (e.g., ibuprofen) for pain, or high-dose aspirin,
• medicines for treating diabetes (such as insulin or metformin),
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis),
• medicines for treating 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 transplantation (e.g., cyclosporine),
• trimethoprim (used to treat infections),
• estramustine (used in cancer treatment),
• medicines frequently used to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class called mTor inhibitors). See section “Warnings and precautions”,
• sacubitril/valsartan (used to treat chronic heart failure). See sections “Do not take Perindopril Aurovitas” and “Warnings and precautions”,
• allopurinol (used to treat gout),
• procainamide (a treatment for irregular heartbeats),
• vasodilators including nitrates (medicines used to widen blood vessels),
• heparin (used to thin the blood),
• medicines used to treat low blood pressure, shock or asthma (e.g., ephedrine, noradrenaline or adrenaline),
• gold salts, especially when given intravenously (used for symptomatic treatment of rheumatoid arthritis).

Taking Perindopril Aurovitas with food and drink

It is preferable to take Perindopril Aurovitas before a meal.

Pregnancy, breast-feeding and fertility

If you are pregnant, breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you think you are (or might be) pregnant. Your doctor will usually advise you to stop taking Perindopril Aurovitas before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Perindopril Aurovitas is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if used beyond the third month of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding or plan to breast-feed. Perindopril Aurovitas is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if the baby is a newborn or premature.

Driving and using machines

Perindopril Aurovitas generally does not affect alertness. However, some patients may feel dizzy or weak due to low blood pressure. If this occurs, your ability to drive or operate machinery may be impaired.

Perindopril Aurovitas contains lactose

Perindopril Aurovitas tablets contain lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Perindopril Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Take your tablet with a glass of water, preferably at the same time each day, in the morning before breakfast. Your doctor will decide the correct dose for you.

The recommended doses of Perindopril Aurovitas are as follows:

High blood pressure: The usual starting and maintenance dose is 4 mg once daily. After one month, it may be increased to 8 mg once daily if necessary. 8 mg per day is the maximum recommended dose for high blood pressure.

If you are 65 years of age or older, the usual starting dose is 2 mg daily. After one month, it may be increased to 4 mg daily and then, if necessary, to 8 mg once daily.

Heart failure: The usual starting dose is 2 mg once daily. After 2 weeks, it may be increased to 4 mg daily, which is the maximum recommended dose for heart failure.

Stable coronary artery disease: The usual starting dose is 4 mg once daily. After 2 weeks, it may be increased to 8 mg daily, which is the maximum recommended dose for this indication.

If you are 65 years of age or older, the usual starting dose is 2 mg once daily. After one week, it may be increased to 4 mg daily and after another week to 8 mg once daily.

Use in children and adolescents

Use in children and adolescents is not recommended.

If you take more Perindopril Aurovitas than you should

The most likely effect in case of overdose is a drop in blood pressure, which may cause dizziness or fainting. If this occurs, lying down with your legs raised may help.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Perindopril Aurovitas

It is important that you take your medication every day. However, if you have forgotten to take one or more tablets, take the missed dose as soon as possible and then continue with your treatment as directed by your doctor. Do not take a double dose to make up for missed doses.

If you stop taking Perindopril Aurovitas

Since treatment with Perindopril Aurovitas is usually lifelong, you should consult your doctor before stopping this medicine.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

Stop taking this medicine and contact your doctor immediately if you experience any of the following adverse effects, which may 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 wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm),

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

• abnormally fast or irregular heartbeat, chest pain (angina), or heart attack,
• weakness in arms or legs, or speech problems which could be signs of a possible stroke,
• inflammation of the pancreas which may cause severe abdominal and back pain accompanied by malaise,
• yellowing of the skin or eyes (jaundice), which could be a sign of hepatitis,
• skin rash that often begins with red, itchy spots on the face, arms, or legs (erythema multiforme).

Inform your doctor if you experience any of the following adverse effects:

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

• headache,
• dizziness,
• vertigo,
• tingling sensations,
• visual disturbances,
• tinnitus (sensation of ringing in the ears),
• cough,
• breathing difficulty (dyspnea),
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, altered taste, dyspepsia or difficulty digesting, diarrhea, constipation),
• allergic reactions (such as skin rashes, itching),
• muscle cramps,
• feeling of weakness.

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

• mood changes,
• sleep disorders,
• dry mouth,
• severe itching or serious skin rashes,
• blistering of the skin,
• kidney problems,
• impotence,
• sweating,
• elevated eosinophil count (a type of white blood cell),
• drowsiness,
• collapse,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitivity reactions (increased skin sensitivity to sunlight),
• arthralgia (joint pain),
• myalgia (muscle pain),
• chest pain,
• general malaise,
• peripheral edema,
• fever,
• fall,
• changes in laboratory values: high blood potassium levels (reversible upon discontinuation of treatment), low sodium levels, hypoglycemia in diabetic patients (very low blood sugar levels), increased blood urea, and elevated blood creatinine.

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

• worsening of psoriasis,
• changes in laboratory parameters: increased liver enzymes, high serum bilirubin levels,
• concentrated urine, feeling unwell (nausea) or feeling sick (vomiting), muscle cramps, confusion, and seizures. These symptoms may indicate a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion),
• reduced or absent urine output,
• facial flushing,
• acute renal failure.

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

• confusion,
• eosinophilic pneumonia (a rare type of pneumonia),
• rhinitis (nasal congestion or runny nose),
• changes in blood parameters such as decreased white and red blood cell counts, decreased hemoglobin concentration, and reduced platelet count.

If you experience any of these symptoms, contact your doctor as soon as possible.

Frequency not known (frequency cannot be estimated from available data):

• change in color, numbness, and pain in fingers or toes (Raynaud's phenomenon).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Perindopril Aurovitas

Keep out of sight and reach of children.

Do not use Perindopril Aurovitas after the expiry date stated on the carton, after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep in the original packaging to protect from moisture and light.

Use within 60 days after the aluminium foil pouch is first opened.

The aluminium foil pouch contains a non-edible desiccant. DO NOT INGEST.

Medicines should not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Perindopril Aurovitas

• The active substance is perindopril terbutylamine.

Each tablet contains 4 mg of perindopril terbutylamine, equivalent to 3.338 mg of perindopril.

• The other components are: lactose, microcrystalline cellulose (E-460), colloidal anhydrous silica (E-551), and magnesium stearate (E-572).

Nature of the product and pack contents

Perindopril Aurovitas 4 mg film-coated tablets are uncoated tablets, capsule-shaped, white to off-white in colour, marked with a "D" on one side and "5" and "8" on each side of the breakline on the other side. The tablets can be divided into equal halves.

Perindopril Aurovitas 4 mg tablets are available in blister packs containing 28, 30, 56, 60, 84, 90, 112 and 120 tablets.

The blisters are packed in an aluminium bag containing a desiccant. Each aluminium bag contains 28 or 30 tablets. Do not ingest the desiccant.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000

Malta

This medicinal product is authorised in the European Economic Area member states under the following names:

Spain: Perindopril Aurovitas 4 mg tablets EFG

France: Perindopril Arrow Lab 4 mg, comprimé sécable

Netherlands: Perindopril tert-butylamine Aurobindo 4 mg, tabletten

Malta: Perindopril Aurobindo 4 mg Tablets

Poland: PERINDANOR

United Kingdom: Perindopril 4 mg tablets

Date of the most recent review of this leaflet: December 2021

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).