PERINDOPRIL AUROVITAS 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Perindopril Aurovitas 4 mg Tablets EFG

perindopril tert-butylamine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Perindopril Aurovitas and what is it used for
2. What you need to know before you take Perindopril Aurovitas
3. How to take Perindopril Aurovitas
4. Possible side effects
5. Storage of Perindopril Aurovitas

1. Contents of the pack and further information

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

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

Perindopril Aurovitas is used to:

• Treat high blood pressure (hypertension).
• Treat heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs).
• Reduce the risk of certain heart problems, such as a heart attack, in patients with stable coronary artery disease (a condition in which the blood supply to the heart is reduced or blocked), and who have already had a heart attack and/or an operation to improve blood flow to the heart, by widening the blood vessels that supply it.

2. What you need to know before you take Perindopril Aurovitas

Do not take Perindopril Aurovitas

• 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 better to avoid perindopril at the start of pregnancy - see the section on pregnancy).
• If you have experienced symptoms such as wheezing, swelling of the face, lips, tongue or throat, intense itching or severe skin rashes when you have taken an ACE inhibitor in the past, or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema).
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• 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 areas such as the throat) is high.
• If you are receiving 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 that reduce blood flow to your kidneys (renal artery stenosis).

Warnings and precautions

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

• if you have aortic stenosis (narrowing of the main blood vessel that comes out of the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the artery that supplies 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 disease of the vascular collagen, such as systemic lupus erythematosus or scleroderma,
• if you have diabetes,
• if you are on a low-salt diet or use a salt substitute that contains potassium,
• if you are going to have a general anaesthetic and/or a major operation,
• if you are going to have an LDL apheresis (a procedure to remove cholesterol from your blood using a machine),
• if you are going to receive treatment to make you less sensitive to the effects of an allergy to bee or wasp stings,
• 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 diabetic kidney problems.
• 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 in areas such as the throat) and this medicine may be less effective at lowering your blood pressure than in patients who are not of black origin.
• 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 rejection in organ transplants and for cancer (e.g. temsirolimus, sirolimus and everolimus)
• vildagliptin, a medicine used to treat diabetes.
• sacubitril (available as a fixed-dose combination with valsartan), used to treat long-term heart failure.

Children and adolescents

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

Other medicines and Perindopril Aurovitas

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

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

• other medicines to treat high blood pressure, including angiotensin II receptor antagonists (ARAs), aliskiren (see also the 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 potassium levels in the blood (e.g. trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, an immunosuppressant medicine 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 medicines (e.g. ibuprofen) for pain, or high doses of aspirin,
• medicines to treat diabetes (such as insulin or metformin),
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis),
• medicines to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics),
• immunosuppressants (medicines that reduce the body's defence mechanism) used to treat autoimmune disorders or after an organ transplant (e.g. ciclosporin),
• trimethoprim (for the treatment of infections),
• estravmustine (used in the treatment of cancer),
• medicines that are commonly used to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (e.g. sirolimus, everolimus, temsirolimus and other medicines belonging to the class called mTor inhibitors). See section “Warnings and precautions”,
• sacubitril/valsartan (used to treat long-term 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 the blood vessels),
• heparin (used to make the blood more fluid),
• medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline),
• gold salts, especially when given intravenously (used to treat the symptoms 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 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 should inform your doctor if you think you are (or might be) pregnant. Your doctor will normally advise you to stop taking Perindopril Aurovitas before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Perindopril Aurovitas. Perindopril Aurovitas is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. Perindopril Aurovitas is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment if you want to breast-feed your baby, especially if your baby is a newborn or was born prematurely.

Driving and using machines

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

Perindopril Aurovitas contains lactose

The tablets of Perindopril Aurovitas contain lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Perindopril Aurovitas

Follow exactly the instructions of administration of this medicine given to you by your doctor or pharmacist. In case of doubt, ask 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 what the correct dose is for you.

The recommended doses of Perindopril Aurovitas are as follows:

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

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

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

Stable coronary artery disease:The normal starting dose is 4 mg once a day. After two weeks, it can be increased to 8 mg a day, which is the maximum recommended dose for this indication.

If you are 65 years or older, the usual starting dose is 2 mg a day. After one week, it can be increased to 4 mg a day and then, after another week, to 8 mg once a day.

Use in children and adolescents

The use of perindopril 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 can cause dizziness or fainting. If this happens to you, lying down with your legs raised may help.

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

If you forget to take Perindopril Aurovitas

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

If you stop taking Perindopril Aurovitas

As treatment with Perindopril Aurovitas is usually for life, you should consult your doctor before stopping this medicine.

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

4. Possible side effects

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

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

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, tongue or throat, difficulty breathing, (angioedema) (see section 2 “Warnings and precautions”),
• sudden wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm),

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

• abnormal heart rhythm, chest pain (angina) or heart attack,
• weakness of the arms or legs, or problems with speech that could be a sign of a possible stroke,
• inflammation of the pancreas that can cause severe abdominal and back pain accompanied by feeling unwell,
• yellowing of the skin or eyes (jaundice) that could be a sign of hepatitis,
• skin rash that often starts with red spots on the face, arms or legs, which may blister (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,
• visual disturbances,
• tinnitus (ringing in the ears),
• cough,
• breathing difficulties (dyspnoea),
• gastrointestinal disorders (nausea, vomiting, abdominal pain, altered taste, dyspepsia or difficulty digesting, diarrhoea, constipation),
• allergic reactions (such as skin rashes, itching),
• muscle cramps,
• feeling weak.

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

• mood changes,
• sleep disorders,
• dry mouth,
• intense itching or severe skin rashes,
• blistering of the skin,
• kidney problems,
• impotence,
• sweating,
• excess eosinophils (a type of white blood cell),
• drowsiness,
• fainting,
• palpitations,
• rapid heartbeat,
• vasculitis (inflammation of blood vessels),
• photosensitivity reactions (increased sensitivity of the skin to the sun),
• arthralgia (joint pain),
• myalgia (muscle pain),
• chest pain,
• general feeling of being unwell,
• peripheral oedema,
• fever,
• fall,
• changes in laboratory values: high potassium levels in the blood reversible upon discontinuation of treatment, low sodium levels, hypoglycaemia in diabetic patients (very low blood sugar levels), elevated blood urea, and elevated creatinine in the blood,
• depression.

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

• worsening of psoriasis,
• changes in laboratory parameters: increased liver enzymes, high bilirubin levels in the blood,
• concentrated urine, feeling unwell (nausea) or sick (vomiting), muscle cramps, confusion and convulsions. These symptoms may be due to a condition called SIADH (inappropriate secretion of antidiuretic hormone),
• decreased or absent urine production,
• flushing,
• acute kidney failure.

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

• confusion,
• eosinophilic pneumonia (a rare type of pneumonia),
• rhinitis (congestion or runny nose),
• changes in blood parameters such as a decrease in the number of white and red blood cells, a decrease in haemoglobin concentration, a decrease in the number of platelets.

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

Not known (frequency cannot be estimated from the available data):

• change in colour, numbness and pain in the fingers of the hands or feet (Raynaud's disease).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side 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 expiration date stated on the carton, after "EXP". The expiration date is the last day of the month indicated.

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

Use within 60 days of first opening the aluminum bag.

The aluminum bag contains a non-edible desiccant, DO NOT INGEST.

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

6. Package Contents and Additional Information

Composition of Perindopril Aurovitas

• The active ingredient is perindopril tert-butylamine.

Each tablet contains 4 mg of perindopril tert-butylamine, equivalent to 3.338 mg of perindopril.

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

Appearance of the Product and Package Contents

Perindopril Aurovitas 4 mg tablets EFG are uncoated tablets, capsule-shaped, white to off-white in color, with the mark "D" on one face and "5" and "8" on each side of the score line on the other face. The tablets can be divided into equal halves.

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

The blisters are packaged in an aluminum bag, which contains a desiccant. Each aluminum bag contains 28 or 30 tablets. Do not ingest the desiccant.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 authorized in the Member States of the European Economic Area 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 last revision of this leaflet: December 2021

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