Leaflet: information for the user

Perindopril Aurovitas 4 mg tablets EFG

perindopril terbutilamine

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6.Contents of the pack and additional information

Perindopril terbutilamine belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. They work by widening blood vessels, making it easier for the heart to pump blood throughout the body.

Perindopril Aurovitasis 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 a heart attack, in patients with established 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 a surgery to improve blood supply to the heart, by widening the blood vessels that supply it.

Do not take Perindopril Aurovitas

• If you are allergic to perindopril or any of the other ingredients in this medicine (including those listed in section 6), or to any other ACE inhibitor.
• If you are more than three months pregnant. (It is also best to avoid perindopril at the beginning of pregnancy - see the pregnancy section).
• If you have experienced symptoms such as wheezing, swelling of the face, lips, tongue or throat, intense itching or severe skin eruptions when you have taken an ACE inhibitor in the past, or if you or a family member has had these symptoms in any other circumstance (a condition called angioedema).
• If you have diabetes or kidney failure 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 an area 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 circumstances apply, consult your doctor or pharmacist before starting to take Perindopril Aurovitas:

• If you have aortic stenosis (narrowing of the main vein that leaves the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that supplies blood to the kidney),
• If you have any other heart problem,
• 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 the blood (primary aldosteronism),
• If you have a disease of the blood vessels, such as systemic lupus erythematosus or scleroderma,
• If you have diabetes,
• If you are following a low-salt diet or using a salt substitute that contains potassium,
• If you are going to have general anaesthesia and/or a major operation,
• If you are going to have LDL apheresis (removing cholesterol from the blood using a machine),
• If you are going to receive a 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 "sartanes" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may need to check your kidney function, blood pressure and blood electrolyte levels (such as potassium) at regular intervals.

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

• If you are of black ethnicity, as you may be at higher risk of angioedema (rapid swelling under the skin in areas such as the throat) and this medicine may be less effective in lowering your blood pressure than in patients who are not of black ethnicity.
• If you are taking any of the following medicines, the risk of angioedema increases:

• Racecadotrilo (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 of age is not recommended.

Other medicines and Perindopril Aurovitas

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

The treatment with Perindopril Aurovitas may be affected by other medicines.You may need to have your dose adjusted and/or take other precautions. These include:

• Other medicines for high blood pressure, includingangiotensin 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), diuretics that save potassium and other medicines that may increase the amount of potassium in the blood (for example, trimetoprim and cotrimoxazol for bacterial infections; ciclosporin, an immunosuppressant used to prevent rejection of organ transplants; and heparin, a medicine used to thin the blood to prevent clots).
• Lithium (a medicine for mania or depression),
• non-steroidal anti-inflammatory medicines (for example ibuprofen), for pain, or high doses of aspirin,
• medicines for treating diabetes (such as insulin or metformin),
• Baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
• medicines for treating mental disorders, such as depression, anxiety, schizophrenia, etc (for example tricyclic antidepressants, antipsychotics),
• immunosuppressants (medicines that reduce the body's defence mechanism) used to treat autoimmune disorders or after a transplant (for example ciclosporin),
• Trimetoprim (for treating infections),
• Estramustine (used in cancer treatment),
• Medicines that are frequently used to treat diarrhoea (racecadotrilo) or to prevent rejection of organ transplants (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”,
• Alopurinol (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 (for example efedrina, noradrenalina or adrenalina),
• Gold salts, especially when given intravenously (used to treat rheumatoid arthritis symptomatically).

Perindopril Aurovitas with food and drink

It is best to take Perindopril Aurovitas before a meal.

Pregnancy, breastfeeding and fertility

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

Pregnancy

You should inform your doctor if you think you are (or may be) pregnant. Normally, your doctor will advise you to stop taking Perindopril Aurovitas before becoming pregnant or as soon as you know you are pregnant and advise you to take another medicine instead of Perindopril Aurovitas. Perindopril Aurovitas is not recommended at the beginning of pregnancy and should not be taken when more than three months pregnant because it could cause serious harm to the baby if used after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding your baby or are planning to start. Perindopril Aurovitas is not recommended in mothers who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed your baby, especially if it is a newborn or premature baby.

Driving and using machines

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

Perindopril Aurovitas contains lactose

The tablets ofPerindoprilAurovitascontain lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication as indicated 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 every day, in the morning before breakfast. Your doctor will decide what is the correct dose for you.

The recommended doses of Perindopril Aurovitas are as follows:

Hypertension:The usual starting and maintenance dose is 4 mg once a day. After a month, it may be increased to 8 mg once a day if necessary. 8 mg per day is the maximum recommended dose for hypertension.

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

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

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

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

Use in children and adolescents

It is not recommended for use in children and adolescents.

If you take more Perindopril Aurovitas than you should

The most likely effect in case of overdose is a drop in blood pressure that may cause dizziness or fainting. If this happens, you may help by lying down with your legs elevated.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Perindopril Aurovitas

It is essential to 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 treatment as your doctor has indicated. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Perindopril Aurovitas

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

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

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

Stop taking this medicine and seek immediate medical attention if you experience any of the following serious side effects::

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

• severe dizziness or fainting due to low blood pressure,

Less common (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 the arms or legs, or speech problems that may be a sign of a possible stroke,
• pancreatitis that can cause severe abdominal and back pain accompanied by discomfort,
• yellowing of the skin or eyes (jaundice) that may be a sign of hepatitis,
• skin rash that often starts with red, itchy patches on the face, arms, or legs (erythema multiforme).

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

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

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

Less common (may affect up to 1 in 100 people):

• mood changes,
• sleep disturbances,
• dry mouth,
• intense itching or severe skin rashes,
• skin blisters,
• kidney problems,
• impotence,
• sweating,
• eosinophilia (a type of white blood cell),
• drowsiness,
• fatigue,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitivity reactions (increased skin sensitivity to the sun),
• arthralgia (joint pain),
• mialgia (muscle pain),
• chest pain,
• general discomfort,
• peripheral edema,
• fever,
• fall,
• change in laboratory values: reversible high potassium levels in the blood upon discontinuing treatment, low sodium levels, hypoglycemia in diabetic patients (very low blood sugar levels), elevated urea levels in the blood, and elevated creatinine levels in the blood,
• depression.

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

• worsening of psoriasis,
• changes in laboratory parameters: elevated liver enzymes, high serum bilirubin levels,
• concentrated urine, feeling unwell (nausea) or vomiting, muscle cramps, confusion, and seizures. These symptoms may be a sign of a condition called SIADH (inadequate secretion of antidiuretic hormone),
• decreased or absent diuresis,
• facial flushing,
• acute renal insufficiency.

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 decreased platelet count.

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

Unknown (frequency cannot be estimated from available data):

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use Perindopril Aurovitas after the expiration date that appears on the packaging, after “CAD”. The expiration date is the last day of the month indicated.

Do not store above 25ºC. Store in the original packaging to protect it from moisture and light.

Use within 60 days from the first time the aluminum bag is opened.

The aluminum bag contains an inedible desiccant, DO NOT INGEST.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Perindopril Aurovitas

• The active ingredient is perindopril terbutilamine.

Each tablet contains 4 mg of perindopril terbutilamine, equivalent to 3,338 mg of perindopril.

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

Appearance of the product and contents of the package

Perindopril Aurovitas 4 mg tablets EFG are non-coated tablets, in the form of a capsule, white to off-white in color, with the mark “D” on one face and “5” and “8” on each side of the groove on the other face. The tablets can be divided into equal halves.

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Perindopril Aurovitas 4 mg tablets EFG

France:Perindopril Arrow Lab 4 mg, scored tablet

Netherlands:Perindopril tert-butylamine Aurobindo 4 mg, tablets

Malta:Perindopril Aurobindo 4 mg Tablets

Poland:PERINDANOR

United Kingdom:Perindopril 4 mg tablets

Last review date of this leaflet: December 2021

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).