Patient Information Leaflet

Perindopril / Indapamida Viatris4 mg/1,25 mg Tablets EFG

perindopril tert-butylamine and indapamide

Read this leaflet carefully before you start taking this medicine, as 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. Do not give it 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.

1.What is Perindopril / Indapamida Viatris and what is it used for

2.What you need to know before starting to take Perindopril / Indapamida Viatris

3.How to take Perindopril / Indapamida Viatris

4.Possible side effects

5.Storage of Perindopril / Indapamida Viatris

6.Contents of the pack and additional information

Perindopril / Indapamida Viatris is a combination of two active principles, perindopril and indapamida. It is an antihypertensive used for the treatment of hypertension (elevated blood pressure).

It belongs to a group of medications called angiotensin-converting enzyme inhibitors. This type of medication widens blood vessels, allowing the heart to pump blood through them more easily. Indapamida is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamida is different from other diuretics, as it only produces a slight increase in urine production. Both active principles reduce blood pressure and exert a combined action to control blood pressure.

Do not take Perindopril / Indapamida Viatris:

• If you are allergic to perindopril, other ACE inhibitors, indapamida, other sulfonamides (which may include other diuretics or antibiotics such as cotrimoxazole) or to any of the other components of this medication (listed in section 6).
• If you have experienced symptoms such as sneezing, swelling of the face or tongue, intense itching or extensive skin eruptions with previous treatments with ACE inhibitors, or if you or a family member has had these symptoms in another circumstance (a condition called angioedema).
• If you have severe liver problems or a condition called hepatic encephalopathy (degenerative brain disease).
• If you have severe kidney insufficiency in which blood flow to your kidneys is decreased (renal artery stenosis).
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, perindopril/indapamida may not be suitable for you.

• If you have low levels of potassium in your blood.
• If you are taking other medications that may affect heart rhythm (see section “Other medications and Perindopril / Indapamida Viatris”).
• If you suspect you have untreated heart failure (severe fluid retention, difficulty breathing).
• If you are more than 3 months pregnant (you should avoid taking this medication in the first months of pregnancy) (see section "Pregnancy and breastfeeding").
• If you are breastfeeding.
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication that contains aliskirén.
• If you have taken or are currently taking sacubitril/valsartán, a medication used to treat a type of long-term (chronic) heart failure in adults, as it increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Perindopril / Indapamida Viatris:

• If you have aortic stenosis (narrowing of the main blood vessel that leaves the heart), hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that carries blood to the kidneys).
• If you have other heart problems such as heart failure (a weakness of the heart muscle) or heart rhythm problems.
• If you have kidney problems or if you only have one functioning kidney or if you are on dialysis,
• If you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased pressure in your eye and can occur within hours to weeks after taking perindopril/indapamida. If not treated, this can lead to permanent vision loss. If you have had a previous allergy to penicillin or sulfonamides, you may have a higher risk of developing this,
• If you have muscle disorders, including muscle pain, sensitivity, weakness or cramps,
• If you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism).
• If you have liver problems.
• If you have a disease of the connective tissue (skin and connective tissue disease) such as systemic lupus erythematosus or scleroderma.
• If you have atherosclerosis (hardening of the arteries) or reduced blood flow to the brain (cerebral circulatory insufficiency).
• If you have hyperparathyroidism (hyperfunction of the parathyroid gland).
• If you have low levels of potassium in your blood.
• If you cannot eat normal amounts of food (malnourished).
• If you have gout.
• If you are diabetic.
• If you are black – this medication may not be as effective for you or you may have a higher risk of experiencing adverse reactions such as swelling (angioedema).
• If you follow a low-sodium diet or use salt substitutes that contain potassium or take potassium supplements.
• If you are taking lithium or potassium-sparing diuretics (triamterene or amiloride) or potassium supplements, as you should avoid using them with perindopril/indapamida (see section "Other medications and Perindopril / Indapamida Viatris").
• If you are elderly, especially over 70 years old. Your doctor may perform additional tests and/or prescribe a lower dose.
• If you have had photosensitivity reactions,
• If you have severe allergic reactions with inflammation of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema). This can occur at any time during treatment. If you develop these symptoms, discontinue treatment and contact your doctor immediately.
• If you are a hemodialysis patient with high-flow membranes,
• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• • An angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.
  • Aliskirén.

• If you are using any of the following medications, you have a higher risk of developing angioedema:

• Racecadotrilo (used to treat diarrhea).
• Sirolimus, everolimus, temsirolimus and other medications that belong to the category of mTOR inhibitors (used to prevent organ rejection after transplantation).
• Linagliptina, saxagliptina, sitagliptina, vildagliptina and other medications that belong to the category of gliptinas, used to treat diabetes.
• Sacubitril (available as a fixed-dose combination with valsartán), used in patients with heart failure.

Your doctor may monitor your renal function, blood pressure, blood sugar levels, and electrolyte levels in your blood (such as potassium) at regular intervals.

Angioedema

In patients treated with ACE inhibitors, including perindopril/indapamida, angioedema (severe allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing) has been reported. This can occur at any time during treatment. If you develop these symptoms, discontinue treatment with perindopril/indapamida and seek medical attention immediately. See also Section 4.

See also the information under the heading “Do not take Perindopril / Indapamida Viatris”.

You must inform your doctor if you are pregnant, think you may be pregnant or intend to become pregnant.This medication is not recommended in the first months of pregnancy and should not be taken if you have exceeded the third month of gestation, as it may cause serious harm to your child if used at that stage (see section "Pregnancy and breastfeeding").

During treatment

When taking this medication, you must also inform your doctor or healthcare staff if:

• You are to receive anesthesia and/or undergo surgery.
• You have recently had diarrhea, vomiting or dehydration.
• You are to receive dialysis or apheresis of LDL (which is the removal of cholesterol from your blood using a machine).
• You are to receive desensitization treatment to reduce the effects of an allergy to bee or wasp stings.
• You are to undergo a medical test that requires the injection of a contrast medium containing iodine (a substance that makes organs, such as the kidneys or stomach, visible in X-rays).
• If you experience changes in your vision or eye pain while taking perindopril/indapamida. This may be a sign that you are developing glaucoma, an increase in pressure in your eye(s). You should discontinue treatment with perindopril/indapamida and seek medical attention.
• You have skin eruptions with redness, itching or inflammation after exposure to UV or sunlight.
• You experience severe stomach pain, with or without nausea. This could be a sign of angioedema of the intestine.

Athletes should be aware that Perindopril / Indapamida Viatris contains an active ingredient (indapamida) that may give a positive result in doping tests.

Children

This medication should not be administered to children. The safety and efficacy of this medication have not yet been evaluated.

Other medications and Perindopril / Indapamida Viatris

Inform your doctor or pharmacist about any other medication you are using, have used recently or may need to use.

Do not take perindopril/indapamida with:

• Lithium (used to treat depression).
• Aliskirén (medication used to treat hypertension) if you do not have diabetes or kidney problems,

• Potassium supplements (including salt substitutes), potassium-sparing diuretics (triamterene, amiloride, …) and other medications that may increase potassium levels in the blood (such as cotrimoxazole, also known as trimethoprim/sulfamethoxazole for bacterial infections; ciclosporina, an immunosuppressant used to prevent organ rejection after transplantation; and heparin, a medication used to thin the blood and prevent clots). See section 2 “Warnings and precautions”.
• Other medications used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.
• Estramustina (used in cancer treatment).

The treatment with perindopril/indapamida may be affected by other medications. Your doctor may need to modify your dose and/or take other precautions. These include:

• Other medications for the treatment of hypertension, such as other ACE inhibitors, an angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Perindopril / Indapamida Viatris” and “Warnings and precautions”).
• Potassium-sparing diuretics used in the treatment of heart failure: eplerenona and espironolactona at doses between 12.5 mg and 50 mg per day.
• Procainamida (to treat arrhythmia).
• Alopurinol (to treat gout).
• Anesthetics.
• Contrast medium containing iodine,
• Antibiotics used to treat bacterial infections (e.g. moxifloxacino, esparfloxacino, eritromicina inyectable).
• Immunosuppressants used to treat autoimmune disorders or after a transplant to prevent rejection (e.g. ciclosporina, tacrolimus).
• Corticosteroids to treat various conditions, such as severe asthma or rheumatoid arthritis, for example, prednisolona.
• Medications that inhibit neprilisina (NEP), such as sacubitril (available as a fixed-dose combination with valsartán) and racecadotrilo (used frequently to treat diarrhea or to prevent organ rejection after transplantation (sirolimus, everolimus, temsirolimus and other medications belonging to the group of mTOR inhibitors). See section “Warnings and precautions”.
• Sacubitril/valsartán (used to treat long-term heart failure).
• Other medications used to treat cancer or orally (for rheumatoid arthritis).
• Digoxina or other cardiac glycosides (to treat heart problems).
• Baclofeno (to treat muscle stiffness caused by diseases such as multiple sclerosis).
• Medications to treat diabetes such as insulin, metformina, glimepirida or gliptinas (linagliptina, saxagliptina, sitagliptina, vildagliptina).
• Calcium as calcium supplements, used in remedies for indigestion and to help strengthen bones.
• Laxatives, used to treat constipation (e.g. sen).
• Medications known as non-steroidal anti-inflammatory drugs (e.g. ibuprofeno) or salicylates in high doses (e.g. aspirina), used to treat pain, fever or swelling.
• Amfotericina B in injection (to treat serious fungal diseases).

• Medications to treat psychiatric disorders such as depression, anxiety, schizophrenia… (e.g. tricyclic antidepressants, neuroleptics (such as amisulprida, sulpirida, sultoprida, tiaprida, haloperidol, droperidol)

• Tetracosactida (to treat Crohn's disease).
• Vasodilators, including nitrates (used to dilate blood vessels).

• Medications used to treat hypotension, shock or asthma (efedrina, epinefrina or norepinefrina).

The following medications may affect heart rhythm, which may be increased by perindopril/indapamida. If you are taking any of the following medications, consult your doctor or pharmacist:

• Mizolastina, terfenadina or astemizol (medications known as antihistamines, used to treat hay fever or allergies).
• An antibiotic called eritromicina administered by injection.
• Moxifloxacino or esparfloxacino, antibiotics used to treat infections.
• Halofantrina (to treat certain types of malaria).
• Pentamidina (to treat pneumonia).
• Vincamina (to treat memory loss in elderly patients).
• Bepridil (to treat heart problems, angina pectoris).
• Sultoprida, sulpirida, amisulprida, tiaprida, tioridazina, trifluoperazina clorpromazina, ciamemazina, levomepromazina, droperidol, haloperidol and pimozida – used to treat psychiatric disorders such as schizophrenia, bipolar disorder or severe depression and psychosis.
• Medications used to treat heart rhythm problems (e.g. quinidina, hidroquinidina, disopiramida, amiodarona, dofetilida, ibutilida, bretilio and sotalol).
• Metadona, used to treat severe pain and reduce withdrawal symptoms in heroin addicts.
• Cisaprida or difemanilo (usually used to treat stomach problems).

Perindopril / Indapamida Viatris with food and drinks

It is best to take this medication before eating.

Pregnancy and breastfeeding

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

Pregnancy

You must inform your doctor if you are pregnant,think you may beor haveintention tobecome pregnant.Your doctor will normally advise you to stop taking this medication before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medication instead. This medication is not recommended in the first months of pregnancy and should not be taken if you have exceeded the third month of gestation, as it may cause serious harm to your child if used at that stage.

Breastfeeding

You should not take this medication if you are breastfeeding.

Driving and operating machines

This medication generally does not affect alertness, however, in certain patients different reactions such as dizziness or weakness may occur due to decreased blood pressure. As a result, it is possible that the ability to drive or operate machines may be impaired.

Perindopril / Indapamida Viatris contains lactose

This medication contains lactose. If your doctor has indicated that you have a intolerance to certain sugars, consult with him before taking this medication.

Perindopril / Indapamida Viatris contains less than 1mmol of sodium (23mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. The recommended dose is one tablet once a day. Your doctor may decide to modify the dose if you have kidney problems. Take the tablet as possible in the morning before eating. Swallow the tablet with a glass of water.

If you take more Perindopril / Indapamida Viatris than you should

If you accidentally take too many tablets, contact your doctor or pharmacist immediately, call the Toxicological Information Service (Tel. 91 562 04 20), indicating the medication and the amount ingested, or go to the emergency department of the nearest hospital. The most likely effect in case of overdose is a drop in blood pressure, sometimes with discomfort, muscle cramps, dizziness, drowsiness, mental confusion, and urinary problems. If a significant drop in blood pressure occurs (symptoms such as dizziness or fainting), lie down with your legs elevated.

If you forgot to take Perindopril / Indapamida Viatris

It is essential to take your medication every day, as regular treatment is more effective. However, if you forget to take a tablet, take the next dose at the usual time.Do nottake a double dose to compensate for the missed doses.

If you interrupt treatment with Perindopril / Indapamida Viatris

Since hypertension treatment is generally lifelong, you should consult your doctor before stopping treatment with this medication.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

The following side effects have been reported in patients taking perindopril and/or indapamide.

If you experience any of the following side effects, stop taking the medication immediately and contact your doctor immediately, or visit the nearest hospital emergency department:

Frequent(may affect up to 1 in 10 people)

• Any change in vision or pain in one or both eyes. This may be a sign of high blood pressure (glaucoma).
• Allergic reactions on the skin such as redness, itching, and rashes, in patients with a known history of respiratory and allergic problems (such as asthma).
• Headache, dizziness, vertigo, drowsiness due to hypotension, especially when standing.

Infrequent(may affect up to 1 in 100 people)

• Swelling of the face, lips, tongue, or throat, or difficulty breathing (more likely in black patients).

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

• Production of little or no urine, cloudy or bloody urine, pain while urinating, or lower back pain (these may be signs of severe kidney problems (acute renal failure)).

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

• Severe skin problems such as a widespread rash with blisters and itching on the face, arms, or legs (erythema multiforme). You may have blisters or bleeding in the lips, eyes, nose, mouth, and genitals (Stevens-Johnson syndrome) and generalized skin peeling (toxic epidermal necrolysis).
• Increased risk of infections such as fever, intense chills, sore throat, or mouth ulcers. These symptoms may indicate low white blood cell count.
• Unexplained bruises or bleeding. These symptoms may indicate low platelet count in the blood.
• Weakness, fatigue, headaches, difficulty breathing during exercise, dizziness, and pale or yellowish skin and sclera. These symptoms may indicate low red blood cell count.
• Low blood cell count, which may manifest as increased infections, unexplained bruises or bleeding, and fatigue, weakness, and difficulty breathing.
• Collapsing, numbness, or weakness in the arms or legs, confusion, difficulty speaking, or vision problems. These may be signs of a stroke and may occur after signs of low blood pressure.
• Irregular or unusually fast heart rhythm, which may be observed on an electrocardiogram (ECG).
• If you have a strong feeling of pressure in the chest with abdominal pain and increased shortness of breath after exercise (may be due to heart problems such as angina).
• Sudden chest pain that may radiate to the neck or arm, with difficulty breathing and a feeling of suffocation. These may be signs of a heart attack and may occur after signs of low blood pressure.
• Hepatitis, which may be due to liver problems, characterized by feeling unwell (nausea), dizziness (vomiting), loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, mild bowel movements, and dark-colored urine.
• Severe stomach pain that may radiate to the back (this may be due to pancreatitis inflammation).
• You experience cough, fever, increased shortness of breath, and nocturnal sweating, which may be caused by rare lung problems called eosinophilic pneumonia.

Unknown frequency(cannot be estimated from available data)

• You feel weak or your heartbeat is faster and/or irregular. This may be due to low potassium levels in the blood (this is more common in elderly patients, malnourished patients, patients with heart failure, or liver or kidney problems).
• Heptatic encephalopathy, characterized by feeling tired, irritable, forgetful, and confused, with tremors, convulsions, unconsciousness, and coma due to brain inflammation (this is common in patients with liver problems).

• Decreased vision or eye pain, possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage).
• Muscle weakness, cramps, muscle sensitivity, or pain, especially if you also feel unwell or have a high temperature, as they may be caused by abnormal muscle breakdown.

Other possible side effects:

Frequent(may affect up to 1 in 10 people)

• Visual problems.
• Dizziness, headaches.
• A feeling of spinning when standing still (vertigo).
• Unpleasant or metallic taste in the mouth.
• Ringing, buzzing, or other persistent sounds in the ears (tinnitus).
• Cough (if persistent (more than several days) consult your doctor), difficulty breathing.
• Unpleasant feeling (nausea), stomach pain, feeling unwell (vomiting), taste disturbances, indigestion (dyspepsia or difficulty digesting), diarrhea, constipation.
• Skin rashes, itching.
• Muscle cramps, numbness.
• Feeling weak.
• Low potassium levels in the blood, which improves when treatment is suspended.

Infrequent(may affect up to 1 in 100 people)

• Increased white blood cell count (eosinophilia).
• Low blood sugar.
• Low sodium levels in the blood, which may cause dehydration and low blood pressure.
• Depression, mood changes, sleep disorders.
• Drowsiness.
• Loss of consciousness.
• Fast or irregular heartbeat (tachycardia), rapid heartbeats that may feel like stabbing in the chest (palpitations).
• Inflammation of blood vessels (vasculitis).
• Feeling of chest tightness, wheezing, and difficulty breathing (bronchospasm).
• Dry mouth.
• Red spots on the skin (purpura), urticaria, increased skin sensitivity to sunlight.
• Muscle or joint pain.
• Kidney problems.
• Inability to achieve or maintain an erection (impotence).
• Excessive sweating.
• Chest pain in the middle or upper back (dyspnea).
• Feeling unwell, fever.
• Swelling of the hands, ankles, or feet (water retention).
• Increased levels of urea and creatinine in the blood that may be observed in a blood test.
• Falls.

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

• Weakness.
• High levels of bilirubin or liver enzymes in the blood, which may be observed in a blood test.
• Low chloride levels in the blood.
• Low magnesium levels in the blood.

• Dark-colored urine, feeling unwell, vomiting, muscle cramps, confusion, and convulsions that may be due to inappropriate secretion of ADH (antidiuretic hormone).
• Decreased or absent diuresis.

• Facial flushing.
• Worsening of psoriasis.

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

• Confusion.
• Runny nose or congestion (rhinitis).
• Increased calcium levels in the blood (which may be shown in blood tests). This may cause you to urinate more than usual, feel unwell, and have nausea with stomach pain.
• Abnormal liver function.
• Decreased levels of hemoglobin and hematocrit, which may be observed in a blood test.

Unknown frequency (cannot be estimated from available data)

• If you have systemic lupus erythematosus (a type of collagen disease), as symptoms may worsen.

• Increased levels of urea and glucose in the blood, which may be observed in a blood test.
• Change in color, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon).

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above25°C.

Do not use this medication after the expiration date that appears on the packaging, after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Perindopril / Indapamida Viatris

The active principles are perindopriltert-butilamine and indapamida.

One tablet contains 4 mg of perindopriltert-butilamine (corresponding to 3.338 mg of perindopril) and 1.25 mg of indapamida.

The other components are: hydrophobic colloidal silica (E-551), lactose, magnesium stearate (E-572), microcrystalline cellulose (E-460), and sodium bicarbonate (E-500).

Appearance of the product and contents of the package

Perindopril / Indapamida Viatris are white tablets, in capsule shape, with both sides curved, marked with ‘PTI’on one face and with ‘M2’on the other face.

It is available in blisters of 14, 30, 90, and 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

or

Mylan Hungary Ltd

H-2900 Komarom,

Mylan utca 1

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

SpainPerindopril / Indapamida Viatris 4 mg/1.25 mg tablets EFG

NetherlandsPerindopril tert-butylamine/Indapamide Mylan 4 mg/1.25 mg tablets

PortugalPerindopril + Indapamida Mylan 4 mg/1.25 mg tablets

Last review date of this leaflet:November 2024

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(AEMPS)https://www.aemps.gob.es/