PERINDOPRIL/INDAPAMIDE VIATRIS 2 mg/0.625 mg TABLETS

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

Do not take Perindopril / Indapamida Viatris:

• If you are allergic to perindopril, other ACE inhibitors, indapamide, other sulfonamides (including other diuretics or antibiotics such as cotrimoxazole) or to any of the other ingredients of this medicine (listed in section 6).
• If you have experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or widespread skin rash with previous treatments with ACE inhibitors, or if you or a member of your family have had these symptoms in any other circumstance (a condition called angioedema).
• If you have severe liver problems or a disease called hepatic encephalopathy (a degenerative brain disease).
• If you have severe kidney problems where blood flow to your kidneys is reduced (renal artery stenosis).
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, perindopril/indapamide may not be suitable for you.
• If you have low potassium levels in your blood.
• If you are taking other medicines that may affect your heart rhythm (see section "Other medicines and Perindopril / Indapamida Viatris").
• If you are suspected of having untreated, decompensated heart failure (severe fluid retention, difficulty breathing).
• If you are pregnant more than 3 months (you should avoid taking this medicine in the first months of pregnancy) (see section "Pregnancy and breastfeeding").
• If you are breastfeeding.
• 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 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 comes out of the heart), hypertrophic cardiomyopathy (a disease of the heart muscle), 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 could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye, and can occur within hours to weeks after taking perindopril/indapamide. If left untreated, this can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at greater 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 (a disease of the skin and connective tissue) 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 (overfunction of the parathyroid gland).
• If you have low potassium levels in your blood.
• If you are unable to eat normal amounts of food (malnourished).
• If you have gout.
• If you are diabetic.
• If you are of African origin - this medicine may not be as effective for you or you may be at greater risk of experiencing adverse reactions such as swelling (angioedema).
• If you follow a salt-free diet or use salt substitutes that contain potassium or take potassium supplements.
• If you take lithium or potassium-sparing diuretics (e.g., spironolactone or triamterene) or potassium supplements, as their use with perindopril/indapamide should be avoided (see section "Other medicines 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, stop treatment and contact your doctor immediately.

• If you are a hemodialysis patient with high-flux membranes.

• If you are taking any of the following medicines used to treat high blood pressure:
• • An angiotensin II receptor antagonist (ARB) (also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), particularly if you have diabetes-related kidney problems.
  • Aliskiren.

• If you are using any of the following medicines, you are at greater risk of developing angioedema:

• Racecadotril (used to treat diarrhea).
• Sirolimus, everolimus, temsirolimus, and other medicines that belong to the category of mTOR inhibitors (used to prevent organ rejection after transplantation).
• Linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines that belong to the category of gliptins, used to treat diabetes.
• Sacubitril (available in fixed-dose combination with valsartan), used in patients with heart failure.

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

Angioedema

In patients treated with ACE inhibitors, including perindopril/indapamide, angioedema (a 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, stop treatment with perindopril/indapamide and see your doctor 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 are planning to become pregnant.This medicine is not recommended during the first months of pregnancy and must not be taken if you have exceeded the third month of pregnancy, as it may cause serious harm to your child if used during this period (see section "Pregnancy and breastfeeding").

During treatment

When taking this medicine, you should also inform your doctor or healthcare professional if:

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

Children

This medicine should not be given to children. The safety and efficacy of this medicine have not yet been established.

Other medicines and Perindopril / Indapamida Viatris

Tell your doctor or pharmacist what you are using, have recently used, or might use, including:

Do not take perindopril/indapamida with:

• Lithium (used to treat depression).
• Aliskiren (a medicine used to treat high blood pressure) if you do not have diabetes or kidney problems.

• Potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., triamterene, amiloride...), and other medicines that can increase potassium levels in the blood (such as cotrimoxazole, also known as trimethoprim/sulfamethoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection; and heparin, a medicine used to thin the blood and prevent clots). See section 2 "Warnings and precautions".
• Other medicines used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.
• Estramustine (used in the treatment of cancer).

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

• Other medicines for treating high blood pressure, such as other ACE inhibitors, an angiotensin II receptor antagonist (ARB), or aliskiren (see also the information under the headings "Do not take Perindopril / Indapamida Viatris" and "Warnings and precautions").
• Potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day.
• Procainamide (for treating arrhythmia).
• Allopurinol (for treating gout).
• Anesthetic medicines.
• Iodinated contrast agents.
• Antibiotics used to treat bacterial infections (e.g., moxifloxacin, esparfloxacin, erythromycin injection).
• Immunosuppressants used to treat autoimmune disorders or after transplantation to prevent rejection (e.g., cyclosporine, tacrolimus).
• Corticosteroids for treating various conditions, such as severe asthma or rheumatoid arthritis, e.g., prednisolone.
• Medicines that inhibit neprilysin (NEP), such as sacubitril (available in fixed-dose combination with valsartan) and racecadotril (used frequently for treating diarrhea or preventing organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of mTOR inhibitors). See section "Warnings and precautions".
• Sacubitril/valsartan (used for treating long-term heart failure).
• Other medicines used for treating cancer or gold injections (for rheumatoid arthritis).
• Digoxin or other cardiac glycosides (for treating heart problems).
• Baclofen (for treating muscle stiffness caused by diseases such as multiple sclerosis).
• Medicines for treating diabetes, such as insulin, metformin, glimepiride, or gliptins (linagliptina, saxagliptina, sitagliptina, vildagliptina).
• Calcium, such as calcium supplements, used in remedies for indigestion and to help strengthen bones.
• Stimulant laxatives, used for treating constipation (e.g., senna).
• Medicines known as non-steroidal anti-inflammatory drugs (e.g., ibuprofen) or salicylates in high doses (e.g., aspirin), used for treating pain, fever, or swelling.
• Amphotericin B injection (for treating severe fungal diseases).

• Medicines for treating psychiatric disorders, such as depression, anxiety, schizophrenia... (e.g., tricyclic antidepressants, neuroleptics (such as amisulpride, sulpiride, sultoprida, tiaprida, haloperidol, droperidol)).

• Tetracosactide (for treating Crohn's disease).
• Vasodilators, including nitrates (used to dilate blood vessels).

• Medicines used to treat low blood pressure, shock, or asthma (ephedrine, epinephrine, or norepinephrine).

The following medicines may have an effect on the heart rhythm, which may sometimes be increased by perindopril/indapamide. If you are taking any of the following medicines, consult your doctor or pharmacist:

• Mizolastine, terfenadine, or astemizole (medicines known as antihistamines, used for hay fever or allergies).
• An antibiotic called erythromycin given by injection.
• Moxifloxacin or esparfloxacin, antibiotics used to treat infections.
• Halofantrine (for treating certain types of malaria).
• Pentamidine (for treating pneumonia).
• Vincamine (for treating memory loss in elderly patients).
• Bepridil (for treating heart problems, angina pectoris (chest pain)).
• Sultoprida, sulpirida, amisulprida, tiaprida, tioridazina, trifluoperazina, clorpromazina, ciamemazina, levomepromazina, droperidol, haloperidol, and pimozida - used for treating psychiatric disorders such as schizophrenia, bipolar disorder, or severe depression and psychosis.
• Medicines used for treating heart rhythm problems (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, dofetilide, ibutilide, bretylium, and sotalol).
• Methadone, used for treating severe pain and reducing withdrawal symptoms in heroin addicts.
• Cisapride or difemanil (normally used for stomach problems).

Perindopril / Indapamida Viatris with food and drinks

It is preferable to take this medicine before meals.

Pregnancy and breastfeeding

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 must inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.Your doctor will normally advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead. This medicine is not recommended at the beginning of pregnancy and must not be taken if you have exceeded the third month of pregnancy, as it may cause serious harm to your child if used during this period.

Breastfeeding

You must not take this medicine if you are breastfeeding.

Driving and using machines

This medicine generally does not affect alertness, however, in certain patients, different reactions such as dizziness or weakness may occur due to the decrease in blood pressure. As a result, the ability to drive or use machines may be impaired.

Perindopril / Indapamida Viatris contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

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

3. How to take Perindopril / Indapamida Viatris

Follow exactly the administration instructions of this medication indicated by your doctor. In case of 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, if possible, in the morning before ingesting food. Swallow the tablet with a glass of water.

The tablet can be divided into equal doses.

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 Toxicology Information Service (Tel. 91 562 04 20), indicating the medication and the amount ingested, or go to the emergency service of the nearest hospital. The most likely effect in case of overdose is a drop in blood pressure, sometimes with a feeling of discomfort, cramps, dizziness, drowsiness, mental confusion, and urination problems. If a substantial drop in blood pressure occurs (symptoms such as dizziness or fainting), lie down with your legs raised.

If you forget to take Perindopril / Indapamida Viatris

It is essential that you 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 make up for the forgotten doses.

If you interrupt treatment with Perindopril / Indapamida Viatris

Since the treatment for arterial hypertension is generally for life, you should consult your doctor before interrupting treatment with this medication.

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

The following adverse effects have been reported in patients taking perindopril and/or indapamida.

If you experience any of the following adverse effects,stop takingthe medication immediately and contact your doctor, or go to the emergency service of the nearest hospital:

Frequent(may affect up to 1 in 10 people)

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

Uncommon(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 urine, or blood in the urine, pain when 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)

• Serious skin problems such as a widespread rash with grains 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 number of infections that you may experience, such as fever, intense chills, sore throat, or mouth ulcers. These symptoms could be indicative of a low concentration of white blood cells.
• Unexpected bruising or prolonged bleeding. These symptoms could be indicative of a low concentration of platelets in the blood.
• Weakness, fatigue, headaches, difficulty breathing during exercise, dizziness, and pale skin or yellowish eyes and sclera. These symptoms could be indicative of low red blood cell levels.
• Low blood cell count, which may be noticed as an increase in infections, bruising, or prolonged bleeding, and fatigue, weakness, difficulty breathing.
• Collapse, numbness, or weakness of 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 can be seen 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 can spread 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) or dizzy (vomiting) with loss of appetite, feeling general discomfort, with fever, itching, yellowing of skin and eyes, with slight intestinal movements, and appearance of dark-colored urine.
• Severe stomach pain, which can spread to the back (this may be due to pancreatitis).
• You suffer from cough, fever, increased shortness of breath, and night sweats, which may be caused by lung problems, called eosinophilic pneumonia (a rare type of pneumonia).

Frequency not known(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 or liver failure, or with kidney problems).
• Hepatic encephalopathy, characterized by feeling tired, irritable, forgetful, and confused, with tremors, seizures, loss of consciousness, and coma due to inflammation in the brain (this is common if you have liver problems).

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

Other possible adverse effects:

Frequent(may affect up to 1 in 10 people)

• Vision problems.
• Dizziness, headaches.
• A feeling of spinning when you are still (vertigo).
• Unpleasant or metallic taste in the mouth.
• Ringing, whistling, or other persistent noises in the ears (tinnitus).
• Cough (if the cough is persistent (more than several days), consult your doctor), difficulty breathing.
• Feeling of discomfort (nausea), stomach pain, discomfort (vomiting), taste disorders, indigestion (dyspepsia or difficulty digesting), diarrhea, constipation.
• Skin rashes, itching.
• Muscle cramps, tingling.
• Feeling of weakness.
• Low potassium levels in the blood, which improve when treatment is suspended.

Uncommon(may affect up to 1 in 100 people)

• Increased number of white blood cells (eosinophilia).
• Low blood sugar levels.
• Low sodium levels in the blood, which can cause dehydration and low blood pressure.
• Depression, mood changes, sleep disorders.
• Drowsiness.
• Fainting.
• Fast heart rate (tachycardia), accelerated heartbeats that can feel like stabbing beats in the chest (palpitations).
• Inflammation of the blood vessels (vasculitis).
• Feeling of chest pressure, wheezing, and difficulty breathing (bronchospasm).
• Dry mouth.
• Red spots on the skin (purpura), hives, increased skin sensitivity to sunlight.
• Muscle or joint pain.
• Kidney problems.
• Impotence.
• Excessive sweating.
• Pain in the middle or upper back (thoracic pain).
• General feeling of discomfort, fever.
• Swelling of the hands, ankles, or feet (water retention).
• Increased levels of urea and creatinine in the blood, which can be seen in a blood test.
• Falls.

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

• Fatigue.
• High levels of bilirubin or liver enzymes in the blood, which can be seen in a blood test.
• Low chloride levels in the blood.
• Low magnesium levels in the blood.

• Concentrated urine (dark-colored), nausea or 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.
• Congested or runny nose (rhinitis).
• An increase in calcium in the blood (which will be shown in blood tests). This may cause you to have more urine than usual, feel sick, and have nausea with stomach pain.
• Abnormal liver function.
• Decreased hemoglobin and hematocrit levels, which can be seen in a blood test.

Frequency not known (cannot be estimated from available data)

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

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

Reporting of adverse effects:

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

5. Conservation of Perindopril / Indapamida Viatris

Keep this medication out of sight and reach of children.

Do not store at a temperature above 25°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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Perindopril / Indapamida Viatris

The active ingredients are perindopril terc-butylamine and indapamida.

One tablet contains 2 mg of perindopril terc-butylamine (corresponding to 1.669 mg of perindopril) and 0.625 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 package contents

Perindopril / Indapamida Viatris are white, capsule-shaped tablets, with both sides curved, marked with a 'P' to the left of the score line and 'TI' to the right, on one face, and with an 'M' to the left of the score line and a '1' to the right, on the other face.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

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:

Spain Perindopril / Indapamida Viatris 2 mg/0.625 mg tablets EFG

Netherlands Perindopril tert-butylamine/Indapamide Mylan 2 mg/0.625 mg tablets

Portugal Perindopril + Indapamida Mylan 2 mg/0.625 mg tablets

Date of the last revision of this prospectus:November 2024

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