Perindopril/indapamide Viatris 2 mg/0.625 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Perindopril / Indapamide Viatris 2 mg/0.625 mg tablets EFG

perindopril tert-butylamine and indapamide

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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Perindopril / Indapamide Viatris is and what it is used for
2. What you need to know before taking Perindopril / Indapamide Viatris
3. How to take Perindopril / Indapamide Viatris
4. Possible adverse effects
5. How to store Perindopril / Indapamide Viatris
6. Contents of the pack and other information

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

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

It belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. These medicines widen 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 differs from other diuretics in that it produces only a slight increase in urine production. Both active substances reduce blood pressure and act together to control blood pressure effectively.

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

Do not take Perindopril / Indapamide Viatris:

• If you are allergic to perindopril, other ACE inhibitors, indapamide, other sulfonamides (which may include other diuretics or antibiotics such as cotrimoxazole), or to any of the other components of this medicine (listed in section 6).
• If you have experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or widespread skin rashes during previous treatments with ACE inhibitors, or if you or a family member has had these symptoms under other circumstances (a condition called angioedema).
• If you have severe liver problems or a condition known as hepatic encephalopathy (degenerative brain disease).
• If you have severe renal failure with reduced blood flow to your kidneys (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 levels of potassium in your blood.
• If you are taking other medicines that may affect your heart rhythm (see section “Other medicines and Perindopril / Indapamide Viatris”).
• If untreated decompensated heart failure is suspected (severe fluid retention, breathing difficulty).
• If you are more than 3 months pregnant (you should avoid taking this medicine during the first months of pregnancy) (see section "Pregnancy and breastfeeding").
• If you are breastfeeding.
• 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 this increases the risk of angioedema (rapid swelling beneath the skin, such as in the throat).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Perindopril / Indapamide Viatris:

• If you have aortic stenosis (narrowing of the main blood vessel leaving the heart), hypertrophic cardiomyopathy (a heart muscle disorder), or renal artery stenosis (narrowing of the artery carrying blood to the kidneys).
• If you have other heart problems such as heart failure (weakened heart muscle) or heart rhythm disorders.
• If you have kidney problems, only one functioning kidney, or if you are on dialysis.
• If you experience a decrease in vision or eye pain. These could be signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking perindopril/indapamide. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.
• If you have muscle disorders, including muscle pain, tenderness, 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 connective tissue disease (skin and connective tissue disorder) 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 (overactive 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 Black race – this medicine may be less effective for you or you may have a higher risk of adverse reactions such as swelling (angioedema).
• If you follow a salt-free diet or use salt substitutes containing potassium or take potassium supplements.
• If you take lithium or potassium-sparing diuretics (spironolactone or triamterene) or potassium supplements, as their use should be avoided with perindopril/indapamide (see section "Other medicines and Perindopril / Indapamide 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 swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema). This may occur at any time during treatment.

If you develop these symptoms, stop treatment immediately and contact your doctor without delay.

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

• 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.

• If you are using any of the following medicines, you have an increased risk of developing angioedema:

• Racecadotril (used to treat diarrhea).

• Sirolimus, everolimus, temsirolimus, and other medicines belonging to the mTOR inhibitors class (used to prevent rejection of transplanted organs).

• Linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the gliptins class, used to treat diabetes.

• Sacubitril (available as a 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 (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 causing difficulty in swallowing or breathing) has been reported. This may occur at any time during treatment. If you develop such symptoms, you must stop treatment with perindopril/indapamide and seek immediate medical attention. See also Section 4.

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

You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. The use of this medicine is not recommended during the first months of pregnancy and must not be taken after the third month of gestation, as it may cause serious harm to your baby if used at that stage (see section "Pregnancy and breastfeeding").

During treatment

While taking this medicine, you should also inform your doctor or healthcare provider if:

• You are due to receive anesthesia and/or undergo surgery.
• You have recently had diarrhea, vomiting, or dehydration.
• You need to undergo dialysis or LDL apheresis (removal of cholesterol from your blood using a device).
• You are receiving desensitization treatment to reduce the effects of an allergy to wasp or bee stings.
• You are due to have a medical test requiring injection of an iodinated contrast medium (a substance that makes organs such as the kidneys or stomach visible on X-rays).
• You experience vision disturbances or eye pain 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.
• You develop skin rashes with redness, along with itching or swelling after exposure to UV or sunlight.
• You experience severe stomach pain, with or without feeling unwell. This could be a sign of intestinal angioedema.

Children

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

Other medicines and Perindopril / Indapamide Viatris

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

Do not take perindopril/indapamide with:

• Lithium (used to treat depression).
• Aliskiren (a medicine used to treat hypertension) 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 may increase potassium levels in the blood (such as cotrimoxazole, also known as trimethoprim/sulfamethoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; 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: angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists.
• Estramustine (used in cancer treatment).

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

• Other medicines for treating hypertension, such as other ACE inhibitors, an angiotensin II receptor antagonist (ARA), or aliskiren (see also information under the headings “Do not take Perindopril / Indapamide Viatris” and “Warnings and precautions”).
• Potassium-sparing drugs used in heart failure treatment: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day.
• Procainamide (to treat arrhythmia).
• Allopurinol (to treat gout).
• Anesthetic agents.
• Iodinated contrast agents.
• Antibiotics used to treat bacterial infections (e.g., moxifloxacin, sparfloxacin, injectable erythromycin).
• Immunosuppressants used to treat autoimmune disorders or after transplantation to prevent rejection (e.g., cyclosporine, tacrolimus).
• Corticosteroids to treat various conditions such as severe asthma or rheumatoid arthritis, e.g., prednisolone.
• Neprilysin inhibitors (NEP), such as sacubitril (available in fixed-dose combination with valsartan) and racecadotril (frequently used to treat diarrhea or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other mTOR inhibitors). See section “Warnings and precautions”.
• Sacubitril/valsartan (used to treat chronic heart failure).
• Other medicines used to treat cancer or injectable gold (for rheumatoid polyarthritis).
• Digoxin or other cardiac glycosides (to treat heart problems).
• Baclofen (to treat muscle stiffness caused by diseases such as multiple sclerosis).
• Medicines to treat diabetes such as insulin, metformin, glimepiride, or gliptins (linagliptin, saxagliptin, sitagliptin, vildagliptin).
• Calcium supplements, used in remedies for indigestion and to support bone strength.
• Stimulant laxatives used to treat constipation (e.g., senna).
• Medicines known as non-steroidal anti-inflammatory drugs (e.g., ibuprofen) or high-dose salicylates (e.g., aspirin), used to treat pain, fever, or swelling.
• Injectable amphotericin B (to treat serious fungal diseases).
• Medicines to treat psychiatric disorders such as depression, anxiety, schizophrenia… (e.g., tricyclic antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)).
• Tetracosactide (for the treatment of 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 affect heart rhythm, which can sometimes be increased by perindopril/indapamide. If you are taking any of the following medicines, consult your doctor or pharmacist:

• Mizolastine, terfenadine, or astemizole (antihistamines used for hay fever or allergies).
• An antibiotic called erythromycin given by injection.
• Moxifloxacin or sparfloxacin, antibiotics used to treat infections.
• Halofantrine (to treat certain types of malaria).
• Pentamidine (to treat pneumonia).
• Vincamine (to treat memory loss in elderly patients).
• Bepridil (to treat heart problems, angina (chest pain)).
• Sultopride, sulpiride, amisulpride, tiapride, thioridazine, trifluoperazine, chlorpromazine, cyamemazine, levomepromazine, droperidol, haloperidol, and pimozide – used to treat psychiatric disorders such as schizophrenia, bipolar disorder, severe depression, and psychosis.
• Medicines used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, dofetilide, ibutilide, bretylium, and sotalol).
• Methadone, used to treat severe pain and reduce withdrawal symptoms in heroin addicts.
• Cisapride or difenoxin (usually used for stomach problems).

Perindopril / Indapamide 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 plan 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 plan to become pregnant. Your doctor will usually advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant and will recommend an alternative medicine. This medicine is not recommended during early pregnancy and must not be taken after the third month of gestation, as it may cause serious harm to your baby if used at that stage.

Breastfeeding

You must not take this medicine if you are breastfeeding.

Driving and using machines

This medicine generally does not affect alertness; however, in some patients, side effects such as dizziness or weakness due to lowered blood pressure may occur. As a result, your ability to drive or operate machinery may be impaired.

Perindopril / Indapamide Viatris contains lactose

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

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

3. How to take Perindopril / Indapamide Viatris

Always follow exactly your doctor's instructions for taking this medicine. If in doubt, consult your doctor or pharmacist again. The recommended dose is one tablet once daily. Your doctor may decide to adjust the dose if you have kidney problems. Take the tablet preferably in the morning, before eating. Swallow the tablet with a glass of water.

The tablet can be divided into equal doses.

If you take more Perindopril / Indapamide 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), stating the name of the medicine and the amount taken, or go to the nearest hospital emergency department. The most likely effect of an overdose is a drop in blood pressure, sometimes accompanied by discomfort, cramps, dizziness, drowsiness, confusion, and difficulty urinating. If a significant drop in blood pressure occurs (symptoms such as dizziness or fainting), lie down with your legs raised.

If you forget to take Perindopril / Indapamide Viatris

It is important that you take your medicine every day, as regular treatment is more effective. However, if you forget to take a dose, take your next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Perindopril / Indapamide Viatris

Since treatment for high blood pressure is usually lifelong, you must consult your doctor before stopping treatment with 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.

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

If you experience any of the following effects, stop taking the medicine immediately and contact your doctor right away, or go to the nearest hospital emergency department:

Common (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 eye pressure (glaucoma).
• Skin allergic reactions such as redness, itching, and rash with spots in patients with known history of respiratory or allergic disorders (such as asthma).
• Headache, dizziness, vertigo, or lightheadedness due to low blood pressure, 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 serious 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 spots and itching on the face, arms, or legs (erythema multiforme). You may develop blisters or bleeding in the lips, eyes, nose, mouth, and genitals (Stevens-Johnson syndrome) and widespread skin peeling (toxic epidermal necrolysis).
• Increase in the number of infections you may experience, such as fever, severe chills, sore throat, or mouth ulcers. These symptoms could indicate low white blood cell count.
• Unusual bruising or prolonged bleeding. These symptoms could indicate low platelet count in the blood.
• Weakness, fatigue, headaches, shortness of breath during exercise, dizziness, paleness, or yellowing of the skin and whites of the eyes. These symptoms could indicate low red blood cell count.
• Low blood cell counts, which you may notice as increased infections, unusual or prolonged bruising or bleeding, and fatigue, weakness, or shortness of breath.
• Collapse, numbness or weakness in arms or legs, confusion, difficulty speaking, or vision problems. These may be signs of stroke and may occur after signs of low blood pressure.
• Irregular or unusually fast heartbeat, which may be seen on an electrocardiogram (ECG).
• If you feel strong pressure in the chest with abdominal pain and increased shortness of breath after exercise (this may be due to heart problems such as angina).
• Sudden chest pain that may spread to the neck or arm, with difficulty breathing and a feeling of warmth. These may be signs of a heart attack and may occur after signs of low blood pressure.
• Hepatitis, possibly due to liver problems, characterized by feeling unwell (nausea) or dizzy (vomiting), loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, light-colored stools, and dark-colored urine.
• Severe stomach pain that may spread to the back (this may be due to inflammation of the pancreas).
• You suffer from cough, fever, worsening 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, malnourished patients, or those with heart, liver, or kidney problems).
• Hepatic encephalopathy, characterized by feeling tired, irritable, forgetful, and confused, with tremors, seizures, unconsciousness, and coma due to brain inflammation (this is common if you have liver problems).
• Decreased vision or eye pain, possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion).
• Muscle weakness, cramps, tenderness, or muscle pain, especially if you also feel unwell or have a high temperature, as these may be caused by abnormal muscle breakdown.

Other possible adverse effects:

Common (may affect up to 1 in 10 people)

• Vision problems.
• Dizziness, headaches.
• A sensation of spinning when still (vertigo).
• Unpleasant or metallic taste in the mouth.
• Ringing, buzzing, 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 unwell (nausea), stomach pain, discomfort (vomiting), disturbances in taste, indigestion (dyspepsia or difficulty digesting), diarrhea, constipation.
• Skin rashes, itching.
• Muscle cramps, tingling.
• Feeling of weakness.
• Low potassium levels in blood, which improves when treatment is stopped.

Uncommon (may affect up to 1 in 100 people)

• Increase in white blood cells (eosinophilia).
• Low blood sugar levels.
• Low sodium levels in blood, which may cause dehydration and low blood pressure.
• Depression, mood changes, sleep disorders.
• Drowsiness.
• Fainting.
• Fast heartbeat (tachycardia), rapid heartbeats that may feel like pounding in the chest (palpitations).
• Inflammation of blood vessels (vasculitis).
• Feeling of tightness in the chest, 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.
• Inability to achieve or maintain an erection (impotence).
• Excessive sweating.
• Pain in the middle or upper part of the back (chest pain).
• General feeling of malaise, fever.
• Swelling of the hands, ankles, or feet (fluid retention).
• Increases in blood urea and creatinine levels, which may be seen in a blood test.
• Falls.

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

• Tiredness.
• High levels of bilirubin or liver enzymes in blood, which may be seen in a blood test.
• Low chloride levels in blood.
• Low magnesium levels in blood.
• Concentrated urine (dark-colored), nausea or vomiting, muscle cramps, confusion, and seizures, which may be due to inappropriate ADH (antidiuretic hormone) secretion.
• Decreased or absent urination.
• Facial flushing.
• Worsening of psoriasis.

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

• Confusion.
• Stuffy or runny nose (rhinitis).
• Increased calcium levels in blood (which will show in blood tests). This may cause you to urinate more than usual, feel unwell, nauseous, and have stomach pain.
• Abnormal liver function.
• Decreased levels of hemoglobin and hematocrit, which may 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 blood glucose, which may be seen in a blood test.
• Change in color, numbness, and pain in fingers or toes (Raynaud's phenomenon).

Reporting of adverse effects:

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

5. Storage of Perindopril / Indapamide Viatris

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the container, after CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Perindopril / Indapamide Viatris

The active substances are perindopril tert-butylamine and indapamide.

One tablet contains 2 mg of perindopril tert-butylamine (equivalent to 1.669 mg of perindopril) and 0.625 mg of indapamide.

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

Appearance of the product and pack contents

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

Available in blister packs containing 14, 30, 90, and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

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

Spain: Perindopril / Indapamide Viatris 2 mg/0.625 mg tablets EFG
Netherlands: Perindopril tert-butylamine/Indapamide Mylan 2 mg/0.625 mg tabletten
Portugal: Perindopril + Indapamida Mylan 2 mg/0.625 mg tablets

Date of the most recent review of this leaflet: November 2024

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