Perindopril/indapamide Stada 2 mg/0.625 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Perindopril/Indapamide Stada 2 mg/0.625 mg tablets EFG

perindopril tert-butylamine/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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 Stada is and what it is used for

2. What you need to know before taking Perindopril/Indapamide Stada

3. How to take Perindopril/Indapamide Stada

4. Possible side effects

5. How to store Perindopril/Indapamide Stada

6. Contents of the pack and other information

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

Perindopril/Indapamida Stada is a combination of two active substances, perindopril and indapamida. It is an antihypertensive and is indicated for the treatment of high blood pressure (hypertension) in adults.

Perindopril belongs to a group of medicines known as ACE inhibitors. It works by widening the blood vessels, allowing your 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 causes only a slight increase in the amount of urine formed. Each of the active substances lowers blood pressure, and together they act in combination to control your blood pressure.

2. What you need to know before taking Perindopril/Indapamida Stada

DO NOT take Perindopril/Indapamida Stada

• if you are allergic to perindopril or any other ACE inhibitor, to indapamide or any other sulfonamide, 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 severe skin rashes during previous treatment with ACE inhibitors, or if you or a family member have had these symptoms under any other circumstances (a disorder called angioedema)

• if you have diabetes or renal failure and are being treated with a blood pressure-lowering medicine containing aliskiren

• if you have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative brain disease)

• if you have severe kidney disease causing 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 suspect you may have untreated decompensated heart failure (severe fluid retention, difficulty breathing)

• if you are more than 3 months pregnant (It is also advisable to avoid perindopril/indapamide in early pregnancy – see section “Pregnancy and breastfeeding”)

• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, for example in the throat) is high.

Warnings and precautions

Consult your doctor or pharmacist before taking Perindopril/Indapamida Stada:

• 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 supplying blood to the kidney)

• if you have heart failure or any other heart condition

• if you have kidney problems or 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 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 have a 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 suffer from a collagen disease (skin disorder) such as systemic lupus erythematosus or scleroderma

• if you have atherosclerosis (hardening of the arteries)

• if you have hyperparathyroidism (overactivity of the parathyroid gland)

• if you have gout

• if you have diabetes

• if you are on a low-salt diet or using salt substitutes containing potassium

• if you are taking lithium or potassium-sparing diuretics (e.g., spironolactone, triamterene) or potassium supplements, as concomitant use with perindopril/indapamide should be avoided (see “Other medicines and Perindopril/Indapamida Stada”)

• if you are elderly

• if you have previously experienced 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 taking any of the following medicines for high blood pressure (hypertension):

  • angiotensin II receptor antagonists (ARA-II) (also known as "sartans", e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes
  • aliskiren

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

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

• if you are of African or Afro-Caribbean origin, as you may have a higher risk of angioedema and this medicine may be less effective in lowering your blood pressure compared to non-Black patients

• if you are a patient undergoing hemodialysis with high-flux dialysis membranes

• if you are taking any of the following medicines, the risk of angioedema increases:

  • racecadotril (used to treat diarrhea)
  • sirolimus, everolimus, temsirolimus, and other medicines belonging to the class called mTor inhibitors (used to prevent organ transplant rejection and in cancer treatment)
  • sacubitril (available as a fixed-dose combination with valsartan), used to treat chronic heart failure
  • linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the class known as gliptins (used to treat diabetes)

Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, causing difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril. 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.

You should inform your doctor if you think you are (or could become) pregnant. Perindopril/indapamide is not recommended in early pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see “Pregnancy and breastfeeding”).

While taking perindopril/indapamide, inform your doctor or healthcare provider:

• if you are undergoing anesthesia and/or surgery

• if you have recently had diarrhea or vomiting, or if you are dehydrated

• if you are undergoing dialysis or LDL apheresis (removal of cholesterol from your blood using a machine)

• if you are undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings

• if you are undergoing any medical test requiring injection of iodinated contrast agents (a substance that makes organs such as the kidney or stomach visible on X-rays)

• if 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 must stop treatment with perindopril/indapamide and seek medical attention.

Athletes should be aware that perindopril/indapamide contains an active substance (indapamide) that may result in a positive doping test.

Children and adolescents

Perindopril/Indapamida Stada must not be administered to children or adolescents.

Other medicines and Perindopril/Indapamida Stada

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

You must avoid taking Perindopril/Indapamida Stada with:

• lithium (used to treat mania or depression)

• aliskiren (a medicine used to treat hypertension) if you do not have diabetes or kidney problems

• potassium-sparing diuretics (e.g., triamterene, amiloride), potassium salts, or other medicines that may increase potassium levels in your body (such as heparin, a medicine used to thin the blood and prevent clots; trimethoprim, and cotrimoxazole also known as trimethoprim/sulfamethoxazole for bacterial infections)

• estramustine (used in cancer treatment)

• other medicines used to treat high blood pressure: angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists

Treatment with perindopril/indapamide may be affected by other medicines.

Your doctor may need to adjust your dose and/or take additional precautions. Make sure to inform your doctor if you are taking any of the following medicines, as you may require special monitoring:

• other medicines for treating high blood pressure, including angiotensin II receptor antagonists (ARA-II), aliskiren (see also information under headings “Do not take Perindopril/Indapamida Stada” and “Warnings and precautions”), or diuretics (medicines that increase urine production by the kidneys)

• potassium-sparing drugs used in heart failure treatment: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily

• medicines frequently used to treat diarrhea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the mTor inhibitor class). See section “Warnings and precautions”

• sacubitril/valsartan (used to treat chronic heart failure). See sections “Do not take Perindopril/Indapamida Stada” and “Warnings and precautions”

• anesthetic agents

• iodinated contrast agents

• antibiotics used to treat bacterial infections (e.g., moxifloxacin, sparfloxacin, injectable erythromycin)

• methadone (used to treat addiction)

• procainamide (for treatment of irregular heartbeat)

• allopurinol (for treatment of gout)

• antihistamines used to treat allergic reactions such as hay fever (e.g., mizolastine, terfenadine, astemizole)

• corticosteroids used to treat various disorders including severe asthma and rheumatoid arthritis

• immunosuppressants used to treat autoimmune disorders or after transplantation to prevent rejection (e.g., cyclosporine, tacrolimus)

• halofantrine (used to treat certain types of malaria)

• pentamidine (used to treat pneumonia)

• injectable gold (used to treat rheumatoid arthritis)

• vincamine (used to treat symptomatic cognitive disorders in the elderly, including memory loss)

• bepridil (used to treat angina pectoris)

• medicines for heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium)

• cisapride, difenoxin (used to treat gastrointestinal problems)

• digoxin or other cardiac glycosides (for treatment of heart problems)

• baclofen (for treatment of muscle stiffness occurring in diseases such as multiple sclerosis)

• medicines for diabetes such as insulin, metformin, or gliptins

• calcium, including calcium supplements

• stimulant laxatives (e.g., senna)

• non-steroidal anti-inflammatory drugs (e.g., ibuprofen) or high doses of salicylates (e.g., acetylsalicylic acid (a substance present in many medicines used to relieve pain, reduce fever, and prevent blood clotting))

• injectable amphotericin B (for treatment of serious fungal diseases)

• medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol))

• tetracosactide (for treatment of Crohn's disease)

• trimethoprim (for treatment of infections)

• vasodilators including nitrates (medicines to widen blood vessels)

• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline)

Taking Perindopril/Indapamida Stada with food and drink

It is preferable to take perindopril/indapamide before a meal.

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 any medicine.

Pregnancy

Inform your doctor if you think you are (or could be) pregnant. Your doctor will usually advise you to stop taking perindopril/indapamide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.

Perindopril/indapamide is not recommended during early pregnancy, and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.

Breast-feeding

Perindopril/indapamide is not recommended during breastfeeding.

Inform your doctor immediately if you are planning to start or are currently breastfeeding.

Seek immediate medical advice.

Driving and using machines

Perindopril/indapamide generally does not affect alertness. However, due to possible lowering of blood pressure, some patients may experience side effects such as dizziness or weakness. If this occurs, your ability to drive or operate machinery may be impaired.

Perindopril/Indapamida Stada contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Perindopril/Indapamide Stada

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet once daily. Your doctor may decide to increase the dose to 2 tablets a day or adjust the dose if you have renal impairment.

Method of administration

Take your tablet preferably in the morning and before breakfast, with a glass of water.

The tablet can be divided into equal doses.

If you take more Perindopril/Indapamide Stada than you should

If you take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department. The most common symptom in case of overdose is a drop in blood pressure. If a significant fall in blood pressure occurs (associated with nausea, vomiting, cramps, dizziness, drowsiness, confusion, and changes in the amount of urine produced by the kidneys), it may help to lie down with your legs raised.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Perindopril/Indapamide Stada

It is important to take this medicine every day, as continuous treatment is more effective. However, if you miss a dose of perindopril/indapamide, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Perindopril/Indapamide Stada

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

Stop taking this medicine and contact your doctor immediately if you experience any of the following adverse effects, which may be serious:

• Severe dizziness or fainting due to low blood pressure (Frequent – may affect up to 1 in 10 people)
• Bronchospasm (tightness in the chest, shortness of breath or difficulty breathing) (Uncommon – may affect up to 1 in 100 people)
• Swelling of the face, lips, mouth, tongue or throat, causing severe difficulty in breathing (angioedema) (See section 2 “Warnings and precautions”) (Uncommon – may affect up to 1 in 100 people)
• Severe skin reactions including erythema multiforme (skin rash that often begins with itchy red spots on the face, arms or legs), or severe rash, hives, redness of the skin all over the body, intense itching, blistering, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome), or other allergic reactions (Very rare – may affect up to 1 in 10,000 people)
• Cardiovascular disorders (irregular heartbeat, angina (chest, jaw and back pain caused by physical exertion), myocardial infarction) (Very rare – may affect up to 1 in 10,000 people)
• Weakness in arms or legs, or speech problems which could be signs of a possible stroke (Very rare – may affect up to 1 in 10,000 people)
• Inflammation of the pancreas which may cause severe abdominal and back pain accompanied by a strong feeling of illness (Very rare – may affect up to 1 in 10,000 people)
• Yellowing of the skin or eyes (jaundice), which could be a sign of hepatitis (Very rare – may affect up to 1 in 10,000 people)
• Life-threatening irregular heartbeat (Frequency not known)
• Brain disease caused by liver disease (hepatic encephalopathy) (Frequency not known)
• 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 (Frequency not known)

In decreasing order of frequency, adverse effects may include:

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

Low blood potassium levels, skin reactions in people predisposed to allergic and asthmatic reactions, headache, dizziness, vertigo, tingling, vision disturbances, tinnitus (sensation of ringing in the ears), cough, difficulty breathing (dyspnea), gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or indigestion, diarrhea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling of tiredness.

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

Mood changes, depression, sleep disorders, urticaria, purpura (red spots on the skin), blistering, kidney problems, impotence (inability to achieve or maintain an erection), sweating, elevated eosinophils (a type of white blood cell), changes in laboratory parameters: increased blood potassium levels (reversible upon discontinuation of treatment), decreased blood sodium levels which may cause dehydration and low blood pressure, drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (rapid heartbeat), hypoglycemia (very low blood sugar levels) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased skin sensitivity to sunlight), arthralgia (joint pain), myalgia (muscle pain), chest pain, feeling unwell, peripheral edema, fever, increased blood urea, increased blood creatinine, fall.

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

Worsening of psoriasis, changes in laboratory results: low blood chloride levels, low blood magnesium levels, increased liver enzymes, high serum bilirubin levels, fatigue, facial flushing, decreased or absent urine output, acute kidney failure.

Concentrated urine, feeling unwell (nausea) or feeling sick (vomiting), muscle cramps, confusion and seizures. These symptoms may indicate a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).

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

Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose), severe kidney problems, changes in blood values such as decreased numbers of white and red blood cells, decreased hemoglobin, decreased platelet count, increased blood calcium levels, abnormal liver function.

• Frequency not known (cannot be estimated from available data):

Abnormal ECG pattern, changes in blood parameters: high levels of uric acid and blood sugar, sudden short-sightedness (myopia), blurred vision, visual disturbances, decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), color changes, numbness and pain in fingers or toes (Raynaud's disease). If you have systemic lupus erythematosus (a type of collagen disease), it may worsen.

Blood, kidney, liver or pancreas disorders and changes in laboratory test results (blood tests) may occur. Your doctor may need to order blood tests to monitor your condition.

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

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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Perindopril/Indapamide Stada

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

Store in the original container to protect it from moisture.

When closed, this medicine does not require any special storage temperature.

Once the protective pouch is opened, the blisters must be stored in the carton at a temperature below 30 °C. All unused tablets should be discarded 2 months after opening the protective pouch.

Do not use this medicine after the expiry date stated on the packaging after 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 containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Perindopril/Indapamida Stada

• The active substances are perindopril tert-butylamine and indapamide. Each 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: monohydrate lactose, magnesium stearate, colloidal anhydrous silica, and microcrystalline cellulose.

Appearance of the product and contents of the pack

White, capsule-shaped tablets, marked with “P” and “I” on either side of the score on one side and a score line on the other side. The tablet can be divided into equal doses.

The tablets are presented in PVC/PVdC-Aluminum blisters with an aluminum protective pouch, including a desiccant to protect the tablets from moisture. Do not ingest the desiccant.

Pack sizes: 30, 90 and 100

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bulgaria: Pontea

Spain: Perindopril/Indapamida Stada 2 mg/0,625 mg comprimidos EFG

Netherlands: Perindopril/Indapamide STADA 2/0,625 mg, tabletten

Slovak Republic: Perindostad Kombi 2 mg/0,625 mg Tablety

Date of the most recent review of this leaflet: December 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/