Perindopril/indapamide Stada 4 mg/1.25 mg tablets EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Perindopril/Indapamide Stada 4 mg/1.25 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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 container 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 medicine indicated for the treatment of high blood pressure (hypertension) in adults.

Perindopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. These work by widening 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 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 ever had these symptoms under any circumstances (a condition called angioedema)

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

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

• 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 equipment used, perindopril/indapamide may not be suitable for you

• if you have low potassium levels in your blood

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

• if you are more than 3 months pregnant (Perindopril/Indapamida Stada should also be avoided 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, e.g., in the throat) is high

Warnings and precautions

Talk to 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 vision changes or eye pain. These may 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 collagen vascular disease (skin disorder) such as systemic lupus erythematosus or scleroderma

• if you have atherosclerosis (hardening of the arteries)

• if you have hyperparathyroidism (overactive 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, which 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 (ARBs) (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 Black 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 hemodialysis patient using high-flux dialysis membranes

• if you are taking any of the following medicines, as 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 in 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 taking perindopril/indapamide immediately and contact your doctor without delay. See also section 4.

Inform your doctor if you think you are (or might become) pregnant. 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 during this period (see “Pregnancy and breastfeeding”).

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

• if you are scheduled for anesthesia and/or surgery

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

• if you are scheduled for 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 scheduled for a medical test requiring injection of an iodinated contrast agent (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 of glaucoma, an increase in pressure in your eye(s). You should stop taking perindopril/indapamide and seek medical attention.

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

Children and adolescents

Perindopril/indapamide must not be given to children or adolescents.

Other medicines and Perindopril/Indapamida Stada

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

You should 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 (ARBs), aliskiren (see also information under the 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 treating irregular heart rhythm)

• allopurinol (for treating 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 to prevent transplant 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, cardiac glycosides, bretylium)

• cisapride, difenoxin (used to treat gastrointestinal problems)

• digoxin or other cardiac glycosides (for treating heart problems)

• baclofen (for treating muscle stiffness in conditions such as multiple sclerosis)

• medicines for treating 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 and reduce fever, as well as to prevent blood clotting))

• injectable amphotericin B (for treating serious fungal infections)

• 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 treating Crohn’s disease)

• trimethoprim (for treating 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 are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

Pregnancy

Inform your doctor if you think you are (or might 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 seriously harm your baby if used beyond the third month.

Breastfeeding

Perindopril/indapamide is not recommended during breastfeeding.

Inform your doctor immediately if you are planning to breastfeed or are already breastfeeding.

Contact your doctor immediately.

Driving and using machines

Perindopril/indapamide generally does not affect alertness. However, due to possible blood pressure lowering effects, some patients may experience symptoms 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 with him before taking this medicine.

3. How to take Perindopril/Indapamida Stada

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

The recommended dose is 1 tablet once daily. Your doctor may decide to 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.

If you take more Perindopril/Indapamida Stada than you should

If you ingest 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 decrease in blood pressure occurs (associated with nausea, vomiting, cramps, dizziness, drowsiness, confusion, and changes in the amount of urine produced by the kidneys), lying down with your legs raised may help.

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

If you forget to take Perindopril/Indapamida Stada

It is important to take this medicine every day, as continuous treatment is more effective. However, if you forget to take a dose of perindopril/indapamida, 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/Indapamida 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 treatment with this medicine and go immediately to your doctor if you experience any of the following adverse effects, which may be serious:

• Severe dizziness or fainting due to low blood pressure (Common – 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 often starting 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, muscle sensitivity or pain, especially if accompanied by feeling unwell or having a high temperature, as these may be caused by abnormal muscle breakdown. (Frequency not known)

In decreasing order of frequency, adverse effects may include:

• Common (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, visual 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 eosinophil count (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 lead to 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, falling.

• 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 renal failure.

Concentrated urine, feeling of discomfort (nausea) or feeling unwell (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, shortness of vision (myopia), blurred vision, visual disturbances, decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), change in color, numbness and pain in fingers or toes (Raynaud's phenomenon). If you have systemic lupus erythematosus (a type of collagen disease), it may worsen.

Blood, kidney, liver or pancreas disorders and changes in laboratory results (blood tests) may occur. Your doctor may need to prescribe 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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.

PVC/PVdC-Aluminum blisters:

Keep in the original packaging to protect it from moisture.

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

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

Aluminum-Aluminum blisters:

Keep in the original packaging to protect it from moisture. Store below 30 ºC.

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. Return unused medicines and their packaging to your pharmacy’s SIGRE collection point. If you have any doubts, 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/Indapamida Stada

• The active substances are perindopril tert-butylamine and indapamide. Each tablet contains 4 mg of perindopril tert-butylamine, equivalent to 3.338 mg of perindopril and 1.25 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, engraved with "PI" on one side.

PVC/PVdC-Aluminum blisters:

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.

Aluminum/Aluminum blisters:

The tablets are presented in Aluminum/Aluminum blisters, packed in a cardboard carton.

Pack sizes: 30, 90 and 100 tablets.

Only certain 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 European Economic Area member states under the following names:

Bulgaria: Pontea

Spain: Perindopril/Indapamida Stada 4 mg/1,25 mg comprimidos EFG

Netherlands: Perindopril/Indapamide STADA 4/1,25 mg, tabletten

Slovak Republic: PerindostadKombi 4 mg/1,25 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 Health Products (AEMPS) http://www.aemps.gob.es