Bipreterax 4 mg/1.25 mg tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Bipreterax 4mg/1.25mg tablets

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 must not be given to other people, even if they have the same symptoms, as it may 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.

Contents of the leaflet:

1. What Bipreterax 4 mg/1.25 mg tablets are and what they are used for
2. What you need to know before taking Bipreterax 4 mg/1.25 mg tablets
3. How to take Bipreterax 4 mg/1.25 mg tablets
4. Possible side effects
5. How to store Bipreterax 4 mg/1.25 mg tablets
6. Contents of the pack and other information

1. What Bipreterax 4 mg/1.25 mg tablets are and what they are used for

Bipreterax 4 mg/1.25 mg tablets is a combination of two active substances, perindopril and indapamide. It is an antihypertensive and is indicated for the treatment of high blood pressure (hypertension) in adults.

Perindopril belongs to a group of medicines called ACE inhibitors. It works by widening the blood vessels, allowing your heart to pump blood through them more easily. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide 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 Bipreterax 4 mg/1.25 mg tablets

Do not take Bipreterax 4 mg/1.25 mg tablets

• 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 has 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 a condition called hepatic encephalopathy (degenerative brain disorder),
• if you have severe kidney disease causing reduced blood flow to the kidneys (renal artery stenosis),
• if you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Bipreterax 4 mg/1.25 mg tablets 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, breathing difficulty),
• if you are more than 3 months pregnant (Bipreterax 4 mg/1.25 mg tablets should also be avoided early in pregnancy – see section “Pregnancy”),
• if you have taken or are currently taking sacubitril/valsartan, a medicine for heart failure, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat) (see “Warnings and precautions” and “Use of Bipreterax 4 mg/1.25 mg tablets with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Bipreterax 4 mg/1.25 mg tablets:

• if you have aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (heart muscle disease) 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 could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from hours to weeks after taking Bipreterax 4 mg/1.25 mg tablets. If untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may have a higher risk of developing this,
• 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 hyperaldosteronism),
• if you have liver problems,
• if you have 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 simultaneous use with Bipreterax 4 mg/1.25 mg tablets should be avoided (see “Other medicines and Bipreterax 4 mg/1.25 mg tablets”),
• if you are elderly,
• if you have experienced photosensitivity reactions,
• if you develop a severe allergic reaction 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 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.

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

See also the information under the heading “Do not take Bipreterax 4 mg/1.25 mg tablets”.

• if you are of Black African or 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 membranes,

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

• racecadotril (used to treat diarrhoea),

• sirolimus, everolimus, temsirolimus, and other medicines belonging to the class called mTor inhibitors (used to prevent organ transplant rejection and for cancer),

• sacubitril (available as a fixed-dose combination with valsartan), used for long-term treatment of heart failure,

• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the class also known as gliptins (used to treat diabetes).

Angioedema

In patients treated with ACE inhibitors, including Bipreterax 4 mg/1.25 mg tablets, 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 Bipreterax 4 mg/1.25 mg tablets and seek immediate medical attention. See also Section 4.

You must inform your doctor if you think you are (or could become) pregnant. Bipreterax 4 mg/1.25 mg tablets is not recommended during 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 Bipreterax 4 mg/1.25 mg tablets, inform your doctor or healthcare provider:

• if you are undergoing anaesthesia and/or surgery,
• if you have recently had diarrhoea or vomiting, or are dehydrated,
• if you are undergoing dialysis or LDL apheresis (removal of cholesterol from your blood using a machine),
• if you are receiving desensitisation treatment to reduce allergic reactions to bee or wasp stings,
• if you are undergoing 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 changes in vision or eye pain while taking Bipreterax 4 mg/1.25 mg tablets. This may be a sign that you are developing glaucoma, an increase in pressure in your eye(s). You must stop treatment with Bipreterax 4 mg/1.25 mg tablets and seek medical attention.

Athletes should be aware that Bipreterax 4 mg/1.25 mg tablets contains an active substance (indapamide) that may lead to a positive doping test.

Children and adolescents

Bipreterax 4 mg/1.25 mg tablets must not be given to children or adolescents.

Other medicines and Bipreterax 4 mg/1.25 mg tablets

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

You must avoid taking Bipreterax 4 mg/1.25 mg tablets 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 inhibitors and angiotensin receptor antagonists.

Treatment with Bipreterax 4 mg/1.25 mg tablets may be affected by other medicines. Your doctor may need to adjust your dose and/or take other 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), aliskiren (see also information under “Do not take Bipreterax 4 mg/1.25 mg tablets” 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 per day,
• medicines frequently used to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class called mTor inhibitors). See section “Warnings and precautions”,
• sacubitril/valsartan (used for long-term treatment of heart failure). See sections “Do not take Bipreterax 4 mg/1.25 mg tablets” and “Warnings and precautions”,
• anaesthetic medicines,
• iodinated contrast agents,
• antibiotics used to treat bacterial infections (e.g., moxifloxacin, sparfloxacin, injectable erythromycin),
• methadone (used for addiction treatment),
• procainamide (for treatment of irregular heart rhythm),
• 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, difemethiazine (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 and reduce fever, as well as to 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).

Bipreterax 4 mg/1.25 mg tabletswith food and drink

It is preferable to take Bipreterax 4 mg/1.25 mg tablets 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

You must inform your doctor if you think you are (or could become) pregnant.

Your doctor will usually advise you to stop taking Bipreterax 4 mg/1.25 mg tablets before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Bipreterax 4 mg/1.25 mg tablets is not recommended during early pregnancy, and you must not take it after the third month of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.

Breastfeeding

Bipreterax 4 mg/1.25 mg tablets is not recommended during breastfeeding.

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

Seek medical advice immediately.

Driving and using machines

Bipreterax 4 mg/1.25 mg tablets usually do not affect alertness. However, due to blood pressure lowering, some patients may experience effects such as dizziness or weakness. If this occurs, your ability to drive or operate machinery may be impaired.

Bipreterax 4 mg/1.25 mg tablets contain lactose.

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

3. How to take Bipreterax 4 mg/1.25 mg tablets

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, please 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. Take your tablet preferably in the morning and before breakfast. Swallow the tablet whole with a glass of water.

If you take more Bipreterax 4 mg/1.25 mg tablets than you should

If you take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department. In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone (91) 562 04 20.

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), it may help to lie down with your legs raised.

If you forget to take Bipreterax 4 mg/1.25 mg tablets

It is important to take this medicine every day, as continuous treatment is more effective. However, if you forget to take a dose of Bipreterax 4 mg/1.25 mg tablets, 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 Bipreterax 4 mg/1.25 mg tablets

Since treatment for high blood pressure is usually lifelong, you should talk to 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 experiences 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 often starting with itchy red spots on the face, arms or legs), or severe skin 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 triggered 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 accompanied by feeling unwell or having a high temperature, as these may be due to abnormal muscle breakdown (Frequency not known).

In decreasing order of frequency, adverse effects may include:

• Frequent (may affect up to 1 in 10 people): 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 fatigue, low blood potassium levels.

• 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 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, fall.

• Rare (may affect up to 1 in 1,000 people): worsening of psoriasis, changes in laboratory test 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 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, 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), color change, numbness and pain in fingers or toes (Raynaud's disease). If you have systemic lupus erythematosus (a type of collagen disease), it may worsen.

Disorders of the blood, kidneys, liver or pancreas, 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, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 Bipreterax 4 mg/1.25 mg tablets

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your usual pharmacy. If you are in doubt, please 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 Bipreterax 4 mg/1.25 mg tablets

• 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 of the tablet are: monohydrate lactose, magnesium stearate (E470B), colloidal anhydrous silica, and microcrystalline cellulose.

Appearance of the product and contents of the pack

Bipreterax 4 mg/1.25 mg tablets are white, rod-shaped tablets. Each tablet contains 4 mg of perindopril tert-butylamine and 1.25 mg of indapamide.

The tablets are available in blisters of 14, 20, 28, 30, 50, 56, 60, 90, 100 or 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex – France

Manufacturer:

Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy – France

or

Servier (Ireland) Industries Ltd
Gorey Road
Arklow – Co. Wicklow – Ireland

or

Laboratorios Servier S.L. (only for the Spanish market)
Avda. de los Madroños 33
28043 Madrid – Spain

or

ANPHARM PRZEDSIĘBIORSTWO FARMACEUTYCZNE S.A.
Ul. Annopol 6B - 03-236 Warszawa
Poland

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

Slovenia: NOLIPREL FORTE 4mg/1.25 mg tablete
Spain: Bipreterax 4 mg/1.25 mg tablets
France: PERINDOPRIL /INDAPAMIDE ARROW LAB 4mg/1.25mg
Hungary: PRETANIX KOMB

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

Detailed 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/.