Patient Information Leaflet

Bipreterax 8 mg/2.5 mg tablets

perindopril terbutilamine/indapamide

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What is Bipreterax 8 mg/2.5 mg tablets and what is it used for

2.What you need to know before you start taking Bipreterax 8 mg/2.5 mg tablets

3.How to take Bipreterax 8 mg/2.5 mg tablets

4.Possible side effects

5.Storage of Bipreterax 8 mg/2.5 mg tablets

6.Contents of the pack and additional information

Bipreterax 8 mg/2,5 mg tabletsis an association of two active principles, perindopril and indapamida. It is an antihypertensive and is indicated for the treatment of high blood pressure (hypertension).Bipreterax 8 mg/2,5 mg tabletsis prescribed to patients who are already receiving 8 mg of perindopril and 2,5 mg of indapamida in separate tablets. Instead, these patients can receive a tablet ofBipreterax 8 mg/2,5 mg tabletsthat contains both ingredients.

Perindopril belongs to the group of medicines called angiotensin-converting enzyme (ACE) inhibitors.. They act by widening blood vessels, so their heart will pump blood more easily through them. Indapamida is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamida is different from other diuretics, as it only produces a slight increase in the amount of urine formed. Each of the active principles lowers blood pressure and acts in conjunction to control blood pressure.

Do not takeBipreterax 8 mg/2.5 mg tablets

• if you are allergic to perindoprilor to any other ACE inhibitor, to indapamide or to 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 with any previous treatment with ACE inhibitors, or if you or a family member has had these symptoms in any other circumstance (a condition called angioedema),
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren,
• if you have a severe liver disease or suffer from a condition called hepatic encephalopathy (a degenerative brain disease),
• if you have a severe kidney diseasedue to which the blood flow to your kidneys is reduced (renal artery stenosis),
• if you are receiving dialysisor any other type of blood filtration. Depending on the machine used,Bipreterax 8 mg/2.5 mg tabletsmay not be suitable for you,
• if you have low potassium levels in your blood,
• if you suspect that you may have untreated heart failure (severe fluid retention, breathing difficulty),
• if you arein the last 3 months of pregnancy orif you are trying to become pregnant (see section “Pregnancy”),
• if you have taken or are currently takingsacubitril/valsartan, a medicine for heart failure, as it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat) (see “Warnings and precautions” and “Taking Bipreterax 8 mg/2.5 mg tabletswith other medicines”).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeBipreterax 8 mg/2.5 mg tablets:

• if you have aortic stenosis (narrowing of the main blood vessel that leaves the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that carries blood to the kidney),
• if you have heart failure or any other heart problem,
• if you have kidney problems or if you are on dialysis,
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the blood vessel layer of the eye (choroidal effusion) or increased pressure in your eye and can occur within hours to weeks of taking Bipreterax 8 mg/2.5 mg tablets. If left untreated, this can lead to permanent vision loss. If you have had a previous allergy to penicillin or sulfonamides, you may be at higher risk of developing this,
• if you have muscle disorders, including muscle pain, sensitivity, weakness, or cramps,
• if you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism),
• if you have liver problems,
• if you suffer from a collagen disease (skin disease) 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 following a low-sodium diet or using salt substitutes that contain potassium,
• if you are taking lithium or potassium-sparing diuretics (e.g. spironolactone, triamterene) or potassium supplements, as you should
• avoid taking them at the same time as Bipreterax 8 mg/2.5 mg tablets (see “Other medicines and Bipreterax 8 mg/2.5 mg tablets”),
• if you are an elderly patient,
• if you have had photosensitivity reactions,
• if you have a severe allergic reaction with facial, lip, mouth, tongue, or throat swelling that can cause difficulty swallowing or breathing (angioedema). This can occur at any time during treatment.

If you develop these symptoms, stop treatment and contact your doctor immediately,

• if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin II receptor antagonist (ARA) (also known as “sartans” - for example, 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 takeBipreterax 8 mg/2.5 mg tablets”.

• if you are of black ethnicity, as you may be at higher risk of angioedemaand this medicine may be less effective in lowering your blood pressure than in patients who are not of black ethnicity,
• if you are a haemodialysis patient using high-flow 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 for cancer),
• sacubitril (available as a fixed-dose combination with valsartan), used to treat heart failure over a long period,
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the class of gliptins (used to treat diabetes).

Angioedema

In patients treated with ACE inhibitors, including Bipreterax 8 mg/2.5 mg tablets, angioedema (severe allergic reactionwith swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing) has been reported. This can occur at any time during treatment. If you develop these symptoms, you should stop treatment withBipreterax 8 mg/2.5 mg tabletsand seek medical attention immediately. See also Section 4.

You should inform your doctorif you think you may be or may become pregnant.Bipreterax 8 mg/2.5 mg tabletsare not recommended at the start of pregnancy and may cause serious harm to your baby after the third month of pregnancy (see section “Pregnancy and breastfeeding”).

When taking Bipreterax 8 mg/2.5 mg tablets, you should inform your doctor or healthcare staff:

• if you are to undergo anaesthesia and/or surgery,
• if you have recently had diarrhoea or vomiting, or are dehydrated,
• if you are to undergo dialysis or LDL apheresis (removal of cholesterol from your blood using a machine),
• if you are to receive a desensitisation treatment to reduce the effects of bee or wasp stings,
• if you are to undergo any medical test that requires an iodinated contrast agent (a substance that allows organs such as the kidney or stomach to be visible with X-rays),
• if you have vision disturbances or eye pain while taking Bipreterax 8 mg/2.5 mg tablets. This may be a sign that you are developing glaucoma, an increase in pressure in your eye(s). You should stop treatment withBipreterax 8 mg/2.5 mg tabletsand seek medical attention

Athletes should be aware thatBipreterax 8 mg/2.5 mg tabletscontain an active ingredient (indapamide) that may give a positive result in a doping test.

Children and adolescents

Bipreterax 8 mg/2.5 mg tabletsshould not be given to children or adolescents.

Other medicines and Bipreterax 8 mg/2.5 mg tablets

Inform your doctor or pharmacist if you aretaking,havetakenrecentlyor may have to take any other medicine.

You should avoid takingBipreterax 8 mg/2.5 mg tabletswith:

• lithium (used to treat mania or depression),
• aliskiren (medicine used to treat high blood pressure) if you do not have diabetes mellitus or kidney problems,
• potassium-sparing diuretics (e.g. triamterene, amiloride), potassium salts,other medicines that can increase potassium levels in your body (such as heparin, a medicine used to thin the blood and prevent blood clots; trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole for bacterial infections),
• estramustine (used in cancer treatment),
• other medicines used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.

The treatment withBipreterax 8 mg/2.5 mg tabletsmay 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 need special care:

• other medicines for the treatment of high blood pressureincluding angiotensin II receptor antagonists (ARAs), aliskiren (see also the information under the headings “Do not take Bipreterax 8 mg/2.5 mg tablets” and “Warnings and precautions”),or diuretics (medicines that increase the amount of urine produced by the kidneys),
• potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• medicines that are frequently used to treat diarrhea (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 to treat heart failure over a long period). See sections “Do not take Bipreterax 8 mg/2.5 mg tablets” and “Warnings and precautions”,
• anaesthetics,
• iodinated contrast agent,
• antibiotics used to treat bacterial infectionsbacterianas (e.g. moxifloxacino, esparfloxacino,eritromicina inyectable),
• metadona (used to treat addiction),
• procainamide (for irregular heart rhythm treatment),
• alopurinol (for gout treatment),
• antihistamines used to treat allergic reactions, such as hay fever (e.g.mizolastina, terfenadina, astemizol),
• corticosteroids used to treat various disorders including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune disorders or after a transplant to prevent rejection (e.g. ciclosporin, tacrolimus),
• halofantrina (used to treat certain types of malaria),
• pentamidine (used to treat pneumonia),
• oro inyectable (used to treat rheumatoid arthritis),
• vincamina (used to treat cognitive disorders in elderly patients including memory loss),
• bepridil (used to treat angina pectoris),
• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitals, bretylium),
• cisaprida, difemanilo (used to treat gastrointestinal problems),
• digoxin or other cardiac glycosides (for heart problems treatment),
• baclofen (for muscle stiffness treatment that occurs in diseases such as multiple sclerosis),
• medicines used to treat diabetes such as insulin, metformin, or gliptins,
• calcium, including calcium supplements,
• laxatives (e.g. sena),
• anti-inflammatory non-steroidal medicines (e.g. ibuprofen) or high doses of salicylates (e.g. aspirin, a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting),
• 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 that make blood vessels wider),
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline).

Bipreterax 8 mg/2.5 mg tablets with food and drink

It is best to takeBipreterax 8 mg/2.5 mg tabletsbefore a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will usually advise you to stop takingBipreterax 8 mg/2.5 mg tabletsbefore becoming pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead ofBipreterax 8 mg/2.5 mg tablets.

Bipreterax 8 mg/2.5 mg tabletsare not recommended at the start of pregnancy and should not be taken after the third month of pregnancy, as they may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Bipreterax 8 mg/2.5 mg tabletsare not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed your baby, especially if your baby is newborn or premature.

Consult your doctor immediately.

Driving and operating machines

Bipreterax 8 mg/2.5 mg tabletsusuallydo not affect your alertness, but due to the lowering of blood pressure, some patients may notice different reactions such as dizziness or weakness. If this happens to you, your ability to drive or operate machinery may be impaired.

Bipreterax 8 mg/2.5 mg tablets contain lactose(a type of sugar).

If your doctor has told you that you have a certain sugar intolerance, consult him before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet per day. Your doctor may decide to modify the dose if you have renal insufficiency. Take your tablet preferably in the morning and before breakfast. Swallow the tablet whole with the help of a glass of water.

If you take moreBipreterax8 mg/2.5mg tabletsthan you should

If you ingest too many tablets, contact your doctor or pharmacist immediately or go to the emergency service of your nearest hospital. In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone (91) 562 04 20, indicating the amount taken.

The most frequent symptom in case of overdose is a decrease 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 elevated.

If you forgot to takeBipreterax8 mg/2.5mg tablets

It is essential to take this medication every day since continuous treatment is more effective. However, if you forgot to take a dose ofBipreterax 8 mg/2.5mg tabletstake the next dose at the usual time. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment withBipreterax8 mg/2.5mg tablets

Since treatment for high blood pressure is usually lifelong, you should talk to your doctor before stopping this medication.

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

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

Stoptaking this medicine andseek medical attention immediately if you experience any of the following side effects that may be serious:

• Severe dizziness or fainting due to low blood pressure, (Common - may affect up to 1 in 10 people),
• Bronchospasm (chest tightness, shortness of breath or difficulty breathing) (Uncommon) (may affect up to 1 in 100 people),
• Swelling of the face, lips, mouth, tongue or throat, which causes severe difficulty breathing (angioedema) (See section 2 "Warnings and precautions") (Uncommon) (may affect up to 1 in 100 people),
• Severe skin reactions that include erythema multiforme (skin rash that often starts with red, itchy patches on the face, arms or legs), or intense skin rash, blisters, widespread skin redness, intense itching, blistering, skin peeling, and inflammation of the 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 pain, jaw pain, 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 that may be a sign of a possible stroke (Very rare - may affect up to 1 in 10,000 people),
• Pancreatitis that can cause severe abdominal and back pain accompanied by a feeling of great discomfort (Very rare) (may affect up to 1 in 10,000 people).
• Yellowing of the skin or eyes (jaundice) that may be a sign of hepatitis (Very rare - may affect up to 1 in 10,000 people),
• Irregular heartbeat with life-threatening implications. (Unknown frequency),
• Brain disease caused by liver disease (Hepatic encephalopathy) (Unknown frequency),
• Muscle weakness, cramps, muscle sensitivity or pain, and especially if you feel unwell or have a high temperature, as they may be caused by abnormal muscle breakdown. (Unknown frequency).

In decreasing order of frequency, side effects may include:

• Common (may affect up to 1 in 10 people): skin reactions in people prone to allergic and asthmatic reactions, headache, dizziness, vertigo, tingling, visual disturbances, tinnitus (sensation of noise in the ears), cough, shortness of breath (dyspnea), gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion or difficulty digesting, diarrhea, constipation), allergic reactions (such as skin rashes, itching), muscle cramps, feeling tired, low potassium levels in the blood.

• 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, an excess of eosinophils (a type of white blood cell), changes in laboratory parameters: reversible increase in blood potassium levels when treatment is stopped, decrease in blood sodium levels that may cause dehydration and low blood pressure, somnolence, fainting, palpitations (feeling the heartbeat), tachycardia (rapid heartbeat), hypoglycemia (very low blood sugar) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased skin sensitivity to the sun), arthralgia (joint pain), myalgia (muscle pain), chest pain, feeling unwell, peripheral edema, fever, elevated urea levels in the blood, and elevated creatinine levels in the blood, fall.

• Rare (may affect up to 1 in 1,000 people): worsening of psoriasis, changes in analytical results: low chloride levels in the blood, low magnesium levels in the blood, increased levels of liver enzymes, high bilirubin levels in the blood, fatigue, facial redness, decreased or absent diuresis, acute renal failure.

May appear blood disorders, kidney, liver, or pancreas problems and changes in analytical results (blood tests). Your doctor may need to prescribe blood tests to monitor your condition.

If you have these symptoms, contact your doctor as soon as possible.

Reporting of side effects

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

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the packaging.

The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at your local SIGRE collection pointat your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofBipreterax8 mg/2.5mg tablets

-The active ingredients are perindopril terbutilamine and indapamide. Each tablet contains 8 mg of perindopril terbutilamine (which corresponds to 6.676 mg of perindopril)and 2.5mg of indapamida.

-The other components (excipients) of the tablet are: lactose monohydrate, magnesium stearate (E470B), hydrophobic colloidal silica, and microcrystalline cellulose.

Appearance of the product and contents of the package

The Bipreterax 8 mg/2.5mg tabletsare white, round, with a diameter of 8mm and a curvature radius of 7mm. A tablet contains 8 mg of perindopril terbutilamine and 2.5mg of indapamida.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex– France

Responsible for manufacturing:

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.

Avenida de Los Madroños, 33

28043 Madrid - SPAIN

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Laboratorios Servier, S.L.

Tel. 91 748.96.30

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this prospectus: May 2022

The detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.