Preterax 2 mg/0.625 mg tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient Preterax 2 mg/0.625 mg 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Preterax 2 mg/0.625 mg tablets are and what they are used for
2. What you need to know before taking Preterax 2 mg/0.625 mg tablets
3. How to take Preterax 2 mg/0.625 mg tablets
4. Possible side effects
5. How to store Preterax 2 mg/0.625 mg tablets
6. Contents of the pack and other information

1. What Preterax 2 mg/0.625 mg tablets are and what they are used for

Preterax 2 mg/0.625 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 known as 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 produces only a slight increase in the amount of urine formed. Each of the active substances lowers blood pressure, and together they work in combination to control your blood pressure.

2. What you need to know before taking Preterax 2 mg/0.625 mg tablets

Do not take Preterax 2 mg/0.625 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 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, Preterax 2 mg/0.625 mg tablets 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 (Preterax 2 mg/0.625 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 Preterax 2 mg/0.625 mg tablets with other medicines”).

Warnings and precautions

Consult your doctor or pharmacist before starting Preterax 2 mg/0.625 mg tablets:

• if you have aortic stenosis (narrowing of the main blood vessel leaving the heart) or 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 undergoing dialysis,
• if you experience vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye, which may occur within hours to weeks after taking Preterax 2 mg/0.625 mg tablets. If untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at 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 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 Preterax 2 mg/0.625 mg tablets should be avoided (see “Other medicines and Preterax 2 mg/0.625 mg tablets”),
• if you are elderly,
• if you have had photosensitivity reactions,
• if you have severe allergic reactions with swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema). This may occur at any time during treatment.

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

• if you are taking any of the following medicines for 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 Preterax 2 mg/0.625 mg tablets”.

• if you are of Black 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 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 in fixed-dose combination with valsartan), used for long-term treatment of heart failure,
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the class known as gliptins (used to treat diabetes).

Angioedema

In patients treated with ACE inhibitors, including Preterax 2 mg/0.625 mg tablets, angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing) has been reported. This may occur at any time during treatment. If you develop such symptoms, you must stop treatment with Preterax 2 mg/0.625 mg tablets and contact your doctor immediately. See also Section 4.

You should inform your doctor if you think you are (or might become) pregnant. Preterax 2 mg/0.625 mg tablets are not recommended during early pregnancy, and you must not take them if you are more than 3 months pregnant, as they may cause serious harm to your baby if used during this period (see “Pregnancy and breastfeeding”).

While taking Preterax 2 mg/0.625 mg tablets, you should inform your doctor or healthcare professional:

• if you are scheduled for anaesthesia and/or surgery,
• if you have recently had diarrhoea or vomiting, or are dehydrated,
• if you are scheduled for dialysis or LDL apheresis (removal of cholesterol from your blood using a machine),
• if you are undergoing desensitisation 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 allows organs such as the kidney or stomach to be visible on X-rays),
• if you experience vision disturbances or eye pain while taking Preterax 2 mg/0.625 mg tablets. This may be a sign that you are developing glaucoma, an increase in pressure in your eye(s). You should stop taking Preterax 2 mg/0.625 mg tablets and seek medical attention.

Athletes should be aware that Preterax 2 mg/0.625 mg tablets contain an active substance (indapamide) that may lead to a positive result in doping tests.

Children and adolescents

Preterax 2 mg/0.625 mg tablets must not be given to children or adolescents.

Other medicines and Preterax 2 mg/0.625 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 Preterax 2 mg/0.625 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 Preterax 2 mg/0.625 mg tablets may be affected by other medicines. Your doctor may need to adjust your dose and/or take other precautions. Be sure to inform your doctor if you are taking any of the following medicines, as you may require special care:

• other medicines for high blood pressure including angiotensin II receptor antagonists (ARA), aliskiren (see also information under the headings “Do not take Preterax 2 mg/0.625 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 to treat long-term heart failure). See sections “Do not take Preterax 2 mg/0.625 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 polyarthritis),
• 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).

Taking Preterax 2 mg/0.625 mg tablets with food and drinks

It is preferable to take Preterax 2 mg/0.625 mg tablets 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

You should inform your doctor if you think you are (or might become) pregnant.

Your doctor will normally advise you to stop taking Preterax 2 mg/0.625 mg tablets before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Preterax 2 mg/0.625 mg tablets are not recommended during early pregnancy, and you must not take them after the third month of pregnancy, as they may cause serious harm to your baby if used beyond the third month of pregnancy.

Breast-feeding

Preterax 2 mg/0.625 mg tablets are not recommended if you are breastfeeding.

Inform your doctor immediately if you are starting or currently breastfeeding.

Seek medical advice immediately.

Driving and using machines

Preterax 2 mg/0.625 mg tablets normally do not affect alertness. However, due to a drop in blood pressure, some patients may experience symptoms such as dizziness or weakness. If this occurs, your ability to drive or operate machinery may be impaired.

Preterax 2 mg/0.625 mg tablets contain lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Preterax 2 mg/0.625 mg tablets

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 increase the dose to 2 tablets per day or 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 Preterax 2 mg/0.625 mg tablets than you should

If you take too many tablets, contact your doctor immediately or go to the emergency department of your nearest hospital. 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 decrease in blood pressure. If a significant drop 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 Preterax 2 mg/0.625 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 Preterax 2 mg/0.625 mg tablets, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Preterax 2 mg/0.625 mg tablets

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 starts with itchy red spots on the face, arms or legs), or severe rash, hives, widespread redness of the skin, intense itching, blistering, peeling and skin inflammation, 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 pain, jaw pain 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 being unwell (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:

• 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 (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 tired, 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 eosinophil count (a type of white blood cell), laboratory test changes: 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 heartbeats), 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, elevated 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 enzyme levels, high serum bilirubin levels, fatigue, facial flushing, reduced 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), serious kidney problems, changes in blood test 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 findings, 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 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.

Disorders of the blood, kidney, 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, talk to your doctor, pharmacist or nurse, 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 Preterax 2 mg/0.625 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. Discard the blister 2 months after opening the outer pouch.

Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Preterax 2 mg/0.625 mg tablets

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

Appearance of the product and contents of the pack

Preterax 2 mg/0.625 mg tablets are white, rod-shaped tablets, scored on both sides. One tablet contains 2 mg of perindopril tert-butylamine and 0.625 mg of indapamide.

The tablets are available in blister packs within an outer pouch containing 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

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

Slovenia NOLIPREL 2mg/0.625 mg tablets

Spain Preterax 2mg/0.625mg tablets

France PERINDOPRIL/INDAPAMIDE ARROW LAB 2mg/0.625 mg

Malta PRETERAX

Date of the most recent revision of this leaflet: May 2022.

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/.