PRETERAX 2.5 мг/0.625 мг Фильм-coated таблетки

Содержание инструкции

1. PRETERAX 2,5 mg/0,625 mg film-coated tablets
   1. What is PRETERAX 2,5 mg/0,625 mg and what is it used for
   2. What you need to know before taking PRETERAX 2.5 mg/0.625 mg
   3. How to take PRETERAX 2,5 mg/0,625 mg
   4. Possible side effects
   5. How to store PRETERAX 2,5 mg/0,625 mg
   6. Package contents and other information
2. PRETERAX 5 mg/1,25 mg film-coated tablets
   1. What PRETERAX 5 mg/1.25 mg is and what it is used for
   2. What you need to know before taking PRETERAX 5 mg/1.25 mg
3. PRETERAX 5 mg/1,25 mg" and "Warnings and precautions") or diuretics (medicines that increase
   1. How to take PRETERAX 5 mg/1,25 mg
   2. Possible side effects
   3. How to store PRETERAX 5 mg/1,25 mg
   4. Package contents and other information

PRETERAX 2,5 mg/0,625 mg film-coated tablets

perindopril arginine/indapamide

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. 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 pass it on to others, even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, speak to your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What PRETERAX 2,5 mg/0,625 mg is and what it is used for
• 2. What you need to know before you take PRETERAX 2,5 mg/0,625 mg
• 3. How to take PRETERAX 2,5 mg/0,625 mg
• 4. Possible side effects
• 5. How to store PRETERAX 2,5 mg/0,625 mg
• 6. Contents of the pack and other information

1. What is PRETERAX 2,5 mg/0,625 mg and what is it used for

PRETERAX 2,5 mg/0,625 mg is a combination of two active ingredients, perindopril and indapamide. It is
an antihypertensive and is used in the treatment of high blood pressure (hypertension) in
adults.
Perindopril belongs to a class of drugs called ACE inhibitors. These drugs work
by dilating blood vessels, which makes it easier for the heart to pump blood through them. 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
produced. Each active ingredient reduces blood pressure and, together, they work to control
blood pressure.

2. What you need to know before taking PRETERAX 2.5 mg/0.625 mg

Do not take PRETERAX 2.5 mg/0.625 mg

• if you are allergic (hypersensitive) to perindopril or to any other ACE inhibitor, or to indapamide or to any other sulfonamide, or to any of the excipients of this medicine,
• if you have experienced symptoms such as shortness of breath, swelling of the face or tongue, intense itching or severe skin rashes related to a previous treatment with ACE inhibitors or if you or a family member has experienced such symptoms in any other circumstance (condition called angioedema),
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren,
• if you have a severe liver disease or if you suffer from a disease called hepatic encephalopathy (a degenerative brain disease),
• if you suffer from a severe kidney disease, where the blood flow to the kidneys is reduced (renal artery stenosis),
• if you are undergoing dialysis, or any type of blood filtration. Depending on the machinery used, therapy with PRETERAX 2.5 mg/0.625 mg may not be suitable for you,
• if you have a decrease in plasma potassium,
• if you suspect you have decompensated heart failure (severe fluid retention, difficulty breathing),
• if you are pregnant for more than three months. (It is best to avoid PRETERAX 2.5 mg/0.625 mg even in the early stages of pregnancy - see paragraph “Pregnancy”),
• if you are being treated with sacubitril/valsartan, a medicine used to treat heart failure (see “Warnings and precautions” and “Other medicines and PRETERAX 2.5mg/0.625mg”).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using PRETERAX 2.5 mg/0.625 mg:

• if you have aortic stenosis (narrowing of the main artery originating from the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
• if you suffer from heart failure or other heart problems,
• if you suffer from kidney problems or are on dialysis,
• if you experience decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within hours or weeks of taking PRETERAX 2.5 mg/0.625 mg. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamides, you may be at greater risk of developing it,
• if you suffer from muscle disorders including muscle pain, sensitivity, weakness or cramps,
• if you have an abnormally high level of a hormone called aldosterone in the 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 suffer from atherosclerosis (hardening of the arteries),
• if you suffer from hyperparathyroidism (overactivity of the parathyroid glands),
• if you suffer from gout,
• if you have diabetes,
• if you are following a diet that limits salt intake or use potassium-containing salt substitutes,
• if you are taking lithium or potassium-sparing medicines (spironolactone, triamterene) or potassium supplements, as their use with PRETERAX 2.5 mg/0.625 mg should be avoided (see “Taking PRETERAX 2.5 mg/0.625 mg with other medicines”),
• if you are elderly,
• if you have experienced photosensitivity reactions,
• if you have severe allergic reactions with swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema). This can occur at any time during treatment. If such symptoms develop, stop treatment and call a doctor immediately,
• if you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood at regular intervals. See also “Do not take PRETERAX 2.5 mg/0.625 mg”. 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 a hemodialysis patient dialyzed with high-flux membranes, if you are taking any of the following medicines, increases the risk of angioedema: racecadotril (used to treat diarrhea), sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used in preventing rejection following organ transplantation),
• sacubitril (available as a fixed-dose combination with valsartan), used in the long-term treatment of heart failure.

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat
with difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including
PRETERAX 2.5 mg/0.625 mg. This can occur at any time during treatment. If you
develop such symptoms, stop treatment with PRETERAX 2.5 mg/0.625 mg and call
your doctor immediately. See also paragraph 4.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). PRETERAX 2.5 mg/0.625 mg is not recommended in early pregnancy, and
should not be taken if you are pregnant for more than three months, as it can cause serious
harm to the baby if taken during this period (see “Pregnancy and breastfeeding”).
If you are taking PRETERAX 2.5 mg/0.625 mg, tell your doctor or medical staff:

• if you are going to have anesthesia and/or surgery,
• if you have recently had diarrhea or vomiting, or if you are dehydrated,
• if you are going to undergo dialysis or LDL apheresis (blood purification from cholesterol using a machine),
• if you are going to have a desensitization treatment to reduce the effects of an allergy to bee or wasp stings,
• if you are going to undergo a medical examination that requires the injection of an iodinated contrast agent (a substance that makes organs such as kidneys or stomach visible on X-rays),
• if you have had changes in vision or eye pain during the intake of PRETERAX 2.5 mg/0.625 mg. This could be a sign that glaucoma, increased pressure in an eye(s) is developing. Stop treatment with PRETERAX 2.5 mg/0.625 mg and consult a doctor.

Athletes should be aware that PRETERAX 2.5 mg/0.625 mg contains an active ingredient
(indapamide) that can induce a positive result in doping tests.

Children and adolescents
PRETERAX 2.5 mg/0.625 mg should not be given to children and adolescents.

Other medicines and PRETERAX 2.5 mg/0.625 mg
Tell your doctor or pharmacist if you are taking or have recently taken or might take
any other medicines.
You should not take PRETERAX 2.5 mg/0.625 mg with:

• lithium (used to treat manic disorder and depression),
• aliskiren (medicine used to treat hypertension) if you do not have diabetes or kidney problems,
• potassium-sparing diuretics (such as triamterene, amiloride), potassium salts, other drugs that can increase potassium levels in the blood (such as heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole),
• estramustine (used in cancer therapy),
• other medicines used to treat high blood pressure: angiotensin converting enzyme inhibitors and angiotensin receptor blockers.

The treatment with PRETERAX 2.5 mg/0.625 mg can be affected by other medicines. Your doctor
may need to adjust the dose and / or take other precautions. Make sure to tell your
doctor if you are taking any of these medicines, as special attention may be needed:

• other medicines for the treatment of high blood pressure, including an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also “Do not take PRETERAX 2.5 mg/0.625 mg” and “Warnings and precautions”) or diuretics (medicines that increase the amount of urine produced by the kidneys),
• potassium-sparing diuretics used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• medicines used mainly for the treatment of diarrhea (racecadotril) or for the prevention of rejection following organ transplantation (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See paragraph “Warnings and precautions”,
• Sacubitril/valsartan (used for the long-term treatment of heart failure). See “Do not take PRETERAX 2.5mg/0.625mg” and “Warnings and precautions”,
• anesthetics,
• iodinated contrast agents,
• antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, injectable erythromycin,
• methadone (used for the treatment of dependencies),
• procainamide (for the treatment of irregular heartbeat),
• allopurinol (for the treatment of gout),
• antihistamines used to treat allergic reactions, such as hay fever (e.g. mizolastine, terfenadine, astemizole,
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune diseases or following transplants to prevent rejection (e.g. cyclosporine, tacrolimus),
• alofantrine (used to treat certain types of malaria),
• pentamidine (used to treat pneumonia),
• gold by injection (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 used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium),
• cisapride, difemanil (used to treat stomach and digestive problems)
• digoxin or other cardiac glycosides (for the treatment of heart problems),
• baclofen (for the treatment of muscle stiffness in conditions such as multiple sclerosis),
• medicines to treat 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-dose salicylates (e.g. aspirin),
• injectable amphotericin B (for the treatment of severe 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 the treatment of Crohn's disease),
• trimethoprim (for the treatment of infections),
• vasodilators including nitrates (products that widen blood vessels),
• medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, norepinephrine or adrenaline).

PRETERAX 2.5 mg/0.625 mg with food and drink
It is preferable to take PRETERAX 2.5 mg/0.625 mg before a meal.

Pregnancy and breastfeeding
If you are pregnant, if you suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist before using this medicine.

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking PRETERAX 2.5
mg/0.625 mg before starting pregnancy or as soon as you find out you are pregnant and advise you to take another medicine instead of PRETERAX 2.5 mg/0.625 mg.
PRETERAX 2.5 mg/0.625 mg is not recommended in early pregnancy, and should not be taken
if you are pregnant for more than three months, as it can cause serious
harm to the baby if taken after the third month of pregnancy.

Breastfeeding
PRETERAX 2.5 mg/0.625 mg is not recommended if you are breastfeeding.
Immediately inform your doctor if you are breastfeeding or are about to start breastfeeding.
Warn your doctor immediately.

Driving and using machines
PRETERAX 2.5 mg/0.625 mg normally does not affect alertness but in some patients may
occur different reactions such as dizziness or fatigue in relation to lowering blood
pressure. If you experience such symptoms, your ability to drive vehicles or operate machinery may
be reduced.
PRETERAX 2.5 mg/0.625 mg contains lactose monohydrate:
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking
this medicine.
PRETERAX 2.5 mg/0.625 mg contains sodium:
PRETERAX 2.5 mg/0.625 mg contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is
essentially "sodium-free".

3. How to take PRETERAX 2,5 mg/0,625 mg

Always take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose is one tablet a day. Your doctor may decide to increase the dose to
two tablets a day or to modify the dosage if you suffer from renal insufficiency. Take the
tablet preferably in the morning and before a meal. The tablet must be swallowed with a
glass of water.
The score line is not designed to divide the tablet.

If you take more PRETERAX 2,5 mg/0,625 mg than you should
If you have taken an excessive amount of tablets, consult your doctor immediately or go
immediately to the nearest emergency room. The most likely effect in case of overdose is a
lowering of blood pressure. If a marked drop in blood pressure occurs (associated with
nausea, vomiting, cramps, dizziness, drowsiness, mental confusion, changes in the amount of urine
produced by the kidneys), it may be helpful to lie down with your legs raised.

If you forget to take PRETERAX 2,5 mg/0,625 mg
It is important to take the medicine every day as regular treatment is more effective. If
however you forget to take a dose of PRETERAX 2,5 mg/0,625 mg, take the next dose
at the usual time. Do not take a double dose to make up for forgetting the previous dose.

If you stop taking PRETERAX 2,5 mg/0,625 mg
Since the treatment of hypertension is usually lifelong, you should talk to your doctor before
stopping taking this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, PRETERAX 2,5 mg/0,625 mg can cause side effects, including serious ones,
although not everybody gets them.

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

• Severe dizziness or fainting due to low blood pressure (common) (up to 1 in 10),
• Bronchospasm (tightness in the chest, wheezing and shortness of breath) (Uncommon) (up to 1 in 100),
• Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (see section 2 “Warnings and precautions”) (Uncommon) (up to 1 in 100),
• Severe skin reactions including intense rash, hives, widespread skin redness, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome) or other allergic reactions (very rare) (up to 1 in 10,000),
• Cardiovascular disorders (irregular heartbeat, angina pectoris (chest, jaw and back pain, caused by physical exertion)) (very rare) (up to 1 in 10,000),
• Weakness of arms or legs, or speech problems which could be a sign of a possible stroke (very rare) (up to 1 in 10,000),
• Inflammation of the pancreas which can cause severe abdominal pain and back pain accompanied by a feeling of unwellness (very rare) (up to 1 in 10,000),
• Jaundice (yellowing of the skin or eyes) which can be a sign of hepatitis (very rare) (up to 1 in 10,000),
• Life-threatening irregular heartbeat (not known),
• Brain disease caused by liver disease (hepatic encephalopathy) (not known),
• Muscle weakness, cramps, tenderness or pain and in particular, if at the same time, you do not feel well or have a high fever, this may be caused by abnormal muscle breakdown (not known).

In decreasing order of frequency, side effects may include:
Common (up to 1 in 10):
Skin reactions in subjects predisposed to allergy and asthmatic reactions, headache, dizziness,
vertigo, tingling, vision disturbances, tinnitus (sensation of noises in the ears), cough,
shortness of breath, dyspnea, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion or difficulty digesting, diarrhoea, constipation), allergic reactions (such as
skin rashes, itching), cramps, feeling tired,
Uncommon (up to 1 in 100):
Mood changes, sleep disorders, hives, purpura (red spots on the skin), clustered blisters, kidney disorders, impotence, sweating, excess of eosinophils (a type of white blood cells), changes in laboratory parameters: high level in the blood of potassium reversible
on discontinuation, low level in the blood of sodium, drowsiness, fainting, palpitations
(awareness of heartbeat), tachycardia (fast heartbeat), hypoglycaemia
(low blood sugar) in diabetic patients, vasculitis (inflammation of the
blood vessels), dry mouth, photosensitivity reactions (increased sensitivity of the
skin to the sun), arthralgia (joint pain), myalgia (muscle pain), chest pain,
malaise, peripheral oedema, fever, increased urea in the blood, increased creatinine in the
blood, falls.
Rare (up to 1 in 1000):
Worsening of psoriasis, change in laboratory parameters: increased levels
of liver enzymes, high levels of serum bilirubin, fatigue.
Very rare (up to 1 in 10,000):
Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose),
serious kidney problems, changes in blood parameters such as lowering of white blood cells and red blood cells, lower haemoglobin, lower number of blood platelets, high
levels of calcium in the blood, abnormal liver function.
Not known (frequency cannot be estimated from the available data):
Abnormal ECG tracing, changes in laboratory parameters: low levels of
potassium, high levels of uric acid and high blood sugar, blurred vision
(myopia), blurred vision, impaired vision, decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer
of the eye (choroidal effusion) or acute angle-closure glaucoma), abnormal colour
vision, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon). If you suffer from
systemic lupus erythematosus (a collagen disease), this may worsen.
Hematological, renal, hepatic or pancreatic disorders and changes in laboratory parameters (blood tests) may occur. Your doctor may prescribe you laboratory tests to
check your condition.
With the use of ACE inhibitors, highly concentrated urine (dark in colour) may occur,
feeling or state of unwellness, muscle cramps, confusion and convulsions, probably due to an
inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact
your doctor immediately.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store PRETERAX 2,5 mg/0,625 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and container. The
expiry date refers to the last day of the month.
Keep the container tightly closed to protect from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PRETERAX 2,5 mg/0,625 mg contains

• The active ingredients are perindopril arginine and indapamide. One film-coated tablet contains 2.5 mg of perindopril arginine (equivalent to 1.6975 mg of perindopril) and 0.625 mg of indapamide.
• The excipients contained in the tablet core are: lactose monohydrate, magnesium stearate (E470B), maltodextrin, anhydrous colloidal silica (E551), sodium starch glycolate (type A), and in the film coating: glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate (E470B), titanium dioxide (E171).

Description of the appearance of PRETERAX 2,5 mg/0,625 mg and package contents
PRETERAX 2,5 mg/0,625 mg tablets are film-coated tablets, white in color, with an
elongated shape, with an embossed line on both sides. One film-coated tablet contains
2.5 mg of perindopril arginine and 0.625 mg of indapamide.
The tablets are available in containers of 14, 20, 28, 30, 50, 56, 60, 90, 100 or 500 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex - France
Marketing Authorisation Holder for Italy
Servier Italia S.p.A.
Via Luca Passi, 85
00166 Rome - Italy

Manufacturers:
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy - France
and
Servier (Ireland) Industries Ltd
Gorey Road
Arklow - Co. Wicklow – Ireland
and
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
ul. Annopol 6B
03-236 Warszawa – Poland

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria PRETERAX-ARGININ
Belgium PRETERAX 2,5 mg/0,625 mg
Cyprus COVERSYL PLUS ARGININE 2,5 mg/0,625
Estonia NOLIPREL ARGININE
Finland PRETERAX NOVUM
France PRETERAX 2,5mg/0,625mg
Germany PRETERAX N 2,5 mg/ 0,625 mg Filmtabletten
Greece PRETERAX 2,5 mg/0,625 mg
Ireland COVERSYL ARGININE PLUS 2.5mg/0.625mg
Italy PRETERAX 2,5 mg/ 0,625 mg
Latvia NOLIPREL ARGININE 2.5mg/0.625mg apvalkotās tabletes
Lithuania NOLIPREL 2,5 mg/0,625 mg tabletės
Luxembourg PRETERAX 2,5 mg/0,625 mg
Poland NOLIPREL (2.5/0.625)
Portugal PRETERAX 2,5 mg/0,625 mg
Romania NOLIPREL ARG 2,5mg/0,625mg
Slovakia NOLIPREL A
Slovenia BIONOLIPREL 2.5 mg /0.625 mg filmsko obložene tablete

PRETERAX 5 mg/1,25 mg film-coated tablets

perindopril arginine/indapamide

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. 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 pass it on to others, even if their symptoms are the same as yours because it may be harmful.
• If you get any side effects, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What PRETERAX 5 mg/1,25 mg is and what it is used for
• 2. What you need to know before you take PRETERAX 5 mg/1,25 mg
• 3. How to take PRETERAX 5 mg/1,25 mg
• 4. Possible side effects
• 6. How to store PRETERAX 5 mg/1,25 mg
• 6. Contents of the pack and other information

1. What PRETERAX 5 mg/1.25 mg is and what it is used for

PRETERAX 5 mg/1.25 mg is a combination of two active ingredients, perindopril and indapamide.
It is an antihypertensive and is used in the treatment of high blood pressure (hypertension) in
adults.
Perindopril belongs to a class of drugs called ACE inhibitors. These drugs work by
dilating blood vessels, which makes it easier for the heart to pump blood through them. 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
produced. Each active ingredient reduces blood pressure and, together, they work to control
blood pressure.

2. What you need to know before taking PRETERAX 5 mg/1.25 mg

Do not take PRETERAX 5 mg/1.25 mg

• if you are allergic (hypersensitive) to perindopril or to any other ACE inhibitor, or to indapamide or to any other sulfonamide, or to any of the excipients of this medicine,
• if you have experienced symptoms such as shortness of breath, swelling of the face or tongue, intense itching or severe skin rashes related to a previous treatment with ACE inhibitors or if you or a family member has experienced such symptoms in any other circumstance (condition called angioedema),
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren,
• if you have a severe liver disease or if you suffer from a disease called hepatic encephalopathy (a degenerative brain disease),
• if you have a severe kidney disease, where the blood flow to the kidneys is reduced (renal artery stenosis),
• if you are undergoing dialysis or any type of blood filtration. Depending on the machinery used, therapy with PRETERAX 5 mg/1.25 mg may not be suitable for you,
• if you have a decrease in plasma potassium,
• if you suspect you have decompensated heart failure (severe fluid retention, difficulty breathing),
• if you are pregnant for more than three months. (It is better to avoid PRETERAX 5 mg/1.25 mg even in the early stages of pregnancy - see paragraph “Pregnancy”),
• if you are being treated with sacubitril/valsartan, a medicine used to treat heart failure (see “Warnings and precautions” and “Other medicines and PRETERAX 5mg/1.25mg”).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using PRETERAX 5 mg/1.25 mg:

• if you have aortic stenosis (narrowing of the main artery originating from the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
• if you suffer from heart failure or other heart problems,
• if you suffer from kidney problems or are on dialysis,
• if you experience decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours or weeks of taking PRETERAX 5 mg/1.25 mg. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamides, you may be at greater risk of developing it,
• if you suffer from muscle disorders including muscle pain, sensitivity, weakness or cramps,
• if you have an abnormally elevated level of a hormone called aldosterone in the 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 suffer from atherosclerosis (hardening of the arteries),
• if you suffer from hyperparathyroidism (overactivity of the parathyroid glands),
• if you suffer from gout,
• if you have diabetes,
• if you are following a diet that limits salt intake or use potassium-containing salt substitutes,
• if you are taking lithium or potassium-sparing medicines (spironolactone, triamterene) or potassium supplements, as their use with PRETERAX 5 mg/1.25 mg should be avoided (see “Taking PRETERAX 5 mg/1.25 mg with other medicines”),
• 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 can cause difficulty swallowing or breathing (angioedema). This can occur at any time during treatment. If such symptoms develop, stop treatment and call your doctor immediately,
• if you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes.
• aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood at regular intervals. See also “Do not take PRETERAX 5 mg/1.25 mg”. 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 a patient on hemodialysis dialyzed with high-flux membranes, if you are taking any of the following medicines, increases the risk of angioedema:

racecadotril (used for the treatment of diarrhea),
sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called
mTOR inhibitors (used in the prevention of rejection following organ transplantation),
sacubitril (available as a fixed-dose combination with valsartan), used in the treatment
of long-term heart failure.
Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat
with difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including
PRETERAX 5 mg/1.25 mg. This can occur at any time during treatment. If you
develop such symptoms, stop treatment with PRETERAX 5 mg/1.25 mg and call
your doctor immediately. See also paragraph 4.
You should inform your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). PRETERAX 5 mg/1.25 mg is not recommended in early pregnancy, and
should not be taken if you are pregnant for more than three months, as it can cause serious
harm to the baby if taken during this period (see “Pregnancy and breastfeeding”).
If you are taking PRETERAX 5 mg/1.25 mg, inform your doctor or medical staff:

• if you are going to have anesthesia and/or surgery,
• if you have recently had diarrhea or vomiting, or if you are dehydrated,
• if you are going to undergo dialysis or LDL apheresis (blood purification from cholesterol by means of a machine),
• if you are going to have a desensitization treatment to reduce the effects of an allergy to bee or wasp stings,
• if you are going to undergo a medical examination that requires the injection of an iodinated contrast agent (a substance that makes organs such as kidneys or stomach visible on X-rays),
• if you have had vision changes or pain in one or both eyes while taking PRETERAX 5 mg/1.25 mg. This could be a sign that glaucoma is developing, increased pressure in an eye(s). Stop treatment with PRETERAX 5 mg/1.25 mg and consult a doctor.

Athletes should be aware that PRETERAX 5 mg/1.25 mg contains an active ingredient
(indapamide) that can induce a positive result in doping tests.

Children and adolescents
PRETERAX 5 mg/1.25 mg should not be given to children and adolescents.

Other medicines and PRETERAX 5 mg/1.25 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
You must not take PRETERAX 5 mg/1.25 mg with:

• lithium (used for the treatment of manic disorder and depression),
• aliskiren (medicine used to treat hypertension) if you do not have diabetes or kidney problems,
• potassium-sparing diuretics (such as triamterene, amiloride), potassium salts, other drugs that can increase potassium levels in the blood (such as heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole),
• estramustine (used in cancer therapy),
• other medicines used to treat high blood pressure: angiotensin-converting enzyme inhibitors and angiotensin receptor blockers.

Treatment with PRETERAX 5 mg/1.25 mg may be affected by other medicines. Your doctor
may need to adjust the dose and/or take other precautions. Make sure to tell your
doctor if you are taking any of these drugs, as special attention may be needed:

• other drugs for the treatment of high blood pressure, including an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also “Do not take”

PRETERAX 5 mg/1,25 mg" and "Warnings and precautions") or diuretics (medicines that increase

the amount of urine produced by the kidneys),

• potassium-sparing diuretics used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• medicines used mainly for the treatment of diarrhoea (racecadotril) or for the prevention of rejection following organ transplantation (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See paragraph “Warnings and precautions”,
• Sacubitril/valsartan (used for the long-term treatment of heart failure). See what is reported under "Do not take PRETERAX 5mg/1,25mg” and “Warnings and precautions”,
• anaesthetics,
• iodinated contrast agents,
• antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, injectable erythromycin,
• methadone (used for the treatment of dependencies),
• procainamide (for the treatment of irregular heartbeat),
• allopurinol (for the treatment of gout),
• antihistamines used to treat allergic reactions, such as hay fever (e.g. mizolastine, terfenadine, astemizole,
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
• immunosuppressants used for the treatment of autoimmune diseases or following transplants to prevent rejection (e.g. cyclosporine, tacrolimus),
• alofantrine (used to treat certain types of malaria),
• pentamidine (used to treat pneumonia),
• gold for injectable use (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 used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium),
• cisapride, difemanil (used to treat stomach and digestive problems)
• digoxin or other cardiac glycosides (for the treatment of heart problems),
• baclofen (for the treatment of 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 salicylates at high doses (e.g. aspirin),
• injectable amphotericin B (for the treatment of severe 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 the treatment of Crohn's disease),
• trimethoprim (for the treatment of infections),
• vasodilators including nitrates (products that make blood vessels wider),
• medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, norepinephrine or adrenaline).

PRETERAX 5 mg/1,25 mg with food and drink
It is preferable to take PRETERAX 5 mg/1,25 mg before a meal.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
You should inform your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Usually your doctor will advise you to stop taking PRETERAX 5
mg/1,25 mg before starting pregnancy or as soon as you become aware of being pregnant and will advise you to take another medicine instead of PRETERAX 5 mg/1,25 mg.
PRETERAX 5 mg/1,25 mg is not recommended in early pregnancy, and should not be taken if
you are pregnant for more than three months, as it can cause serious harm to the baby if
taken after the third month of pregnancy.

Breastfeeding
PRETERAX 5 mg/1,25 mg is not recommended if you are breastfeeding.
Immediately inform your doctor if you are breastfeeding or are about to start breastfeeding.
Immediately warn your doctor.

Driving and operating machinery
PRETERAX 5 mg/1,25 mg normally does not affect alertness but in some patients may
occur different reactions such as dizziness or fatigue in relation to the reduction of blood
pressure. If you experience such symptoms, your ability to drive vehicles or operate machinery may
be reduced.
PRETERAX 5 mg/1,25 mg contains lactose monohydrate:
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.
PRETERAX 5 mg/1,25 mg contains sodium:
PRETERAX 5 mg/1,25 mg contains less than 1 mmol of sodium (23 mg) per tablet, therefore it is
essentially "sodium-free".

3. How to take PRETERAX 5 mg/1,25 mg

Always take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts
ask your doctor or pharmacist.
The recommended dose is one tablet a day. Your doctor may decide to modify the
dosage if you suffer from renal insufficiency. Take the tablet preferably in the morning and before
a meal. The tablet should be swallowed with a glass of water.

If you take more PRETERAX 5 mg/1,25 mg than you should
If you have taken an excessive amount of tablets, consult your doctor immediately or go
immediately to the nearest emergency room. The most likely effect in case of overdose is a
lowering of blood pressure. If a marked drop in blood pressure occurs (associated with
nausea, vomiting, cramps, dizziness, drowsiness, mental confusion, changes in the amount of urine
produced by the kidneys), it may be helpful to lie down with your legs raised.

If you forget to take PRETERAX 5 mg/1,25 mg
It is important to take the medicine every day as regular treatment is more effective. If
however you forget to take a dose of PRETERAX 5 mg/1,25 mg, take the next dose
at the usual time. Do not take a double dose to make up for forgetting the previous dose.

If you stop taking PRETERAX 5 mg/1,25 mg
Since the treatment of hypertension is usually lifelong, you should talk to your doctor before
stopping taking this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, PRETERAX 5 mg/1.25 mg can cause side effects, including serious ones,
although not everyone gets them.

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

• Severe dizziness or fainting due to low blood pressure (common) (up to 1 in 10),
• Bronchospasm (chest tightness, wheezing and shortness of breath) (Uncommon) (up to 1 in 100),
• Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (see section 2 “Warnings and precautions”) (Uncommon) (up to 1 in 100),
• Severe skin reactions including intense rash, hives, widespread skin redness, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome) or other allergic reactions (very rare) (up to 1 in 10,000),
• Cardiovascular disorders (irregular heartbeat, angina pectoris (chest, jaw and back pain, caused by physical exertion)) (very rare) (up to 1 in 10,000),
• Weakness of arms or legs, or speech problems which could be a sign of a possible stroke (very rare) (up to 1 in 10,000),
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of unwellness (very rare) (up to 1 in 10,000),
• Jaundice of skin or eyes (jaundice) which may be a sign of hepatitis (very rare) (up to 1 in 10,000),
• Life-threatening irregular heartbeat (not known),
• Brain disease caused by liver disease (hepatic encephalopathy) (not known),
• Muscle weakness, cramps, tenderness or pain and in particular, if at the same time, you do not feel well or have a high fever, this may be caused by abnormal muscle breakdown

In decreasing order of frequency, side effects may include:
Common (up to 1 in 10):
Skin reactions in people predisposed to allergy and asthma, headache, dizziness,
vertigo, tingling, vision disorders, tinnitus (sensation of noises in the ears), cough,
shortness of breath, dyspnea, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion or difficulty digesting food, diarrhea, constipation), allergic reactions (such as skin rashes, itching), cramps, feeling tired,
Uncommon (up to 1 in 100):
Mood changes, sleep disorders, hives, purpura (red spots on the skin), clustered blisters, kidney disorders, impotence, sweating, excess eosinophils (a type of white blood cells),
alteration of laboratory parameters: high level in the blood of potassium reversible upon discontinuation, low level in the blood of sodium, drowsiness, fainting, palpitations
(awareness of heartbeat), tachycardia (fast heartbeat), hypoglycemia
(low blood sugar) in diabetic patients, vasculitis (inflammation of the
blood vessels), dry mouth, photosensitivity reactions (increased sensitivity of the skin
to the sun), arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise,
peripheral edema, fever, increased urea in the blood, increased creatinine in the blood,
fall.
Rare (up to 1 in 1000):
Worsening of psoriasis, change in laboratory parameters: increased levels of
liver enzymes, high levels of serum bilirubin, fatigue.
Very rare (up to 1 in 10,000):
Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose),
serious kidney problems, changes in blood parameters such as lowering of the number of
white and red blood cells, lower hemoglobin, lower number of blood platelets, high levels
of calcium in the blood, abnormal liver function.
Not known (frequency cannot be estimated from available data):
Abnormal ECG tracing, change in laboratory parameters: low levels of potassium,
high levels of uric acid and high blood sugar, blurred vision (myopia),
impaired vision, decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye
(choroidal effusion) or acute angle-closure glaucoma), abnormal color vision, numbness and
pain in the fingers of the hands or feet (Raynaud's phenomenon). If you suffer from systemic lupus erythematosus (a connective tissue disease), this may worsen.
Hematological, renal, hepatic or pancreatic disorders and changes in laboratory parameters (blood tests) may occur. Your doctor may prescribe laboratory tests to
check your condition.
With the use of ACE inhibitors, very concentrated urine (dark in color) may occur,
feeling or state of unwellness, muscle cramps, confusion and convulsions, probably due to
inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, consult
your doctor immediately.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store PRETERAX 5 mg/1,25 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and the container. The
expiry date refers to the last day of the month.
Keep the container tightly closed to protect from moisture.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PRETERAX 5 mg/1.25 mg contains
The active ingredients are perindopril arginine and indapamide. One film-coated tablet contains 5
mg of perindopril arginine (equivalent to 3.395 mg of perindopril) 1.25 mg of indapamide.

• The excipients contained in the tablet core are: lactose monohydrate, magnesium stearate (E470B), maltodextrin, anhydrous colloidal silica (E551), sodium starch glycolate (type A), and in the film coating: glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate (E470B), titanium dioxide (E171).

Description of the appearance of PRETERAX 5 mg/1.25 mg and package contents
PRETERAX 5 mg/1.25 mg tablets are film-coated tablets of white
color, elongated in shape. One film-coated tablet contains 5 mg of perindopril arginine and 1.25 mg of
indapamide.
The tablets are available in containers of 14, 20, 28, 30, 50, 56, 60, 90, 100 or 500 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex (France)
Sales representative for Italy
SERVIER ITALIA S.p.A.
Via Luca Passi, 85
00166 Rome

Manufacturers:
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy - France
and
Servier (Ireland) Industries Ltd
Gorey Road
Arklow - Co. Wicklow – Ireland
and
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
ul. Annopol 6B
03-236 Warszawa – Poland

This medicinal product is authorised in the Member States of the European Economic Area under
the following denominations:
Austria BI_PRETERAX-ARGININ
Belgium Preterax 5 mg/1.25 mg
Cyprus Preterax 5mg/1.25mg
Denmark COVERSYL COMP NOVUM
Estonia NOLIPREL FORTE ARGININE
Finland COVERSYL COMP NOVUM
France BIPRETERAX 5 mg/1.25 mg
Germany BI PRETERAX N 5 mg / 1.25 mg filmtabletten
Greece PRETERAX 5 mg/1.25 mg
Ireland COVERSYL ARGININE PLUS 5mg/1.25mg Film-coated
tablets
Italy PRETERAX 5 mg/1.25 mg
Latvia NOLIPREL FORTE ARGININE
Lithuania Noliprel forte 5 mg/1.25 mg tabletės
Luxembourg Preterax 5 mg/1.25 mg
Netherlands Coversyl Plus arg 5mg/1.25mg
Poland TERTENSIF KOMBI (5/1.25)
Portugal PRETERAX 5 mg/1.25 mg
Romania NOLIPREL ARG FORTE 5 mg/ 1.25 mg
Slovakia NOLIPREL FORTE A
Slovenia BIONOLIPREL 5mg/1.25 mg filmsko obložene tablete
United Kingdom
(Northern Ireland)
Coversyl Arginine Plus 5 mg/1.25 mg