Prelectal: detailed information

Package leaflet: Information for the patient

PRELECTAL 2.5 mg/0.625 mg film-coated tablets

perindopril arginine/indapamide
Please read all of 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. Never give it to other people, even if they have the same condition as yours, as it may be harmful.
If you experience any side effect, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What PRELECTAL 2.5 mg/0.625 mg is and what it is used for
What you need to know before taking PRELECTAL 2.5 mg/0.625 mg
How to take PRELECTAL 2.5 mg/0.625 mg
Possible side effects
How to store PRELECTAL 2.5 mg/0.625 mg
Contents of the pack and other information

1. What PRELECTAL 2.5 mg/0.625 mg is and what it is used for

PRELECTAL 2.5 mg/0.625 mg is a combination of two active substances, perindopril and indapamide.
It is an antihypertensive agent used for the treatment of high blood pressure (hypertension) in adults.
Perindopril belongs to a class of medicines called ACE inhibitors. These medicines work by dilating blood vessels, making 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 substance helps reduce blood pressure, and together they act to control blood pressure.

2. What you should know before taking PRELECTAL 2.5 mg/0.625 mg

Do not take PRELECTAL 2.5 mg/0.625 mg

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

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

if you have aortic stenosis (narrowing of the main artery leaving the heart) or hypertrophic cardiomyopathy (a 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 have kidney problems or are on dialysis,
if you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure inside the eye, which may occur within hours or weeks of taking PRELECTAL 2.5 mg/0.625 mg. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk,
if you suffer from muscle disorders including muscle pain, tenderness, weakness, or cramps,
if you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism),
if you have liver problems,
if you have a connective tissue 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 on a low-salt diet or use salt substitutes containing potassium,
if you are taking lithium or potassium-sparing medicines (spironolactone, triamterene) or potassium supplements, as their use with PRELECTAL 2.5 mg/0.625 mg should be avoided (see “Taking PRELECTAL 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 may cause difficulty swallowing or breathing (angioedema). This may occur at any time during treatment. If such symptoms develop, stop treatment and contact 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), particularly if you have kidney problems related to diabetes,
aliskiren. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals. See also section "Do not take PRELECTAL 2.5 mg/0.625 mg".
if you are of Black African origin, as you may have a higher risk of angioedema and this medicine may be less effective in lowering your blood pressure compared to non-Black patients,
if you are a patient undergoing hemodialysis with high-flux dialysis membranes,
if you are taking any of the following medicines, which increase 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 to prevent organ transplant rejection),
sacubitril (available as a fixed-dose combination with valsartan), used for long-term treatment of heart failure.

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, causing difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including PRELECTAL 2.5 mg/0.625 mg. This may occur at any time during treatment. If such symptoms develop, stop treatment with PRELECTAL 2.5 mg/0.625 mg and contact a doctor immediately. See also section 4.

You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). PRELECTAL 2.5 mg/0.625 mg is not recommended during early pregnancy and must not be taken after the first three months of pregnancy, as it may cause serious harm to the unborn baby if taken during this period (see “Pregnancy and breastfeeding”).

If you are taking PRELECTAL 2.5 mg/0.625 mg, inform your doctor or medical staff:

if you are due to undergo anaesthesia and/or surgery,
if you have recently had diarrhoea or vomiting, or if you are dehydrated,
if you are due to undergo dialysis or LDL apheresis (blood purification to remove cholesterol using a machine),
if you are due to undergo desensitisation treatment to reduce the effects of allergy to bee or wasp stings,
if you are due to undergo a medical examination requiring injection of an iodinated contrast agent (a substance that makes organs such as kidneys or stomach visible on X-rays),
if you experience changes in vision or pain in one or both eyes while taking PRELECTAL 2.5 mg/0.625 mg. This could be a sign of developing glaucoma, increased pressure in the eye(s). Stop treatment with PRELECTAL 2.5 mg/0.625 mg and consult a doctor.

Athletes should be aware that PRELECTAL 2.5 mg/0.625 mg contains an active substance (indapamide) that may cause a positive result in anti-doping tests.

Children and adolescents
PRELECTAL 2.5 mg/0.625 mg must not be given to children and adolescents.

Other medicines and PRELECTAL 2.5 mg/0.625 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You must not take PRELECTAL 2.5 mg/0.625 mg with:

lithium (used to treat manic disorder and depression),
aliskiren (a medicine used to treat hypertension) if you do not have diabetes or kidney problems,
potassium-sparing diuretics (such as triamterene, amiloride), potassium salts, or other medicines that may 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 (ACE) inhibitors and angiotensin receptor blockers.

Treatment with PRELECTAL 2.5 mg/0.625 mg may be affected by other medicines. Your doctor may need to adjust the dose and/or take other precautions. Make sure to inform your doctor if you are taking any of the following medicines, as special care may be required:

other medicines for treating high blood pressure, including an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also “Do not take PRELECTAL 2.5 mg/0.625 mg” and “Warnings and precautions”) or diuretics (medicines that increase urine production 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 to treat diarrhoea (racecadotril) or to prevent transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”,
sacubitril/valsartan (used for long-term treatment of heart failure). See information under “Do not take PRELECTAL 2.5 mg/0.625 mg” and “Warnings and precautions”,
anaesthetics,
iodinated contrast agents,
antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, injectable erythromycin),
methadone (used to treat addiction),
procainamide (for treating irregular heartbeat),
allopurinol (for treating 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 to prevent transplant rejection (e.g. cyclosporine, tacrolimus),
halofantrine (used to treat certain types of malaria),
pentamidine (used to treat pneumonia),
injectable gold (used to treat rheumatoid arthritis),
vincamine (used to treat symptomatic cognitive disorders in the elderly, including memory loss),
bepridil (used to treat angina pectoris),
medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium),
cisapride, difemanil (used to treat gastrointestinal and digestive problems),
digoxin or other cardiac glycosides (for treating heart problems),
baclofen (to treat muscle stiffness in conditions such as multiple sclerosis),
medicines for treating diabetes such as insulin, metformin or gliptins,
calcium, including calcium supplements,
stimulant laxatives (e.g. senna),
non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high-dose salicylates (e.g. aspirin),
injectable amphotericin B (for treating serious fungal infections),
medicines used to treat mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol),
tetracosactide (for treating Crohn's disease),
trimethoprim (for treating infections),
vasodilators including nitrates (substances that widen blood vessels),
medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline or adrenaline).

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult 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). Your doctor will usually advise you to stop taking PRELECTAL 2.5 mg/0.625 mg before starting pregnancy or as soon as you become aware of being pregnant, and will recommend an alternative medicine.
PRELECTAL 2.5 mg/0.625 mg is not recommended during early pregnancy and must not be taken after the first three months of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the third month of pregnancy.

Breastfeeding
PRELECTAL 2.5 mg/0.625 mg is not recommended during breastfeeding.
Inform your doctor immediately if you are breastfeeding or about to start breastfeeding.
Contact your doctor immediately.

Driving and using machines
PRELECTAL 2.5 mg/0.625 mg normally does not affect alertness, but in some patients, side effects such as dizziness or fatigue may occur due to blood pressure lowering. If you experience such symptoms, your ability to drive or operate machinery may be impaired.

PRELECTAL 2.5 mg/0.625 mg contains lactose monohydrate:
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

PRELECTAL 2.5 mg/0.625 mg contains sodium:
PRELECTAL 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 PRELECTAL 2.5 mg/0.625 mg

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet daily. Your doctor may decide to increase the dose to two tablets daily or adjust the dosage regimen if you have renal impairment. Take the tablet preferably in the morning and before a meal. Swallow the tablet with a glass of water.
The score line is not intended for dividing the tablet.

If you take more PRELECTAL 2.5 mg/0.625 mg than you should
If you have taken an excessive amount of tablets, contact your doctor immediately or go immediately to the nearest emergency department. 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, confusion, 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 PRELECTAL 2.5 mg/0.625 mg
It is important to take the medicine every day, as regular treatment is more effective. However, if you forget to take a dose of PRELECTAL 2.5 mg/0.625 mg, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking PRELECTAL 2.5 mg/0.625 mg
Since treatment for hypertension is usually lifelong, you must speak with your doctor before stopping this medicine.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, PRELECTAL 2.5 mg/0.625 mg can cause side effects, some of which may be serious,
although not everyone experiences them.
Stop taking this medicine immediately and contact your doctor straight away if you experience
any of the following symptoms, which may be serious:

Severe dizziness or fainting due to low blood pressure (common) (up to 1 in 10),
Bronchospasm (chest tightness, wheezing, 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, urticaria, widespread skin redness, severe itching, blisters, peeling and swelling of the skin, inflammation of 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 in arms or legs, or speech problems which could be signs of a possible stroke (very rare) (up to 1 in 10,000),
Inflammation of the pancreas which may cause severe abdominal pain and backache accompanied by malaise (very rare) (up to 1 in 10,000),
Yellowing of the skin or eyes (jaundice), which may be a sign of hepatitis (very rare) (up to 1 in 10,000),
Life-threatening irregular heartbeat (frequency not known),
Brain disorder caused by liver disease (hepatic encephalopathy) (frequency not known),
Muscle weakness, cramps, tenderness or pain, particularly if you also feel unwell or have a high fever, which may be due to abnormal muscle breakdown (frequency not known).

In descending order of frequency, the side effects may include:

Common (up to 1 in 10):
Skin reactions in individuals predisposed to allergy and asthmatic reactions, headache, dizziness,
vertigo, tingling, visual disturbances, tinnitus (ringing in the ears), cough,
shortness of breath (dyspnea), gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or indigestion, diarrhea, constipation), allergic reactions (such as
skin rashes, itching), cramps, feeling of fatigue.

Uncommon (up to 1 in 100):
Mood changes, sleep disorders, urticaria, purpura (small red spots on the skin), blistering rash,
kidney disorders, impotence, sweating, elevated eosinophils (a type of white blood cell), changes in laboratory parameters: increased blood potassium levels (reversible upon discontinuation), low blood sodium levels, drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (rapid heartbeat), hypoglycaemia (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, malaise, peripheral oedema, fever, increased blood urea, increased blood creatinine, falls.

Rare (up to 1 in 1,000):
Worsening of psoriasis, changes in laboratory parameters: increased liver enzymes, elevated serum bilirubin levels, fatigue.

Very rare (up to 1 in 10,000):
Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose), severe kidney problems, changes in blood parameters such as reduced white and red blood cell counts, lower haemoglobin, reduced platelet count, elevated blood calcium levels, abnormal liver function.

Frequency not known (cannot be estimated from available data):
Abnormal ECG pattern, changes in laboratory parameters: low potassium levels, elevated uric acid levels, and high blood sugar levels, decreased vision (myopia), blurred vision, visual impairment, reduced 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 skin colour, numbness and pain in fingers or toes (Raynaud’s phenomenon). If you have systemic lupus erythematosus (a collagen disease), this may worsen.

Haematological, renal, hepatic or pancreatic disorders and changes in laboratory parameters (blood tests) may occur. Your doctor may prescribe laboratory tests to monitor your condition.

With the use of ACE inhibitors, very concentrated (dark-coloured) urine, feeling unwell, muscle cramps, confusion and seizures may occur, probably due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly via 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 PRELECTAL 2.5 mg/0.625 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and container. The expiry date refers to the last day of the month.
Store the container tightly closed to protect from moisture.
Do not dispose of any medicine via 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 PRELECTAL 2.5 mg/0.625 mg contains

The active substances 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: monohydrate lactose, magnesium stearate (E470B), maltodextrin, anhydrous colloidal silica (E551), sodium starch glycolate (type A). The film coating contains: glycerol (E422), hypromellose (E464), macrogol 6000, magnesium stearate (E470B), titanium dioxide (E171).

Description of the appearance of PRELECTAL 2.5 mg/0.625 mg and package contents
PRELECTAL 2.5 mg/0.625 mg tablets are white, film-coated, elongated tablets with a raised line on both sides. Each film-coated tablet contains 2.5 mg of perindopril arginine and 0.625 mg of indapamide.
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 Authorization Holder and Manufacturer

Marketing Authorization Holder:
I.F.B Stroder S.r.l
Via Luca Passi, 85
00166 Roma - Italy

Manufacturers:
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy - France
and
EGIS Pharmaceuticals Private Limited Company
Mátyás király u. 65– 9900 Körmend – Hungary
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 authorized in the European Economic Area Member States under the following names:
Belgium COVERSYL PLUS 2.5 mg/0.625 mg
France PRETERVAL 2.5 mg/0.625 mg, comprimé pelliculé
Hungary Coverex-AS Prekomb
Italy PRELECTAL 2.5 mg/0.625 mg
Luxembourg COVERSYL PLUS 2.5 mg/0.625 mg

Patient information leaflet

PRELECTAL 5 mg/1.25 mg film-coated tablets

perindopril arginine/indapamide
Please read all of this leaflet carefully before 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. Never give it to other people, even if they have the same symptoms as yours, as it may be harmful to them.
If you experience any side effect, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What PRELECTAL 5 mg/1.25 mg is and what it is used for
What you need to know before taking PRELECTAL 5 mg/1.25 mg
How to take PRELECTAL 5 mg/1.25 mg
Possible side effects
How to store PRELECTAL 5 mg/1.25 mg
Contents of the pack and other information

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

PRELECTAL 5 mg/1.25 mg is a combination of two active substances, perindopril and indapamide.
It is an antihypertensive medicine used to treat high blood pressure (hypertension) in adults.
Perindopril belongs to a class of medicines called ACE inhibitors. These medicines work by relaxing blood vessels, making 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 substance helps reduce blood pressure, and together they work to control blood pressure.

4. What you need to know before taking PRELECTAL 5 mg/1.25 mg

Do not take PRELECTAL 5 mg/1.25 mg

if you are allergic (hypersensitive) to perindopril or any other ACE inhibitor, or to indapamide or 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 previous treatment with ACE inhibitors, or if you or a family member has experienced such symptoms under any other circumstances (a condition called angioedema),
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren,
if you have severe liver disease or suffer from a condition called hepatic encephalopathy (a degenerative brain disorder),
if you have severe kidney disease with reduced blood flow to the kidneys (renal artery stenosis),
if you are undergoing dialysis or any type of blood filtration. Depending on the equipment used, treatment with PRELECTAL 5 mg/1.25 mg may not be suitable for you,
if you have low plasma potassium levels,
if you suspect you have untreated decompensated heart failure (severe fluid retention, difficulty breathing),
if you are more than three months pregnant. (It is best to avoid PRELECTAL 5 mg/1.25 mg even in the early stages of pregnancy – see section “Pregnancy”),
if you are being treated with sacubitril/valsartan, a medicine used to treat heart failure (see information under “Warnings and precautions” and “Other medicines and PRELECTAL 5 mg/1.25 mg”).

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

if you have aortic stenosis (narrowing of the main artery leaving the heart), hypertrophic cardiomyopathy (a 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 have kidney problems or are on dialysis,
if you experience vision changes or eye pain. These could be signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours or weeks of taking PRELECTAL 5 mg/1.25 mg. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk,
if you suffer from muscle disorders including muscle pain, tenderness, weakness, or cramps,
if you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism),
if you have liver problems,
if you have a collagen disease (skin disorder) such as systemic lupus erythematosus or scleroderma,
if you suffer from atherosclerosis (hardening of the arteries),
if you have hyperparathyroidism (overactivity of the parathyroid glands),
if you suffer from gout,
if you have diabetes,
if you are on a salt-restricted diet or use salt substitutes containing potassium,
if you are taking lithium or potassium-sparing medicines (spironolactone, triamterene) or potassium supplements, as their use with PRELECTAL 5 mg/1.25 mg should be avoided (see “Taking PRELECTAL 5 mg/1.25 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 may cause difficulty swallowing or breathing (angioedema). This may occur at any time during treatment. If such symptoms develop, stop treatment and contact a doctor immediately,
if you are taking any of the following medicines for high blood pressure:
an "angiotensin II receptor antagonist" (AIIRA), also known as sartans (e.g., valsartan, telmisartan, irbesartan), especially 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 section "Do not take PRELECTAL 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 undergoing hemodialysis with high-flux membranes,
if you are taking any of the following medicines, which increase the risk of angioedema:

racecadotril (used to treat diarrhoea),
sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of so-called
mTOR inhibitors (used to prevent organ transplant rejection),
sacubitril (available as a fixed-dose combination with valsartan), used for long-term treatment
of heart failure.

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, causing difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including PRELECTAL 5 mg/1.25 mg. This may occur at any time during treatment. If such symptoms develop, stop treatment with PRELECTAL 5 mg/1.25 mg and contact a doctor immediately. See also section 4.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). PRELECTAL 5 mg/1.25 mg is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see “Pregnancy and breastfeeding”).

If you are taking PRELECTAL 5 mg/1.25 mg, inform your general practitioner or medical staff:

if you are scheduled for anaesthesia and/or surgery,
if you have recently had diarrhoea or vomiting, or if you are dehydrated,
if you are scheduled for dialysis or LDL apheresis (blood purification to remove cholesterol using a machine),
if you are undergoing desensitisation treatment to reduce the effects of allergy to bee or wasp stings,
if you are scheduled for a medical examination requiring injection of an iodinated contrast agent (a substance that makes organs such as kidneys or stomach visible on X-rays),
if you experience vision changes or pain in one or both eyes while taking PRELECTAL 5 mg/1.25 mg. This could be a sign of developing glaucoma, increased pressure in one or both eyes. Stop treatment with PRELECTAL 5 mg/1.25 mg and consult a doctor.

Athletes
Athletes should be aware that PRELECTAL 5 mg/1.25 mg contains an active substance (indapamide) that may lead to a positive result in doping tests.

Children and adolescents
PRELECTAL 5 mg/1.25 mg must not be administered to children and adolescents.

Other medicines and PRELECTAL 5 mg/1.25 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You must not take PRELECTAL 5 mg/1.25 mg with:

lithium (used to treat manic disorder and depression),
aliskiren (a medicine used to treat hypertension) if you do not have diabetes or kidney problems,
potassium-sparing diuretics (such as triamterene, amiloride), potassium salts, or other medicines that may 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 (ACE) inhibitors and angiotensin receptor blockers.

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

other medicines for treating high blood pressure, including an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take PRELECTAL 5 mg/1.25 mg” and “Warnings and precautions”), or diuretics (medicines that increase urine production by the kidneys),
potassium-sparing diuretics used in heart failure treatment: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily,
medicines primarily used to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”,
sacubitril/valsartan (used for long-term treatment of heart failure). See section “Do not take PRELECTAL 5 mg/1.25 mg” and “Warnings and precautions”,
anaesthetics,
iodinated contrast agents,
antibiotics used to treat bacterial infections (e.g., moxifloxacin, sparfloxacin, injectable erythromycin),
methadone (used to treat addiction),
procainamide (for treating irregular heartbeat),
allopurinol (for treating 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 to prevent transplant rejection (e.g., cyclosporine, tacrolimus),
halofantrine (used to treat certain types of malaria),
pentamidine (used to treat pneumonia),
injectable gold (used to treat rheumatoid arthritis),
vincamine (used to treat symptomatic cognitive disorders in the elderly, including memory loss),
bepridil (used to treat angina pectoris),
medicines used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium),
cisapride, difemanil (used to treat gastrointestinal and digestive problems),
digoxin or other cardiac glycosides (for treating heart problems),
baclofen (to treat muscle stiffness in conditions such as multiple sclerosis),
medicines used 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 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 (substances that widen blood vessels),
medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline).

PRELECTAL 5 mg/1.25 mg with food and drink
It is preferable to take PRELECTAL 5 mg/1.25 mg before a meal.

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

Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking PRELECTAL 5 mg/1.25 mg before starting pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine.
PRELECTAL 5 mg/1.25 mg is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.

Breast-feeding
You must not take PRELECTAL 5 mg/1.25 mg if you are breast-feeding.
Inform your doctor immediately if you are breast-feeding or planning to start breast-feeding.
Contact your doctor immediately.

Driving and using machines
PRELECTAL 5 mg/1.25 mg normally does not affect alertness, but in some patients, different reactions such as dizziness or fatigue may occur due to blood pressure reduction. If you experience such symptoms, your ability to drive or operate machinery may be impaired.

PRELECTAL 5 mg/1.25 mg contains lactose monohydrate:
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

PRELECTAL 5 mg/1.25 mg contains sodium:
PRELECTAL 5 mg/1.25 mg contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

5. How to take PRELECTAL 5 mg/1.25 mg

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet per day. Your doctor may decide to adjust the
dosage if you have renal impairment. Take the tablet preferably in the morning and before
a meal. Swallow the tablet with a glass of water.
If you take more PRELECTAL 5 mg/1.25 mg than you should
If you have taken an excessive amount of tablets, contact your doctor immediately or go
immediately to the nearest emergency department. 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, confusion, changes in the amount of urine
produced by the kidneys), it may help to lie down with your legs elevated.
If you forget to take PRELECTAL 5 mg/1.25 mg
It is important to take the medicine every day, as regular treatment is more effective. If
you forget to take a dose of PRELECTAL 5 mg/1.25 mg, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
If you stop taking PRELECTAL 5 mg/1.25 mg
Since treatment for hypertension is usually lifelong, you must speak with your doctor before
stopping this medicine.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, PRELECTAL 5 mg/1.25 mg may cause side effects, some of which can be serious,
although not everyone experiences them.
Stop taking the medicine immediately and contact your doctor straight away if you experience
any of the following side effects, which may be serious:

Severe dizziness or fainting due to low blood pressure (common) (up to 1 in 10 people),
Bronchospasm (chest tightness, wheezing, and shortness of breath) (uncommon) (up to 1 in 100 people),
Swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema) (see section 2 “Warnings and precautions”) (uncommon) (up to 1 in 100 people),
Severe skin reactions including severe rash, urticaria, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome), or other allergic reactions (very rare) (up to 1 in 10,000 people),
Cardiovascular disorders (irregular heartbeat, angina pectoris (chest, jaw, and back pain caused by physical exertion)) (very rare) (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) (up to 1 in 10,000 people),
Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by malaise (very rare) (up to 1 in 10,000 people),
Yellowing of the skin or eyes (jaundice), which may be a sign of hepatitis (very rare) (up to 1 in 10,000 people),
Life-threatening irregular heartbeat (frequency not known),
Brain disease caused by liver disease (hepatic encephalopathy) (frequency not known),
Muscle weakness, cramps, tenderness or pain, particularly if at the same time you feel unwell or have a high fever, which may be due to abnormal muscle breakdown (frequency not known).

In decreasing order of frequency, side effects may include:
Common (up to 1 in 10 people):
Skin reactions in people predisposed to allergies and asthmatic reactions, headache, dizziness,
vertigo, tingling, visual disturbances, tinnitus (sensation of ringing in the ears), cough,
shortness of breath, dyspnea, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or indigestion, diarrhea, constipation), allergic reactions (such as rashes, itching), cramps, feeling of fatigue.
Uncommon (up to 1 in 100 people):
Mood changes, sleep disorders, urticaria, purpura (red spots on the skin), blistering in clusters, kidney disorders, impotence, sweating, eosinophilia (an increased number of eosinophils, a type of white blood cell), changes in laboratory parameters: high blood potassium levels (reversible upon discontinuation), low blood sodium levels, drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (rapid heartbeat), hypoglycaemia (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, malaise, peripheral edema, fever, increased blood urea, increased blood creatinine, falls.
Rare (up to 1 in 1,000 people):
Worsening of psoriasis, changes in laboratory parameters: increased liver enzymes, elevated serum bilirubin levels, fatigue.
Very rare (up to 1 in 10,000 people):
Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked or runny nose), severe kidney problems, changes in blood parameters such as decreased numbers of white and red blood cells, lower hemoglobin, lower platelet count, elevated blood calcium levels, abnormal liver function.
Not known (frequency cannot be estimated from available data):

Abnormal ECG trace, changes in laboratory parameters: low potassium levels, high uric acid levels, high blood sugar levels, reduced vision (myopia), blurred vision, visual impairment, 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 skin colour, numbness and pain in fingers or toes (Raynaud's phenomenon). If you suffer from systemic lupus erythematosus (a collagen disease), this may worsen.

Haematological, renal, hepatic or pancreatic disorders and changes in laboratory parameters (blood tests) may occur. Your doctor may prescribe laboratory tests to monitor your condition.
When using ACE inhibitors, very concentrated (dark-coloured) urine, sensation or state of malaise, muscle cramps, confusion and seizures may occur, probably due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor immediately.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor, pharmacist or nurse. You can also report side effects directly via 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 PRELECTAL 5 mg/1.25 mg

6. Package contents and other information

What PRELECTAL 5 mg/1.25 mg contains

The active substances are perindopril arginine and indapamide. One film-coated tablet contains 5 mg of perindopril arginine (equivalent to 3.395 mg of perindopril) and 1.25 mg of indapamide.
The excipients contained in the tablet core are: monohydrate lactose, 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 PRELECTAL 5 mg/1.25 mg and package contents

PRELECTAL 5 mg/1.25 mg tablets are white, film-coated, elongated tablets. Each film-coated tablet contains 5 mg of perindopril arginine and 1.25 mg of indapamide.

Tablets are available in containers containing 14, 20, 28, 30, 50, 56, 60, 90, 100 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
I.F.B Stroder S.r.l
Via Luca Passi, 85
00166 Rome - Italy

This medicinal product is authorized in the European Economic Area Member States under the following names:
Belgium COVERSYL PLUS 5 mg/1.25 mg
Czech Republic Prestarium Neo Combi 5mg/1.25mg
France PRETERVAL 5 mg/1.25 mg
Hungary Coverex-AS Komb
Italy PRELECTAL 5 mg/1.25 mg
Latvia PRESTARIUM COMBI ARGININE
Luxembourg COVERSYL PLUS 5 mg/1.25 mg
Malta Coversyl Plus 5 mg/1.25 mg
Poland NOLIPREL FORTE (5/1.25)
Romania PREXAREL 5 mg/1.25 mg
Slovakia Prestarium combi A
Slovenia BIOPREXANIL COMBI 5mg/1.25 mg film-coated tablets