Perindopril and indapamide Doc Generici: detailed information

Patient Information Leaflet

PERINDOPRIL AND INDAPAMIDE DOC 2.5 mg/0.625 mg Film-coated Tablets

Equivalent medicine
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. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg is and what it is used for

PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg is a combination of two active substances,
perindopril and indapamide. It is an antihypertensive agent 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 act to control blood pressure.

2. What you need to know before taking PERINDOPRIL E INDAPAMIDE DOC

2.5 mg/0.625 mg
Do not take PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg

if you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any other sulfonamide, or to any of the other ingredients of this medicine (listed in section 6),
if you have experienced symptoms such as 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 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 PERINDOPRIL E INDAPAMIDE DOC may not be suitable for you,
if you have low potassium levels in your blood,
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 PERINDOPRIL E INDAPAMIDE DOC even in early pregnancy – see “Pregnancy and breastfeeding”),
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, e.g., in the throat) is increased.

Warnings and precautions
Talk to your doctor or pharmacist before taking PERINDOPRIL E INDAPAMIDE DOC
2.5 mg/0.625 mg.

if you have aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (a heart muscle disorder) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
if you suffer from heart failure or other heart problems,
if you have kidney problems or are on dialysis,
if you notice a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from a few hours to several weeks after taking PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg. If untreated, these conditions may lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may have an increased risk of developing this disorder.
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 hyperaldosteronism),
if you have liver problems,
if you have a connective tissue disease (skin disorder) 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 potassium-containing salt substitutes,
if you are taking lithium or potassium-sparing medicines (spironolactone, triamterene) or potassium supplements, as their use with PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg should be avoided (see section “Other medicines and PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg”),
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 electrolyte levels (e.g., potassium) at regular intervals.

See also the information under "Do not take PERINDOPRIL E INDAPAMIDE DOC
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 patient on hemodialysis using high-flux dialysis membranes,
if you are taking any of the following medicines, which increase the risk of angioedema:
racecadotril, a medicine used to treat diarrhoea;
medicines used to prevent organ transplant rejection or for cancer (e.g., temsirolimus, sirolimus, everolimus);
sacubitril (available as a fixed-dose combination with valsartan), used in long-term treatment of heart failure;
linagliptin, saxagliptin, sitagliptin, vildagliptin, and other drugs belonging to the class of so-called gliptins (used to treat diabetes).

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 PERINDOPRIL E INDAPAMIDE DOC. This may occur at any time during treatment. If such symptoms develop, stop treatment with PERINDOPRIL E INDAPAMIDE DOC 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). PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 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 baby if taken during this period (see section “Pregnancy and breastfeeding”).
If you are taking PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg, inform your doctor or medical staff:

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

Athletes should be aware that PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg
contains an active substance (indapamide) that may lead to a positive result in anti-doping tests.
Children and adolescents
PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg must not be administered to children and
adolescents.
Other medicines and PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
You must not take PERINDOPRIL E INDAPAMIDE DOC 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 supplements (including salt substitutes), potassium-sparing diuretics (such as triamterene, amiloride), and other medicines that may increase potassium levels in the blood (such as trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots),
estramustine (used in cancer therapy),
other medicines used to treat high blood pressure: angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers.

Treatment with PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg may be affected by
other medicines. Your doctor may consider it necessary to adjust the dose and/or take additional precautions.
Ensure you 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 information under "Do not take PERINDOPRIL E INDAPAMIDE DOC 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 daily,
medicines used mainly for treating diarrhoea (racecadotril) or to prevent rejection of transplanted organs (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 sections “Do not take PERINDOPRIL E INDAPAMIDE DOC 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 for addiction treatment),
procainamide (for irregular heartbeat),
allopurinol (for gout treatment),
antihistamines used to treat allergic reactions such as hay fever (e.g., mizolastine, terfenadine or 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 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 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., acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting)),
injectable amphotericin B (for treating severe fungal infections),
medicines for treating 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).

PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg with food and drink
It is preferable to take PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg before a meal.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
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 PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg.
PERINDOPRIL E INDAPAMIDE DOC 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.
Breast-feeding
PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg is not recommended for breastfeeding mothers. Inform your doctor immediately if you are breastfeeding or planning to breastfeed.
Inform your doctor immediately.
Driving and using machines
PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg normally does not affect alertness, but in some patients, side effects such as dizziness or fatigue related to blood pressure reduction may occur. If you experience such symptoms, your ability to drive or operate machinery may be impaired.
PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.5 mL, i.e., it is essentially ‘sodium-free’.

3. How to take PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg

Always take this medicine exactly as instructed by your doctor. 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 break line is intended to facilitate splitting the tablet in case you have difficulty swallowing it whole.

If you take more PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg than you should
If you have taken an excessive amount of tablets, go immediately to the nearest emergency room or contact your doctor immediately. The most likely effect in case of overdose is low blood pressure. If a marked drop in blood pressure occurs (associated with nausea, vomiting, cramps, dizziness, drowsiness, confusion, or 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 PERINDOPRIL E INDAPAMIDE DOC 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 PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg
Since treatment for high blood pressure is usually lifelong, you must speak with your doctor before stopping this medicine.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Severe dizziness or fainting due to low blood pressure (Common) (may affect up to 1 in 10 people),
Bronchospasm (tightness of the chest, wheezing, shortness of breath) (Uncommon) (may affect 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) (may affect up to 1 in 100 people),
Severe skin reactions including erythema multiforme (skin rash often starting with itchy red patches on the face, arms or legs) or intense rash, hives, 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) (may affect up to 1 in 10,000 people),
Cardiovascular disorders (irregular heartbeat, angina pectoris (chest, jaw and back pain caused by physical exertion), heart attack) (Very rare) (may affect up to 1 in 10,000 people),
Weakness in arms or legs, or speech problems which could be signs of a possible stroke (Very rare) (may affect up to 1 in 10,000 people),
Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of illness (Very rare) (may affect up to 1 in 10,000 people),
Yellowing of the skin or eyes (jaundice), which could be a sign of hepatitis (Very rare) (may affect up to 1 in 10,000 people),
Life-threatening irregular heartbeat (Not known),
Brain disease caused by liver disease (hepatic encephalopathy) (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 (Not known).

In decreasing order of frequency, side effects may include:

Common: (may affect up to 1 in 10 people) Low blood potassium levels, skin reactions in people predisposed to allergies 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, diarrhoea, constipation), allergic reactions (such as skin rashes, itching), cramps, feeling of fatigue.
Uncommon: (may affect up to 1 in 100 people) Mood changes, sleep disorders, depression, urticaria, purpura (small red spots on the skin), blistering rash, kidney disorders, impotence, sweating, elevated eosinophils (a type of white blood cells), 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 (very low blood sugar levels) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased skin sensitivity to sunlight), arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise, peripheral oedema, fever, increased blood urea, increased blood creatinine, falls.
Rare: (may affect up to 1 in 1,000 people) Worsening of psoriasis, changes in laboratory parameters: low blood chloride levels, low blood magnesium levels, increased liver enzyme levels, high serum bilirubin levels, fatigue, flushing, reduced or absent urine output, acute kidney failure. Dark-coloured urine, feeling unwell (nausea) or being unwell (vomiting), muscle cramps, confusion and seizures. These symptoms may be related to a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
Very rare: (may affect up to 1 in 10,000 people) Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked or runny nose), severe kidney problems, changes in blood parameters such as reduced numbers of white and red blood cells, lower haemoglobin, reduced platelet count, high blood calcium levels, abnormal liver function.
Not known (frequency cannot be estimated from the available data): Abnormal ECG trace, changes in laboratory parameters: high uric acid levels and high blood sugar levels, decreased vision (myopia), blurred vision, impaired vision, reduced vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), abnormal colour, numbness and pain in fingers of hands or feet (Raynaud's phenomenon). If you suffer from systemic lupus erythematosus (a connective tissue disease), this may worsen.

Blood, kidney, liver or pancreas disorders and changes in laboratory parameters (blood tests) may occur.
Your doctor may prescribe laboratory tests to monitor your condition.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist. 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 PERINDOPRIL AND INDAPAMIDE DOC 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 bottle after Exp.
The expiry date refers to the last day of that month.
Keep the container tightly closed to protect the medicine from moisture.
This medicine does not require any special storage temperature.
Do not dispose of medicines 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 PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg contains

The active substances are perindopril tosilate and indapamide. Each film-coated tablet contains 2.5 mg of perindopril tosilate (equivalent to 1.704 mg of perindopril) and 0.625 mg of indapamide.
The other components are monohydrate lactose, maize starch, sodium hydrogen carbonate (E 500 (ii)), pregelatinized maize starch, Povidone K30 (E 1201), magnesium stearate (E 470b), polyvinyl alcohol - partially hydrolyzed, titanium dioxide (E171), macrogol/PEG 3350 and talc.

Description of the appearance of PERINDOPRIL E INDAPAMIDE DOC and contents of the pack
The film-coated tablets of PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg are
white, biconvex, capsule-shaped, approximately 4 mm wide and 8 mm long, with a break line engraved on one side and smooth on the other side.
The engraved line is intended to facilitate breaking the tablet for easier swallowing and does not allow division into equal doses.
The tablets are available in polypropylene (PP) containers with a polyethylene (PE) cap containing a desiccant, each containing 30 film-coated tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano, Italy.
Manufacturers

Teva Gyogyszergyar Zrt., Pallagi Ut 13, Hajdu-Bihar 4042 Debrecen, Hungary.
Teva Operations Poland Sp. z o.o., Ul. Mogilska 80, Małopolskie 31-546 Kraków, Poland.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Netherlands Perindopril tosilaat/Indapamide DOC 2.5 mg/0.625 mg filmomhulde tabletten
Italy PERINDOPRIL E INDAPAMIDE DOC

Patient information leaflet

PERINDOPRIL AND INDAPAMIDE DOC 5 mg/1.25 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg is and what it is used for

PERINDOPRIL E INDAPAMIDE DOC is a combination of two active substances, perindopril and indapamide. It is an antihypertensive medicine 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 PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg

Do not take PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg

if you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any other sulfonamide, or to any of the other ingredients of this medicine (listed in section 6),
if you have had symptoms such as shortness of breath, facial or tongue swelling, severe itching or serious 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 a kidney disease causing 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 PERINDOPRIL E INDAPAMIDE DOC may not be suitable for you,
if you have low potassium levels in your blood,
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 PERINDOPRIL E INDAPAMIDE DOC even in the early stages of pregnancy – see “Pregnancy and breastfeeding”),
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, e.g. in the throat) is increased.

Warnings and precautions
Talk to your doctor or pharmacist before taking PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg.

if you have aortic stenosis (narrowing of the main blood vessel 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 notice a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from a few hours to several weeks after taking PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg. If left untreated, these conditions may lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this disorder.
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 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 on a low-salt diet or use potassium-containing salt substitutes,
if you are taking lithium or potassium-sparing medicines (spironolactone, triamterene) or potassium supplements, as their use with PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg must be avoided (see section “Other medicines and PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg”),
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 can 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 the section “Do not take PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg”.
if you are of 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, a medicine used to treat diarrhoea;
medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus);
sacubitril (available as a fixed-dose combination with valsartan), used in long-term treatment of heart failure;
linagliptin, saxagliptin, sitagliptin, vildagliptin and other drugs belonging to the so-called gliptins (used to treat diabetes).

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat causing difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including PERINDOPRIL E INDAPAMIDE DOC. This may occur at any time during treatment. If such symptoms develop, stop treatment with PERINDOPRIL E INDAPAMIDE DOC and call 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). PERINDOPRIL E INDAPAMIDE DOC 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 section “Pregnancy and breastfeeding”).
If you are taking PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg, inform your doctor or medical staff:

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

Athletes should be aware that PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg contains an active substance (indapamide) that may lead to a positive result in anti-doping tests.
Children and adolescents
PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg must not be administered to children and adolescents.
Other medicines and PERINDOPRIL E INDAPAMIDE DOC 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 PERINDOPRIL E INDAPAMIDE DOC 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 supplements (including salt substitutes), potassium-sparing diuretics (such as triamterene, amiloride) and other medicines that may increase potassium levels in the blood (such as trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots),
estramustine (used in cancer therapy),
other medicines used to treat high blood pressure: angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers.

Treatment with PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg may be affected by other medicines. Your doctor may need to adjust the dose and/or take additional 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 PERINDOPRIL E INDAPAMIDE DOC 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 used mainly to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”,
sacubitril/valsartan (used for long-term treatment of heart failure). See sections “Do not take PERINDOPRIL E INDAPAMIDE DOC 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 for addiction treatment),
procainamide (for irregular heartbeat),
allopurinol (for gout treatment),
antihistamines used to treat allergic reactions such as hay fever (e.g. mizolastine, terfenadine or astemizole),
corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
immunosuppressants used to treat autoimmune diseases or 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, difemethiazine (used to treat gastrointestinal and digestive problems),
digoxin or other cardiac glycosides (for heart problems),
baclofen (to treat muscle stiffness in conditions such as multiple sclerosis),
medicines for diabetes such as insulin, metformin or gliptins,
calcium, including calcium supplements,
stimulant laxatives (e.g. senna),
non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high-dose salicylates (e.g. acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting)),
injectable amphotericin B (for severe fungal infections),
medicines for mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)),
tetracosactide (for 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).

PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg with food and drink
It is preferable to take PERINDOPRIL E INDAPAMIDE DOC 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 taking this medicine.
Pregnancy
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 PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken beyond the third month of pregnancy.
Breastfeeding
PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg is not recommended during breastfeeding. Inform your doctor immediately if you are breastfeeding or planning to start breastfeeding.
Contact your doctor immediately.
Driving and using machines
PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg normally does not affect alertness, but in some patients, side effects such as dizziness or fatigue related to blood pressure reduction may occur. If you experience such symptoms, your ability to drive or operate machinery may be impaired.
PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.5 mL, i.e. it is essentially 'sodium-free'.

3. How to take PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
The recommended dose is one tablet daily. Your doctor may decide to adjust the
dosage if you have impaired kidney function.
Take the tablet preferably in the morning and before a meal. Swallow the tablet with a
glass of water.
The tablet can be divided into equal parts.

If you take more PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg than you should
If you have taken an excessive amount of tablets, go immediately to the nearest emergency room or contact your doctor immediately. The most likely effect of an overdose is low 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 PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 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 PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg
Since treatment for high blood pressure 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, this medicine can cause side effects, although not everybody will experience 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) (may affect up to 1 in 10 people),
Bronchospasm (chest tightness, wheezing, shortness of breath) (Uncommon) (may affect 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) (may affect up to 1 in 100 people),
Severe skin reactions including erythema multiforme (a rash often starting with itchy red patches on the face, arms or legs) or intense rash, hives, widespread redness of the skin, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson Syndrome) or other allergic reactions (Very rare) (may affect up to 1 in 10,000 people),
Cardiovascular disorders (irregular heartbeat, angina pectoris (chest, jaw and back pain caused by physical exertion), heart attack) (Very rare) (may affect up to 1 in 10,000 people),
Weakness in arms or legs, or speech problems which could be signs of a possible stroke (Very rare) (may affect up to 1 in 10,000 people),
Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of illness (Very rare) (may affect up to 1 in 10,000 people),
Yellowing of the skin or eyes (jaundice), which may be a sign of hepatitis (Very rare) (may affect up to 1 in 10,000 people),
Life-threatening irregular heartbeat (Not known),
Brain disease caused by liver disease (hepatic encephalopathy) (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 (Not known).

In decreasing order of frequency, side effects may include:

Common: (may affect up to 1 in 10 people) Low blood potassium levels, skin reactions in people predisposed to allergies 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, indigestion or difficulty digesting, diarrhoea, constipation), allergic reactions (such as skin rashes, itching), cramps, feeling of tiredness.
Uncommon: (may affect up to 1 in 100 people) Mood changes, sleep disorders, depression, urticaria, purpura (small red spots on the skin), blistering rash, kidney disorders, impotence, sweating, elevated eosinophils (a type of white blood cells), 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 (very low blood sugar levels) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased skin sensitivity to sunlight), arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise, peripheral oedema, fever, increased blood urea, increased blood creatinine, falls.
Rare: (may affect up to 1 in 1,000 people) Worsening of psoriasis, changes in laboratory parameters: low blood chloride levels, low blood magnesium levels, increased liver enzyme levels, elevated serum bilirubin levels, fatigue, flushing, reduced or absent urine output, acute kidney failure. Dark-coloured urine, feeling unwell (nausea) or being unwell (vomiting), muscle cramps, confusion and seizures. These symptoms may be related to a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
Very rare: (may affect up to 1 in 10,000 people) Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked or runny nose), severe kidney problems, changes in blood parameters such as decreased white blood cell and red blood cell counts, lower haemoglobin, lower platelet count, high blood calcium levels, abnormal liver function.
Not known (frequency cannot be estimated from available data): Abnormal ECG trace, changes in laboratory parameters: high uric acid levels and high blood sugar levels, decreased vision (myopia), blurred vision, visual impairment, decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), abnormal colour, numbness and pain in fingers of hands or feet (Raynaud's phenomenon). If you suffer from systemic lupus erythematosus (a connective tissue disease), this may worsen.

Blood, kidney, liver or pancreas disorders and changes in laboratory parameters (blood tests) may occur.
Your doctor may prescribe laboratory tests to monitor your condition.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store PERINDOPRIL AND INDAPAMIDE DOC 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 stated on the carton and bottle after Exp.
The expiry date refers to the last day of that month.
Keep the container tightly closed to protect the medicine from moisture.
This medicine does not require any special storage temperature.
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 PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg contains

The active substances are perindopril tosilate and indapamide. Each film-coated tablet contains 5 mg of perindopril tosilate (equivalent to 3.408 mg of perindopril) and 1.25 mg of indapamide.
The other components are monohydrate lactose, maize starch, sodium hydrogen carbonate (E 500 (ii)), pregelatinized maize starch, povidone K30 (E 1201), magnesium stearate (E 470b), polyvinyl alcohol - partially hydrolysed, titanium dioxide (E171), macrogol/PEG 3350 and talc.

Description of the appearance of PERINDOPRIL E INDAPAMIDE DOC and contents of the pack
The film-coated tablets of PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg are white,
capsule-shaped, biconvex, approximately 5 mm wide and 10 mm long, with the letters “P” and “I”
imprinted and a break line on one side, and smooth on the other side. The tablet can be divided into equal parts.
The tablets are available in polypropylene (PP) containers with polyethylene (PE) caps and
desiccant, containing 30 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano, Italy.
Manufacturers

Teva Gyogyszergyar Zrt., Pallagi Ut 13, Hajdu-Bihar 4042 Debrecen, Hungary.
Teva Operations Poland Sp. z o.o., Ul. Mogilska 80, Małopolskie 31-546 Kraków, Poland.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands: Perindopril tosilate/Indapamide DOC 5 mg/1.25 mg film-coated tablets
Italy: PERINDOPRIL E INDAPAMIDE DOC

Patient information leaflet

PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before using 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

What PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg is and what it is used for
What you need to know before taking PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg
How to take PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg
Possible side effects
How to store PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg
Contents of the pack and other information

1. What PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg is and what it is used for

PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg is a combination of two active substances, perindopril and indapamide. It is an antihypertensive medicine used for the treatment of high blood pressure (hypertension) in adults.
PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg is indicated for patients who are already taking perindopril 10 mg and indapamide 2.5 mg as separate tablets, and who may therefore switch to one tablet of PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg containing both active substances.
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 need to know before taking PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg

Do not take PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg

if you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any other sulfonamide, or to any of the other ingredients of this medicine (listed in section 6),
if you have had symptoms such as shortness of breath, swelling of the face or tongue, severe itching or serious 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 (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 a kidney disease causing 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 PERINDOPRIL E INDAPAMIDE DOC may not be suitable for you,
if you have low potassium levels in your blood,
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 PERINDOPRIL E INDAPAMIDE DOC even in the early stages of pregnancy – see "Pregnancy and breastfeeding"),
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, for example in the throat) is increased.

Warnings and precautions
Talk to your doctor or pharmacist before taking PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg.

if you have aortic stenosis (narrowing of the main blood vessel 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 suffer from kidney problems or are undergoing dialysis,
if you notice a decrease in 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 may occur from a few hours to several weeks after taking PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg. If untreated, these conditions may lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this disorder.
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 hyperaldosteronism),
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 diet restricting 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 PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg must be avoided (see section “Other medicines and PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg”),
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), especially if you have kidney problems related to diabetes.
aliskiren.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the section “Do not take PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg”.

if you are of African descent, 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, a medicine used to treat diarrhoea;
medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus);
sacubitril (available as a fixed-dose combination with valsartan), used in the long-term treatment of heart failure;
linagliptin, saxagliptin, sitagliptin, vildagliptin and other drugs belonging to the so-called gliptins (used to treat diabetes).

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat causing difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including PERINDOPRIL E INDAPAMIDE DOC. This may occur at any time during treatment. If such symptoms develop, stop treatment with PERINDOPRIL E INDAPAMIDE DOC 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). PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken during this period (see section “Pregnancy and breastfeeding”).
If you are taking PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg, inform your general practitioner or medical staff:

if you are to undergo anaesthesia and/or surgery,
if you have recently had diarrhoea or vomiting, or if you are dehydrated,
if you are to undergo dialysis or LDL apheresis (blood purification from cholesterol using a machine),
if you are to undergo desensitisation treatment to reduce the effects of an allergy to bee or wasp stings,
if you are to undergo a medical examination requiring injection of an iodinated contrast agent (a substance that makes organs such as the kidney or stomach visible on X-rays),
if you have experienced vision disturbances or pain in one or both eyes while taking PERINDOPRIL E INDAPAMIDE DOC. This could be a sign of developing glaucoma, an increase in pressure in one or both eyes. Stop treatment with PERINDOPRIL E INDAPAMIDE DOC and consult a doctor.

Athletes should be aware that PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg contains an active substance (indapamide) that may cause a positive result in anti-doping tests.
Children and adolescents
PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg must not be given to children or adolescents.
Other medicines and PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You must not take PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 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 supplements (including salt substitutes), potassium-sparing diuretics (such as triamterene, amiloride) and other medicines that may increase potassium levels in the blood (such as trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole for bacterial infections; cyclosporine, an immunosuppressant medicine used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clots),
estramustine (used in cancer therapy),
other medicines used to treat high blood pressure: angiotensin-converting enzyme inhibitors and angiotensin receptor blockers.

Treatment with PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg may be affected by other medicines. Your doctor may consider it necessary to adjust the 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 “Do not take PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 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 daily,
medicines used mainly to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”,
sacubitril/valsartan (used for the long-term treatment of heart failure). See sections “Do not take PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 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 or astemizole),
corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
immunosuppressants used to treat autoimmune diseases or after organ transplants to prevent rejection (e.g. cyclosporine, tacrolimus),
halofantrine (used to treat certain types of malaria),
pentamidine (used to treat pneumonia),
injectable gold (used to treat rheumatoid arthritis),
vincamine (used to treat symptomatic cognitive disorders in the elderly, including memory loss),
bepridil (used to treat angina pectoris),
medicines 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. acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting)),
injectable amphotericin B (for treating severe fungal infections),
medicines for treating 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).

PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg with food and drinks
It is preferable to take PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg before a meal.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking 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 PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg before starting pregnancy or as soon as you find out you are pregnant, and will recommend an alternative medicine instead of PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg.
PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken after the third month of pregnancy.
Breastfeeding
PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg is not recommended if you are breastfeeding. Inform your doctor immediately if you are breastfeeding or planning to breastfeed.
Inform your doctor immediately.
Driving and using machines
PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 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.
PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 0.5 mL, i.e. it is essentially 'sodium-free'.

3. How to take PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet per day.
Take the tablet preferably in the morning and before a meal. Swallow the tablet with a glass of water.

If you take more PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg than you should
If you have taken an excessive amount of tablets, go immediately to the nearest emergency room or contact your doctor immediately. The most likely effect in case of overdose is low 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 help to lie down with your legs raised.

If you forget to take PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 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 PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg
Since the treatment of 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, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine immediately and contact your doctor straight away if you experience
any of the following, which may be serious:

Severe dizziness or fainting due to low blood pressure (Common) (may affect up to 1 in 10 people),
Bronchospasm (tightness of the chest, wheezing, shortness of breath) (Uncommon) (may affect 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) (may affect up to 1 in 100 people),
Severe skin reactions including erythema multiforme (skin rash often starting with itchy red patches on the face, arms or legs) or severe skin rash, hives, widespread redness of the skin, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson Syndrome) or other allergic reactions (Very rare) (may affect up to 1 in 10,000 people),
Cardiovascular disorders (irregular heartbeat, angina pectoris (chest, jaw and back pain caused by physical exertion), heart attack) (Very rare) (may affect up to 1 in 10,000 people),
Weakness in arms or legs, or speech problems which could be signs of a possible stroke (Very rare) (may affect up to 1 in 10,000 people),
Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of illness (Very rare) (may affect up to 1 in 10,000 people),
Yellowing of the skin or eyes (jaundice), which may be a sign of hepatitis (Very rare) (may affect up to 1 in 10,000 people),
Life-threatening irregular heartbeat (Not known),
Brain disease caused by liver disease (hepatic encephalopathy) (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 (Not known).

In decreasing order of frequency, side effects may include:

Common: (may affect up to 1 in 10 people) Low blood potassium levels, skin reactions in people predisposed to allergies and asthmatic reactions, headache, dizziness, vertigo, tingling, visual disturbances, tinnitus (sensation of noise in the ears), cough, shortness of breath (dyspnea), gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or indigestion, diarrhoea, constipation), allergic reactions (such as skin rashes, itching), cramps, feeling of fatigue.
Uncommon: (may affect up to 1 in 100 people) Mood changes, sleep disorders, depression, urticaria, purpura (small red spots on the skin), blistering rash, kidney disorders, impotence, sweating, increased eosinophils (a type of white blood cells), 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 (very low blood sugar levels) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased skin sensitivity to sunlight), arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise, peripheral oedema, fever, increased blood urea, increased blood creatinine, falls.
Rare: (may affect up to 1 in 1,000 people) Worsening of psoriasis, changes in laboratory parameters: low blood chloride levels, low blood magnesium levels, increased liver enzyme levels, high serum bilirubin levels, fatigue, flushing, reduced or absent urine output, acute kidney failure. Dark-coloured urine, feeling unwell (nausea) or being unwell (vomiting), muscle cramps, confusion and seizures. These symptoms may be due to a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
Very rare: (may affect up to 1 in 10,000 people) Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked or runny nose), severe kidney problems, changes in blood parameters such as decreased numbers of white and red blood cells, lower haemoglobin, lower platelet count, high blood calcium levels, abnormal liver function.
Not known (frequency cannot be estimated from the available data): Abnormal ECG trace, changes in laboratory parameters: high uric acid levels and high blood sugar levels, decreased vision (myopia), blurred vision, impaired vision, decreased vision or eye pain due to increased 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.

Blood, kidney, liver or pancreas disorders and changes in laboratory parameters (blood tests) may occur.
Your doctor may prescribe laboratory tests to monitor your condition.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 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 after Exp.
The expiry date refers to the last day of that month.
Keep the container tightly closed to protect the medicine from moisture.
This medicine does not require any special storage temperature.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg contains

The active substances are perindopril tosylate and indapamide. Each film-coated tablet contains 10 mg of perindopril tosylate (equivalent to 6.816 mg of perindopril) and 2.5 mg of indapamide.
The other components are monohydrate lactose, maize starch, sodium hydrogen carbonate (E 500 (ii)), pregelatinized maize starch, Povidone K30 (E 1201), magnesium stearate (E 470b), polyvinyl alcohol - partially hydrolysed, titanium dioxide (E171), macrogol/PEG 3350 and talc.

Description of the appearance of PERINDOPRIL E INDAPAMIDE DOC and the contents of the pack
The film-coated tablets of PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg are white,
round and biconvex, approximately 10 mm in diameter, smooth on both sides.
The tablets are available in polypropylene (PP) containers with a polyethylene (PE) cap and
desiccant, containing 30 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano, Italy.
Manufacturers

Teva Gyogyszergyar Zrt., Pallagi Ut 13, Hajdu-Bihar 4042 Debrecen, Hungary.
Teva Operations Poland Sp. z o.o., Ul. Mogilska 80, Małopolskie 31-546 Kraków, Poland.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands Perindopril tosilaat/Indapamide DOC 10 mg/2.5 mg filmomhulde tabletten
Italy PERINDOPRIL E INDAPAMIDE DOC