PERINDOPRIL 2.5 мг/0.625 мг Фильм-coated таблетки

Содержание инструкции

1. PERINDOPRIL E INDAPAMIDE DOC 2,5 mg/0,625 mg film-coated tablets
   1. What is PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg and what is it used for?
   2. Cosa deve sapere prima di prendere PERINDOPRIL E INDAPAMIDE DOC
   3. How to take PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg
   4. Possible side effects
   5. How to store PERINDOPRIL E INDAPAMIDE DOC 2,5 mg/0,625 mg
   6. Package contents and other information
2. PERINDOPRIL E INDAPAMIDE DOC 5 mg/1,25 mg film-coated tablets
   1. What is PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg and what is it used for
   2. What you need to know before taking PERINDOPRIL AND INDAPAMIDE DOC 5 mg/1.25 mg
   3. How to take PERINDOPRIL E INDAPAMIDE DOC 5 mg/1,25 mg
   4. Possible side effects
   5. How to store PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg
   6. Package contents and other information
3. PERINDOPRIL E INDAPAMIDE DOC 10 mg/2,5 mg film-coated tablets
   1. What is PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg and what is it used for?
   2. What you need to know before taking PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg
   3. How to take PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg
   4. Possible side effects
   5. How to store PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg
   6. Package contents and other information

PERINDOPRIL E INDAPAMIDE DOC 2,5 mg/0,625 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg is a combination of two active ingredients, perindopril and indapamide. It is an antihypertensive and is used in the treatment of high blood pressure (hypertension) in adults.
Perindopril belongs to a class of drugs called ACE inhibitors. These drugs work by dilating blood vessels, which makes it easier for the heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in the amount of urine produced.
Each active ingredient reduces blood pressure and, together, they work to control blood pressure.

2. Cosa deve sapere prima di prendere 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 to any other ACE inhibitor, or to indapamide or to any other sulfonamide, or to any of the other components of this medicine (listed in section 6),
• if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes related to a previous treatment with ACE inhibitors or if you or a family member has experienced such symptoms in any other circumstance (condition called angioedema),
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure containing aliskiren,
• if you have a severe liver disease or if you suffer from a disease called hepatic encephalopathy (a degenerative brain disease),
• if you suffer from a severe kidney disease, where the blood flow to the kidneys is reduced (renal artery stenosis),
• if you are undergoing dialysis, or any type of blood filtration. Depending on the machinery used, therapy with PERINDOPRIL E INDAPAMIDE DOC may not be suitable for you,
• if you have low potassium levels in your blood,
• if you suspect you have decompensated heart failure (severe fluid retention, difficulty breathing),
• if you are pregnant for more than three months. (It is best to avoid 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 a long-term (chronic) type of heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as 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 (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
• if you suffer from heart failure or other heart problems,
• if you suffer from kidney problems or are on dialysis,
• if you 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 pressure in the eye and can occur within a period ranging from a few hours to a few weeks after taking PERINDOPRIL E INDAPAMIDE DOC 2,5 mg/0,625 mg. If left untreated, these conditions can lead to permanent vision loss. If you have 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 an abnormally high level of an 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 following a diet with a restriction on 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 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 had photosensitivity reactions,
• if you have severe allergic reactions with swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema). This can occur at any time during treatment. If such symptoms develop, stop treatment and call your doctor immediately,
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also what is reported 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 reducing 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, increases the risk of angioedema:
• racecadotril, a medicine used for the treatment of diarrhea;
• medicines used to prevent rejection after organ transplantation 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 class of so-called gliptins (used for the treatment of diabetes).

Angioedema
Angioedema (a serious allergic reaction with swelling of the face, lips, tongue or throat with difficulty
swallowing or breathing) has been reported in patients treated with ACE inhibitors, including PERINDOPRIL E
INDAPAMIDE DOC. This can happen at any time during treatment. If such symptoms develop,
stop treatment with PERINDOPRIL E INDAPAMIDE DOC and call
your doctor immediately. See also paragraph 4.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). PERINDOPRIL E INDAPAMIDE DOC 2,5 mg/0,625 mg is not recommended
at the beginning of pregnancy, and must not be taken if you are pregnant for more than 3 months, as
it can cause serious harm to the baby if taken during this period (see the paragraph “Pregnancy and
breastfeeding”).
If you are taking PERINDOPRIL E INDAPAMIDE DOC 2,5 mg/0,625 mg, inform your doctor
or healthcare staff:

• if you need to undergo anesthesia and/or surgery,
• if you have recently had diarrhea or vomiting, or if you are dehydrated,
• if you need to undergo dialysis or LDL apheresis (blood purification from cholesterol by means of a machine),
• if you need to undergo a desensitization treatment to reduce the effects of an allergy to bee or wasp stings,
• if you need to undergo a medical examination requiring the injection of an iodine-containing contrast agent (a substance that makes organs such as the kidney or stomach visible on X-rays),
• if you have had vision changes or eye pain during the intake of PERINDOPRIL E INDAPAMIDE DOC. This could be a sign that glaucoma is developing, 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 2,5 mg/0,625 mg
contains an active ingredient (indapamide) that can induce a positive result in doping tests.

Children and adolescents
PERINDOPRIL E INDAPAMIDE DOC 2,5 mg/0,625 mg should not be given to children and
adolescents.

Other medicines and PERINDOPRIL E INDAPAMIDE DOC 2,5 mg/0,625 mg
Tell 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 for the treatment of manic disorder and depression),
• aliskiren (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 can increase potassium levels in the blood (such as trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole for infections caused by bacteria; 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 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 you tell your doctor if you are taking any of these medicines, as
particular care may be needed:

• other medicines for the treatment of high blood pressure, including an angiotensin II receptor blocker (AIIRA) or aliskiren (see also “Do not take PERINDOPRIL E INDAPAMIDE DOC 2,5 mg/0,625 mg” and “Warnings and precautions”) or diuretics (medicines that increase the amount of urine produced by the kidneys),
• potassium-sparing diuretics used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• medicines used mainly for the treatment of diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See paragraph “Warnings and precautions”,
• sacubitril/valsartan (used for the treatment of long-term heart failure). See the paragraphs “Do not take PERINDOPRIL E INDAPAMIDE DOC 2,5 mg/0,625 mg” and “Warnings and precautions”,
• anesthetics,
• iodine contrast agent,
• antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, injectable erythromycin),
• methadone (used for the treatment of addictions),
• procainamide (for the treatment of irregular heartbeat),
• allopurinol (for the treatment of gout),
• antihistamines used to treat allergic reactions, such as hay fever (e.g. mizolastine, terfenadine or astemizole),
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune diseases or following transplants to prevent rejection (e.g. cyclosporine, tacrolimus),
• alofantrine (used to treat certain types of malaria),
• pentamidine (used to treat pneumonia),
• 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 stomach and digestive problems),
• digoxin or other cardiac glycosides (for the treatment of heart problems),
• baclofen (for the treatment of muscle stiffness in conditions such as multiple sclerosis),
• medicines for the treatment of diabetes such as insulin, metformin or gliptins,
• calcium including calcium supplements,
• stimulant laxatives (e.g. senna),
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting)),
• injectable amphotericin B (for the treatment of severe fungal infections),
• medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)),
• tetracosactide (for the treatment of Crohn's disease),
• trimethoprim (for the treatment of infections),
• vasodilators including nitrates (products that make blood vessels wider),
• medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, norepinephrine or adrenaline).

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, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast milk,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You should inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant).
Normally, your doctor will advise you to stop taking PERINDOPRIL E INDAPAMIDE
DOC 2,5 mg/0,625 mg before starting pregnancy or as soon as you find out you are pregnant and will advise you to take another 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 in the early
stages of pregnancy, and should not be taken if you are more than three months pregnant, as it may
cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
PERINDOPRIL E INDAPAMIDE DOC 2,5 mg/0,625 mg is not recommended for mothers who are
breastfeeding. Inform your doctor immediately if you are breastfeeding or are about to start breastfeeding.
Notify your doctor immediately.

Driving and using machines
PERINDOPRIL E INDAPAMIDE DOC 2,5 mg/0,625 mg normally does not affect alertness but
some patients may experience different reactions such as dizziness or fatigue related to
lowering of blood pressure. If you experience these symptoms, your ability to drive vehicles 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 intolerance to certain sugars, contact them 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

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
The recommended dose is one tablet a day. Your doctor may decide to increase the dose to
2 tablets a day or to modify the dosage if you suffer from renal impairment.
Take the tablet preferably in the morning and before a meal. The tablet must be swallowed
with a glass of water.
The score line is to facilitate breaking 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
consult 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 be helpful 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 the usual time. Do not take a double dose to compensate for forgetting
the dose.

If you stop taking PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg
Since treatment for hypertension is usually lifelong, you should talk to your doctor before
stopping taking this medicine.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Severe dizziness or fainting due to low blood pressure (Common) (can affect up to 1 in 10 people),
• Bronchospasm (tightness in the chest, wheezing and shortness of breath) (Uncommon) (can 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) (can affect up to 1 in 100 people),
• Severe skin reactions including erythema multiforme (skin rash that often starts 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 the mucous membranes (Stevens Johnson Syndrome) or other allergic reactions (Very rare) (can 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) (can affect up to 1 in 10,000 people),
• Weakness of arms or legs, or speech problems which could be a sign of a possible stroke (Very rare) (can affect up to 1 in 10,000 people),
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe malaise (Very rare) (can affect up to 1 in 10,000 people),
• Yellowing of the skin or eyes (jaundice) which can be a sign of hepatitis (Very rare) (can 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 and in particular, if at the same time you do not feel well or have a high fever, this may be caused by abnormal muscle breakdown (Not known).

In decreasing order of frequency, side effects may include:

• Common: (can affect up to 1 in 10 people) Low level of potassium in the blood, skin reactions in subjects predisposed to allergy and asthma, headache, dizziness, vertigo, tingling, vision disorders, tinnitus (sensation of noises in the ears), cough, shortness of breath (dyspnea), gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbance, dyspepsia or difficulty digesting food, diarrhea, constipation), allergic reactions (such as skin rashes, itching), cramps, feeling tired.
• Uncommon: (can affect up to 1 in 100 people) Mood changes, sleep disorders, depression, hives, purpura (small red spots on the skin), clustered blisters, kidney disorders, impotence, sweating, excess eosinophils (a type of white blood cells), changes in laboratory parameters: high level of potassium in the blood reversible upon discontinuation, low level of sodium in the blood, drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (fast heartbeat), hypoglycemia (very low blood sugar) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased sensitivity of the skin to the sun), arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise, peripheral edema, fever, increased urea in the blood, increased creatinine in the blood, falls.
• Rare: (can affect up to 1 in 1,000 people) Worsening of psoriasis, changes in laboratory parameters: low level of chloride in the blood, low level of magnesium in the blood, increased levels of liver enzymes, high level of serum bilirubin, fatigue, redness, reduction or absence of urine, acute kidney failure. Dark urine, feeling sick (nausea) or being sick (vomiting), muscle cramps, confusion and convulsions. These symptoms may be due to a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
• Very rare: (can affect up to 1 in 10,000 people) Confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (stuffy or runny nose), severe kidney problems, changes in blood parameters such as lowering of white blood cells and red blood cells, lower hemoglobin, lower number of platelets in the blood, high levels of calcium in the blood, abnormal liver function.
• Not known (frequency cannot be estimated from available data) Abnormal ECG tracing, changes in laboratory parameters: high levels of uric acid and high levels of sugar in the blood, worsening of vision (myopia), blurred vision, impaired vision, decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), abnormal color vision, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon). If you suffer from systemic lupus erythematosus (a connective tissue disease), this may worsen.

Blood, kidney, liver or pancreas disorders and changes in laboratory parameters (blood tests) may occur. The doctor may prescribe laboratory tests to check your condition.

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

5. How to store PERINDOPRIL E 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 which is stated on the package and the 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 particular storage temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What contains PERINDOPRIL E INDAPAMIDE DOC 2.5 mg/0.625 mg

• The active ingredients are perindopril tosylate and indapamide. Each film-coated tablet contains 2.5 mg of perindopril tosylate (equivalent to 1.704 mg of perindopril) and 0.625 mg of indapamide.
• The other ingredients are lactose monohydrate, corn starch, sodium hydrogen carbonate (E 500 (ii)), pregelatinized corn 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 package contents
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 fracture line
engraved on one side and smooth on the other side.
The incision line is intended to facilitate breaking the tablet to make it easier to swallow and not
to divide it into equal doses.
The tablets are available in polypropylene (PP) containers with a polyethylene (PE) cap with
desiccant, containing 30 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan, 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 Krakow, Poland.

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

PERINDOPRIL E INDAPAMIDE DOC 5 mg/1,25 mg film-coated tablets

Generic medicine

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

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

Contents of this leaflet

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

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

PERINDOPRIL E INDAPAMIDE DOC is a combination of two active ingredients, perindopril and
indapamide. It is an antihypertensive and is used in the treatment of high blood pressure
(hypertension) in adults.
Perindopril belongs to a class of drugs called ACE inhibitors. These drugs work
by dilating blood vessels, which makes it easier for the heart to pump blood through them. Indapamide is
a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs
from other diuretics in that it causes only a slight increase in the amount of urine produced.
Each active ingredient reduces blood pressure and, together, they work to control blood
pressure.

2. What you need to know before taking PERINDOPRIL AND INDAPAMIDE DOC 5 mg/1.25 mg

Do not take PERINDOPRIL AND 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 experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes related to a previous treatment with ACE inhibitors or if you or a family member has experienced such symptoms in any other circumstance (condition called angioedema),
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure containing aliskiren,
• if you have a severe liver disease or if you suffer from a disease called hepatic encephalopathy (a degenerative brain disease),
• if you suffer from a kidney disease, where the blood flow to the kidneys is reduced (renal artery stenosis),
• if you are undergoing dialysis, or any type of blood filtration. Depending on the machinery used, therapy with PERINDOPRIL AND INDAPAMIDE DOC may not be suitable for you,
• if you have low potassium levels in your blood,
• if you suspect you have decompensated heart failure (severe fluid retention, difficulty breathing),
• if you are pregnant for more than three months. (It is best to avoid PERINDOPRIL AND 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 a long-term (chronic) type of heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.

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

• if you have aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
• if you suffer from heart failure or other heart problems,
• if you suffer from kidney problems or are on dialysis,
• if you 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 an increase in pressure in the eye and can occur within a period of a few hours to a few weeks after taking PERINDOPRIL AND INDAPAMIDE DOC 5 mg/1.25 mg. If left untreated, these conditions can lead to permanent vision loss. If you have 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 an abnormally high level of an 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 following a diet that restricts 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 AND INDAPAMIDE DOC 5 mg/1.25 mg should be avoided (see section “Other medicines and PERINDOPRIL AND INDAPAMIDE DOC 5 mg/1.25 mg”),
• if you are elderly,
• if you have had photosensitivity reactions,
• if you have severe allergic reactions with swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema). This can occur at any time during treatment. If such symptoms develop, stop treatment and call a doctor immediately,
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also what is reported under "Do not take PERINDOPRIL AND INDAPAMIDE DOC 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, increases the risk of angioedema:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent rejection after organ transplantation 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 class of so-called gliptins (used for the treatment of diabetes).

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat with difficulty
swallowing or breathing) has been reported in patients treated with ACE inhibitors, including PERINDOPRIL AND
INDAPAMIDE DOC. This can occur at any time during treatment. If such symptoms develop, stop treatment with PERINDOPRIL AND INDAPAMIDE DOC and call
your doctor immediately. See also paragraph 4.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). PERINDOPRIL AND INDAPAMIDE DOC 5 mg/1.25 mg is not recommended
in the early stages of pregnancy, and should not be taken if you are pregnant for more than 3 months, as
it can cause serious harm to the baby if taken during this period (see the paragraph “Pregnancy and
breastfeeding”).
If you are taking PERINDOPRIL AND INDAPAMIDE DOC 5 mg/1.25 mg, inform your doctor or
medical staff:

• if you need to undergo anesthesia and/or surgery,
• if you have recently had diarrhea or vomiting, or if you are dehydrated,
• if you need to undergo dialysis or LDL apheresis (blood purification from cholesterol by means of a machine),
• if you need to undergo a medical examination requiring the injection of an iodine-containing contrast agent (a substance that makes organs such as the kidney or stomach visible on X-rays),
• if you have had changes in vision or eye pain during the intake of PERINDOPRIL AND INDAPAMIDE DOC. This could be a sign that glaucoma, an increase in pressure in one or both eyes, is developing. Stop taking PERINDOPRIL AND INDAPAMIDE DOC and consult a doctor.

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

Children and adolescents
PERINDOPRIL AND INDAPAMIDE DOC 5 mg/1.25 mg should not be given to children and
adolescents.

Other medicines and PERINDOPRIL AND INDAPAMIDE DOC 5 mg/1.25 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
You must not take PERINDOPRIL AND 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 can increase potassium levels in the blood (such as trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole for infections caused by bacteria; 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.

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

• other medicines for the treatment of high blood pressure, including an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is reported under "Do not take PERINDOPRIL AND INDAPAMIDE DOC 5 mg/1.25 mg" and "Warnings and precautions") or diuretics (medicines that increase the amount of urine produced by the kidneys),
• potassium-sparing diuretics used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• medicines used mainly for the treatment of diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See paragraph “Warnings and precautions”,
• sacubitril/valsartan (used for the treatment of long-term heart failure). See the paragraphs “Do not take PERINDOPRIL AND INDAPAMIDE DOC 5 mg/1.25 mg” and “Warnings and precautions”,
• anesthetics,
• iodine contrast agent,
• antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, injectable erythromycin),
• methadone (used for the treatment of dependencies),
• procainamide (for the treatment of irregular heartbeat),
• allopurinol (for the treatment of gout),
• antihistamines used to treat allergic reactions, such as hay fever (e.g. mizolastine, terfenadine or astemizole),
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune diseases or following transplants to prevent rejection (e.g. cyclosporine, tacrolimus),
• alofantrine (used to treat certain types of malaria),
• pentamidine (used to treat pneumonia),
• 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 stomach and digestive problems),
• digoxin or other cardiac glycosides (for the treatment of heart problems),
• baclofen (for the treatment of muscle stiffness in conditions such as multiple sclerosis),
• medicines for treating diabetes such as insulin, metformin or gliptins,
• calcium including calcium supplements,
• stimulant laxatives (e.g. senna),
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting)),
• injectable amphotericin B (for the treatment of severe fungal infections),
• medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)),
• tetracosactide (for the treatment of Crohn's disease),
• trimethoprim (for the treatment of infections),
• vasodilators including nitrates (products that make blood vessels wider),
• medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, norepinephrine or adrenaline).

PERINDOPRIL AND INDAPAMIDE DOC 5 mg/1.25 mg with food and drink
It is preferable to take PERINDOPRIL AND INDAPAMIDE DOC 5 mg/1.25 mg before a meal.

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

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy).
As a rule, your doctor will advise you to stop taking PERINDOPRIL E INDAPAMIDE
DOC 5 mg/1.25 mg before starting pregnancy or as soon as you become aware of being pregnant and will advise you to take another medicine instead of PERINDOPRIL E INDAPAMIDE
DOC 5 mg/1.25 mg.
PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg is not recommended in early pregnancy,
and should not be taken if you are pregnant for more than three months, as it can cause serious
harm to the baby if taken after the third month of pregnancy.

Breastfeeding
PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg is not recommended if you are breastfeeding. Inform
your doctor immediately if you are breastfeeding or are about to start breastfeeding.
Notify your doctor immediately.

Driving and operating machinery
PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg normally does not affect alertness but in
some patients, different reactions such as dizziness or fatigue may occur in relation to
lowering of blood pressure. If you experience such symptoms, your ability to drive vehicles or operate
machinery may be impaired.

PERINDOPRIL E INDAPAMIDE DOC 5 mg/1.25 mg contains lactose
If your doctor has diagnosed you with 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is one tablet a day. Your doctor may decide to modify the
dosage if you suffer from kidney impairment.
Take the tablet preferably in the morning and before a meal. The tablet must be swallowed
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
consult your doctor immediately. The most likely effect in case of overdose is low
blood pressure. If a significant drop in blood pressure occurs
(associated with nausea, vomiting, cramps, dizziness, drowsiness, mental confusion, changes in the amount
of urine produced by the kidneys), it may be helpful to lie down with your legs raised.

If you forget to take 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 the usual time. Do not take a double dose to make up for the forgotten
dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Severe dizziness or fainting due to low blood pressure (Common) (can affect up to 1 in 10 people),
• Bronchospasm (chest tightness, wheezing and shortness of breath) (Uncommon) (can 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) (can affect up to 1 in 100 people),
• Severe skin reactions including erythema multiforme (skin rash that often starts with itchy red patches on the face, arms or legs) or severe rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson Syndrome) or other allergic reactions (Very rare) (can 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) (can affect up to 1 in 10,000 people),
• Weakness of arms or legs, or speech problems which could be a sign of a possible stroke (Very rare) (can affect up to 1 in 10,000 people),
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe malaise (Very rare) (can affect up to 1 in 10,000 people),
• Yellowing of the skin or eyes (jaundice) which can be a sign of hepatitis (Very rare) (can 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 and in particular, if at the same time you do not feel well or have a high fever, this may be caused by abnormal muscle breakdown (Not known).

In decreasing order of frequency, side effects may include:

• Common: (can affect up to 1 in 10 people) Low level of potassium in the blood, skin reactions in subjects predisposed to allergy and asthma, headache, dizziness, vertigo, tingling, visual disturbances, tinnitus (sensation of noises 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: (can affect up to 1 in 100 people) Mood changes, sleep disorders, depression, hives, purpura (small red spots on the skin), clustered blisters, kidney disorders, impotence, sweating, excess of eosinophils (a type of white blood cells), changes in laboratory parameters: high level in the blood of potassium reversible upon discontinuation, low level in the blood of sodium, drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (fast heartbeat), hypoglycemia (very low blood sugar) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased sensitivity of the skin to the sun), arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise, peripheral edema, fever, increased urea in the blood, increased creatinine in the blood, falls.
• Rare: (can affect up to 1 in 1,000 people) Worsening of psoriasis, changes in laboratory parameters: low level of chloride in the blood, low level of magnesium in the blood, increased levels of liver enzymes, high level of serum bilirubin, fatigue, redness, reduction or absence of urine, acute renal failure. Dark urine, feeling unwell (nausea) or feeling sick (vomiting), muscle cramps, confusion and convulsions. These symptoms may be due to a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
• Very rare: (can 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 lowering of white blood cells and red blood cells, lower hemoglobin, lower number of platelets in the blood, high levels of calcium in the blood, abnormal liver function.
• Not known (frequency cannot be estimated from available data) Abnormal ECG tracing, changes in laboratory parameters: high levels of uric acid and high levels of sugar in the blood, worsening of vision (myopia), blurred vision, impaired vision, decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), abnormal color vision, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon). If you suffer from systemic lupus erythematosus (a connective tissue disease), this may worsen.

Blood, kidney, liver or pancreas disorders and changes in laboratory parameters (blood tests) may occur.
Your doctor may prescribe laboratory tests to check your condition.

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

5. How to store PERINDOPRIL E 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 which is stated on the package and bottle after Scad.
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 particular storage temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that 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 ingredients are perindopril tosylate and indapamide. Each film-coated tablet contains 5 mg of perindopril tosylate (equivalent to 3.408 mg of perindopril) and 1.25 mg of indapamide.
• The other ingredients are lactose monohydrate, corn starch, sodium hydrogen carbonate (E 500 (ii)), pregelatinized corn starch, Povidone K30 (E 1201), magnesium stearate (E 470b), partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol/PEG 3350 and talc.

Description of the appearance of PERINDOPRIL E INDAPAMIDE DOC and package contents
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 “P”, “I”
imprinted and a fracture 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 a polyethylene (PE) cap with
desiccant, containing 30 film-coated tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan, 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 Krakow, Poland.

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Netherlands Perindopril tosilaat/Indapamide DOC 5 mg/1.25 mg filmomhulde tabletten
Italy PERINDOPRIL E INDAPAMIDE DOC

PERINDOPRIL E INDAPAMIDE DOC 10 mg/2,5 mg film-coated tablets

Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What PERINDOPRIL E INDAPAMIDE DOC 10 mg/2,5 mg is and what it is used for
• 2. What you need to know before you take PERINDOPRIL E INDAPAMIDE DOC 10 mg/2,5 mg
• 3. How to take PERINDOPRIL E INDAPAMIDE DOC 10 mg/2,5 mg
• 4. Possible side effects
• 5. How to store PERINDOPRIL E INDAPAMIDE DOC 10 mg/2,5 mg
• 6. Contents of the pack and other information

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

PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg is a combination of two active ingredients, perindopril and indapamide. It is an antihypertensive and is used in the treatment of high blood pressure (hypertension) in adults.
PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg is indicated in those patients who are already taking perindopril 10 mg and indapamide 2.5 mg separately, who may instead take a tablet of PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg which contains both active ingredients.
Perindopril belongs to a class of drugs called ACE inhibitors. These drugs work by dilating blood vessels, which makes it easier for the heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in the amount of urine produced.
Each active ingredient reduces blood pressure and, together, they work to control blood pressure.

2. What you need to know before taking PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg

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

• if you are allergic to perindopril or to any other ACE inhibitor, or to indapamide or to any other sulfonamide, or to any of the other components of this medicine (listed in section 6),
• if you have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes related to a previous treatment with ACE inhibitors or if you or a family member has experienced such symptoms in any other circumstance (condition called angioedema),
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure containing aliskiren,
• if you have a severe liver disease or if you suffer from a disease called hepatic encephalopathy (a degenerative brain disease),
• if you suffer from a kidney disease, where the blood flow to the kidneys is reduced (renal artery stenosis),
• if you are undergoing dialysis, or any type of blood filtration. Depending on the machinery used, therapy with PERINDOPRIL AND INDAPAMIDE DOC may not be suitable for you,
• if you have low potassium levels in your blood,
• if you suspect you have decompensated heart failure (severe fluid retention, difficulty breathing),
• if you are pregnant for more than three months. (It is best to avoid PERINDOPRIL AND 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 a long-term (chronic) type of heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.

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

• if you have aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
• if you suffer from heart failure or other heart problems,
• if you suffer from kidney problems or are on dialysis,
• if you notice a decrease in vision or pain in your eyes. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a period ranging from a few hours to a few weeks after taking PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg. If left untreated, these conditions can lead to permanent vision loss. If you have 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 an abnormally high level of an 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 following a diet that restricts 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 AND INDAPAMIDE DOC 10 mg/2.5 mg should be avoided (see section “Other medicines and PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg”),
• if you are elderly,
• if you have had photosensitivity reactions,
• if you have severe allergic reactions with swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema). This can occur at any time during treatment. If such symptoms develop, stop treatment and call a doctor immediately,
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren.

The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is reported in the section "Do not take PERINDOPRIL AND INDAPAMIDE DOC
10 mg/2.5 mg".

• if you are of black origin as you may have a higher risk of angioedema and this medicine may be less effective in reducing 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, increases the risk of angioedema:
• racecadotril, a medicine used for the treatment of diarrhea;
• medicines used to prevent rejection after organ transplantation 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 class of so-called gliptins (used for the treatment of diabetes).

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat with difficulty
swallowing or breathing) has been reported in patients treated with ACE inhibitors, including PERINDOPRIL AND
INDAPAMIDE DOC. This can occur at any time during treatment. If such symptoms develop,
stop treatment with PERINDOPRIL AND INDAPAMIDE DOC and call
your doctor immediately. See also paragraph 4.
You should inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg is not recommended
at the beginning of pregnancy, and should not be taken if you are pregnant for more than 3 months, as
it can cause serious harm to the baby if taken during this period (see the paragraph “Pregnancy and
breastfeeding”).
If you are taking PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg, inform your doctor or
medical staff:

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

Athletes should be aware that PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg
contains an active ingredient (indapamide) that can cause a positive result in doping tests.

Children and adolescents
PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg should not be given to children and
adolescents.

Other medicines and PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
You must not take PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg with:

• lithium (used to treat manic disorder and depression),
• aliskiren (medicine used to treat hypertension) if you do not have diabetes or kidney problems,
• potassium supplements (including salt substitutes), potassium-sparing diuretics (such as triamterene, amiloride) and other drugs that can increase potassium levels in the blood (such as trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole for infections caused by bacteria; cyclosporine, an immunosuppressant drug used to prevent organ rejection after transplantation; 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 AND INDAPAMIDE DOC 10 mg/2.5 mg may be affected by other
medicines. Your doctor may need to adjust the dose and/or take other precautions. Make sure to tell your
doctor if you are taking any of these medicines, as special attention may be needed:

• other medicines for the treatment of high blood pressure, including an angiotensin II receptor blocker (AIIRA) or aliskiren (see also “Do not take PERINDOPRIL AND 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 per day,
• medicines used mainly for the treatment of diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See paragraph “Warnings and precautions”,
• sacubitril/valsartan (used for the treatment of long-term heart failure). See the paragraphs “Do not take PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg” and “Warnings and precautions”,
• anesthetics,
• iodine contrast agent,
• antibiotics used to treat bacterial infections (e.g. moxifloxacin, sparfloxacin, injectable erythromycin),
• methadone (used for the treatment of dependencies),
• procainamide (for the treatment of irregular heartbeat),
• allopurinol (for the treatment of gout),
• antihistamines used to treat allergic reactions, such as hay fever (e.g. mizolastine, terfenadine or astemizole),
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune diseases or following transplants to prevent rejection (e.g. cyclosporine, tacrolimus),
• alofantrine (used to treat certain types of malaria),
• pentamidine (used to treat pneumonia),
• 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 stomach and digestive problems),
• digoxin or other cardiac glycosides (for the treatment of heart problems),
• baclofen (for the treatment of muscle stiffness in conditions such as multiple sclerosis),
• medicines for treating diabetes such as insulin, metformin or gliptins,
• calcium including calcium supplements,
• stimulant laxatives (e.g. senna),
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting)),
• injectable amphotericin B (for the treatment of severe fungal infections),
• medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics (such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol),
• tetracosactide (for the treatment of Crohn's disease),
• trimethoprim (for the treatment of infections),
• vasodilators including nitrates (products that make blood vessels wider),
• medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, norepinephrine or adrenaline).

PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg with food and drink
It is preferable to take PERINDOPRIL AND INDAPAMIDE DOC 10 mg/2.5 mg before a meal.

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

Pregnancy
You should inform your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy).
Normally, your doctor will advise you to stop taking PERINDOPRIL E INDAPAMIDE
DOC 10 mg/2,5 mg before starting a pregnancy or as soon as you become aware of being pregnant and will advise you to take another medicine instead of PERINDOPRIL E INDAPAMIDE
DOC 10 mg/2,5 mg.
PERINDOPRIL E INDAPAMIDE DOC 10 mg/2,5 mg is not recommended in the early stages of pregnancy,
and should not be taken if you are pregnant for more than three months, as it can cause serious
harm to the baby if taken after the third month of pregnancy.

Breastfeeding
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 are about to start breastfeeding.
Notify your doctor immediately.

Driving and operating machinery
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 in relation to
lowering of blood pressure. If you experience such symptoms, your ability to drive vehicles or operate
machinery may be impaired.

PERINDOPRIL E INDAPAMIDE DOC 10 mg/2,5 mg contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is one tablet a day.
Take the tablet preferably in the morning and before a meal. The tablet must be swallowed
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
consult 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 be helpful 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 a forgotten
dose.

If you stop taking PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg
Since treatment for hypertension is usually lifelong, you should talk to your doctor before
stopping taking this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Severe dizziness or fainting due to low blood pressure (Common) (can affect up to 1 in 10 people),
• Bronchospasm (chest tightness, wheezing and shortness of breath) (Uncommon) (can 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) (can affect up to 1 in 100 people),
• Severe skin reactions including erythema multiforme (skin rash that often starts with itchy red patches on the face, arms or legs) or severe rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson Syndrome) or other allergic reactions (Very rare) (can affect up to 1 in 10,000 people),
• Cardiovascular disorders (irregular heartbeat, angina pectoris (chest, jaw and back pain, caused by exertion), heart attack) (Very rare) (can affect up to 1 in 10,000 people),
• Weakness of arms or legs, or speech problems which could be a sign of a possible stroke (Very rare) (can affect up to 1 in 10,000 people),
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe illness (Very rare) (can affect up to 1 in 10,000 people),
• Yellowing of the skin or eyes (jaundice) which can be a sign of hepatitis (Very rare) (can 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 and in particular, if at the same time you do not feel well or have a high fever, this may be caused by abnormal muscle breakdown (Not known).

In decreasing order of frequency, side effects may include:

• Common: (can affect up to 1 in 10 people) Low level of potassium in the blood, skin reactions in subjects predisposed to allergy and asthma, headache, dizziness, vertigo, tingling, vision disorders, tinnitus (sensation

of noises in the ears), cough, shortness of breath (dyspnea), gastrointestinal disorders (nausea,
vomiting, abdominal pain, taste disturbances, indigestion or difficulty digesting, diarrhea,
constipation), allergic reactions (such as skin rashes, itching), cramps, feeling of
tiredness.

• Uncommon: (can affect up to 1 in 100 people) Mood changes, sleep disorders, depression, hives, purpura (small red spots on the skin), clustered blisters, kidney disorders, impotence, sweating, excess of eosinophils (a type of white blood cells), changes in laboratory parameters: high level in the blood of potassium reversible upon discontinuation, low level in the blood of sodium, drowsiness, fainting, palpitations (awareness of heartbeat), tachycardia (fast heartbeat), hypoglycemia (very low blood sugar) in diabetic patients, vasculitis (inflammation of blood vessels), dry mouth, photosensitivity reactions (increased sensitivity of the skin to the sun), arthralgia (joint pain), myalgia (muscle pain), chest pain, malaise, peripheral edema, fever, increased urea in the blood, increased creatinine in the blood, falls.
• Rare: (can affect up to 1 in 1,000 people) Worsening of psoriasis, change in laboratory parameters: low level of chloride in the blood, low level of magnesium in the blood, increased levels of liver enzymes, high level of serum bilirubin, fatigue, redness, reduction or absence of urine, acute renal failure. Dark urine, feeling unwell (nausea) or feeling sick (vomiting), muscle cramps, confusion and convulsions. These symptoms may be due to a condition called SIADH (syndrome of inappropriate secretion of the antidiuretic hormone).
• Very rare: (can 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 lowering of white blood cells and red blood cells, lower hemoglobin, lower number of platelets in the blood, high levels of calcium in the blood, abnormal liver function.
• Not known (frequency cannot be estimated from the available data) Abnormal ECG tracing, changes in laboratory parameters: high levels of uric acid and high levels of blood sugar, worsening of vision (myopia), blurred vision, impaired vision, decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), abnormal color vision, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon). If you suffer from systemic lupus erythematosus (a connective tissue disease), this may worsen.

Blood, kidney, liver or pancreas disorders and changes in laboratory parameters (blood tests) may occur.
The doctor may prescribe laboratory tests to check your condition.

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

5. How to store PERINDOPRIL E 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 which is stated on the package 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 particular storage temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What contains PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg

• The active ingredients 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 ingredients are lactose monohydrate, corn starch, sodium hydrogen carbonate (E 500 (ii)), pregelatinized corn 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 package contents
The film-coated tablets of PERINDOPRIL E INDAPAMIDE DOC 10 mg/2.5 mg are white,
round and biconvex with a diameter of approximately 10 mm, smooth on both sides.
The tablets are available in polypropylene (PP) containers with a polyethylene (PE) cap with
desiccant, 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 Cracow, Poland.

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Netherlands Perindopril tosylate/Indapamide DOC 10 mg/2.5 mg film-coated tablets
Italy PERINDOPRIL E INDAPAMIDE DOC