PERAMIND 4 мг/1,25 мг/5 мг Таблетки

Содержание инструкции

1. What is PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC and what is it used for
2. What you need to know before taking PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC
3. How to take PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC
4. Possible side effects
5. How to store PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC
6. Package Contents and Other Information

PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 4 mg/1.25 mg/5 mg tablets
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 4 mg/1.25 mg/10 mg tablets
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 8 mg/2.5 mg/5 mg tablets
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 8 mg/2.5 mg/10 mg tablets
Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, 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/INDAPAMIDE/AMLODIPINA DOC is and what it is used for
• 2. What you need to know before you take PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC
• 3. How to take PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC
• 4. Possible side effects
• 5. How to store PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC
• 6. Contents of the pack and other information

1. What is PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC and what is it used for

PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC is prescribed for the treatment of high blood pressure (hypertension). All three active ingredients help to control high blood pressure (hypertension). Patients who are already taking the fixed combination of perindopril/indapamide and amlodipine as separate tablets may instead take a tablet of PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC which contains all three active ingredients. PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC is a combination of three active ingredients: perindopril, indapamide and amlodipine. Perindopril is an ACE inhibitor (Angiotensin Converting Enzyme). Amlodipina is a calcium channel blocker (belonging to the class of medicines called dihydropyridines). Indapamide is a diuretic. In patients with high blood pressure (hypertensive) perindopril and amlodipine work by relaxing the blood vessels, making it easier for blood to flow through them. Indapamide increases the amount of urine produced by the kidneys. Each active ingredient lowers blood pressure and, together, they work to control it.

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

Do not take PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC

• if you are allergic to perindopril or to any other ACE inhibitor, to indapamide or to any other sulfonamide, to amlodipine besylate or to other dihydropyridines, or to any of the other components of this medicine (listed in section 6),
• if you have experienced symptoms such as wheezing (difficulty breathing), 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 have a severe liver disease or if you suffer from a condition called hepatic encephalopathy (a degenerative brain disease caused by a liver disease),
• if you have a severe kidney disease where the blood flow to the kidneys is reduced (renal artery stenosis),

PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 8 mg/2.5 mg/5 mg and
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 8 mg/2.5 mg/10 mg are contraindicated in
cases of severe and moderate kidney problems.

• if you are undergoing dialysis or any type of blood filtration. Depending on the machinery used, therapy with PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC may not be suitable for you,
• if you have high or low levels of potassium in your blood,
• if you suspect you have decompensated heart failure (severe fluid retention, difficulty breathing),
• if you have cardiogenic shock (a condition in which the heart is unable to provide enough blood to the body), aortic stenosis (narrowing of the main blood vessel originating from the heart) or unstable angina (chest pain that occurs at rest),
• if you have severe low blood pressure (severe hypotension),
• if you suffer from heart failure (a condition in which the heart is unable to pump blood adequately causing shortness of breath or peripheral swelling such as swelling of legs, ankles or feet) following an acute heart attack,
• if you are pregnant for more than three months (it is best to avoid PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC even in the early stages of pregnancy - see “Pregnancy and Breastfeeding”),
• if you are breastfeeding,
• 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 taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking PERINDOPRIL/INDAPAMIDE/AMLODIPINA
DOC:

• if you have had a recent heart attack,
• if you have aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (disease of the heart muscle) or renal artery stenosis (narrowing of the artery that supplies blood to the kidneys),
• if you suffer from heart failure or other heart problems,
• if you have kidney problems or are undergoing dialysis,
• if you suffer from a severe increase in blood pressure (hypertensive crisis),
• if you have an abnormal increase in the levels of a hormone called aldosterone in the blood (primary aldosteronism),
• if you have liver problems,
• if you are affected by 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 gland),
• 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 take lithium or potassium-sparing diuretics (spironolactone, triamterene), as their use with PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC must be avoided (see “Other medicines and PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC”),
• if you are elderly and your dosage needs to be increased,
• if you have had photosensitivity reactions,
• if you have a severe allergic reaction 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 you develop these symptoms, stop treatment immediately and contact your doctor.
• 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. 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/INDAPAMIDE/AMLODIPINA DOC".

If you are of black ethnicity you may have a higher incidence of angioedema (swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing) and a lesser effect in lowering blood pressure,

• 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 (rapid swelling under the skin in areas such as the throat):
• racecadotril (used for the treatment of diarrhea),
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used in preventing rejection following transplantation and in cancer),
• vildagliptin, a medicine used to treat diabetes,
• sacubitril (available as a fixed-dose combination with valsartan), used in the long-term treatment of heart failure.

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat
with difficulty breathing and swallowing) has been reported in patients treated with ACE inhibitors including
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC.
This can occur at any time during treatment.
If you experience these symptoms, stop taking
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC immediately and contact your doctor. 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/INDAPAMIDE/AMLODIPINA DOC is not recommended in the early
stages of pregnancy, and must not be taken if you are pregnant for more than three months, as it can
cause serious harm to the baby if taken during this period (see “Pregnancy and breastfeeding”).
If you are taking PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC, 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 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 kidneys or stomach visible on X-rays).
• If you notice a change in vision or pain in one or both eyes while taking PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC. 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/INDAPAMIDE/AMLODIPINA DOC. 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 experience these symptoms, stop taking PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC immediately and consult a doctor. For those who engage in sports: the use of the drug without a therapeutic need constitutes doping and may still result in positive doping tests.

Children and adolescents
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC should not be given to children and
adolescents.

Other medicines and PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You should avoid taking PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC with:

• lithium (used for the treatment of depression),
• aliskiren (medicine used to treat high blood pressure) unless you suffer from diabetes mellitus or kidney problems,
• potassium supplements (including salt substitutes containing potassium), potassium-sparing diuretics and other medicines that can increase potassium levels in the blood (such as trimethoprim and co-trimoxazole 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 oncological therapy),
• other medicines used to treat high blood pressure: angiotensin converting enzyme inhibitors and angiotensin receptor blockers. Treatment with PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC may be affected by other medicines. Make sure to tell your doctor if you are taking any of the following medicines as special attention may be required:
• other medicines for the treatment of hypertension, including an angiotensin II receptor antagonist (AIIRA), aliskiren (see also the information under “Do not take PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC” 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,
• sacubitril/valsartan (used for the long-term treatment of heart failure). See section “Do not take PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC” and “Warnings and precautions”,
• anaesthetics,
• iodinated contrast agents,
• moxifloxacin, sparfloxacin (antibiotics: medicines used to treat infections),
• methadone (used for the treatment of dependencies),
• procainamide (for the treatment of irregular heartbeat),
• allopurinol (for the treatment of gout),
• terfenadine or astemizole (antihistamines for hay fever or allergies),
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis,
• immunosuppressants used to treat autoimmune diseases or after an organ transplant to prevent rejection (e.g. cyclosporine),
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV),
• medicines for the treatment of cancer,
• ketoconazole, itraconazole (for the treatment of fungal diseases),
• rifampicin, erythromycin, clarithromycin (antibiotics),
• halofantrine (used to treat some types of malaria),
• pentamidine (used for the treatment of pneumonia),
• gold salts, especially for intravenous administration (used to treat rheumatoid polyarthritis),
• vincamine (used to treat symptomatic cognitive diseases in the elderly including memory loss),
• bepridil, verapamil, diltiazem (heart medicines),
• sultopride (for the treatment of psychosis),
• medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide,

amiodarone, sotalol),

• cisapride, difemamile (used to treat stomach and digestive problems),
• digoxin and other cardiac glycosides (for the treatment of heart problems),
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
• medicines for the treatment of diabetes such as insulin or metformin or vildagliptin,
• 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 (aspirin),
• injectable amphotericin B (for the treatment of severe fungal diseases),
• medicines for the treatment of mental health disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antidepressants, antipsychotics),
• tetracosactide (for the treatment of Crohn's disease),
• trimethoprim (for the treatment of infections),
• vasodilators including nitrates (medicines that dilate blood vessels),
• medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline),
• hypericum perforatum (St John's Wort),
• dantrolene (infusion for severe alterations of body temperature),
• tacrolimus (a medicine used to modify the functioning of our immune system),
• simvastatin (a medicine to reduce cholesterol),
• cyclosporine (an immunosuppressant),
• anaesthetics,
• medicines used mainly for the treatment of diarrhoea (racecadotril) or for the prevention of rejection following organ transplantation (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”.

The doctor may modify your dose and/or take further precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the information under “Do not take PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC” and “Warnings and precautions”).

PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC with food and drink
It is preferable to take PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC before meals.
People taking PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC should not drink grapefruit juice or eat grapefruit. Grapefruit and its juice can induce an increase in the levels of the active substance amlodipine in the blood, which may determine an unquantifiable increase in the hypotensive effect of PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting a pregnancy). Usually your doctor will advise you to stop taking PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC before starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC.
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC is not recommended in the first trimester 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
Amlodipine has been shown to pass into breast milk in small amounts.
Tell your doctor if you are breastfeeding or are about to start breastfeeding.
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC is contraindicated for women who are breastfeeding and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newly born or premature.
Contact your doctor immediately.

Driving and operating machinery
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC does not alter your ability to concentrate but may cause dizziness or weakness due to low blood pressure which may alter your ability to drive vehicles or use machinery. It is advisable not to drive vehicles or use machinery until you know how PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC affects you.

PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC contains sodium
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC contains less than 1 mmol of sodium (23 mg) per tablet, i.e. is essentially “sodium-free”.

3. How to take PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult 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.
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 4 mg/1.25 mg/10 mg tablets
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 8 mg/2.5 mg/10 mg tablets
The score line is to facilitate breaking the tablet in case you have difficulty
swallowing it whole.
The doctor will decide the right dose for you. PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC is
prescribed to patients already undergoing treatment with perindopril/indapamide and amlodipine as single tablets.

If you take more PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC than you should
If you take an excessive number of tablets, contact your doctor or the emergency room of the
nearest hospital immediately .The most likely manifestation in case of overdose is a lowering
of blood pressure. If a marked lowering of blood pressure occurs (with
symptoms such as dizziness or weakness), it may be helpful to lie down with your legs elevated.
Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath that
may develop up to 24-48 hours after ingestion.

If you forget to take PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC
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/INDAPAMIDE/AMLODIPINA DOC, take the
next dose at the usual time. Do not take a double dose to compensate for forgetting the
tablet.

If you stop taking PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC
Since treatment for hypertension is usually lifelong, you will need to 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.

If you experience any of the following serious side effects, stop taking the medicine immediately and
contact your doctor immediately:

• severe dizziness or fainting due to low blood pressure (common) (may affect up to 1 in 10 people),
• bronchospasm (chest pain, shortness of breath or difficulty breathing) (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 that often starts with itchy red patches on the face, arms and legs) or severe rash, hives, redness all over the skin, severe itching, blisters, peeling and swelling of the skin, inflammation of the 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), myocardial infarction) (very rare) (may affect up to 1 in 10,000 people),
• weakness of the arms or legs, or difficulty speaking, which could be a sign of a possible stroke (very rare) (may 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) (may affect up to 1 in 10,000 people),
• yellowing of the skin or eyes (jaundice) which can 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).

In order of decreasing frequency, side effects may include:

• Very common (may affect more than 1 in 10): edema (fluid retention).
• Common (may affect up to 1 in 10): skin reactions in subjects predisposed to allergic and asthmatic reactions, headache, dizziness, vertigo, tingling, drowsiness, impaired vision, lightheadedness due to a drop in pressure, tinnitus (ringing in the ears), low blood pressure, palpitations (very rapid heartbeat), flushing (feeling of warmth on the face), shortness of breath (dyspnea), cough, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, changes in bowel habits, dyspepsia or indigestion, diarrhea, constipation), dry mouth, allergic reactions (such as skin rashes, itching), muscle spasms, swelling of the ankles, feeling tired, weakness.
• Uncommon (may affect up to 1 in 100 people): rhinitis (stuffy or runny nose), excess of eosinophils (a type of white blood cells), hypoglycemia (very low blood sugar levels), changes in laboratory parameters: reversible elevated plasma potassium levels after discontinuation, low blood sodium levels, mood changes, sleep disorders, insomnia, depression, tremors, loss of sensation of pain, tachycardia (rapid heartbeat), irregular heartbeat, vasculitis (inflammation of blood vessels), bronchospasm (chest pain, shortness of breath and difficulty breathing), angioedema (symptoms such as shortness of breath, swelling of the face or tongue), urticaria, clusters of blisters on the skin, purpura (red spots on the skin), changes in skin color, sweating, hair loss, red and discolored patches on the skin, photosensitivity reaction (increased sensitivity of the skin to sunlight), back, muscle and joint pain, kidney disorders, increased need to urinate especially at night, impotence, breast enlargement in men, chest pain, pain, general feeling of discomfort, fever, increased blood urea, increased plasma creatinine, weight gain or loss, falls,

fainting.
If you suffer from systemic lupus erythematosus (a type of collagen disease), this may worsen.

• Rare (may affect up to 1 in 1,000 people): confused state, worsening of psoriasis, changes in laboratory parameters: increased calcium levels, increased liver enzyme levels, high serum bilirubin levels. Dark urine, feeling unwell (nausea) or feeling sick (vomiting), muscle cramps, confusion and convulsions. These symptoms may be attributable to a condition called SIADH (syndrome of inappropriate secretion of antidiuretic hormone). Reduced or absent urine, acute renal failure.
• Very rare (may affect up to 1 in 10,000 people): Changes in blood values such as decreased number of white blood cells and red blood cells, reduced hemoglobin and hematocrit, decreased number of platelets in the blood, high blood sugar levels, cardiovascular disorders (angina, heart attack, stroke), eosinophilic pneumonia (a rare type of pneumonia), swelling of the gums, inflamed pancreas (pancreatitis), abdominal bloating (gastritis), abdominal bloating (gastritis), peripheral neuropathy (disease that causes loss of sensation, pain, inability to control muscles), severe skin manifestations such as erythema multiforme. Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may have an impact on some medical tests.
• Not known (frequency cannot be estimated based on available data): Abnormal ECG heart tracing, changes in laboratory parameters: low potassium levels in the blood, high uric acid levels, low sodium levels with a low blood volume causing dehydration and dizziness when standing up, rapid onset of distant vision impairment (acute myopia), blurred 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), life-threatening irregular heartbeat (torsades de pointes). In case of liver failure (liver problems), there is a possibility of developing hepatic encephalopathy (degenerative brain disease). Tremors, postural rigidity, mask-like face, slow movements, unbalanced gait. Discoloration, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon). If you experience these symptoms, seek immediate medical attention.

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/INDAPAMIDE/AMLODIPINA DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC contains

• The active ingredients are perindopril tert-butylamine, indapamide and amlodipine (besilate). PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 4 mg/1.25 mg/5 mg Each tablet contains 4 mg of perindopril tert-butylamine, 1.25 mg of indapamide and 5 mg of amlodipine (as besilate). PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 4 mg/1.25 mg/10 mg Each tablet contains 4 mg of perindopril tert-butylamine, 1.25 mg of indapamide and 10 mg of amlodipine (as besilate). PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 8 mg/2.5 mg/5 mg Each tablet contains 8 mg of perindopril tert-butylamine, 2.5 mg of indapamide and 5 mg of amlodipine (as besilate). PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 8 mg/2.5 mg/10 mg Each tablet contains 8 mg of perindopril tert-butylamine, 2.5 mg of indapamide and 10 mg of amlodipine (as besilate).
• The other ingredients are sodium hydrogen carbonate, microcrystalline cellulose (E460), pregelatinized starch (type 1500), sodium starch glycolate (type A), hydrated colloidal silica, magnesium stearate (E470b) and calcium chloride hexahydrate. See section 2 “PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC contains sodium”.

Description of the appearance of PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC and package contents
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 4 mg/1.25 mg/5 mg tablets:
white or almost white, round, slightly biconvex tablets with beveled edges and a diameter of
7 mm.
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 4 mg/1.25 mg/10 mg tablets:
white or almost white, oval, biconvex tablets with a score line on one side and a length of
12 mm. The score line on the tablet is intended to aid in breaking the tablet for easier swallowing and not for dividing it into equal doses.
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 8 mg/2.5 mg/5 mg tablets:
white or almost white, round, biconvex tablets with beveled edges and a diameter of 9 mm.
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 8 mg/2.5 mg/10 mg tablets:
white or almost white, round, biconvex tablets with a score line on one side with beveled
edges and a diameter of 9 mm. The score line on the tablet is intended to aid in breaking the tablet for easier swallowing and not for dividing it into equal doses.
The tablets are available in boxes of 30 tablets in blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan, Italy.

Manufacturer
Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Italy PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC