Peramind: detailed information

Package leaflet: Information for the patient

PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC 4 mg/1.25 mg/5 mg tablets
PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC 4 mg/1.25 mg/10 mg tablets
PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC 8 mg/2.5 mg/5 mg tablets
PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC 8 mg/2.5 mg/10 mg tablets
Please read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

2. What you should know before taking PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC

Do not take PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC

if you are allergic to perindopril or any other ACE inhibitor, to indapamide or any other sulfonamide, to amlodipine besylate or other dihydropyridines, or to any of the other ingredients of this medicine (listed in section 6),
if you have had symptoms such as wheezing (shortness of breath), facial or tongue swelling, 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 under any circumstances (a condition called angioedema),
if you have severe liver disease or suffer from a condition known as hepatic encephalopathy (a degenerative brain disorder caused by liver disease),
if you have severe kidney disease where blood flow to the kidneys is reduced (renal artery stenosis). PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC 8 mg/2.5 mg/5 mg and PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC 8 mg/2.5 mg/10 mg are contraindicated in cases of moderate to severe kidney problems.
if you are undergoing dialysis or any type of blood filtration. Depending on the equipment used, treatment with PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC may not be suitable for you,
if you have high or low levels of potassium in your blood,
if you suspect you have untreated decompensated heart failure (severe fluid retention, difficulty breathing),
if you have cardiogenic shock (a condition in which the heart cannot supply sufficient blood to the body), aortic stenosis (narrowing of the main blood vessel leaving the heart), or unstable angina (chest pain occurring at rest),
if you have severe low blood pressure (severe hypotension),
if you have heart failure (a condition in which the heart cannot pump blood adequately, causing shortness of breath or peripheral swelling such as in legs, ankles, or feet) following an acute heart attack,
if you are more than three months pregnant (PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC should also be avoided in early pregnancy—see “Pregnancy and Breast-feeding”),
if you are breast-feeding,
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren,
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).

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

if you have recently had a heart attack,
if you have aortic stenosis (narrowing of the main blood vessel leaving the heart), hypertrophic cardiomyopathy (a heart muscle disease), or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
if you suffer from heart failure or other heart conditions,
if you have kidney problems or are undergoing dialysis,
if you have a severe increase in blood pressure (hypertensive crisis),
if you have abnormally high levels of a hormone called aldosterone in your blood (primary hyperaldosteronism),
if you have liver problems,
if you have a connective tissue disease (skin disease) such as systemic lupus erythematosus or scleroderma,
if you suffer from atherosclerosis (hardening of the arteries),
if you have hyperparathyroidism (overactivity of the parathyroid gland),
if you suffer from gout,
if you have diabetes,
if you are on a low-salt diet or use potassium-containing salt substitutes,
if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as their use with PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC should be avoided (see “Other medicines and PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC”),
if you are elderly and your dosage needs to be increased,
if you have experienced photosensitivity reactions,
if you have a severe allergic reaction with swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema). This can occur at any time during treatment. If you develop such 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—e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
aliskiren. Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also the section "Do not take PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC".
if you are of Black ethnicity, you may have a higher incidence of angioedema (swelling of the face, lips, mouth, tongue, or throat causing difficulty swallowing or breathing) and a reduced blood pressure-lowering effect,
if you are a dialysis patient undergoing hemodialysis with high-flux membranes,
if you are taking any of the following medicines, which increase the risk of angioedema (rapid swelling under the skin, e.g., in the throat):
racecadotril (used to treat diarrhea),
sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of so-called mTOR inhibitors (used to prevent transplant rejection and in cancer),
vildagliptin, a medicine used to treat diabetes,
sacubitril (available as a fixed-dose combination with valsartan), used in long-term treatment of heart failure.

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, causing breathing or swallowing difficulties) has been reported in patients treated with ACE inhibitors, including PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC. This may occur at any time during treatment. If you experience these symptoms, stop treatment with PERINDOPRIL/INDAPAMIDE/AMLODIPINE 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/AMLODIPINE DOC is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken during this period (see “Pregnancy and Breast-feeding”).
If you are taking PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC, inform your doctor or medical staff:

if you are to undergo anesthesia and/or surgery,
if you have recently had diarrhea or vomiting, or if you are dehydrated,
if you are to undergo dialysis or LDL apheresis (blood purification to remove cholesterol using a machine),
if you are to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings,
if you are to undergo a medical examination requiring injection of an iodinated contrast agent (a substance used to make organs such as kidneys or stomach visible on X-rays).
If you notice changes in vision or pain in one or both eyes during treatment with PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from a few hours to several weeks after taking PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC. If untreated, these conditions may lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this condition. If you experience these symptoms, stop treatment with PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC immediately and consult a doctor.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC must not be administered to children and adolescents.

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

lithium (used to treat depression),
aliskiren (a medicine used to treat high blood pressure) if you do not have diabetes mellitus or kidney problems,
potassium supplements (including potassium-containing salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots),
estramustine (used in cancer therapy),
other medicines used to treat high blood pressure: angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers. Treatment with PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC may be affected by other medicines. Make sure to inform your doctor if you are taking any of the following medicines, as special attention may be required:
other medicines for treating high blood pressure, including an angiotensin II receptor antagonist (AIIRA), aliskiren (see also "Do not take PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC" and "Warnings and precautions") or diuretics (medicines that increase urine production by the kidneys), potassium-sparing diuretics used in heart failure treatment: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily,
sacubitril/valsartan (used for long-term treatment of heart failure). See section "Do not take PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC" and "Warnings and precautions",
anesthetics,
iodinated contrast agents,
moxifloxacin, sparfloxacin (antibiotics: medicines used to treat infections),
methadone (used to treat addiction),
procainamide (for treating irregular heartbeat),
allopurinol (for treating 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 organ transplantation to prevent rejection (e.g., cyclosporine),
ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV),
medicines for treating cancer,
ketoconazole, itraconazole (for treating fungal diseases),
rifampicin, erythromycin, clarithromycin (antibiotics),
halofantrine (used to treat certain types of malaria),
pentamidine (used to treat pneumonia),
gold salts, especially for intravenous administration (used to treat rheumatoid polyarthritis),
vincamine (used to treat symptomatic cognitive disorders in the elderly, including memory loss),
bepridil, verapamil, diltiazem (heart medicines),
sultopride (for treating psychosis),
medicines used for heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol),
cisapride, difemamil (used to treat gastric and digestive problems),
digoxin and other cardioactive glycosides (for treating heart conditions),
baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
medicines for treating 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-dose salicylates (e.g., acetylsalicylic acid (aspirin)),
injectable amphotericin B (for treating serious fungal diseases),
medicines for treating mental health disorders such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antidepressants, neuroleptics),
tetracosactide (for treating Crohn's disease),
trimethoprim (for treating infections),
vasodilators including nitrates (medicines that dilate blood vessels),
medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline),
Hypericum perforatum (St. John's wort),
dantrolene (infusion for severe body temperature disturbances),
tacrolimus (a medicine used to modify the function of our immune system),
simvastatin (a medicine to lower cholesterol),
cyclosporine (an immunosuppressant),
anesthetics,
medicines mainly used to treat diarrhea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”.

Your doctor may adjust your dose and/or take additional precautions:

if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also "Do not take PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC" and "Warnings and precautions").

PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC with food and drinks
It is preferable to take PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC before meals.
People taking PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC should not drink grapefruit juice or eat grapefruit. Grapefruit and its juice may increase blood levels of the active ingredient amlodipine, potentially leading to an unpredictable increase in the blood pressure-lowering effect of PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC.

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC before starting pregnancy or as soon as you find out you are pregnant, and will recommend an alternative medicine.
PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken after the third month.
Breast-feeding
It has been shown that amlodipine passes into breast milk in small amounts.
Inform your doctor if you are breast-feeding or planning to start breast-feeding.
PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC is contraindicated for women who are breast-feeding. Your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is newborn or was born prematurely.
Contact your doctor immediately.

Driving and using machines
PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC does not impair your attention, but may cause dizziness or weakness due to low blood pressure, which could affect your ability to drive or operate machinery. It is advisable not to drive or use machinery until you know how PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC affects you.

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

3. How to take PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet daily. Take the tablet preferably in the morning and before a meal. Swallow the tablet with a glass of water.
PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC 4 mg/1.25 mg/10 mg tablets
PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC 8 mg/2.5 mg/10 mg tablets
The break line on the tablet is intended to facilitate breaking the tablet in case you have difficulty swallowing it whole.
Your doctor will determine the appropriate dose for you. PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC is prescribed for patients already being treated with perindopril/indapamide and amlodipine as separate tablets.

If you take more PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC than you should
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately. The most likely symptom of overdose is low blood pressure. If a marked drop in blood pressure occurs (with symptoms such as dizziness or weakness), lying down with your legs raised may be helpful.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop within 24–48 hours after ingestion.

If you forget to take PERINDOPRIL/INDAPAMIDE/AMLODIPINE 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/AMLODIPINE DOC, take the next dose at your usual time. Do not take a double dose to make up for the forgotten tablet.

If you stop taking PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC
Since treatment for high blood pressure is usually lifelong, you must speak to your doctor before stopping this medicine.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking the medicine immediately and
contact your doctor straight away:

severe dizziness or fainting due to low blood pressure (common) (may affect up to 1 in 10 people),
bronchospasm (chest pain, breathlessness 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 (a skin rash that often starts with itchy red patches on the face, arms and legs), or severe skin rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome) or other allergic reactions (very rare) (may affect up to 1 in 10,000 people),
cardiovascular disorders (irregular heartbeat, angina pectoris (chest, jaw and back pain caused by physical exertion), myocardial infarction) (very rare) (may affect up to 1 in 10,000 people),
weakness in the arms or legs, or difficulty speaking, which could be signs of a possible stroke (very rare) (may affect up to 1 in 10,000 people),
inflammation of the pancreas which may cause severe abdominal and back pain associated with a strong feeling of illness (very rare) (may affect up to 1 in 10,000 people),
yellowing of the skin or eyes (jaundice), which may be a sign of hepatitis (very rare) (may affect up to 1 in 10,000 people),
life-threatening irregular heartbeat (not known),
brain disease caused by liver disease (hepatic encephalopathy) (not known).

Undesirable effects in order of decreasing frequency may include:

Very common (may affect more than 1 in 10 people): oedema (fluid retention).
Common (may affect up to 1 in 10 people): skin reactions in individuals predisposed to allergic and asthmatic reactions, headache, dizziness, vertigo, tingling, drowsiness, visual disturbances, light-headedness due to low blood pressure, tinnitus (sensation of noise in the ears), low blood pressure, palpitations (very rapid heartbeat), flushing (sensation of warmth in the face), shortness of breath (dyspnoea), cough, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, changes in bowel habits, dyspepsia or difficulty digesting, diarrhoea, constipation), dry mouth, allergic reactions (such as skin rashes, itching), muscle spasms, swollen ankles, feeling of fatigue, weakness.
Uncommon (may affect up to 1 in 100 people): rhinitis (blocked or runny nose), eosinophilia (excess of eosinophils, a type of white blood cells), hypoglycaemia (very low blood sugar levels), changes in laboratory parameters: elevated plasma potassium levels reversible after discontinuation, low blood sodium levels, mood changes, sleep disorders, insomnia, depression, tremors, loss of pain sensation, tachycardia (rapid heartbeat), irregular heartbeat, vasculitis (inflammation of blood vessels), bronchospasm (chest pain, breathlessness and shortness of breath), angioedema (symptoms such as breathlessness, swelling of the face or tongue), urticaria, clusters of blisters on the skin, purpura (small red spots on the skin), skin colour changes, sweating, hair loss, red and discoloured patches on the skin, photosensitivity reaction (increased skin sensitivity to sunlight), back pain, muscle and joint pain, kidney disorders, increased need to urinate, especially at night, impotence, breast enlargement in men, chest pain, pain, general feeling of malaise, fever, increased plasma 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): confusion, worsening of psoriasis, changes in laboratory parameters: increased calcium levels, increased liver enzyme levels, high serum bilirubin levels. Dark-coloured urine, feeling unwell (nausea) or illness (vomiting), muscle cramps, confusion and seizures. These symptoms may be related to a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion). Decreased or absent urine output, acute renal failure.
Very rare (may affect up to 1 in 10,000 people): changes in blood values such as decreased number of white and red blood cells, reduced haemoglobin and haematocrit, decreased number of platelets in the blood, high blood sugar levels, cardiovascular disorders (angina, heart attack, stroke), eosinophilic pneumonia (a rare type of pneumonia), swollen gums, inflamed pancreas (pancreatitis), abdominal swelling (gastritis), abdominal swelling (gastritis), peripheral neuropathy (a disease causing 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 affect certain medical tests.
Not known (frequency cannot be estimated from the available data): abnormal ECG trace, changes in laboratory parameters: low potassium levels in the blood, high levels of uric acid, low sodium levels with low blood volume causing dehydration and dizziness when standing up, sudden-onset reduction in distance vision (acute myopia), blurred vision, decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), 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 fingers of hands or feet (Raynaud's phenomenon). If you experience any of these symptoms, contact your doctor immediately.

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

5. How to store PERINDOPRIL/INDAPAMIDE/AMLODIPINE DOC

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

6. Package contents and other information

What PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC contains

The active substances are perindopril tert-butylamine, indapamide and amlodipine (besylate).
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 besylate).
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 besylate).
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 besylate).
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 besylate).
The other components are sodium hydrogen carbonate, microcrystalline cellulose (E460), pregelatinized corn 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 the contents of the
pack
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 4 mg/1.25 mg/5 mg tablets:
white or almost white, round, slightly biconvex tablets with bevelled 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 facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet into equal doses.
PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC 8 mg/2.5 mg/5 mg tablets:
white or almost white, round, biconvex tablets with bevelled 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, bevelled edges and a diameter of 9 mm. The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet 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 Milano, Italy.
Manufacturer
Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.

This medicinal product is authorised in the European Economic Area countries under the following
names:
Italy PERINDOPRIL/INDAPAMIDE/AMLODIPINA DOC