Perindopril, indapamide and amlodipine EG
Italy
Table of Contents
Patient Information Leaflet: Information for the Patient
Perindopril, Indapamide and Amlodipine EG 5 mg/1.25 mg/5 mg film-coated tablets, 5 mg/1.25 mg/10 mg film-coated tablets, 10 mg/2.5 mg/5 mg film-coated tablets, 10 mg/2.5 mg/10 mg film-coated tablets
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Perindopril, Indapamide and Amlodipine EG is and what it is used for
- What you need to know before taking Perindopril, Indapamide and Amlodipine EG
- How to take Perindopril, Indapamide and Amlodipine EG
- Possible side effects
- How to store Perindopril, Indapamide and Amlodipine EG
- Package contents and other information
1. What Perindopril, Indapamide and Amlodipine EG is and what it is used for
Perindopril, Indapamide and Amlodipine EG is a combination of 3 active substances: perindopril, indapamide and amlodipine. It is an antihypertensive medicine used in the treatment of 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 and Amlodipine EG, which contains the three active substances at the same dosage.
Each active substance reduces blood pressure and, together, they act to control it:
- Perindopril belongs to a class of medicines called Angiotensin-Converting Enzyme (ACE) inhibitors. It works by relaxing blood vessels, thereby making it easier for the heart to pump blood through them.
- Indapamide is a diuretic (belonging to a class of medicines called sulfonamide derivatives with an indoline ring). 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.
- Amlodipine is a calcium channel blocker (belonging to the class of medicines called dihydropyridines). It works by relaxing blood vessels, allowing blood to pass through more easily.
2. What you need to know before taking Perindopril, indapamide and amlodipine EG
Do not take Perindopril, indapamide and amlodipine EG
- if you are allergic to perindopril or other ACE inhibitors, to indapamide or other sulfonamides, to amlodipine or other dihydropyridines, or to any of the other ingredients of this medicine (listed in section 6);
- if you have experienced symptoms such as wheezing, facial or tongue swelling, severe itching or serious skin rashes related to a previous treatment with ACE inhibitors, or if you or a family member has had such symptoms under any circumstances (a condition called angioedema);
- if you have severe liver disease or suffer from a condition called hepatic encephalopathy (a brain disorder caused by liver disease);
- if you suspect you have untreated decompensated heart failure (severe fluid retention, breathing difficulties);
- if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body);
- if you have heart failure following a heart attack;
- if your blood pressure is severely low (hypotension);
- if your blood potassium levels are low;
- if you have severe kidney problems due to reduced blood flow to the kidneys (renal artery stenosis);
- if you are undergoing dialysis or any type of blood filtration. Depending on the equipment used, treatment with Perindopril, indapamide and amlodipine EG may not be suitable for you;
- if you have moderate kidney problems (for Perindopril, indapamide and amlodipine EG dosages containing 10 mg/2.5 mg/5 mg and 10 mg/2.5 mg/10 mg);
- if you are more than three months pregnant (it is also advisable to avoid Perindopril, indapamide and amlodipine EG during early pregnancy – see section on pregnancy);
- 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 heart failure, as the risk of angioedema (rapid swelling under the skin, e.g. in the throat) is increased (see "Warnings and precautions" and "Other medicines and Perindopril, indapamide and amlodipine EG").
Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril, indapamide and amlodipine EG:
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if you have hypertrophic cardiomyopathy (a heart muscle disorder) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys);
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if you suffer from heart failure or any other heart condition;
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if you have severe high blood pressure (hypertensive crisis);
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if you have liver problems;
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if you suffer from a connective tissue disease (skin disorder) such as systemic lupus erythematosus or scleroderma;
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if you suffer from atherosclerosis (hardening of the arteries);
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if you are scheduled for a test to assess parathyroid gland function;
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if you suffer from gout;
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if you have diabetes;
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if you are on a salt-restricted diet or use potassium-containing salt substitutes (it is essential to maintain a well-balanced level of potassium in the blood);
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if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as their use with Perindopril, indapamide and amlodipine EG should be avoided (see "Other medicines and Perindopril, indapamide and amlodipine EG");
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if you are elderly and your dosage needs to be increased;
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if you have experienced photosensitivity reactions;
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if you are of Black ethnicity, you may have a higher incidence of angioedema (swelling of the face, lips, mouth, tongue or throat that may cause difficulty swallowing or breathing) and a reduced blood pressure-lowering effect;
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if you are a dialysis patient undergoing hemodialysis with high-flux membranes;
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if you have kidney problems or are undergoing dialysis;
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if you experience 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 intraocular pressure and may occur within hours or weeks of taking Perindopril, indapamide and amlodipine EG. If untreated, this condition may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at increased risk of developing this condition;
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if you suffer from muscle disorders including muscle pain, tenderness, weakness or cramps;
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if you have abnormally high blood levels of a hormone called aldosterone (primary hyperaldosteronism);
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if you have too much acid in your blood, which may cause rapid breathing;
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if you have cerebral circulatory insufficiency (low blood pressure in the brain);
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if you develop swelling of the face, lips, mouth, tongue or throat that may cause difficulty swallowing or breathing (angioedema), which may occur at any time during treatment, stop treatment immediately and contact your doctor without delay;
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if you are taking any of the following medicines, your risk of angioedema may be increased:
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racecadotril (used to treat diarrhoea),
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sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTor inhibitors (used to prevent organ transplant rejection and in cancer treatment),
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sacubitril (available as a fixed-dose combination with valsartan), used for long-term treatment of heart failure,
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linagliptin, saxagliptin, sitagliptin, vildagliptin and other medicines belonging to the class of so-called gliptins (used to treat diabetes);
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if you are taking any of the following medicines used to treat high blood pressure:
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an "angiotensin II receptor antagonist" (AIIRA), also known as sartans (e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
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aliskiren. Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take Perindopril, indapamide and amlodipine EG".
Your doctor may order blood tests to check for low levels of sodium or potassium or high levels of calcium.
You must inform your doctor if you suspect (or are planning) a pregnancy. Perindopril, indapamide and amlodipine EG is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see "Pregnancy and breastfeeding").
If you are taking Perindopril, indapamide and amlodipine EG, also inform your doctor or medical staff:
- if you are scheduled for anaesthesia and/or surgery,
- if you have recently had diarrhoea or vomiting or if you are dehydrated,
- if you are scheduled for dialysis or LDL apheresis (blood purification to remove cholesterol using a machine),
- if you are scheduled for desensitisation treatment to reduce allergic reactions to bee or wasp stings,
- if you are scheduled for a medical examination requiring injection of an iodinated contrast medium (a substance used to make organs such as kidneys or stomach visible on X-rays).
Athletes should be aware that Perindopril, indapamide and amlodipine EG contains an active substance (indapamide) that may lead to positive results in doping tests.
Children and adolescents
Perindopril, indapamide and amlodipine EG must not be administered to children and adolescents.
Other medicines and Perindopril, indapamide and amlodipine EG
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Do not take aliskiren (used to treat high blood pressure) if you have diabetes or kidney problems.
Avoid concomitant use of Perindopril, indapamide and amlodipine EG with:
- lithium (used to treat certain mental health disorders such as mania, manic depression and recurrent depression),
- potassium-sparing diuretics (e.g. triamterene, amiloride), potassium supplements or potassium-containing salt substitutes, other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood and prevent clotting); trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole (used to treat bacterial infections),
- dantrolene (by infusion), also used to treat malignant hyperthermia during anaesthesia (symptoms include very high fever and muscle rigidity),
- estramustine (used in cancer therapy),
- medicines used mainly to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTor inhibitors). See section "Warnings and precautions",
- sacubitril/valsartan (used for long-term treatment of heart failure). See sections "Do not take Perindopril, indapamide and amlodipine EG" and "Warnings and precautions",
- other medicines used to treat high blood pressure: angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers.
Treatment with Perindopril, indapamide and amlodipine EG may be affected by other medicines. Your doctor may consider it necessary to adjust the dose and/or take other precautions. Make sure to inform your doctor if you are taking any of the following medicines, as special attention may be required:
- other medicines for treating hypertension, including an angiotensin II receptor antagonist (AIIRA), aliskiren (see also sections "Do not take Perindopril, indapamide and amlodipine EG" and "Warnings and precautions") or diuretics (medicines that increase the amount of urine produced by the kidneys),
- potassium-sparing diuretics used in heart failure treatment: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily,
- anaesthetics,
- iodinated contrast media,
- bepridil (used to treat angina pectoris),
- methadone (used to treat addiction),
- medicines used to treat heart rhythm disorders (e.g. dofetilide, ibutilide, bretylium, cisapride, difemamil, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol),
- verapamil, diltiazem (heart medicines),
- digoxin or other digitalis glycosides (for treating heart problems),
- antibiotics used to treat bacterial infections (e.g. rifampicin, erythromycin, clarithromycin, sparfloxacin, moxifloxacin),
- antifungal medicines (e.g. itraconazole, ketoconazole, intravenous amphotericin B),
- allopurinol (for treating gout),
- antihistamines used to treat allergic reactions such as hay fever (e.g. mizolastine, terfenadine, astemizole),
- corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis, and non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high-dose salicylates (e.g. acetylsalicylic acid, a substance found in many medicines used to relieve pain and reduce fever and to prevent blood clotting),
- immunosuppressants (medicines used to control the body’s immune response) for treating autoimmune diseases or after organ transplantation (e.g. cyclosporine, tacrolimus),
- tetracosactide (for treating Crohn’s disease),
- gold salts, especially for intravenous administration (used to treat symptoms of rheumatoid arthritis),
- halofantrine (used to treat certain types of malaria),
- baclofen, used to treat muscle stiffness in diseases such as multiple sclerosis,
- medicines for treating diabetes such as insulin or metformin,
- calcium, including calcium supplements,
- stimulant laxatives (e.g. senna),
- medicines for treating cancer,
- vincamine (used to treat symptomatic cognitive disorders in the elderly, including memory loss),
- medicines used to treat mental health disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol),
- pentamidine (used to treat pneumonia),
- ritonavir, indinavir, nelfinavir (so-called protease inhibitors, used to treat HIV),
- Hypericum perforatum (St. John’s Wort),
- trimethoprim (for treating infections),
- medicines used to treat low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline),
- nitroglycerin and other nitrates or other vasodilators that may further reduce blood pressure.
Perindopril, indapamide and amlodipine EG with food and drinks
People taking Perindopril, indapamide and amlodipine EG should not consume grapefruit or grapefruit juice, as grapefruit and its juice may increase blood levels of the active substance amlodipine, potentially causing an unpredictable increase in the blood pressure-lowering effect of Perindopril, indapamide and amlodipine EG.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you suspect (or are planning) a pregnancy.
Your doctor will usually advise you to stop treatment with Perindopril, indapamide and amlodipine EG before becoming pregnant or as soon as pregnancy is confirmed, and will prescribe an alternative medicine instead.
Perindopril, indapamide and amlodipine EG is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
Consult your doctor if you are breastfeeding or intend to breastfeed.
Perindopril, indapamide and amlodipine EG is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.
Driving and using machines
Perindopril, indapamide and amlodipine EG may affect your ability to drive or operate machinery.
If the tablets make you feel unwell, dizzy, tired or cause headaches, avoid driving or operating machinery and contact your doctor immediately.
Perindopril, indapamide and amlodipine EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially "sodium-free".
3. How to take Perindopril, indapamide and amlodipine EG
Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the tablet with a glass of water, preferably in the morning and before a meal. Your doctor
will determine the correct dose for you. Normally, the dose is one tablet once daily.
If you take more Perindopril, indapamide and amlodipine EG than you should
If you take too many tablets, your blood pressure may drop excessively, which
can be dangerous and sometimes associated with nausea, vomiting, cramps, dizziness, drowsiness, mental confusion,
oliguria (passing less urine than normal), anuria (no urine production or passage).
You may experience mental dullness, weakness or fainting. If the drop in blood pressure is severe enough, it
may cause shock. Your skin may become cold and clammy, and you may lose consciousness.
Excess fluid may accumulate in the lungs (pulmonary edema), causing breathlessness, which may
occur up to 24–48 hours after ingestion.
If you have taken too many tablets of Perindopril, indapamide and amlodipine EG,
contact your doctor immediately.
If you forget to take Perindopril, indapamide and amlodipine EG
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 and amlodipine EG, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Perindopril, indapamide and amlodipine EG
Since treatment for high blood pressure is usually lifelong, you should speak with your doctor before stopping
this medicine.
If you have any questions about how to use this medicine, consult your doctor, pharmacist or nurse.
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
side effects, which may be serious:
- Sudden wheezing, chest pain, shortness of breath or difficulty breathing (uncommon – may affect up to 1 in 100 people);
- Swelling of the eyelids, face or lips (uncommon – may affect up to 1 in 100 people);
- Swelling of the mouth, tongue and throat which may cause severe breathing difficulties (uncommon – may affect up to 1 in 100 people);
- Severe skin reactions including severe 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, Toxic Epidermal Necrolysis) or other allergic reactions (very rare – may affect up to 1 in 10,000 people);
- Severe dizziness or fainting (common – may affect up to 1 in 10 people);
- Heart attack (very rare – may affect up to 1 in 10,000 people), irregular heartbeat which may be life-threatening (frequency not known);
- Inflammation of the pancreas which may cause severe abdominal and back pain accompanied by a general feeling of illness (very rare – may affect up to 1 in 10,000 people);
- Muscle weakness, cramps, tenderness or pain, particularly if you also feel unwell and have a high fever, which may be due to abnormal muscle breakdown (frequency not known).
In order of decreasing frequency, side effects may include:
- Very common (may affect more than 1 in 10 people): Edema (fluid retention).
- Common (may affect up to 1 in 10 people):
Low blood potassium levels, headache, dizziness, palpitations (awareness of heartbeat), hot flushes, vertigo, pins and needles sensation, visual disturbances, double vision, tinnitus (ringing in the ears), mental confusion due to low blood pressure, cough, shortness of breath, gastrointestinal disturbances (nausea, vomiting, abdominal pain, altered taste, indigestion or difficulty digesting, diarrhea, constipation, changes in bowel regularity), allergic reactions (such as skin rashes, itching), muscle spasms, feeling tired, weakness, drowsiness, swelling of the ankles.
- Uncommon (may affect up to 1 in 100 people): Mood swings, anxiety, depression, sleep disorders, tremors, hives, fainting, loss of pain sensation, irregular and/or rapid heartbeat, rhinitis (stuffy or runny nose), hair loss, purpura (small red spots on the skin), skin discoloration, skin itching, sweating, chest pain, joint or muscle pain, back pain, pain, feeling unwell (malaise), kidney problems, difficulty passing urine, increased need to urinate at night, increased frequency of urination, impotence (inability to achieve or maintain an erection), fever or high temperature, discomfort or enlargement of the breasts in men, weight gain or loss, increased number of certain white blood cells, high potassium levels in the blood, hypoglycemia (very low blood sugar levels), low sodium levels in the blood which may lead to dehydration and low blood pressure, vasculitis (inflammation of blood vessels), photosensitivity reaction (skin changes) following exposure to sunlight or artificial UVA rays, clusters of blisters on the skin, swelling of hands or feet, increased creatinine in the blood and increased blood urea, falls, dry mouth.
- Rare (may affect up to 1 in 1,000 people): Confusion, changes in laboratory parameters: low chloride levels in the blood, low magnesium levels in the blood, increased liver enzyme levels, high serum bilirubin levels, and worsening of psoriasis. Reduced or absent urination, acute kidney failure. Dark urine, feeling unwell (nausea) or unwell (vomiting), muscle cramps, confusion and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
- Very rare (may affect up to 1 in 10,000 people): Decrease in white blood cell count, decrease in platelet count (leading to bruising and nosebleeds), anemia (reduction in red blood cells), angina pectoris (chest, jaw and back pain caused by physical exertion due to problems with blood supply to the heart), eosinophilic pneumonia (a rare type of pneumonia), gum swelling, severe skin reactions including severe rash, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, erythema multiforme (a skin rash that often starts with red, itchy patches on the face, arms or legs), painful or swollen gums, bleeding, abnormal liver function, inflammation of the liver (hepatitis), severe kidney problems, yellowing of the skin (jaundice), abdominal swelling (gastritis), nerve disorders which may cause weakness, tingling or numbness, increased muscle tension, hyperglycemia (very high blood sugar levels), high calcium levels in the blood, stroke possibly secondary to excessive lowering of blood pressure.
- Not known (frequency cannot be estimated from the available data): Hepatic encephalopathy (brain disorder caused by liver disease), abnormal ECG pattern, if you have systemic lupus erythematosus (a type of collagen disease), this may worsen. 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). Tremors, postural rigidity, mask-like face, slow movements and shuffling, unbalanced gait. Discoloration, numbness and pain in fingers or toes (Raynaud's phenomenon).
Changes in laboratory parameters (blood tests) may occur. Your doctor may consider it necessary to order blood tests to monitor your condition.
If you experience any of these symptoms, contact your doctor as soon as possible.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Perindopril, indapamide and amlodipine EG
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 blister pack or on the outer packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Perindopril, indapamide and amlodipine EG contains
- The active substances are perindopril arginine, indapamide and amlodipine. Each film-coated tablet contains 5 mg of perindopril arginine equivalent to 3.395 mg of perindopril, 1.25 mg of indapamide and 5 mg of amlodipine (as amlodipine besilate). Each film-coated tablet contains 5 mg of perindopril arginine equivalent to 3.395 mg of perindopril, 1.25 mg of indapamide and 10 mg of amlodipine (as amlodipine besilate). Each film-coated tablet contains 10 mg of perindopril arginine equivalent to 6.790 mg of perindopril, 2.5 mg of indapamide and 5 mg of amlodipine (as amlodipine besilate). Each film-coated tablet contains 10 mg of perindopril arginine equivalent to 6.790 mg of perindopril, 2.5 mg of indapamide and 10 mg of amlodipine (as amlodipine besilate).
The other components are: microcrystalline cellulose, calcium carbonate, pregelatinized starch,
sodium croscarmellose, magnesium stearate and anhydrous colloidal silica.
[5 mg/1.25 mg/5 mg and 10 mg/2.5 mg/10 mg:]
The tablet coating contains poly(vinyl alcohol) grafted copolymer with macrogol, talc, titanium
dioxide (E171), glycerol monocaprylocaprate and poly(vinyl alcohol).
[5 mg/1.25 mg/10 mg and 10 mg/2.5 mg/5 mg:]
The tablet coating contains poly(vinyl alcohol) grafted copolymer with macrogol, talc, titanium
dioxide (E171), glycerol monocaprylocaprate, poly(vinyl alcohol), yellow iron oxide (E172), black iron
oxide (E172) and red iron oxide (E172).
Description of the appearance of Perindopril, indapamide and amlodipine EG and pack contents
[5 mg/1.25 mg/5 mg:] The film-coated tablets are white, oblong, with “TEV” engraved on one side and “2” on the other. The tablet measures approximately 12.3 mm x 6.5 mm.
[5 mg/1.25 mg/10 mg:] The film-coated tablets are light beige, round, with “TEV” engraved on one side and “3” on the other. The tablet has a diameter of approximately 9.0 mm.
[10 mg/2.5 mg/5 mg:] The film-coated tablets are light beige, oblong, with “TEV” engraved on one side and “4” on the other. The tablet measures approximately 12.3 mm x 6.5 mm.
[10 mg/2.5 mg/10 mg:] The film-coated tablets are white, round, with “TEV” engraved on one side and “5” on the other. The tablet has a diameter of approximately 9.0 mm.
Perindopril, indapamide and amlodipine EG is available in blisters containing 10, 30, 90 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A., via Pavia 6, 20136 Milano, Italy
Manufacturers
Actavis Ltd, BLB015, BLB016, Bulebel Industrial Estate, Zejtun ZTN3000 - Malta
STADA Arzneimittel AG, Stadastrasse 2 – 18 Bad Vilbel, 61118 – Germany
This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
BE Perindopril/Indapamide/Amlodipine EG 5 mg/1.25 mg/5 mg - 5 mg/1.25 mg/10 mg - 10 mg/2.5 mg/5 mg - 10 mg/2.5 mg/10 mg - filmomhulde tabletten, comprimés pelliculés, Filmtabletten
CZ Ridupresa
LU Perindopril/Indapamid/Amlodipin EG 5 mg - 1.25 mg - 5 mg / 5 mg - 1.25 mg - 10 mg /10 mg - 2.5 mg - 5 mg /10 mg - 2.5 mg - 10 mg comprimés pelliculés
IT Perindopril, indapamide e amlodipina EG
SK Perindopril-Indapamid-Amlodipín STADA 5 mg/1.25 mg/5 mg - 5 mg/1.25 mg/10mg - 10 mg/2.5 mg/5 mg - 10 mg/2.5 mg/10 mg