Coaramlessa

Package Leaflet: Information for the Patient

CoAramlessa, 5 mg + 1.25 mg + 5 mg, tablets

CoAramlessa, 10 mg + 2.5 mg + 5 mg, tablets

CoAramlessa, 10 mg + 2.5 mg + 10 mg, tablets

Perindopril arginine + Indapamide + Amlodipine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of Contents of the Leaflet

• 1. What is CoAramlessa and what is it used for
• 2. Important information before taking CoAramlessa
• 3. How to take CoAramlessa
• 4. Possible side effects
• 5. How to store CoAramlessa
• 6. Contents of the pack and other information

1. What is CoAramlessa and what is it used for

CoAramlessa is a combination product containing three active substances: perindopril, indapamide, and amlodipine. It is an antihypertensive medicine used to treat high blood pressure (hypertension). Adult patients already taking perindopril and indapamide in one medicine and amlodipine in another can take one CoAramlessa tablet, which contains these three active substances in the same doses. Each active substance lowers blood pressure, and together they help control blood pressure in the patient:

• Perindopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by widening the blood vessels, making it easier for the heart to pump blood.
• Indapamide is a diuretic (a type of medicine that increases urine production) belonging to the group of sulfonamide derivatives with an indole ring. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics because it only slightly increases urine production.
• Amlodipine is a calcium antagonist (belonging to the group of medicines called dihydropyridines). It causes relaxation of the blood vessels, making it easier for blood to flow through them.

2. Important information before taking CoAramlessa

When not to take CoAramlessa

• if you are allergic to perindopril or other ACE inhibitors, indapamide or other sulfonamides, amlodipine or other dihydropyridines, or any of the other ingredients of this medicine (listed in section 6),
• if you have had symptoms such as wheezing, swelling of the face or tongue, intense itching, or severe rash during previous treatment with an ACE inhibitor, or if you have had such symptoms in any other circumstances (a condition called angioedema),
• if you have severe liver disease or a condition called hepatic encephalopathy (a brain disorder caused by liver disease),
• if you have suspected or untreated heart failure (severe water retention, breathing difficulties),
• if you have a narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body),
• if you have heart failure after a heart attack,
• if you have very low blood pressure (hypotension),
• if you have low potassium levels in the blood,
• if you have severe kidney disease that reduces blood flow to the kidneys (renal artery stenosis),
• if you are undergoing dialysis or blood filtration using a method other than hemodialysis. Depending on the device used, CoAramlessa may not be suitable for you.
• if you have moderate kidney disease (for CoAramlessa 10 mg + 2.5 mg + 5 mg and 10 mg + 2.5 mg + 10 mg),
• after the third month of pregnancy (it is also recommended to avoid taking CoAramlessa during early pregnancy - see section on pregnancy),
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren,
• if you have taken or are currently taking a combination medicine containing sacubitril and valsartan, used to treat chronic heart failure, as the risk of angioedema (rapid swelling of tissues under the skin, in the area of the throat, which can cause difficulty swallowing or breathing) increases (see "Warnings and precautions" and "CoAramlessa and other medicines").

Warnings and precautions

Before taking CoAramlessa, discuss with your doctor or pharmacist:

• if you have hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the blood vessel supplying the kidney),
• if you have heart failure or any other heart disease,
• if you have a significant increase in blood pressure (hypertensive crisis),
• if you have liver disease,
• if you have collagen disease (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma,
• if you have atherosclerosis (hardening of the arteries),
• if you are going to have parathyroid function tests,
• if you have gout,
• if you have diabetes,
• if you are on a low-salt diet or using salt substitutes containing potassium (it is essential to have the right potassium level in the blood),
• if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as you should avoid taking them with CoAramlessa (see "CoAramlessa and other medicines"),
• if you are elderly and the dose needs to be increased,
• if you have had light-induced allergic reactions,
• in black patients, angioedema (swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing) may occur more frequently, and the medicine may be less effective in lowering blood pressure,
• if you are undergoing dialysis using high-flux membranes,
• if you have kidney disease or are on dialysis,
• if you experience vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or glaucoma, which can occur within a few hours to a few weeks after taking CoAramlessa. If left untreated, they can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be at greater risk of such a reaction.

If you experience muscle disorders, including pain, tenderness, weakness, or cramps, or if you have hyperkalemia (high potassium levels in the blood), tell your doctor. Your doctor may recommend blood tests to check if your potassium or sodium levels are low or if your calcium levels are high. Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. It is not recommended to take CoAramlessa during early pregnancy, and you must not take it after the third month of pregnancy, as it may seriously harm your baby (see "Pregnancy and breastfeeding"). If you are taking CoAramlessa, tell your doctor or medical staff if: you are going to have anesthesia and/or surgery, you have recently had diarrhea or vomiting, or you are dehydrated, you are going to have dialysis or LDL apheresis (a procedure to remove cholesterol from the blood), you are going to have desensitization treatment to reduce allergic reactions to bee or wasp stings, you are going to have a test that requires the use of a contrast agent containing iodine (a substance that allows organs such as the kidney or stomach to be seen on an X-ray).

• if you are taking any of the following medicines, as the risk of angioedema increases:
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of so-called mTOR inhibitors (used to prevent transplant rejection and treat cancer),
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure,
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes),
• if you are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan (e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the subsection "When not to take CoAramlessa".

Your doctor may recommend a blood test to check if your sodium or potassium levels are low or if your calcium levels are high. Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. It is not recommended to take CoAramlessa during early pregnancy, and you must not take it after the third month of pregnancy, as it may seriously harm your baby (see "Pregnancy and breastfeeding").

Children and adolescents

Do not give CoAramlessa to children and adolescents.

CoAramlessa and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Patients with diabetes or kidney disease must not take aliskiren (used to treat high blood pressure). You must avoid taking CoAramlessa with:

• lithium (used to treat certain mental illnesses, such as mania, manic-depressive illness, and recurrent depression),
• potassium-sparing medicines (triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood and prevent clot formation; trimethoprim and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections),
• dantrolene (given by infusion), also used to treat malignant hyperthermia (a condition characterized by very high fever and muscle stiffness) during anesthesia,
• estramustine (used to treat cancer),
• medicines used to treat diarrhea or medicines used to prevent transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of so-called mTOR inhibitors). See the "Warnings and precautions" section,
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See the subsections "When not to take CoAramlessa" and "Warnings and precautions",
• other medicines used to treat high blood pressure: ACE inhibitors and angiotensin II receptor antagonists.

Taking other medicines may affect your treatment with CoAramlessa. Your doctor may recommend changing the dose and/or taking other precautions. Tell your doctor if you are taking any of the following medicines, as special care may be needed:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonist (AIIRA), aliskiren (see also the subsections "When not to take CoAramlessa" and "Warnings and precautions"), or diuretics (medicines that increase urine production),
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses of 12.5 mg to 50 mg per day,
• anesthetics,
• iodine-containing contrast agents,
• bepridil (used to treat angina pectoris),
• methadone (used to treat addiction),
• medicines used to treat heart rhythm disorders (e.g., dofetilide, ibutilide, bretylium, cyzapride, difemanil, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol),
• verapamil, diltiazem (used to treat heart conditions),
• digoxin or other cardiac glycosides (used to treat heart conditions),
• antibiotics used to treat bacterial infections (e.g., rifampicin, erythromycin, clarithromycin, sparfloxacin, moxifloxacin),
• antifungal medicines (e.g., itraconazole, ketoconazole, amphotericin B given by infusion),
• allopurinol (used to treat gout),
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, terfenadine, astemizole),
• corticosteroids used to treat various diseases, including severe asthma and rheumatoid arthritis, and non-steroidal anti-inflammatory medicines (e.g., ibuprofen) or high doses of

salicylates (e.g., acetylsalicylic acid, a substance found in many medicines, used as a pain reliever and to prevent blood clot formation),

• immunosuppressants (given to control the immune system's response) used to treat autoimmune diseases or after organ transplantation (e.g., cyclosporine, tacrolimus),
• tetracosactide (used to treat Crohn's disease),
• gold salts, especially given intravenously (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 used to treat diabetes, such as insulin or metformin,
• calcium, including calcium supplements,
• laxatives with a stimulant effect on peristalsis (e.g., senna),
• medicines used to treat cancer,
• vinpocetine (used to treat symptomatic cognitive disorders in the elderly, including memory loss),
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, imipramine-type 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 infections),
• Hypericum perforatum(St. John's Wort),
• trimethoprim (used to treat infections),
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline),
• nitroglycerin and other nitrates or other vasodilators, as they may further lower blood pressure.

CoAramlessa with food and drink

Do not eat grapefruits or drink grapefruit juice while taking CoAramlessa, as the level of the active substance amlodipine may increase, which may lead to an unexpected increase in the blood pressure-lowering effect of CoAramlessa.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually recommend stopping CoAramlessa before planned pregnancy or as soon as possible after confirmation of pregnancy, and will recommend an alternative medicine. Do not take CoAramlessa during early pregnancy, and do not take it after the third month of pregnancy, as it may seriously harm your baby.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take CoAramlessa during breastfeeding, and your doctor may recommend an alternative medicine if you want to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

CoAramlessa may affect your ability to drive or use machines. If you experience nausea, dizziness, fatigue, or headache while taking the medicine, do not drive or use machines, and contact your doctor immediately.

CoAramlessa contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially "sodium-free".

3. How to take CoAramlessa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Swallow the tablet with a glass of water, preferably in the morning, before breakfast. Your doctor will determine the appropriate dose for you. The recommended dose is usually one tablet per day.

If you take more CoAramlessa than you should

Taking too many tablets may cause your blood pressure to drop, even to a dangerous level, which may be accompanied by nausea, vomiting, cramps, dizziness, sleepiness, disorientation, or decreased urine production. Up to 24-48 hours after taking the medicine, you may experience shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema). You may feel "empty" in your head, or you may experience fainting or weakness. If you take too many CoAramlessa tablets, seek medical attention immediately.

If you forget to take CoAramlessa

It is important to take the medicine every day, as regular treatment ensures better effectiveness. However, if you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking CoAramlessa

Treatment of high blood pressure is usually long-term, so before stopping the medicine, consult your doctor. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• sudden onset of 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 mucous membranes of the mouth, tongue, or throat, causing severe difficulty breathing (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, blistering, peeling, and swelling of the skin, 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), life-threatening heart rhythm disorders (frequency not known),
• pancreatitis, which can cause severe abdominal pain and very poor general condition (very rare - may affect up to 1 in 10,000 people),
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high temperature, which may be due to abnormal muscle breakdown (frequency not known).

The following side effects may occur, listed in order of frequency:

Very common: may affect more than 1 in 10 people

Edema (fluid retention).

Common: may affect up to 1 in 10 people

Low potassium levels in the blood, headache, dizziness, palpitations (feeling of heartbeat), flushing, dizziness, tingling or numbness, vision disturbances, double vision, tinnitus (ringing in the ears), feeling of "emptiness" in the head due to low blood pressure, cough, shortness of breath, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disorders, diarrhea, constipation, change in bowel movements), allergic reactions (such as rash, itching), muscle cramps, feeling of tiredness, weakness, drowsiness, swelling of the ankles.

Uncommon: may affect up to 1 in 100 people

Mood changes, anxiety, depression, sleep disturbances, tremors, hives, fainting, loss of pain sensation, irregular or rapid heartbeat, nasal congestion (swelling or runny nose), hair loss, skin discoloration, itching, sweating, chest pain, muscle or joint pain, back pain, pain, poor general condition, kidney disorders, urinary disorders, increased need to urinate at night, frequent urination, impotence (inability to achieve or maintain an erection), fever or elevated body temperature, discomfort or enlargement of the breasts in men, weight gain or loss, increased white blood cell count, high potassium levels in the blood, hypoglycemia (very low blood sugar), low sodium levels in the blood, which may cause dehydration and low blood pressure, vasculitis (inflammation of blood vessels), photosensitivity reaction (skin changes after sun exposure), blistering skin, swelling of the hands or feet, increased creatinine and urea levels in the blood, falls, dry mouth.

Rare: may affect up to 1 in 1,000 people

Low chloride levels in the blood, low magnesium levels in the blood. Dark urine, nausea or vomiting, muscle cramps, confusion, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion). Acute kidney failure. Decreased or absent urine production. Confusion, changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood, and worsening of psoriasis.

Very rare: may affect up to 1 in 10,000 people

Decreased white blood cell count, decreased platelet count (which can cause easy bruising and nosebleeds), anemia (decreased red blood cell count), angina pectoris (chest pain, jaw pain, and back pain caused by heart disease), eosinophilic pneumonia (a rare type of pneumonia), gum hypertrophy (gum overgrowth), severe skin reactions, including severe rash, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, or other allergic reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and other skin reactions, thrombocytopenia (low platelet count), agranulocytosis (low white blood cell count), neutropenia (low neutrophil count), leukopenia (low white blood cell count), hemolytic anemia (anemia caused by the breakdown of red blood cells), cardiac arrhythmias (abnormal heart rhythms), including atrial fibrillation, atrial flutter, and ventricular arrhythmias, vasculitis (inflammation of blood vessels), including leukocytoclastic vasculitis, and other blood vessel disorders, hepatitis (inflammation of the liver), liver failure, acute kidney failure, jaundice (yellowing of the skin and eyes), pancreatitis (inflammation of the pancreas), and other pancreatic disorders, nephritis (inflammation of the kidneys), nephrotic syndrome (a kidney disorder characterized by excessive loss of protein in the urine), and other kidney disorders, gout (a condition characterized by elevated uric acid levels in the blood), and other metabolic disorders, confusion, changes in laboratory test results, including increased liver enzyme activity, and other liver disorders, seizures, and other nervous system disorders, hyperkalemia (high potassium levels in the blood), hypercalcemia (high calcium levels in the blood), stroke, possibly due to a significant decrease in blood pressure, and other cardiovascular disorders.

Frequency not known: cannot be estimated from the available data

Hepatic encephalopathy (a brain disorder caused by liver disease), abnormal electrocardiogram (ECG) readings, and other heart disorders, lupus-like syndrome (a condition that resembles systemic lupus erythematosus), myasthenia gravis (a condition characterized by muscle weakness), and other muscle disorders, short-sightedness, blurred vision, or eye pain due to high pressure (possible symptoms of choroidal effusion or acute angle-closure glaucoma). Parkinson's disease-like symptoms, such as tremors, rigidity, mask-like facial expression, slow movements, and shuffling gait. Raynaud's phenomenon (a condition characterized by discoloration, numbness, and pain in the fingers and toes). Changes in laboratory test results. Your doctor may recommend blood tests to monitor your health.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CoAramlessa

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month. There are no special storage instructions for this medicine. Store in the original package to protect from light and moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What CoAramlessa contains

• The active substances of CoAramlessa are perindopril arginine, indapamide, and amlodipine. CoAramlessa, 5 mg + 1.25 mg + 5 mg, tablets Each tablet contains 5 mg of perindopril arginine (which corresponds to 3.395 mg of perindopril), 1.25 mg of indapamide, and amlodipine besylate equivalent to 5 mg of amlodipine. CoAramlessa, 10 mg + 2.5 mg + 5 mg, tablets Each tablet contains 10 mg of perindopril arginine (which corresponds to 6.79 mg of perindopril), 2.5 mg of indapamide, and amlodipine besylate equivalent to 5 mg of amlodipine.

CoAramlessa, 10 mg + 2.5 mg + 10 mg, tablets Each tablet contains 10 mg of perindopril arginine (which corresponds to 6.79 mg of perindopril), 2.5 mg of indapamide, and amlodipine besylate equivalent to 10 mg of amlodipine.

• The other ingredients are calcium chloride hexahydrate, microcrystalline cellulose, maize starch, sodium carboxymethylcellulose (type A), sodium hydrogen carbonate, colloidal anhydrous silica, and magnesium stearate. See section 2 "CoAramlessa contains sodium".

What CoAramlessa looks like and contents of the pack

CoAramlessa, 5 mg + 1.25 mg + 5 mg, tablets White or almost white, round, biconvex tablets, with the marking K1 on one side. Tablet size: diameter approximately 7 mm. CoAramlessa, 10 mg + 2.5 mg + 5 mg, tablets White or almost white, biconvex tablets in the shape of a capsule, with the marking K3 on one side. Tablet size: approximately 13 mm x 6 mm. CoAramlessa, 10 mg + 2.5 mg + 10 mg, tablets White or almost white, oval, biconvex tablets, with the marking K2 on one side. Tablet size: approximately 14 mm x 7 mm. CoAramlessa is available in packs of 10, 30, 60, 90, or 100 tablets in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany For more information on the names of medicines in other European Economic Area countries, please contact the local representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o. ul. Równoległa 5 02-235 Warszawa Tel. 22 57 37 500

Date of last revision of the leaflet: