Coaramlessa

Package Leaflet: Information for the Patient

CoAramlessa, 7 mg + 5 mg + 2.5 mg, Tablets

Perindopril Arginine + Amlodipine + Indapamide

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 medication containing three active substances: perindopril, amlodipine, and indapamide.
CoAramlessa is a medication used to treat high blood pressure (hypertension) in adults.
Patients already taking perindopril and amlodipine in one medication and indapamide 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 medications called angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by widening blood vessels, making it easier for the heart to pump blood.
• Amlodipine is a calcium antagonist (belonging to a group of medications called dihydropyridines). It causes relaxation of blood vessels, making it easier for blood to flow through them.
• Indapamide is a diuretic (belonging to a group of medications called sulfonamide derivatives with an indole ring). Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics, as it only causes a slight increase in urine production.

2. Important information before taking CoAramlessa

When not to take CoAramlessa

• if you are allergic to perindopril or any other ACE inhibitor, amlodipine or any other calcium antagonist, indapamide or any other sulfonamide, or any of the other ingredients of this medication (listed in section 6),
• if you have severe kidney disease,
• if you are undergoing dialysis or blood filtration by other methods. Depending on the device used, CoAramlessa may not be suitable for you.
• if you have kidney disease that reduces blood flow to the kidneys (renal artery stenosis),
• if you have taken or are currently taking a combination medication containing sacubitril and valsartan, used to treat heart failure, as the risk of angioedema (rapid swelling of tissues under the skin, e.g., around the throat) increases (see "Warnings and precautions" and "CoAramlessa and other medications").
• if you have severe liver disease or a condition called hepatic encephalopathy (liver disease that affects the brain and central nervous system),
• if you have low potassium levels in your blood,
• if you have experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe rash during previous treatment with an ACE inhibitor, or if such symptoms have occurred in you or a family member in any other circumstances (a condition called angioedema),
• after the third month of pregnancy (it is also recommended to avoid taking CoAramlessa during early pregnancy - see the section on pregnancy),
• if you have very low blood pressure (hypotension),
• if you have a narrowing of the aortic valve in your 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 diabetes or kidney problems and are being treated with a blood pressure-lowering medication containing aliskiren.

Warnings and precautions

Before starting to take CoAramlessa, discuss it with your doctor or pharmacist:

• if you have had allergic reactions to sunlight,
• if you have hypertrophic cardiomyopathy (a disease of the heart muscle),
• if you have heart failure or any heart rhythm disorders,
• if you have a significant increase in blood pressure (hypertensive crisis),
• if you have any other heart diseases,
• if you have liver diseases,
• if you have kidney disease (including kidney transplant),
• if you experience vision impairment 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 higher risk of such a reaction.
• if you have muscle disorders, including muscle pain, tenderness, weakness, or cramps,
• if you have an excessive level of a hormone called aldosterone in your blood (primary aldosteronism),
• if you have a collagen vascular disease (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma,
• if you have diabetes,
• if you are on a low-salt diet or using salt substitutes that contain potassium (it is essential to have the right potassium level in your blood),
• if you are elderly,
• if you are taking any of the following medications for high blood pressure:
• an "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 your blood. See also the section "When not to take CoAramlessa".

• if you are of black African descent, as the risk of angioedema may be higher, and the medication may be less effective in lowering blood pressure than in patients of other ethnicities,
• if you have gout,
• if you are to undergo parathyroid function tests,
• if you are taking any of the following medications, as the risk of angioedema increases:
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus, and other medications belonging to the group of so-called mTOR inhibitors (used to prevent organ rejection and treat cancer),
• sacubitril (available in a combination medication containing sacubitril and valsartan), used to treat chronic heart failure,
• linagliptin, saxagliptin, sitagliptin, wildagliptin, and other medications belonging to the group of medications called gliptins (used to treat diabetes).

Angioedema:
In patients treated with ACE inhibitors, including perindopril, angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing) has been reported. This reaction can occur at any time during treatment. If you experience such symptoms, stop taking CoAramlessa and contact your doctor immediately. See also section 4.
Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. CoAramlessa should not be used during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the baby (see sections on pregnancy and breastfeeding).
When taking CoAramlessa, inform your doctor or medical staff:

• if you are to undergo general anesthesia and/or major surgery,
• if you have recently experienced diarrhea or vomiting,
• if you are to undergo desensitization treatment to reduce allergic reactions after insect stings,
• if you are to undergo 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). Your doctor may perform blood tests to check for low sodium or potassium levels or high calcium levels. Athletes should be aware that CoAramlessa contains the active substance indapamide, which may cause a positive result in anti-doping tests.

Children and adolescents

CoAramlessa should not be given to children and adolescents.

CoAramlessa and other medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Avoid taking CoAramlessa with:

• lithium (used to treat mania or depression),
• estramustine (used to treat cancer),
• potassium-sparing medications (triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, other medications that may increase potassium levels in the body (such as heparin, a medication used to thin blood and prevent clotting),
• aliskiren (used to treat high blood pressure), (see also the information in the sections "When not to take CoAramlessa" and "Warnings and precautions"),
• angiotensin II receptor antagonists (ARBs), (used to treat high blood pressure), (e.g., valsartan, telmisartan, irbesartan),
• dantrolene (used to treat muscle stiffness in conditions such as multiple sclerosis or malignant hyperthermia during anesthesia),
• medications commonly used to treat diarrhea (racecadotril) or medications used to prevent organ rejection (sirolimus, everolimus, temsirolimus, and other medications belonging to the group of so-called mTOR inhibitors). See the section "Warnings and precautions".
• a combination medication containing sacubitril and valsartan (used to treat chronic heart failure). See the sections "When not to take CoAramlessa" and "Warnings and precautions".

Taking other medications may affect treatment with CoAramlessa. Tell your doctor if you are taking any of the following medications, as special caution may be required:

• other medications used to treat high blood pressure, including diuretics (medications that increase urine production) and ACE inhibitors (used to treat high blood pressure and heart failure),
• medications used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium),
• procainamide (used to treat irregular heartbeat),
• ephedrine, norepinephrine, or epinephrine (medications used to treat low blood pressure, shock, or asthma),
• medications 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)),
• antibiotics used to treat bacterial infections (e.g., rifampicin, erythromycin injection, clarithromycin, sparfloxacin, moxifloxacin),
• bepridil (used to treat angina pectoris, a condition that causes chest pain),
• cisapride (used to treat reduced motility of the esophagus and stomach),
• difemanil (used to treat gastrointestinal problems, such as ulcers, excessive acid, or hyperacidity),
• vinkamine injection (used to treat cognitive impairment in the elderly, including memory loss),
• halofantrine (an antiparasitic medication used to treat certain types of malaria),
• pentamidine (used to treat certain types of pneumonia),
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, astemizole, terfenadine),
• antifungal medications (e.g., itraconazole, ketoconazole, amphotericin B injection),
• tetracosactide (used to treat Crohn's disease),
• laxatives with a stimulant effect on peristalsis,
• medications used to treat diabetes (such as insulin or metformin),
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis),
• potassium-sparing medications used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day, amiloride, triamterene,
• nonsteroidal anti-inflammatory medications (e.g., ibuprofen) used for pain relief or high doses of acetylsalicylic acid, a substance found in many medications, used for pain relief and to prevent blood clots,
• Hypericum perforatum(St. John's Wort, a herbal medication used to treat depression),
• vasodilators, including nitrates (medications that widen blood vessels),
• corticosteroids (used to treat various conditions, including severe asthma and rheumatoid arthritis),
• alpha-adrenergic blockers used to treat prostate enlargement, such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin,
• amifostine (used to prevent or reduce the side effects of other medications or radiation therapy, used to treat cancer),
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV infections),
• gold salts, especially when given intravenously (used to treat symptoms of rheumatoid arthritis),
• iodine-containing contrast agents (used in X-ray examinations),
• calcium or calcium supplements,
• immunosuppressive medications (medications that lower the body's defenses), used to treat autoimmune diseases or after organ transplantation (e.g., cyclosporine, tacrolimus),
• allopurinol (used to treat gout),
• antiepileptic medications, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
• trimethoprim (used to treat infections),
• methadone (used to treat addiction).

CoAramlessa with food and drink

See section 3.
Do not consume grapefruits or 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 medication.

Pregnancy

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
Normally, your doctor will advise you to stop taking CoAramlessa before planned pregnancy or as soon as pregnancy is confirmed, and will recommend an alternative medication.
CoAramlessa should not be used during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the baby.

Breastfeeding

Amlodipine has been shown to pass into human breast milk in small amounts. Tell your doctor if you are breastfeeding or plan to breastfeed. CoAramlessa is not recommended during breastfeeding, and your doctor may recommend an alternative medication if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

CoAramlessa may affect your ability to drive or operate machines. If you experience nausea, dizziness, weakness, fatigue, or headache while taking this medication, do not drive or operate machines, and contact your doctor immediately.

CoAramlessa contains sodium

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

3. How to take CoAramlessa

Always take CoAramlessa exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one CoAramlessa tablet per day.
Take the tablet at the same time each day, in the morning, before breakfast.
Do not take more than the prescribed dose.

If you take more CoAramlessa than you should

If you have taken too many tablets, contact your nearest emergency department or doctor immediately.
The most likely effect of overdose is low blood pressure, which can cause dizziness or fainting. If you experience these symptoms, lying down with your legs raised may help.
It may also cause nausea (vomiting), vomiting, cramps, drowsiness, disorientation, and changes in urine production.
You may feel "lightheaded" or weak. If the blood pressure drop is significant, it can lead to shock, in which case the skin becomes cool and moist, and you may lose consciousness.
Up to 24-48 hours after taking the medication, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

If you forget to take CoAramlessa

It is important to take your medication every day, as regular treatment ensures better efficacy. However, if you miss a dose of CoAramlessa, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking CoAramlessa

Treatment with CoAramlessa is usually long-term, so before stopping this medication, consult your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, CoAramlessa can cause side effects, although not everybody gets them.

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

• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm) (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 breathing difficulties (angioedema) (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 (erythema multiforme) (rare - may affect up to 1 in 1,000 people), blistering, peeling, and swelling of the skin (exfoliative dermatitis) (rare - may affect up to 1 in 1,000 people), inflammation of the mucous membranes (Stevens-Johnson syndrome) (rare - may affect up to 1 in 1,000 people), or other allergic reactions (common - may affect up to 1 in 10 people), toxic epidermal necrolysis (frequency not known - cannot be estimated from the available data),
• severe dizziness or fainting (common - may affect up to 1 in 10 people),
• weakness or numbness in the arms or legs, or speech disorders, which may be symptoms of a stroke (very rare - may affect up to 1 in 10,000 people);
• heart attack, chest pain (angina pectoris) (very rare - may affect up to 1 in 10,000 people), abnormal or irregular heartbeat (common - may affect up to 1 in 10 people),
• inflammation of the pancreas, which can cause severe abdominal pain and very poor general condition (very rare - may affect up to 1 in 10,000 people),
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare - may affect up to 1 in 10,000 people),
• liver disease caused by liver disease (encephalopathy) (frequency not known),
• muscle weakness, cramps, tenderness, or pain, especially if you feel unwell or have a high temperature, which may be caused by abnormal muscle breakdown (frequency not known).

Side effects are listed below by 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, feeling of numbness or tingling in the limbs, drowsiness (especially at the start of treatment), abnormal taste, vision disturbances (including double vision), ringing in the ears (tinnitus), dizziness of inner ear origin, palpitations (feeling of heartbeat), sudden reddening of the face and neck, feeling of "emptiness" in the head, cough, shortness of breath, abdominal pain, constipation, diarrhea, indigestion or digestive disorders, nausea, vomiting, changes in bowel movements, itching, allergic reactions, such as skin rash, itching, redness of the skin, muscle cramps, swelling of the ankles, feeling of tiredness, weakness.

Uncommon (may affect up to 1 in 100 people)

Rhinitis (inflammation or congestion of the nasal passages), increased white blood cell count, low blood sugar (hypoglycemia), high potassium levels in the blood, which can cause heart rhythm disorders (hyperkalemia), low sodium levels in the blood (hyponatremia), which can cause dehydration and low blood pressure, insomnia, mood swings, anxiety, depression, sleep disturbances, loss of sensation, tremors, fainting, inflammation of blood vessels, dry mouth, hair loss, red spots on the skin (purpura), skin discoloration, increased sweating, sensitivity to light (photosensitivity) after exposure to sunlight or UVA radiation, formation of blisters on the skin, muscle or joint pain, back pain, urinary disorders, increased need to urinate at night, frequent urination, kidney disorders, impotence (inability to achieve or maintain an erection), discomfort or enlargement of the breasts in men, chest pain, pain, poor general condition, fever, weight gain or loss, increased levels of urea or creatinine in the blood, falls.

Rare (may affect up to 1 in 1,000 people)

Low chloride levels in the blood, low magnesium levels in the blood, disorientation, worsening of psoriasis, high bilirubin levels in the blood, elevated liver enzyme levels, decreased or absent urine production, acute kidney failure.
Dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion).

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

Changes in blood parameters, such as decreased white or red blood cell count, decreased hemoglobin, decreased platelet count, high blood sugar (hyperglycemia), high calcium levels in the blood (hypercalcemia), increased muscle tone, nerve disorders, which can cause weakness, eosinophilic pneumonia (a rare form of pneumonia), gum hypertrophy (gum overgrowth), gastrointestinal disorders (gastritis), yellowing of the skin (jaundice), acute kidney failure.

Frequency not known (cannot be estimated from the available data)

Nearsightedness, blurred vision, impaired vision, or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute glaucoma, in case of systemic lupus erythematosus (a type of collagen disease), worsening of symptoms may occur, abnormal electrocardiogram (ECG) tracing, tremors, stiffness, mask-like face, slow movements, and shuffling gait, increased uric acid levels, which can cause or worsen gout (joint pain, especially in the feet), discoloration, numbness, and pain in the fingers or toes (Raynaud's phenomenon).
If you experience any of these symptoms, contact your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocides)
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store CoAramlessa

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions for this medication.
Store in the original package to protect from light and moisture.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. 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, amlodipine, and indapamide. Each tablet contains 7 mg of perindopril arginine (which corresponds to 4.75 mg of perindopril), amlodipine besylate equivalent to 5 mg of amlodipine, and 2.5 mg of indapamide.
• The other ingredients are calcium chloride hexahydrate, microcrystalline cellulose, cornstarch, sodium carbonate, colloidal anhydrous silica, and magnesium stearate. See section 2 "CoAramlessa contains sodium".

What CoAramlessa looks like and contents of the pack

CoAramlessa is a white or almost white, round (8 mm in diameter), biconvex tablet, with the marking K4 on one side.
CoAramlessa is available in packs of 10, 30, 60, 90, 100, or 120 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

This medication is authorized in the European Economic Area under the following names:

To obtain more detailed information on this medication, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of last revision of the package leaflet: