Coaramlessa

Package leaflet: information for the patient

CoAramlessa, 7 mg + 5 mg + 2.5 mg, tablets
Perindoprilum argininum + Amlodipinum + Indapamidum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What CoAramlessa is and what it is 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 CoAramlessa is and what it is used for

CoAramlessa is a combination medicine containing three active substances: perindopril, amlodipine, and indapamide.
CoAramlessa is an antihypertensive medicine used to treat high blood pressure (arterial hypertension) in adults.
Patients already taking perindopril and amlodipine in one medicine and indapamide in another may instead take one tablet of CoAramlessa, which contains these three active substances at the same doses.
Each of the active substances lowers blood pressure, and together they help control the patient's blood pressure:

• Perindopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. It works by widening blood vessels, making it easier for the heart to pump blood through them.
• Amlodipine is a calcium antagonist (belonging to a group of medicines called dihydropyridines). It causes blood vessels to relax, facilitating blood flow through them.
• Indapamide is a diuretic (belonging to a group of medicines called sulfonamide derivatives with an indole 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 urine production.

2. Important information before using CoAramlessa

When not to use CoAramlessa

• if the patient is allergic to perindopril or any other ACE inhibitors, amlodipine or any other calcium channel blockers, indapamide or any other sulfonamides, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe kidney disease,
• if the patient is undergoing dialysis or another form of blood filtration. Depending on the equipment used, CoAramlessa may not be suitable for the patient,
• if the patient has kidney disease causing reduced blood supply to the kidneys (renal artery stenosis),
• if the patient has taken or is currently taking a medication containing sacubitril and valsartan, used to treat heart failure, as this increases the risk of angioedema (rapid swelling of the tissues under the skin, e.g. in the throat area) (see "Warnings and precautions" and "CoAramlessa with other medicines"),
• if the patient has severe liver disease or a condition called hepatic encephalopathy (liver disease affecting the brain and central nervous system),
• if the patient has low blood potassium levels,
• if the patient previously experienced symptoms during treatment with an ACE inhibitor, such as wheezing, facial or tongue swelling, intense itching or severe rash, or if such symptoms occurred in the patient or a family member under any circumstances (a condition called angioedema),
• after the 3rd month of pregnancy (it is also advisable to avoid using CoAramlessa in early pregnancy – see pregnancy section),
• if the patient has very low blood pressure (hypotension),
• if the patient has aortic valve stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart cannot deliver sufficient blood to the body),
• if the patient has heart failure following a heart attack,
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting treatment with CoAramlessa, discuss with your doctor or pharmacist:

• if the patient has previously experienced light sensitivity reactions,
• if the patient has hypertrophic cardiomyopathy (a heart muscle disorder),
• if the patient has heart failure or any heart rhythm disorders,
• if the patient has a significant increase in blood pressure (hypertensive crisis),
• if the patient has any other heart diseases,
• if the patient has liver diseases,
• if the patient has kidney disease (including kidney transplant),
• if the patient experiences worsening vision or eye pain in one or both eyes. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid buildup between the choroid and sclera) or glaucoma, increased pressure in one or both eyes – which may occur from several hours to several weeks after taking CoAramlessa. If left untreated, these conditions may lead to permanent vision loss. Patients who previously had an allergy to penicillin or sulfonamides may be at higher risk of such a reaction.
• if the patient has muscle disorders, including muscle pain, tenderness, weakness, or cramps,
• if the patient has abnormally high levels of a hormone called aldosterone in the blood (primary hyperaldosteronism),
• if the patient has a collagen vascular disease (connective tissue disease), such as systemic lupus erythematosus or scleroderma,
• if the patient has diabetes,
• if the patient is on a low-salt diet or uses potassium-containing salt substitutes (adequate potassium levels in the blood are important),
• if the patient is elderly,
• if the patient is taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA), (also known as a sartan – e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes,
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section "When not to use CoAramlessa".

• if the patient is of Black race, as the risk of angioedema may be higher and the medicine may be less effective in lowering blood pressure compared to patients of non-Black races,
• if the patient has gout,
• if the patient is undergoing parathyroid function tests,
• if the patient is taking any of the following medicines, as they increase the risk of angioedema:
• racecadotril (used to treat diarrhoea),
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the so-called mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment),
• 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 drugs called gliptins (used to treat diabetes).

Angioedema:
In patients treated with ACE inhibitors, including perindopril, cases of angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat, and difficulty swallowing or breathing) have been reported. This reaction may occur at any time during treatment. If such symptoms occur, stop taking CoAramlessa immediately and contact your doctor without delay. See also section 4.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Use of CoAramlessa is not recommended in early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child (see sections on pregnancy and breastfeeding).
When taking CoAramlessa, inform your doctor or medical staff:

• if the patient is to undergo general anaesthesia and/or major surgery,
• if the patient has recently experienced diarrhoea or vomiting,
• if desensitization treatment is planned to reduce allergic reactions following bee or wasp stings,
• if an imaging test requiring iodine-containing contrast agents (substances allowing visualization of organs such as the kidney or stomach in X-ray examinations) is to be performed. The doctor may perform blood tests to check for low sodium or potassium levels or high calcium levels. Athletes should be aware that CoAramlessa contains an active substance (indapamide) that may lead to a positive result in anti-doping tests.

Children and adolescents
CoAramlessa must not be given to children or adolescents.
CoAramlessa with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Avoid taking CoAramlessa with:

• lithium (used to treat mania or depression),
• estramustine (used to treat cancer),
• potassium-sparing medicines (triamterene, amiloride), potassium supplements or potassium-containing salt substitutes, or other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent clots; trimethoprim and co-trimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections),
• aliskiren (used to treat high blood pressure), (see also information in sections "When not to use CoAramlessa" and "Warnings and precautions"),
• angiotensin II receptor antagonists (ARBs), (used to treat high blood pressure), (e.g. valsartan, telmisartan, irbesartan…),
• dantrolene (by infusion), (used to treat muscle stiffness in conditions such as multiple sclerosis or to treat malignant hyperthermia during anaesthesia, symptoms of which include very high fever and muscle rigidity),
• medicines most commonly used to treat diarrhoea (racecadotril) or medicines used to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the group of so-called mTOR inhibitors). See section "Warnings and precautions".
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to use CoAramlessa" and "Warnings and precautions".

Other medicines may affect treatment with CoAramlessa. Inform your doctor if the patient is taking any of the following medicines, as this may require special precautions:

• other medicines used to treat high blood pressure, including diuretics (medicines increasing urine production by the kidneys) and angiotensin-converting enzyme (ACE) inhibitors (used to treat high blood pressure and heart failure),
• medicines used to treat heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis, bretylium),
• procainamide (used to treat irregular heartbeat),
• ephedrine, noradrenaline or adrenaline (medicines used to treat low blood pressure, shock or asthma),
• medicines used to treat psychiatric 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, intravenous erythromycin, clarithromycin, sparfloxacin, moxifloxacin),
• bepridil (used to treat angina pectoris, a condition causing chest pain),
• cisapride (used to treat reduced motility of the oesophagus and stomach),
• difemanil (used to treat gastrointestinal problems such as ulcers, excess acid, overactive digestive system),
• vinpocetine by injection (used to treat symptomatic cognitive disorders in elderly patients, including memory loss),
• halofantrine (an antiparasitic medicine 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 medicines (e.g. itraconazole, ketoconazole, intravenous amphotericin B),
• tetracosactide (used to treat Crohn's disease),
• stimulant laxatives,
• medicines used to treat diabetes (such as insulin or metformin),
• baclofen used to treat muscle stiffness in conditions such as multiple sclerosis,
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses from 12.5 mg to 50 mg per day, amiloride, triamterene,
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) used for pain relief, or high doses of acetylsalicylic acid, a substance found in many medicines used for pain and fever relief and for preventing blood clots,
• Hypericum perforatum (St. John's wort, a herbal medicine used to treat depression),
• vasodilators, including nitrates (medicines that dilate blood vessels),
• corticosteroids (used to treat various diseases, including severe asthma and rheumatoid arthritis),
• alpha-adrenolytics used to treat benign prostatic hyperplasia, such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin,
• amifostine (used to prevent or reduce side effects caused by other medicines or radiotherapy, used in cancer treatment),
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV infection),
• gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis),
• iodine-containing contrast agents (used in X-ray imaging),
• calcium or calcium supplements,
• immunosuppressive medicines (medicines that suppress the body's immune mechanisms), used to treat autoimmune diseases or after organ transplantation (e.g. cyclosporine, tacrolimus),
• allopurinol (used to treat gout),
• antiepileptic medicines 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.
While taking CoAramlessa, do not consume grapefruit or grapefruit juice, as this may increase the concentration of the active substance – amlodipine – which could lead to an unexpected intensification of the blood pressure-lowering effect of CoAramlessa.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy.
Usually, the doctor will recommend discontinuing CoAramlessa before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine.
CoAramlessa is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
It has been shown that amlodipine passes into human milk in small amounts. Inform your doctor if you are breastfeeding or plan to breastfeed. CoAramlessa is not recommended during breastfeeding, and your doctor may recommend an alternative medicine if you wish to breastfeed, especially if the infant is a newborn or premature.
Driving and using machines
CoAramlessa may affect the ability to drive or operate machinery. If taking the medicine causes nausea, dizziness, weakness, fatigue, or headache, do not drive or operate machinery and contact your doctor immediately.
CoAramlessa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to take CoAramlessa

CoAramlessa must always be taken exactly as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
The recommended dose is one tablet of CoAramlessa once daily.
The tablet should be taken at approximately the same time each day, preferably in the morning, before a meal.
Do not take a higher dose than prescribed.
Taking more CoAramlessa than recommended
If too many tablets are taken, contact the nearest emergency department or inform your doctor immediately.
The most likely consequence of overdose is low blood pressure, which may cause dizziness or fainting. In such cases, lying down with legs elevated may be helpful.
It may cause nausea, vomiting, cramps, drowsiness, disorientation, and changes in the amount of urine produced by the kidneys.
The patient may feel a "void" in the head, and may experience a sensation of fainting or weakness. If the drop in blood pressure is significant, shock may occur, in which the skin becomes cold and clammy, and the patient may lose consciousness.
Breathlessness due to excess fluid accumulating in the lungs (pulmonary edema) may occur up to 24–48 hours after taking the medicine.
Missing a dose of CoAramlessa
It is important to take the medicine every day, as regular use ensures more effective treatment. However, if a dose of CoAramlessa is missed, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
Stopping CoAramlessa
Treatment with CoAramlessa is usually long-term, so you should contact your doctor before stopping the medicine.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences any of the following adverse effects, which may be
severe, treatment must be discontinued and immediate medical advice must be sought:

• sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm) (uncommon – may occur in less than 1 in 100 patients),
• swelling of the eyelids, face or lips (uncommon – may occur in less than 1 in 100 patients),
• swelling of the mucous membranes of the mouth, tongue or throat, causing significant breathing difficulties (angioedema) (uncommon – may occur in less than 1 in 100 patients),
• severe skin reactions, including severe rash, hives, redness of the entire skin surface, intense itching (erythema multiforme) (very rare – may occur in less than 1 in 10,000 patients), blistering, peeling and swelling of the skin (exfoliative dermatitis) (very rare – may occur in less than 1 in 10,000 patients), mucosal inflammation (Stevens-Johnson syndrome) (very rare – may occur in less than 1 in 10,000 patients), or other allergic reactions (common – may occur in less than 1 in 10 patients), toxic epidermal necrolysis (frequency not known – cannot be estimated from available data),
• severe dizziness or fainting (common – may occur in less than 1 in 10 patients),
• weakness of the arms or legs, or speech disturbances, which may be signs of stroke (very rare – may occur in less than 1 in 10,000 patients);
• heart attack, chest pain (angina pectoris) (very rare – may occur in less than 1 in 10,000 patients), unusually fast or irregular heartbeat (common – may occur in less than 1 in 10 patients),
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and severe malaise (very rare – may occur in less than 1 in 10,000 patients),
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare – may occur in less than 1 in 10,000 patients),
• brain disease caused by liver disease (hepatic encephalopathy) (frequency not known),
• muscle weakness, cramps, tenderness or pain, particularly if the patient also feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (frequency not known).

Adverse effects listed by decreasing frequency of occurrence may include:
Very common (affects at least 1 in 10 patients)
Swelling (fluid retention).
Common (affects less than 1 in 10 patients)
Low blood potassium levels, headache, tingling or numbness in the limbs, drowsiness (especially at the beginning of treatment), altered taste sensation, visual disturbances (including double vision), tinnitus (sensation of hearing sounds), vertigo, palpitations (awareness of heartbeat), sudden flushing of the face and neck, sensation of "emptiness" in the head, cough, shortness of breath (dyspnea), abdominal pain, constipation, diarrhea, indigestion or digestive disturbances, nausea, vomiting, changes in bowel habits, itching, allergic reactions such as skin rash, itching, skin redness, muscle cramps, swelling around the ankles (edema), fatigue, weakness.
Uncommon (affects less than 1 in 100 patients)
Inflammation of the nasal mucosa (nasal swelling or discharge), increased number of a certain type of white blood cells (eosinophilia), low blood sugar levels (hypoglycemia), high blood potassium levels, which may cause heart rhythm disturbances (hyperkalemia), low blood sodium levels (hyponatremia), which may cause dehydration and low blood pressure, insomnia, mood swings, anxiety, depression, sleep disturbances, inability to feel pain, tremor, fainting, vasculitis, dry mouth, hair loss, red spots on the skin (purpura), skin discoloration, increased sweating, photosensitivity reaction (skin changes) after exposure to sunlight or artificial UVA radiation, formation of blister clusters on the skin, muscle or joint pain, back pain, urinary disorders, increased need to urinate at night, increased frequency of urination, kidney disorders, impotence (inability to achieve or maintain an erection), discomfort or enlargement of the breasts in men, chest pain, pain, malaise, fever, weight gain or weight loss, increased blood urea levels, increased blood creatinine levels, falls.
Rare (affects less than 1 in 1,000 patients)
Low blood chloride levels, low blood magnesium levels, disorientation, exacerbation of psoriasis, high serum bilirubin levels, elevated liver enzymes, reduced or absent urine output, acute kidney failure.
Dark urine, nausea or vomiting, muscle cramps, disorientation and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
Very rare (affects less than 1 in 10,000 patients)
Changes in blood parameters such as reduced number of white and red blood cells, reduced hemoglobin concentration, reduced platelet count, high blood sugar levels (hyperglycemia), high blood calcium levels (hypercalcemia), increased muscle tension, nerve disorders causing weakness, eosinophilic pneumonia (a rare form of pneumonia), gum swelling, abdominal bloating (gastritis), yellowing of the skin (jaundice), acute kidney failure.
Frequency not known (cannot be estimated from available data)
Short-sightedness, blurred vision, worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the choroidal layer of the eye (choroidal effusion) or acute angle-closure glaucoma). In patients with systemic lupus erythematosus (a type of collagenosis), symptoms may worsen. Abnormal ECG findings, tremor, postural rigidity, facial masking, slowed movements and dragging gait, unsteady gait, increased uric acid levels, a substance which may cause or worsen gout (joint pain, especially in the feet), discoloration, numbness and pain in fingers or toes (Raynaud's phenomenon).
If any of the above symptoms occur, medical advice should be sought as soon as possible.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps 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 stated month.
There are no special temperature storage requirements for this medicine.
Store in the original packaging 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 in the medicine are perindopril with arginine, amlodipine, and indapamide. Each tablet contains 7 mg of perindopril arginine (equivalent to 4.75 mg of perindopril), amlodipine besylate corresponding to 5 mg of amlodipine, and 2.5 mg of indapamide.
• The other ingredients (excipients) are: calcium chloride dihydrate, microcrystalline cellulose, pregelatinized maize starch, sodium carboxymethyl starch (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 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 containing 10, 30, 60, 90, 100 or 120 tablets, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation 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 medicinal product is authorised for marketing in the European Economic Area member states under the following names:

For more detailed information on this medicinal product, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: +48 22 57 37 500