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
Perindoprilum argininum + Indapamidum + Amlodipinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as 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 personally. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What CoAramlessa is and what it is used for
What you need to know before taking CoAramlessa
How to take CoAramlessa
Possible side effects
How to store CoAramlessa
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,
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 may instead take one tablet of CoAramlessa, which contains these three active substances in the same doses.
Each of the active substances helps lower 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.
Indapamide is a diuretic (which belongs 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.
Amlodipine is a calcium antagonist (which belongs to a group of medicines called dihydropyridines). It causes blood vessels to relax, making it easier for blood to flow through them.

2. Important information before using CoAramlessa

When not to use CoAramlessa

if the patient is allergic to perindopril or other ACE inhibitors, indapamide or other sulphonamides, amlodipine or other dihydropyridines, or to any of the other ingredients of this medicine (listed in section 6),
if the patient has previously experienced symptoms such as wheezing, facial or tongue swelling, intense itching or severe rash while being treated with an ACE inhibitor, or if such symptoms occurred in the patient or a family member under any circumstances (a condition known as angioedema),
if the patient has severe liver disease or a condition called hepatic encephalopathy (a brain dysfunction caused by liver disease),
if untreated, decompensated heart failure is suspected in the patient (severe fluid retention, difficulty breathing),
if the patient has aortic valve stenosis (narrowing of the aorta) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body),
if the patient has heart failure following a myocardial infarction,
if the patient has very low blood pressure (hypotension),
if the patient has low potassium levels in the blood,
if the patient has severe kidney disease causing reduced blood flow to the kidneys (renal artery stenosis),
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 moderate kidney disease (applies to CoAramlessa 10 mg + 2.5 mg + 5 mg and 10 mg + 2.5 mg + 10 mg),
after the 3rd month of pregnancy (it is also advisable to avoid using CoAramlessa in early pregnancy – see the section on pregnancy),
if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren,
if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used to treat heart failure, as this increases the risk of angioedema (rapid swelling of tissues under the skin in the throat area) (see "Warnings and precautions" and "CoAramlessa with other medicines").

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

if the patient has hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney),
if the patient has heart failure or any other heart conditions,
if the patient has significantly elevated blood pressure (hypertensive crisis),
if the patient has liver diseases,
if the patient has collagenosis (connective tissue disease), such as systemic lupus erythematosus or scleroderma,
if the patient has atherosclerosis (hardening of the arteries),
if tests of parathyroid function are to be performed in the patient,
if the patient has gout,
if the patient has diabetes,
if the patient is on a low-salt diet or uses potassium-containing salt substitutes (maintaining appropriate potassium levels in the blood is important),
if the patient is taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as these should be avoided with CoAramlessa (see "CoAramlessa with other medicines"),
if the patient is elderly and the dose needs to be increased,
if the patient has previously experienced photosensitivity reactions,
angioedema (swelling of the face, lips, mouth, tongue or throat, possibly causing difficulty in swallowing or breathing) occurs more frequently in black patients, and the medicine may be less effective in lowering blood pressure,
if the patient is undergoing dialysis using high-flux membranes,
if the patient has kidney disease or is on dialysis,
if the patient experiences worsening vision or eye pain in one or both eyes. These may be symptoms of fluid accumulation in the uvea (excessive fluid accumulation between the choroid and sclera) or glaucoma, increased pressure in one or both eyes – these may occur from several hours to several weeks after taking CoAramlessa. Untreated, they may lead to permanent vision loss. If the patient previously had an allergy to penicillin or sulphonamides, they may be at higher risk of such a reaction.
if the patient has muscle disorders, including pain, tenderness, weakness or cramps,
if the patient has abnormally elevated levels of a hormone called aldosterone in the blood (primary hyperaldosteronism),
if there is excessive acid in the blood, which may cause rapid breathing,
if the patient has cerebral circulatory insufficiency (low blood pressure in the brain),
if the patient develops swelling of the face, lips, mouth, tongue or throat, possibly causing difficulty in swallowing or breathing (angioedema), which may occur at any time during treatment – treatment must be stopped immediately and medical advice sought,
if the patient is taking any of the following medicines, as this increases the risk of angioedema:
racecadotril (used to treat diarrhoea),
sirolimus, everolimus, temsirolimus and other medicines belonging to the group of 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),
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".

The doctor may recommend blood tests to assess whether sodium or potassium levels have decreased or calcium levels have increased.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a 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 section "Pregnancy and breastfeeding").
When taking CoAramlessa, inform your doctor or medical staff if:

the patient is to undergo anaesthesia and/or surgery,
the patient has recently experienced diarrhoea or vomiting, or is dehydrated,
the patient is to undergo dialysis or LDL apheresis (mechanical removal of cholesterol from the blood),
desensitisation treatment is planned to reduce allergic reactions following bee or wasp stings,
an imaging test requiring an iodine-containing contrast agent (a substance allowing organs such as the kidney or stomach to be visualised in X-ray examinations) is to be performed.

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
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Patients with diabetes or kidney disease must not take aliskiren (used to treat high blood pressure).
Avoid taking CoAramlessa with:

lithium (used to treat certain mental illnesses such as mania, bipolar disorder and recurrent depression),
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),
dantrolene (given by infusion), also used to treat malignant hyperthermia occurring during anaesthesia (symptoms include very high fever and muscle rigidity),
estramustine (used to treat cancer),
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 used to treat high blood pressure: angiotensin-converting enzyme inhibitors and angiotensin II receptor antagonists.

The use of other medicines may affect treatment with CoAramlessa. The doctor may recommend a dose adjustment and/or additional precautions. Inform your doctor if the patient is taking any of the following medicines, as this may require special caution:

other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRA), aliskiren (see also sections "When not to use CoAramlessa" and "Warnings and precautions") or diuretics (medicines that increase urine production by the kidneys),
potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at doses from 12.5 mg to 50 mg per day,
anaesthetics,
iodine-containing contrast agents,
bepridil (used to treat angina),
methadone (used to treat addiction),
medicines used to treat heart rhythm disorders (e.g. dofetilide, ibutilide, bretylium, cisapride, difemanyl, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol),
verapamil, diltiazem (used in heart diseases),
digoxin or other cardiac glycosides (used in heart diseases),
antibiotics used to treat bacterial infections (e.g. rifampicin, erythromycin, clarithromycin, sparfloxacin, moxifloxacin),
antifungal medicines (e.g. itraconazole, ketoconazole, intravenous amphotericin B),
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 drugs (e.g. ibuprofen) or high doses of salicylates (e.g. acetylsalicylic acid, a substance found in many medicines used for pain relief, fever reduction and prevention of blood clots),
immunosuppressive medicines (given to control immune system responses) used to treat autoimmune diseases or after organ transplantation (e.g. cyclosporine, tacrolimus),
tetracosactide (used to treat Crohn's disease),
gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis),
halofantrine (used to treat certain types of malaria),
baclofen used to treat muscle stiffness occurring in diseases such as multiple sclerosis,
medicines used to treat diabetes, such as insulin or metformin,
calcium, including calcium supplements,
stimulant laxatives (e.g. sena),
medicines used to treat cancer,
vinpocetine (used to treat symptomatic cognitive disorders in elderly patients, 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 vasodilating medicines, as they may further reduce blood pressure.

CoAramlessa with food and drink
While taking CoAramlessa, do not consume grapefruit or grapefruit juice, as this may increase the concentration of the active substance – amlodipine – potentially causing an unpredictable 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 a pregnancy.
Usually, the doctor will recommend stopping CoAramlessa before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine instead of CoAramlessa. 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.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Use of CoAramlessa is not recommended during breastfeeding, and the doctor may recommend an alternative medicine if the patient wishes to breastfeed, especially if the baby is a newborn or premature infant.
Driving and operating machinery
CoAramlessa may affect the ability to drive or operate machinery. If taking the medicine causes nausea, dizziness, 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 use CoAramlessa

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably in the morning, before a meal. Your doctor will determine
the appropriate dose for the patient. The usual recommended dose is one tablet once daily.

Taking more CoAramlessa than prescribed
Taking too many tablets may cause blood pressure to drop, even to a dangerous extent, which may sometimes be accompanied by nausea, vomiting, cramps, dizziness, drowsiness, disorientation, oliguria (passing less urine than usual), or anuria (lack of urine production or excretion).
Breathing difficulties caused by excess fluid accumulating in the lungs (pulmonary edema) may occur even 24–48 hours after taking the medicine.
The patient may experience a "blank" feeling in the head, faintness, or weakness. If the drop in blood pressure is severe, shock may occur, characterized by cold and clammy skin and possible loss of consciousness.
If too many tablets of CoAramlessa have been taken, seek immediate medical help.

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, the next dose should be taken at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping CoAramlessa treatment
Treatment of high blood pressure is usually long-term; therefore, you should contact your doctor before stopping this medicine.

If you have any further questions about 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 any of the following adverse effects occur in the patient, which may be serious,
the medicine should be discontinued immediately and the doctor contacted without delay:

sudden onset of wheezing, chest pain, breathlessness or difficulty breathing (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 (uncommon – may occur in less than 1 in 100 patients),
severe skin reactions, including severe rash, urticaria, redness of the skin over the entire body, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions (very rare – may occur in less than 1 in 10,000 patients),
severe dizziness or fainting (common – may occur in less than 1 in 10 patients),
heart attack (very rare – may occur in less than 1 in 10,000 patients), life-threatening heart rhythm disturbances (frequency not known),
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),
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: affecting at least 1 in 10 patients
Swelling (fluid retention).
Common: affecting less than 1 in 10 patients
Low blood potassium levels, headache, central dizziness, palpitations (awareness of heartbeat), sudden flushing of the face and neck, vestibular dizziness, tingling/numbness, visual disturbances, double vision, tinnitus (perception of ringing or other sounds), feeling of "emptiness" in the head due to low blood pressure, cough, breathlessness, gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disorders, diarrhoea, constipation, changes in bowel habits), allergic reactions (such as rashes, itching), muscle cramps, fatigue, weakness, drowsiness, swelling of the ankle area.
Uncommon: affecting less than 1 in 100 patients
Mood swings, anxiety, depression, sleep disorders, tremor, urticaria, fainting, insensitivity to pain, irregular and/or rapid heartbeat, inflammation of the nasal mucosa (nasal swelling or discharge), hair loss, purpura (red spots on the skin), skin discoloration, itching, sweating, chest pain, muscle or joint pain, back pain, pain, malaise, kidney disorders, urinary disorders, increased need to urinate at night, increased frequency of 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 weight loss, increased number of a certain type of white blood cells, high blood potassium levels, hypoglycaemia (very low blood sugar levels), low blood sodium levels, which may lead to dehydration and low blood pressure, vasculitis, photosensitivity reactions (skin changes) after exposure to sunlight or artificial UVA rays, clusters of blisters on the skin, swelling of hands or feet, increased levels of creatinine and urea in the blood, falls, dryness of the oral mucosa.
Rare: affecting less than 1 in 1,000 patients
Low blood chloride levels, low blood magnesium levels.
Dark-coloured urine, nausea or vomiting, muscle cramps, disorientation and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion). Acute kidney failure. Reduced or absent urine output.
Disorientation, changes in laboratory test results: increased liver enzyme activity, high serum bilirubin levels, and exacerbation of psoriasis.
Very rare: affecting less than 1 in 10,000 patients
Decreased number of white blood cells, decreased platelet count (leading to easy bruising and nosebleeds), anaemia (reduced number of red blood cells), angina pectoris (chest pain, jaw and back pain, triggered by physical exertion and caused by impaired blood supply to the heart), eosinophilic pneumonia (a rare type of lung inflammation), gum swelling, severe skin reactions, including severe rash, redness of the entire skin, intense itching, blistering, peeling and swelling of the skin, erythema multiforme (rash, often starting with red, itchy spots on the face, arms or legs), bleeding, sensitive or enlarged gums, liver function disorders, hepatitis, severe kidney function disorders, yellowing of the skin (jaundice), abdominal distension (gastritis), nerve disorders, which may cause weakness, tingling or numbness, increased muscle tone, hyperglycaemia (very high blood sugar levels), high blood calcium levels, stroke, possibly secondary to significant drop in blood pressure.
Frequency not known: cannot be estimated from available data
Hepatic encephalopathy (brain disorder caused by liver disease), abnormal electrocardiogram (ECG) findings, in patients with systemic lupus erythematosus (a type of collagenosis), symptoms may worsen.
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).
Tremor, rigidity, facial masking, bradykinesia and shuffling gait. Raynaud's phenomenon (bluish discoloration, numbness and pain in fingers or toes).
Changes in laboratory test results (blood tests) may occur. The doctor may recommend blood tests to monitor the patient's health.
Reporting of adverse effects
If any symptoms of adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the 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 requirements regarding the storage temperature of this medicine.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What CoAramlessa contains

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

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

Other components (excipients): calcium chloride dihydrate, microcrystalline cellulose, maize starch, sodium carboxymethyl starch (type A), sodium hydrogen carbonate, colloidal hydrated 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, marked with "K1" on one side.
Tablet dimensions: approximately 7 mm in diameter.
CoAramlessa 10 mg + 2.5 mg + 5 mg tablets
White or almost white, biconvex, capsule-shaped tablets, marked with "K3" on one side.
Tablet dimensions: approximately 13 mm x 6 mm.
CoAramlessa 10 mg + 2.5 mg + 10 mg tablets
White or almost white, oval, biconvex tablets, marked with "K2" on one side.
Tablet dimensions: approximately 14 mm x 7 mm.
CoAramlessa is available in packs containing 10, 30, 60, 90 or 100 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
TAD Pharma GmbH,
Heinz-Lohmann-Straße 5,
27472 Cuxhaven,
Germany

For further information on the names of the medicinal products in other European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500