Co-amlessa

Leaflet attached to the packaging: patient information

Co-Amlessa, 2 mg + 5 mg + 0.625 mg, tablets

Co-Amlessa, 4 mg + 5 mg + 1.25 mg, tablets

Co-Amlessa, 4 mg + 10 mg + 1.25 mg, tablets

Co-Amlessa, 8 mg + 5 mg + 2.5 mg, tablets

Co-Amlessa, 8 mg + 10 mg + 2.5 mg, tablets

tert-Butylamine perindopril + amlodipine + indapamide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Co-Amlessa and what is it used for

Co-Amlessa is used to treat high blood pressure (hypertension). All three active substances help control high blood pressure. Patients already taking perindopril/indapamide and amlodipine in separate tablets may take one Co-Amlessa tablet instead, which contains all three components.
Co-Amlessa is a combination of three active substances: perindopril, indapamide, and amlodipine. Perindopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).
Amlodipine is a calcium antagonist (belonging to a group of medicines called dihydropyridines).
Indapamide is a diuretic.
In patients with high blood pressure, perindopril and amlodipine cause blood vessels to relax, making it easier for blood to flow through them. Indapamide increases the amount of urine excreted by the kidneys. Each active substance lowers blood pressure, and together they effectively control it.

2. Important information before taking Co-Amlessa

When not to take Co-Amlessa

• if the patient is allergic to perindopril or any other ACE inhibitor, indapamide or any other sulfonamide, amlodipine besylate or any other dihydropyridine, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rashes during previous treatment with an ACE inhibitor or if the patient or a family member has experienced such symptoms in any other situation (a condition called angioedema);

ACE inhibitors or if the patient or a family member has experienced such symptoms in any other situation (a condition called angioedema);

• if the patient has liver disease or a disease called hepatic encephalopathy (a disease that causes brain damage);
• if the patient has severe kidney problems (creatinine clearance below 30 ml/min);
• if the patient has severe kidney disease that reduces blood flow to the kidneys (renal artery stenosis). Co-Amlessa 8 mg + 5 mg + 2.5 mg and 8 mg + 10 mg + 2.5 mg are contraindicated in severe or moderate kidney disease;
• if the patient is undergoing dialysis or blood filtration by another method. Depending on the device used, Co-Amlessa may not be suitable for the patient;
• if the patient has low or high potassium levels in the blood;
• if there is a suspicion of untreated, uncontrolled heart failure (symptoms include fluid retention in the body and breathing difficulties);
• if the patient has cardiogenic shock (a condition where the heart cannot supply blood in the amount needed by the body), aortic stenosis (narrowing of the main blood vessel leaving the heart), or unstable angina (chest pain that may occur at rest);
• if the patient has very low blood pressure (severe hypotension);
• if the patient has heart failure (the heart is not able to pump blood strongly enough, leading to shortness of breath and swelling of the legs, ankles, or feet) after a recent heart attack;
• if the patient is pregnant more than 3 months (it is also recommended to avoid taking Co-Amlessa in early pregnancy - see "Pregnancy and breastfeeding");
• if the patient has diabetes or kidney problems 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 (a medicine used to treat a certain type of long-term (chronic) heart failure in adults), as this increases the risk of angioedema (rapid swelling of tissues under the skin, such as the throat).

Warnings and precautions

Before starting to take Co-Amlessa, the patient should discuss it with their doctor or pharmacist.

• If the patient has recently had a heart attack;
• If the patient has aortic stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the artery supplying blood to the kidney);
• If the patient has heart failure or any other heart disease;
• If the patient has kidney disease or is undergoing dialysis;
• If the patient has experienced a significant increase in blood pressure (hypertensive crisis);
• If the patient has muscle disorders, including muscle pain, tenderness, weakness, or cramps;
• If the patient has an abnormally high level of a hormone called aldosterone in the blood (primary aldosteronism);
• If the patient has liver problems;
• If the patient has a collagen disease (such as systemic lupus erythematosus or scleroderma);
• If the patient has atherosclerosis (hardening of the arteries);
• If the patient has hyperparathyroidism;
• If the patient has gout;
• If the patient has diabetes;
• If the patient is on a low-salt diet or taking salt substitutes that contain potassium;
• If the patient is taking lithium or potassium-sparing diuretics (such as spironolactone, triamterene) or potassium supplements, as their use with Co-Amlessa is not recommended (see "Co-Amlessa and other medicines");
• If the patient is elderly and requires a dose increase;
• If the patient has experienced hypersensitivity reactions to light;
• If the patient experiences a severe allergic reaction with swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema). Angioedema may occur at any time during treatment. If such symptoms occur, the patient should stop taking Co-Amlessa and consult their doctor immediately;
• If the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes,
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood at regular intervals. See also the information under the heading "When not to take Co-Amlessa" and "Warnings and precautions".
• If the patient is black - in this case, there may be a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure than in patients of other races;
• If the patient is undergoing dialysis using high-flux membranes;
• If the patient is taking any of the following medicines, which may increase the risk of angioedema (rapid swelling of tissues under the skin, such as the throat):
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus, and other mTOR inhibitors (used to prevent organ rejection and treat cancer),
• linagliptin, saxagliptin, sitagliptin, vildagliptin used to treat diabetes,
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure.

Angioedema
Angioedema has been reported in patients treated with ACE inhibitors, including Co-Amlessa. This reaction may occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Co-Amlessa and consult their doctor immediately. See also section 2 "Warnings and precautions".
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Co-Amlessa before planned pregnancy or as soon as pregnancy is confirmed and prescribe another medicine. Co-Amlessa is not recommended during the first trimester of pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby if taken during this period (see "Pregnancy and breastfeeding").
During treatment with Co-Amlessa, the patient should also inform their doctor or medical staff:

• if they have a dry cough;
• if they are to undergo general anesthesia and/or surgery;
• if they have recently had diarrhea or vomiting, or if they are dehydrated;
• if they are to undergo dialysis or LDL apheresis (removal of cholesterol from the blood using a special device);
• if they are to undergo desensitization to reduce the allergic reaction in case of bee or wasp stings;
• if they are to undergo tests that require the use of a contrast agent containing iodine (a substance that makes certain organs, such as the kidneys or stomach, visible on X-ray);
• if they experience blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye. If left untreated, they may lead to permanent vision loss. Patients with a history of penicillin or sulfonamide allergy may be more prone to developing this condition. The patient should stop taking Co-Amlessa and consult their doctor.

Athletes should be informed that Co-Amlessa contains an active substance (indapamide) that may give a positive result in doping tests.

Children and adolescents

Co-Amlessa is not recommended for children and adolescents.

Co-Amlessa and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should avoid taking Co-Amlessa with:

• lithium (used to treat depression);
• aliskiren (a medicine used to treat high blood pressure) in patients who do not have diabetes or kidney problems;
• potassium-sparing diuretics (such as triamterene, amiloride), potassium salts, and other medicines that may increase potassium levels in the body (such as trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection and treat certain diseases; heparin, a medicine used to thin the blood and prevent blood clots);
• sacubitril/valsartan (used to treat chronic heart failure). See sections "When not to take Co-Amlessa" and "Warnings and precautions".
• estramustine (used to treat cancer);
• other medicines used to treat high blood pressure: ACE inhibitors and angiotensin receptor antagonists.

Other medicines may affect the action of Co-Amlessa.
The patient should inform their doctor about taking any of the following medicines, as special care may be needed:

• other medicines used to treat high blood pressure, including angiotensin receptor antagonists (ARB) or aliskiren (see also sections "When not to take Co-Amlessa" and "Warnings and precautions"), or diuretics (medicines that increase urine production);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• anesthetics;
• iodine-containing contrast agents;
• antibiotics such as moxifloxacin, sparfloxacin, rifampicin, erythromycin, clarithromycin;
• methadone (used to treat addiction);
• procainamide (used to treat heart rhythm disorders);
• allopurinol (used to treat gout);
• antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, terfenadine, or astemizole);
• corticosteroids (used to treat various conditions, including asthma and rheumatoid arthritis);
• immunosuppressive medicines used to treat autoimmune disorders or prevent organ rejection (e.g., cyclosporine);
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infections);
• medicines used to treat cancer;
• ketoconazole, itraconazole (antifungal medicines);
• halofantrine (used to treat certain types of malaria);
• pentamidine (used to treat pneumonia);
• gold in injectable medicines (used to treat rheumatoid arthritis);

The doctor may need to change the dose and/or take other precautions:

• if the patient is taking an angiotensin receptor antagonist (ARB) or aliskiren (see also sections "When not to take Co-Amlessa" and "Warnings and precautions").

Taking Co-Amlessa with food and drink

It is recommended to take Co-Amlessa before a meal.
Patients taking Co-Amlessa should not consume grapefruit juice or grapefruits, as they may increase the levels of the active substance amlodipine in the blood, which may lead to an unexpected increase in the blood pressure-lowering effect of Co-Amlessa.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Co-Amlessa before planned pregnancy or as soon as pregnancy is confirmed and prescribe another medicine. Co-Amlessa is not recommended during the first trimester of pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby if taken during this period.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk.
The patient should inform their doctor about breastfeeding or planned breastfeeding. Co-Amlessa is not recommended for breastfeeding women. The doctor may prescribe another medicine if the patient wants to continue breastfeeding, especially if the baby is a newborn or premature.
The patient should consult their doctor immediately.

Driving and using machines

Co-Amlessa does not affect the ability to concentrate, but dizziness or weakness due to low blood pressure may occur, which may affect the ability to drive and use machines. The patient should not drive or use machines until they know how they react to Co-Amlessa.

Co-Amlessa contains sodium

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

3. How to take Co-Amlessa

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose is one tablet per day. It is recommended to take the medicine in the morning before a meal.
The tablet should be swallowed with a glass of water.
The doctor will decide what dose is suitable for the patient. Co-Amlessa is recommended for patients who are already taking perindopril/indapamide and amlodipine in separate tablets.

Overdose of Co-Amlessa

If the patient has taken more than the recommended dose, they should immediately consult their doctor or go to the emergency department of the nearest hospital. The most likely side effect of an overdose is low blood pressure. If the patient experiences a significant drop in blood pressure (symptoms such as dizziness or fainting), they should lie down with their legs raised.
Up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Co-Amlessa

It is important to take the medicine every day, as this ensures the effectiveness of the treatment. If the patient misses a dose of Co-Amlessa, they should take the next dose at the usual time.
The patient should not take a double dose to make up for the missed tablet.

Stopping treatment with Co-Amlessa

Since antihypertensive therapy is usually long-term, the patient should discuss stopping the medicine with their doctor before doing so.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Co-Amlessa can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects, they should stop taking Co-Amlessa and consult their doctor immediately:

• severe dizziness or fainting due to low blood pressure (frequent - may occur in up to 1 in 10 patients),
• bronchospasm (feeling of compression in the chest, wheezing, and shortness of breath) (uncommon - may occur in up to 1 in 100 patients),
• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema, see section 2 "Warnings and precautions") (uncommon - may occur in up to 1 in 100 patients),
• severe skin reactions, including erythema multiforme (a skin rash that often starts with the appearance of red, itchy spots on the face, arms, or legs) or severe skin rash, hives, redness of the skin all over the body, intense itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome), or other allergic reactions (very rare - may occur in up to 1 in 10,000 patients),
• cardiovascular disorders (heart rhythm disorders, angina pectoris (chest pain radiating to the jaw and back, caused by exertion), heart attack) (very rare - may occur in up to 1 in 10,000 patients),
• weakness or numbness of the arms or legs, or speech disorders, which may be symptoms of a stroke (very rare - may occur in up to 1 in 10,000 patients),
• pancreatitis, which may cause severe abdominal pain radiating to the back with very poor general condition (very rare - may occur in up to 1 in 10,000 patients),
• jaundice (yellowing of the skin or eyes), which may be a symptom of liver inflammation (very rare - may occur in up to 1 in 10,000 patients),
• life-threatening heart rhythm disorders (frequency not known),
• liver disease causing brain damage (hepatic encephalopathy) (frequency not known),
• muscle weakness, cramps, tenderness, or pain, especially if the patient feels unwell or has a high fever, which may be caused by abnormal muscle breakdown (frequency not known).

Side effects are listed in order of decreasing frequency:

• Very common (may occur in more than 1 in 10 patients): edema (fluid retention).
• Common (may occur in up to 1 in 10 patients): skin reactions in patients prone to allergic and asthmatic reactions, low potassium levels in the blood, headache, dizziness, balance disorders, tingling or numbness, drowsiness, vision disorders, feeling of "emptiness" in the head due to low blood pressure, tinnitus (ringing in the ears), low blood pressure, rapid heartbeat (very fast heart rate), sudden reddening of the skin, especially the face (feeling of heat or warmth on the face), shortness of breath, cough, gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disorders, changes in bowel movements, indigestion or digestive disorders, diarrhea, constipation), dryness of the mouth, allergic reactions (such as skin rashes, itching), muscle cramps, swelling of the ankles, weakness, feeling of fatigue.
• Uncommon (may occur in up to 1 in 100 patients): nasal congestion (nasal stuffiness or runny nose), increased eosinophil count (a type of white blood cell), hypoglycemia (very low blood sugar), changes in laboratory test results: high potassium levels in the blood, which may disappear after stopping the treatment, low sodium levels in the blood, which may cause dehydration and low blood pressure,

mood changes, sleep disorders, insomnia, depression, tremors, loss of pain sensation, rapid heartbeat (tachycardia), heart rhythm disorders, inflammation of blood vessels, bronchospasm (feeling of compression in the chest, wheezing, and shortness of breath), angioedema (symptoms such as wheezing, facial or tongue swelling), hives, blistering of the skin, skin discoloration, sweating, hair loss, red or discolored spots on the skin, hypersensitivity reactions to light (increased skin sensitivity to sunlight), back pain, muscle or joint pain, kidney disorders, increased frequency of urination (especially at night), impotence (inability to achieve or maintain an erection), breast enlargement in men, chest pain, pain, general poor condition, fever, increased urea levels in the blood, increased creatinine levels in the blood, increased or decreased body weight, falls, fainting.
In patients with systemic lupus erythematosus (a type of collagen disease), there may be an exacerbation of symptoms.

• Rare (may occur in up to 1 in 1,000 patients): disorientation, worsening of psoriasis, acute kidney failure, decreased or absent urine production, changes in laboratory test results: high calcium levels, increased liver enzyme activity, high bilirubin levels in the blood, dark urine color, nausea or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion), low chloride levels in the blood, low magnesium levels in the blood.
• Very rare (may occur in up to 1 in 10,000 patients): changes in blood parameters, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin and hematocrit values, decreased platelet count, high glucose levels in the blood (hyperglycemia), cardiovascular disorders (such as angina, heart attack, stroke), eosinophilic pneumonia (a rare type of pneumonia), gum swelling, pancreatitis, abdominal bloating (gastritis), peripheral neuropathy (a disease that causes loss of sensation, pain, or inability to control muscles), severe skin reactions (such as erythema multiforme). Abnormal liver function, liver inflammation, jaundice (yellowing of the skin), increased liver enzyme activity, as shown by blood tests.
• Unknown (frequency cannot be estimated from available data): abnormal heart function, as shown by ECG, changes in laboratory test results: high uric acid levels, myopia, blurred vision, decreased vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute glaucoma), life-threatening heart rhythm disorders (torsades de pointes). In patients with liver failure (liver disorders), there is a risk of developing hepatic encephalopathy (a disease that causes brain damage). Tremors, stiffness, mask-like face, slow movements, and shuffling gait. Cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 the medicine.

5. How to store Co-Amlessa

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the packaging after "Lot".
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Co-Amlessa contains

• The active substances of Co-Amlessa are perindopril tert-butylamine, amlodipine (as besylate), and indapamide. Co-Amlessa, 2 mg + 5 mg + 0.625 mg, tablets Each tablet contains 2 mg of perindopril tert-butylamine, 5 mg of amlodipine (as besylate), and 0.625 mg of indapamide. Co-Amlessa, 4 mg + 5 mg + 1.25 mg, tablets Each tablet contains 4 mg of perindopril tert-butylamine, 5 mg of amlodipine (as besylate), and 1.25 mg of indapamide. Co-Amlessa, 4 mg + 10 mg + 1.25 mg, tablets Each tablet contains 4 mg of perindopril tert-butylamine, 10 mg of amlodipine (as besylate), and 1.25 mg of indapamide. Co-Amlessa, 8 mg + 5 mg + 2.5 mg, tablets Each tablet contains 8 mg of perindopril tert-butylamine, 5 mg of amlodipine (as besylate), and 2.5 mg of indapamide. Co-Amlessa, 8 mg + 10 mg + 2.5 mg, tablets Each tablet contains 8 mg of perindopril tert-butylamine, 10 mg of amlodipine (as besylate), and 2.5 mg of indapamide.
• Other ingredients are: microcrystalline cellulose type 200, microcrystalline cellulose type 112, maize starch, sodium carboxymethylcellulose (type A), calcium chloride hexahydrate, sodium bicarbonate, colloidal anhydrous silica, magnesium stearate (E 470b). See section 2 "Co-Amlessa contains sodium".

What Co-Amlessa looks like and contents of the pack

Co-Amlessa, 2 mg + 5 mg + 0.625 mg, tablets: white to almost white, oval, biconvex tablets with a score line on one side, 9 mm in length. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Co-Amlessa, 4 mg + 5 mg + 1.25 mg, tablets: white to almost white, round, slightly biconvex tablets with beveled edges, 7 mm in diameter.
Co-Amlessa, 4 mg + 10 mg + 1.25 mg, tablets: white to almost white, oval, biconvex tablets with a score line on one side, 12 mm in length. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Co-Amlessa, 8 mg + 5 mg + 2.5 mg, tablets: white to almost white, round, biconvex tablets with beveled edges, 9 mm in diameter.
Co-Amlessa, 8 mg + 10 mg + 2.5 mg, tablets: white to almost white, round, biconvex tablets with a score line on one side, beveled edges, 9 mm in diameter. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Packaging:10, 14, 20, 28, 30, 56, 60, 84, and 90 tablets in blisters 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
KRKA-POLSKA Sp. z o.o., Równoległa 5, 02-235 Warsaw
To obtain more detailed information on the names of medicinal products in other EU member states, the patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet: 2.09.2022