Amlessa

Leaflet accompanying the packaging: patient information

Amlessa, 4 mg + 5 mg, tablets

Amlessa, 4 mg + 10 mg, tablets

Amlessa, 8 mg + 5 mg, tablets

Amlessa, 8 mg + 10 mg, tablets

tert-butylamine perindopril + amlodipine

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

1. What is Amlessa and what is it used for

Amlessa is used to treat high blood pressure (hypertension) and/or stable coronary artery disease (a condition in which blood flow to the heart is reduced or blocked). Patients already taking perindopril and amlodipine in separate tablets may take one Amlessa tablet containing both active substances instead. Amlessa is a combination of two active substances: perindopril 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). Both active substances work by widening and relaxing blood vessels, which lowers blood pressure. Blood can flow more easily through the body, and the heart is less strained.

2. Important information before taking Amlessa

When not to take Amlessa:

• if the patient is allergic to perindopril with tert-butylamine or any other ACE inhibitor, amlodipine besylate or any other dihydropyridine, or any of the other ingredients of this medicine (listed in section 6);
• after the third month of pregnancy (it is also recommended to avoid taking Amlessa in early pregnancy - see section "Pregnancy and breastfeeding");
• if the patient has experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rash while taking ACE inhibitors in the past;
• in cardiogenic shock (a condition in which the heart cannot supply enough blood to the body), aortic stenosis (narrowing of the main blood vessel leaving the heart), or unstable angina pectoris (chest pain that may occur at rest);
• in patients with very low blood pressure (severe hypotension);
• in patients with heart failure (the heart is not able to pump blood sufficiently, leading to shortness of breath or swelling of the legs, ankles, or feet) after a recent heart attack;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient is undergoing dialysis or blood filtration by another method. Depending on the device used, Amlessa may not be suitable for the patient.
• if the patient has kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used to treat a certain type of chronic heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases.

Warnings and precautions

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

• if the patient has 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 other heart diseases;
• if the patient has liver function disorders;
• if the patient has kidney disease or is undergoing dialysis;
• if the patient has primary aldosteronism (a condition in which the blood contains too much of a hormone called aldosterone);
• if the patient has collagenosis (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
• if the patient has diabetes;
• if the patient is on a low-salt diet or is taking potassium-sparing diuretics (it is necessary to adjust the potassium level in the blood);
• if the patient is elderly and needs to adjust the dose;
• if the patient is taking any of the following medicines for high blood pressure:
• angiotensin receptor blockers (ARBs) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney disease,
• aliskiren.
• if the patient is taking any of the following medicines, the risk of angioedema increases:
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent transplant rejection and to treat cancer (e.g., sirolimus, everolimus, temsirolimus, and other mTOR inhibitors),
• wildagliptin, a medicine used to treat diabetes.
• 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.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under the heading "When not to take Amlessa". Angioedema Patients treated with ACE inhibitors, including perindopril, have reported angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Amlessa and contact their doctor immediately. See also section 4. The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Amlessa in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken during this period (see section "Pregnancy and breastfeeding"). The patient should inform their doctor or medical staff about taking Amlessa if:

• general anesthesia and/or surgery are planned,
• recently experienced diarrhea or vomiting,
• LDL apheresis (removal of cholesterol from the blood using a special device) is planned,
• desensitization treatment is to be performed to reduce the allergic reaction to bee or wasp stings.

Children and adolescents

Amlessa is not recommended for children and adolescents.

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 Amlessa with:

• lithium (used to treat mania or depression),
• estradiol (used to treat cancer),
• potassium supplements (including salt substitutes), potassium-sparing diuretics (spironolactone, triamterene), and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection and hepatitis),
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at a dose of 12.5 mg to 50 mg per day.

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

• other blood pressure-lowering medicines, including angiotensin receptor blockers (ARBs), aliskiren (see also sections "When not to take Amlessa" and "Warnings and precautions"), or diuretics (which increase the amount of urine excreted by the kidneys),
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Amlessa" and "Warnings and precautions".
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen), given to relieve pain or high doses of acetylsalicylic acid,
• antidiabetic medicines (e.g., insulin or wildagliptin),
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (e.g., tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics),
• immunosuppressive medicines (which weaken the immune system), used to treat autoimmune disorders or after organ transplantation (e.g., cyclosporine, tacrolimus),
• trimethoprim and cotrimoxazole (used to treat infections),
• allopurinol (a medicine used to treat gout),
• procainamide (a medicine used to treat heart rhythm disorders),
• vasodilators, including nitrates,
• ephedrine, noradrenaline, or adrenaline (medicines used to treat low blood pressure, shock, or asthma),
• baclofen or dantrolene (given by infusion), used to treat muscle stiffness in diseases such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia (a condition characterized by very high fever and muscle stiffness) during anesthesia,

Amlessa may lower blood pressure more, if the patient is taking other blood pressure-lowering medicines.

Amlessa with food and drink

Amlessa should be taken before a meal. Patients taking Amlessa should not consume grapefruit juice or grapefruits, as they may increase the level of the active substance amlodipine in the blood, which may lead to an unexpected increase in the action of Amlessa, lowering blood pressure.

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. PregnancyThe patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Amlessa before planned pregnancy or as soon as pregnancy is confirmed and recommend taking another medicine. It is not recommended to take Amlessa in the first trimester of pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken during this period. BreastfeedingThe patient should inform their doctor about breastfeeding or intending to breastfeed. It is not recommended to take Amlessa during breastfeeding. The doctor may choose another medicine if the patient intends to breastfeed, especially when breastfeeding a newborn or premature baby. It has been shown that small amounts of amlodipine pass into human milk.

Driving and using machines

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

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 Amlessa

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The tablet should be swallowed with a glass of water, preferably once a day, at the same time, in the morning before a meal. The doctor will determine the dose suitable for the patient. It is usually one tablet per day. Amlessa is usually recommended for patients who are already taking perindopril and amlodipine in separate tablets.

Use in children and adolescents

Amlessa is not recommended for children and adolescents.

Taking a higher dose of Amlessa than recommended

In case of taking too many tablets, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital. The most likely symptom of overdose is low blood pressure, which may cause dizziness or fainting. If such symptoms occur, the patient should lie down and raise their legs.

Missing a dose of Amlessa

It is important to take the medicine every day, as regular treatment is most effective. If a dose is missed, the next dose should be taken at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping Amlessa treatment

Since treatment with Amlessa usually lasts for life, the patient should consult their doctor before stopping the medicine. 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, Amlessa can cause side effects, although not everybody gets them. If the patient experiences any of the following symptoms, they should stop taking Amlessa and contact their doctor immediately:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue and throat, causing significant difficulty breathing;
• severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• severe dizziness or fainting;
• heart attack, too fast or irregular heart rate, or chest pain;
• pancreatitis, which can cause severe abdominal pain radiating to the back and very poor general condition.

The following common side effects have been reported. If any of these side effects bother the patient or last for more than a week, they should contact their doctor.

• Very common side effects (may affect more than 1 in 10 people): swelling (fluid retention).
• Common side effects (may affect up to 1 in 10 people): headache, dizziness of central origin, drowsiness (especially at the beginning of treatment), dizziness of labyrinthine origin, feeling of numbness or tingling in the limbs, vision disturbances (including double vision), tinnitus (feeling of hearing sounds), palpitations (feeling of heartbeat), sudden flushing of the face, feeling of "emptiness" in the head due to low blood pressure, cough, shortness of breath, nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disorders, changes in bowel movements, diarrhea, constipation, allergic reactions (such as skin rash, itching), muscle cramps, fatigue, weakness, swelling of the ankles (peripheral edema).

Other side effects that have been reported are listed below. If any of the side effects get worse or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist.

• Uncommon side effects (may affect up to 1 in 100 people): mood changes, anxiety, depression, insomnia, sleep disturbances, tremors, fainting, loss of pain sensation, heart rhythm disturbances, nasal congestion (nasal stuffiness), hair loss, red spots on the skin, skin discoloration, back pain, joint pain, muscle pain, chest pain, urinary disorders, nocturia (need to urinate at night), increased frequency of urination, pain, poor general condition, bronchospasm (feeling of constriction in the chest, wheezing, and shortness of breath), dryness of the mucous membranes of the mouth, angioedema (symptoms such as wheezing, facial or tongue swelling), blistering of the skin, kidney disorders, impotence, increased sweating, increased eosinophil count (a type of white blood cell), discomfort or enlargement of the breasts in men, weight gain or weight loss, tachycardia (fast heart rate), vasculitis (inflammation of blood vessels), photosensitivity reactions (increased sensitivity of the skin to sunlight), fever, falls, changes in laboratory test results: high potassium levels in the blood, low sodium levels, hypoglycemia (very low blood sugar levels) in patients with diabetes, increased urea levels in the blood, increased creatinine levels in the blood.
• Rare side effects (may affect up to 1 in 1,000 people): confusion, exacerbation of psoriasis, changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in serum, dark urine, nausea or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate secretion of antidiuretic hormone), decreased or absent urine production, acute kidney failure.
• Very rare side effects (may affect up to 1 in 10,000 people): cardiovascular disorders (angina pectoris, heart attack, and stroke), eosinophilic pneumonia (a rare type of pneumonia), swelling of the eyelids, face, or lips, swelling of the tongue and throat, causing significant difficulty breathing, severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, mucous membrane inflammation (Stevens-Johnson syndrome), erythema multiforme (a skin rash, often starting with the appearance of red, itchy patches on the face, arms, or legs), photosensitivity reactions, changes in blood parameters, such as decreased white blood cell count and red blood cell count, decreased hemoglobin levels, decreased platelet count, blood disorders, pancreatitis, which can cause severe abdominal pain radiating to the back and very poor general condition, liver function disorders, hepatitis, jaundice (yellowing of the skin), increased liver enzyme activity, which may affect some test results, abdominal bloating (gastritis), nerve disorders, which can cause weakness, numbness, or tingling, increased muscle tone, swelling and/or bleeding of the gums, increased blood sugar levels (hyperglycemia).
• Frequency not known (cannot be estimated from the available data): tremors, stiffness of posture, mask-like face, slow movements and dragging of the feet, unsteady 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: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store 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 stated. The batch number is stated on the packaging after "Lot". Store in the original packaging to protect from light and moisture. There are no special storage temperature requirements. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Amlessa contains

• The active substances of Amlessa are perindopril with tert-butylamine and amlodipine. Amlessa, 4 mg + 5 mg, tablets Each tablet contains 4 mg of perindopril with tert-butylamine (equivalent to 3.34 mg of perindopril) and 5 mg of amlodipine (in the form of besylate). Amlessa, 4 mg + 10 mg, tablets Each tablet contains 4 mg of perindopril with tert-butylamine (equivalent to 3.34 mg of perindopril) and 10 mg of amlodipine (in the form of besylate). Amlessa, 8 mg + 5 mg, tablets Each tablet contains 8 mg of perindopril with tert-butylamine (equivalent to 6.68 mg of perindopril) and 5 mg of amlodipine (in the form of besylate). Amlessa, 8 mg + 10 mg, tablets Each tablet contains 8 mg of perindopril with tert-butylamine (equivalent to 6.68 mg of perindopril) and 10 mg of amlodipine (in the form of besylate).
• Other ingredients are: sodium hydrogen carbonate, microcrystalline cellulose, maize starch, sodium carboxymethylcellulose (Type A), anhydrous colloidal silica, and magnesium stearate (E470b). See section 2 "Amlessa contains sodium".

What Amlessa looks like and contents of the pack

Amlessa, 4 mg + 5 mg, tablets: white to almost white, round, slightly convex tablets with beveled edges, with the inscription "U 1" on one side of the tablet. Diameter: approximately 7 mm. Amlessa, 4 mg + 10 mg, tablets: white to almost white, convex tablets in the shape of a capsule, with a dividing line on one side. The tablets have the inscription "U" on one side and "2" on the other side of the dividing line. Dimensions: approximately 12.5 mm x 5.5 mm. The dividing line on the tablet is only to facilitate breaking and does not allow for division into equal doses. Amlessa, 8 mg + 5 mg, tablets: white to almost white, round, convex tablets with beveled edges, with the inscription "U 3" on one side of the tablet. Diameter: approximately 9 mm. Amlessa, 8 mg + 10 mg, tablets: white to almost white, round, convex tablets with beveled edges and a dividing line on one side. The tablets have the inscription "U" on one side and "4" on the other side of the dividing line. Diameter: approximately 9 mm. The tablet can be divided into equal doses. Packaging:10, 20, 30, 60, or 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 Lek Pharmaceuticals, d.d., Verovškova 57, 1526 Ljubljana, Slovenia For more information on the names of the medicines in other European Economic Area countries, please contact the local representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o. ul. Równoległa 5 02-235 Warsaw Tel. 22 57 37 500 Date of last revision of the leaflet:02.12.2021