Amlessini

Leaflet accompanying the packaging: patient information

Amlessini, 2.85 mg + 2.5 mg, tablets

Amlessini, 5.7 mg + 5 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 you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. 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 Amlessini and what is it used for
• 2. Important information before taking Amlessini
• 3. How to take Amlessini
• 4. Possible side effects
• 5. How to store Amlessini
• 6. Package contents and other information

1. What is Amlessini and what is it used for

Amlessini is a combination preparation containing two active substances: perindopril and amlodipine. Both of these substances help regulate high blood pressure. Perindopril is an ACE inhibitor (an enzyme called angiotensin-converting enzyme). Amlodipine is a calcium antagonist, belonging to a group of drugs called dihydropyridines. Together, these drugs work by dilating and relaxing blood vessels, making it easier for blood to flow through them and for the heart to maintain normal blood flow. Amlessini is used to treat high blood pressure (hypertension) in adults.

2. Important information before taking Amlessini

When not to take Amlessini

• if the patient is allergic to perindopril with tert-butylamine or amlodipine, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe kidney problems;
• if the patient has previously experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe rash when taking an ACE inhibitor, or if such symptoms have occurred in a relative under any other circumstances (a condition called angioedema);
• if the patient has a narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body);
• if the patient has very low blood pressure (hypotension);
• if the patient has heart failure after a heart attack;
• if the patient is pregnant over 3 months (it is also recommended to avoid taking Amlessini in early pregnancy - see "Pregnancy");
• 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 has blood filtered by another method - depending on the device used, Amlessini 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 sacubitril with valsartan, a medicine used to treat a certain type of chronic (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) increases (see "Warnings and precautions" and "Amlessini and other medicines").

Warnings and precautions

Before starting to take Amlessini, you should discuss it with your doctor or pharmacist if:

• the patient has hypertrophic cardiomyopathy (a disease of the heart muscle);
• the patient has heart failure;
• the patient has experienced a significant increase in blood pressure (hypertensive crisis);
• the patient has any other heart problems;
• the patient has liver disease;
• the patient has kidney disease (including kidney transplant);
• the patient has an abnormally high level of a hormone called aldosterone in the blood (primary hyperaldosteronism);
• the patient has collagen vascular disease, such as systemic lupus erythematosus or scleroderma;
• the patient has diabetes;
• the patient is on a low-salt diet or uses salt substitutes containing potassium (it is essential to have the right level of potassium in the blood);
• the patient is elderly and needs to increase the dose;
• the patient is taking any of the following medicines used to treat high blood pressure:
• 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 electrolyte levels (e.g. potassium) in the blood.
• see also subsection "When not to take Amlessini";
• the patient is black - in this case, there is a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure than in patients of other races;
• the patient is taking any of the following medicines, as the risk of angioedema increases:
• racecadotril, a medicine used to treat diarrhea;
• sirolimus, everolimus, temsirolimus, and other medicines belonging to a group of medicines called mTOR inhibitors (used to prevent rejection of a transplanted organ and to treat cancer);
• 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 a group of medicines also called gliptins (used to treat diabetes).

Angioedema: In patients treated with ACE inhibitors, including perindopril, angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat and difficulty swallowing or breathing) has been reported. This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Amlessini and contact their doctor immediately. See also section 4. If the patient thinks they may be pregnant, they should tell their doctor. Amlessini should not be taken during pregnancy, especially after the third month, as it may seriously harm the baby if taken during this period (see "Pregnancy"). When taking Amlessini, the patient should also inform their doctor or medical staff if:

• they are to be given general anesthesia and/or undergo major surgery;
• they have recently had diarrhea or vomiting;
• they are to undergo LDL apheresis (removal of cholesterol from the blood using a special device);
• they are to undergo desensitization treatment to reduce allergic reactions to bee stings or wasp stings.

Children and adolescents

Amlessini should not be taken by children and adolescents.

Amlessini 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 Amlessini with the following medicines:

• lithium (used to treat mania or depression);
• estradiol (used to treat cancer);
• potassium-sparing medicines (e.g. triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent clotting, trimethoprim and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat infections, and cyclosporine, an immunosuppressive medicine used to prevent rejection of a transplanted organ);
• aliskiren (used to treat high blood pressure) (see also subsections "When not to take Amlessini" and "Warnings and precautions");
• angiotensin II receptor antagonists (medicines used to treat high blood pressure) (e.g. valsartan, telmisartan, irbesartan, etc.);
• dantrolene (in infusion), used to treat muscle stiffness in diseases such as multiple sclerosis or to treat malignant hyperthermia that may occur during anesthesia (symptoms include very high fever and muscle stiffness);
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Amlessini" and "Warnings and precautions".

Taking other medicines may affect treatment with Amlessini. The patient should tell their doctor if they are taking any of the following medicines, as it may require special caution:

• other medicines used to treat high blood pressure, including diuretics (medicines that increase the amount of urine produced by the kidneys);
• medicines commonly used to treat diarrhea (racecadotril) or to prevent rejection of a transplanted organ (sirolimus, everolimus, temsirolimus, and other medicines belonging to a group of medicines called mTOR inhibitors). See "Warnings and precautions";

Non-steroidal anti-inflammatory drugs (e.g. ibuprofen) used to relieve pain or high doses of acetylsalicylic acid;

• medicines used to treat diabetes (such as insulin, gliptins);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics, antidepressants similar to imipramine, neuroleptics);
• immunosuppressive medicines (which weaken the body's defense mechanisms), used to treat autoimmune diseases or after organ transplantation (e.g. cyclosporine, tacrolimus);
• allopurinol (used to treat gout);
• procainamide (used to treat heart rhythm disorders);
• vasodilators, including nitrates;
• ephedrine, norepinephrine, or epinephrine (medicines used to treat low blood pressure, shock, or asthma);
• baclofen, used to treat muscle stiffness in diseases such as multiple sclerosis;
• certain antibiotics, such as rifampicin, erythromycin, clarithromycin (used to treat bacterial infections);
• antiepileptic medicines, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone;
• itraconazole, ketoconazole (medicines used to treat fungal infections);
• alpha-adrenergic receptor blockers, used to treat prostate enlargement (prostate), such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin;
• amifostine (used to prevent or reduce side effects associated with the use of other medicines or radiation therapy in cancer treatment);
• corticosteroids (used to treat various diseases, including severe asthma and rheumatoid arthritis);
• gold salts, especially given intravenously (used to treat symptoms of rheumatoid arthritis);
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV),
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day;
• Hypericum perforatum(St. John's Wort, used to treat depression).

Amlessini with food and drink

See section 3. Patients taking Amlessini should not eat grapefruits or drink grapefruit juice, as grapefruits and grapefruit juice may increase the level of the active substance amlodipine, which may cause unexpected intensification of the blood pressure-lowering effect of Amlessini.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Pregnancy The patient should tell their doctor if they think they may be pregnant or are planning to become pregnant. Usually, the doctor will advise stopping Amlessini before becoming pregnant or as soon as the patient finds out they are pregnant and will prescribe a different medicine instead of Amlessini. Amlessini should not be taken during early pregnancy and should not be taken if the patient is pregnant over 3 months, 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 tell their doctor if they are breastfeeding or start breastfeeding. Amlessini is not recommended for mothers who are breastfeeding, and the doctor may choose a different treatment if the patient wants to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines

Amlessini may affect the ability to drive or operate machines. If dizziness, lightheadedness, weakness, fatigue, or headache occurs, the patient should not drive or operate machines and should contact their doctor immediately.

Amlessini 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 Amlessini

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 Amlessini 2.85 mg + 2.5 mg tablet per day. If the patient has moderate kidney problems, the doctor may initially prescribe one Amlessini 2.85 mg + 2.5 mg tablet every other day. Depending on the patient's response to treatment, the doctor may decide to increase the dose after one month of treatment to 5.7 mg + 5 mg Amlessini per day, if necessary. One Amlessini 5.7 mg + 5 mg tablet per day is the maximum recommended dose for the treatment of high blood pressure. The tablet should be taken once daily, at the same time, in the morning, before breakfast. The patient should not take more than the prescribed dose.

Taking a higher dose of Amlessini than recommended

If the patient has taken too many tablets, they should contact their doctor or go to the emergency department of the nearest hospital immediately. The most common symptom of overdose is low blood pressure, which can cause dizziness or fainting. In this case, it may be helpful to lie down with elevated legs. Up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Amlessini

It is essential to take the medicine every day, as regular treatment is more effective. However, if a dose of Amlessini 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 treatment with Amlessini

Treatment with Amlessini is usually long-term, so before stopping the tablets, the patient should consult their doctor. 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, Amlessini can cause side effects, although not everybody gets them. If the patient experiences any of the following potentially serious side effects, they should stop taking the medicine and contact their doctor immediately:

• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm) (uncommon - may affect up to 1 in 100 people);
• swelling of the eyelids, face, or lips (uncommon - may affect up to 1 in 100 people);
• swelling of the tongue and throat, which can cause significant difficulty breathing (angioedema) (uncommon - may affect up to 1 in 100 people);
• severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching (erythema multiforme) (rare - may affect up to 1 in 10,000 people), blistering and peeling of the skin (exfoliative dermatitis) (rare - may affect up to 1 in 10,000 people), Stevens-Johnson syndrome (very rare - may affect up to 1 in 10,000 people), and toxic epidermal necrolysis (frequency cannot be estimated from the available data) or other allergic reactions (uncommon - may affect up to 1 in 100 people);
• severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people);
• weakness or numbness in the arms or legs, or difficulty speaking, which can be a sign of a stroke (very rare - may affect up to 1 in 10,000 people);
• heart attack, chest pain (angina pectoris) (very rare - may affect up to 1 in 10,000 people), abnormal heart rhythm (common - may affect up to 1 in 10 people);
• pancreatitis, which can cause severe abdominal pain and very poor general condition (very rare - may affect up to 1 in 10,000 people);
• yellowing of the skin or eyes (jaundice), which can be a sign of liver inflammation (very rare - may affect up to 1 in 10,000 people). After taking Amlessini, the following side effects have been reported. If any of these side effects are troublesome for the patient, they should contact their doctor:
• common side effects (may affect up to 1 in 10 people): feeling of "emptiness" in the head, cough, swelling (fluid retention);
• uncommon side effects (may affect up to 1 in 100 people): high levels of potassium in the blood, which can cause heart rhythm disturbances (hyperkalemia), high blood sugar levels (hyperglycemia), fatigue.

After taking perindopril or amlodipine, the following side effects have been reported, which were not observed after taking Amlessini or were observed more frequently after taking Amlessini. These side effects may also occur after taking Amlessini. If any of these side effects are troublesome for the patient, 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, drowsiness (especially at the start of treatment), taste disturbance, feeling of numbness or tingling in the limbs, vertigo, vision disturbances (including double vision), tinnitus (ringing in the ears), palpitations (feeling of heartbeat), sudden flushing of the face (hot flashes), shortness of breath, abdominal pain, nausea, vomiting, indigestion or digestive disturbances, changes in bowel movements, constipation, diarrhea, itching, rash, redness of the skin, itching, swelling of the ankles, muscle cramps, fatigue, weakness;
• uncommon side effects (may affect up to 1 in 100 people): increased white blood cell count, low sodium levels in the blood (hyponatremia), low blood sugar levels (hypoglycemia), mood changes, anxiety, insomnia, depression, sleep disturbances, fainting, loss of sensation, tremors, vasculitis, rhinitis (inflammation or congestion of the nasal passages), dryness of the mucous membranes, excessive sweating, hair loss, red spots on the skin, skin discoloration, formation of blisters on the skin, increased sensitivity to light, back pain, muscle or joint pain, urinary disturbances, increased need to urinate at night, increased frequency of urination, kidney problems, impotence, discomfort or enlargement of the breasts in men, chest pain, poor general condition, pain, weight gain or loss;
• rare side effects (may affect up to 1 in 1,000 people): acute kidney failure; symptoms of a condition called SIADH (inappropriate secretion of antidiuretic hormone): dark urine, nausea or vomiting, muscle cramps, disorientation, and seizures; decreased or absent urine production;
• very rare side effects (may affect up to 1 in 10,000 people): changes in blood, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin, decreased platelet count, increased muscle tension, nerve disorders that can cause weakness, numbness, or tingling, eosinophilic pneumonia (a rare type of pneumonia), gum hypertrophy, abdominal bloating (gastritis), jaundice (yellowing of the skin);
• frequency not known (cannot be estimated from the available data): tremors, stiffness, 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 Adverse Reaction Monitoring 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 Amlessini

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated. Store in a temperature below 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 that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Amlessini contains

• The active substances of Amlessini are perindopril with tert-butylamine and amlodipine. Amlessini, 2.85 mg + 2.5 mg, tablets Each tablet contains 2.85 mg of perindopril with tert-butylamine (which corresponds to 2.38 mg of perindopril) and 2.5 mg of amlodipine (in the form of amlodipine besylate). Amlessini, 5.7 mg + 5 mg, tablets Each tablet contains 5.7 mg of perindopril with tert-butylamine (which corresponds to 4.76 mg of perindopril) and 5 mg of amlodipine (in the form of amlodipine besylate).
• Other ingredients are: sodium hydrogen carbonate, microcrystalline cellulose, maize starch, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, and magnesium stearate. See section 2 "Amlessini contains sodium".

What Amlessini looks like and contents of the pack

Amlessini, 2.85 mg + 2.5 mg, tablets: white or almost white, round, slightly convex tablets with beveled edges. Diameter: 5.5 mm. Amlessini, 5.7 mg + 5 mg, tablets: white or almost white, round, slightly convex tablets with beveled edges and a score line on one side. Diameter: 7 mm. The score line on the tablet is not intended for breaking the tablet. The tablets are available in a carton containing:

• 30, 60, or 90 tablets in blisters.

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 For more detailed information, the patient should contact their local representative of the marketing authorization holder: Krka - Polska Sp. z o.o. ul. Równoległa 5 02-235 Warsaw phone: +48 22 573 75 00 Date of last revision of the leaflet:01.03.2024