Aldan Combo

Leaflet accompanying the packaging: patient information

Aldan Combo, 5 mg + 5 mg, tablets

Aldan Combo, 10 mg + 5 mg, tablets

Aldan Combo, 10 mg + 10 mg, tablets

Perindopril arginine + Amlodipine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, so you can read it again if you need to. If you have any doubts, consult your doctor, pharmacist, or nurse. 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 as yours. If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What is Aldan Combo and what is it used for? Important information before taking Aldan Combo How to take Aldan Combo Possible side effects How to store Aldan Combo Contents of the packaging and other information

What is Aldan Combo and what is it used for

Aldan Combo is used to treat high blood pressure (hypertension) and (or) stable coronary artery disease (a condition where blood flow to the heart is reduced or blocked). Patients already taking perindopril and amlodipine in separate tablets may use one tablet of Aldan Combo, which contains both active ingredients. Aldan Combo is a combination medicine containing two active substances: perindopril and amlodipine. Perindopril is an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine is a calcium antagonist (belonging to a group of medicines called dihydropyridines). Together, these medicines work by widening and relaxing blood vessels, making it easier for blood to flow through them and for the heart to maintain a normal blood flow.

Important information before taking Aldan Combo

When not to take Aldan Combo:

if you are allergic to perindopril or any other ACE inhibitor, to amlodipine or other calcium antagonists, or to any of the other ingredients of this medicine (listed in section 6); if you are pregnant over 3 months (it is also recommended to avoid taking Aldan Combo in early pregnancy - see "Pregnancy"); if you have ever had symptoms such as wheezing, swelling of the face or tongue, intense itching, or severe rash when taking an ACE inhibitor; if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren; if you have narrowing of the aortic valve (aortic stenosis) or are in cardiogenic shock (a condition where the heart is unable to supply enough blood to the body); if you have very low blood pressure (hypotension); if you have heart failure after a heart attack; if you are undergoing dialysis or blood filtration by another method. Depending on the device used, Aldan Combo may not be suitable for you; if you have kidney problems that reduce blood flow to the kidneys (renal artery stenosis); if you are taking a combination medicine containing sacubitril and valsartan, used to treat heart failure, as the risk of angioedema (rapid swelling of tissues under the skin in the throat area) increases (see "Warnings and precautions" and "Aldan Combo with other medicines").

Warnings and precautions

Before starting treatment with Aldan Combo, discuss it with your doctor, pharmacist, or nurse if you have any of the following conditions: hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney); heart failure; significant increase in blood pressure (hypertensive crisis); any other heart disease; liver disease; kidney disease or dialysis; you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism); collagen vascular diseases (connective tissue diseases), such as systemic lupus erythematosus or scleroderma; diabetes; taking a low-sodium diet or using salt substitutes containing potassium (it is necessary to monitor potassium levels in the blood); the need to increase the dose in elderly patients; if you are taking any of the following medicines for high blood pressure: angiotensin II receptor antagonist (AIIRA), also known as a sartan - for example, valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes, aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the subsection "When not to take Aldan Combo". if you are taking any of the following medicines, as the risk of angioedema increases: racecadotril (used to treat diarrhea); sirolimus, everolimus, temsirolimus, and other medicines belonging to the 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 the group of medicines called gliptins (used to treat diabetes); if you are 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. Angioedema In patients treated with ACE inhibitors, including Aldan Combo, 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 you experience such symptoms, stop taking Aldan Combo and contact your doctor immediately. See also section 4. You should inform your doctor about pregnancy, suspected pregnancy, or planning pregnancy. It is not recommended to take Aldan Combo in early pregnancy and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the fetus (see "Pregnancy"). When taking Aldan Combo, you should also inform your doctor or medical staff if: you are to undergo general anesthesia and (or) surgery; you have recently had diarrhea or vomiting; you are to undergo LDL apheresis (removal of cholesterol from the blood using a special device); you are to undergo desensitization treatment to reduce allergic reactions to bee stings or wasp stings.

Children and adolescents

Aldan Combo is not recommended for children and adolescents.

Aldan Combo with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take. You should avoid taking Aldan Combo: with lithium (used to treat mania or depression); with estramustine (used to treat cancer); with potassium-sparing medicines (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 blood clots; trimethoprim and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections); with potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at a dose of 12.5 mg to 50 mg per day. The use of other medicines may affect treatment with Aldan Combo. Your doctor may recommend changing the dose and (or) taking other precautions. You should tell your doctor if you are taking any of the following medicines, as it may require special caution: other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRA), aliskiren (see also subsections "When not to take Aldan Combo" and "Warnings and precautions"); medicines commonly used to treat diarrhea (racecadotril) or to prevent rejection of a transplanted organ (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See "Warnings and precautions". a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See subsections "When not to take Aldan Combo" and "Warnings and precautions". non-steroidal anti-inflammatory medicines (e.g., ibuprofen) used to relieve pain or high doses of acetylsalicylic acid, a substance found in many medicines, used as a pain reliever and anti-inflammatory, as well as to prevent blood clots; medicines used to treat diabetes (such as insulin); medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics); immunosuppressive medicines (weakening the body's defense mechanisms), used to treat autoimmune diseases or after organ transplantation (e.g., cyclosporine, tacrolimus); trimethoprim and cotrimoxazole (used to treat bacterial infections); allopurinol (used to treat gout); procainamide (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 (used to treat muscle stiffness in diseases such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia that occurs during anesthesia); certain antibiotics, such as rifampicin, erythromycin, clarithromycin (used to treat bacterial infections); Hypericum perforatum(St. John's Wort, used to treat depression); simvastatin (a medicine that lowers cholesterol levels in the blood); antiepileptic medicines, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone; itraconazole, ketoconazole (medicines used to treat fungal infections); alpha-adrenergic receptor antagonists - medicines used to treat prostate enlargement (prostate), such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin; amifostine (used to prevent or reduce the side effects of other medicines or radiation therapy for cancer); corticosteroids (used to treat various diseases, including severe asthma and rheumatoid arthritis); gold salts, especially when given by injection (used to treat symptoms of rheumatoid arthritis); ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV infection).

Aldan Combo with food and drink

Aldan Combo should be taken before a meal. When taking Aldan Combo, do not drink grapefruit juice or eat grapefruits, as grapefruits and grapefruit juice can cause an increase in the level of the active substance amlodipine, which may result in unpredictable intensification of the blood pressure-lowering effect of Aldan Combo.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. PregnancyYou should tell your doctor about pregnancy, suspected pregnancy, or planning pregnancy. Usually, your doctor will recommend stopping Aldan Combo before becoming pregnant or as soon as you find out you are pregnant, and will recommend taking another medicine instead of Aldan Combo. It is not recommended to take Aldan Combo in early pregnancy and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the fetus. BreastfeedingIt has been shown that small amounts of amlodipine pass into human milk. You should tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Aldan Combo during breastfeeding. Your doctor may recommend taking another medicine if you want to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

Aldan Combo may affect your ability to drive or use machines. If you experience nausea, dizziness, weakness, fatigue, or headache after taking the medicine, do not drive or use machines and contact your doctor immediately.

Aldan Combo contains lactose

Each Aldan Combo 5 mg + 5 mg tablet contains 58.0 mg of lactose. Each Aldan Combo 10 mg + 5 mg tablet contains 122.7 mg of lactose. Each Aldan Combo 10 mg + 10 mg tablet contains 116.1 mg of lactose. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

How to take Aldan Combo

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. The tablet should be swallowed with a glass of water, preferably at the same time every day, in the morning, before a meal. Your doctor will determine the appropriate dose for you. The recommended dose is usually one tablet per day. Aldan Combo is usually recommended for patients already taking perindopril and amlodipine in separate tablets.

Use in children and adolescents

Aldan Combo is not recommended for children and adolescents.

Overdose of Aldan Combo

If you have taken too many tablets, go to the emergency department of the nearest hospital or contact your doctor immediately. The most common symptom of overdose is low blood pressure, which can cause dizziness or fainting. In such a situation, lying down with your legs raised may help. Up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missed dose of Aldan Combo

It is important to take the medicine every day, as regular treatment is most effective. If you miss a dose of Aldan Combo, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Aldan Combo

Treatment with Aldan Combo is usually long-term, so before stopping the tablets, consult your doctor. If you have any further doubts about taking this medicine, consult your doctor, pharmacist, or nurse.

Side effects of Aldan Combo

Like all medicines, Aldan Combo can cause side effects, although not everybody gets them. If you experience any of the following side effects, stop taking the medicine and contact your doctor immediately: sudden wheezing, chest pain, shortness of breath, or difficulty breathing; swelling of the eyelids, face, or lips; swelling of the tongue or throat, causing severe difficulty breathing; severe skin reactions, including intense 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, toxic epidermal necrolysis) or other allergic reactions; severe dizziness or fainting; heart attack, too fast or irregular heartbeat, or chest pain; pancreatitis, which can cause severe abdominal pain, radiating to the back, and very poor general condition. The following very common and common side effects have been reported. If any of these side effects bother you, or if they last for more than a week, you should contact your doctor. Very common side effects (may affect at least 1 in 10 people): swelling (fluid retention). Common side effects (may affect up to 1 in 10 people): headache, dizziness, drowsiness (especially at the beginning of treatment), vertigo, feeling of numbness or tingling in the limbs, vision disturbances (including double vision), ringing in the ears (feeling of hearing sounds), palpitations (feeling of heartbeat), sudden reddening of the face and neck, 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 rashes, itching), muscle cramps, fatigue, weakness, swelling of the ankles (peripheral edema). Other side effects reported include: Uncommon side effects (may affect up to 1 in 100 people): mood changes, anxiety, depression, insomnia, sleep disturbances, tremors, fainting, loss of pain sensation, irregular heartbeat, inflammation of the nasal mucosa (nasal congestion or runny nose), hair loss, red spots on the skin, skin discoloration, back pain, joint pain, muscle pain, chest pain, urinary disorders, nocturia, increased 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, swelling of the face or tongue), 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 loss, tachycardia (fast heartbeat), vasculitis, hypersensitivity to light, changes in blood test results, such as high potassium levels in the blood, low sodium levels, hypoglycemia (very low blood sugar) in patients with diabetes, increased urea levels in the blood. Rare side effects (may affect up to 1 in 1,000 people): acute kidney failure; symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion): dark urine, nausea or vomiting, muscle cramps, disorientation, and seizures; decreased or absent urination; worsening of psoriasis; changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood. Very rare side effects (may affect up to 1 in 10,000 people): cardiovascular disorders (angina pectoris, myocardial infarction, and stroke), eosinophilic pneumonia (a rare type of pneumonia), swelling of the eyelids, face, or lips, swelling of the tongue and throat, causing severe difficulty breathing, severe skin reactions, including intense 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), erythema multiforme (a skin rash, often starting with the appearance of red, itchy spots on the face, arms, or legs), hypersensitivity to light, changes in blood test results, 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 disorders, hepatitis, jaundice, increased liver enzyme activity, which may affect some test results, abdominal bloating (gastritis), nerve disorders, which can cause weakness, numbness, or tingling, increased muscle tension, gum swelling, increased blood sugar levels (hyperglycemia). 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). If you experience any of these symptoms, contact your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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 PL-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, you can help provide more information on the safety of this medicine.

5. How to store Aldan Combo

Keep the medicine out of sight and reach of children. Do not store above 25°C. Store in the original packaging to protect from light. Shelf life after first opening the immediate packaging: 30 days. 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. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Aldan Combo contains

The active substances of Aldan Combo are: perindopril and amlodipine besylate. Aldan Combo, 5 mg + 5 mg: one tablet contains 5 mg of perindopril arginine and 5 mg of amlodipine (in the form of 6.94 mg of amlodipine besylate). Aldan Combo, 10 mg + 5 mg: one tablet contains 10 mg of perindopril arginine and 5 mg of amlodipine (in the form of 6.94 mg of amlodipine besylate). Aldan Combo, 10 mg + 10 mg: one tablet contains 10 mg of perindopril arginine and 10 mg of amlodipine (in the form of 13.87 mg of amlodipine besylate). The other ingredients of the tablet are: lactose monohydrate, microcrystalline cellulose type 102, anhydrous colloidal silica, magnesium stearate.

What Aldan Combo looks like and contents of the packaging

Aldan Combo, 5 mg + 5 mg, are white to light cream-colored, round, 7 mm in nominal diameter, biconvex tablets. Aldan Combo, 10 mg + 5 mg, are white to light cream-colored, round, 9 mm in nominal diameter, biconvex tablets with a score line on one side. The score line is not intended for breaking the tablet. Aldan Combo, 10 mg + 10 mg, are white to light cream-colored, oval, 12.0 mm x 5.4 mm, biconvex tablets with a score line on one side. The score line is not intended for breaking the tablet. Aldan Combo is packaged in blisters of OPA/Aluminum/PVC/Aluminum foil or HDPE containers with a PP cap, with a desiccant in an LDPE capsule. The container or blisters are packaged in a cardboard box with an information leaflet. The packaging contains 30 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A. ul. Józefów 9 99-300 Kutno Poland Tel.: +48 24 357 44 44 Fax: +48 24 357 45 45 e-mail: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland Aldan Combo, 5 mg + 5 mg, tablets Aldan Combo, 10 mg + 5 mg, tablets Aldan Combo, 10 mg + 10 mg, tablets Czech Republic Perindopril arginine/Amlodipine Polfarmex 5 mg/5 mg tablets Perindopril arginine/Amlodipine Polfarmex 10 mg/5 mg tablets Perindopril arginine/Amlodipine Polfarmex 10 mg/10 mg tablets

Date of last revision of the leaflet: