Sumilar Hct

Leaflet accompanying the packaging: patient information

Sumilar HCT, 5 mg + 5 mg + 12.5 mg, hard capsules

Sumilar HCT, 5 mg + 5 mg + 25 mg, hard capsules

Sumilar HCT, 10 mg + 5 mg + 25 mg, hard capsules

Sumilar HCT, 10 mg + 10 mg + 25 mg, hard capsules

Ramipril + Amlodipine + Hydrochlorothiazide

You should carefully read the contents of this 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 further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Sumilar HCT and what is it used for

Sumilar HCT contains three active substances: ramipril, amlodipine, and hydrochlorothiazide. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors) and works by: reducing the production of substances in the body that can increase blood pressure, reducing tension and dilating blood vessels, and making it easier for the heart to pump blood to all parts of the body. Amlodipine belongs to a group of medicines called calcium antagonists and works by: reducing tension and dilating blood vessels, making it easier for blood to flow. Hydrochlorothiazide belongs to a group of so-called thiazide diuretics and works by: increasing the amount of urine excreted, which reduces blood pressure. Sumilar HCT is used to treat high blood pressure (hypertension) in adult patients who have achieved adequate blood pressure control with the individual active substances at the same doses as in the combination medicine, but in the form of separate tablets.

2. Important information before taking Sumilar HCT

When not to take Sumilar HCT

If you are allergic to ramipril, amlodipine, or hydrochlorothiazide (active substances), to other calcium antagonists, ACE inhibitors, other thiazide diuretics, or to any of the other ingredients of this medicine (listed in section 6), if you have severe narrowing of the aortic valve (aortic stenosis) or are in cardiogenic shock (a condition in which the heart cannot supply enough blood to the body), if you have ever had a severe allergic reaction called "angioedema" - symptoms include: itching, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing, if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) increases, if you are undergoing dialysis or other type of blood filtration - depending on the equipment used, the administration of Sumilar HCT may not be suitable for you, if you have severe kidney problems, if you have liver problems, if you have abnormal levels of electrolytes (calcium, potassium, sodium) and uric acid (with symptoms of gout or kidney stones) in the blood, if you have kidney problems where blood flow to the kidney is reduced (renal artery stenosis), in the last 6 months of pregnancy and during breastfeeding (see "Pregnancy, breastfeeding, and fertility" below), if your blood pressure is very low or unstable, if you have heart failure after a heart attack, if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren. You must not take Sumilar HCT if any of the above conditions apply to you. If in doubt, consult your doctor before taking Sumilar HCT.

Warnings and precautions

Before taking Sumilar HCT, discuss it with your doctor or pharmacist. Tell your doctor if you have or have had any of the following conditions: you are elderly and need to increase the dose of the medicine, you have heart, liver, or kidney problems, you have very high blood pressure (hypertensive crisis), you have lost a lot of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, a low-sodium diet, taking diuretics for a long time, or undergoing dialysis), you are going to undergo desensitization therapy to reduce your allergy to bee or wasp stings (desensitization), you are going to receive anesthesia, e.g., before surgery or dental procedures - it may be necessary to stop taking Sumilar HCT the day before the procedure; consult your doctor, you have high levels of potassium in the blood, detected in blood tests, you are taking medicines or have conditions that may cause low sodium levels in the blood - your doctor may order regular blood tests, especially to check sodium levels in the blood (especially in elderly patients), you are taking any of the following medicines, which may increase the risk of angioedema: mTOR inhibitors, used to prevent organ rejection and treat cancer (e.g., temsirolimus, everolimus, sirolimus), vildagliptin, a medicine used to treat type 2 diabetes, neprilysin inhibitors (NEP), such as racecadotril, a medicine used to treat diarrhea, sacubitril/valsartan (see "When not to take Sumilar HCT" above); you have been diagnosed with collagenosis, such as scleroderma or systemic lupus erythematosus; you have experienced vision problems 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 - they can occur within a few hours to a week after taking Sumilar HCT and, if left untreated, can lead to permanent vision loss. The risk of developing such disorders may be higher in patients who are at risk of developing a disease called glaucoma or have previously been allergic to penicillin or sulfonamides; if you experience hypersensitivity reactions to light - you should then stop taking Sumilar HCT; if you have diabetes - you may need to adjust your insulin dose or take oral antidiabetic medicines; if you are taking any of the following antihypertensive medicines: angiotensin II receptor antagonist (also known as sartan, e.g., valsartan, telmisartan, irbesartan), especially if you have diabetic kidney disease, aliskiren; your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the information under "When not to take Sumilar HCT". If you have had skin cancer or have experienced unexpected skin changes during treatment - taking hydrochlorothiazide, especially for a long time and in high doses, may increase the risk of developing certain types of skin and lip cancer (non-melanoma skin cancer); when taking Sumilar HCT, you should protect your skin from sunlight and UV radiation. If you have had breathing or lung problems after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If you experience severe shortness of breath or difficulty breathing after taking Sumilar HCT, seek medical attention immediately. Your doctor may recommend regular monitoring of uric acid levels in the blood. See also the information under "When not to take Sumilar HCT". If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should inform your doctor if you are pregnant or think you may be pregnant or are planning to become pregnant. Sumilar HCT should not be taken during the first 12 weeks of pregnancy and should not be taken after the 12th week of pregnancy, as it may harm the baby. If you become pregnant while taking Sumilar HCT, you should immediately inform your doctor. If you are planning to become pregnant, your doctor will advise you to take a different medicine.

Children and adolescents

Sumilar HCT should not be used in children and adolescents under 18 years of age due to the lack of data on safety and efficacy.

Sumilar HCT and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription (including herbal medicines). Sumilar HCT may affect the action of other medicines, and other medicines may affect the action of Sumilar HCT. Your doctor may recommend changing the dose of the medicine and/or taking other precautions: if you are taking an angiotensin II receptor antagonist or aliskiren (see also "When not to take Sumilar HCT" and "Warnings and precautions"). The following medicines may reduce the effect of Sumilar HCT: pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen, indomethacin, and acetylsalicylic acid); medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, norepinephrine, or epinephrine - your doctor will recommend regular monitoring of blood pressure; rifampicin (an antibiotic used to treat tuberculosis); St. John's Wort (Hypericum perforatum, a herbal medicine used to treat depression). The following medicines may increase the risk of side effects when taken with Sumilar HCT: a combination medicine containing sacubitril and valsartan - used to treat chronic heart failure in adults (see section 2, "When not to take Sumilar HCT"); pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen, indomethacin, and acetylsalicylic acid); anticancer medicines (used in chemotherapy); medicines that may lower potassium levels in the blood, such as medicines used to treat constipation, glucocorticoids, tetracosactide (used to test adrenal function), amphotericin B (used to treat fungal infections); diuretics (e.g., furosemide); desmopressin (used to treat congenital bleeding disorders); steroid anti-inflammatory medicines (e.g., prednisolone); potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (such as spironolactone, triamterene, amiloride, trimetoprim, or trimetoprim in combination with sulfamethoxazole [co-trimoxazole], used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection and treat hepatitis; heparin, a medicine used to thin the blood to prevent blood clots); medicines used to treat heart conditions, including arrhythmias (quinidine, amiodarone); calcium preparations; allopurinol (used to reduce uric acid levels in the blood); procainamide (used to treat arrhythmias); cholestyramine (used to reduce cholesterol levels in the blood); carbamazepine, oxcarbazepine (antiepileptic medicines); ketoconazole, itraconazole (used to treat fungal infections); erythromycin, clarithromycin (antibiotics used to treat certain bacterial infections); ritonavir, indinavir, nelfinavir (protease inhibitors used in HIV-infected patients); verapamil, diltiazem (used to treat certain heart conditions and high blood pressure); dantrolene (given as an infusion in severe temperature regulation disorders); temsirolimus (used to treat cancer); sirolimus, everolimus (used to prevent organ rejection); vildagliptin (used to treat type 2 diabetes); racecadotril (an anti-diarrheal medicine); tacrolimus (an immunosuppressive medicine that allows the body to accept a transplanted organ); other blood pressure-lowering medicines, such as 5-phosphodiesterase inhibitors (used to treat erectile dysfunction), nitrates, alpha-adrenergic blockers (used in urology to reduce muscle tension in the prostate and urethra), methyldopa, certain medicines used to treat Parkinson's disease, tricyclic antidepressants, and neuroleptics, amifostine (used in chemotherapy), and baclofen (a muscle relaxant). Medicines whose action may be affected by Sumilar HCT: diabetes medicines (oral hypoglycemic agents and insulin) - Sumilar HCT may lower blood sugar levels, so blood sugar levels should be closely monitored during its use; lithium (used to treat mental disorders) - Sumilar HCT may increase lithium levels in the blood, so your doctor will recommend close monitoring of lithium levels in the blood; simvastatin (a medicine used to lower cholesterol levels) - since amlodipine increases exposure to simvastatin, your doctor will recommend reducing the dose of simvastatin in patients taking Sumilar HCT; iodine-containing medicines (contrast agents used in imaging tests, e.g., X-ray); oral anticoagulants, such as warfarin. If any of the above conditions apply to you (or you are in doubt), consult your doctor before taking Sumilar HCT. Before taking this medicine, consult your doctor or pharmacist if: you are going to have a parathyroid function test, as ramipril and hydrochlorothiazide may affect the results; you are an athlete and are going to have a doping test, as ramipril and hydrochlorothiazide may cause a positive test result.

Sumilar HCT with food, drink, and alcohol

Sumilar HCT can be taken before or after a meal. Do not eat grapefruits or drink grapefruit juice while taking Sumilar HCT, as they may increase the levels of the active substance amlodipine in the blood and, consequently, unpredictably increase the blood pressure-lowering effect of Sumilar HCT. Drinking alcohol while taking Sumilar HCT may cause dizziness or fainting. If you are in doubt about the amount of alcohol that can be consumed while taking Sumilar HCT, consult your doctor, as blood pressure-lowering medicines and alcohol can enhance each other's sedative effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. PregnancyYou should inform your doctor if you are pregnant or think you may be pregnant or are planning to become pregnant. Sumilar HCT should not be taken during the first 12 weeks of pregnancy and should not be taken after the 12th week of pregnancy, as it may harm the baby. If you become pregnant while taking Sumilar HCT, you should immediately inform your doctor. If you are planning to become pregnant, your doctor will advise you to take a different medicine. BreastfeedingYou should not take Sumilar HCT while breastfeeding. Before taking any medicine, consult your doctor or pharmacist. FertilityThere is not enough data on the potential impact on fertility.

Driving and using machines

Sumilar HCT may affect your ability to drive or operate machinery. If you experience nausea, dizziness, fatigue, or headache while taking the medicine, do not drive or operate machinery; consult your doctor immediately.

Sumilar HCT contains sodium

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

3. How to take Sumilar HCT

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist. The recommended dose is one Sumilar HCT capsule of the strength prescribed by your doctor, taken once a day. Depending on the response to treatment, your doctor may adjust the dose. The maximum dose is one 10 mg + 10 mg + 25 mg capsule, taken once a day. Take the medicine orally, once a day, at the same time, before or after a meal. Swallow the hard capsules whole with a drink of water. Do not crush or chew the capsules. Do not take the medicine with grapefruit juice. Kidney problemsYour doctor may adjust the dose of the medicine if you have kidney problems. Elderly patientsYour doctor may recommend a lower initial dose and gradually increase it. Sumilar HCT should not be used in elderly patients who are frail.

Use in children and adolescents

Sumilar HCT should not be given to children and adolescents under 18 years of age due to the lack of data on efficacy and safety.

Taking too much Sumilar HCT

Taking too many capsules may cause a significant drop in blood pressure, including a severe drop. You may experience dizziness, fainting, or weakness. A significant drop in blood pressure can cause shock. The skin becomes cool and moist, and you may lose consciousness. Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur. If you have taken too much Sumilar HCT, contact your doctor or go to the emergency department of the nearest hospital immediately. Do not drive yourself, but ask someone else to drive you or call an ambulance. Take the packaging of the medicine with you so that the doctor knows what medicine has been taken.

Missing a dose of Sumilar HCT

If you miss a dose, do not take the missed capsule. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Sumilar HCT treatment

Your doctor will tell you how long to take the medicine. Stopping treatment without consulting your doctor may cause the disease to recur. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sumilar HCT can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Sumilar HCT and contact your doctor immediately - you may need urgent medical attention.

Swelling of the face, lips, or throat, making it difficult to swallow or breathe, as well as itching and rash. These may be symptoms of a severe allergic reaction to Sumilar HCT. Severe skin reactions, including rash, hives, mouth ulcers, exacerbation of existing skin conditions, redness, severe itching, blistering, and peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme). Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Tell your doctor immediately if you experience any of the following symptoms:

rapid heartbeat, irregular or strong heartbeats (palpitations), chest pain, tightness in the chest, or more severe disorders, including heart attack and stroke; shortness of breath or cough, which may be symptoms of lung diseases, including pneumonia; easy bruising, prolonged bleeding, or any signs of bleeding (e.g., bleeding from the gums), purpura, or increased susceptibility to infections, sore throat, and fever, fatigue, fainting, dizziness, or pallor, which may be symptoms of blood or bone marrow disorders; severe abdominal pain, which may radiate to the back - it may be a symptom of pancreatitis; fever, chills, fatigue, loss of appetite, stomach pain, nausea, jaundice (yellowing of the skin and eyes) - these may be symptoms of liver diseases, such as hepatitis or liver damage; reduced urine output or increased urine output at night, which may be symptoms of severe kidney problems (interstitial nephritis or acute kidney failure); worsening of existing proteinuria (increased protein levels in the urine); general malaise; weight gain or loss; dizziness (peripheral vertigo), tremors; hair loss (alopecia); itching, purpura, or petechiae; abnormal sensations on the skin, such as numbness, tingling, prickling, burning, or stinging (paresthesia), reduced skin sensitivity (hypoesthesia); taste disturbances; increased sweating; myocardial infarction, coronary artery disease (myocardial ischemia), chest tightness, and chest pain (angina pectoris), rapid heartbeat (tachycardia), or arrhythmias; slow heartbeat (bradycardia), certain arrhythmias (atrial fibrillation, ventricular tachycardia); joint pain, back pain, general pain; increased body temperature/fever; decreased libido in men and women, gynecomastia in men; increased white blood cell count (eosinophilia), detected in blood tests; liver function test abnormalities (increased liver enzyme activity and/or increased bilirubin levels), pancreas (increased pancreatic enzyme activity), or kidney (increased creatinine levels) function test abnormalities, detected in blood tests; increased glucose levels in the urine, detected in urine tests; cough; vasculitis, often with skin rash, purpura, itching, fever, chills, and fatigue; Rare(may affect up to 1 in 1,000 people) confusion, balance disorders; redness and swelling of the tongue (glossitis); skin peeling (exfoliative dermatitis); nail diseases (e.g., nail loosening or separation from the nail bed); redness, itching, swelling, or tearing of the eyes (conjunctivitis); hearing disorders; severe itching, jaundice, dark urine, light-colored stools due to liver or bile duct disorders; narrowing of blood vessels; circulatory disorders (reduced blood flow); reduced red blood cell count, white blood cell count (including neutropenia or agranulocytosis, leukopenia), or hemoglobin levels, detected in blood tests; reduced platelet count, detected in blood tests; increased blood sugar levels, detected in blood tests, worsening of diabetes in patients with diabetes; increased sensitivity of the skin to sunlight or artificial light (photosensitivity); increased calcium levels in the blood (hypercalcemia); allergic reactions; Very rare(may affect up to 1 in 10,000 people) widespread rash with blistering and peeling of the skin, especially on the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome); liver inflammation (mostly with bile duct obstruction); skin rash with possible blistering, resembling target-like lesions (erythema multiforme); lupus-like reaction, lupus reactivation, vasculitis, and toxic epidermal necrolysis; gum hypertrophy; increased muscle tone; peripheral neuropathy; bone marrow failure; severe reduction in red blood cells, detected in blood tests; allergic reactions; metabolic acidosis; respiratory failure (including pneumonia and pulmonary edema); Frequency not known(cannot be estimated from the available data) reduction in red blood cell count, white blood cell count, and platelet count (pancytopenia), detected in blood tests; anaphylactic or anaphylactoid reactions; skin blisters (pemphigus); increased antinuclear antibody titers; attention disorders; oral mucosal inflammation with small ulcers (aphthous stomatitis); aplastic anemia; discoloration of fingers and toes upon cooling and sensation of burning or pain upon rewarming (Raynaud's phenomenon); cerebral hypoperfusion, including ischemic stroke and transient ischemic attack; psychomotor disorders; burning sensation; smell disorders; acute liver failure, cholestatic and cytolytic hepatitis (in rare cases, fatal); skin inflammation (psoriasis-like dermatitis), acute skin rash (pemphigoid or lichenoid dermatitis), exacerbation of psoriasis; increased urine concentration (dark color), nausea, or vomiting, muscle cramps, confusion, and seizures, which may be caused by inadequate secretion of antidiuretic hormone (vasopressin) - if you experience such symptoms, consult your doctor as soon as possible; tremors, rigidity, mask-like face, slow movements, and shuffling gait; sudden loss of vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye or acute angle-closure glaucoma); non-melanoma skin cancer and lip cancer; Reporting of side effectsIf you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, you can help provide more information on the safety of this medicine.

5. How to store Sumilar HCT

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Store in a temperature not exceeding 30°C. 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 Sumilar HCT contains

The active substances are ramipril, amlodipine, and hydrochlorothiazide. Sumilar HCT, 5 mg + 5 mg + 12.5 mgEach hard capsule contains 5 mg of ramipril, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide. Sumilar HCT, 5 mg + 5 mg + 25 mgEach hard capsule contains 5 mg of ramipril, 5 mg of amlodipine (as amlodipine besylate), and 25 mg of hydrochlorothiazide. Sumilar HCT, 10 mg + 5 mg + 25 mgEach hard capsule contains 10 mg of ramipril, 5 mg of amlodipine (as amlodipine besylate), and 25 mg of hydrochlorothiazide. Sumilar HCT, 10 mg + 10 mg + 25 mgEach hard capsule contains 10 mg of ramipril, 10 mg of amlodipine (as amlodipine besylate), and 25 mg of hydrochlorothiazide. The other ingredients are: capsule contents: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, maize starch, sodium starch glycolate (type A), sodium stearyl fumarate

capsule shell

(5 mg + 5 mg + 12.5 mg)iron oxide red (E 172), iron oxide black (E 172), titanium dioxide (E 171), gelatin (5 mg + 5 mg + 25 mg) and (10 mg + 5 mg + 25 mg)iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), gelatin (10 mg + 10 mg + 25 mg)iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172), titanium dioxide (E 171), gelatin

What Sumilar HCT looks like and contents of the pack

Sumilar HCT, 5 mg + 5 mg + 12.5 mgThe capsule has a pink opaque cap and a light gray opaque body. Sumilar HCT, 5 mg + 5 mg + 25 mgThe capsule has a pink opaque cap and an ivory opaque body. Sumilar HCT, 10 mg + 5 mg + 25 mgThe capsule has a dark pink opaque cap and a yellow opaque body. Sumilar HCT, 10 mg + 10 mg + 25 mgThe capsule has a brown opaque cap and a caramel opaque body. The hard capsules are packaged in PA/Aluminum/PVC/Aluminum blisters and placed in a cardboard box. Pack sizes: 10, 20, 30, 50, 60, 90, 100 hard capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria Manufacturer Lek Pharmaceuticals d.d. Verovškova 57, 1526 Ljubljana, Slovenia

For more information about this medicine, including its names in EU member states, please contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00 Logo Sandoz Date of last revision of the leaflet:07/2022