SUMILAR 10 mg/5 mg /25 Mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Sumilar HCT, 5 mg + 5 mg + 25 mg, hard capsules
   2. Sumilar HCT, 10 mg + 5 mg + 25 mg, hard capsules
   3. Sumilar HCT, 10 mg + 10 mg + 25 mg, hard capsules
   4. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   5. Table of contents of the leaflet:
2. What is Sumilar HCT and what is it used for
3. Important information before taking Sumilar HCT
   1. When not to take Sumilar HCT
   2. Warnings and precautions
   3. Sumilar HCT with food, drink, and alcohol
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
   6. Sumilar HCT contains sodium
4. How to take Sumilar HCT
   1. Use in children and adolescents
   2. Taking more than the recommended dose of Sumilar HCT
   3. Missing a dose of Sumilar HCT
   4. Stopping treatment with Sumilar HCT
5. Possible side effects
   1. 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.
   2. Tell your doctor immediately if you experience any of the following symptoms:
   3. All side effects are listed below by frequency:
6. How to store Sumilar HCT
7. Contents of the packaging and other information
   1. What Sumilar HCT contains
   2. What Sumilar HCT looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. For more information about this medicine and its names in the Member States of the European Economic Area, please contact:

Leaflet attached to 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 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 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 expanding blood vessels, 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 expanding 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), or to other calcium antagonists, ACE inhibitors, other thiazide diuretics, or to any of the excipients 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" - its 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 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 that contains 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 to bee or wasp venom (desensitization), you are going to receive anesthesia, e.g., before surgery or dental procedures - it may be necessary to discontinue Sumilar HCT for a 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 decrease sodium levels in the blood - your doctor may order regular blood tests, especially to measure 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 rejection of a transplanted organ and to 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 loss 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 have experienced hypersensitivity reactions to light - you should then discontinue Sumilar HCT, you have diabetes - it may be necessary to modify the dose of insulin or oral antidiabetic medicines, you are taking any of the following antihypertensive medicines: angiotensin II receptor antagonist (also called sartan, e.g., valsartan, telmisartan, irbesartan), especially if you have diabetic kidney disease, aliskiren; your doctor may order 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 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 result, 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. PregnancyInform your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Sumilar HCT should not be taken during the first 12 weeks of pregnancy and should not be taken from the 13th week of pregnancy, as the medicine taken during this period can harm the baby. If you become pregnant while taking Sumilar HCT, tell your doctor immediately. If you are planning to become pregnant, your doctor will advise you to take a different, suitable medicine. BreastfeedingDo 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 machines. If you experience nausea, dizziness, fatigue, or headache while taking the medicine, do not drive or operate machines; 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 1 capsule of Sumilar HCT at the strength prescribed by your doctor, taken once a day. Depending on the result of the treatment, your doctor may adjust the dose. The maximum dose is 1 capsule of 10 mg + 10 mg + 25 mg, 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 diseaseYour doctor may adjust the dose of the medicine if you have kidney disease. ElderlyYour doctor may recommend a lower initial dose and gradually increase it. Sumilar HCT is not recommended for patients who are very elderly or frail.

Use in children and adolescents

Sumilar HCT is not recommended for children and adolescents under 18 years of age, due to the lack of data on safety and efficacy.

Taking more than the recommended dose of Sumilar HCT

Taking too many capsules can cause a significant drop in blood pressure, including a very significant 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. Up to 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 more than the recommended dose of 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 medicine packaging with you so that the doctor knows what medicine you have 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 treatment with Sumilar HCT

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, or 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, any signs of bleeding (e.g., bleeding from the gums), purpura, or increased susceptibility to infections, sore throat, and fever, feeling tired, fainting, dizziness, or paleness of the skin, which may be symptoms of blood or bone marrow disorders; severe abdominal pain, which 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; decreased or increased urination, which may be accompanied by fever, nausea, fatigue, pain in the side, swelling of the feet, ankles, face, and hands, or blood in the urine. These side effects are due to severe kidney problems (interstitial nephritis, acute renal failure); inflammation of blood vessels, often accompanied by a rash, purpura, itching, fever, chills, and fatigue.

All side effects are listed below by frequency:

Very common(may affect more than 1 in 10 people): swelling, low potassium levels in the blood (hypokalemia), high lipid levels in the blood (hyperlipidemia) Common(may affect up to 1 in 10 people): headache, dizziness, drowsiness (especially at the beginning of treatment), feeling tired (fatigue), palpitations (feeling of heartbeats), swelling of the ankles, low blood pressure (hypotension), especially when standing up quickly or sitting down (orthostatic hypotension), fainting, sudden flushing of the skin (especially on the face and neck), dry, irritating cough, sinusitis, bronchitis, shortness of breath, abdominal pain, diarrhea, gastritis, gastrointestinal disorders, and discomfort in the abdomen (including indigestion), nausea, vomiting, gastrointestinal disorders (including diarrhea and constipation), rash, hives, chest pain, muscle cramps or pain, low magnesium and sodium levels in the blood, detected in blood tests, feeling weak and lacking energy (weakness), high uric acid or potassium levels in the blood, detected in blood tests, impotence, vision disturbances (including double vision and blurred vision) Uncommon(may affect up to 1 in 100 people): swelling of the skin, mucous membranes, and surrounding tissues (angioedema; in rare cases, airway obstruction due to angioedema can be fatal), swelling of the hands and feet (peripheral edema, which may be a sign of excessive water retention), intestinal swelling (intestinal angioedema), mood changes, depression, anxiety, nervousness, restlessness, sleep disturbances (insomnia), ringing in the ears (tinnitus), sneezing, runny nose (rhinitis), nasal congestion, breathing difficulties (bronchospasm), including asthma exacerbation, dryness of the mouth, abdominal pain, including gastritis, pancreatitis (rarely reported in association with ACE inhibitors), kidney problems, including interstitial nephritis and renal failure, urinary disorders, including increased urination during the day or night, exacerbation 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, or burning (paresthesia), reduced skin sensitivity (hypoesthesia), taste disturbances, increased sweating, myocardial infarction, coronary artery disease (myocardial ischemia), chest pain, or tightness (angina pectoris), rapid or irregular heartbeat (tachycardia) or arrhythmias, back pain, muscle pain, or pain in the extremities, increased body temperature (fever), increased levels of liver enzymes, pancreas enzymes, or kidney function parameters, detected in blood tests, high blood sugar levels, detected in blood tests, photosensitivity reactions, high calcium levels in the blood (hypercalcemia), allergic reactions 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 disorders (e.g., nail loosening or separation from the nail bed), redness, itching, swelling, or tearing of the eyes (conjunctivitis), hearing disturbances, liver damage (including hepatitis, in rare cases with jaundice), skin rash with blistering, resembling target-like lesions (erythema multiforme), vasculitis (inflammation of blood vessels), often with a rash, purpura, itching, fever, chills, and fatigue Very rare(may affect up to 1 in 10,000 people): widespread rash with blisters and skin peeling, especially on the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), liver inflammation (in most cases with jaundice), skin rash with blisters, resembling target-like lesions (erythema multiforme), toxic epidermal necrolysis, or pemphigoid, exacerbation of systemic lupus erythematosus, or lupus-like reactions, bone marrow failure, severe reduction in the number of red blood cells, white blood cells (including neutropenia or agranulocytosis, leukopenia), or platelets, detected in blood tests, high blood sugar levels, detected in blood tests, worsening of diabetes in patients with diabetes, photosensitivity reactions, high calcium levels in the blood (hypercalcemia), allergic reactions Frequency not known(cannot be estimated from the available data): reduction in the number of red blood cells, white blood cells, and platelets (pancytopenia), detected in blood tests, anaphylactic or anaphylactoid reactions, blistering skin disorders (pemphigus), increased levels of antinuclear antibodies, attention disorders, oral ulcers with small sores (aphthous stomatitis), aplastic anemia, Raynaud's phenomenon (discoloration of fingers and toes after cooling, and tingling or pain after warming), cerebral ischemia (including ischemic stroke and transient ischemic attack), psychomotor disorders, burning sensation, smell disturbances, acute liver failure, cholestatic, or cytolytic hepatitis (in rare cases fatal), skin inflammation (psoriasis-like dermatitis), acute rash (pemphigus or lichen planus), exacerbation of psoriasis, skin rash on the mucous membranes, dark urine (due to elevated bilirubin levels), 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 facial expression, 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 - excessive fluid accumulation between the choroid and sclera - or acute glaucoma), non-melanoma skin cancer and lip cancer (non-melanoma skin cancer) Reporting 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 out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of that month. Store in a temperature below 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: Contents of the capsule: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, maize starch, sodium carboxymethylcellulose (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 blisters made of PA/Aluminum/PVC/Aluminum foil 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 and its names in the Member States of the European Economic Area, please contact:

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