Sumilar

Leaflet accompanying the packaging: patient information

Sumilar, 5 mg + 5 mg, hard capsules

Sumilar, 5 mg + 10 mg, hard capsules

Sumilar, 10 mg + 5 mg, hard capsules

Sumilar, 10 mg + 10 mg, hard capsules

Ramipril + Amlodipine

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Sumilar and what is it used for

Sumilar contains two active substances - ramipril and amlodipine. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors), while amlodipine belongs to a group of medicines called calcium channel blockers.
Ramipril works by:

• reducing the production of substances in the body that can increase blood pressure,
• relaxing and dilating blood vessels,
• making it easier for the heart to pump blood throughout the body. Amlodipine works by:
• relaxing and dilating blood vessels.

Sumilar can be used to treat high blood pressure (hypertension) in adult patients who have their blood pressure adequately controlled when taking both active substances separately in the same doses as in Sumilar.

2. Important information before taking Sumilar

When not to take Sumilar

• if the patient is allergic to ramipril, amlodipine (active substances), other dihydropyridine calcium channel blockers, other ACE inhibitors, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction

may include: itching, rash, difficulty swallowing or breathing, and swelling of the lips, face, throat, or tongue;

• if the patient has liver function disorders;
• if the patient has unstable heart failure after a recent heart attack;
• if the patient has experienced shock, including cardiogenic shock (due to acute heart failure);
• if the patient has a narrowing of the outflow tract from the left ventricle (e.g., significant aortic stenosis);
• if the patient has ever experienced 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 the patient is undergoing dialysis or other blood filtration. Depending on the device used, treatment with Sumilar may not be suitable;
• if the patient has kidney disease that reduces blood flow to the kidney (renal artery stenosis);
• after the 3rd month of pregnancy (see "Pregnancy and breastfeeding");
• if the patient has abnormally low or unstable blood pressure - the doctor will recommend appropriate monitoring;
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren,
• if the patient has taken or is taking a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure in adults), as the risk of angioedema (rapid swelling of the subcutaneous tissue, e.g., in the throat area) increases.

If any of the above conditions apply to the patient, Sumilar should not be taken.
In case of doubts, before taking Sumilar, consult a doctor.

Warnings and precautions

Before starting to take Sumilar, discuss it with a doctor or pharmacist. Inform the doctor if any of the following conditions apply to the patient:

• if the patient is elderly;
• if the patient has heart or kidney disorders;
• if the patient experiences sudden swelling of the face, lips, tongue, and/or throat and difficulty breathing or swallowing. These may be symptoms of angioedema (a severe allergic reaction) - if they occur, stop taking Sumilar and contact a doctor;
• if the patient is at risk of circulatory disorders in the heart or brain in case of very low blood pressure;
• if there has been significant loss of electrolytes or fluids from the body (due to vomiting, diarrhea, excessive sweating, low-sodium diet, prolonged use of diuretics, or dialysis);
• if desensitization therapy to bee or wasp venom is planned;
• if anesthesia is planned for surgery or dental procedures. It may be necessary to discontinue Sumilar one day in advance - the doctor will inform how to proceed;
• if the patient has high potassium levels in the blood (detected in a blood test);
• if the patient has collagenosis (a connective tissue disease), such as scleroderma or systemic lupus erythematosus;
• if the patient is black - these patients are at increased risk of angioedema, and the effect of ramipril may be weakened (insufficient blood pressure reduction);
• if the patient experiences a dry, persistent cough;
• if the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g., valsartan, telmisartan, irbesartan, especially if the patient has kidney function disorders associated with diabetes;
• aliskiren;
• if the patient is taking any of the following medicines, as the risk of angioedema may increase:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent transplant rejection and treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

Inform the doctor if the patient is pregnant, suspects they may be pregnant, or plans to become pregnant. Sumilar is not recommended during the first three months of pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").
The doctor may recommend regular monitoring of white blood cell count, especially at the beginning of treatment, in patients with kidney function disorders or collagenosis, as well as when taking medicines that affect blood cell count.
The 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 Sumilar".

Children and adolescents

Sumilar should not be taken in children and adolescents under 18 years of age due to the lack of data on its safety and efficacy in this patient group.

Sumilar and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This is necessary because Sumilar may affect the action of other medicines, and other medicines may affect the action of Sumilar.
Tell the doctor about taking any of the following medicines. These medicines may weaken the effect of Sumilar:

• analgesic and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, or acetylsalicylic acid);
• medicines used in case of low blood pressure, shock, heart failure, asthma, or allergy, such as ephedrine, norepinephrine, adrenaline, dobutamine, or dopamine - the doctor will recommend regular blood pressure monitoring;
• rifampicin (an antibiotic used to treat tuberculosis);
• St. John's wort (a herbal medicine used to treat depression).

Tell the doctor about taking any of the following medicines. These medicines may increase the risk of side effects when taken with Sumilar:

• analgesic and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, or acetylsalicylic acid);
• anticancer medicines (used in chemotherapy), such as temsirolimus;
• medicines used to prevent transplant rejection, such as tacrolimus or everolimus;
• diuretics (e.g., furosemide);
• other blood pressure-lowering medicines, such as aliskiren;
• potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection, and heparin, used to thin the blood and prevent clots) - when taking these medicines, close monitoring of potassium levels in the blood is required;
• corticosteroid anti-inflammatory medicines, such as prednisolone;
• allopurinol (used to reduce uric acid levels in the blood);
• procainamide (used to treat heart rhythm disorders);
• medicines that may affect blood cell count;
• ketoconazole, itraconazole (antifungal medicines);
• erythromycin, clarithromycin (used to treat bacterial infections);
• ritonavir, indinavir, nelfinavir (used to treat HIV-infected patients);
• verapamil, diltiazem (used to treat heart rhythm disorders and high blood pressure).

Tell the doctor about taking any of the following medicines. Sumilar may affect the action of these medicines:

• antidiabetic medicines, such as oral glucose-lowering medicines and insulin. Sumilar may lower blood sugar levels. When taking Sumilar, blood sugar levels should be closely monitored;
• lithium (used to treat mental disorders). Sumilar may increase lithium levels in the blood. The doctor will recommend regular monitoring of lithium levels in the blood;
• simvastatin (a medicine that lowers cholesterol levels in the blood). Sumilar may increase simvastatin levels in the blood.

The doctor may recommend changing the dose and/or taking other precautions:

• if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the subsections "When not to take Sumilar" and "Warnings and precautions").

If any of the above conditions apply to the patient (or in case of any doubts), before taking Sumilar, consult a doctor.

Sumilar with food, drink, and alcohol

Sumilar can be taken with or without food.
Drinking alcohol while taking Sumilar may cause dizziness or a feeling of "emptiness" in the head. In case of doubts about the amount of alcohol that can be consumed while taking Sumilar, consult a doctor, as alcohol and blood pressure-lowering medicines can enhance each other's effects.
While taking Sumilar, do not consume grapefruits or grapefruit juice. This is because grapefruits and grapefruit juice can increase the levels of the active substance amlodipine in the blood, which may cause unpredictable enhancement of Sumilar's blood pressure-lowering effect.

Pregnancy and breastfeeding

If the patient is pregnant, suspects they may be pregnant, or plans to become pregnant, they should consult a doctor or pharmacist before taking this medicine.
Sumilar 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 seriously harm the fetus. If the patient becomes pregnant while taking Sumilar, they should immediately inform their doctor.
The doctor will recommend using a different medicine in case of planned pregnancy.
Sumilar should not be taken during breastfeeding.

Driving and using machines

Sumilar may impair the ability to drive or operate machines, as it may cause dizziness, headache, and/or fatigue. This is most likely to occur at the beginning of treatment or when increasing the dose of Sumilar. If such symptoms occur, do not drive or operate machines.

3. How to take Sumilar

This medicine should always be taken exactly as prescribed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

Method of administration

• The medicine should be taken orally, once a day, at the same time, with or without food.
• The hard capsules should be swallowed whole, with a liquid (not grapefruit juice), without crushing or chewing.

Dosage

• The usual dose is 1 capsule of the prescribed strength per day.
• Depending on the effect achieved, the doctor may adjust the dose.
• The maximum dose is 1 capsule of 10 mg + 10 mg once a day.

If the patient feels that the effect of the medicine is too strong or too weak, they should inform their doctor.

Elderly patients

Sumilar is not recommended for elderly patients who are frail or have a very advanced age.

Use in children and adolescents

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

Taking a higher dose of Sumilar than recommended

In case of taking too high a dose of the medicine, the following symptoms may occur: low blood pressure (even severe) with dizziness, a feeling of "emptiness" in the head, fainting. If blood pressure drops to critical values, shock may occur with loss of consciousness.
Even 24-48 hours after taking the medicine, shortness of breath may occur due to excess fluid accumulation in the lungs (pulmonary edema).
In case of taking too high a dose of the medicine, immediately consult a doctor or the emergency department of the nearest hospital. Do not drive a car yourself, ask someone to drive you or call an ambulance. Take the medicine packaging with you. This will allow the doctor to know what medicine was taken.

Missing a dose of Sumilar

In case of missing a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping Sumilar treatment

Do not suddenly stop taking Sumilar or change the prescribed dose without consulting a doctor, as the disease may worsen.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Sumilar can cause side effects, although not everybody gets them.
If any of the following serious side effects occur, stop taking Sumilar and immediately consult a doctor - urgent medical attention may be necessary:

• swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing, as well as itching and rash. These may be symptoms of a severe allergic reaction to Sumilar (angioedema);
• severe skin reactions, including rash, oral mucosa ulceration, exacerbation of existing skin disease, redness, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme) or other allergic reactions.

Immediately inform the doctor if:

• rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, feeling of compression in the chest, or more severe disorders, including heart attack or stroke;
• shortness of breath or cough - these may be symptoms of lung disorders;
• easy bruising, prolonged bleeding, bleeding of various types (e.g., bleeding from the gums), purple spots on the skin (purpura), or more frequent than usual infections, sore throat, and fever, feeling of fatigue, fainting, dizziness, or paleness of the skin. These may be symptoms of blood or bone marrow disorders;
• severe abdominal pain radiating to the back - this may be a symptom of pancreatitis;
• fever, chills, fatigue, loss of appetite, abdominal pain, nausea, or yellowing of the skin and eyes (jaundice). These may be symptoms of liver disorders, such as hepatitis or liver damage;
• concentrated urine (dark in color), nausea, or vomiting, muscle cramps, feeling of confusion, and seizures, which may be due to inappropriate secretion of antidiuretic hormone (ADH, vasopressin).

Other side effects:

If any of the following side effects worsen or persist for more than a few days, inform the doctor.
Frequently(occurring in less than 1 in 10 patients):

• palpitations (irregular or stronger heartbeat);
• headache, dizziness, drowsiness;
• low blood pressure (abnormally low blood pressure), orthostatic hypotension (especially when standing up quickly or sitting up from a lying position), fainting, sudden flushing (especially of the face and neck);
• dry, persistent cough, bronchitis, sinusitis, shortness of breath;
• gastritis and/or enteritis, digestive disorders, indigestion, abdominal pain, diarrhea, nausea, or vomiting;
• skin rash, especially with papules;
• chest pain, fatigue, swelling (fluid accumulation in tissues);
• muscle pain, muscle cramps, swelling of the ankle area;
• increased potassium levels in the blood, detected in blood tests.

Less frequently(occurring in less than 1 in 100 patients):

• vision disorders (including blurred vision, double vision);
• tinnitus (e.g., ringing in the ears);
• kidney function disorders, including acute kidney failure, urinary disorders (increased frequency and amount of urine, nocturia), worsening of proteinuria, increased levels of urea and creatinine in the blood (indicating kidney function);
• joint pain, back pain;
• weight gain or loss;
• vertigo, tremor, abnormal sensations, such as numbness, tingling, prickling, or burning of the skin (paresthesia), decreased sensation (hypoesthesia), loss of taste;
• mood changes, depression, anxiety, nervousness, restlessness, sleep disorders, including insomnia or drowsiness;
• bronchospasm, including asthma exacerbation, nasal congestion or rhinitis;
• pancreatitis (rarely fatal), increased activity of pancreatic enzymes (indicating pancreatic function), detected in blood tests, intestinal angioedema (presenting with abdominal pain, vomiting, and diarrhea), abdominal pain, including gastritis, change in bowel habits (including diarrhea and constipation), heartburn, dry mouth;
• increased activity of liver enzymes and/or bilirubin levels (indicating liver function), detected in blood tests;
• decreased or lost appetite (anorexia);
• fever, weakness, pain, malaise;
• transient erectile dysfunction, impotence, decreased libido in men and women, gynecomastia in men;
• increased eosinophil count (a type of white blood cell), detected in blood tests;
• angina pectoris or myocardial infarction, tachycardia, arrhythmias, edema of hands or feet;
• angioedema (rarely fatal), see above, itching, sweating, hair loss, purple spots on the skin (purpura), skin discoloration.

Rarely(occurring in less than 1 in 1,000 patients):

• disorientation;
• balance disorders;
• conjunctivitis;
• glossitis;
• skin exfoliation, urticaria (itching rash with blisters), nail detachment;
• hearing disorders;
• decreased red blood cell count, white blood cell count, or platelet count, or decreased hemoglobin levels, detected in blood tests;
• vasoconstriction, decreased blood flow, vasculitis;
• jaundice due to bile stasis, liver cell damage.

Very rarely(occurring in less than 1 in 10,000 patients):

• increased blood sugar levels;
• hepatitis;
• photosensitivity reactions, and skin changes, including blistering and peeling (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• increased muscle tone;
• peripheral nerve disorders;
• gingival hyperplasia.

Frequency not known(frequency cannot be estimated from available data):

• concentration disorders;
• oral mucosa inflammation with small ulcers (aphthous stomatitis);
• decreased sodium levels in the blood, detected in blood tests;
• concentrated urine (dark in color), nausea, or vomiting, muscle cramps, feeling of confusion, and seizures - syndrome of inappropriate antidiuretic hormone secretion - see above;
• change in finger and toe color in response to cold, followed by tingling or pain upon warming (Raynaud's phenomenon);
• cerebral circulation disorders, including stroke, slowed or impaired reactions, burning sensation, impaired sense of smell;
• severe skin and mucous membrane disorders with blistering and peeling, pemphigus (a skin disease with blisters), exacerbation of psoriasis (a skin disease with red, scaly patches), other types of skin rashes or mucous membrane disorders;
• bone marrow failure, decreased blood cell count, anemia due to increased red blood cell destruction (hemolytic anemia);
• severe allergic reactions, both allergic and non-allergic (anaphylactic and pseudoanaphylactic reactions), positive antinuclear antibody titer (indicating connective tissue diseases);
• acute liver failure;
• parkinsonism, rigidity, mask-like face, slow movements, and shuffling gait.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, inform the 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
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Sumilar

Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging and blister.
The expiry date stated on the packaging after the abbreviation "EXP" and the batch number after the abbreviation "Lot" or "LOT".
The expiry date stated is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Sumilar contains

• The active substances of Sumilar are amlodipine and ramipril. Each hard capsule of 5 mg + 5 mg strength contains 5 mg of ramipril and 5 mg of amlodipine (as amlodipine besylate). Each hard capsule of 5 mg + 10 mg strength contains 5 mg of ramipril and 10 mg of amlodipine (as amlodipine besylate). Each hard capsule of 10 mg + 5 mg strength contains 10 mg of ramipril and 5 mg of amlodipine (as amlodipine besylate). Each hard capsule of 10 mg + 10 mg strength contains 10 mg of ramipril and 10 mg of amlodipine (as amlodipine besylate).
• Other ingredients are: microcrystalline cellulose, hypromellose, crospovidone (type B), glycerol dibehenate, gelatin, titanium dioxide (E171), indigo carmine (E132) (only Sumilar, 5 mg + 5 mg, Sumilar, 5 mg + 10 mg, Sumilar, 10 mg + 10 mg).

What Sumilar looks like and contents of the pack

Sumilar, 5 mg + 5 mg, are hard, gelatinous, light blue capsules filled with white or almost white powder or slightly compressed aggregate; capsule size - No. 3
Sumilar, 5 mg + 10 mg, are hard, gelatinous capsules with a white body and blue cap, filled with white or almost white powder or slightly compressed aggregate; capsule size

• No. 1

Sumilar, 10 mg + 5 mg, are hard, gelatinous, white capsules filled with white or almost white powder or slightly compressed aggregate; capsule size - No. 1
Sumilar, 10 mg + 10 mg, are hard, gelatinous, blue capsules filled with white powder or almost white or slightly compressed aggregate; capsule size - No. 1
The pack contains 30, 60, or 90 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Zaklady Farmaceutyczne POLPHARMA SA
(Pharmaceutical Works Polpharma SA)
ul. Pelplinska 19
83-200 Starogard Gdanski
Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana,
Slovenia
Date of last revision of the leaflet:06/2022