Sumilar

Package Leaflet: Information for the Patient

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 package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What Sumilar is and what it is 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 antagonists.
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 at the same doses as in Sumilar.

2. Important information before taking Sumilar

When not to take Sumilar

• if you are allergic to ramipril, amlodipine (active substances), other dihydropyridine calcium antagonists, 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 you have liver function disorders;
• if you have unstable heart failure after a recent heart attack;
• if you have had shock, including cardiogenic shock (due to acute heart failure);
• if you have a narrowing of the outflow tract from the left ventricle (e.g., significant aortic stenosis);
• 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 are undergoing dialysis or other types of blood filtration. Depending on the device used, treatment with Sumilar may not be suitable;
• if you have kidney disease that reduces blood flow to the kidney (renal artery stenosis);
• after the 3rd month of pregnancy (see "Pregnancy and breastfeeding");
• if you have abnormally low or unstable blood pressure - your doctor will advise on proper monitoring;
• if you have diabetes or kidney function disorders and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you have taken or are 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 you, do not take Sumilar.
In case of doubt, consult your doctor before taking Sumilar.

Warnings and precautions

Before starting to take Sumilar, discuss it with your doctor or pharmacist. You should inform your doctor if any of the following conditions apply to you:

• if you are elderly;
• if you have heart or kidney problems;
• if you experience 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 your doctor;
• if you are at risk of circulatory problems in the heart or brain in case of very low blood pressure;
• if you have experienced 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 you are scheduled to undergo desensitization treatment for bee or wasp stings;
• if you are scheduled to receive anesthetics for surgery or dental procedures. It may be necessary to discontinue Sumilar one day in advance - your doctor will advise on how to proceed;
• if you have high potassium levels in the blood (detected in a blood test);
• if you have collagenosis (a connective tissue disease), such as scleroderma or systemic lupus erythematosus;
• if you are of black race - in these patients, there is an increased risk of angioedema, and the effect of ramipril may be weakened (insufficient blood pressure reduction);
• if you experience a dry, persistent cough;
• if you are 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 you have kidney problems related to diabetes;
• aliskiren;
• if you are 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 to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

Tell your doctor if you are taking any of the above medicines. Sumilar may affect the way they work:

• medicines for low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, norepinephrine, adrenaline, dobutamine, or dopamine - your doctor will advise on regular blood pressure monitoring;
• rifampicin (an antibiotic used to treat tuberculosis);
• St. John's Wort (a herbal medicine used to treat depression).

Tell your doctor if you are taking any of the above medicines. They may increase the risk of side effects when taken with Sumilar:

• medicines for pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, or acetylsalicylic acid);
• cancer medicines (used in chemotherapy), such as temsirolimus;
• medicines used to prevent transplant rejection, such as tacrolimus or everolimus;
• diuretics (water pills), such as 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 immunosuppressant used to prevent transplant rejection, and heparin, used to thin the blood to prevent clots) - when taking these medicines, close monitoring of potassium levels in the blood is required;
• corticosteroids, such as prednisolone;
• allopurinol (used to reduce uric acid levels in the blood);
• procainamide (used to treat heart rhythm disorders);
• medicines that can 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 your doctor if you are taking any of the above medicines. Sumilar may affect their way of working:

• medicines for diabetes, such as oral glucose-lowering medicines and insulin. Sumilar may lower blood sugar levels. When taking Sumilar, it is essential to closely monitor blood sugar levels;
• lithium (used to treat mental disorders). Sumilar may increase lithium levels in the blood. Your doctor will advise on 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.

Your doctor may advise on changing the dose and/or taking other precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to take Sumilar" and "Warnings and precautions").

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

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. If you have any doubts about the amount of alcohol you can consume while taking Sumilar, consult your doctor, as alcohol and blood pressure-lowering medicines can enhance each other's effects.
While taking Sumilar, do not eat grapefruits or drink grapefruit juice. This is because grapefruits and grapefruit juice can cause an increase in the levels of the active substance amlodipine in the blood, which may lead to unpredictable enhancement of Sumilar's blood pressure-lowering effect.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Do not take Sumilar during the first 12 weeks of pregnancy and do not take it after the 12th week of pregnancy, as it may seriously harm your baby if taken during this period (see "Pregnancy and breastfeeding").
If you become pregnant while taking Sumilar, tell your doctor immediately.
Your doctor will advise on using a different medicine if you are planning to become pregnant.
Do not take Sumilar while breastfeeding.

Driving and using machines

Sumilar may impair your ability to drive or operate machines, as it can cause dizziness, headache, and/or fatigue. This is most likely to happen at the beginning of treatment or when the dose of Sumilar is increased. If you experience these symptoms, do not drive or operate machines.

3. How to take Sumilar

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Method of administration

• Take the medicine orally, once a day, at the same time, with or without food.
• Swallow the hard capsules whole with a drink of water, do not crush or chew them.

Dosage

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

If you feel that the effect of Sumilar is too strong or too weak, tell your doctor.

Elderly patients

Sumilar is not recommended for patients who are very elderly or frail.

Use in children and adolescents

Do not use Sumilar in children and adolescents under 18 years of age due to a lack of data on its safety and efficacy.

Overdose

If you have taken more than the prescribed dose of Sumilar, the following symptoms may occur: low blood pressure (possibly severe) with dizziness, a feeling of "emptiness" in the head, fainting. If blood pressure drops to critical levels, 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).
If you have taken more than the prescribed dose of Sumilar, seek medical attention immediately. Do not drive yourself, ask someone to drive you or call an ambulance. Bring the medicine packaging with you, so the doctor knows what medicine was taken.

Missed dose

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

Stopping treatment with Sumilar

Do not stop taking Sumilar suddenly or change the prescribed dose without consulting your doctor, as your condition may worsen.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sumilar can cause side effects, although not everybody gets them.
If you experience any of the following severe side effects, stop taking Sumilar and seek medical attention immediately:

• 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, mouth ulcers, exacerbation of existing skin conditions, redness, blistering, or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme) or other allergic reactions.

Tell your doctor immediately if you experience:

• rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, feeling of compression in the chest, or more severe heart problems, including heart attack or stroke;
• shortness of breath or cough - these may be symptoms of lung problems;
• easy bruising, prolonged bleeding, bleeding of various types (e.g., bleeding from the gums), purple spots on the skin (purpura), or more frequent infections than usual, sore throat, and fever, feeling of tiredness, 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, vomiting, yellowing of the skin or eyes (jaundice). These may be symptoms of liver problems, 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 (SIADH).

Other side effects:

If any of the following side effects get worse or last longer than a few days, tell your doctor.
Common(occurring in less than 1 in 10 patients):

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

Uncommon(occurring in less than 1 in 100 patients):

• vision disturbances (including blurred vision, double vision);
• tinnitus (e.g., ringing in the ears);
• kidney problems, 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);
• back pain, joint pain;
• weight gain or loss;
• dizziness, tremor, abnormal sensations, such as tingling, numbness, prickling, or burning of the skin (paresthesia), decreased sensitivity (hypoesthesia), loss or disturbance of taste;
• mood changes, depression, anxiety, nervousness, restlessness, sleep disturbances, 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;
• increased liver enzymes and/or bilirubin levels (indicating liver function), detected in blood tests;
• loss of appetite (anorexia);
• fever, weakness, pain, malaise;
• transient erectile dysfunction, impotence, decreased libido in men and women, gynaecomastia in men;
• increased eosinophil count (a type of white blood cell), detected in blood tests;
• angina pectoris or myocardial infarction, increased heart rate, arrhythmias, edema of the hands or feet;
• angioedema (rarely fatal), see above, itching, sweating, hair loss, purpura, skin discoloration.

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

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

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

• increased blood sugar levels;
• hepatitis;
• photosensitivity reactions, and blistering, peeling, or rashes on the skin and mucous membranes (erythema multiforme, Stevens-Johnson syndrome) - see above;
• increased muscle tone;
• peripheral nerve disorders;
• gingival hyperplasia.

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

• concentration disorders;
• aphthous stomatitis (mouth ulcers);
• low sodium levels in the blood, detected in blood tests;
• concentrated urine (dark in color), nausea, or vomiting, muscle cramps, feeling of confusion, and seizures - SIADH, see above;
• change in finger or toe color in response to cold, followed by tingling or pain upon warming (Raynaud's phenomenon);
• cerebrovascular disorders, including stroke, slowed or impaired reactions, feeling of burning, disorders of smell;
• severe skin and mucous membrane disorders with blistering, peeling, or shedding of large areas of skin (toxic epidermal necrolysis), pemphigus (a skin disease with blistering), 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, or 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;
• parkinsonian symptoms, such as tremor, rigidity, mask-like face, slow movements, and shuffling gait.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects 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. You can also report side effects 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

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton and blister.
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. These measures will help protect the environment.

6. Contents of the pack and other information

What Sumilar contains

• The active substances 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).
• The other ingredients are: microcrystalline cellulose, hypromellose, crospovidone (type B), glycerol dibehenate, gelatin, titanium dioxide (E171), indigo carmine (E132) (only in 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