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
Ramiprilum + Amlodipinum
Please read all of this leaflet carefully before taking this medicine, as it contains important
information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the 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 body's production of substances that may raise blood pressure,
• relaxing and widening blood vessels,
• helping the heart pump blood throughout the body. Amlodipine works by:
• relaxing and widening blood vessels.

Sumilar may be used in the treatment of high blood pressure (hypertension) in adult
patients whose blood pressure is adequately controlled with the combination of
both active substances at the same doses as in Sumilar, but taken as separate preparations.
2. Important information before taking Sumilar
When not to take Sumilar

• if you are allergic to ramipril, amlodipine (the active substances), other medicines from the group of dihydropyridine calcium antagonists, other ACE inhibitors, or to 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 following acute myocardial infarction;
• if you have experienced shock, including cardiogenic shock (due to acute heart failure);
• if you have obstruction of the outflow tract from the left ventricle (e.g. significant aortic valve stenosis);
• if you have ever experienced a severe allergic reaction called angioedema. Symptoms include: itching, urticaria, red spots on hands, feet and throat, swelling of the throat and tongue, swelling around eyes and lips, difficulty breathing and swallowing;
• if you are undergoing dialysis or other types of blood filtration. Depending on the equipment used, treatment with Sumilar may not be appropriate;
• if you have kidney disease causing reduced blood flow to the kidney (renal artery stenosis);
• after the 3rd month of pregnancy (see section "Pregnancy and breastfeeding");
• if you have abnormally low or unstable blood pressure – your doctor will advise appropriate 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 medicine containing sacubitril and valsartan (used in the treatment of long-term (chronic) heart failure in adults), as this increases the risk of angioedema (rapid swelling of subcutaneous tissue, e.g. in the throat area).

Do not take Sumilar if any of the above conditions apply to you.
If in doubt, speak to your doctor before taking Sumilar.
Warnings and precautions
Before starting Sumilar, discuss this with your doctor or pharmacist. Inform your doctor if any of the following conditions apply to you:

• if you are elderly;
• if you have heart or kidney disorders;
• 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 immediately and contact your doctor;
• if you are at risk of impaired blood flow to the heart or brain due to very low blood pressure;
• if you have significant loss of electrolytes or fluids from the body (due to vomiting, diarrhoea, excessive sweating, low-sodium diet, prolonged use of diuretics (water tablets) or dialysis);
• if you are undergoing treatment to reduce allergic reactions to bee or wasp venom (desensitisation therapy);
• if you are scheduled to receive anaesthetics, both for surgery and dental procedures. It may be necessary to stop taking Sumilar one day beforehand – your doctor will advise you on what to do;
• if you have high potassium levels in the blood (detected in a blood laboratory test);
• if you have collagenosis (connective tissue disease), e.g. scleroderma or systemic lupus erythematosus;
• if you are of black race – such patients have an increased risk of angioedema, and the effect of medicines in the class to which ramipril belongs may be reduced (insufficient lowering of blood pressure);
• if you develop a persistent dry 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 disorders 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 diarrhoea;
• medicines used to prevent rejection of transplanted organs and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy.
Sumilar is not recommended during the first three months of pregnancy and must not be used after the 3rd
month of pregnancy, as it may seriously harm the unborn child if taken during this period (see section "Pregnancy and breastfeeding").
Your doctor may recommend regular monitoring of white blood cell count, especially at the beginning of
treatment, in patients with kidney function disorders or collagenosis, and also if medicines affecting white blood cell count are used.
Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte
levels (e.g. potassium).
See also the section "When not to take Sumilar".
Children and adolescents
Do not use Sumilar in children and adolescents under 18 years of age due to lack of data
on safety and efficacy in this patient group.
Sumilar with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is necessary because
Sumilar may affect the action of other medicines, and other medicines may affect the action of Sumilar.
Tell your doctor if you are taking any of the following medicines. These medicines may
weaken the effect of Sumilar:

• painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indometacin or acetylsalicylic acid);
• medicines used for low blood pressure, shock, heart failure, asthma or allergies, such as ephedrine, noradrenaline, adrenaline, dobutamine or dopamine – your 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 your doctor if you are taking any of the following medicines. These medicines may
increase the risk of adverse effects if taken together with Sumilar:

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

Tell your doctor if you are 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 glucose levels. Blood glucose levels should be closely monitored during treatment with Sumilar;
• lithium (used to treat psychiatric disorders). Sumilar may increase lithium levels in the blood. Your doctor will recommend regular monitoring of blood lithium levels;
• simvastatin (a medicine that lowers blood cholesterol levels). Sumilar may increase simvastatin levels in the blood.

Your doctor may recommend dose adjustment and (or) additional 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 if you have any doubts), speak to your doctor before
taking Sumilar.
Sumilar with food, drink and alcohol
Sumilar may be taken with or without food.
Drinking alcohol while taking Sumilar may cause dizziness or a "hollow" feeling in the head. If you have any doubts about the amount of alcohol you may consume while
taking Sumilar, speak to your doctor, as alcohol and blood pressure-lowering medicines may mutually enhance their effects.
Do not eat grapefruit or drink grapefruit juice while taking Sumilar. This is because grapefruit and grapefruit juice may increase the blood concentration of the active substance amlodipine, which could lead to unpredictable intensification of Sumilar's blood pressure-lowering effect.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a
child, you should 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 the unborn child if used during this period. If you become pregnant while taking Sumilar, inform your doctor immediately.
Your doctor will recommend an alternative medicine if you are planning pregnancy.
Do not take Sumilar while breastfeeding.
Driving and operating machinery
Sumilar may impair your ability to drive or operate machinery, as dizziness, headache and (or) fatigue may occur during treatment. This is most likely at the beginning of treatment or when the dose of Sumilar is increased. If such symptoms occur, do not drive or operate machinery.

3. How to take Sumilar

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Method of administration

• This medicine should be taken orally, at the same time each day, with or without food.
• Hard capsules should be swallowed whole with liquid (do not use grapefruit juice), and must not be crushed or chewed.

Dosage

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

If you feel that the effect of the medicine is too strong or too weak, inform your doctor.
Elderly patients
Sumilar is not recommended for use in very elderly or debilitated patients.
Use in children and adolescents
Sumilar must not be used in children and adolescents under 18 years of age due to lack of data on safety and efficacy.
Taking more Sumilar than prescribed
If you take too much medicine, the following symptoms may occur: lowering of blood pressure (even severe), dizziness,
feeling of "emptiness" in the head, fainting. If blood pressure drops to critical levels, shock with loss of consciousness may occur.
Breathing difficulties caused by excess fluid accumulating in the lungs (pulmonary edema) may occur up to 24–48 hours after taking the medicine.
If you take too much medicine, you should immediately contact your doctor or go to the nearest hospital emergency department.
Do not drive yourself; ask someone to take you or call an ambulance. You should bring the medicine packaging with you. This way, the doctor will know which medicine has been taken.
Missing a dose of Sumilar
If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for a missed dose.
Stopping Sumilar treatment
Do not suddenly stop taking this medicine or change the prescribed dose without consulting your doctor, as this may lead to worsening of the condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse symptoms occur, stop taking
Sumilar and seek immediate medical advice – urgent medical assistance may be required:

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

Contact your doctor immediately if you experience:

• increased heart activity, irregular or stronger heartbeat (palpitations), chest pain, feeling of pressure in the chest, or more serious disturbances, including heart attack or stroke;
• shortness of breath or cough – these may be symptoms of lung disorders;
• easier bruising, prolonged bleeding time, various types of bleeding (e.g. bleeding gums), purple spots on the skin (petechiae), or more frequent than usual infections, sore throat and fever, feeling of fatigue, fainting, dizziness or pale skin. These may be symptoms of blood or bone marrow disorders;
• severe upper abdominal pain radiating to the back – this may be a symptom of pancreatitis;
• fever, chills, fatigue, loss of appetite, abdominal pain, nausea, yellowing of the skin or 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, confusion and seizures, which may result from inappropriate ADH secretion (vasopressin, antidiuretic hormone).

Other adverse reactions:
If any of the following adverse reactions worsen or persist for longer than a few
days, inform your doctor.
Common (occur in fewer than 1 in 10 patients):

• palpitations (irregular or stronger heartbeat);
• headache, central dizziness, drowsiness;
• hypotension (abnormally low blood pressure), orthostatic hypotension (especially when standing up or sitting down quickly 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 disturbances, dyspepsia, abdominal pain, diarrhoea, nausea or vomiting;
• skin rash, especially with skin nodules;
• chest pain, fatigue, oedema (fluid accumulation in tissues);
• muscle pain, muscle cramps, ankle swelling;
• increased potassium levels in blood, detected in blood tests.

Uncommon (occur in fewer than 1 in 100 patients):

• visual disturbances (including blurred vision, double vision);
• tinnitus (e.g. ringing in the ears);
• kidney function disorders, including acute kidney failure, disturbances in urination (increased frequency and volume of urine, nocturia), worsening proteinuria, increased blood urea and creatinine levels (parameters indicating kidney function);
• joint pain, back pain;
• weight gain or weight loss;
• labyrinthine dizziness, tremor, unusual sensory sensations such as numbness, tingling, pricking, burning or stinging of the skin (paresthesia), reduced sensation (hypoesthesia), loss or disturbances of taste;
• low mood or mood changes, depression, anxiety, nervousness, restlessness, sleep disturbances, including insomnia or drowsiness;
• bronchospasm, including worsening of asthma, nasal mucosal congestion or rhinitis;
• pancreatitis (rarely fatal), increased pancreatic enzyme activity (indicating pancreatic function) detected in blood tests, intestinal angioedema (intestinal swelling), presenting with abdominal pain, vomiting and diarrhoea, upper abdominal pain, including gastric irritation, changes in bowel rhythm (including diarrhoea and constipation), heartburn, dryness of the oral mucosa;
• increased liver enzyme activity and/or bilirubin levels (parameters indicating liver function), detected in blood tests;
• decreased or loss of appetite (anorexia);
• fever, weakness, pain, malaise;
• transient erectile dysfunction, impotence, decreased libido in men and women, gynaecomastia in men;
• increased number of certain types of white blood cells (eosinophilia), detected in laboratory blood tests;
• angina pectoris or myocardial infarction, increased heart rate, cardiac arrhythmias, oedema of hands or feet;
• swelling of the face, lips, tongue or throat (angioedema), rarely fatal – see above;
• itching, excessive sweating, hair loss, purple spots on the skin (purpura), skin discoloration.

Rare (occur in fewer than 1 in 1,000 patients):

• disorientation;
• balance disorders;
• conjunctivitis;
• glossitis (inflammation of the tongue);
• skin inflammation with desquamation, urticaria (itchy rash with skin blisters), nail plate separation from the nail bed;
• hearing disturbances;
• decreased number of red blood cells, white blood cells or platelets, or decreased haemoglobin concentration, detected in laboratory blood tests;
• vasoconstriction, reduced blood flow through vessels, vasculitis (inflammation of blood vessels);
• cholestatic jaundice, liver cell damage.

Very rare (occur in fewer than 1 in 10,000 patients):

• increased blood glucose levels;
• hepatitis;
• photosensitivity reactions, erythematous-edematous changes and blistering of the skin and mucous membranes (erythema multiforme, Stevens-Johnson syndrome) – see above;
• increased muscle tone;
• peripheral nerve disorders;
• gingival hyperplasia (overgrowth of gums).

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

• concentration disturbances;
• inflammation of the oral mucosa with small ulcers (aphthous stomatitis);
• decreased sodium levels in blood, detected in laboratory blood tests;
• concentrated urine (dark in color), nausea or vomiting, muscle cramps, confusion and seizures – syndrome of inappropriate antidiuretic hormone secretion – see above;
• color change of fingers and toes 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, disturbances in smell;
• severe skin and mucous membrane disease with erythematous-edematous changes, blistering and detachment of large areas of epidermis (toxic epidermal necrolysis), blistering skin disease (pemphigus), exacerbation of psoriasis (skin disease with red, scaly lesions), other types of skin rashes or mucosal rashes;
• bone marrow failure, decreased counts of all blood cells, anaemia due to increased destruction of red blood cells (haemolytic anaemia);
• severe reactions of allergic and non-allergic origin (anaphylactic and pseudoanaphylactic reactions), positive antinuclear antibody titre (indicating connective tissue diseases);
• acute liver failure;
• tremor, postural rigidity, facial masking, slowed movements and shuffling gait.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the 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. Adverse reactions can also be reported
to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Sumilar

Keep this 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 carton and blister.
The marking on the packaging after EXP indicates the expiry date, and after Lot/LOT indicates the batch number.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 strength 5 mg + 5 mg contains 5 mg ramipril and 5 mg amlodipine (as amlodipine besylate). Each hard capsule of strength 5 mg + 10 mg contains 5 mg ramipril and 10 mg amlodipine (as amlodipine besylate). Each hard capsule of strength 10 mg + 5 mg contains 10 mg ramipril and 5 mg amlodipine (as amlodipine besylate). Each hard capsule of strength 10 mg + 10 mg contains 10 mg ramipril and 10 mg amlodipine (as amlodipine besylate).
• 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, gelatin, light blue capsules filled with white or almost white powder or lightly compressed agglomerate; capsule size – No. 3
Sumilar 5 mg + 10 mg are hard, gelatin capsules with white body and blue cap, filled with white or almost white powder or lightly compressed agglomerate; capsule size – No. 1
Sumilar 10 mg + 5 mg are hard, gelatin, white capsules filled with white or almost white powder or lightly compressed agglomerate; capsule size – No. 1
Sumilar 10 mg + 10 mg are hard, gelatin, blue capsules filled with white or almost white powder or lightly compressed agglomerate; capsule size – No. 1
The pack contains 30, 60 or 90 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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