Rimal

Leaflet accompanying the packaging: patient information

Rimal, 5 mg + 5 mg, hard capsules

Rimal, 5 mg + 10 mg, hard capsules

Rimal, 10 mg + 5 mg, hard capsules

Rimal, 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.
• 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 tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Rimal and what is it used for

Rimal 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.

Rimal can be used to treat high blood pressure (hypertension) in adult patients who have their blood pressure properly controlled while taking both active substances at the same doses as in Rimal, but in separate preparations.

2. Important information before taking Rimal

When not to take Rimal

• 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., severe 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 type of blood filtration. Depending on the device used, treatment with Rimal 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 recommend 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, in areas such as the throat) increases.

If any of the above conditions apply to you, do not take Rimal.
In case of doubts, before taking Rimal, consult your doctor.

Warnings and precautions

Before starting to take Rimal, 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 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 Rimal and contact your doctor;
• if you are at risk of circulatory disorders 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 receive 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 Rimal one day in advance - your doctor will inform you how to proceed;
• if you have high levels of potassium in the blood (detected in a blood test);
• if you have collagenosis (a disease of the connective tissue), such as scleroderma or systemic lupus erythematosus;
• if you are black - 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 function disorders associated with 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);
• saxagliptin, a medicine used to treat diabetes.

Tell your doctor if you are taking any of the following medicines. Rimal may affect their action:

• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, norepinephrine, 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. They may increase the risk of side effects when taken with Rimal:

• medicines used to treat 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 (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; cyclosporin, 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 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 your doctor if you are taking any of the following medicines. Rimal may affect their action:

• medicines used to treat diabetes, such as oral glucose-lowering medicines and insulin. Rimal may lower blood sugar levels. While taking Rimal, it is necessary to carefully monitor blood sugar levels;
• lithium (used to treat mental disorders). Rimal may increase lithium levels in the blood. Your doctor will recommend regular monitoring of lithium levels in the blood;
• simvastatin (a medicine used to lower cholesterol levels in the blood). Rimal may increase simvastatin levels in the blood.

Your doctor may recommend a dose change and/or take other precautions:

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

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

Rimal with food, drink, and alcohol

Rimal can be taken with or without food.
Drinking alcohol while taking Rimal 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 Rimal, consult your doctor, as alcohol and blood pressure-lowering medicines can enhance each other's effects.
While taking Rimal, 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 Rimal's blood pressure-lowering effect.

Pregnancy and breastfeeding

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.
Rimal 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 baby if taken during this period (see "Pregnancy and breastfeeding").
If you become pregnant while taking Rimal, tell your doctor immediately.
Your doctor will recommend using a different medicine if you are planning to become pregnant.
Rimal should not be taken during breastfeeding.

Driving and using machines

Rimal may affect your ability to drive or use 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 Rimal is increased. If you experience these symptoms, do not drive or use machines.

3. How to take Rimal

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 drink grapefruit juice), do not chew or crush them.

Dosage

• The usual dose is 1 capsule of the prescribed strength per 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 Rimal is too strong or too weak, tell your doctor.

Elderly patients

Rimal should not be used in very elderly or frail patients.

Use in children and adolescents

Rimal should not be used in children and adolescents under 18 years of age due to a lack of data on its safety and efficacy.

Overdose

If you take more Rimal than you should, 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 excessive fluid accumulation in the lungs (pulmonary edema). If you take more Rimal than you should, contact your doctor or the emergency department of the nearest hospital immediately. Do not drive yourself, ask someone to drive you or call an ambulance. Take the medicine packaging with you so that the doctor knows what medicine has been 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

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

4. Possible side effects

Like all medicines, Rimal can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking Rimal and contact your doctor immediately - urgent medical attention may be required:

• 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 Rimal (angioedema);
• severe skin reactions, including rash, ulcers of the mucous membranes, 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 pressure in the chest, or more severe heart 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 infections than usual, sore throat, and fever, 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, vomiting, 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, 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 flushing (especially of the face and neck);
• dry, persistent cough, bronchitis, sinusitis, shortness of breath;
• gastritis and/or enteritis, digestive disorders, nausea, 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 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 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);
• back pain, joint pain;
• weight gain or loss;
• dizziness, tremors, abnormal sensations, such as numbness, tingling, prickling, or burning of the skin (paresthesia), reduced sensation (hypoesthesia), loss of taste;
• mood changes, depression, anxiety, nervousness, restlessness, sleep disorders, including insomnia or drowsiness;
• bronchospasm, including exacerbation of asthma, 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 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, gynecomastia in men;
• increased eosinophil count (a type of white blood cell), detected in blood tests;
• angina pectoris or myocardial infarction, rapid heartbeat, arrhythmias, edema of the hands or feet;
• angioedema (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 detachment;
• hearing disorders;
• reduced red blood cell count, white blood cell count, or platelet count, or reduced hemoglobin levels, detected in blood tests;
• vasoconstriction, reduced blood flow, 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 changes in skin color;
• increased muscle tone;
• peripheral nerve disorders;
• gingival hyperplasia.

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

• concentration disorders;
• oral aphthous ulcers;
• reduced 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 and 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;
• severe skin and mucous membrane disorders with changes in skin color, blisters, and peeling of large areas of the skin (toxic epidermal necrolysis), 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, reduced count of all blood cells, anemia due to increased breakdown of red blood cells (hemolytic anemia);
• severe allergic and non-allergic reactions (anaphylactic and pseudoanaphylactic reactions), positive antinuclear antibody titer (indicating connective tissue diseases);
• acute liver failure;
• tremors, rigidity, mask-like facial expression, slow movements, and shuffling gait.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please 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, Tel.: +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 Rimal

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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of that 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 Rimal contains

• The active substances of Rimal 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 Rimal 5 mg + 5 mg, Rimal 5 mg + 10 mg, Rimal 10 mg + 10 mg).

What Rimal looks like and contents of the pack

Rimal 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
Rimal 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
Rimal 10 mg + 5 mg are hard, gelatinous, white capsules filled with white or almost white powder or slightly compressed aggregate; capsule size - No. 1
Rimal 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 and manufacturer

Polpharma S.A.
Pelplińska 19
83-200 Starogard Gdański
tel. +48 22 364 61 01

Date of last revision of the leaflet: