Rimal

Package Leaflet: Information for the Patient

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 package 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 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.

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

2. Important information before taking Rimal

When not to take Rimal

• if you are 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 you have liver problems;
• 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 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. 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 advise on proper monitoring;
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren,
• if you have taken or are taking a combination medicine that contains sacubitril and valsartan (used to treat chronic heart failure in adults), as the risk of angioedema (rapid swelling of the skin and mucous membranes, e.g., in the throat) increases.

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

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 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 Rimal and contact your doctor immediately;
• 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 (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 Rimal one day in advance - your doctor will advise on how to proceed;
• if you have high levels of potassium in the blood (as determined by a blood test);
• if you have collagen disease (e.g., scleroderma or systemic lupus erythematosus);
• if you are of African descent - these patients have an increased risk of developing angioedema, and the effect of ramipril may be reduced (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 diabetic kidney problems;
• 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 following medicines. Rimal may affect the way they work:

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

Your doctor may need to adjust the dose 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 if you are in doubt), consult your doctor before taking Rimal.

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. If you are in doubt about the amount of alcohol you can consume 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 the blood pressure-lowering effect of Rimal.

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.
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").
Your doctor may advise on the use of a different medicine if you are planning to become pregnant.
Rimal should not be taken during breastfeeding.

Driving and using machines

Rimal may impair your ability to drive or operate machinery, 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 operate machinery.

3. How to take Rimal

Always take this medicine exactly as your doctor or pharmacist has told you. If you are in doubt, consult 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 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 per 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 than the prescribed dose of Rimal, the following symptoms may occur: low blood pressure (possibly severe) with dizziness, 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 take more than the prescribed dose of Rimal, 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 the missed dose.

Stopping treatment with Rimal

Do not stop taking Rimal suddenly or change the prescribed dose without consulting your doctor, as your condition may worsen.
If you have any further doubts about taking this medicine, consult 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 in the mouth, worsening 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 tightness 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 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 - these may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).

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, vomiting, diarrhea;
• 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, as determined by 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);
• joint pain, back pain;
• weight gain or loss;
• dizziness, tremors, abnormal sensations (such as numbness, tingling, burning, or prickling of the skin), reduced sensation (hypoesthesia), loss of taste;
• mood changes, depression, anxiety, nervousness, restlessness, sleep disturbances, including insomnia or drowsiness;
• bronchospasm, including exacerbation of asthma, nasal congestion or rhinitis;
• pancreatitis (rarely fatal), increased activity of pancreatic enzymes (indicating pancreatic function), as determined by 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), as determined by 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), as determined by blood tests;
• angina pectoris or myocardial infarction, tachycardia, arrhythmias, edema of the hands or feet;
• angioedema (see above), itching, sweating, hair loss, purple spots on the skin (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), separation of the nail plate from the nail bed;
• hearing disorders;
• decreased red blood cell count, white blood cell count, or platelet count, or decreased hemoglobin levels, as determined by blood tests;
• vasoconstriction, decreased 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 resembling lupus erythematosus, including Stevens-Johnson syndrome and toxic epidermal necrolysis (see above);
• increased muscle tone;
• peripheral neuropathy;
• gingival hyperplasia.

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

• concentration disorders;
• oral mucosal ulcers (aphthous stomatitis);
• low sodium levels in the blood, as determined by blood tests;
• concentrated urine (dark in color), nausea, or vomiting, muscle cramps, feeling of confusion, and seizures - SIADH (see above);
• color change of fingers and toes in response to cold, followed by tingling or pain upon warming (Raynaud's phenomenon);
• cerebrovascular disorders, including stroke, slowed or impaired reactions, burning sensation, impaired sense of smell;
• severe skin and mucous membrane disorders with rash, blisters, and peeling of large areas of 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, decreased blood cell count, hemolytic anemia (anemia due to increased breakdown of red blood cells);
• severe allergic reactions, including anaphylactic and pseudoanaphylactic reactions, positive antinuclear antibody titers (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. 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.
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 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. This 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
Phone: +48 22 364 61 01

Date of last revision of the leaflet: