Ramicor

Leaflet attached to the packaging: patient information

Ramicor, 2.5 mg, tablets

Ramicor, 5 mg, tablets

Ramicor, 10 mg, tablets

Ramipril

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 Ramicor is and what it is used for
• 2. Important information before taking Ramicor
• 3. How to take Ramicor
• 4. Possible side effects
• 5. How to store Ramicor
• 6. Contents of the packaging and other information

1. What Ramicor is and what it is used for

Ramicor contains the active substance ramipril, which belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
The action of Ramicor is based on:

• 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.

Ramicor is used to:

• treat high blood pressure (hypertension);
• reduce the risk of heart attack or stroke;
• reduce the risk of kidney disease or slow its progression (regardless of whether the patient has diabetes);
• treat heart failure when the heart is not able to pump enough blood to the rest of the body;
• treat patients with heart failure after a heart attack.

2. Important information before taking Ramicor

When not to take Ramicor:

• if the patient is allergic to ramipril, any other ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the face, lips, throat, or tongue;
• if the patient has ever had a severe allergic reaction called "angioedema". Its symptoms include: itching, hives, red spots on the palms, soles, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing;

if the patient has taken or is currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) increases;

Warnings and precautions

Before starting to take Ramicor, discuss it with your doctor or pharmacist.

• If the patient has heart, liver, or kidney disease.
• If the patient has recently lost a significant amount of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, taking diuretics for a long time, or dialysis).
• If the patient is to undergo desensitization treatment for bee or wasp stings.
• If the patient is to undergo anesthesia during surgical or dental procedures. It may be necessary to stop taking Ramicor the day before the procedure; in case of doubts, consult a doctor.
• If the patient has high potassium levels in the blood (as shown in blood test results).
• If the patient is taking medicines that lower sodium levels in the blood or has a disease that causes low potassium levels in the blood. The doctor will regularly check sodium levels in the blood, especially in elderly patients.
• If the patient is taking any of the following medicines, the risk of angioedema may increase:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent the rejection of transplanted organs and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat type 2 diabetes.
• If the patient has collagenosis, such as scleroderma or systemic lupus erythematosus.
• The patient should inform their doctor if they are pregnant or plan to become pregnant. Ramicor is not recommended during the first 12 weeks of pregnancy, and its use after the 13th week of pregnancy is contraindicated, as it may harm the fetus (see below, "Pregnancy, breastfeeding, and fertility").
• If the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes.
• aliskiren.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Ramicor".
Children and adolescents
Ramicor should not be used in children and adolescents under 18 years of age, as there is insufficient data on the safety and efficacy of the medicine in children.
If any of the above situations apply to the patient or if they have doubts, they should discuss it with their doctor before starting to take Ramicor.

Ramicor and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, as Ramicor may affect the action of other medicines. Some medicines may affect the action of Ramicor.
Tell your doctor or pharmacist about taking the following medicines, as they may reduce the effect of Ramicor:

• medicines used to treat pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, or aspirin),
• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, norepinephrine, or adrenaline. The doctor will monitor blood pressure.

Tell your doctor about taking the following medicines, as they may increase the risk of side effects when used with Ramicor:

• medicines used to treat pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin),
• medicines used to treat cancer (chemotherapy),
• medicines used to prevent organ transplant rejection, such as cyclosporine,
• diuretics (e.g., furosemide),
• medicines that increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (a blood thinner),
• trimethoprim and co-trimoxazole (used to treat bacterial infections),
• corticosteroids, such as prednisolone,
• allopurinol (used to lower uric acid levels in the blood),
• procainamide (used to treat heart rhythm disorders),
• temsirolimus (used to treat cancer),
• sirolimus, everolimus (used to prevent transplant rejection)
• wildagliptin (type 2 diabetes treatment)
• The doctor may need to change the dose and/or take other precautions if the patient is taking an angiotensin receptor antagonist (ARB) or aliskiren (see also the information under the headings "When not to take Ramicor" and "Warnings and precautions").

Tell your doctor about taking the following medicines, as their action may be affected by Ramicor:

• oral hypoglycemic agents, such as glucose-lowering medicines and insulin. Ramicor may lower blood glucose levels. Blood glucose levels should be regularly monitored while taking Ramicor.
• lithium (used to treat mental illnesses). Ramicor may increase lithium levels in the blood. The doctor will closely monitor lithium levels in the blood.

In particular, the patient should discuss with their doctor or pharmacist if they are currently taking, have recently taken, or may take any of the following medicines:

• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection, and heparin, a blood thinner). If any of the above situations apply to the patient or if they have doubts, they should discuss it with their doctor before starting to take Ramicor.

Ramicor with food and drink

• Drinking alcohol while taking Ramicor may cause dizziness and drowsiness. If in doubt about the amount of alcohol allowed while taking Ramicor, consult a doctor about the potential interaction between blood pressure-lowering medicines and alcohol.
• Ramicor can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
Ramicor is not recommended during the first 12 weeks of pregnancy, and its use after the 13th week of pregnancy is contraindicated, as it may harm the fetus. If you become pregnant while taking Ramicor, tell your doctor immediately. A change in treatment to an alternative should be made before planned pregnancy.

• BreastfeedingDo not take Ramicor while breastfeeding. Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

While taking Ramicor, dizziness may occur. The risk of dizziness is higher at the beginning of treatment with Ramicor or after a dose increase. If dizziness occurs, do not drive, use tools, or operate machines.

3. How to take Ramicor

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

Dosage

Treatment of high blood pressure

• The initial dose is usually 1.25 mg or 2.5 mg once a day.
• The doctor will adjust the dose until blood pressure is controlled.
• The maximum dose should not exceed 10 mg once a day.
• If diuretics (water pills) are being taken, the doctor may stop or reduce the dose of the diuretic before starting Ramicor.

Prevention of heart attack or stroke

• The initial dose is usually 2.5 mg once a day.
• The doctor may decide to increase the dose.
• The usual dose is 10 mg once a day.

Reducing or slowing the progression of kidney disease

• The initial dose is usually 1.25 mg or 2.5 mg once a day.
• The doctor may adjust the dose.
• The usual dose is 5 mg or 10 mg once a day.

Treatment of heart failure

• The initial dose is usually 1.25 mg once a day.
• The doctor may adjust the dose.
• The maximum dose is 10 mg per day. It is recommended to take the medicine in two divided doses.

Treatment after a heart attack

• The initial dose is usually 1.25 mg to 2.5 mg twice a day.
• The doctor may adjust the dose.
• The usual dose is 10 mg per day. It is recommended to take the medicine in two divided doses.

Elderly patients
The doctor will reduce the initial dose and increase it more slowly.

How to take the medicine

Take the medicine orally, once a day, at the same time every day.
Swallow the tablet whole with water.
Do not crush or chew the tablets.

Overdose of Ramicor

Consult a doctor or go to the nearest hospital emergency department.
Do not drive yourself; ask someone to drive you to the hospital or call an ambulance.
Take the packaging of the medicine with you, so the doctor knows what medicine was taken.

Missing a dose of Ramicor

• If a dose is missed, take the next planned dose.
• Do not take a double dose to make up for a missed dose.

If you have any further doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ramicor can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, stop taking Ramicor and contact your doctor immediately - prompt treatment may be necessary:

• swelling of the face, lips, or throat, making it difficult to swallow or breathe, as well as itching and rash. These may be symptoms of a severe allergic reaction to Ramicor.
• severe skin reactions, including rash, ulcers in the mouth, worsening of existing skin conditions, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

If you experience any of the following, tell your doctor immediately:

• rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, tightness in the chest, or more serious side effects, including heart attack or stroke.

shortness of breath or cough. These may indicate lung disease.

• easy bruising, prolonged bleeding time, any signs of bleeding (e.g., bleeding gums), purple spots on the skin, or more frequent infections, sore throat, and fever, fatigue, fainting, dizziness, or paleness of the skin. These may indicate blood or bone marrow disorders.
• severe abdominal pain, which may radiate to the back. This may be a sign of pancreatitis.
• fever, chills, feeling tired, loss of appetite, abdominal pain, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice). These may be symptoms of liver disease, such as hepatitis or liver damage.

Other side effects

Tell your doctor if any of the following symptoms worsen or persist for more than a few days.
Common(may affect up to 1 in 10 people)

• headache or feeling tired;
• dizziness. The risk of dizziness is higher at the beginning of treatment with Ramicor or after a dose increase;
• fainting, low blood pressure, especially if it occurs after a rapid change from a lying to a sitting or standing position;
• dry, persistent cough, sinusitis, or bronchitis, shortness of breath;
• abdominal pain, diarrhea, nausea, or vomiting;
• skin rash, including raised patches;
• chest pain;
• muscle cramps or pain;
• high potassium levels in the blood, as shown in laboratory tests.

Uncommon(may affect up to 1 in 100 people)

• balance disorders (dizziness);
• itching of the skin and sensory disturbances, such as numbness, tingling, prickling, burning, or a feeling of crawling under the skin (paresthesia);
• loss or disturbance of taste;
• sleep disorders;
• depression, anxiety, nervousness, or restlessness;
• stuffy nose, difficulty breathing, or worsening of asthma;
• intestinal angioedema, which can cause abdominal pain, vomiting, and diarrhea;
• heartburn, constipation, or dry mouth;
• increased urine production during the day;
• excessive sweating;
• loss or decreased appetite (anorexia);
• rapid or irregular heartbeat;
• swelling of the hands and feet. These may be signs of water retention;
• hot flashes;
• blurred vision;
• joint pain;
• fever;
• impotence, decreased libido in men and women;
• increased white blood cell count (eosinophilia) in blood tests;
• blood test results indicating liver, pancreas, or kidney function disorders.

Rare(may affect up to 1 in 1,000 people)

• feeling of trembling and confusion;
• red, swollen tongue;
• severe skin peeling, itchy papular rash;
• nail disorders (e.g., reduced nail adhesion or separation from the nail bed);
• skin rash or bruising;
• spots on the skin and cold extremities;
• redness, itching, swelling, or tearing of the eyes;
• hearing or ringing in the ears;
• weakness;
• decreased red blood cell count, white blood cell count, or platelet count, or hemoglobin level in blood tests.

Very rare(may affect up to 1 in 10,000 people)

• sensitivity to sunlight.

Frequency not known

• dark urine;
• nausea;
• muscle cramps;
• feeling of confusion and seizures, which may be due to abnormal secretion of antidiuretic hormone (ADH - vasopressin). If any of the above symptoms occur, seek medical attention immediately.

Other reported side effects:

Tell your doctor if any of the following symptoms worsen or persist for more than a few days.

• difficulty concentrating;
• swelling of the lips;
• low blood cell count, as shown in blood tests;
• low sodium levels in the blood, as shown in blood tests;
• change in finger color in response to cold, followed by tingling or pain in response to heat (Raynaud's phenomenon);
• breast enlargement in men;
• slowed or impaired reactions;
• burning sensation;
• disturbances of smell;
• hair loss.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 to gather more information on the safety of the medicine.

5. How to store Ramicor

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special storage precautions for the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ramicor contains

• The active substance of Ramicor is ramipril.
• Each tablet contains 2.5, 5, or 10 mg of ramipril. The other ingredients are: hypromellose, microcrystalline cellulose (Avicel PH 112), microcrystalline cellulose (Avicel PH 101), corn starch, yellow iron oxide (5 mg and 10 mg tablets) (E 172), red iron oxide (E 172) (2.5 mg tablets), sodium stearyl fumarate.

What Ramicor looks like and contents of the pack

• Ramicor 2.5 mg tablets are pink to red with speckles, 8.1x4.1x3.1 mm, oblong with the symbols "R" and "18" embossed on one side of the tablet and a dividing line on the other side. The tablet can be divided into equal doses.
• Ramicor 5 mg tablets are light yellow to yellow with speckles, 8.1x4.1x3.15 mm, oblong with the symbols "R" and "19" embossed on one side of the tablet and a dividing line on the other side. The tablet can be divided into equal doses.
• Ramicor 10 mg tablets are light yellow to yellow with speckles, 12.1x6.0x3.75 mm, oblong with the symbols "R" and "20" embossed on one side of the tablet and a dividing line on the other side. The tablet can be divided into equal doses.

Ramicor is available in:

OPA/Aluminum/PVC/Aluminum blister and OPA/Aluminum/PE/moisture-absorbing medium/HDPE/Aluminum blister.

Package sizes:

Ramicor is available in packs of 28 and 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Ranbaxy (Poland) Sp. z o.o., Idzikowskiego 16, 00-710 Warsaw

Manufacturer:

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp,
Netherlands
Terapia SA, Str. Fabrici nr.124, Cluj Napoca, 400 632 Romania
Date of last revision of the leaflet: 28.10.2023