Ramicor

Warnings and precautions

Before starting to take Ramicor, the patient should discuss it with their 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, or long-term use of diuretics 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, and in case of doubt, the patient should consult their 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 above the 13th week of pregnancy, Ramicor 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 Ramicor in children.
If any of the above situations apply to the patient or the patient has doubts, they should discuss it with their doctor before starting to take Ramicor.

Ramicor and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, as Ramicor may affect the action of other medicines. Some medicines may affect the action of Ramicor.
The patient should inform their 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, noradrenaline, or adrenaline. The doctor will monitor blood pressure.

The patient should inform their doctor about taking the following medicines, as they may increase the risk of side effects when taken 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 (treatment of type 2 diabetes)
• The doctor may need to adjust 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 heading "When not to take Ramicor" and "Warnings and precautions").

The patient should inform their doctor about taking the following medicines, as their action may be altered 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 used to prevent blood clots). If any of the above situations apply to the patient or the patient has 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 fainting. If in doubt about the amount of alcohol allowed while taking Ramicor, the patient should discuss it with their doctor regarding the potential interaction between blood pressure-lowering medicines and alcohol.
• Ramicor can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy
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 above the 13th week of pregnancy, Ramicor is contraindicated, as it may harm the fetus. If the patient becomes pregnant while taking Ramicor, they should immediately inform their doctor. A change in treatment to an alternative should be made before planned pregnancy.

• BreastfeedingRamicor should not be taken during breastfeeding. Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

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

3. How to take Ramicor

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, the patient should consult their 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 the patient is taking diuretics (water pills), the doctor may discontinue 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 adjust it more slowly.

Administration

The medicine should be taken orally, once a day, at the same time.
The patient should swallow the tablet whole, with a glass of water.
The tablets should not be crushed or chewed.

Overdose

The patient should contact their doctor or go to the nearest hospital emergency department.
The patient should not drive themselves, but ask someone to drive them to the hospital or call an ambulance.
The patient should take the packaging of the medicine with them, so that the doctor knows what medicine was taken.

Missed dose

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

If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient notices any of the following serious side effects, they should stop taking Ramicor and contact their 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, mouth ulcers, worsening of existing skin conditions, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

If the patient experiences any of the following, they should inform their 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), purpura, 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

The patient should inform their 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 Ramicor treatment or after a dose increase;
• fainting, hypotension (abnormally 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 elevated rash;
• 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, whose symptoms are 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 symptoms 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;
• abnormal liver, pancreas, or kidney function, as shown in blood tests.

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

• feeling of shaking and disorientation;
• red, swollen tongue;
• severe skin peeling, itchy papular rash;
• nail disorders (e.g., reduced nail adhesion or nail 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 levels 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 the patient experiences any of these, they should contact their doctor as soon as possible.

Other reported side effects:

The patient should inform their 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 a feeling of 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their 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:
Aleje Jerozolimskie 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ramicor

The medicine should be stored out of sight and reach of children.
Ramicor should not be taken 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 instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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), maize starch, yellow iron oxide (E 172) (5 mg and 10 mg tablets), 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, 8.1x4.1x3.1 mm, oblong with the symbols "R" and "18" embossed on either side of the score line on one side of the tablet and a score line on the other side. The tablet can be divided into equal doses.
• Ramicor 5 mg tablets are light yellow to yellow, 8.1x4.1x3.15 mm, oblong with the symbols "R" and "19" embossed on either side of the score line on one side of the tablet and a score line on the other side. The tablet can be divided into equal doses.
• Ramicor 10 mg tablets are light yellow to yellow, 12.1x6.0x3.75 mm, oblong with the symbols "R" and "20" embossed on either side of the score line on one side of the tablet and a score line on the other side. The tablet can be divided into equal doses.

Ramicor is available in:

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

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., ul. 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