Ramicor

Package leaflet: Information for the patient

Ramicor, 2.5 mg, tablets
Ramicor, 5 mg, tablets
Ramicor, 10 mg, tablets
Ramipril
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, 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.

Leaflet contents

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 pack and other information

1. What Ramicor is and what it is used for

Ramicor contains an active substance called ramipril, which belongs to a group of medicines known as
ACE inhibitors (angiotensin-converting enzyme inhibitors).
The action of Ramicor works by:

• reducing the production in the body of substances that may increase blood pressure;
• relaxing and widening blood vessels;
• helping the heart to pump blood more easily.

Ramicor is used for:

• treating high blood pressure (hypertension);
• reducing the risk of heart attack or stroke;
• reducing the risk of kidney disease or delaying its progression (regardless of whether the patient has diabetes);
• treating heart failure, when the heart is unable to pump sufficient blood to the rest of the body (heart failure);
• treating patients with heart failure after a heart attack.

2. Important information before using Ramicor

When not to use Ramicor:

• if the patient is allergic to ramipril, any other medicine in the class of ACE inhibitors, or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic (hypersensitivity) reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue;
• if the patient has ever experienced a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red patches on the hands, feet, 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 using sacubitril with valsartan, a medicine used to treat certain types of chronic heart failure in adults, because the risk of angioedema (rapid swelling of tissues beneath the skin, such as in the throat) increases;
• if the patient has undergone dialysis or another type of blood filtration. Depending on the type of equipment used, Ramicor may not be suitable;
• if the patient has kidney diseases related to reduced blood flow to the kidneys (renal artery stenosis);
• during the last 6 months of pregnancy (see below, section "Pregnancy, breastfeeding and fertility");
• if the patient has very low or unstable blood pressure. The doctor should assess blood pressure;
• if the patient has diabetes or impaired kidney function and is being treated with a blood pressure-lowering medicine containing aliskiren.

Do not use Ramicor if any of the above situations apply. If in doubt, consult a doctor before taking Ramicor.

Warnings and precautions
Before starting Ramicor, discuss this with your doctor or pharmacist.

• If the patient has heart, liver, or kidney diseases.
• If the patient has recently lost significant amounts of electrolytes or fluids (due to vomiting, diarrhoea, excessive sweating, a low-salt diet, prolonged use of diuretics (water tablets), or dialysis).
• If the patient is scheduled for allergen immunotherapy (desensitisation) to bee or wasp venom.
• If the patient is scheduled for anaesthesia during surgical or dental procedures. It may be necessary to stop taking Ramicor one day before the procedure; consult your doctor if in doubt.
• If the patient has been diagnosed with high potassium levels in the blood (as shown in blood tests).
• If the patient is taking medicines that reduce sodium levels in the blood or has a condition causing low potassium levels. The doctor will regularly monitor 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 diarrhoea;
  • medicines used to prevent organ transplant rejection or to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
  • vildagliptin, a medicine used to treat diabetes.
• If the patient has been diagnosed with a collagen disease such as scleroderma or systemic lupus erythematosus.
• Inform the doctor if the patient is pregnant or planning to become pregnant. Ramicor is not recommended during the first 3 months of pregnancy, and its use is contraindicated after the third month of pregnancy, as it may seriously harm the unborn child (see below, section "Pregnancy, breastfeeding and fertility").
• If the patient is taking any of the following medicines used to treat high blood pressure:
  • an angiotensin II receptor antagonist (Angiotensin Receptor Blockers, ARBs), 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 blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under the heading "When not to use Ramicor".

Children and adolescents
Ramicor is not recommended for use in children and adolescents under 18 years of age, as there is insufficient data on safety and efficacy in this age group.
If any of the above situations apply or if the patient has any doubts, speak to a doctor before starting Ramicor.

Ramicor and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use, because Ramicor may affect the action of other medicines. Some medicines may affect the action of Ramicor.

Inform the doctor or pharmacist if the patient is taking the following medicines, as they may reduce the effectiveness of Ramicor:

• painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs [NSAIDs], such as ibuprofen, indometacin, 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.

Inform the doctor if the patient is taking any of the following medicines, as they may increase the risk of adverse effects when taken together with Ramicor:

• painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs [NSAIDs], such as ibuprofen or indometacin, and aspirin);
• medicines used in cancer treatment (chemotherapy);
• medicines used to prevent organ transplant rejection, such as cyclosporine;
• diuretics (water tablets), such as furosemide;
• medicines that increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (a blood-thinning medicine);
• trimethoprim and co-trimoxazole (used to treat bacterial infections);
• steroid anti-inflammatory medicines, such as prednisolone;
• allopurinol (used to lower uric acid levels in the blood);
• procainamide (used for heart rhythm disorders);
• temsirolimus (used to treat malignant tumours);
• sirolimus, everolimus (used to prevent transplant rejection);
• vildagliptin (used to treat type 2 diabetes).

The doctor may need to adjust the dose and/or take additional precautions if the patient is taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also information under "When not to use Ramicor" and "Warnings and precautions").

Inform the doctor if the patient is taking any of the following medicines, as their effects may be altered by Ramicor:

• antidiabetic medicines, such as oral glucose-lowering agents and insulin. Ramicor may lower blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Ramicor.
• lithium (used in psychiatric disorders). Ramicor may increase lithium levels in the blood. The doctor will closely monitor lithium levels in the blood.

In particular, talk to your doctor or pharmacist if the patient is currently taking, has 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 for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots).

If any of the above situations apply or if the patient has any doubts, speak to a doctor before starting Ramicor.

Ramicor, food, and alcohol

• Drinking alcohol while taking Ramicor may cause dizziness and drowsiness. If in doubt about how much alcohol is safe while taking Ramicor, consult your doctor about the potential additive effects of blood pressure-lowering medicines and alcohol.
• Ramicor can be taken with or without food.

Pregnancy, breastfeeding and fertility
Pregnancy
Inform your doctor if you think you may be pregnant or are planning to become pregnant.
Ramicor is not recommended during the first 12 weeks of pregnancy. Do not use this medicine after the 13th week of pregnancy, as it may harm the unborn child. If pregnancy occurs while taking Ramicor, inform your doctor immediately. Alternative treatment should be initiated before planning a pregnancy.

Breastfeeding
Do not take Ramicor while breastfeeding. Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Dizziness may occur while taking Ramicor. The risk of dizziness is higher at the beginning of treatment with Ramicor or after an increase in dose. If dizziness occurs, do not drive, operate tools, or handle machinery.

3. How to take Ramicor

This medicine should always be taken as prescribed by your doctor. If you have any doubts, consult
your doctor or pharmacist.
Dosage
Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust the dose until blood pressure is controlled.
• The maximum dose should not exceed 10 mg once daily.
• If you are taking diuretics (water pills), your doctor may stop or reduce the dose of your diuretic before starting treatment with Ramicor.

Prevention of heart attack or stroke

• The usual starting dose is 2.5 mg once daily.
• Your doctor may decide to increase the dose.
• The usual maintenance dose is 10 mg once daily.

Slowing or delaying the progression of kidney damage

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor may adjust the dose.
• The usual dose is 5 mg or 10 mg once daily.

Treatment of heart failure

• The usual starting dose is 1.25 mg once daily.
• Your doctor may adjust the dose.
• The maximum dose is 10 mg per day. It is recommended to divide this dose into two doses taken twice daily.

Treatment after heart attack

• The usual starting dose is 1.25 mg to 2.5 mg twice daily.
• Your doctor may adjust the dose.
• The usual dose is 10 mg per day. It is recommended to divide this dose into two doses taken twice daily.

Elderly patients
Your doctor will reduce the starting dose and adjust it more gradually.
How to take the medicine
Take this medicine orally, at the same time each day.
Swallow the tablet whole with water.
Do not crush or chew the tablets.
If you take more Ramicor than you should
Contact your doctor or go to the nearest hospital emergency department immediately.
Do not drive—ask someone to take you to the hospital or call an ambulance.
Take the medicine pack with you so the doctor knows which medicine has been taken.
If you forget to take Ramicor

• If you miss a dose, take your next scheduled dose at the usual time.
• Do not take a double dose to make up for the missed dose.

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 reactions occur, treatment with Ramicor must be stopped and
medical advice must be sought immediately – prompt treatment may be necessary:

• swelling of the face, lips or throat causing difficulty in swallowing or breathing, together with itching and rash. These may be symptoms of a severe hypersensitivity reaction to Ramicor.
• severe skin reactions, including rashes, mouth ulcers, worsening of pre-existing skin disorders, redness, blisters or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

If any of the following symptoms occur, contact your doctor immediately:

• rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, chest tightness or more serious adverse reactions, including heart attack or stroke.
• shortness of breath or cough. These may indicate lung disorders.
• easy bruising, longer-than-usual bleeding time, any signs of bleeding (e.g. bleeding gums), purplish spots on the skin, or more frequent infections, sore throat and fever, fatigue, fainting, dizziness or pale skin. These may indicate blood or bone marrow disorders.
• severe abdominal pain which may radiate to the back. This may be a symptom of pancreatitis.
• fever, chills, feeling of fatigue, loss of appetite, abdominal pain, nausea, yellowing of the skin or whites of the eyes (jaundice). These may be symptoms of liver disorders, such as hepatitis or liver damage.

Other adverse reactions
Inform your doctor if any of the following symptoms become severe or persist for more than a few days.
Common (may occur in less than 1 in 10 patients)

• headache or feeling of fatigue;
• dizziness. The risk is higher at the beginning of treatment with Ramicor or after an increase in dose;
• fainting, hypotension (abnormally low blood pressure), especially if occurring after a rapid change from lying to sitting or standing position;
• dry, persistent cough, sinusitis or bronchitis, shortness of breath;
• abdominal pain, diarrhoea, indigestion, nausea or vomiting;
• skin rashes, including raised rashes;
• chest pain;
• muscle cramps or pain;
• detection of higher-than-normal potassium levels in blood tests.

Uncommon (may occur in less than 1 in 100 patients)

• balance disorders (dizziness);
• skin itching and sensory disturbances such as numbness, tingling, pricking, burning or crawling sensations on the skin (paresthesias);
• loss or disturbance of taste sensation;
• sleep disorders;
• depression, anxiety, nervousness or restlessness;
• nasal congestion, breathing difficulties or worsening of asthma;
• intestinal swelling known as "intestinal angioedema", with symptoms such as abdominal pain, vomiting and diarrhoea;
• heartburn, constipation or dry mouth;
• increased volume of urine passed during the day;
• excessive sweating;
• loss or decrease in appetite (anorexia);
• rapid or irregular heartbeat;
• swelling of hands and feet. These may be signs of fluid retention;
• hot flushes;
• blurred vision;
• joint pain;
• fever;
• impotence, decreased libido in men and women;
• increased number of certain white blood cells (eosinophilia) in blood tests;
• blood test results indicating impaired liver, pancreas or kidney function.

Rare (may occur in less than 1 in 1000 patients)

• feeling of trembling and disorientation;
• red, swollen tongue;
• severe skin peeling, itchy nodular rash;
• nail disorders (e.g. reduced adherence or separation of the nail from its bed);
• skin rash or bruising;
• skin spots and cold extremities;
• redness, itching, swelling or watering of the eyes;
• hearing disturbances and tinnitus;
• weakness;
• decreased number of red blood cells, white blood cells or platelets, or decreased haemoglobin concentration in blood tests.

Very rare (may occur in less than 1 in 10,000 patients)

• photosensitivity (increased sensitivity to sunlight).

Frequency not known

• dark-coloured (concentrated) urine;
• nausea;
• muscle cramps;
• confusion and seizures, which may result from abnormal secretion of antidiuretic hormone (ADH - vasopressin). If any of the above symptoms occur, the patient should contact a doctor as soon as possible.
  Other reported adverse reactions: Inform your doctor if any of the following symptoms become severe or persist for more than a few days.
• difficulty concentrating;
• swelling of the lips;
• detection of low blood cell counts in blood tests;
• detection of lower-than-normal sodium levels in blood tests;
• colour change of fingers upon exposure to cold, followed by tingling or pain upon warming (Raynaud's phenomenon);
• breast enlargement in men;
• slowed or impaired reactions;
• burning sensation;
• disturbances of smell;
• hair loss.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. 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.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ramicor

Keep this 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 stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Ramicor contains

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

What Ramicor looks like and contents of the pack

• Ramicor tablets 2.5 mg with pink to red specks, 8.1x4.1x3.1 mm, elongated, with the symbols “R” and “18” embossed on both sides of the breakline on one side of the tablet and a breakline on the other side of the tablet. The tablet can be divided into equal doses.
• Ramicor tablets 5 mg with light yellow to yellow specks, 8.1x4.1x3.15 mm, elongated, with the symbols “R” and “19” embossed on both sides of the breakline on one side of the tablet and a breakline on the other side of the tablet. The tablet can be divided into equal doses.
• Ramicor tablets 10 mg with light yellow to yellow specks, 12.1x6.0x3.75 mm, elongated, with the symbols “R” and “20” embossed on both sides of the breakline on one side of the tablet and a breakline on the other side of the tablet. The tablet can be divided into equal doses.

Ramicor is available in packs:
Blister OPA/Aluminium/PVC/Aluminium and blister OPA/Aluminium/PE/desiccant/HDPE/Aluminium.
Pack sizes:
Ramicor is available in packs of 28 and 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o., ul. Idzikowskiego 16, 00-710 Warsaw, Poland
Manufacturer:
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp,
The Netherlands
Terapia SA, Str. Fabrici nr.124, Cluj Napoca, 400 632, Romania