Ramipril Krka

Leaflet accompanying the packaging: information for the user

Ramipril Krka, 5 mg, tablets

Ramipril Krka, 10 mg, tablets

Ramipril

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.
• In case of any doubts, consult a 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ramipril Krka and what is it used for

Ramipril Krka contains the active substance ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Ramipril Krka works by:

• reducing the production of substances in the body that may increase blood pressure,
• reducing tension and dilating blood vessels,
• making it easier for the heart to pump blood throughout the body.

Ramipril Krka can be used:

• to treat high blood pressure (hypertension),
• to reduce the risk of heart attack or stroke,
• to reduce the risk of or delay kidney function deterioration (in patients with diabetes, as well as without diabetes),
• to treat heart failure, if the heart is not able to pump enough blood to meet the body's needs,
• to treat heart failure after a heart attack.

2. Important information before taking Ramipril Krka

When not to take Ramipril Krka:

• 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 lips, face, throat, or tongue.
• If the patient has 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 the patient is undergoing dialysis or other blood filtration procedures. Depending on the type of device used, Ramipril Krka may not be a suitable medicine.
• If the patient has kidney problems related to reduced blood flow to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see also the "Pregnancy and breastfeeding" section).
• If the blood pressure is very low or unstable. The doctor will assess the blood pressure.
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.
• If the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat a certain type of chronic (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases.

Warnings and precautions

Before taking this medicine, consult a doctor or pharmacist if:

• the patient has heart, liver, or kidney disease;
• the patient has recently lost a significant amount of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, or prolonged use of diuretics or dialysis);
• allergy desensitization treatment is planned (e.g., for bee or wasp stings);
• anesthesia is planned. These may be used during surgical or dental procedures. It may be necessary to stop taking Ramipril Krka the day before the procedure - consult a doctor.
• the patient has high potassium levels in the blood (as shown by blood test results);
• the patient has collagenosis, such as scleroderma or systemic lupus erythematosus;
• the patient is taking any of the following medicines, which may increase the risk of angioedema (rapid swelling of tissues under the skin, such as the throat):
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent organ rejection and treat cancer (e.g., temsirolimus, sirolimus, everolimus, and other mTOR inhibitors),
• vildagliptin and other medicines belonging to the class of DPP-4 inhibitors, used to treat diabetes.
• 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 Ramipril Krka:".
• if the patient is taking medicines or has conditions that may lower sodium levels in the blood. The doctor may order regular blood tests, especially to check sodium levels in the blood, particularly in elderly patients.

Inform the doctor about suspected or planned pregnancy. Ramipril Krka is not recommended during the first 12 weeks of pregnancy and should not be taken after the 13th week of pregnancy, as it may seriously harm the fetus. If a woman taking Ramipril Krka becomes pregnant, she should immediately inform her doctor. The doctor will recommend changing the treatment to another suitable medicine.
Pregnancy
Inform the doctor about suspected or planned pregnancy. Ramipril Krka is not recommended during the first 12 weeks of pregnancy and should not be taken after the 13th week of pregnancy, as it may seriously harm the fetus. If a woman taking Ramipril Krka becomes pregnant, she should immediately inform her doctor. The doctor will recommend changing the treatment to another suitable medicine.
Breastfeeding
Ramipril Krka should not be used during breastfeeding.

Children and adolescents

Ramipril Krka should not be used in children and adolescents under 18 years of age, as the safety and efficacy of Ramipril Krka in this patient group have not been established.
If any of the above situations apply to the patient (or there are doubts), before starting to take Ramipril Krka, consult a doctor.

Ramipril Krka and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned to be taken, including those available without a prescription (including herbal medicines). Ramipril Krka may affect the action of other medicines, and other medicines may affect the action of Ramipril Krka.
Inform the doctor about taking any of the following medicines, as they may weaken the effect of Ramipril Krka:

• pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, and acetylsalicylic acid);
• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. The doctor will assess the blood pressure.

Inform the doctor about taking any of the following medicines. They may increase the risk of side effects when used with Ramipril Krka:

• pain and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, and acetylsalicylic acid);
• cancer medicines (chemotherapy);
• diuretics (e.g., furosemide);
• 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; cyclosporine, an immunosuppressive medicine used to prevent organ rejection, and heparin, a medicine used to thin the blood to prevent clots;
• corticosteroids, such as prednisolone;
• allopurinol (used to reduce uric acid levels in the blood);
• procainamide (used to treat irregular heart rhythms);
• medicines most commonly used to prevent organ rejection or treat cancer (e.g., temsirolimus, sirolimus, everolimus, and other mTOR inhibitors) or vildagliptin and other medicines belonging to the class of DPP-4 inhibitors (used to treat diabetes). See the "Warnings and precautions" section.

Inform the doctor about taking any of the following medicines. Their action may be changed when used with Ramipril Krka:

• medicines used to treat diabetes, such as oral glucose-lowering medicines and insulin. Ramipril Krka may lower blood glucose levels. When taking Ramipril Krka, blood glucose levels should be regularly monitored.
• lithium (used to treat mental disorders). Ramipril Krka may increase lithium levels in the blood. The doctor will closely monitor lithium levels in the blood.

If any of the above situations apply to the patient (or there are doubts), before starting to take Ramipril Krka, consult a doctor.
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 heading "When not to take Ramipril Krka:" and "Warnings and precautions").

Ramipril Krka with food, drink, and alcohol

• Consuming alcohol while taking Ramipril Krka may cause dizziness and a feeling of "emptiness" in the head. In case of doubts about the amount of alcohol allowed during Ramipril Krka treatment, consult a doctor, as blood pressure-lowering medicines and alcohol may enhance each other's effects.
• Ramipril Krka can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Inform the doctor about suspected or planned pregnancy. Ramipril Krka is not recommended during the first 12 weeks of pregnancy and should not be taken after the 13th week of pregnancy, as it may seriously harm the fetus. If a woman taking Ramipril Krka becomes pregnant, she should immediately inform her doctor. The doctor will recommend changing the treatment to another suitable medicine.
Breastfeeding
Ramipril Krka should not be used during breastfeeding.

Driving and using machines

While taking Ramipril Krka, drowsiness or dizziness may occur.
The likelihood of these symptoms is higher at the beginning of Ramipril Krka treatment and after dose increases. If drowsiness or dizziness occurs, do not drive vehicles or operate machinery.

Ramipril Krka contains lactose and sodium

If the patient has been informed by their doctor that they have an intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Ramipril Krka

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

Taking the medicine

• The medicine should be taken orally, once a day, at the same time.
• The tablets should be swallowed whole, with a drink of water.
• The tablets should not be crushed or chewed.

Dosage

Treatment of high blood pressure

• The usual initial dose is 1.25 mg or 2.5 mg once a day.
• The doctor will adjust the dose until blood pressure is controlled.
• The maximum dose is 10 mg once a day.
• If diuretics are being used, the doctor may stop or reduce the dose of the diuretic before starting Ramipril Krka.

Reducing the risk of heart attack or stroke

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

Treatment to reduce the risk of or delay kidney function deterioration

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

Treatment of heart failure

• The usual initial dose is 1.25 mg once a day.
• The doctor will 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 usual initial dose is 1.25 mg once a day to 2.5 mg twice a day.
• The doctor will 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 recommend a lower initial dose and will slowly adjust the dose.

Taking a higher dose of Ramipril Krka than recommended

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

Missing a dose of Ramipril Krka

• If a dose is missed, take the next dose at the usual time.
• Do not take a double dose of the medicine to make up for the missed dose.

Stopping Ramipril Krka treatment

Do not stop taking the medicine unless the doctor recommends it. Do not stop taking Ramipril Krka just because the condition has improved. Stopping the treatment may worsen the hypertension.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

In case of any of the following serious side effects, stop taking Ramipril Krka and immediately contact a doctor - urgent medical attention may be necessary:

• Swelling of the face, lips, or throat, making swallowing or breathing difficult, as well as itching and rash. These may be symptoms of a severe allergic reaction to Ramipril Krka.
• Severe skin changes, including rash, mouth ulcers, worsening of existing skin conditions, redness, blistering, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

In case of the following disorders, immediately inform a doctor:

• Rapid heartbeat, irregular or strong heartbeat (palpitations), chest pain, tightness in the chest, or more serious disorders, including heart attack or stroke.
• Shortness of breath or cough. These may be symptoms of lung disorders.
• Easy bruising, prolonged bleeding, 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 be symptoms of blood or bone marrow disorders.
• Severe stomach pain, which may radiate to the back. This may be a symptom of pancreatitis.
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, vomiting, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disorders, such as inflammation or liver damage.

Other side effects

Inform the doctor if any of the following symptoms worsen or persist for more than a few days.
Side effects are classified into the following frequency groups:

Common side effects (may affect up to 1 in 10 people):

• Headache or feeling tired.
• Dizziness. The likelihood of this is higher at the beginning of Ramipril Krka treatment and after dose increases.
• Fainting, low blood pressure (abnormally low blood pressure) occurring especially when changing position from lying down to sitting or standing.
• Dry, persistent cough, sinusitis, or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhea, indigestion, nausea, or vomiting.
• Rash with raised skin lesions or without.
• Chest pain.
• Muscle cramps or pain.
• High potassium levels in the blood, as shown by laboratory tests.

Uncommon side effects (may affect up to 1 in 100 people):

• Balance disorders (dizziness of labyrinthine origin).
• Itching of the skin and unusual sensations in the skin, such as numbness, tingling, prickling, burning, or a feeling of crawling under the skin (paresthesia).
• Loss of or changes in taste.
• Sleep disorders.
• Depression, anxiety, nervousness, or restlessness, especially motor restlessness.
• Nasal congestion, difficulty breathing, or worsening of asthma.
• Intestinal edema, called "angioedema of the intestine", whose symptoms are abdominal pain, vomiting, and diarrhea.
• Heartburn, constipation, or dry mouth.
• Increased urine production during the day.
• Excessive sweating.
• Loss of or decreased appetite (anorexia).
• Rapid or irregular heartbeat. Swelling of the hands and feet. This may be a sign of excessive fluid retention in the body.
• Hot flashes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence, decreased libido in men or women.
• Increased white blood cell count (eosinophilia), as shown by blood tests.
• Disorders of liver, pancreas, or kidney function, as shown by laboratory tests.

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

• Feeling of uncertainty or disorientation.
• Redness and swelling of the tongue.
• Severe skin peeling, itchy papular rash.
• Nail disorders (e.g., loosening or separation of the nail 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, white blood cell, or platelet count, or hemoglobin level, as shown by laboratory tests.

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

• Sensitivity to sunlight.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Concentrated urine (dark urine color), nausea, vomiting, muscle cramps, disorientation, and seizures; these symptoms may be caused by inappropriate secretion of antidiuretic hormone (ADH); if these symptoms occur, immediately contact a doctor.

Other reported side effects:

Inform the doctor if any of the following symptoms worsen or persist for more than a few days:

• Difficulty concentrating.
• Swollen lips.
• Too few blood cells, as shown by laboratory tests.
• Decreased sodium levels, as shown by laboratory tests.
• Changes in finger color when cold and a feeling of tingling or pain when warmed (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or impaired reactions.
• Burning sensation.
• Disorders of smell.
• Hair loss.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. 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:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.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 this medicine.

5. How to store Ramipril Krka

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.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. What Ramipril Krka contains

• The active substance of the medicine is ramipril. Each tablet contains 5 mg or 10 mg of ramipril.
• The other ingredients are: sodium hydrogen carbonate, lactose monohydrate, croscarmellose sodium, corn starch, sodium stearyl fumarate, yellow iron oxide (only in 5 mg tablets), and red iron oxide (only in 5 mg tablets). See section 2 "Ramipril Krka contains lactose and sodium".

What Ramipril Krka looks like and what the packaging contains

5 mg, tablets: pink, uncoated, flat tablets in a capsule shape (8.8 x 4.4 mm)
10 mg, tablets: white to almost white, uncoated, flat tablets in a capsule shape (11.0 x 5.5 mm)
Packaging: 10, 14, 20, 28, 30, 50, 60, 90, and 100 tablets in blisters, in a cardboard box
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on the names of medicinal products in other European Economic Area member states, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:13.09.2019