Ramipril krka

Patient Information Leaflet

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Ramipril Krka is and what it is 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 in the body of a substance that can increase blood pressure,
• reducing tension and widening blood vessels,
• helping the heart to pump blood around the body.

Ramipril Krka may be used:

• to treat high blood pressure (hypertension),
• to reduce the risk of heart attack or stroke,
• to reduce the risk of or delay worsening of kidney function (in patients with or without diabetes),
• to treat heart failure (when the heart is unable to pump sufficient blood to meet the body's needs),
• to treat patients after a heart attack complicated by heart failure.

2. Important information before using Ramipril Krka

When not to use 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 experienced a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red patches on 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 equipment used, Ramipril Krka may not be suitable.
• If the patient has kidney problems due to reduced blood flow to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see section "Pregnancy and breastfeeding" below).
• If blood pressure is very low or unstable. The doctor will assess 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 is taking or has recently taken sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, because the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) increases.

Warnings and precautions
Before using 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, long-term use of diuretics, or dialysis);
• desensitization treatment for bee or wasp venom (allergy desensitization) is planned;
• administration of anesthetic medicines is planned. These may be used during surgical or dental procedures. It may be necessary to stop treatment with Ramipril Krka one day before the procedure – contact your doctor.
• the patient has high potassium levels in the blood (shown in blood tests);
• the patient has collagenosis, such as scleroderma or systemic lupus erythematosus;
• the patient is taking any of the following medicines, which increase the risk of angioedema (rapid subcutaneous swelling in the throat area):
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors),
• vildagliptin and other medicines belonging to the class of DPP-4 inhibitors, used in the treatment of diabetes.
• the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARB) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes,
• aliskiren. The treating 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 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, particularly to check blood sodium levels, especially in elderly patients.

Inform the doctor if pregnancy is suspected or planned. Use of Ramipril Krka is not recommended during the first 3 months of pregnancy, and from the fourth month of pregnancy onwards, use of Ramipril Krka may seriously harm the unborn child (see section "Pregnancy and breastfeeding").
Children and adolescents
Ramipril Krka is not recommended for use 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), contact a doctor before starting treatment with Ramipril Krka.
Ramipril Krka and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines (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 if taking any of the following medicines, as they may weaken the effect of Ramipril Krka:

• painkillers 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 blood pressure.

Inform the doctor if taking any of the following medicines. They may increase the risk of adverse effects when taken together with Ramipril Krka:

• painkillers and anti-inflammatory medicines (e.g. NSAIDs such as ibuprofen or indomethacin, and acetylsalicylic acid);
• medicines used in cancer treatment (chemotherapy);
• diuretics (water tablets), such as 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 co-trimoxazole, used for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots);
• corticosteroid anti-inflammatory medicines, such as prednisolone;
• allopurinol (used to reduce uric acid levels in the blood);
• procainamide (used for heart rhythm disorders);
• medicines most commonly used to prevent rejection of transplanted organs (temsirolimus, sirolimus, everolimus, and other mTOR inhibitors) or vildagliptin and other DPP-4 inhibitors (used in diabetes treatment). See section "Warnings and precautions".

Inform the doctor if taking any of the following medicines. Their effect may be altered when taking Ramipril Krka:

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

If any of the above situations apply to the patient (or there are doubts), contact a doctor before starting treatment with Ramipril Krka.
The treating 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 the headings "When not to use Ramipril Krka:" and "Warnings and precautions").

Ramipril Krka with food, drink, and alcohol

• Drinking alcohol while taking Ramipril Krka may cause dizziness and a feeling of "emptiness" in the head. If in doubt about the amount of alcohol allowed while taking Ramipril Krka, consult a doctor, as blood pressure-lowering medicines and alcohol may intensify each other's effects.
• Ramipril Krka can be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Inform the doctor if pregnancy is suspected or planned. Ramipril Krka is not recommended during the first 12 weeks of pregnancy and must not be taken after week 13 of pregnancy, as it may seriously harm the unborn child. If a woman taking Ramipril Krka becomes pregnant, she should inform her doctor immediately. The doctor should recommend switching to another appropriate medicine before pregnancy occurs.
Breastfeeding
Do not use Ramipril Krka during breastfeeding.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
Drowsiness or dizziness may occur while taking Ramipril Krka.
The likelihood of such symptoms is higher at the beginning of treatment with Ramipril Krka and after increasing the dose. If drowsiness or dizziness occurs, do not drive motor vehicles or operate tools and machinery.
Ramipril Krka contains lactose and sodium
If the patient has been informed by a doctor that they have an intolerance to certain sugars, they should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ramipril Krka

This medicine should always be taken exactly as your doctor or pharmacist has told you.
If you are unsure, please consult your doctor or pharmacist.
Taking the medicine

• Take this medicine orally, every day at the same time.
• Swallow the tablets whole with a drink of liquid.
• Do not crush or chew the tablets.

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 your blood pressure is controlled.
• The maximum dose is 10 mg once daily.
• If you are taking diuretics (water tablets), your doctor may stop or reduce the dose of the diuretic before starting treatment with Ramipril Krka.

Reducing the risk 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 dose is 10 mg once daily.

Treatment to reduce or delay worsening of kidney function

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor will 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 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 heart attack

• The usual starting dose ranges from 1.25 mg once daily to 2.5 mg twice daily.
• Your 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

• Your doctor will recommend a lower starting dose and will adjust the dose more slowly.

Taking more Ramipril Krka than recommended
Seek immediate medical attention or go to the nearest emergency department.
Do not drive yourself—ask someone to take you to the hospital or call an ambulance.
Bring the medicine packaging with you so the doctor knows which medicine has been taken.
If you miss a dose of Ramipril Krka

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

Stopping Ramipril Krka treatment
Do not stop taking this medicine unless your doctor tells you to. Do not stop taking Ramipril Krka just because you feel better. Stopping treatment may cause your high blood pressure to worsen.
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, stop taking Ramipril Krka and contact your doctor immediately –
urgent medical attention may be required:

• 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 allergic reaction to Ramipril Krka.
• Severe skin changes, including rash, ulceration of the mouth, worsening of pre-existing skin disorders, redness, blistering or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

If any of the following conditions occur, inform your doctor immediately:

• Increased heart rate, irregular or forceful heartbeat (palpitations), chest pain, chest tightness or more serious disturbances, including heart attack or stroke.
• Shortness of breath or cough. These may be symptoms of lung-related disorders.
• 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 pale 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, yellowing of the skin or 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 worsen or persist for more than a few days.
Adverse reactions have been classified into the following groups according to frequency of occurrence:
Common adverse reactions (may occur in up to 1 in 10 patients):

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

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• Disturbances of balance (vestibular dizziness).
• Itching of the skin and unusual skin sensations such as numbness, tingling, pricking, burning or crawling sensations on the skin (paresthesia).
• Loss or disturbances of taste.
• Sleep disturbances.
• Depression, anxiety, nervousness or restlessness, especially motor restlessness.
• Nasal congestion, breathing difficulties or worsening of asthma.
• Intestinal swelling known as "intestinal angioedema", with symptoms of abdominal pain, vomiting and diarrhoea.
• Heartburn, constipation or dryness of the oral mucosa.
• Increased urine output during the day.
• Excessive sweating.
• Loss of or decreased appetite (anorexia).
• Rapid or irregular heartbeat. Swelling of hands and feet. May be a sign of increased fluid retention in the body.
• Hot flushes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence, decreased libido in men or women.
• Increased number of certain white blood cells (eosinophilia), detected in blood tests.
• Liver, pancreas or kidney function disorders, detected in blood tests.

Rare adverse reactions (may occur in up to 1 in 1000 patients):

• Feeling of uneasiness or disorientation.
• Redness and swelling of the tongue.
• Severe peeling of the skin, itchy nodular rash.
• Nail disorders (e.g. loosening or separation of the nail from the nail 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, detected in blood tests.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• Photosensitivity (increased sensitivity to sunlight).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

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

Other reported adverse reactions:
Inform your doctor if any of the following symptoms worsen or persist for more than a few days:

• Difficulty concentrating.
• Swelling of the lips.
• Low number of blood cells, detected in blood tests.
• Decreased sodium concentration, detected in blood tests.
• Change in finger colour upon cold exposure, together with tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or impaired reactions.
• Burning sensation.
• Smell disturbances.
• Hair loss.

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information 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 stated month.
Do not store above 25°C.
Keep in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of Ramipril Krka

• The active substance is ramipril. Each tablet contains 5 mg or 10 mg of ramipril.
• Other ingredients: sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose, pregelatinized 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 contents of the pack
5 mg tablets: pink, uncoated, flat, capsule-shaped tablets (8.8 x 4.4 mm)
10 mg tablets: white to almost white, uncoated, flat, capsule-shaped tablets (11.0 x 5.5 mm)
Packaging: 10, 14, 20, 28, 30, 50, 60, 90 and 100 tablets in blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information on product names in other European Economic Area countries, contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Tel. 22 57 37 500