Ramipril Krka

Patient Information Leaflet: Information for the User

Ramipril Krka 1.25 mg tablets, 2.5 mg tablets, 5 mg tablets, 10 mg tablets

Ramipril
Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist (see section 4).

Contents of this leaflet

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. Package contents and other information

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

Ramipril Krka contains a medicine called ramipril. This belongs to a group of medicines known as
ACE-inhibitors (Angiotensin-Converting Enzyme inhibitors).
Ramipril Krka works by:

• Decreasing the body's production of substances that may cause an increase in blood pressure.
• Relaxing and widening blood vessels.
• Helping the heart to pump blood around the body more easily.

Ramipril Krka can be used:

• To treat high blood pressure (hypertension).
• To reduce the risk of heart attack or stroke.
• To reduce the risk or delay the worsening of kidney problems (with or without diabetes).
• To treat heart failure (when the heart cannot pump enough blood to the rest of the body).
• As treatment after a heart attack (myocardial infarction) when associated with heart failure.

2. What you need to know before taking Ramipril Krka

Do not take Ramipril Krka:

• If you are allergic to ramipril, to other ACE inhibitors, or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have previously experienced a severe allergic reaction called “angioedema”. These signs 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 or swallowing.

• If you are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, Ramipril Krka may not be suitable for you.
• If you have kidney problems due to reduced blood flow to the kidneys (e.g. due to renal artery stenosis).
• During the last 6 months of pregnancy (see section below “Pregnancy and breastfeeding”).
• If your blood pressure is excessively low or unstable. Your doctor will assess this.
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, e.g. in the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ramipril Krka
Consult your doctor or pharmacist before taking this medicine:

• If you have heart, liver, or kidney problems.
• If you have lost significant amounts of body salts or fluids (due to illness such as vomiting, diarrhoea, excessive sweating, following a low-salt diet, prolonged use of oral diuretics, or after dialysis).
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
• If you are about to undergo anaesthesia, which may be administered during surgery or dental procedures. You may need to stop taking Ramipril Krka the day before: consult your doctor.
• If you have high levels of potassium in your blood (shown by a blood test).
• If you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, e.g. in the throat) is increased:
• racecadotril, a medicine used to treat diarrhoea.
• medicines used to prevent rejection of transplanted organs or to treat cancer (e.g. temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors).
• vildagliptin (and other medicines belonging to the DPP-4 inhibitor class, used to treat diabetes).
• If you are taking any of the following medicines used to treat high blood pressure:
• an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under “Do not take Ramipril Krka”.
• if you are taking medicines or have a condition that may reduce sodium levels in your blood. Your doctor may perform regular blood tests, particularly to check your blood sodium levels, especially if you are elderly.

Inform your doctor if you think you may be pregnant (or could become pregnant). Ramipril Krka is not recommended
during the first trimester of pregnancy and can cause serious harm to the unborn child after the first three months of
pregnancy (see section below “Pregnancy and breastfeeding”).
Children and adolescents
The use of Ramipril Krka is not recommended in children and adolescents under 18 years of age, as the
safety and efficacy of Ramipril Krka in children have not been established.
If any of the above conditions apply to you (or if you have any doubts), consult your doctor before taking
Ramipril Krka.
Other medicines and Ramipril Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines (including herbal remedies).
This is because Ramipril Krka may affect how other medicines work. Conversely, some medicines may affect how Ramipril Krka works.
Inform your doctor if you are taking any of the following medicines. These medicines may interfere with
the effectiveness of Ramipril Krka:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin, and aspirin).
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor must monitor your blood pressure.

Inform your doctor if you are taking any of the following medicines. Taking these medicines together with Ramipril
Krka may increase the likelihood of side effects:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacine, aspirin).
• Medicines for cancer treatment (chemotherapy).
• Diuretics such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride), and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood).
• Steroid medicines used to treat inflammation, such as prednisolone.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Medicines often used to prevent transplant rejection (temsirolimus, sirolimus, everolimus, and other medicines belonging to the mTOR inhibitor class) or vildagliptin and other DPP-4 inhibitors (used to treat diabetes). See section “Warnings and precautions”.

Inform your doctor if you are taking any of the following medicines. The action of these medicines
may be affected by Ramipril Krka:

• Medicines for diabetes such as oral antidiabetics and insulin. Ramipril Krka may lower blood sugar levels. Monitor your blood sugar levels carefully when taking Ramipril Krka.
• Lithium (for psychiatric conditions). Ramipril Krka may increase lithium levels in the blood. Your doctor must monitor your blood lithium levels carefully. If any of the above conditions apply (or if you have any doubts), consult your doctor before taking Ramipril Krka. Your doctor may need to adjust your dose and/or take other precautions: if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also information under “Do not take Ramipril Krka” and “Warnings and precautions”).

Ramipril Krka with food, drinks, and alcohol

• Drinking alcohol while taking Ramipril Krka may cause dizziness or lightheadedness. If you want to know how much alcohol you can drink while taking Ramipril Krka, discuss this with your doctor, as blood pressure-lowering medicines and alcohol may have additive effects.
• Ramipril Krka can be taken with or without food.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your
doctor or pharmacist before taking this medicine.
Pregnancy
If you are a woman of childbearing age, inform your doctor if you think you may be pregnant (or could become pregnant).
You must not take Ramipril Krka during the first 12 weeks of pregnancy and must not take it at all after week 13,
as it may harm the unborn child.
If you become pregnant while taking Ramipril Krka, inform your doctor immediately. Before planning a pregnancy,
you should switch to an alternative suitable medicine.
Consult your doctor or pharmacist before taking any medicine.
Breastfeeding
You must not take Ramipril Krka if you are breastfeeding.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Ramipril Krka may cause drowsiness and dizziness. This is more likely when you first start taking Ramipril Krka or when your dose has just been increased. If this occurs, do not drive or operate machinery.
Ramipril Krka contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Ramipril Krka

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Taking this medicine

• Take this medicine by mouth at the same time each day.
• Swallow the tablets whole with liquid.
• Do not break 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 your dose until your blood pressure is under control.
• The maximum dose is 10 mg once daily.
• If you are already taking diuretics, your doctor may stop or reduce them before starting treatment with Ramipril Krka.

To reduce 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 prevent worsening of kidney problems

• You may start with a dose of 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust your dose accordingly.
• 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 your dose accordingly.
• The maximum dose is 10 mg daily. Two daily administrations are preferred.

Treatment after a heart attack

• The usual starting dose ranges from 1.25 mg once daily to 2.5 mg twice daily.
• Your doctor will adjust your dose accordingly.
• The usual dose is 10 mg daily. Two daily administrations are preferred.

Elderly patients

• Your doctor will reduce the initial dose and adjust treatment more slowly.

If you take more Ramipril Krka than you should

Contact your doctor or go to the nearest hospital emergency department immediately. Do not drive yourself—have someone drive you or call an ambulance. Bring the medicine package with you so the doctor knows what you have taken.

If you forget to take Ramipril Krka

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

If you stop taking Ramipril Krka

Continue taking this medicine for as long as your doctor tells you to. Do not stop taking Ramipril Krka just because you feel better. If you stop, your condition may return.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking Ramipril Krka and contact your doctor immediately if you notice any of the following serious side effects – you may need urgent medical treatment:

• Swelling of the face, lips or throat causing difficulty in swallowing or breathing, as well as itching or skin rash (blisters or red patches on the skin). This may be a sign of a severe allergic reaction to Ramipril Krka.
• Severe skin reactions including rash, mouth ulcers, worsening of a pre-existing skin condition, redness, blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Inform your doctor immediately if you experience:

• Rapid heartbeat, irregular or forceful heartbeat (palpitations), chest pain, feeling of chest tightness or more serious problems including heart attack and stroke.
• Shortness of breath or cough. These may be signs of lung problems.
• Easy bruising, prolonged bleeding, any sign of bleeding (e.g. bleeding gums), purple spots on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, weakness, dizziness or pale appearance. These may be signs of blood or bone marrow problems.
• Severe stomach pain that may radiate to the back. This may be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (liver inflammation) or liver damage.

Other side effects include:
Inform your doctor if any of the conditions listed below become severe or persist for more than a few days.
Side effects are classified into the following groups according to frequency:
Common (may affect up to 1 in 10 people):

• Headache or feeling of tiredness.
• Dizziness. This is more likely when you have just started taking Ramipril Krka or have recently increased your dose.
• Weakness, hypotension (unusually low blood pressure), especially when standing up or getting up quickly.
• Dry, irritating cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath.
• Stomach or intestinal pain, diarrhoea, indigestion, feeling unwell or malaise.
• Rash with or without swelling.
• Chest pain.
• Muscle cramps or muscle pain.
• Blood tests show higher than normal potassium levels.

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

• Balance problems (dizziness).
• Itching and unusual skin sensations such as numbness, tingling, pricking, burning, stinging or scraping sensations on the skin (paraesthesia).
• Loss or change in taste.
• Sleep problems.
• Depressed mood, anxiety, increased nervousness or restlessness.
• Stuffy nose, breathing difficulties or worsening of asthma.
• Intestinal swelling known as “intestinal angioedema”, presenting with symptoms such as abdominal pain, vomiting and diarrhoea.
• Heartburn, constipation or dry mouth.
• Increased amount of urine during the day.
• Increased sweating.
• Loss of appetite or reduced appetite (anorexia).
• Fast or irregular heartbeat. Swollen arms and legs. This may be a sign that your body is retaining more fluid than usual.
• Hot flushes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence in men, reduced sex drive in men and women.
• Increased number of certain white blood cells (eosinophilia) detected in blood tests.
• Changes in liver, pancreas or kidney function indicated by blood tests.

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

• Feeling faint or confused.
• Red and swollen tongue.
• Severe peeling or shedding of the skin, itching, rash with pustules.
• Nail problems (such as loss or separation of the nail from its bed).
• Rash or bruising.
• Spots on the skin and cold hands and feet.
• Red, swollen, watery or itchy eyes.
• Hearing problems and ringing in the ears.
• Feeling weak.
• Decreased number of red blood cells, white blood cells, platelets or haemoglobin, as shown by blood tests.

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

• Increased sensitivity to sunlight.

Not known (frequency cannot be estimated from the available data):

• Concentrated urine (dark in colour), feeling unwell or malaise, muscle cramps, confusion and seizures which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor promptly.

Other side effects reported:
Inform your doctor if any of the conditions listed below become severe or persist for more than a few days.

• Difficulty concentrating.
• Mouth swelling.
• Blood tests showing too low a number of blood cells.
• Blood tests showing lower than normal sodium levels in the blood.
• Fingers of the hands and feet changing colour when exposed to cold, with tingling or pain upon warming (Raynaud's phenomenon).
• Enlargement of the breasts in men.
• Slowed or altered reflexes.
• Burning sensation.
• Change in the perception of smells.
• Hair loss.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ramipril Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Keep in the original packaging to protect from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ramipril Krka contains

• The active substance is ramipril. Each tablet contains 1.25 mg, 2.5 mg, 5 mg, or 10 mg of ramipril.
• The other components are sodium hydrogen carbonate (E500), lactose monohydrate, sodium croscarmellose, pregelatinized maize starch, sodium stearyl fumarate, yellow iron oxide (E172) – only in the 2.5 mg and 5 mg tablets, and red iron oxide (E172) – only in the 5 mg tablets. See section 2 “Ramipril Krka contains lactose and sodium”.

Description of the appearance of Ramipril Krka and package contents
1.25 mg tablets: white to off-white, capsule-shaped, uncoated, flat tablets (8.0 x 4.0 mm).
2.5 mg tablets: yellow, capsule-shaped, uncoated, flat tablets (10.0 x 5.0 mm).
5 mg tablets: pink, capsule-shaped, uncoated, flat tablets (8.8 x 4.4 mm).
10 mg tablets: white to off-white, capsule-shaped, uncoated, flat tablets (11.0 x 5.5 mm).
Ramipril Krka tablets are available in packs of 10, 14, 20, 28, 30, 50, 60, 90, and 100 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative in Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorized in the European Economic Area Member States under the following names: