RAMIPRIL 1.25 mg Coated tablet

Зміст інструкції

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

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

Ramipril
Generic medicine

Read this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 a medicine called ramipril. This belongs to the group of medicines called
ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
Ramipril Krka works by:

• Decreasing the production, by the body, of substances that can cause an increase in blood pressure.
• Relaxing and widening the blood vessels.
• Making it easier for the heart to pump blood around the body.

Ramipril Krka can be used:

• To treat high blood pressure (hypertension).
• To reduce the risk of a heart attack or stroke.
• To reduce the risk or delay the worsening of kidney problems (whether or not diabetes is present).
• To treat the heart when it cannot pump enough blood around the rest of the body (heart failure).
• As treatment after a heart attack (myocardial infarction) if 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 inhibitor drugs or to any of the other ingredients of this medicine. (listed in section 6). The signs of an allergic reaction can be skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• If you have had a serious allergic reaction called “angioedema”. These signs include itching,

urticaria, red patches on the hands, feet and in the throat, swelling of the throat and tongue, swelling
around the eyes and lips, difficulty breathing and swallowing.

• If you are on dialysis or undergoing any other type of blood filtration. Depending on the machinery used, Ramipril Krka may not be suitable for you.
• If you have kidney problems due to reduced blood flow to the kidney (due to narrowing of the renal artery).
• 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 still make this assessment.
• If you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• If you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

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

• If you have heart, liver or kidney problems.
• If you have lost a lot of salts or body fluids (due to an illness such as vomiting, diarrhea, excessive sweating, or following a low-salt diet, or after taking oral diuretics for a long time or having undergone dialysis).
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization).
• If you are about to undergo anesthesia. This may be given for a surgical operation or a dental procedure. It may be necessary to stop treatment with Ramipril Krka the day before: ask your doctor for advice.
• If you have a high amount of potassium in your blood (shown by a blood test).
• If you have a connective tissue 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 in areas such as the throat) is increased:
• racecadotril, a medicine used to treat diarrhea.
• medicines used to prevent rejection of transplanted organs and for cancer (e.g. temsirolimus, sirolimus, everolimus and other medicines that belong to the class of mTOR inhibitors.
• vildagliptin (and other medicines that belong to the class of DPP-IV inhibitors, medicines used to treat diabetes).
• If you are taking any of the following medicines used to treat high blood pressure:
• an “angiotensin II receptor blocker” (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes.
• aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also the information under the heading "Do not take Ramipril Krka".
• if you are taking medicines or are in a condition that may decrease the level of sodium in your blood. Your doctor may perform regular blood tests, especially to check the levels of sodium in your blood, particularly if you are elderly.

Tell your doctor if you think you may be pregnant (or might become pregnant). Ramipril Krka is not recommended
during the first trimester of pregnancy and can cause serious harm to the baby after the first three months of
pregnancy (see paragraph below “Pregnancy and breastfeeding”).

Children and adolescents
The use of Ramipril Krka is not recommended in children and adolescents under 18 years of age, because the
safety and efficacy of Ramipril Krka in children have not been established.
If any of the above conditions occur (or you have any doubts), ask your doctor before taking
Ramipril Krka.

Other medicines and Ramipril Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription (including herbal medicines).
This is because Ramipril Krka can affect the way other medicines work. Also, some medicines
can affect the way Ramipril Krka works.
Tell 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 should check your blood pressure.

Tell your doctor if you are taking any of the following medicines. These medicines, when taken 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, indometacin, aspirin).
• Cancer medicines (chemotherapy).
• Diuretics such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride) and other medicines that can increase the amount of potassium in the blood (e.g. trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs and heparin, a medicine used to make the blood more fluid).
• Steroid medicines for treating inflammation, such as prednisolone.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Medicines that are often used for preventing transplant rejection (temsirolimus, sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors) or vildagliptin and other medicines belonging to the class of DPP-IV inhibitors (used for the treatment of diabetes). See section “Warnings and precautions“.

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

• Diabetes medicines such as oral hypoglycemic agents and insulin. Ramipril Krka may lower blood sugar levels. Carefully monitor your blood sugar levels when taking Ramipril Krka.
• Lithium (for psychiatric problems). Ramipril Krka may increase the amount of lithium in the blood. Your doctor should carefully monitor the level of lithium in your blood. If any of the above conditions occur (or you have any doubts), ask your doctor before taking Ramipril Krka. Your doctor may need to adjust the dose and/or take other precautions: if you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is stated under "Do not take Ramipril Krka" and "Warnings and precautions").

Ramipril Krka with food, drinks and alcohol

• Drinking alcoholic beverages with Ramipril Krka can cause dizziness or lightheadedness. If you want to know how much alcohol to drink when taking Ramipril Krka, talk to your doctor, as medicines used to lower blood pressure and alcohol can have additive effects.
• Ramipril Krka can be taken with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.

Pregnancy
If you are a woman of childbearing age, you should inform your doctor if you think you might be pregnant (or might become pregnant).
You should not take Ramipril Krka in the first 12 weeks of pregnancy and should definitely not
take it after the 13th week because it can be harmful to the baby.
If you become pregnant while taking Ramipril Krka, tell your doctor immediately. Before
planning a pregnancy, you should switch to an alternative medicine that is suitable.
Ask your doctor or pharmacist for advice before taking any medicine.

Breastfeeding
You should not take Ramipril Krka if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
You may feel drowsy and dizzy while taking Ramipril Krka. This is more likely
when you first start taking Ramipril Krka or have just increased the dose. If this happens, do not
drive or use machines.

Ramipril Krka contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact your doctor 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Taking this medicine

• Take this medicine by mouth at the same time of day, every day.
• Swallow the tablets whole with liquid.
• Do not break or chew the tablets.

How much to use

Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once a day.
• Your doctor will adjust the amount you take until your blood pressure is under control.
• The maximum dose is 10 mg once a day.
• If you are already taking diuretics, your doctor may stop them or reduce the amount before starting you on treatment with Ramipril Krka. To reduce the risk of a heart attack or stroke
• The usual starting dose is 2.5 mg once a day.
• Your doctor may decide to increase the dosage.
• The usual dose is 10 mg once a day. Treatment to reduce or prevent worsening of kidney problems
• You can start with a dose of 1.25 mg or 2.5 mg once a day.
• Your doctor will adjust the amount you take.
• The usual dose is 5 mg or 10 mg once a day. Treatment of heart failure
• The usual starting dose is 1.25 mg once a day.
• Your doctor will adjust the amount you take.
• The maximum dose is 10 mg per day. Two administrations per day are preferable. Treatment after a heart attack
• The usual starting dose is from 1.25 mg once a day to 2.5 mg twice a day.
• Your doctor will adjust the amount you take.
• The usual dose is 10 mg per day. Two administrations per day are preferable. Elderly
• Your doctor will reduce the starting dose and adjust the treatment more slowly.

If you take more Ramipril Krka than you should
Inform your doctor or go to the nearest hospital emergency room. Do not drive to the hospital, have
someone accompany you or call an ambulance. Bring the package of the medicine with you. This
is so that the doctor knows what you have taken.

If you forget to take Ramipril Krka

• If you forget a dose, take the normal dose when it is time.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Ramipril Krka
Continue to take the medicine until your doctor tells you to stop. Do not stop taking
Ramipril Krka just because you feel better. If you stop, the illness may return.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

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 which makes it difficult to swallow or breathe, as well as itching or rash (blisters or red patches on the skin). This can be a sign of a severe allergic reaction to Ramipril Krka.
• Severe skin reactions including rash, mouth sores, 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).

Tell your doctor immediately if you experience:

• Fast heartbeat, irregular or strengthened heartbeat (palpitations), chest pain, feeling of tightness in the chest or more serious problems including heart attack and stroke.
• Shortness of breath or cough. These can be signs of lung problems.
• Easier bruising, bleeding that lasts longer than normal, any sign of bleeding (e.g. bleeding gums), purple spots on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, weak, dizziness or pale skin. These can be signs of problems with the blood circulation or bone marrow.
• Severe stomach pain that may extend to the back. This can 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 can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:
Tell your doctor if any of the following conditions becomes serious or lasts for more than a few
days.
Side effects are classified into the following groups according to their frequency:

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

• Headache or feeling tired.
• Feeling dizzy. This is more likely when you have just started taking Ramipril Krka or have just increased the dose.
• Weakness, low blood pressure (unusually low blood pressure), especially when standing up or getting up quickly.
• Dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath.
• Stomach or intestinal pain, diarrhea, indigestion, feeling unwell or generally unwell.
• Rash with or without swelling.
• Chest pain.
• Muscle cramps or pain.
• Blood tests show a higher than normal level of potassium.

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

• Problems with balance (vertigo).
• Itching and unusual skin sensations such as numbness, tingling, prickling, burning, a feeling of crawling or burning on the skin (paresthesia).
• Loss or change of taste.
• Difficulty sleeping.
• Depressed mood, anxiety, increased nervousness than usual or restlessness.
• Blocked nose, difficulty breathing or worsening of asthma.
• Swelling of the intestine called “intestinal angioedema”, which presents with symptoms such as abdominal pain, vomiting and diarrhea.
• Heartburn, constipation or dry mouth.
• Increased amount of urine during the day.
• Increased sweating than usual.
• Loss or decrease of appetite (anorexia).
• Fast or irregular heartbeat. Swollen arms and legs. This may be a sign that your body is retaining more water than usual.
• Hot flushes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence in men, reduced sexual desire in men and women.
• Increased number of certain white blood cells (eosinophilia) found during blood tests.
• Changes in liver, pancreas or kidney function as shown by blood tests.

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

• Feeling faint or confused.
• Red and swollen tongue.
• Severe flaking or peeling of the skin, itching, rash with pustules.
• Problems with nails (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.
• Decrease in the number of red blood cells, white blood cells and platelets or the amount of hemoglobin, as shown by blood tests.

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

• Increased sensitivity to the sun.

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

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

Other side effects reported:
Tell your doctor if any of the following conditions becomes serious or lasts for more than a few
days.

• Difficulty concentrating.
• Swelling of the mouth.
• Blood tests showing a too low number of blood cells.
• Blood tests showing a lower than normal level of sodium in the blood.
• Fingers of the hands and feet that change color when cooled and tingle or hurt when warmed (Raynaud’s phenomenon).
• Breast enlargement in men.
• Slowed or altered reflexes.
• Burning sensation.
• Change in the perception of smells.
• Hair loss.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after EXP. The expiry date
refers to the last day of that month.
Do not store at a temperature above 25  C.
Store in the original package to protect from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ramipril Krka contains

• The active ingredient is ramipril. Each tablet contains 1.25 mg, 2.5 mg, 5 mg or 10 mg of ramipril.
• The other ingredients are sodium hydrogen carbonate (E500), lactose monohydrate, croscarmellose sodium, pregelatinized 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 contents of the pack
1.25 mg tablets: white-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-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, 100 tablets in
blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy
This medicinal product is authorised in the Member States of the European Economic Area under the following
names: