PERINDOPRIL 2 mg Tablets

Зміст інструкції

1. Perindopril Krka 2 mg tablets
   1. What is Perindopril Krka and what it is used for
   2. What you need to know before taking Perindopril Krka
   3. How to take Perindopril Krka
   4. Possible side effects
   5. How to store Perindopril Krka
   6. Contents of the pack and other information
2. Perindopril Krka 4 mg tablets
   1. What is Perindopril Krka and what it is used for
   2. What you need to know before taking Perindopril Krka
   3. How to take Perindopril Krka
   4. Possible side effects
   5. How to store Perindopril Krka
   6. Package Contents and Other Information
   7. What is Perindopril Krka and what is it used for
   8. What you need to know before taking Perindopril Krka
   9. How to take Perindopril Krka
   10. Possible side effects
   11. How to store Perindopril Krka
   12. Contents of the pack and other information

Perindopril Krka 2 mg tablets

Perindopril tert-butylamine

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

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

The active substance of Perindopril Krka tablets belongs to a group of medicines called
angiotensin converting enzyme (ACE) inhibitors. They work by widening the blood vessels,
making it easier for the heart to pump blood through them.
Perindopril Krka 2 mg tablets is used:

• to treat high blood pressure (hypertension),
• to treat symptomatic heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs),
• to reduce the risk of cardiovascular events, such as heart attack, in patients with stable coronary artery disease (a condition in which blood supply to the heart is reduced or blocked) and in those who have already had a heart attack and/or surgery to improve blood flow to the heart by widening the blood vessels that supply it.

2. What you need to know before taking Perindopril Krka

Do not take Perindopril Krka

• if you are allergic to perindopril, to any other ACE inhibitor or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously experienced reactions of hypersensitivity with sudden swelling of the lips and face, neck, potentially also of hands and feet, or choking or hoarseness (angioedema) after the use of an ACE inhibitor.
• if someone in your family has suffered from angioedema or if you have had angioedema in any other circumstance.
• if you are pregnant for more than 3 months (it is best to avoid Perindopril Krka in the early stages of pregnancy
• see the section relating to pregnancy).
• if you suffer from diabetes or kidney dysfunction and if you have been treated with a medicine containing aliskiren to lower blood pressure.
• if you are undergoing dialysis or another type of blood filtration. Depending on the machine being used, Perindopril Krka may not be suitable for you;
• if you have kidney problems where the blood supply to them is reduced (renal artery stenosis);
• 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).

The use of Perindopril Krka tablets is not recommended in children and adolescents.

Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril Krka
Perindopril Krka may not be suitable for you. Before starting treatment with Perindopril
Krka tablets you should therefore inform your doctor of the following.

• if you have been told you have a reduced or absent blood supply to the heart (unstable angina pectoris)
• if you have been told that your heart muscle is enlarged or if you have a problem with your heart valves
• if you have been diagnosed with a narrowing of the artery supplying blood to the kidneys (renal artery stenosis)
• if you have abnormally high levels of a hormone called aldosterone in the blood (primary aldosteronism)
• if you suffer from diabetes
• if you suffer from any other disease of the kidneys, liver or heart
• if you are on dialysis or have recently undergone a kidney transplant
• if you are following a low-salt diet, or if you have suffered from excessive vomiting or diarrhoea or if you have used medicines that increase the amount of urine (diuretics)
• if you are taking lithium, a medicine used to treat mania or depression
• if you are taking potassium supplements or salt substitutes containing potassium, or other drugs associated with increased serum potassium e.g. heparin
• if you are to undergo a procedure in which cholesterol is removed from the blood using a special machine (LDL apheresis)
• if you are to undergo treatment to reduce the effects of an allergy to bee or wasp stings
• if you have a collagen disease such as systemic lupus erythematosus or scleroderma, if you are undergoing immunosuppressive therapy
• if your blood pressure has not lowered sufficiently due to your ethnic origin (particularly in patients with black skin)
• if you are about to undergo surgery or general anesthesia
• if you suffer from cerebrovascular disease.
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (ARB) (known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems due to diabetes.
• aliskiren. The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in the blood at regular intervals. See also the information under "Do not take Perindopril Krka".
• if you are taking any of the following medicines the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:
• racecadotril (used for the treatment of diarrhoea),
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent organ rejection and for cancer).
• vildagliptin (a medicine used to treat diabetes).

Angioedema
In patients treated with ACE inhibitors, including Perindopril Krka, angioedema (a
serious allergic reaction with swelling of the face, lips, tongue or throat with difficulty
swallowing or breathing) has been reported. This can happen at any time during treatment. If you develop such
symptoms, stop taking Perindopril Krka and go to your doctor immediately. See
also section 4.
You must tell your doctor if you think you are pregnant (or might become pregnant). Perindopril Krka is not
recommended in the early stages of pregnancy, and must not be taken if you are pregnant for more than 3
months, as it can cause serious harm to the baby if used at this stage (see the section relating
to pregnancy).
Children and adolescents
The use of perindopril is not recommended in children and adolescents up to 18 years of age.

Other medicines and Perindopril Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take over-the-counter medicines without consulting your doctor. This can happen
when you take:

• cold remedies containing pseudoephedrine or phenylephrine as active ingredients
• pain remedies, including acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, and also to prevent blood clotting).
• potassium supplements
• salt substitutes containing potassium.

Tell your doctor if you are taking any of the following medicines, to make sure it is safe
to take Perindopril Krka tablets at the same time:

• other medicines to treat high blood pressure and/or heart failure, including medicines that increase the amount of urine (diuretics),
• potassium-sparing diuretics (e.g. triamterene, amiloride), potassium supplements or salt substitutes containing potassium, other medicines that can increase potassium levels in the body such as heparin (a medicine used to thin the blood to prevent clots), trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole (for the treatment of infections caused by bacteria) and cyclosporine or tacrolimus (immunosuppressant medicines used to prevent organ rejection),
• potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• medicines for the treatment of irregular heartbeat (procainamide)
• medicines for the treatment of diabetes (insulin or oral antidiabetics such as vildagliptin)
• baclofen (used for the treatment of muscle stiffness and diseases such as multiple sclerosis),
• medicines for the treatment of gout (allopurinol)
• non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac), including acetylsalicylic acid for pain
• vasodilators including nitrates (products that dilate blood vessels)
• estramustine (used in cancer therapy),
• medicines with a stimulating action in a particular area of the nervous system such as ephedrine, noradrenaline or adrenaline (sympathomimetics)
• medicines for the treatment of mania or depression (lithium)
• medicines for mental illnesses such as depression, anxiety, schizophrenia or other psychoses (tricyclic antidepressants and antipsychotics)
• gold for injection for the treatment of arthritis (sodium aurothiomalate)
• medicines that are often used for the treatment of diarrhoea (racecadotril)
• medicines that are often used to prevent organ rejection (sirolimus,

everolimus, temsirolimus or other medicines belonging to the class of inhibitors called
mTOR). See section “Warnings and precautions”.
Your doctor may need to adjust the dose and/or take other precautions:

• if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under "Do not take Perindopril Krka" and "Warnings and precautions").

Perindopril Krka with food and drink
It is recommended to take Perindopril Krka before meals to reduce the influence of food on the action
of the medicine.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you are pregnant (or might become pregnant). Your doctor will normally advise you to
stop taking Perindopril Krka before becoming pregnant or as soon as you find out you
are pregnant and will advise you to take another medicine instead of Perindopril Krka. Perindopril Krka
is not recommended in the early stages of pregnancy, and must not be taken if you are pregnant for more than
3 months, as it can cause serious harm to the baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Perindopril Krka is not recommended
for mothers who are breastfeeding, and your doctor may choose another treatment if you want to breastfeed,
especially if your baby is newly born or premature.

Driving and using machines
It is advisable not to drive vehicles or operate machinery until you know how Perindopril Krka
affects you. Perindopril Krka usually does not impair alertness but some patients may experience
dizziness or weakness due to low blood pressure, especially at the start of
treatment or in combination with other antihypertensive medicines.
As a result, the ability to drive or operate machinery may be impaired.

Perindopril Krka tablets contains lactose (as lactose monohydrate)
If you have been told by your doctor that you have an intolerance to some sugars, tell your doctor before taking
this medicine.

3. How to take Perindopril Krka

as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
The recommended dose for the treatment of high blood pressure is 4 mg of perindopril (1
tablet of Perindopril Krka 4 mg) once a day. If necessary, the dose may be
increased to 8 mg of perindopril (2 tablets of Perindopril Krka 4 mg) once a day.
The recommended dose for the treatment of symptomatic heart failure is 2 mg of perindopril
(1 tablet of Perindopril Krka 2 mg) once a day; the dose may be increased to 4 mg of
perindopril (1 tablet of Perindopril Krka 4 mg or 2 tablets of Perindopril Krka 2 mg), once
a day, as needed.
The initial recommended dose for the treatment of stable coronary artery disease is 4 mg of perindopril
(1 tablet of Perindopril Krka 4 mg) once a day; if it is well tolerated, the dose may be
increased to 8 mg of perindopril (2 tablets of Perindopril Krka 4 mg) per day.
Take the tablet with a glass of water, preferably at the same time each day, in the morning,
before a meal.
During the course of treatment, the doctor will adjust the dosage according to the effect of the treatment,
according to your needs. The dosage may be reduced compared to the usual one and will be determined
by the doctor:

• in elderly patients
• in patients with impaired renal function
• in patients with high blood pressure caused by narrowing of the arteries that supply the kidneys with blood (renovascular hypertension)
• in patients who are being treated at the same time with medicines that increase the amount of urine (diuretics)
• in hypertensive patients in whom diuretics cannot be stopped
• in patients with severe heart failure and
• in patients treated with medicines that dilate blood vessels - vasodilating agents)

The doctor will determine the duration of treatment based on your medical condition.
Use in children
Use in children has not been established. Therefore, use in children is not recommended.
If you feel that the effect of the medicine is too strong or too weak, tell your doctor or
pharmacist.

If you take more Perindopril Krka than you should
If you have taken too many tablets, tell your doctor or pharmacist immediately.
The most likely sign of overdose is a sudden drop in blood pressure
(hypotension). Other symptoms may include a fast or slow heartbeat, unpleasant sensations of
irregular and/or strong heartbeats, hyperventilation, dizziness, anxiety and/or cough.
If your blood pressure drops considerably, you should lie down, raise your legs and use a small
pillow to support your head.

If you forget to take Perindopril Krka
It is important to take the medicine every day. However, if you forget to take a dose,
continue with the next dose as usual. Do not take a double dose to make up for the
forgotten tablet. If you forget to take more than one dose, take it as soon as you
remember and then continue as prescribed.

If you stop taking Perindopril Krka
After stopping treatment, blood pressure may rise again and this may
increase the risk of complications due to high blood pressure, especially in the heart, in the
brain and in the kidneys. The condition of patients with heart failure may worsen up to
justifying hospitalization. If you are therefore considering stopping Perindopril Krka,
you must first inform your doctor.
If you have any further questions on 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.

Stop taking the medicine and contact your doctor immediately if you experience
any of the following side effectswhich may be serious:

• swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (See section 2 “Warnings and precautions”) (Uncommon - may affect up to 1 in 100 people),
• severe dizziness or fainting due to low blood pressure (Common - may affect up to 1 in 10 people),
• unusually fast or irregular heartbeat, chest pain (angina) or heart attack (Very rare - may affect up to 1 in 10,000 people),
• weakness of arms and legs, or speech problems which may be possible signs of a stroke (Very rare - may affect up to 1 in 10,000 people),
• sudden shortness of breath, chest pain, wheezing or difficulty breathing (bronchospasm) (Uncommon - may affect up to 1 in 100 people),
• inflamed pancreas which can cause severe abdominal and back pain accompanied by a feeling of unwellness (Very rare - may affect up to 1 in 10,000 people),
• yellowing of the skin or eyes (jaundice) which could be a sign of hepatitis (Very rare - may affect up to 1 in 10,000 people),
• skin rash which often starts with red spots on the face, arms or legs (erythema multiforme) (Very rare - may affect up to 1 in 10,000 people).

Side effects that may occur:

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

• headache, dizziness, feeling of spinning (vertigo), tingling or numbness in the hands or feet (paresthesia)
• vision disturbances
• tinnitus, ringing, buzzing, metallic sound in the ears, etc. (tinnitus)
• low blood pressure (hypotension) and effects related to hypotension
• cough, shortness of breath (dyspnea)
• feeling sick (nausea), sickness (vomiting), abdominal pain, altered taste (dysgeusia), indigestion (dyspepsia), diarrhea and constipation
• skin rash, itching
• muscle cramps
• weakness (asthenia)

Uncommon (may affect up to 1 in 100):

• low blood sugar (hypoglycemia)
• high blood potassium levels reversible upon discontinuation
• low sodium levels
• changes in mood or sleep disturbances
• drowsiness, fainting
• palpitations, tachycardia
• vasculitis (inflammation of blood vessels)
• wheezing (bronchospasm)
• dry mouth
• hypersensitivity reactions with sudden swelling of the face, neck, lips, mucous membranes, tongue or throat (with hoarseness or suffocation), possibly also with swelling of the hands and feet (angioedema), urticaria
• photosensitivity reactions (increased sensitivity of the skin to sunlight)
• arthralgia (joint pain), myalgia (muscle pain)
• reduced kidney function
• inability to achieve or maintain an erection (impotence)
• chest pain, malaise, peripheral edema, fever
• increased urea in the blood and increased blood creatinine
• falls

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

• changes in laboratory parameters: increased liver enzymes, high serum bilirubin levels.
• worsening of psoriasis.

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

• confusion
• abnormal heart rate (arrhythmia), chest pain (angina pectoris), heart attack and stroke possibly due to excessive lowering of blood pressure in high-risk patients
• inflammation of the lungs associated with accumulation of certain blood cells (eosinophils) in the lung tissue (eosinophilic pneumonia), inflammation of the mucous membranes of the nose (rhinitis)
• inflammation of the pancreas (pancreatitis)
• inflammation of the liver (hepatitis)
• allergic rash appearing as flat red spots (erythema multiforme)
• acute kidney failure.

Concentrated urine (dark in color), feeling sick or unwell, muscle cramps,
confusion or convulsions which may be due to inappropriate secretion of ADH (antidiuretic
hormone) which can occur with ACE inhibitors.
Frequency not known (cannot be estimated from the available data):

• discoloration, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly through the national
reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .. Reporting side effects helps to
provide more information on the safety of this medicine.

5. How to store Perindopril Krka

Keep this medicine out of the sight and reach of children.
Do not use Perindopril Krka after the expiry date which is stated on the package and blister after Exp.
The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture and light.
Do not store at a temperature above 30°C.
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 Perindopril Krka contains

• The active substance is perindopril tert-butylamine. Each tablet contains 2 mg of perindopril tert-butylamine, equivalent to 1.669 mg of perindopril.
• The other ingredients are calcium chloride hexahydrate, lactose monohydrate, crospovidone (type A), microcrystalline cellulose, anhydrous colloidal silica and magnesium stearate. See section 2 “Perindopril Krka tablets contains lactose (as lactose monohydrate)”.

Description of the appearance of Perindopril Krka and contents of the pack
The tablets are white to almost white, round (diameter 7 mm), slightly biconvex, with
bevelled edges.
Perindopril Krka tablets are available in packs of 10, 14, 28, 30, 50, 56, 60, 90 and 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

Perindopril Krka 4 mg tablets

Perindopril tert-butylamine
Generic medicine

Read this leaflet carefully before you start taking this medicine because 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 their symptoms are the same as yours, as it could 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 Perindopril Krka is and what it is used for
• 2. What you need to know before you take Perindopril Krka
• 3. How to take Perindopril Krka
• 4. Possible side effects
• 5. How to store Perindopril Krka
• 6. Contents of the pack and other information

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

The active substance of Perindopril Krka tablets belongs to a group of medicines called
angiotensin converting enzyme (ACE) inhibitors. They work by widening blood vessels,
making it easier for the heart to pump blood through them.
Perindopril Krka 4 mg, tablets is used:

• to treat high blood pressure (hypertension),
• to treat symptomatic heart failure (a condition in which the heart is unable to pump a sufficient amount of blood to meet the body's needs),
• to reduce the risk of cardiac events, such as heart attack, in patients with stable coronary artery disease (a condition in which the blood supply to the heart is reduced or blocked) and in those who have already had a heart attack and/or surgery to improve blood flow to the heart by widening the blood vessels that supply it.

2. What you need to know before taking Perindopril Krka

Do not take Perindopril Krka

• if you are allergic to perindopril, to any other ACE inhibitor or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously experienced reactions of hypersensitivity with sudden swelling of the lips and face, neck, potentially also of hands and feet, or choking or hoarseness (angioedema) after using an ACE inhibitor.
• if someone in your family has suffered from angioedema or if you have had angioedema in any other circumstance.
• if you are pregnant for more than 3 months (it is best to avoid Perindopril Krka in the early stages of pregnancy
• see the section relating to pregnancy).
• if you suffer from diabetes or kidney dysfunction and if you have been treated with a medicine containing aliskiren to lower your blood pressure.
• if you are undergoing dialysis or another type of blood filtration. Depending on the machine being used, Perindopril Krka may not be suitable for you;
• if you have kidney problems where the blood supply to them is reduced (renal artery stenosis);
• 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).

The use of Perindopril Krka tablets is not recommended in children and adolescents.

Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril Krka.
Perindopril Krka may not be suitable for you. Before starting treatment with Perindopril
Krka tablets you must therefore inform your doctor of the following.

• if you have been told you have reduced or no blood flow to your heart (unstable angina pectoris)
• if you have been told that your heart muscle is enlarged or if you have a problem with your heart valves
• if you have been diagnosed with a narrowing of the artery supplying blood to your kidneys (renal artery stenosis)
• if you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism)
• if you suffer from diabetes
• if you suffer from any other disease of the kidneys, liver or heart
• if you are on dialysis or have recently had a kidney transplant
• if you are following a low-salt diet, or if you have suffered from excessive vomiting or diarrhoea or if you have used medicines that increase the amount of urine (diuretics)
• if you are taking lithium, a medicine used to treat mania or depression
• if you are taking potassium supplements or salt substitutes containing potassium, or other drugs associated with increased serum potassium e.g. heparin
• if you are to undergo a procedure in which cholesterol is removed from the blood using a special machine (LDL apheresis)
• if you are to undergo treatment to reduce the effects of an allergy to bee or wasp stings
• if you have a connective tissue disease such as systemic lupus erythematosus or scleroderma, if you are undergoing immunosuppressive therapy
• if your blood pressure has not lowered sufficiently due to your ethnicity (particularly in patients with black skin)
• if you are about to undergo surgery or general anesthesia
• if you suffer from cerebrovascular disease.
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (ARB) (known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems due to diabetes,
• aliskiren. The 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 Perindopril Krka".
• if you are taking any of the following medicines the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent organ transplant rejection and for cancer).
• vildagliptin (a medicine used to treat diabetes).

Angioedema
In patients treated with ACE inhibitors, including Perindopril Krka, angioedema has been reported (a
serious allergic reaction with swelling of the face, lips, tongue or throat with difficulty
swallowing or breathing). This can happen at any time during treatment. If you develop such
symptoms, stop taking Perindopril Krka and go to your doctor immediately. See also
section 4.
You must tell your doctor if you think you are pregnant (or might become pregnant). Perindopril Krka is not
recommended in the early stages of pregnancy, and must not be taken if you are pregnant for more than 3
months, as it can cause serious harm to the baby if used at this stage (see the section relating
to pregnancy).
Children and adolescents
The use of perindopril is not recommended in children and adolescents up to 18 years of age.

Other medicines and Perindopril Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take over-the-counter medicines without consulting your doctor. This can happen
when you take:

• cold remedies containing pseudoephedrine or phenylephrine as active ingredients
• pain relievers, including acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, and also to prevent blood clotting).
• potassium supplements
• salt substitutes containing potassium Inform your doctor if you are taking any of the following medicines, to make sure it is safe to take Perindopril Krka tablets at the same time:
• other medicines to treat high blood pressure and/or heart failure, including medicines that increase the amount of urine (diuretics),
• potassium-sparing diuretics (e.g. triamterene, amiloride), potassium supplements or salt substitutes containing potassium, other medicines that can increase potassium levels in the body such as heparin (a medicine used to thin the blood to prevent clots), trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole (for the treatment of infections caused by bacteria) and cyclosporine or tacrolimus (immunosuppressant medicines used to prevent organ rejection),
• potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• medicines for the treatment of irregular heartbeat (procainamide)
• medicines for the treatment of diabetes (insulin or oral antidiabetics such as vildagliptin)
• baclofen (used to treat muscle stiffness and diseases such as multiple sclerosis),
• medicines for the treatment of gout (allopurinol)
• non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac), including acetylsalicylic acid for pain
• vasodilators including nitrates (products that dilate blood vessels)
• estramustine (used in cancer therapy),
• medicines with a stimulating action in a particular area of the nervous system such as ephedrine, norepinephrine or adrenaline (sympathomimetics)
• medicines for the treatment of mania or depression (lithium)
• medicines for mental illnesses such as depression, anxiety, schizophrenia or other psychoses (tricyclic antidepressants and antipsychotics)
• gold for injection for the treatment of arthritis (sodium aurothiomalate)
• medicines that are often used to treat diarrhea (racecadotril)
• medicines that are often used to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus or other medicines belonging to the class of inhibitors called mTOR). See section “Warnings and precautions”.

The doctor may need to adjust the dose and/or take other precautions:

• if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Perindopril Krka" and "Warnings and precautions").

Taking Perindopril Krka with food and drink
It is recommended to take Perindopril Krka before meals to reduce the influence of food on the action
of the medicine.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning to
become pregnant, ask your doctor or pharmacist before taking this medicine.

Pregnancy
You must tell your doctor if you think you are pregnant (or might become pregnant). Your doctor will normally
advise you to stop taking Perindopril Krka before becoming pregnant or as soon as you find
out you are pregnant and will advise you to take another medicine instead of Perindopril Krka. Perindopril Krka
is not recommended in the early stages of pregnancy, and must not be taken if you are pregnant for more than
3 months, as it can cause serious harm to the baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Perindopril Krka is not recommended
for mothers who are breastfeeding, and your doctor may choose another treatment if you want to breastfeed,
especially if your baby is newly born or premature.

Driving and using machines
It is advisable not to drive vehicles or operate machinery until you know how Perindopril Krka
affects you. Perindopril Krka usually does not impair alertness but in some patients dizziness or weakness may occur due to low blood pressure, especially at the beginning of
treatment or in association with other antihypertensive medicines.
As a result, the ability to drive or operate machinery may be impaired.

Perindopril Krka tablets contains lactose (as lactose monohydrate)
If you have been told by your doctor that you have an intolerance to some sugars, tell your doctor before taking
this medicine.

3. How to take Perindopril Krka

as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for the treatment of high blood pressure is 4 mg of perindopril (1
tablet of Perindopril Krka 4 mg) once a day. If necessary, the dose may be
increased to 8 mg of perindopril (2 tablets of Perindopril Krka 4 mg) once a day.
The recommended dose for the treatment of symptomatic heart failure is 2 mg of perindopril
(1 tablet of Perindopril Krka 2 mg) once a day; the dose may be increased to 4 mg of
perindopril (1 tablet of Perindopril Krka 4 mg or 2 tablets of Perindopril Krka 2 mg), once
a day, as needed.
The initial recommended dose for the treatment of stable coronary artery disease is 4 mg of perindopril
(1 tablet of Perindopril Krka 4 mg) once a day; if it is well tolerated the dose may be
increased to 8 mg of perindopril (2 tablets of Perindopril Krka 4 mg) per day.
Take the tablet with a glass of water, preferably at the same time each day, in the morning,
before a meal.
During the course of treatment, the doctor will adjust the dosage according to the effect of the treatment,
according to your needs. The dosage may be reduced compared to the usual one and will be determined
by the doctor:

• in elderly patients
• in patients with impaired renal function
• in patients with high blood pressure caused by narrowing of the arteries that supply the kidneys with blood (renovascular hypertension)
• in patients who are being treated at the same time with medicines that increase the amount of urine (diuretics)
• in hypertensive patients in whom diuretics cannot be discontinued
• in patients with severe heart failure and
• in patients treated with medicines that dilate blood vessels - vasodilating agents)

The doctor will determine the duration of treatment based on your medical condition.

Use in children
Use in children has not been established. Therefore, use in children is not recommended.
If you feel that the effect of the medicine is too strong or too weak, tell your doctor or
pharmacist.

If you take more Perindopril Krka than you should
If you have taken too many tablets, inform your doctor or pharmacist immediately.
The most likely sign of overdose is a sudden drop in blood pressure
(hypotension). Other symptoms may include rapid or slow heartbeat, unpleasant sensations of
irregular and/or strong heartbeats, hyperventilation, dizziness, anxiety and/or cough.
If your blood pressure drops considerably, you should lie down, raise your legs and use a small
pillow to support your head.

If you forget to take Perindopril Krka
It is important to take the medicine every day. However, if you forget to take a dose,
continue with the next dose as usual. Do not take a double dose to make up for the
forgotten tablet. If you forget to take more than one dose, take it as soon as you
remember and then continue as prescribed.

If you stop taking Perindopril Krka
After stopping treatment, blood pressure may rise again and this may
increase the risk of complications due to high blood pressure, especially in the heart, in the
brain and in the kidneys. The condition of patients with heart failure may worsen up to
warranting hospitalization. Therefore, if you are considering stopping Perindopril Krka,
you must first inform your doctor.
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.

Stop taking the medicine and see your doctor immediately if you experience
any of the following side effectswhich may be serious:

• swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (See section 2 “Warnings and precautions”) (Uncommon - may affect up to 1 in 100 people),
• severe dizziness or fainting due to low blood pressure (Common - may affect up to 1 in 10 people),
• unusually fast or irregular heartbeat, chest pain (angina) or heart attack (Very rare - may affect up to 1 in 10,000 people),
• weakness of arms and legs, or speech problems which may be possible signs of a stroke (Very rare - may affect up to 1 in 10,000 people),
• sudden shortness of breath, chest pain, wheezing or difficulty breathing (bronchospasm) (Uncommon - may affect up to 1 in 100 people),
• inflamed pancreas which can cause severe abdominal and back pain accompanied by a feeling of unwellness (Very rare - may affect up to 1 in 10,000 people),
• yellowing of the skin or eyes (jaundice) which could be a sign of hepatitis (Very rare - may affect up to 1 in 10,000 people),
• skin rash which often starts with red patches on the face, arms or legs (erythema multiforme) (Very rare - may affect up to 1 in 10,000 people).

Side effects that may occur:

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

• headache, dizziness, feeling of spinning (vertigo), tingling or numbness in the hands or feet (paresthesia)
• vision disturbances
• tinnitus, ringing, buzzing, crackling, metallic sound in the ears, etc. (tinnitus)
• low blood pressure (hypotension) and effects related to hypotension
• cough, shortness of breath (dyspnea)
• feeling unwell (nausea), sickness (vomiting), abdominal pain, altered taste (dysgeusia), indigestion (dyspepsia), diarrhea and constipation
• skin rash, itching
• muscle cramps
• weakness (asthenia)

Uncommon (may affect up to 1 in 100):

• low blood sugar (hypoglycemia)
• high blood potassium levels reversible on discontinuation
• low sodium levels
• mood changes or sleep disorders
• drowsiness, fainting,
• palpitations, tachycardia
• vasculitis (inflammation of blood vessels),
• wheezing (bronchospasm)
• dry mouth
• hypersensitivity reactions with sudden swelling of the face, neck, lips, mucous membranes, tongue or throat (with hoarseness or suffocation), possibly also with swelling of the hands and feet (angioedema), urticaria
• photosensitivity reactions (increased sensitivity of the skin to sunlight)
• arthralgia (joint pain), myalgia (muscle pain)
• reduced kidney function
• inability to achieve or maintain an erection (impotence)
• chest pain, malaise, peripheral edema, fever,
• increased urea in the blood and increased blood creatinine,
• falling Rare (may affect up to 1 in 1000):
• changes in laboratory parameters: increased liver enzymes, high serum bilirubin levels.
• worsening of psoriasis.

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

• confusion
• abnormal heart rate (arrhythmia), chest pain (angina pectoris), heart attack and stroke possibly due to excessive lowering of blood pressure in high-risk patients
• inflammation of the lungs associated with accumulation of certain blood cells (eosinophils) in the lung tissue (eosinophilic pneumonia), inflammation of the mucous membranes of the nose (rhinitis)
• inflammation of the pancreas (pancreatitis)
• inflammation of the liver (hepatitis)
• allergic rash appearing as flat red patches (erythema multiforme)
• acute kidney failure

Concentrated urine (dark in color), feeling unwell or sick, muscle cramps,
confusion or convulsions which may be due to inappropriate secretion of ADH (antidiuretic
hormone) which can occur with ACE inhibitors.
Frequency not known (cannot be estimated from available data):

• discoloration, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon).

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

5. How to store Perindopril Krka

Keep this medicine out of the sight and reach of children.
Do not use Perindopril Krka after the expiry date which is stated on the package and on the blister after Exp.
The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture and light.
Do not store at a temperature above 30°C.
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. Package Contents and Other Information

What contains Perindopril Krka

• The active ingredient is perindopril tert-butylamine. Each tablet contains 4 mg of perindopril tert-butylamine, equivalent to 3.338 mg of perindopril.
• The other ingredients are calcium chloride hexahydrate, lactose monohydrate, crospovidone type A, microcrystalline cellulose, anhydrous colloidal silica and magnesium stearate. See section 2 “Perindopril Krka contains lactose (as lactose monohydrate)”.

Description of the appearance of Perindopril Krka and package contents
The tablets are white to almost white, oval (8.5 millimeters in length, thickness 2.8-3.9
mm), slightly biconvex, notched on one side, with rounded edges. The tablet can be divided
into two equal halves.
Perindopril Krka tablets are available in packs of 10, 14, 28, 30, 50, 56, 60, 90 and 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

Perindopril Krka 8 mg tablets
Perindopril tert-butylamine
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 their symptoms are the same as yours, 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 is Perindopril Krka and what it is used for
• 2. What you need to know before you take Perindopril Krka
• 3. How to take Perindopril Krka
• 4. Possible side effects
• 5. How to store Perindopril Krka
• 6. Package Contents and Other Information

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

The active substance of Perindopril Krka tablets belongs to a group of medicines called
angiotensin converting enzyme (ACE) inhibitors. They work by widening blood vessels,
making it easier for the heart to pump blood through them.
Perindopril Krka 8 mg, tablets is used:

• to treat high blood pressure (hypertension),
• to reduce the risk of cardiovascular events, such as heart attack, in patients with stable coronary artery disease (a condition in which blood supply to the heart is reduced or blocked) and in those who have already had a heart attack and/or surgery to improve blood flow to the heart by widening the blood vessels that supply it.

2. What you need to know before taking Perindopril Krka

Do not take Perindopril Krka

• if you are allergic to perindopril, to any other ACE inhibitor or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously experienced reactions of hypersensitivity with sudden swelling of the lips and face, neck, potentially also of hands and feet, or choking or hoarseness (angioedema) after using an ACE inhibitor.
• if someone in your family has suffered from angioedema or if you have had angioedema in any

other circumstance.

• if you are pregnant for more than 3 months (it is best to avoid Perindopril Krka in the early stages of pregnancy,
• see the section relating to pregnancy).
• if you suffer from diabetes or kidney dysfunction and if you have been treated with a medicine containing aliskiren to lower your blood pressure.
• if you are undergoing dialysis or another type of blood filtration. Depending on the machine being used, Perindopril Krka may not be suitable for you;
• if you have kidney problems where the blood supply to them is reduced (renal artery stenosis);
• 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).

The use of Perindopril Krka tablets is not recommended in children and adolescents.

Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril Krka
It is possible that Perindopril Krka is not suitable for you. Before starting treatment with Perindopril
Krka tablets you must therefore inform your doctor of the following.

• if you have been told you have reduced or no blood flow to your heart (unstable angina pectoris)
• if you have been told that your heart muscle is enlarged or if you have a problem with your heart valves
• if you have been diagnosed with a narrowing of the artery supplying blood to your kidneys (renal artery stenosis)
• if you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism)
• if you suffer from diabetes
• if you suffer from any other disease of the kidneys, liver or heart
• if you are on dialysis or have recently had a kidney transplant
• if you are following a low-salt diet, or if you have suffered from excessive vomiting or diarrhoea or if you have used medicines that increase the amount of urine (diuretics)
• if you are taking lithium, a medicine used to treat mania or depression
• if you are taking potassium supplements or salt substitutes containing potassium, or other drugs associated with increased serum potassium e.g. heparin
• if you are to undergo a procedure in which cholesterol is removed from the blood using a special machine (LDL apheresis)
• if you are to undergo treatment to reduce the effects of an allergy to bee or wasp stings
• if you have a collagen disease such as systemic lupus erythematosus or scleroderma, if you are undergoing immunosuppressive therapy
• if your blood pressure has not lowered sufficiently due to your ethnic origin (particularly in patients with black skin)
• if you are about to undergo surgery or general anesthesia
• if you suffer from cerebrovascular disease.
• If you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor blocker (ARB) (known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems due to diabetes.
• aliskiren

The 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 Perindopril Krka".
If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin
in areas such as the throat) may increase:

• racecadotril (used for the treatment of diarrhoea),
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent organ rejection and for cancer).
• vildagliptin (a medicine used to treat diabetes).

Angioedema
In patients treated with ACE inhibitors, including Perindopril Krka, angioedema has been reported (a
serious allergic reaction with swelling of the face, lips, tongue or throat with difficulty
swallowing or breathing). This can happen at any time during treatment. If you develop such
symptoms, stop taking Perindopril Krka and go to the doctor immediately. See also
section 4.
You must tell your doctor if you think you are pregnant (or might become pregnant). Perindopril Krka is not
recommended in the early stages of pregnancy, and must not be taken if you are pregnant for more than 3
months, as it can cause serious harm to the baby if used at this stage (see the section relating
to pregnancy).
Children and adolescents
The use of perindopril is not recommended in children and adolescents up to 18 years of age.

Other medicines and Perindopril Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take over-the-counter medicines without consulting your doctor. This can happen
when you take:

• cold remedies containing pseudoephedrine or phenylephrine as active ingredients
• pain remedies, including acetylsalicylic acid (a substance present in many medicines used to relieve pain and reduce fever, and also to prevent blood clotting).
• potassium supplements
• salt substitutes containing potassium.

Tell your doctor if you are taking any of the following medicines, to make sure it is safe
to take Perindopril Krka tablets at the same time:

• other medicines to treat high blood pressure and/or heart failure, including medicines that increase the amount of urine (diuretics)
• potassium-sparing diuretics (e.g. triamterene, amiloride), potassium supplements or salt substitutes containing potassium, other medicines that can increase potassium levels in the body such as heparin (a medicine used to thin the blood to prevent clots), trimethoprim and co-trimoxazole also known as trimethoprim/sulfamethoxazole (for the treatment of infections caused by bacteria) and cyclosporine or tacrolimus (immunosuppressant medicines used to prevent organ rejection),
• potassium-sparing diuretics used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• medicines for the treatment of irregular heartbeat (procainamide)
• medicines for the treatment of diabetes (insulin or oral antidiabetics such as vildagliptin)
• baclofen (used for the treatment of muscle stiffness and diseases such as multiple sclerosis),
• medicines for the treatment of gout (allopurinol)
• non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac), including acetylsalicylic acid for pain
• vasodilators including nitrates (products that dilate blood vessels)
• estramustine (used in cancer therapy),
• medicines with a stimulating action in a particular area of the nervous system such as ephedrine, noradrenaline or adrenaline (sympathomimetics)
• medicines for the treatment of mania or depression (lithium)
• medicines for mental illnesses such as depression, anxiety, schizophrenia or other psychoses (tricyclic antidepressants and antipsychotics)
• gold for injection for the treatment of arthritis (sodium aurothiomalate)
• medicines that are often used to treat diarrhoea (racecadotril)
• medicines that are often used to prevent organ rejection (sirolimus, everolimus, temsirolimus or other medicines belonging to the class of inhibitors called mTOR). See section “Warnings and precautions”. Your doctor may need to adjust the dose and/or take other precautions:
• if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Perindopril Krka" and "Warnings and precautions").

Perindopril Krka with food and drink
It is recommended to take Perindopril Krka before meals to reduce the influence of food on the action
of the medicine.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist before taking this medicine.

Pregnancy
You must tell your doctor if you think you are pregnant (or might become pregnant). Your doctor will normally
advise you to stop taking Perindopril Krka before becoming pregnant or as soon as you find
out you are pregnant and advise you to take another medicine instead of Perindopril Krka. Perindopril Krka
is not recommended in the early stages of pregnancy, and must not be taken if you are pregnant for more than
3 months, as it can cause serious harm to the baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Perindopril Krka is not recommended
for mothers who are breastfeeding, and your doctor may choose another treatment if you want to breastfeed,
especially if your baby is newly born or premature.

Driving and using machines
It is advisable not to drive vehicles or use machines until you know how Perindopril Krka
affects you. Perindopril Krka usually does not impair alertness but in some patients dizziness or weakness may occur due to low blood pressure, especially at the beginning of
treatment or in association with other antihypertensive medicines.
As a result, the ability to drive or use machines may be impaired.

Perindopril Krka tablets contains lactose (as lactose monohydrate).
If your doctor has told you that you have an intolerance to some sugars, tell your doctor before taking
this medicine.

3. How to take Perindopril Krka

as your doctor or pharmacist have told you. If you have any doubts, ask your doctor or pharmacist.
The recommended dose for the treatment of high blood pressure is 4 mg of perindopril (1
tablet of Perindopril Krka 4 mg) once a day. If necessary, the dose may be
increased to 8 mg of perindopril (2 tablets of Perindopril Krka 4 mg once a day or 1
tablet of Perindopril Krka 8 mg once a day).
The initial recommended dose for the treatment of stable coronary artery disease is 4 mg of perindopril
(1 tablet of Perindopril Krka 4 mg) once a day; if it is well tolerated, the dose may be
increased to 8 mg of perindopril (2 tablets of Perindopril Krka 4 mg or 1 tablet of Perindopril
Krka 8 mg) once a day.
Take the tablet with a glass of water, preferably at the same time each day, in the morning,
before a meal.
During the course of treatment, your doctor will adjust the dosage according to the effect of the treatment,
according to your needs. The dosage may be reduced compared to the usual one and will be determined
by the doctor:

• in elderly patients
• in patients with impaired renal function
• in patients with high blood pressure caused by narrowing of the arteries supplying blood to the kidneys (renovascular hypertension)
• in patients who are being treated at the same time with medicines that increase the amount of urine (diuretics)
• in hypertensive patients in whom diuretics cannot be stopped
• in patients with severe heart failure and
• in patients treated with medicines that dilate blood vessels - vasodilators). The doctor will determine the duration of treatment based on your medical condition.

Use in children
Use in children has not been established. Therefore, use in children is not recommended.
If you feel that the effect of the medicine is too strong or too weak, tell your doctor or
pharmacist.

If you take more Perindopril Krka than you should
If you have taken too many tablets, inform your doctor or pharmacist immediately.
The most likely sign of overdose is a sudden drop in blood pressure
(hypotension). Other symptoms may include a fast or slow heartbeat, unpleasant sensations of
irregular and/or strong heartbeats, hyperventilation, dizziness, anxiety and/or cough.
If your blood pressure drops considerably, you should lie down, raise your legs and use a small
pillow to support your head.

If you forget to take Perindopril Krka
It is important to take the medicine every day. However, if you forget to take a dose,
continue with the next dose as usual. Do not take a double dose to make up for the
missed tablet. If you forget to take more than one dose, take it as soon as you
remember and then continue as prescribed.

If you stop taking Perindopril Krka
After stopping treatment, blood pressure may rise again and this may
increase the risk of complications due to high blood pressure, especially in the heart, in the
brain and in the kidneys. The condition of patients with heart failure may worsen to the point of
requiring hospitalization. Therefore, if you are considering stopping Perindopril Krka,
you should first inform your doctor.
If you have any questions about using 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.

Stop taking the medicine and contact your doctor immediately if you experience
any of the following side effectswhich may be serious:

• swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (See section 2 “Warnings and precautions”) (Uncommon - may affect up to 1 in 100 people),
• severe dizziness or fainting due to low blood pressure (Common - may affect up to 1 in 10 people),
• unusually fast or irregular heartbeat, chest pain (angina) or heart attack (Very rare - may affect up to 1 in 10,000 people),
• weakness of arms and legs, or speech problems which may be possible signs of a stroke (Very rare - may affect up to 1 in 10,000 people),
• sudden shortness of breath, chest pain, wheezing or difficulty breathing (bronchospasm) (Uncommon - may affect up to 1 in 100 people),
• inflamed pancreas which can cause severe abdominal and back pain accompanied by a feeling of unwellness (Very rare - may affect up to 1 in 10,000 people),
• yellowing of the skin or eyes (jaundice) which could be a sign of hepatitis (Very rare - may affect up to 1 in 10,000 people),
• skin rash which often starts with red spots on the face, arms or legs (erythema multiforme) (Very rare - may affect up to 1 in 10,000 people).

Side effects that may occur:

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

• headache, dizziness, feeling of spinning (vertigo), tingling or numbness in the hands or feet (paresthesia)
• vision disturbances
• tinnitus, ringing, buzzing, metallic sound in the ears, etc.
• low blood pressure (hypotension) and effects related to hypotension
• cough, shortness of breath (dyspnea)
• feeling sick (nausea), sickness (vomiting), abdominal pain, altered taste (dysgeusia), indigestion (dyspepsia), diarrhoea and constipation
• rash, itching
• muscle cramps
• weakness (asthenia)

Uncommon (may affect up to 1 in 100):

• low blood sugar (hypoglycemia)
• high blood potassium levels that are reversible upon discontinuation
• low sodium levels
• changes in mood or sleep disturbances
• drowsiness, fainting
• palpitations, tachycardia
• vasculitis (inflammation of blood vessels)
• wheezing (bronchospasm)
• dry mouth
• hypersensitivity reactions with sudden swelling of the face, neck, lips, mucous membranes, tongue or throat (with hoarseness or suffocation), possibly also with swelling of the hands and feet (angioedema), urticaria
• photosensitivity reactions (increased sensitivity of the skin to the sun)
• arthralgia (joint pain), myalgia (muscle pain)
• reduced kidney function
• inability to achieve or maintain an erection (impotence)
• chest pain, malaise, peripheral edema, fever
• increased urea in the blood, and increased creatinine in the blood
• falls.

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

• changes in laboratory parameters: increased liver enzymes, high serum bilirubin levels.
• worsening of psoriasis.

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

• confusion
• abnormal heart rate (arrhythmia), chest pain (angina pectoris), heart attack and stroke possibly due to excessive lowering of blood pressure in high-risk patients
• inflammation of the lungs associated with accumulation of certain blood cells (eosinophils) in the lung tissue (eosinophilic pneumonia), inflammation of the mucous membranes of the nose (rhinitis)
• inflammation of the pancreas (pancreatitis)
• inflammation of the liver (hepatitis)
• allergic rash that appears as flat red spots (erythema multiforme)
• acute kidney failure

Concentrated urine (dark in color), feeling unwell or sick, muscle cramps,
confusion or convulsions which may be due to inappropriate secretion of ADH (antidiuretic
hormone) which can occur with ACE inhibitors.
Frequency not known (cannot be estimated based on available data):

• discoloration, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Perindopril Krka

Keep this medicine out of the sight and reach of children.
Do not use Perindopril Krka after the expiry date which is stated on the package and on the blister after Exp.
The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture and light.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Perindopril Krka contains

• The active ingredient is perindopril tert-butylamine. Each tablet contains 8mg of perindopril tert-butylamine, equivalent to 6.676 mg of perindopril.
• The other ingredients are calcium chloride hexahydrate, lactose monohydrate, crospovidone type A, microcrystalline cellulose, anhydrous colloidal silica and magnesium stearate. See section 2 “Perindopril Krka contains lactose (as lactose monohydrate)”.

Description of the appearance of Perindopril Krka and contents of the pack
The tablets are white to almost white, round (diameter 12 mm, slightly biconvex,
engraved on one side, with bevelled edges. The fracture line is designed to facilitate breaking for easier
swallowing of the tablet and not for dividing into two equal parts.
Perindopril Krka tablets are available in packs of 10, 14, 28, 30, 50, 56, 60, 90 and 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