Package leaflet: Information for the patient

Perindopril Krka 2 mg tablets

Perindopril tert-butylamine
Generic medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Perindopril Krka is and what it is used for
What you need to know before taking Perindopril Krka
How to take Perindopril Krka
Possible side effects
How to store Perindopril Krka
Contents of the pack and other information

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

The active substance in Perindopril Krka tablets belongs to a group of medicines called
angiotensin-converting enzyme (ACE) inhibitors. They work by dilating blood vessels,
making it easier for the heart to pump blood through them.
Perindopril Krka 2 mg tablets are 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 cardiac 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 a procedure 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 hypersensitivity reactions with sudden swelling of the lips and face, neck, potentially also hands and feet, or suffocation or hoarseness (angioedema) after taking an ACE inhibitor;
if someone in your family has suffered from angioedema or if you have had angioedema under any other circumstances;
if you are more than 3 months pregnant (it is better to avoid Perindopril Krka during early pregnancy – see section on pregnancy);
if you have diabetes or renal dysfunction and are being treated with a medicine containing aliskiren to lower blood pressure;
if you are undergoing dialysis or another type of blood filtration. Depending on the equipment used, Perindopril Krka may not be suitable for you;
if you have kidney problems due to reduced blood flow to the kidneys (renal artery stenosis);
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, for example in 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 inform your doctor if:

you have been told that you have reduced or no blood flow to the heart (unstable angina pectoris);
you have been told that your heart muscle is enlarged or if you have a heart valve disorder;
you have been diagnosed with narrowing of the artery supplying blood to the kidneys (renal artery stenosis);
you have abnormally high levels of a hormone called aldosterone in your blood (primary hyperaldosteronism);
you have diabetes;
you suffer from any other kidney, liver, or heart disease;
you are on dialysis or have recently undergone kidney transplantation;
you are on a low-salt diet, or if you have experienced excessive vomiting or diarrhea, or have used medicines that increase urine output (diuretics);
you are taking lithium, a medicine used to treat mania or depression;
you are taking potassium supplements or potassium-containing salt substitutes, or other drugs that may increase serum potassium levels, such as heparin;
you are scheduled to undergo a procedure to remove cholesterol from the blood using a special machine (LDL apheresis);
you are scheduled to receive treatment for allergic reactions to bee or wasp stings;
you have a connective tissue disease such as systemic lupus erythematosus or scleroderma, or are undergoing immunosuppressive therapy;
your blood pressure has not decreased sufficiently due to your ethnic background (especially in black patients);
you are about to undergo surgery or general anesthesia;
you have cerebrovascular disease;
you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor blocker (ARB) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems due to diabetes;
- aliskiren. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals. See also information under "Do not take Perindopril Krka".
you are taking any of the following medicines, as the risk of angioedema (rapid swelling under the skin, for example in 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 in cancer treatment);
- vildagliptin (a medicine used to treat diabetes).

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, possibly causing difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Perindopril Krka. This may occur at any time during treatment. If you develop such symptoms, stop taking Perindopril Krka immediately and contact your doctor without delay. See also section 4.
You must inform your doctor if you think you are pregnant (or could become pregnant). Perindopril Krka is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if used at this stage (see section on pregnancy).
Children and adolescents
The use of perindopril is not recommended in children and adolescents under 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 first consulting your doctor. This may occur when taking:

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

Inform your doctor if you are taking any of the following medicines to ensure 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 urine output (diuretics);
potassium-sparing diuretics (e.g. triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes, and other medicines that may 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, used to treat bacterial infections), and cyclosporine or tacrolimus (immunosuppressive medicines used to prevent rejection of transplanted organs);
potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily;
medicines used to treat irregular heartbeat (procainamide);
medicines used to treat diabetes (insulin or oral antidiabetics such as vildagliptin);
baclofen (used to treat muscle stiffness and conditions such as multiple sclerosis);
medicines used to treat gout (allopurinol);
non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac), including acetylsalicylic acid for pain relief;
vasodilators including nitrates (substances that dilate blood vessels);
estramustine (used in cancer therapy);
medicines with a stimulating effect on specific areas of the nervous system such as ephedrine, noradrenaline, or adrenaline (sympathomimetics);
medicines used to treat mania or depression (lithium);
medicines used for mental illnesses such as depression, anxiety, schizophrenia, or other psychoses (tricyclic antidepressants and antipsychotics);
injectable gold used to treat arthritis (sodium aurothiomalate);
medicines often used to treat diarrhea (racecadotril);
medicines often used to prevent rejection of organ transplants (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 your 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 medicine's action.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, talk to your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you think you are pregnant (or could become pregnant). Your doctor will usually advise you to stop taking Perindopril Krka before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine. Perindopril Krka is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if used beyond the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to start breastfeeding. Perindopril Krka is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or premature.
Driving and using machines
It is advisable not to drive or operate machinery until you know how Perindopril Krka affects you. Perindopril Krka generally does not impair alertness, but in some patients dizziness or weakness due to low blood pressure may occur, especially at the beginning of treatment or when used in combination with other antihypertensive medicines.
As a result, your ability to drive or operate machinery may be impaired.
Perindopril Krka tablets contain lactose (as monohydrate lactose)
If your doctor has informed you that you have an intolerance to certain sugars, inform your doctor before taking this medicine.

3. How to take Perindopril Krka

Take this medicine exactly as described in this leaflet, or as your doctor or pharmacist has prescribed. If you are in doubt, 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 daily. When necessary, the dose may be increased to 8 mg of perindopril (2 tablets of Perindopril Krka 4 mg) once daily.

The recommended dose for the treatment of symptomatic heart failure is 2 mg of perindopril (1 tablet of Perindopril Krka 2 mg) once daily; the dose may be increased, as needed, to 4 mg of perindopril (1 tablet of Perindopril Krka 4 mg or 2 tablets of Perindopril Krka 2 mg) once daily.

The recommended starting dose for the treatment of stable coronary artery disease is 4 mg of perindopril (1 tablet of Perindopril Krka 4 mg) once daily; if well tolerated, the dose may be increased to 8 mg of perindopril (2 tablets of Perindopril Krka 4 mg) daily.

Take the tablet with a glass of water, preferably at the same time each day, in the morning, before a meal.

During treatment, your doctor will adjust the dosage according to the treatment effect and your individual needs. The dosage may be reduced from the usual dose and will be determined by your doctor:

in elderly patients
in patients with impaired kidney function
in patients with high blood pressure caused by narrowing of the arteries supplying blood to the kidneys (renovascular hypertension)
in patients who have been treated simultaneously with medicines that increase urine production (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 (vasodilators)

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

Use in children
The use of this medicine in children has not been established. Therefore, use in children is not recommended.

If you feel the effect of the medicine is too strong or too weak, inform 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 significantly, 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 at the usual time. 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, then continue as prescribed.

If you stop taking Perindopril Krka
After stopping treatment, blood pressure may rise again, increasing the risk of complications due to high blood pressure, especially affecting the heart, brain, and kidneys. The condition of patients with heart failure may worsen, possibly requiring hospitalization. Therefore, if you are considering stopping Perindopril Krka, you must first consult your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
Stop taking the medicine and go to the doctor immediately if you experience
any of the following side effects, which 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 in arms and legs, or problems speaking which may be possible signs of stroke (Very rare – may affect up to 1 in 10,000 people),
sudden breathlessness, chest pain, shortness of breath or difficulty breathing (bronchospasm) (Uncommon – may affect up to 1 in 100 people),
inflamed pancreas which may cause severe abdominal and back pain accompanied by a feeling of illness (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 that 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, sensation of spinning (vertigo), tingling or numbness in hands or feet (paraesthesia)
vision disturbances
ringing, buzzing, roaring, metallic sounds in the ears, etc. (tinnitus)
low blood pressure (hypotension) and effects related to hypotension
cough, shortness of breath (dyspnea)
feeling unwell (nausea), malaise (vomiting), abdominal pain, altered taste (dysgeusia), indigestion (dyspepsia), diarrhoea and constipation
skin rash, itching
muscle cramps
weakness (asthenia)

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

low blood sugar (hypoglycaemia)
reversible increase in blood potassium levels upon discontinuation
low sodium levels
mood changes or sleep disturbances
drowsiness, fainting
palpitations, tachycardia
vasculitis (inflammation of blood vessels)
laboured breathing (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 skin sensitivity to sunlight)
arthralgia (joint pain), myalgia (muscle pain)
reduced kidney function
inability to achieve or maintain erection (impotence)
chest pain, malaise, peripheral oedema, fever
increased blood urea and increased blood creatinine
falls

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

changes in laboratory parameters: increased liver enzymes, elevated serum bilirubin levels
worsening of psoriasis

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

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
lung inflammation associated with accumulation of certain blood cells (eosinophils) in 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

Dark-coloured (concentrated) urine, feeling unwell or malaise, muscle cramps,
confusion or seizures which may be due to inappropriate secretion of ADH (antidiuretic hormone),
which may occur with ACE inhibitors.
Frequency not known (cannot be estimated from available data):

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
please inform your doctor or pharmacist. Side effects can also be reported
directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects
helps 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 stated on the carton and blister after Exp.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture and light.
Do not store above 30°C.
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 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 components are calcium chloride dihydrate, lactose monohydrate, crospovidone (type A), microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate. See section 2 “Perindopril Krka tablets contain lactose (as monohydrate)”.

Description of the appearance of Perindopril Krka and pack contents
The tablets are white to almost white, round (7 mm in diameter), slightly biconvex, with bevelled edges.
Perindopril Krka tablets are available in blister packs containing 10, 14, 28, 30, 50, 56, 60, 90 and 100 tablets.
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

Patient Information Leaflet

Perindopril Krka 4 mg tablets

Perindopril tert-butylamine
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 reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Perindopril Krka is and what it is used for
What you need to know before taking Perindopril Krka
How to take Perindopril Krka
Possible side effects
How to store Perindopril Krka
Contents of the pack and other information

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

The active substance in Perindopril Krka tablets belongs to a group of medicines called
angiotensin-converting enzyme (ACE) inhibitors. These work by dilating blood vessels,
thereby making it easier for the heart to pump blood through them.
Perindopril Krka 4 mg tablets are 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 cardiac 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 previously had a heart attack and/or undergone a procedure to improve blood flow to the heart by widening the blood vessels supplying it.

2. What you should 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 hypersensitivity reactions with sudden swelling of the lips and face, neck, potentially also hands and feet, or suffocation or hoarseness (angioedema) after taking an ACE inhibitor.
if anyone in your family has had angioedema or if you have ever had angioedema under any circumstances.
if you are more than 3 months pregnant (Perindopril Krka should be avoided during early pregnancy; see the section on pregnancy).
if you have diabetes or renal dysfunction and are being treated with a medicine containing aliskiren to lower blood pressure.
if you are undergoing dialysis or another type of blood filtration. Depending on the equipment used, Perindopril Krka may not be suitable for you.
if you have kidney problems due to reduced blood flow to the kidneys (renal artery stenosis).
if you are taking or have recently taken sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in 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, inform your doctor if any of the following apply to you:

if you have been diagnosed with reduced or no blood flow to the heart (unstable angina pectoris)
if you have been told that your heart muscle is enlarged or if you have a heart valve disorder
if you have been diagnosed with narrowing of the artery supplying blood to the kidneys (renal artery stenosis)
if you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism)
if you have diabetes
if you suffer from any other kidney, liver, or heart disease
if you are on dialysis or have recently undergone a kidney transplant
if you are on a low-salt diet, or if you have experienced excessive vomiting or diarrhoea, or if you have taken medicines that increase urine output (diuretics)
if you are taking lithium, a medicine used to treat mania or depression
if you are taking potassium supplements or potassium-containing salt substitutes, or other medicines that may increase serum potassium levels, such as heparin
if you are scheduled to undergo a procedure in which cholesterol is removed from the blood using a special machine (LDL apheresis)
if you are scheduled to receive 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, or if you are receiving immunosuppressive therapy
if your blood pressure has not decreased sufficiently due to your ethnic background (particularly in black patients)
if you are about to undergo surgery or general anaesthesia
if you have a cerebrovascular disease
if you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor blocker (ARB) (also known as sartans – for example valsartan, telmisartan, irbesartan), especially if you have kidney problems due to diabetes
- aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) 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, for example in the throat) may increase:
- racecadotril (used to treat diarrhoea)
- sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment)
- vildagliptin (a medicine used to treat diabetes)

Children and adolescents
The use of perindopril is not recommended in children and adolescents under 18 years of age.

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

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

Inform your doctor if you are taking any of the following medicines to ensure 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 urine output (diuretics)
potassium-sparing diuretics (e.g. triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes, and other medicines that may 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, used to treat bacterial infections), and cyclosporine or tacrolimus (immunosuppressive medicines used to prevent rejection of transplanted organs)
potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily
medicines used to treat irregular heartbeat (procainamide)
medicines used to treat diabetes (insulin or oral antidiabetics such as vildagliptin)
baclofen (used to treat muscle stiffness and conditions such as multiple sclerosis)
medicines used to treat gout (allopurinol)
non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac), including acetylsalicylic acid for pain relief
vasodilators, including nitrates (substances that dilate blood vessels)
estramustine (used in cancer therapy)
medicines with stimulant effects on specific areas of the nervous system, such as ephedrine, noradrenaline, or adrenaline (sympathomimetics)
medicines used to treat mania or depression (lithium)
medicines used for mental illnesses such as depression, anxiety, schizophrenia, or other psychoses (tricyclic antidepressants and antipsychotics)
gold injections used to treat arthritis (sodium aurothiomalate)
medicines often used to treat diarrhoea (racecadotril)
medicines often used to prevent rejection of organ transplants (sirolimus, everolimus, temsirolimus, or other medicines belonging to the class of inhibitors known as mTOR inhibitors). See section "Warnings and precautions".

Your doctor may need to adjust your 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").

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

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

Pregnancy
You must inform your doctor if you think you are pregnant (or could become pregnant). Your doctor will usually advise you to stop taking Perindopril Krka before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Perindopril Krka is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause severe harm to the unborn child if used after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or intend to start breastfeeding. Perindopril Krka is not recommended for breastfeeding mothers. Your doctor may choose an alternative treatment if you wish to breastfeed, particularly if your baby is newborn or premature.

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

Perindopril Krka tablets contain lactose (as monohydrate lactose)
If your doctor has informed you of an intolerance to certain sugars, inform your doctor before taking this medicine.

3. How to take Perindopril Krka

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has prescribed. If you are unsure, 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 daily. If necessary, the dose may be increased to 8 mg of perindopril (2 tablets of Perindopril Krka 4 mg) once daily.

The recommended dose for the treatment of symptomatic heart failure is 2 mg of perindopril (1 tablet of Perindopril Krka 2 mg) once daily; the dose may be increased, if needed, to 4 mg of perindopril (1 tablet of Perindopril Krka 4 mg or 2 tablets of Perindopril Krka 2 mg) once daily.

The recommended starting dose for the treatment of stable coronary artery disease is 4 mg of perindopril (1 tablet of Perindopril Krka 4 mg) once daily; if this dose is well tolerated, it may be increased to 8 mg of perindopril (2 tablets of Perindopril Krka 4 mg) daily.

Take the tablet with a glass of water, preferably at the same time each day, in the morning, before a meal.

During treatment, your doctor will adjust the dosage according to the treatment effect and your individual needs. The dosage may be reduced from the usual dose and will be determined by your doctor:

in elderly patients
in patients with impaired kidney 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 simultaneously with medicines that increase urine production (diuretics)
in hypertensive patients in whom diuretics cannot be discontinued
in patients with severe heart failure
in patients treated with medicines that dilate blood vessels (vasodilators)

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

Use in children
The use of Perindopril Krka in children has not been established. Therefore, use in children is not recommended.

If you feel that the effect of this medicine is too strong or too weak, inform 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 significantly, 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 miss more than one dose, take it as soon as you remember, then continue as prescribed.

If you stop taking Perindopril Krka
After stopping treatment, your blood pressure may rise again, increasing the risk of complications due to high blood pressure, especially affecting the heart, brain, and kidneys. The condition of patients with heart failure may worsen, possibly requiring hospitalization. Therefore, if you are considering stopping Perindopril Krka, you must first consult your doctor.

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 experiences them.
Stop taking the medicine and see a doctor immediately if you experience
any of the following side effects, which 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 in arms and legs, or speech difficulties which may be possible signs of stroke (Very rare – may affect up to 1 in 10,000 people),
sudden shortness of breath, chest pain, breathlessness or difficulty breathing (bronchospasm) (Uncommon – may affect up to 1 in 100 people),
inflamed pancreas which may cause severe abdominal and back pain accompanied by a feeling of illness (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 often starting 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, spinning sensation (vertigo), tingling or pins and needles in hands or feet (paraesthesia)
vision disturbances
ringing, buzzing, roaring, metallic sounds in the ears, etc. (tinnitus)
low blood pressure (hypotension) and effects related to hypotension
cough, shortness of breath (dyspnoea)
feeling unwell (nausea), illness (vomiting), abdominal pain, altered taste (dysgeusia), indigestion (dyspepsia), diarrhoea and constipation
skin rash, itching
muscle cramps
weakness (asthenia)

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

low blood sugar (hypoglycaemia)
high blood potassium levels, reversible upon discontinuation
low sodium levels
mood changes or sleep disturbances
drowsiness, fainting
palpitations, tachycardia
vasculitis (inflammation of blood vessels)
laboured breathing (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 skin sensitivity to sunlight)
arthralgia (joint pain), myalgia (muscle pain)
reduced kidney function
inability to achieve or maintain an erection (impotence)
chest pain, malaise, peripheral oedema, fever
increased blood urea and increased blood creatinine
hair loss

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

changes in laboratory parameters: increased liver enzymes, elevated serum bilirubin levels
worsening of psoriasis

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

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
lung inflammation associated with accumulation of certain blood cells (eosinophils) in 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 colour), feeling unwell or malaise, muscle cramps,
confusion or seizures which may be due to inappropriate ADH (antidiuretic hormone) secretion, which can occur with ACE inhibitors.
Frequency not known (cannot be estimated from available data):

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps 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 stated on the carton and blister after Exp.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture and light.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Perindopril Krka contains

The active substance is perindopril tert-butylamine. Each tablet contains 4 mg of perindopril tert-butylamine, equivalent to 3.338 mg of perindopril.
The other components are calcium chloride dihydrate, 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 millimetres in length, thickness 2.8–3.9 mm), slightly biconvex, scored on one side, with bevelled edges. The tablet can be divided 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 in Italy:
KRKA Farmaceutici Milano s.r.l., Viale Achille Papa 30, 20149 Milano, Italy

Patient information leaflet

Perindopril Krka 8 mg tablets

Perindopril tert-butylamine
Generic medicine
Please read this 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, ask 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 may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Perindopril Krka is and what it is used for
What you need to know before taking Perindopril Krka
How to take Perindopril Krka
Possible side effects
How to store Perindopril Krka
Contents of the pack and other information

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

to treat high blood pressure (hypertension),
to reduce the risk of cardiac 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 previously had a heart attack and/or undergone a procedure to improve blood flow to the heart by widening the blood vessels supplying 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 hypersensitivity reactions with sudden swelling of the lips and face, neck, potentially also hands and feet, or suffocation or hoarseness (angioedema) after using an ACE inhibitor.
if anyone in your family has suffered from angioedema or if you have had angioedema under any other circumstances.
if you are more than 3 months pregnant (it is better to avoid Perindopril Krka during early pregnancy; see the section on pregnancy).
if you have diabetes or renal dysfunction and are being treated with a medicine containing aliskiren to lower blood pressure.
if you are undergoing dialysis or another type of blood filtration. Depending on the equipment used, Perindopril Krka may not be suitable for you.
if you have kidney problems resulting in reduced blood flow to the kidneys (renal artery stenosis).
if you have taken or are currently 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 beneath the skin, for example in 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 inform your doctor if any of the following apply to you:

if you have been told that you have reduced or no blood flow to the heart (unstable angina pectoris)
if you have been told that your heart muscle is enlarged or if you have a heart valve disorder
if you have been diagnosed with narrowing of the artery supplying blood to the kidneys (renal artery stenosis)
if you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism)
if you have diabetes
if you suffer from any other kidney, liver, or heart disease
if you are undergoing dialysis or have recently received a kidney transplant
if you are on a low-salt diet, or if you have experienced excessive vomiting or diarrhea, or if you have used medicines that increase urine output (diuretics)
if you are taking lithium, a medicine used to treat mania or depression
if you are taking potassium supplements or potassium-containing salt substitutes, or other medicines associated with increased serum potassium levels, e.g. heparin
if you are scheduled to undergo a procedure where cholesterol is removed from the blood using a special machine (LDL apheresis)
if you are scheduled to receive 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, or if you are undergoing immunosuppressive therapy
if your blood pressure has not been adequately lowered due to your ethnic background (particularly in black patients)
if you are about to undergo surgery or general anesthesia
if you have 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

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information under the section "Do not take Perindopril Krka".
If you are taking any of the following medicines, the risk of angioedema (rapid swelling beneath the skin, for example in 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 in cancer treatment)
vildagliptin (a medicine used to treat diabetes)

Angioedema
In patients treated with ACE inhibitors, including Perindopril Krka, angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat causing difficulty in swallowing or breathing) has been reported. This may occur at any time during treatment. If you develop such symptoms, stop taking Perindopril Krka immediately and contact your doctor without delay. See also section 4.
You must inform your doctor if you think you are pregnant (or could become pregnant). Perindopril Krka is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause severe harm to the unborn child when used at this stage (see the section on pregnancy).

Children and adolescents
The use of perindopril is not recommended in children and adolescents under 18 years of age.

Other medicines and Perindopril Krka
Inform 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 may occur when you take:

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

Inform your doctor if you are taking any of the following medicines, to ensure 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 urine output (diuretics)
potassium-sparing diuretics (e.g. triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes, other medicines that may 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 (used to treat bacterial infections), and cyclosporine or tacrolimus (immunosuppressive medicines used to prevent rejection of transplanted organs)
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 to treat irregular heartbeat (procainamide)
medicines to treat diabetes (insulin or oral antidiabetics such as vildagliptin)
baclofen (used to treat muscle stiffness and conditions such as multiple sclerosis)
medicines to treat gout (allopurinol)
non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac), including acetylsalicylic acid for pain
vasodilators including nitrates (substances that dilate blood vessels)
estramustine (used in cancer therapy)
medicines with a stimulating effect on a specific area of the nervous system such as ephedrine, noradrenaline, or adrenaline (sympathomimetics)
medicines to treat mania or depression (lithium)
medicines for mental illnesses such as depression, anxiety, schizophrenia, or other psychoses (tricyclic antidepressants and antipsychotics)
gold injections for the treatment of arthritis (sodium aurothiomalate)
medicines often used to treat diarrhea (racecadotril)
medicines often used to prevent rejection of organ transplants (sirolimus, everolimus, temsirolimus, or other medicines belonging to the class of inhibitors called mTOR inhibitors). See section "Warnings and precautions". Your doctor may need to adjust your 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 minimize the influence of food on the medicine's effect.

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

Pregnancy
You must inform your doctor if you think you are pregnant (or could become pregnant). Your doctor will usually advise you to stop taking Perindopril Krka before becoming pregnant or as soon as pregnancy is detected, and will recommend an alternative medicine. Perindopril Krka is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if used after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or intend to start breastfeeding. Perindopril Krka is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines
It is advisable not to drive 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 due to low blood pressure may occur, particularly at the beginning of treatment or when used in combination with other antihypertensive medicines.
As a result, your ability to drive or operate machinery may be impaired.

Perindopril Krka tablets contain lactose (as monohydrate lactose).
If your doctor has informed you that you have an intolerance to certain sugars, inform your doctor before taking this medicine.

3. How to take Perindopril Krka

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed 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 daily. If necessary, the dose may be increased to 8 mg of perindopril (2 tablets of Perindopril Krka 4 mg once daily or 1 tablet of Perindopril Krka 8 mg once daily).
The recommended starting dose for the treatment of stable coronary heart disease is 4 mg of perindopril (1 tablet of Perindopril Krka 4 mg) once daily; if this dose is well tolerated, it may be increased to 8 mg of perindopril (2 tablets of Perindopril Krka 4 mg or 1 tablet of Perindopril Krka 8 mg) once daily.
Take the tablet with a glass of water, preferably at the same time each day, in the morning, before a meal.
During treatment, your doctor will adjust the dosage according to the treatment response and your individual needs. The dosage may be reduced from the usual dose and will be determined by your doctor:

in elderly patients
in patients with impaired kidney 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 simultaneously with medicines that increase urine output (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 (vasodilators)
Your doctor will determine the duration of treatment based on your medical condition.

Use in children
The use of this medicine 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, inform 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 forceful heartbeats, hyperventilation, dizziness, anxiety, and/or cough.
If your blood pressure drops significantly, 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, then continue as prescribed.

If you have any questions about the use of this medicine, consult 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 effects, which 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 in arms and legs, or speech problems which could be possible signs of stroke (Very rare – may affect up to 1 in 10,000 people),
sudden breathlessness, chest pain, shortness of breath or difficulty breathing (bronchospasm) (Uncommon – may affect up to 1 in 100 people),
inflamed pancreas which may cause severe abdominal and back pain accompanied by a feeling of illness (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, sensation of spinning (vertigo), tingling or pins and needles in hands or feet (paraesthesia)
vision disorders
ringing, buzzing, roaring, metallic sound in the ears, etc. (tinnitus)
low blood pressure (hypotension) and effects related to hypotension
cough, shortness of breath (dyspnea)
feeling unwell (nausea), illness (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 people):

low blood pressure (hypoglycaemia)
high blood potassium level, reversible upon discontinuation
low sodium level
mood changes or sleep disturbances
drowsiness, fainting
palpitations, tachycardia
vasculitis (inflammation of blood vessels)
laboured breathing (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 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 erection (impotence)
chest pain, malaise, peripheral oedema, fever
increased blood urea, and increased blood creatinine
fall.

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

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

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

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
lung inflammation associated with accumulation of certain blood cells (eosinophils) in 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 renal failure

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported
directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects helps 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 carton and on the blister after Exp.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture and light.
Do not store above 30°C.
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 Perindopril Krka contains

The active substance is perindopril tert-butylamine. Each tablet contains 8 mg of perindopril tert-butylamine, equivalent to 6.676 mg of perindopril.
The other components are calcium chloride dihydrate, 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 the contents of the pack
The tablets are white to almost white, round (12 mm in diameter, slightly biconvex,
bevelled edges), with a break line on one side. The break line is intended to facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet into 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 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