Package Leaflet: Information for the Patient

Perindopril Krka 8 mg Tablets EFG

perindoprilterbutilamine

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

The active ingredient of Perindopril Krka belongs to the group of anti-hypertensive medications, angiotensin-converting enzyme (ACE) inhibitors.

Perindopril Krka is indicated for:

• treatment of high blood pressure (hypertension),
• reducing the risk of cardiac events, such as myocardial infarction, in patients with established coronary artery disease (a situation in which blood flow to the heart is blocked or reduced) or in patients who have previously experienced myocardial infarction and/or have undergone surgical intervention to improve blood flow to the heart through coronary artery widening.

Do not take Perindopril Krka

• If you are allergic to perindopril, any of the other components of this medication (listed in section 6), or any other ACE inhibitor,
• If you have had a previous hypersensitivity reaction that has included swelling of the lips, face, and neck, including possibly hands and feet, flushing, or hoarseness (angioedema) after taking an ACE inhibitor,
• If there is a family or personal history of angioedema in any other situation,
• If you are more than three months pregnant (it is better not to take Perindopril Krka in the initial stage of pregnancy, first trimester - see section pregnancy),
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén,
• If you are receiving dialysis or any other type of blood filtration. Depending on the machine used, Perindopril Krka may not be suitable for you,
• If you have kidney problems where the blood supply to the kidneys is reduced (renal artery stenosis),
• If you have taken or are currently taking sacubitril/valsartán, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Perindopril Krka.

Perindopril Krka may not be suitable for you, or may require regular individualized follow-up.

Therefore, before starting to take Perindopril Krka, inform your doctor of the following:

• If you have aortic stenosis (narrowing of the main blood vessel that leaves the heart),If you have an increase in the thickness of the heart muscle or have problems with the heart valves,
• If you have narrowing of the renal arteries (renal artery stenosis),
• If you have abnormally high levels of a hormone called aldosterone in the blood (primary aldosteronism),
• If you have diabetes,
• If you have any kidney, liver, or heart disease,
• If you are on hemodialysis or have recently received a kidney transplant,
• If you have a vascular disease of the collagen (connective tissue disease) such as lupus erythematosus or scleroderma,
• If you are following a low-sodium diet, have recently had excessive vomiting or diarrhea, or have been treated with medications to increase urine production (diuretics),
• If you are being treated with lithium, a medication used for mania and depression,
• If you are taking potassium supplements or salt substitutes that contain potassium,
• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• An angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.
• Aliskirén.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in the blood (such as potassium) at regular intervals.

See also the information under the heading "Do not take Perindopril Krka".

• If you are taking any of the following medications, the risk of angioedema (rapid swelling under the skin in an area, such as the throat) may be increased:
• Racecadotril (used for diarrhea)
• Sirolimus, everolimus, temsirolimus, and other medications that belong to the group of mTOR inhibitors (used to prevent organ transplant rejection and for cancer)
• Vildagliptina (used to treat diabetes)
• If you are of black origin, as you may have a higher risk of angioedema and this medication may be less effective in lowering your blood pressure than in patients who are not of black origin.

Angioedema

In patients treated with ACE inhibitors, including Perindopril Krka, angioedema (severe allergic reaction with swelling of the face, lips, tongue, or throat, with difficulty swallowing or breathing) has been reported. This can occur at any time during treatment.If you develop these symptoms, you should interrupt treatment with Perindopril Krka and seek medical attention immediately. See also Section 4.

Inform your doctor if you think you may be or are pregnant. Perindopril Krka is not recommended in the initial stages of pregnancy, and should not be taken if you are more than three months pregnant, as it could seriously harm your baby if taken during this period (see section pregnancy)

If you develop any of the following symptoms, consult your doctor immediately:

• You feel dizzy after taking the first dose. Some people experience dizziness, weakness, and fatigue after the first dose or when the dose is increased.

• Elevated temperature, dry throat, and mouth ulcers (these may be symptoms of an infection caused by a decrease in the number of white blood cells).
• Yellowing of the skin and the white part of the eyes (jaundice) that may be signs of liver problems.
• Persistent and dry cough for a long time. Angioedema has been reported with the use of ACE inhibitors, but it may also be a symptom of other respiratory problems in the upper airway.

At the beginning of treatment and during periods of dose adjustment, it may be necessary to increase the frequency of medical follow-up. You should attend all appointments scheduled by your doctor, even if you feel well. Your doctor will indicate how often you should attend appointments.

To prevent any possible complications with Perindopril Krka, you should also inform your doctor if you are taking Perindopril Krka:

• If you are going to undergo surgery or anesthesia (including a visit to the dentist).
• If you are going to undergo desensitization treatment to reduce the effect of an allergy to a bee or wasp sting (desensitization).
• If you are on hemodialysis or LDL cholesterol apheresis (which involves removing cholesterol from the blood using a machine).

Children and adolescents

Perindopril is not recommended for use in children and adolescents until the age of 18.

Other medications and Perindopril Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take medications that can be purchased without a prescription without consulting your doctor first. This includes:

• Natural remedies containing pseudoephedrine or phenylephrine as active ingredients,
• Common pain relievers, including aspirin (a substance used to relieve pain, reduce fever, and prevent platelet aggregation),
• Potassium supplements, and salt substitutes that contain potassium.

Inform your doctor if you are taking any of the following to ensure that it is safe to take Perindopril Krka at the same time:

• Other medications to treat high blood pressure and/or heart failure, including medications that increase urine production (diuretics),

• Vasodilators, including nitrates (medications that produce the widening of blood vessels),
• Diuretics that conserve potassium (such as triamterene, amiloride), potassium supplements, or salt substitutes that contain potassium, other medications that can increase potassium in your body (such as heparin, a medication used to thin the blood to prevent clots; trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole, for infections caused by bacteria; cyclosporine or tacrolimus, an immunosuppressant medication used to prevent organ transplant rejection),
• Medications that conserve potassium used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,

• Medications to treat irregular heartbeat (procainamide),
• Medications to treat diabetes (insulin or oral antidiabetic medications such as vildagliptina),

• Baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),

• Medications to treat gout (allopurinol),
• Nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac), including aspirin for pain,

• Estramustine (used in cancer treatment),

• Medications that stimulate part of the nervous system, such as ephedrine, norepinephrine, or adrenaline (sympathomimetics),
• Medications to treat depression or mania (lithium),
• Medications to treat mental disorders such as depression, anxiety, schizophrenia, or other psychoses (tricyclic antidepressants and antipsychotics),
• Gold injections for the treatment of arthritis (aurtiomalate sodium),

• Medications frequently used to treat diarrhea (racecadotril) and to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medications that belong to the group of 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 antagonist (ARA) or aliskirén (see also the information under the headings "Do not take Perindopril Krka" and "Warnings and precautions").

Perindopril Krka with food, drinks, and alcohol

It is recommended to take Perindopril Krka before eating to reduce the influence of food on the way the medication works.

Drinking alcohol while taking Perindopril Krka may cause dizziness. You should consult your doctor if drinking alcohol is recommended for you while you are being treated with Perindopril Krka.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Inform your doctor if you are pregnant or may be pregnant. Your doctor will advise you to stop taking Perindopril Krka before becoming pregnant or as soon as you know you are pregnant and will prescribe another medication for you. Perindopril Krka is not recommended in the first trimester of pregnancy, and should not be taken if you are more than three months pregnant, as it could seriously harm your baby if taken during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start. Perindopril Krka is not recommended for breastfeeding mothers. Your doctor will prescribe another medication, especially if the baby is newborn or premature.

Driving and operating machines

It is recommended not to drive a car or operate machines until you know how Perindopril Krka affects you.Perindoprilusually does not alter alertness, but due to the lowering of blood pressure, some patients may experience dizziness or weakness, particularly at the beginning of treatment or in combination with other anti-hypertensive medication.

As a result, the ability to drive or operate machines may be affected.

Perindopril Krka contains lactose monohydrate and sodium.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per dose; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The generally recommended dose for the treatment of high blood pressure is 4 mg once a day (1 Perindopril Krka 4 mg tablet). If necessary, the dose may be increased to 8 mg once a day (1 Perindopril Krka 8 mg tablet or 2 Perindopril Krka 4 mg tablets), which is also the maximum recommended dose.

The initial recommended dose for the treatment of stable coronary artery disease is 4 mg of perindopril (1 Perindopril Krka 4 mg tablet) once a day; after two weeks, the dose may be increased to 8 mg of perindopril once a day (1 Perindopril Krka 8 mg tablet or 2 Perindopril Krka 4 mg tablets) if well tolerated.

The tablets should be swallowed with a glass of water, before breakfast, at the same time of day.

During treatment, your doctor will adjust the dose in relation to the effects to be achieved, taking into account your therapeutic needs.

Kidney problems

Your doctor should prescribe a lower dose.

Liver problems

No dose adjustment is required.

Older patients

The recommended dose in the elderly depends on renal function.

Your doctor will determine the most suitable dose for you based on your clinical condition.

Use in children and adolescents

The efficacy and safety of perindopril in children and adolescents under 18 years have not been established. Therefore, its use is not recommended in children.

If you estimate that the action of this medication is too weak or too strong for you, consult your doctor or pharmacist.

If you take more Perindopril Krka than you should

If you take more Perindopril Krka than you should, consult your doctor or pharmacist immediately.

The most common symptom in case of overdose is a sudden drop in blood pressure (hypotension). Other symptoms are: tachycardia or bradycardia, palpitations, hyperventilation, dizziness, anxiety, and/or cough.

If severe hypotension occurs, it can be treated by lying the patient down with their legs elevated.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Perindopril Krka

It is essential to take this medication every day.

However, if you forget to take a dose, continue taking the next one normally. Do not take a double dose to compensate for the missed doses. If you forget to take more than one dose, take another as soon as you remember and then continue with the prescribed treatment.

If you interrupt treatment with Perindopril Krka

Stopping treatment with Perindopril Krka may increase blood pressure, increasing the risk of secondary complications, especially cardiovascular, cerebral, and renal. Therefore, before stopping your treatment with Perindopril Krka, consult your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stoptreatment with this medicine andimmediately consult your doctorif you experience any of the following serious side effects:

• face, lip, mouth, tongue, or throat inflammation, difficulty breathing (angioedema) (See Section 2 "Warnings and precautions")(Uncommon - may affect up to1 in 100 people),
• severe dizziness or fainting due to low blood pressure (Frequent - may affect up to1 in 10 people),
• abnormally rapid or irregular heartbeat, chest pain (angina) or heart attack (Very rare - may affect up to1 in 10,000 people),
• weakness in arms or legs, or speech problems that may be a sign of a possible stroke (Very rare - may affect up to1 in 10,000 people),
• sudden wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm)(Uncommon - may affect up to1 in 100 people),
• pancreatitis that can cause intense abdominal and back pain accompanied by discomfort(Very rare - may affect up to1 in 10,000 people),
• yellowing of the skin or eyes (jaundice) that may be a sign of hepatitis(Very rare - may affect up to1 in 10,000 people),
• skin rash that often starts with red, itchy patches on the face, arms, or legs(erythema multiforme) (Very rare - may affect up to1 in 10,000 people).

Side effects were categorized according to incidence, as follows:

Frequent(may affect up to 1 in 10 people)

• headache,
• dizziness,
• vertigo,
• tingling and pins and needles,
• visual disturbances,

• tinnitus (sensation of noise in the ears),

• cough,
• breathing difficulties (dyspnea),

• gastrointestinal disturbances (nausea, vomiting, abdominal pain, changes in taste, indigestion, heavy digestion, diarrhea, and constipation),
• allergic reactions (such as skin rashes and itching),

• muscle cramps,
• weakness (asthenia).

Uncommon(may affect up to 1 in 100 people)

• mood changes,
• sleep disturbances,
• depression,
• dry mouth,

• intense itching or severe skin rashes,
• skin blistering,
• renal problems,
• impotence,
• sweating,
• eosinophilia (an increase in a type of white blood cell),
• drowsiness,
• fatigue,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitivity reactions (increased skin sensitivity to the sun),
• arthralgia (joint pain),
• myalgia (muscle pain),
• chest pain,
• discomfort,
• peripheral edema,
• fever,
• falls,
• change in laboratory values: reversible high potassium levels in blood, low sodium levels, hypoglycemia in diabetic patients (very low blood sugar levels), elevated urea levels in blood, and elevated creatinine levels in blood.

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

• change in laboratory values: increased liver enzyme levels, increased serum bilirubin levels,
• psoriasis worsening,
• concentrated urine, feeling unwell (nausea) or vomiting, muscle cramps, confusion, and seizures. These symptoms may be a sign of a disease called SIADH (inadequate secretion of antidiuretic hormone),
• decreased or absent diuresis,
• facial flushing,
• acute renal failure.

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

• confusion,
• eosinophilic pneumonia (a rare type of pneumonia),
• rhinitis (nasal congestion or runny nose),
• change in blood values such as a decrease in white and red blood cell count, decrease in hemoglobin, decrease in platelet count.

Frequency not known(cannot be estimated from available data)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Perindopril Krka

• The active ingredient is tert-butylamine salt of perindopril. Each tablet contains 8 mg of tert-butylamine salt of perindopril, equivalent to 6.68 mg of perindopril.
• The other components are lactose monohydrate, microcrystalline cellulose (E460), sodium hydrogen carbonate, anhydrous colloidal silica, magnesium stearate (E470b).

See section 2 “Perindopril Krka contains lactose monohydrateand sodium”.

Appearance of the product and contents of the pack

White, round, slightly biconvex tablets with scored edges and marked on one face.

The tablets can be divided into equal doses.

PVC/PE/PVDC/Al blisters of 7, 14, 28, 30, 50, 60, 90 or 100 tablets, in a cardboard box.

Only some pack sizes may be marketed.

Marketing Authorization Holder:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

KRKA-POLSKA Sp. z o.o., ul. Równolegla 5, 02-235 Warszawa, Poland

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/Anabel Segura 10, Ground floor, Office 1, 28108 Alcobendas, Madrid, Spain

This medicinal product has been authorized in the Member States of the EEA with the following names:

Last update of this leaflet: November 2021

Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/