Leaflet: Information for the Patient

Perindopril Krka 4 mg Tablets EFG

perindopril terbutilamine

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 that inhibit the angiotensin-converting enzyme (ACE).

Perindopril Krka is used:

• to treat high blood pressure (hypertension),
• to treat symptomatic heart failure (a condition in which the heart cannot pump enough blood to meet the body's needs),

• to reduce the risk of cardiac events, such as myocardial infarction, in patients with established coronary artery disease (a situation in which the blood supply 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 supply to the heart through coronary artery widening.

Do not take Perindopril Krka

• if you are allergic to perindopril or any of the other ingredients in this medicine (listed in section 6) or to 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 a member of your family or you have had angioedema in any other circumstances.

• 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 pregnancy section).
• if you have diabetes or kidney disease and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• 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/valsartan, a medicine used to treat a type of long-term (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 you 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 been warned that you have narrowing of the arteries that carry blood to the kidney (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 haemodialysis or have recently received a kidney transplant,

• if you suffer from a vascular disease of the connective tissue (connective tissue disease) such as systemic lupus erythematosus or scleroderma,

• if you are following a low-sodium diet, or have recently had excessive vomiting or diarrhea or have been treated with medicines to increase urine production (diuretics),
• if you are being treated with lithium, a medicine used for mania or depression,
• if you are taking potassium supplements or salt substitutes that contain potassium,
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• • an angiotensin II receptor antagonist (ARA) (also known as "sartans" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • aliskiren.

Your doctor may need to monitor your kidney function, blood pressure, and blood electrolyte levels (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 medicines, 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 medicines that belong to the group of mTOR inhibitors (used to prevent organ transplant rejection and for cancer).
  • vildagliptin (used to treat diabetes).

• if you are of black origin, as you may have a higher risk of angioedema and this medicine 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 stop taking Perindopril Krka and see your doctor immediately. See also section 4.

Inform your doctor if you plan to become pregnant or think you may be pregnant. Perindopril Krka is not recommended in early 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 pregnancy section).

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.

• fever, 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.
• dry and persistent cough for a long time. Coughing 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 start 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 that your doctor has scheduled for you, even if you feel well. Your doctor will tell you 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 haemodialysis or lipid-lowering therapy (apheresis of LDL cholesterol, 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 medicines and Perindopril Krka

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

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

• natural remedies containing pseudoephedrine or phenylephrine as active ingredients,
• common painkillers, including aspirin (a substance used to relieve pain, reduce fever, and prevent blood clotting),
• 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 medicines for treating high blood pressure and/or heart failure, including medicines that increase urine production (diuretics),

• vasodilators, including nitrates (medicines that produce the widening of blood vessels),
• diuretics that save potassium (for example, triamterene, amiloride), potassium supplements or salt substitutes that contain potassium, other medicines that may increase potassium in your body (such as heparin, a medicine used to thin the blood to prevent blood clots); trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole, for bacterial infections;
• ciclosporin or tacrolimus, immunosuppressive medicines used to prevent organ transplant rejection.

• diuretics that save potassium used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,

• medicines for treating irregular heartbeat (procainamide),
• medicines for treating diabetes (insulin or oral antidiabetic medicines, such as vildagliptin)
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
• medicines for treating gout (allopurinol),
• non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac), including aspirin for pain,
• estramustine (used in cancer therapy),
• stimulants of the sympathetic nervous system, such as ephedrine, noradrenaline, or adrenaline (sympathomimetics),
• medicines for treating depression or mania (lithium),
• medicines for treating mental disorders such as depression, anxiety, schizophrenia, or other psychoses (tricyclic antidepressants and antipsychotics),
• gold injections for treating arthritis (aurintrimalate sodium).

• medicines used frequently to treat diarrhea (racecadotril) and to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines that belong to the group of mTOR inhibitors. (see "Warnings and precautions" section)

Your doctor may need to adjust your dose and/or take other precautions:

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

Taking 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 medicine works. Drinking alcohol while taking Perindopril Krka may cause dizziness. You should consult your doctor if drinking alcohol is advised 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 medicine.

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 medicine 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, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

It is recommended not to drive a car or use machines until you know how Perindopril Krka affects you. Individual reactions such as dizziness and weakness may occur in some patients, particularly at the start of treatment or in combination with other anti-hypertensive medication.

As a result, your ability to drive or use machines may be affected.

Perindopril Krka contains lactose monohydrate and sodium.

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

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The initial and maintenance dose for the treatment of hypertension is generally 4 mg once a day (1 tablet of Perindopril Krka 4 mg). If necessary, after one month of treatment the dose may be increased to 8 mg once a day (2 tablets of Perindopril Krka 4 mg).

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

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

If you have kidney problems, your doctor may prescribe a lower dose.

Liver problems

No dose adjustment is necessary.

Older patients

The recommended dose in older patients depends on renal function.

Your doctor will determine the duration of your treatment 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 rapid or slow heart rate (tachycardia or bradycardia), unpleasant sensation of irregular and/or strong heartbeat (palpitations), excessive frequency and depth of breathing, dizziness, anxiety, and/or cough.

If your blood pressure drops significantly, it can be counteracted by lying the patient down with their legs elevated and using only a small pillow to support their head.

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 forgot to take Perindopril Krka

It is essential to take this medication every day. However, if you forgot to take a dose, continue taking the next one normally. Do not take a double dose to compensate for the missed doses. If you forgot to take more than one dose, take another as soon as you remember and then continue with the prescribed treatment by your doctor.

If you interrupt the treatment with Perindopril Krka

Interrupting the treatment with Perindopril Krka may increase blood pressure, increasing the risk of secondary complications, especially cardiovascular, cerebral, and renal. In patients with heart failure, it may lead to complications requiring hospitalization. Therefore, before interrupting 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:.

• inflammation of the face, lips, mouth, tongue, or throat, 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 (Common - may affect up to1 in 10 people),
• abnormal heartbeats or irregular heart rhythms, 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 (bronchoconstriction) (Uncommon - may affect up to1 in 100 people),
• pancreatitis that can cause severe 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 could 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).

The side effects were categorized according to their incidence, as follows:

Common(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,
• shortness of breath (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,
• sensation of weakness.

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

• mood changes,
• sleep disturbances,
• depression,
• dry mouth,
• intense itching or severe skin rashes,
• skin blisters,
• renal problems,
• impotence,
• sweating,
• eosinophilia (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),
• mialgia (muscle pain), chest pain,
• general discomfort,
• peripheral edema,
• fever,
• fall,
• change in laboratory values: reversible high potassium levels in blood upon stopping treatment, 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)

• changes in laboratory parameters: elevated liver enzyme levels, high serum bilirubin levels,
• worsening of psoriasis,
• concentrated urine, feeling unwell (nausea) or vomiting, muscle cramps, confusion, and convulsions. These symptoms may be a sign of a condition called SIADH (inadequate secretion of antidiuretic hormone),
• decreased or absent diuresis,
• facial flushing,
• acute renal insufficiency.

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),
• changes in blood values, such as a lower number of white and red blood cells, lower hemoglobin, and lower platelet count in the blood.

Unknown frequency(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 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 Pharmacovigilance of Medicines 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.

Do not store above 30°C.

Store in the original packaging.

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 point of your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Perindopril Krka

• The active ingredient is perindopril tert-butylamine. Each tablet contains 4 mg of perindopril tert-butylamine salt, equivalent to 3.338 mg of perindopril.

• The other components are lactose monohydrate, microcrystalline cellulose, sodium hydrogen carbonate, anhydrous colloidal silica, and magnesium stearate. See section 2 “Perindopril Krka contains lactose monohydrateand sodium”.

Appearance of the product and contents of the pack

The tablets are white, oblong, biconvex with beveled edges and marked on one face. The tablet can be divided into equal doses.

The tablets are available in boxes of 7, 14, 28, 30, 50, 60, 90, or 100 tablets in blister packs.

Only some pack sizes may be marketed.

Marketing Authorization Holder:

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

Responsible for manufacturing:

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, Pta. Baja,Office 1, 28108 Alcobendas, Madrid, Spain

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

Czech RepublicPrenessa 4 mg tablets

DenmarkPerindopril tert-butylamine Krka 4 mg tablets

EstoniaPrenessa

FinlandPerindopril Krka 4 mg tablets

FrancePrenessa 4 mg tablets

GermanyPrenessa 4 mg tablets

LatviaPrenessa 4 mg tablets

LithuaniaPrenessa 4 mg tablets

PolandPrenessa 4 mg tablets

RomaniaPrenessa 4 mg tablets

SlovakiaPrenessa 4 mg tablets

SpainPerindopril Krka 4 mg tablets

United KingdomPerindopril 4 mg tablets

PortugalPerindopril Krka 4 mg

Last review date of this leaflet: November 2021

Further 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/