PERINDOPRIL KRKA 4 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Perindopril Krka 4 mg Tablets EFG

perindopril tert-butylamine

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

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

The active substance of Perindopril Krka belongs to the group of antihypertensive medicines, angiotensin-converting enzyme inhibitors (ACE inhibitors).

Perindopril Krka is used:

• to treat high blood pressure (hypertension),
• to treat symptomatic heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs),

• to reduce the risk of cardiac events, such as myocardial infarction, in patients with stable coronary artery disease (a situation in which the blood flow to the heart is blocked or reduced) or in patients who have had a myocardial infarction and/or have undergone surgical intervention to improve blood flow to the heart by widening the coronary arteries.

2. What you need to know before you take Perindopril Krka

Do not take Perindopril Krka

• if you are allergic to perindopril or any of the other ingredients of this medicine (listed in section 6) or to any other ACE inhibitor.
• if you have ever had a hypersensitivity reaction, which caused swelling of the lips, face, and throat, including possible 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 circumstance.

• if you are more than 3 months pregnant (it is better not to take Perindopril Krka in the initial stages of pregnancy, first trimester - see section pregnancy).
• if you have diabetes or kidney problems 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.

It may not be suitable for you, or you may require regular individual monitoring. 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 comes out of the heart),
• if you have an increased thickness of the heart muscle or have problems with the heart valves,
• if you have been warned that you have a narrowing of the arteries that supply blood to the kidneys (renal artery stenosis),
• if you have abnormally high levels of a hormone called aldosterone in the blood (primary aldosteronism),
• if you 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 suffer from a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma,

• if you follow a low-salt diet, or have recently had excessive vomiting or diarrhea, or have followed treatment with medicines to increase urine production (diuretics),
• if you are being treated with lithium, a medicine used in 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-), especially 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 such symptoms, you should stop treatment with Perindopril Krka and see a doctor immediately. See also section 4.

Tell your doctor if you are planning to become pregnant or think you may be pregnant. Perindopril Krka is not recommended in the early stages of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may 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 may feel dizzy, weak, and tired 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) which can be signs of liver problems.
• Dry and persistent cough for a long time. Cough has been reported with the use of ACE inhibitors but may also be a symptom of other respiratory problems of the upper respiratory tract.

At the start of treatment and during dose adjustment periods, it may be necessary to increase the frequency of medical check-ups. You should attend all the appointments that your doctor schedules for you, even if you feel well. Your doctor will tell you how often you should come for a check-up.

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

• if you are going to have 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

The use of perindopril is not recommended in children and adolescents up to the age of 18.

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 medicines that can be obtained without a prescription without consulting your doctor first. This includes:

• natural remedies that contain 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.

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

• other medicines for the treatment of high blood pressure and/or heart failure, including medicines that increase urine production (diuretics),

• vasodilators, including nitrates (medicines that cause the blood vessels to widen),
• potassium-sparing diuretics (such as triamterene, amiloride), potassium supplements, or salt substitutes that contain potassium, other medicines that may increase potassium levels in your body (such as heparin, a medicine used to thin the blood to prevent clots); trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, for bacterial infections; cyclosporin or tacrolimus, immunosuppressive medicines used to prevent organ transplant rejection.
• potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,

• medicines for the treatment of irregular heartbeat (procainamide),
• medicines for the treatment of diabetes (insulin or oral antidiabetics, such as vildagliptin)
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis),
• medicines for the treatment of gout (allopurinol),
• non-steroidal anti-inflammatory medicines (NSAIDs such as ibuprofen, diclofenac), including acetylsalicylic acid for pain relief,
• estracytine (used in cancer therapy),
• stimulant medicines that affect part of the nervous system, such as ephedrine, noradrenaline, or adrenaline (sympathomimetics),
• medicines for the treatment of depression or mania (lithium),
• medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia, or other psychoses (tricyclic antidepressants and antipsychotics),
• gold injections for the treatment of arthritis (sodium aurothiomalate).

• medicines commonly used 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 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 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 meals 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 alcohol consumption is advisable for you while being treated with Perindopril Krka.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Tell your doctor if you are pregnant (or might be). Your doctor will advise you to stop taking Perindopril Krka before you become pregnant or as soon as you know you are pregnant and will prescribe another medicine for you instead. Perindopril Krka is not recommended in the first trimester of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken from the third month onwards.

Breastfeeding

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

Driving and using machines

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

As a result, the 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 some sugars, consult with them before taking this medicine.

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

3. How to take Perindopril Krka

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The initial and maintenance dose for the treatment of arterial hypertension is usually 4 mg once a day (1 tablet of Perindopril Krka 4 mg). If necessary, after a 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 a tablet of Perindopril Krka 4 mg or 1 tablet of Perindopril Krka 2 mg if available) once a day; this dose may be increased to 4 mg of perindopril (1 tablet of Perindopril Krka 4 mg or 2 tablets of Perindopril Krka 2 mg, 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 tablet of Perindopril Krka 4 mg); after two weeks, the dose may be increased to 8 mg of perindopril once a day (2 tablets of Perindopril Krka 4 mg) if well tolerated.

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

During the course of treatment, your doctor will adjust the dose according 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.

Elderly patients

The recommended dose in elderly patients depends on kidney 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 of age have not been established. Therefore, its use is not recommended in children.

If you think the action of this medicine 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 heartbeat (tachy or bradycardia), unpleasant sensation of irregular heartbeat and/or strong heartbeat (palpitations), excessive frequency and depth of breathing, dizziness, anxiety, and/or cough.

If your blood pressure drops substantially, it can be treated by laying 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Perindopril Krka

It is important to take this medicine every day. However, if you forget to take a dose, continue with the next dose as normal. Do not take a double dose to make up for forgotten doses. If you forget to take more than one dose, take another as soon as you remember and then continue with the treatment prescribed by your doctor.

If you stop taking Perindopril Krka

Stopping treatment with Perindopril Krka may increase blood pressure, increasing the risk of secondary complications to hypertension, especially at the cardiac, cerebral, and renal levels. In patients with heart failure, it may lead to complications that require hospitalization. Therefore, before stopping your treatment with Perindopril Krka, consult your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stoptreatment with this medicine andgoimmediately to your doctorif you experience any of the following adverse effects that can be serious:

• inflammation 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 (Frequent - may affect up to 1 in 10 people),
• abnormally fast or irregular heartbeats, chest pain (angina) or heart attack (Very Rare - may affect up to 1 in 10,000 people),
• weakness in arms or legs, or speech problems that could be a sign of a possible stroke (Very Rare - may affect up to 1 in 10,000 people),
• sudden wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm) (Uncommon - may affect up to 1 in 100 people),
• inflammation of the pancreas that can cause severe abdominal and back pain accompanied by discomfort (Very Rare - may affect up to 1 in 10,000 people),
• yellowing of the skin or eyes (jaundice) that 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 that itch on the face, arms, or legs (erythema multiforme) (Very Rare - may affect up to 1 in 10,000 people).

Adverse effects were categorized according to incidence, as follows:

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

• headache,
• dizziness,
• vertigo,
• tingling and numbness,
• visual disturbances,
• tinnitus (feeling of noise in the ears),
• cough,
• shortness of breath (dyspnea),
• gastrointestinal disorders (nausea, vomiting, abdominal pain, changes in taste, dyspepsia, heavy digestion, diarrhea, and constipation),
• allergic reactions (such as skin rashes and itching),
• muscle cramps,
• feeling of weakness.

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

• mood changes,
• sleep disorders,
• depression,
• dry mouth,
• intense itching or severe skin rashes,
• blistering of the skin,
• kidney problems,
• impotence,
• sweating,
• excess eosinophils (a type of white blood cell),
• drowsiness,
• fainting,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitivity reactions (increased skin sensitivity to the sun),
• arthralgia (joint pain),
• myalgia (muscle pain), chest pain,
• general discomfort,
• peripheral edema,
• fever,
• fall,
• changes in analytical values: high potassium levels in blood reversible by stopping treatment, low sodium levels, hypoglycemia in diabetic patients (very low blood sugar levels), elevated blood urea, and elevated creatinine in blood.

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

• changes in laboratory parameters: increased liver enzyme levels, high bilirubin levels,
• worsening of psoriasis,
• concentrated urine, feeling of discomfort (nausea) or being sick (vomiting), muscle cramps, confusion, and convulsions. These symptoms may be due to a disease called SIADH (inadequate secretion of antidiuretic hormone),
• decreased or absent diuresis,
• facial flushing,
• acute kidney 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),
• changes in blood values, such as a lower number of white and red blood cells, lower hemoglobin, lower platelet count in blood.

Frequency Not Known(cannot be estimated from available data)

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

Reporting of Adverse Effects

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

5. Storage of Perindopril Krka

Keep this medicine out of sight and reach of children.

Do not use this medicine 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 thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Perindopril Krka

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

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

Appearance of the Product and Package Contents

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 blisters.

Only some package 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine has been authorized in the EEA Member States with the following names:

Czech Republic Prenessa 4 mg tablets

Denmark Perindopril tert-butylamin Krka 4 mg tablets

Estonia Prenessa

Finland Perindopril Krka 4 mg tablets

France Prenessa 4 mg tablets

Germany Prenessa 4 mg tablets

Latvia Prenessa 4 mg tablets

Lithuania Prenessa 4 mg tablets

Poland Prenessa 4 mg tablets

Romania Prenessa 4 mg tablets

Slovakia Prenessa 4 mg tablets

Spain Perindopril Krka 4 mg tablets

United Kingdom Perindopril 4 mg tablets

Portugal Perindopril Krka 4 mg

Date of the Last Revision of this Leaflet: November 2021

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/