Perindopril Krka 4 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Perindopril Krka 4 mg tablets EFG

perindopril terbutamine

Read this entire 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

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

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 stable coronary artery disease (a condition in which blood flow to the heart is blocked or reduced) or in patients who have previously suffered a myocardial infarction and/or have undergone surgical intervention to improve blood flow to the heart by widening the coronary blood vessels.

2. What you need to know before taking Perindopril Krka

Do not take Perindopril Krka

• if you are allergic to perindopril or to any of the other ingredients of this medicine (listed in section 6) or to any other ACE inhibitor.

• if you have previously experienced a hypersensitivity reaction with swelling of the lips, face, and neck, possibly including hands and feet, flushing, or hoarseness (angioedema) after taking an ACE inhibitor.

• if you or a family member has ever had angioedema under any circumstances.

• if you are more than three months pregnant (it is better not to take Perindopril Krka during the early phase of pregnancy, first trimester – see pregnancy section).

• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

• if you are undergoing 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 involving reduced blood supply 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 the risk of angioedema (rapid swelling beneath the skin in areas such as the throat) is high.

Warnings and precautions

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

Perindopril Krka may not be suitable for you, or you may require regular individual monitoring. Therefore, before starting Perindopril Krka, inform your doctor if you:

• have aortic stenosis (narrowing of the main blood vessel leaving the heart),

• have thickening of the heart muscle or heart valve problems,

• have been told you have narrowing of the arteries supplying blood to the kidneys (renal artery stenosis),

• have abnormally high levels of a hormone called aldosterone in your blood (primary hyperaldosteronism),

• have diabetes,

• have any kidney, liver, or heart disease,

• are undergoing hemodialysis or have recently received a kidney transplant,

• suffer from a collagen vascular disease (connective tissue disorder) such as systemic lupus erythematosus or scleroderma,

• are on a low-salt diet, or have recently experienced excessive vomiting or diarrhea, or have been treated with medicines that increase urine output (diuretics),

• are taking lithium, a medicine used for mania or depression,

• are taking potassium supplements or salt substitutes containing potassium,

• are taking any of the following medicines for 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 monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

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

• if you are taking any of the following medicines, the risk of angioedema (rapid swelling beneath the skin in areas such as the throat) may be increased:

  • racecadotril, used for diarrhea.
  • sirolimus, everolimus, temsirolimus, and other medicines belonging to the mTOR inhibitor group (used to prevent organ transplant rejection and for cancer treatment).
  • vildagliptin (used to treat diabetes).

• if you are of Black African or Caribbean origin, as you may have a higher risk of angioedema and this medicine may be less effective in lowering your blood pressure compared to patients of non-Black origin.

Angioedema

In patients treated with ACE inhibitors, including Perindopril Krka, angioedema (a 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 must stop treatment with Perindopril Krka and seek medical help immediately. See also section 4.

Inform your doctor if you are planning a pregnancy or think you might be pregnant. Perindopril Krka is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may seriously harm your baby if taken during this period (see pregnancy section).

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

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

• Fever, sore throat, and mouth ulcers (these may be symptoms of an infection caused by a decrease in white blood cells).

• Yellowing of the skin and whites of the eyes (jaundice), which may indicate liver problems.

• A persistent dry cough over a long period. Cough has been reported with the use of ACE inhibitors but may also be a symptom of other upper respiratory tract problems.

At the beginning of treatment and during dose adjustment periods, more frequent medical monitoring may be necessary. You should attend all scheduled appointments with your doctor, even if you feel well. Your doctor will advise you how often you need to attend.

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

• you are scheduled for surgery or anesthesia (including a visit to the dentist).
• you are scheduled for desensitization treatment to reduce the effect of an allergy to bee or wasp stings (desensitization).
• you are undergoing hemodialysis or LDL cholesterol apheresis (a procedure to remove cholesterol from the blood using a machine).

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 need to take any other medicines.

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

• herbal remedies containing pseudoephedrine or phenylephrine as active ingredients,

• common painkillers, including aspirin (a substance used to relieve pain, reduce fever, and prevent platelet aggregation),

• potassium supplements,

• and salt substitutes containing potassium.

Inform your doctor if you are taking any of the following to ensure 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 output (diuretics),

• vasodilators including nitrates (medicines that cause blood vessels to widen),

• potassium-sparing diuretics (e.g., triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, other medicines that may increase potassium 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; cyclosporine or tacrolimus, immunosuppressant 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 treating irregular heartbeat (procainamide),

• medicines for treating diabetes (insulin or oral antidiabetics, such as vildagliptine),

• 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 acetylsalicylic acid for pain,

• estramustine (used in cancer therapy),

• medicines that stimulate part of the 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),

• injected gold for treating arthritis (sodium aurothiomalate).

• medicines frequently used to treat diarrhea (racecadotril) and to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the mTOR inhibitor group. (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 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 how the medicine works. Drinking alcohol while taking Perindopril Krka may cause dizziness. You should consult your doctor about whether alcohol consumption is advisable while you are being treated with Perindopril Krka.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant (or might be). 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 instead. Perindopril Krka is not recommended during the first trimester of pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the baby if taken from the third month onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan 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 a newborn or was born prematurely.

Driving and using machines

You are advised not to drive a car or operate machinery until you know how Perindopril Krka affects you. Individual reactions such as dizziness and weakness may occur in some patients, particularly at the beginning of treatment or in combination with other antihypertensive medicines.

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

Perindopril Krka contains lactose monohydrate and sodium.

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

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

3. How to take Perindopril Krka

Follow exactly the instructions for use given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual initial and maintenance dose for the treatment of hypertension is 4 mg once daily (1 tablet of Perindopril Krka 4 mg). If necessary, after one month of treatment, the dose may be increased to 8 mg once daily (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 daily; 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 daily, as needed.

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

During treatment, your doctor will adjust the dose according to the desired effects and your individual therapeutic needs.

Renal problems

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

Hepatic problems

Dose adjustment is not required.

Elderly patients

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

If you think that the effect 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 prescribed, contact your doctor or pharmacist immediately.

The most common symptom in case of overdose is a sudden drop in blood pressure (hypotension). Other symptoms include fast or slow heartbeat (tachy or bradycardia), uncomfortable sensation of irregular and/or strong heartbeat (palpitations), increased rate and depth of breathing, dizziness, anxiety, and/or cough.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the name of 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, take the next one as usual. Do not take a double dose to make up for forgotten doses. If you forget more than one dose, take another as soon as you remember, and then continue with your prescribed treatment.

If you stop taking Perindopril Krka

If you stop treatment with Perindopril Krka, your blood pressure may increase, raising the risk of complications due to hypertension, especially affecting the heart, brain, and kidneys. In patients with heart failure, this could lead to complications requiring hospitalization. Therefore, before stopping treatment with Perindopril Krka, consult your doctor.

If you have any further questions about 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 everyone will experience them.

Stop taking this medicine and seek immediate medical attention if you experience any of the following adverse 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 (Frequent – may affect up to 1 in 10 people),
• abnormally rapid or irregular heartbeat, 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, which could be signs 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, which may cause severe abdominal and back pain accompanied by malaise (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 itchy red spots 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 their incidence as follows:

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

• headache,
• dizziness,
• vertigo,
• tingling and pricking sensations,
• visual disturbances,
• tinnitus (ringing or noise in the ears),
• cough,
• shortness of breath (dyspnea),
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, altered 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,
• elevated eosinophil count (a type of white blood cell),
• drowsiness,
• collapse,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitivity reactions (increased skin sensitivity to sunlight),
• arthralgia (joint pain),
• myalgia (muscle pain), chest pain,
• general malaise,
• peripheral edema,
• fever,
• falls,
• changes in laboratory values: high blood potassium levels (reversible upon discontinuation of treatment), low sodium levels, hypoglycemia in diabetic patients (very low blood sugar levels), increased blood urea, and elevated blood creatinine.

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

• changes in laboratory parameters: increased liver enzyme levels, elevated serum bilirubin levels,
• worsening of psoriasis,
• concentrated urine, feeling unwell (nausea) or feeling sick (vomiting), muscle cramps, confusion, and seizures. These symptoms may indicate a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion),
• decreased or absent urine output,
• 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),
• changes in blood test values, such as reduced numbers of white and red blood cells, reduced hemoglobin, and reduced platelet count.

Frequency not known (cannot be estimated from available data):

• discoloration, numbness, and pain in fingers or toes (Raynaud's phenomenon).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Perindopril Krka

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Perindopril Krka

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

Appearance of the product and contents of the container

The tablets are white, oblong, biconvex with bevelled edges, marked on one side. 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

Manufacturer:

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

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

For more information about this medicine, contact 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 Member States of the EEA under 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 most recent revision of this leaflet: November 2021

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