Perindopril Krka 8 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Perindopril Krka 8 mg tablets EFG

perindopril tert-butylamine

Read the 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 other people, 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 they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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 side 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 a group of antihypertensive medicines known as angiotensin-converting enzyme (ACE) inhibitors.

Perindopril Krka is indicated:

• for the treatment of high arterial blood pressure (hypertension),
• 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 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, 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 have a personal or family history of angioedema in any situation,
• if you are more than three months pregnant (it is better not to take Perindopril Krka during early pregnancy, first trimester – see pregnancy section),
• if you have diabetes or renal 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 under the skin, for example in 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 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), if you have thickening of the heart muscle, or heart valve problems,
• you have narrowing of the renal arteries (renal artery stenosis),
• you have abnormally high levels of a hormone called aldosterone in your blood (primary hyperaldosteronism),
• you have diabetes,
• you have any kidney, liver, or heart disease,
• you are on hemodialysis or have recently received a kidney transplant,
• you suffer from a collagen vascular disease (connective tissue disorder) such as systemic lupus erythematosus or scleroderma,
• you are on a low-salt diet, have recently had excessive vomiting or diarrhea, or have been treated with medicines that increase urine output (diuretics),
• you are being treated with lithium, a medicine used in manic and depressive states,
• you are taking potassium supplements or salt substitutes containing potassium,
• you are taking any of the following medicines for high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (also known as “sartans” – e.g., 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 (e.g., 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, for example in 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),
• 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 may occur at any time during treatment. If you develop such symptoms, you must stop taking Perindopril Krka and seek immediate medical attention. See also section 4.

Inform your doctor if you are or think you may be (or could 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 experience dizziness, weakness, and fatigue after the first dose or when the dose is increased.

• High temperature, sore throat, and mouth ulcers (these may be symptoms of an infection due to a decrease in white blood cells).

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

• Persistent dry cough over a long period. Cough has been reported with ACE inhibitors, but it 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 appointments scheduled by 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:

• if you are scheduled for surgery or anesthesia (including a visit to the dentist).
• if you are scheduled for desensitization treatment to reduce the effect of an allergy to bee or wasp stings (desensitization).
• if 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 over-the-counter medicines without first consulting your doctor. This includes:

• herbal remedies containing pseudoephedrine or phenylephrine as active ingredients,
• common painkillers, including aspirin (a substance used for pain relief, fever reduction, and prevention of 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 diuretics (medicines that increase urine output),
• vasodilators, including nitrates (medicines that cause blood vessels to widen),
• potassium-sparing diuretics (e.g., triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes, or 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; cyclosporine or tacrolimus, immunosuppressant medicines used to prevent organ transplant rejection),
• potassium-sparing agents used in heart failure treatment: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily,
• medicines for treating irregular heartbeat (procainamide),
• medicines for treating diabetes (insulin or oral antidiabetics such as vildagliptin),
• baclofen (used to treat muscle stiffness in conditions 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 treatment),
• nervous system stimulants 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 commonly used to treat diarrhea (racecadotril) and to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other 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 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 on treatment with Perindopril Krka.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you might 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 suspect you may 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 an alternative medicine. 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. Your doctor will prescribe an alternative medicine, especially if the baby is a newborn or premature.

Driving and using machines

You are advised not to drive or operate machinery until you know how Perindopril Krka affects you. Perindopril generally does not affect alertness, but due to blood pressure lowering, some patients may experience dizziness or weakness, particularly at the beginning of treatment or when used 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.

This medicine contains lactose. If your doctor has informed 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 (1 mmol) per dose unit; hence, it is essentially “sodium-free”.

3. How to take Perindopril Krka

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

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

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

Renal problems

Your doctor should prescribe a lower dose.

Hepatic problems

No dose adjustment is required.

Elderly patients

The recommended dose in the elderly depends on renal function.

Your doctor will determine the most appropriate 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 of age has 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 you should, 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: tachycardia or bradycardia, palpitations, hyperventilation, dizziness, anxiety and/or cough.

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

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 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 dose as usual. Do not take a double dose to make up for forgotten doses. If you have missed more than one dose, take a dose as soon as you remember, and then continue with your prescribed treatment.

If you stop taking Perindopril Krka

Stopping treatment with Perindopril Krka may cause your blood pressure to rise, increasing the risk of complications due to hypertension, particularly affecting the heart, brain, and kidneys. 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 everybody will experience them.

Stop taking this medicine immediately and contact your doctor straight away 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 (Common – may affect up to 1 in 10 people),
• abnormally fast 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, tightness in the chest, 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 which often starts as red, itchy 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:

Common (may affect up to 1 in 10 people)

• headache,
• dizziness,
• vertigo,
• tingling and prickling sensations,
• visual disturbances,
• tinnitus (ringing or other noise in the ears),
• cough,
• shortness of breath (dyspnea),
• gastrointestinal disturbances (nausea, vomiting, abdominal pain, altered taste, dyspepsia, heavy digestion, diarrhoea 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 disorders,
• depression,
• dry mouth,
• severe itching or serious skin rashes,
• blistering of the skin,
• kidney problems,
• impotence,
• sweating,
• increased eosinophils (a type of white blood cells),
• drowsiness,
• collapse,
• palpitations,
• tachycardia,
• vasculitis (inflammation of blood vessels),
• photosensitivity reactions (increased skin sensitivity to sunlight),
• arthralgia (joint pain),
• myalgia (muscle pain),
• chest pain,
• malaise,
• peripheral oedema,
• fever,
• falls,
• changes in laboratory values: high blood potassium levels (reversible upon discontinuation of treatment), low sodium levels, hypoglycaemia in diabetic patients (very low blood sugar levels), increased blood urea, and increased blood creatinine.

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

• changes in laboratory parameters: increased liver enzyme levels, increased serum bilirubin levels,
• worsening of psoriasis,
• concentrated urine, feeling unwell (nausea) or feeling sick (vomiting), muscle cramps, confusion and seizures. These symptoms may be due to 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 values such as reduced numbers of white and red blood cells, decreased haemoglobin, reduced platelet count.

Frequency not known (cannot be estimated from available data)

• discolouration, 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.

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

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

6. Contents of the pack and other information

Composition of Perindopril Krka

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

See section 2 “Perindopril Krka contains lactose monohydrate and sodium”.

Appearance of the product and contents of the pack

White, round, slightly biconvex tablet with bevelled edges, notched and marked on one side.

The tablet can be divided into equal doses.

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

Only certain 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

This medicinal product has been authorised in the EEA Member States under the following names:

Date of the most recent review of this leaflet: November 2021

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