PERINDOPRIL KRKA 8 mg TABLETS

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 reaction to an ACE inhibitor that caused swelling of the face, lips, tongue, or throat, with or without difficulty breathing (angioedema) after taking an ACE inhibitor,
• if you have a family or personal history of angioedema in any other situation,
• if you are more than 3 months pregnant (it is also better to avoid Perindopril Krka in early pregnancy - see section Pregnancy),
• if you have diabetes or kidney problems and are taking a medicine called aliskiren to reduce your blood pressure,
• if you are having 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 are taking a medicine called sacubitril/valsartan, used to treat a type of long-term heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased.

Warnings and precautions

Consult your doctor or pharmacist before starting Perindopril Krka.

Perindopril Krka may not be suitable for you, or you may require regular individual monitoring.

Therefore, before starting Perindopril Krka, tell your doctor about:

• if you have a narrowing of the main blood vessel that leaves the heart (aortic stenosis), if you have an increase in the thickness of the heart muscle or heart valve problems,
• if 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 your blood (primary aldosteronism),
• if you have diabetes,
• if you have kidney, liver, or heart disease,
• if you are on hemodialysis or have recently received a kidney transplant,
• if you have a disease of the blood vessels that supply the skin (collagen vascular disease) such as lupus erythematosus or scleroderma,
• if you are on a low-salt diet, have recently had excessive vomiting or diarrhea, or are taking diuretics (medicines that increase urine production),
• if you are taking lithium (a medicine used to treat mania and 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 (ARB) (also known as a "sartan" - 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 in areas 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 reducing your blood pressure than in patients who are not of 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 these symptoms, stop taking Perindopril Krka and see a doctor immediately. See also Section 4.

Tell your doctor if you think you might be pregnant or if you are planning to become pregnant. Perindopril Krka is not recommended in early pregnancy and must 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, contact your doctor immediately:

• You feel dizzy after taking the first dose. Some people may feel dizzy, weak, or tired after the first dose or when the dose is increased.

• High 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 whites of the eyes (jaundice), which can be signs of liver problems.
• Dry, 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 airways.

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 appointments that your doctor schedules, even if you feel well. Your doctor will tell you how often you should have check-ups.

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 have surgery or anesthesia (including a visit to the dentist).
• if you are going to have 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 in children and adolescents up to the age of 18 is not recommended.

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:

• herbal remedies that contain pseudoephedrine or phenylephrine as active ingredients,
• common pain relievers, including aspirin (used for pain relief, to lower fever, and to prevent blood clots),
• potassium supplements and salt substitutes that contain potassium.

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

• vasodilators, including nitrates (medicines that cause blood vessels to widen),
• potassium-sparing diuretics (e.g., 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, an immunosuppressive medicine used to prevent organ transplant rejection),
• potassium-sparing medicines used to treat 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 aspirin for pain relief,

• estramustine (used in the treatment of cancer),

• stimulants of 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 (ARB) 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 you are 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 think you might be pregnant. 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. Perindopril Krka is not recommended in the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may seriously harm your baby if taken after the third month.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Perindopril Krka is not recommended for breastfeeding mothers. Your doctor will prescribe another medicine, 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. Perindopril Krka usually does not affect alertness, but due to the lowering of blood pressure, some patients may feel dizzy or weak, especially at the start of treatment or in combination with other antihypertensive medicines.

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

Perindopril Krka contains lactose monohydrate and sodium.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

3. How to take Perindopril Krka

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The generally recommended dose for the treatment of high blood pressure is 4 mg once a day (1 tablet of Perindopril Krka 4 mg). If necessary, the dose may be increased to 8 mg once a day (1 tablet of Perindopril Krka 8 mg or 2 tablets of Perindopril Krka 4 mg), 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 tablet of Perindopril Krka 4 mg) once a day; after two weeks, the dose may be increased to 8 mg of perindopril once a day (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 effects achieved, taking into account your therapeutic needs.

Kidney problems

Your doctor should prescribe a lower dose.

Liver problems

No dose adjustment is required.

Elderly patients

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

If you think the effect of this medicine is too weak or too strong, talk to 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 are: rapid or slow heartbeat, palpitations, hyperventilation, dizziness, anxiety, and/or cough.

If severe 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

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 taking 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 prescribed treatment.

If you stop taking Perindopril Krka

Stopping treatment with Perindopril Krka may increase blood pressure, increasing the risk of complications secondary to hypertension, especially at the cardiac, cerebral, and renal levels. 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 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 fast or irregular heartbeats, chest pain (angina) or heart attack (Very Rare - may affect up to 1 in 10,000 people),
• weakness of 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 (ringing 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,
• weakness (asthenia).

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,
• discomfort,
• peripheral edema,
• fever,
• falls,
• change 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)

• change in laboratory parameters: increased liver enzyme levels, increased 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 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 reduction in the number of white and red blood cells, decrease in hemoglobin, decrease in platelet count.

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 is not listed in this prospectus. 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.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines that you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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, colloidal anhydrous silica, magnesium stearate (E470b).

See section 2 "Perindopril Krka contains lactose monohydrate and sodium".

Appearance of the Product and Package Contents

White, round, slightly biconvex tablet with notched edges and marked on one of its faces.

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 a cardboard box.

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, Planta baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

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

Date of the Last Revision of this Prospectus: 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/