Perindopril/amlodipine Krka

Package Leaflet: Information for the Patient

Perindopril/Amlodipine Krka, 4 mg + 5 mg, tablets

Perindopril/Amlodipine Krka, 4 mg + 10 mg, tablets

Perindopril/Amlodipine Krka, 8 mg + 5 mg, tablets

Perindopril/Amlodipine Krka, 8 mg + 10 mg, tablets

tert-butylamine perindopril + amlodipine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Perindopril/Amlodipine Krka and what is it used for
• 2. Important information before taking Perindopril/Amlodipine Krka
• 3. How to take Perindopril/Amlodipine Krka
• 4. Possible side effects
• 5. How to store Perindopril/Amlodipine Krka
• 6. Contents of the pack and other information

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

Perindopril/Amlodipine Krka is used to treat high blood pressure (hypertension) and/or stable coronary heart disease (a condition in which the blood flow to the heart is reduced or blocked).
Patients already taking perindopril and amlodipine in separate tablets may take one Perindopril/Amlodipine Krka tablet containing both active substances instead.
Perindopril/Amlodipine Krka is a combination of two active substances: perindopril and amlodipine. Perindopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).
Amlodipine is a calcium antagonist (belonging to a class of medicines known as dihydropyridines). Both active substances work by widening and relaxing blood vessels, which lowers blood pressure. Blood can flow more easily through the body, and the heart is less strained.

2. Important information before taking Perindopril/Amlodipine Krka

When not to take Perindopril/Amlodipine Krka

• if you are allergic to perindopril tert-butylamine or any other ACE inhibitor, amlodipine besylate or any other dihydropyridine, or any of the other ingredients of this medicine (listed in section 6);
• after the third month of pregnancy (you should also avoid taking Perindopril/Amlodipine Krka during early pregnancy - see section "Pregnancy and breastfeeding");
• if you have ever had symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rash when taking ACE inhibitors in the past;
• in cardiogenic shock (a condition where the heart cannot supply enough blood to the body), aortic stenosis (narrowing of the main blood vessel leaving the heart), or unstable angina (chest pain that may occur at rest);
• in patients with very low blood pressure (severe hypotension);
• in patients with heart failure (the heart is not able to pump blood sufficiently, leading to shortness of breath or swelling of the legs, ankles, or feet) after a heart attack;
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
• if you are undergoing dialysis or blood filtration by other methods. Depending on the device used, Perindopril/Amlodipine Krka may not be suitable for you.
• if you have kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if you have taken or are currently taking a combination medicine containing sacubitril and valsartan, used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases.

Warnings and precautions

Before taking Perindopril/Amlodipine Krka, discuss with your doctor or pharmacist:

• if you have hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the artery supplying blood to the kidney);
• if you have other heart problems;
• if you have liver problems;
• if you have kidney problems or are undergoing dialysis;
• if you have an abnormally high level of a hormone called aldosterone in your blood (primary aldosteronism);
• if you have a collagen disease (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
• if you have diabetes;
• if you are on a low-salt diet or taking salt substitutes containing potassium (it is necessary to adjust the potassium level in your blood);
• if you are elderly and need to adjust the dose;
• if you are taking any of the following medicines for high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
• aliskiren.
• if you are taking any of the following medicines, the risk of angioedema increases:
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent transplant rejection and to treat cancer (e.g., sirolimus, everolimus, temsirolimus, and other mTOR inhibitors),
• wildagliptin, a medicine used to treat diabetes.
• if you are black - in this case, there may be a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure than in patients of other races.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.
See also the information under the heading "When not to take Perindopril/Amlodipine Krka".
Angioedema
Angioedema has been reported in patients treated with ACE inhibitors, including perindopril. This reaction can occur at any time during treatment. If you experience such symptoms, stop taking Perindopril/Amlodipine Krka and contact your doctor immediately. See also section 4.
You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. It is not recommended to take Perindopril/Amlodipine Krka during the first trimester of pregnancy and it must not be taken after the third month of pregnancy, as it may seriously harm the baby (see section "Pregnancy and breastfeeding").
You must inform your doctor or healthcare professional if you are taking Perindopril/Amlodipine Krka and:

• are scheduled for general anesthesia and/or surgery,
• have recently experienced diarrhea or vomiting,
• are scheduled for LDL apheresis (removal of cholesterol from the blood using a special device),
• are undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings.

Children and adolescents

Perindopril/Amlodipine Krka is not recommended for children and adolescents.

Perindopril/Amlodipine Krka with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
Do not take Perindopril/Amlodipine Krka with:

• lithium (used to treat mania or depression),
• estrmustine (used to treat cancer),
• potassium supplements (including salt substitutes), potassium-sparing diuretics (spironolactone, triamterene), and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent transplant rejection and to treat certain diseases),
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at a dose of 12.5 mg to 50 mg per day.

Other medicines may affect the action of Perindopril/Amlodipine Krka. Inform your doctor if you are taking any of the following medicines, as special care may be needed:

• other blood pressure-lowering medicines, including angiotensin receptor antagonists (ARBs), aliskiren (see also sections "When not to take Perindopril/Amlodipine Krka" and "Warnings and precautions"), or diuretics (which increase the amount of urine produced by the kidneys),
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Perindopril/Amlodipine Krka" and "Warnings and precautions".
• non-steroidal anti-inflammatory drugs (e.g., ibuprofen), given to relieve pain or high doses of acetylsalicylic acid,
• antidiabetic medicines (e.g., insulin or wildagliptin),
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (e.g., tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics),
• immunosuppressants (which weaken the immune system), used to treat autoimmune disorders or after organ transplantation (e.g., cyclosporine, tacrolimus),
• trimethoprim and cotrimoxazole (used to treat bacterial infections),
• allopurinol (used to treat gout),
• procainamide (used to treat irregular heart rhythms),
• vasodilators, including nitrates,
• ephedrine, noradrenaline, or adrenaline (used to treat low blood pressure, shock, or asthma),
• baclofen or dantrolene (given by infusion), used to treat muscle stiffness in diseases such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia (a condition characterized by very high fever and muscle stiffness) during anesthesia,
• certain antibiotics, such as rifampicin, erythromycin,
• clarithromycin (used to treat bacterial infections),
• antiepileptic medicines, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
• itraconazole, ketoconazole (used to treat fungal infections),
• alpha-adrenergic blockers, used to treat enlarged prostate, such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin,
• amifostine (given to prevent or reduce the side effects of other medicines or radiation therapy used to treat cancer),
• corticosteroids (used to treat various conditions, including severe asthma and rheumatoid arthritis),
• gold salts, especially given intravenously (used to treat symptoms of rheumatoid arthritis),
• simvastatin (used to lower cholesterol levels),
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV),
• St. John's Wort (Hypericum perforatum),
• verapamil, diltiazem (used to treat heart conditions),
• medicines commonly used to treat diarrhea (racecadotril) or to prevent transplant rejection (sirolimus, everolimus, temsirolimus, or other mTOR inhibitors). See section "Warnings and precautions".

Perindopril/Amlodipine Krka may lower blood pressure more, if you are taking other blood pressure-lowering medicines.

Perindopril/Amlodipine Krka with food and drink

Perindopril/Amlodipine Krka should be taken before a meal.
Patients taking Perindopril/Amlodipine Krka should not consume grapefruit juice or grapefruits, as they may increase the level of the active substance amlodipine in the blood, which may result in an unexpected increase in the action of Perindopril/Amlodipine Krka, lowering blood pressure.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking Perindopril/Amlodipine Krka before planned pregnancy or as soon as you know you are pregnant, and will prescribe another medicine. It is not recommended to take Perindopril/Amlodipine Krka during the first trimester of pregnancy and it must not be taken after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
You must inform your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Perindopril/Amlodipine Krka during breastfeeding. Your doctor may choose another medicine if you plan to breastfeed, especially if you are breastfeeding a newborn or premature baby. It has been shown that small amounts of amlodipine pass into human milk.

Driving and using machines

Perindopril/Amlodipine Krka does not affect concentration, but dizziness or weakness due to low blood pressure may occur, which may impair your ability to drive or operate machinery. Do not drive or operate machinery until you know how Perindopril/Amlodipine Krka affects you.

Perindopril/Amlodipine Krka contains sodium

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

3. How to take Perindopril/Amlodipine Krka

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablet with a glass of water, preferably in the morning, before breakfast. The dose will be determined by your doctor. It is usually one tablet per day.
Perindopril/Amlodipine Krka is usually recommended for patients who are already taking perindopril and amlodipine in separate tablets.

Use in children and adolescents

Perindopril/Amlodipine Krka is not recommended for children and adolescents.

Overdose of Perindopril/Amlodipine Krka

If you have taken too many tablets, contact your doctor or go to the emergency department of the nearest hospital immediately. The most likely symptom of overdose is low blood pressure, which can cause dizziness or fainting.
In case of such symptoms, lie down and raise your legs.
Up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missed dose of Perindopril/Amlodipine Krka

It is important to take the medicine every day, as regular treatment is most effective. If you miss a dose, take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping Perindopril/Amlodipine Krka treatment

Since treatment with Perindopril/Amlodipine Krka usually lasts for life, consult your doctor before stopping the treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Perindopril/Amlodipine Krka can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, stop taking the medicine and contact your doctor immediately:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue and throat, causing severe difficulty breathing;
• severe skin reactions, including intense rash, hives, redness of the skin all over the body, intense itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• severe dizziness or fainting;
• heart attack, very fast or irregular heartbeat, or chest pain;
• pancreatitis, which can cause severe abdominal pain, radiating to the back, and very poor general condition.

The following side effects have been reported. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Very common side effects (may affect more than 1 in 10 people): swelling (fluid retention).
• Common side effects (may affect up to 1 in 10 people): headache, dizziness of central origin, drowsiness (especially at the start of treatment), dizziness of labyrinthine origin, feeling of numbness or tingling in the limbs, visual disturbances (including double vision), ringing in the ears (feeling of hearing sounds), palpitations (feeling of heartbeat), sudden flushing of the face, feeling of "emptiness" in the head due to low blood pressure, cough, shortness of breath, nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disorders, change in bowel movements, diarrhea, constipation, allergic reactions (such as skin rash, itching), muscle cramps, fatigue, weakness, swelling of the ankles (peripheral edema).

Other side effects that have been reported are listed below. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• Uncommon side effects (may affect up to 1 in 100 people): mood changes, anxiety, depression, insomnia, sleep disturbances, tremors, fainting, loss of sensation, irregular heartbeat, inflammation of the nasal mucosa (nasal congestion or runny nose), hair loss, red spots on the skin, skin discoloration, back pain, joint pain, muscle pain, chest pain, urinary disorders, frequent urination at night, increased urination, pain, poor general condition, bronchospasm (feeling of chest tightness, wheezing, and shortness of breath), dry mouth, angioedema (symptoms such as wheezing, swelling of the face or tongue), skin eruptions, kidney problems, impotence, increased sweating, increased eosinophils (a type of white blood cell), gynecomastia (breast enlargement in men), weight gain or loss, tachycardia (fast heartbeat), vasculitis (inflammation of blood vessels), photosensitivity reactions (increased sensitivity of the skin to sunlight), fever, falls, changes in laboratory test results: high potassium levels in the blood, low sodium levels, hypoglycemia (very low blood sugar levels) in diabetic patients, increased urea levels in the blood, increased creatinine levels in the blood.
• Rare side effects (may affect up to 1 in 1,000 people): confusion, worsening of psoriasis, changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood, dark urine, nausea or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate secretion of antidiuretic hormone), decreased urine production or absence of urine production, acute kidney failure.
• Very rare side effects (may affect up to 1 in 10,000 people): cardiovascular disorders (angina pectoris, heart attack, and stroke),

eosinophilic pneumonia (a rare type of pneumonia), swelling of the eyelids, face, or lips, swelling of the tongue and throat, causing severe difficulty breathing, severe skin reactions, including intense rash, hives, redness of the skin all over the body, intense itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome), erythema multiforme (a skin rash, often starting with the appearance of red, itchy patches on the face, arms, or legs), photosensitivity reactions, changes in blood parameters, such as decreased white blood cell count and red blood cell count, decreased hemoglobin levels, decreased platelet count, blood disorders, pancreatitis, which can cause severe abdominal pain, radiating to the back, and very poor general condition, liver problems, hepatitis, jaundice (yellowing of the skin), increased liver enzyme activity, which may affect some laboratory test results, abdominal bloating (gastritis), nerve disorders, which can cause weakness, numbness, or tingling, increased muscle tone, gum swelling, increased blood sugar levels (hyperglycemia).

• Frequency not known (cannot be estimated from the available data): tremors, stiffness, mask-like face, slow movements and dragging of the feet, unsteady gait, cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Perindopril/Amlodipine Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month.
Store in the original package to protect from light and moisture.
There are no special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Perindopril/Amlodipine Krka contains

• The active substances are perindopril tert-butylamine and amlodipine. Perindopril/Amlodipine Krka, 4 mg + 5 mg, tablets Each tablet contains 4 mg of perindopril tert-butylamine (equivalent to 3.34 mg of perindopril) and 5 mg of amlodipine (as besylate). Perindopril/Amlodipine Krka, 4 mg + 10 mg, tablets

Each tablet contains 4 mg of perindopril tert-butylamine (equivalent to 3.34 mg of perindopril) and 10 mg of amlodipine (as besylate).
Perindopril/Amlodipine Krka, 8 mg + 5 mg, tablets
Each tablet contains 8 mg of perindopril tert-butylamine (equivalent to 6.68 mg of perindopril) and 5 mg of amlodipine (as besylate).
Perindopril/Amlodipine Krka, 8 mg + 10 mg, tablets
Each tablet contains 8 mg of perindopril tert-butylamine (equivalent to 6.68 mg of perindopril) and 10 mg of amlodipine (as besylate).

• Other ingredients are sodium hydrogen carbonate, microcrystalline cellulose, maize starch, sodium carboxymethylcellulose (Type A), anhydrous colloidal silica, and magnesium stearate. See section 2 "Perindopril/Amlodipine Krka contains sodium".

What Perindopril/Amlodipine Krka looks like and contents of the pack

Perindopril/Amlodipine Krka, 4 mg + 5 mg, tablets: white to almost white, round, slightly convex tablets with beveled edges, with the inscription "U 1" on one side of the tablet. Diameter: approximately 7 mm.
Perindopril/Amlodipine Krka, 4 mg + 10 mg, tablets: white to almost white, biconvex tablets in the shape of a capsule, with a score line on one side. The tablets have the inscription "U" on one side and "2" on the other side of the score line. Dimensions: approximately 12.5 mm x 5.5 mm. The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
Perindopril/Amlodipine Krka, 8 mg + 5 mg, tablets: white to almost white, round, biconvex tablets with beveled edges, with the inscription "U 3" on one side of the tablet. Diameter: approximately 9 mm.
Perindopril/Amlodipine Krka, 8 mg + 10 mg, tablets: white to almost white, round, biconvex tablets with beveled edges and a score line on one side. The tablets have the inscription "U" on one side and "4" on the other side of the score line. Diameter: approximately 9 mm. The tablet can be divided into equal doses.
Packaging:10, 20, 30, 60, or 90 tablets in blisters in a cardboard box
Not all 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
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
To obtain more detailed information on the names of the medicines in other EU Member States, contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:22.08.2022