Perindopril/amlodipine Krka

Leaflet accompanying the packaging: patient information

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 artery disease (a condition in which blood flow to the heart is reduced or blocked).
Patients already taking perindopril and amlodipine in separate tablets may take one tablet of Perindopril/Amlodipine Krka, which contains both active substances.
Perindopril/Amlodipine Krka is a combination of two active substances: perindopril and amlodipine. Perindopril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Amlodipine is a calcium antagonist (it belongs to a group of medicines called 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 the patient is 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 (it is also recommended to avoid taking Perindopril/Amlodipine Krka in early pregnancy - see section "Pregnancy and breastfeeding");
• if the patient has experienced 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 in which the heart cannot supply enough blood to the body), aortic stenosis (narrowing of the main blood vessel leaving the heart), or unstable angina pectoris (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 effectively, leading to shortness of breath or swelling of the legs, ankles, or feet) after a recent heart attack;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient is undergoing dialysis or blood filtration using a different method. Depending on the device used, Perindopril/Amlodipine Krka may not be suitable for the patient.
• if the patient has kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used to treat a certain type of chronic (long-term) 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 starting to take Perindopril/Amlodipine Krka, the patient should discuss it with their doctor or pharmacist:

• if the patient has hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the artery that supplies blood to the kidney);
• if the patient has other heart diseases;
• if the patient has liver function disorders;
• if the patient has kidney disease or is undergoing dialysis;
• if the patient has a condition called primary aldosteronism (a condition in which the blood contains too much of a hormone called aldosterone);
• if the patient has a collagen disease (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
• if the patient has diabetes;
• if the patient is on a low-salt diet or is taking salt substitutes that contain potassium (it is necessary to adjust the potassium level in the blood);
• if the patient is elderly and needs to adjust the dose;
• if the patient is 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 the patient has kidney problems related to diabetes,
• aliskiren.
• if the patient is taking any of the following medicines, which may increase the risk of angioedema:
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent the rejection of a transplanted organ and to treat cancer (e.g., sirolimus, everolimus, temsirolimus, and other mTOR inhibitors),
• vildagliptin, a medicine used to treat diabetes.
• if the patient is 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.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
See also the information under the heading "When not to take Perindopril/Amlodipine Krka".
Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril. This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Perindopril/Amlodipine Krka and contact their doctor immediately. See also section 4.
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Perindopril/Amlodipine Krka during early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken during this period (see section "Pregnancy and breastfeeding").
The patient should inform their doctor or medical staff about taking Perindopril/Amlodipine Krka if:

• general anesthesia and/or surgery are planned,
• recently experienced diarrhea or vomiting,
• LDL apheresis (removal of cholesterol from the blood using a special device) is planned,
• desensitization treatment is to be performed to reduce the allergic reaction to bee or wasp stings.

Children and adolescents

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

Perindopril/Amlodipine Krka and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should avoid taking Perindopril/Amlodipine Krka with:

• lithium (used to treat mania or depression),
• estradiol (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 immunosuppressive medicine used to prevent organ rejection and treat certain diseases),
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day.

Other medicines may affect the action of Perindopril/Amlodipine Krka. The patient should inform their doctor about taking any of the following medicines, as special care may be necessary:

• 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 excreted 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 vildagliptin),
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (e.g., tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics),
• immunosuppressive medicines (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 (a medicine used to treat gout),
• procainamide (a medicine used to treat heart rhythm disorders),
• vasodilators, including nitrates,
• ephedrine, noradrenaline, or adrenaline (medicines 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) that occurs during anesthesia,
• certain antibiotics, such as rifampicin, erythromycin,
• clarithromycin (a medicine used to treat bacterial infections),
• antiepileptic medicines, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
• itraconazole, ketoconazole (medicines used to treat fungal infections),
• alpha-adrenergic blockers, used to treat prostate enlargement, such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin,
• amifostine (a medicine given to prevent or reduce the side effects of other medicines or radiation therapy used to treat cancer),
• corticosteroids (medicines used to treat various conditions, including severe asthma and rheumatoid arthritis),
• gold salts, especially those given intravenously (used to treat symptoms of rheumatoid arthritis),
• simvastatin (a medicine used to lower cholesterol levels),
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV),
• St. John's Wort (Hypericum perforatum),
• verapamil, diltiazem (medicines used to treat heart conditions),
• medicines commonly used to treat diarrhea (racecadotril) or to prevent the rejection of a transplanted organ (sirolimus, everolimus, temsirolimus, or other mTOR inhibitors). See section "Warnings and precautions".

Perindopril/Amlodipine Krka may lower blood pressure more when the patient takes 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 blood pressure-lowering effect of Perindopril/Amlodipine Krka.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually advise stopping Perindopril/Amlodipine Krka before planned pregnancy or as soon as pregnancy is confirmed and recommend taking a different medicine. It is not recommended to take Perindopril/Amlodipine Krka during the first trimester of pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken during this period.
Breastfeeding
The patient should inform their doctor about breastfeeding or intending to breastfeed. It is not recommended to take Perindopril/Amlodipine Krka during breastfeeding. The doctor may choose a different medicine if the patient intends to breastfeed, especially if 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 the ability to drive and use machines. The patient should not drive or use machines until they know how they react to Perindopril/Amlodipine Krka.

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

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably once a day, at the same time, in the morning before a meal. The doctor will determine the dose suitable for the patient. 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.

Taking a higher dose of Perindopril/Amlodipine Krka than recommended

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

Missing a dose of Perindopril/Amlodipine Krka

It is important to take the medicine every day, as regular treatment is most effective. If a dose is missed, the next dose should be taken at the usual time.
The patient should not take a double dose to make up for the missed dose.

Stopping Perindopril/Amlodipine Krka

Since treatment with Perindopril/Amlodipine Krka usually lasts for life, the patient should consult their doctor before stopping the medicine.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Perindopril/Amlodipine Krka can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they should stop taking the medicine and contact their 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 severe rash, hives, redness of the skin all over the body, severe 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 side effect is troubling or lasts for more than a week, the patient should consult their doctor.

• 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, drowsiness (especially at the start of treatment), vertigo, numbness or tingling of the limbs, vision 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, changes 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 side effect worsens or any side effect not listed in the leaflet occurs, the patient should tell their 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, nocturia (need to urinate at night), increased frequency of urination, pain, malaise, bronchospasm (feeling of constriction in the chest, wheezing, and shortness of breath), dryness of the mouth, angioedema (symptoms such as wheezing, swelling of the face or tongue), blistering of the skin, kidney disorders, 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), sensitivity to light, changes in blood test results: high potassium levels in the blood, transient, after stopping treatment, 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 blood 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 antidiuretic hormone secretion), decreased or absent 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 severe rash, hives, redness of the skin all over the body, severe 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 spots on the face, arms, or legs), sensitivity to light, 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 disorders, hepatitis, jaundice (yellowing of the skin), increased liver enzyme activity, which may affect some test results, abdominal bloating (gastritis), nervous system disorders, which can cause weakness, numbness, or tingling, increased muscle tone, gum hypertrophy, 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 side effects occur, including any side effects not listed in this leaflet, the patient should tell their 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:
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Perindopril/Amlodipine Krka

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store in the original packaging to protect from light and moisture.
There are no special storage temperature requirements.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Perindopril/Amlodipine Krka contains

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

Each tablet contains 4 mg of perindopril tert-butylamine (which corresponds to 3.34 mg of perindopril) and 10 mg of amlodipine (in the form of besylate).
Perindopril/Amlodipine Krka, 8 mg + 5 mg, tablets
Each tablet contains 8 mg of perindopril tert-butylamine (which corresponds to 6.68 mg of perindopril) and 5 mg of amlodipine (in the form of besylate).
Perindopril/Amlodipine Krka, 8 mg + 10 mg, tablets
Each tablet contains 8 mg of perindopril tert-butylamine (which corresponds to 6.68 mg of perindopril) and 10 mg of amlodipine (in the form of 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 dividing line on one side. The tablets have the inscription "U" on one side and "2" on the other side of the dividing line. Dimensions: approximately 12.5 mm x 5.5 mm. The dividing line on the tablet is only to facilitate breaking and does not divide the tablet 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 dividing line on one side. The tablets have the inscription "U" on one side and "4" on the other side of the dividing 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 medicines in other EU member states, the patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:22.08.2022