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 Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. 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, tell 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 where the blood flow to the heart is reduced or blocked). Patients already taking perindopril and amlodipine in separate tablets can 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 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

• after the third month of pregnancy (it is also recommended to avoid taking Perindopril/Amlodipine Krka in early pregnancy - see section "Pregnancy and breast-feeding");

Warnings and precautions

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

• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if you have diabetic kidney disease,
• aliskiren.
• 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),
• vildagliptin, a medicine used to treat diabetes.

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 In patients treated with ACE inhibitors, including perindopril, angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing) has been reported. 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 in early pregnancy and it must 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 breast-feeding"). You must inform your doctor or healthcare professional if you are taking Perindopril/Amlodipine Krka, if:

• general anesthesia and/or surgery are planned,
• you have recently had 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

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take. You should avoid taking 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 immunosuppressive medicine 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. You should inform your doctor if you are taking any of the following medicines, as special care may be required:

• 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) during anesthesia,
• certain antibiotics, e.g., rifampicin, erythromycin,
• clarithromycin (a medicine used to treat bacterial infections),
• antiepileptic medicines, e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
• itraconazole, ketoconazole (medicines used to treat fungal infections),
• alpha-adrenergic blockers, used to treat enlarged prostate, e.g., 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 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 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 eat 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 breast-feeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. PregnancyYou 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 advise you to take 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 if taken during this period. Breast-feedingYou must inform your doctor if you are breast-feeding or plan to breast-feed. It is not recommended to take Perindopril/Amlodipine Krka during breast-feeding. Your doctor may choose another medicine if you plan to breast-feed, especially if you are breast-feeding 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, check with your 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 breakfast. Your doctor will determine the dose that is right for you. 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.

What to do if you take more Perindopril/Amlodipine Krka than you should

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. If you experience such symptoms, lie down and raise your legs.

What to do if you forget to take Perindopril/Amlodipine Krka

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

What to do if you stop taking Perindopril/Amlodipine Krka

Since treatment with Perindopril/Amlodipine Krka usually lasts for life, consult your doctor before stopping the medicine. 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 are common side effects that have been reported. If any of these side effects bother you, or if they last for more than a week, you should contact your 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 of central origin, drowsiness (especially at the beginning of treatment), dizziness of labyrinthine origin, feeling of numbness or tingling in 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 associated with 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 of the side effects get worse, or if you notice any side effects not listed in this leaflet, you should 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, 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 mucous membranes 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 weight loss, tachycardia (fast heart rate), 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, 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 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 antidiuretic hormone secretion), 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, itching spots on the face, arms, or legs), photosensitivity reactions, changes in blood test results, 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 function disorders, liver inflammation, jaundice (yellowing of the skin), increased liver enzyme activity, which may affect some laboratory 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, parkinsonian symptoms, mask-like face, rigidity, slow movements, and shuffling gait, cyanosis, numbness, and pain in the fingers and toes (Raynaud's phenomenon).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. You can also report side effects 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 of Perindopril/Amlodipine Krka 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), colloidal anhydrous 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, convex 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 not to divide into equal doses. Perindopril/Amlodipine Krka, 8 mg + 5 mg, tablets: white to almost white, round, convex 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, convex 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 For more information on the names of the medicines in other EU countries, please contact the local representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o. ul. Równoległa 5 02-235 Warsaw Tel. 22 57 37 500 Date of last revision of the leaflet:22.08.2022