Vilpin Combi

Package Leaflet: Information for the User

Vilpin Combi, 5 mg + 5 mg, tablets

Vilpin Combi, 5 mg + 10 mg, tablets

Vilpin Combi, 10 mg + 5 mg, tablets

Vilpin Combi, 10 mg + 10 mg, tablets

Perindopril tosilate + Amlodipine

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

• Keep this package 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Vilpin Combi and what is it used for

Vilpin Combi is used to treat high blood pressure (hypertension) and/or stable coronary artery disease (a condition in which the blood flow to the heart is reduced or blocked). Patients who have previously taken perindopril and amlodipine in separate tablets may be switched to Vilpin Combi, which contains both active substances. Vilpin Combi is a combination medicine that contains two active substances: perindopril and amlodipine. Perindopril is an angiotensin-converting enzyme inhibitor (ACE inhibitor). Amlodipine is a calcium antagonist (belonging to the dihydropyridine group). Both active substances work by widening and relaxing blood vessels, making it easier for blood to flow through the vessels and helping the heart to pump blood to the whole body.

2. Important information before taking Vilpin Combi

When not to take Vilpin Combi

if you are allergic to perindopril or other ACE inhibitors, or to amlodipine, or to other calcium antagonists, or to any of the other ingredients of this medicine (listed in section 6),

• if you are pregnant more than 3 months (it is also recommended to avoid taking Vilpin Combi in early pregnancy - see section 2 "Pregnancy and breastfeeding"),
• if you have had symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rash when taking an ACE inhibitor in the past,

such as angioedema (a condition characterized by swelling of the face, lips, tongue, or throat), if you have aortic stenosis (narrowing of the aortic valve).

• if you have cardiogenic shock (a condition in which the heart is unable to supply the body with enough blood), if you have significantly low blood pressure (hypotension), if you have heart failure after a heart attack, if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine that contains aliskiren,
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases (see "Warnings and precautions" and "Vilpin Combi with other medicines"),
• if you are undergoing dialysis or blood filtration by other methods. Depending on the device used, Vilpin Combi may not be suitable for you,
• if you have kidney problems that reduce blood flow to the kidneys (renal artery stenosis).

Warnings and precautions

Before taking Vilpin Combi, discuss with your doctor or pharmacist if you have any of the following conditions: hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the blood vessel supplying the kidney), heart failure, significantly high blood pressure (hypertensive crisis), any other heart disease, liver disease, kidney disease or if you are undergoing dialysis, you have abnormally high levels of a hormone called aldosterone in your blood (primary aldosteronism), collagen disease (such as systemic lupus erythematosus or scleroderma), diabetes, you are taking a low-salt diet or taking salt substitutes that contain potassium (it is necessary to adjust the potassium levels in the blood), it is necessary to increase the dose in elderly patients, if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin II receptor antagonist (AIIRA), also known as a sartan - for example, valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes,
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood. See also the subsection "When not to take Vilpin Combi". you are taking any of the following medicines, as they may increase the risk of angioedema:
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors (used to prevent rejection of transplanted organs and to treat cancer),
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure,

linagliptin, saxagliptin, sitagliptin, wildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes), you are black - in this case, there may be a greater risk of angioedema, and the medicine may be less effective in lowering blood pressure than in other patients.

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (also known as sartans, such as valsartan, telmisartan, irbesartan), aliskiren, or diuretics (medicines that increase the amount of urine produced by the kidneys), non-steroidal anti-inflammatory drugs (such as ibuprofen), given to relieve pain or large doses of aspirin (acetylsalicylic acid), a substance found in many medicines, used as a pain reliever and antipyretic, as well as to prevent blood clots, medicines used to treat diabetes (such as insulin and gliptins, such as linagliptin, saxagliptin, sitagliptin, wildagliptin), medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (such as tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics), immunosuppressants (weakening the immune system), used to treat autoimmune diseases or after organ transplantation (such as cyclosporine and tacrolimus), allopurinol (used to treat gout), trimethoprim and co-trimoxazole (used to treat bacterial infections), procainamide (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, occurring in diseases such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia during anesthesia (symptoms include very high fever and muscle stiffness), certain antibiotics used to treat bacterial infections, such as rifampicin, erythromycin, and clarithromycin, antiepileptic drugs, 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 (used to prevent or reduce the side effects of other medicines or radiation therapy, used to treat cancer), corticosteroids (used to treat various diseases, including severe asthma and rheumatoid arthritis), gold salts, especially given intravenously (used to treat symptoms of rheumatoid arthritis), ritonavir, indinavir, nelfinavir (so-called protease inhibitors, used to treat HIV infection), simvastatin (used to lower cholesterol levels), sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure, Hypericum perforatum(St. John's Wort, a herbal medicine used to treat depression).

  Vilpin Combi with food and drink

  Vilpin Combi should be taken before a meal. Do not eat grapefruits or drink grapefruit juice while taking Vilpin Combi, as this may increase the levels of the active substance amlodipine in the blood, which may cause unpredictable potentiation of the blood pressure-lowering effect of Vilpin Combi.

  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 You must tell your doctor if you are pregnant or think you may be pregnant or are planning to have a baby. Your doctor will normally advise you to stop taking Vilpin Combi before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Vilpin Combi. Do not take Vilpin Combi if you are more than 3 months pregnant. It is also not recommended to take Vilpin Combi during the first few months of pregnancy. Do not take Vilpin Combi if you are more than 3 months pregnant, as it may cause serious harm to your baby. Breastfeeding Small amounts of amlodipine have been shown to pass into breast milk. You must tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Vilpin Combi while breastfeeding. Your doctor may choose a different medicine if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

  Driving and using machines

  Vilpin Combi may affect your ability to drive or use machines. If you experience nausea, dizziness, weakness, fatigue, or headache after taking the tablets, do not drive or use machines and contact your doctor immediately.

  Vilpin Combi contains sodium

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

  Vilpin Combi contains isomalt

  If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

  3. How to take Vilpin Combi

  Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The tablet should be swallowed with a glass of water, preferably in the morning, at the same time every day, before a meal. Your doctor will decide the dose that is right for you. The usual dose is one tablet per day. Vilpin Combi is usually recommended for patients who are already taking perindopril and amlodipine in separate tablets.

  Use in children and adolescents

  Do not give Vilpin Combi to children and adolescents.

  If you take more Vilpin Combi than you should

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

  If you forget to take Vilpin Combi

  It is important to take your medicine every day to ensure that it works properly. However, if you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

  If you stop taking Vilpin Combi

  Treatment with Vilpin Combi is usually long-term, so before stopping your medicine, you should talk to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

  4. Possible side effects

  Like all medicines, Vilpin Combi 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: severe dizziness or fainting due to low blood pressure, sudden wheezing, chest pain, shortness of breath, or difficulty breathing, swelling of the eyelids, face, or lips, swelling of the tongue and throat, causing difficulty breathing, severe skin reactions, including increased sensitivity to the sun, severe rash, itching, blistering, or peeling of the skin, angioedema (a condition characterized by swelling of the face, lips, tongue, or throat), weakness or paralysis of the arms or legs, or speech disturbances, which may be symptoms of a stroke, rapid or irregular heartbeat, chest pain (angina pectoris), or heart attack, pancreatitis, which may cause severe abdominal pain, radiating to the back, and very poor general condition, jaundice (yellowing of the skin and eyes), which may be a sign of liver inflammation. The following side effects have been reported: Very common side effects (may affect more than 1 in 10 people): edema (fluid retention) Common side effects (may affect up to 1 in 10 people): headache, dizziness, drowsiness (especially at the start of treatment), vertigo, tingling or numbness of the limbs, visual disturbances (including double vision), tinnitus (a feeling of noise in the ears), palpitations (awareness of heartbeat), sudden reddening (especially 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 disturbances, changes in bowel movements, diarrhea, constipation, allergic reactions (such as skin rash, itching), muscle cramps, feeling of fatigue, weakness, swelling of the ankles (edema). Other side effects reported include: Uncommon side effects (may affect up to 1 in 100 people): mood changes, anxiety, depression, insomnia, sleep disturbances, tremors, loss of consciousness, loss of pain sensation, rhinitis (nasal congestion or runny nose), arrhythmias (abnormal heart rhythms), hair loss, red spots or discoloration of the skin, back pain, muscle or joint pain, chest pain, urinary disturbances, nocturia (waking up to urinate at night), increased frequency of urination, pain, malaise, bronchospasm (a feeling of constriction in the chest, wheezing, and shortness of breath), dryness of the mucous membranes, angioedema (a condition characterized by swelling of the face, lips, tongue, or throat), blistering of the skin, kidney problems, impotence, increased sweating, discomfort or enlargement of the breasts in men, weight gain or loss, rapid heartbeat, fever, falls, vasculitis (inflammation of blood vessels), photosensitivity reactions (increased sensitivity of the skin to sunlight), changes in blood 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): disorientation (feeling of confusion), exacerbation of psoriasis, abnormal blood test results: increased liver enzyme activity, increased 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 output or absence of urine output, acute kidney failure. Very rare side effects (may affect up to 1 in 10,000 people): cardiovascular disorders (angina pectoris and myocardial infarction), eosinophilic pneumonia (a rare form of pneumonia), swelling of the eyelids, face, or lips, swelling of the tongue and throat, causing significant difficulty breathing, severe skin reactions, including increased sensitivity to the sun, severe rash, itching, blistering, or peeling of the skin, Stevens-Johnson syndrome (a condition characterized by blistering of the skin and mucous membranes), toxic epidermal necrolysis (a condition characterized by widespread skin blistering and peeling), erythema multiforme (a condition characterized by rash and blistering of the skin), changes in blood test results, such as decreased white blood cell count, decreased red blood cell count, decreased platelet count, blood disorders, pancreatitis, which may cause severe abdominal pain, radiating to the back, and very poor general condition, liver problems, liver inflammation, jaundice (yellowing of the skin and eyes), increased liver enzyme activity, which may affect some blood test results, abdominal bloating (gastritis), nerve problems, which may cause weakness, tingling, or numbness, increased muscle tone, gum hypertrophy, increased blood sugar levels (hyperglycemia). Frequency not known (frequency cannot be estimated from the available data): tremors, stiffness of the body, mask-like face, slow movements and shuffling gait, unsteady gait, cyanosis (blue discoloration of the skin), numbness and pain in the fingers or toes (Raynaud's phenomenon), very severe skin reaction (toxic epidermal necrolysis). If you experience any of these symptoms, contact your doctor immediately.

  Reporting side effects

  If you experience any side effects, including any not listed in this leaflet, please tell 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 Tel.: +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 Vilpin Combi

  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 and blister after "EXP". The expiry date refers to the last day of that month. There are no special storage instructions for this medicine. Store in the original package to protect from light and moisture. Store the container tightly closed. 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 Vilpin Combi contains

  • The active substances are perindopril tosilate and amlodipine. Each tablet contains 5 mg of perindopril tosilate, equivalent to 3.4 mg of perindopril, and 6.935 mg of amlodipine besylate, equivalent to 5 mg of amlodipine. Each tablet contains 5 mg of perindopril tosilate, equivalent to 3.4 mg of perindopril, and 13.87 mg of amlodipine besylate, equivalent to 10 mg of amlodipine. Each tablet contains 10 mg of perindopril tosilate, equivalent to 6.8 mg of perindopril, and 6.935 mg of amlodipine besylate, equivalent to 5 mg of amlodipine. Each tablet contains 10 mg of perindopril tosilate, equivalent to 6.8 mg of perindopril, and 13.87 mg of amlodipine besylate, equivalent to 10 mg of amlodipine.
  • The other ingredients are sodium hydrogen carbonate, povidone K30, isomalt, microcrystalline cellulose, sodium carboxymethylcellulose (Type A), magnesium stearate.

  What Vilpin Combi looks like and contents of the pack

  Vilpin Combi, 5 mg + 5 mg, tablets are white, oval, biconvex tablets with "5/5" engraved on one side and smooth on the other. Vilpin Combi, 5 mg + 10 mg, tablets are white, round, biconvex tablets with "5/10" engraved on one side and smooth on the other. Vilpin Combi, 10 mg + 5 mg, tablets are white, oval, biconvex tablets with "10/5" engraved on one side and smooth on the other. Vilpin Combi, 10 mg + 10 mg, tablets are white, round, biconvex tablets with "10/10" engraved on one side and smooth on the other. Vilpin Combi is available in tablet containers (propylene containers (PP) with a desiccant in the cap) in packs of: 5 mg + 5 mg: 10, 30, and collective packs of 90 (3 x 30) tablets 5 mg + 10 mg, 10 mg + 5 mg, and 10 mg + 10 mg: 30, and collective packs of 90 (3 x 30) tablets. Not all pack sizes may be marketed.

  Marketing authorization holder and manufacturer

  Marketing authorization holder:

  Teva B.V. Swensweg 5 2031 GA Haarlem Netherlands

  Manufacturer:

  TEVA Gyógyszergyár Zrt. Pallagi út 13 4042 Debrecen Hungary Teva Operations Poland Sp. z o.o. ul. Mogilska 80 31-546 Kraków For more information on this medicine, contact the marketing authorization holder: Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater 53 00-113 Warszawa Tel.: (22) 345 93 00

  This medicine is authorized in the Member States of the European Economic Area under the following names:

  Belgium:

  Perindopril / Amlodipine Teva

  Bulgaria:

  Zalpam

  Croatia:

  Perindopril/amlodipin Pliva

  Czech Republic:

  Perindopril/amlodipin Teva BV

  Estonia:

  Perindopril/ Amlodipine Teva

  France:

  PERINDOPRIL/AMLODIPINE TEVA

  Netherlands:

  Perindopril tosilaat/Amlodipine Teva

  Ireland:

  Perindopril Tosilate/Amlodipine Teva B.V.

  Lithuania:

  Perindopril/ Amlodipine Teva Pharma

  Latvia:

  Perindopril/ Amlodipine Teva Pharma

  Poland:

  Vilpin Combi

  Portugal:

  Perindopril + Amlodipina Teva

  Slovenia:

  Perindopril/amlodipin Teva

  Italy:

  PERIDOPRIL E AMLODIPINA TEVA ITALIA

  Date of last revision of the package leaflet:November 2023