VILPIN 5 mg/10 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Vilpin Combi, 5 mg + 5 mg, tablets
3. Vilpin Combi, 5 mg + 10 mg, tablets
4. Vilpin Combi, 10 mg + 5 mg, tablets
5. Vilpin Combi, 10 mg + 10 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
6. What is Vilpin Combi and what is it used for
7. Important information before taking Vilpin Combi
   1. When not to take Vilpin Combi
   2. Warnings and precautions
   3. Angioedema
   4. Children and adolescents
   5. Vilpin Combi with other medicines
   6. The use of other medicines may affect treatment with Vilpin Combi. The patient should tell their doctor about taking any of the following medicines, as this may require
   7. Vilpin Combi with food and drink
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
   10. Vilpin Combi contains sodium
   11. Vilpin Combi contains isomalt
8. How to take Vilpin Combi
   1. Use in children and adolescents
   2. Taking a higher dose of Vilpin Combi than recommended
   3. Missing a dose of Vilpin Combi
   4. Stopping treatment with Vilpin Combi
9. Possible side effects
   1. Reporting side effects
10. How to store Vilpin Combi
11. Contents of the packaging and other information
    1. What Vilpin Combi contains
    2. What Vilpin Combi looks like and contents of the packaging
    3. Marketing authorization holder and manufacturer
    4. Marketing authorization holder:
    5. Manufacturer:
    6. This medicine is authorized in the Member States of the European Economic Area under the following names:
    7. Belgium:

Leaflet accompanying the packaging: 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

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 to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any possible 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 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 packaging 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 blood flow to the heart is reduced or blocked). Patients who have previously taken perindopril and amlodipine in separate tablets may receive one Vilpin Combi tablet, 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 (it belongs to a group of medicines called dihydropyridines). Both active substances work by dilating and relaxing blood vessels, which makes it easier for blood to flow through the vessels and helps the heart pump blood to the whole body.

2. Important information before taking Vilpin Combi

When not to take Vilpin Combi

if the patient is 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 the patient is pregnant for more than 3 months (it is also recommended to avoid taking Vilpin Combi in early pregnancy - see section 2 "Pregnancy and breastfeeding"),
• if the patient has experienced symptoms while taking an ACE inhibitor, such as wheezing, swelling of the face or tongue, intense itching or severe skin rash, or if such symptoms have occurred in the patient or any family member in any other circumstances (a condition called angioedema),

if the patient has a narrowing of the aortic valve (aortic stenosis)

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

Warnings and precautions

Before starting to take Vilpin Combi, the patient should discuss with their doctor or pharmacist if they have any of the following conditions: hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney), heart failure, significant increases in blood pressure (hypertensive crisis), any other heart diseases, liver diseases, kidney diseases or if the patient is undergoing dialysis, the patient has abnormally high levels of a hormone called aldosterone in the blood (primary aldosteronism), collagenosis (a disease of connective tissue), such as systemic lupus erythematosus or scleroderma, diabetes, the patient is taking a low-salt diet or is taking salt substitutes containing potassium (it is necessary to balance potassium levels in the blood), it is necessary to increase the dose in elderly patients, if the patient is 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 the patient has kidney problems related to diabetes,
• aliskiren. The 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". The patient is 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 a 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,

in patients with a history of angioedema, the patient is 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.

Angioedema

Angioedema has been reported in patients treated with ACE inhibitors, including Vilpin Combi. This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Vilpin Combi and contact their doctor immediately. See also section 4. The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. Vilpin Combi should not be taken during pregnancy and should not be taken after 3 months of pregnancy, as it may cause serious harm to the baby if taken during this period (see section "Pregnancy"). The patient should also inform their doctor or medical staff about taking Vilpin Combi if: the patient is to undergo general anesthesia and/or major surgery, recently experienced diarrhea or vomiting, a LDL apheresis procedure is planned (removal of cholesterol from the blood using a special device), desensitization treatment is planned to reduce allergic reactions to bee or wasp stings.

Children and adolescents

Vilpin Combi should not be used in children and adolescents.

Vilpin Combi with 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 Vilpin Combi with: lithium (used to treat mania or depression), estramustine (used to treat cancer), potassium supplements (including salt substitutes), potassium-sparing diuretics (triamterene, amiloride), and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections),

The use of other medicines may affect treatment with Vilpin Combi. The patient should tell their doctor about taking any of the following medicines, as this may require

special caution: medicines used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to a group of medicines called mTOR inhibitors, tacrolimus, and wildagliptin), as they may increase the risk of a serious allergic reaction. See the "Warnings and precautions" section; other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (also known as sartans, e.g., valsartan, telmisartan, irbesartan), aliskiren, or diuretics (medicines that increase urine production in the kidneys), non-steroidal anti-inflammatory medicines (e.g., ibuprofen), given to relieve pain or large doses of aspirin (acetylsalicylic acid), a substance found in many medicines, used to relieve pain and reduce fever, as well as to prevent blood clots, medicines used to treat diabetes (such as insulin and gliptins, e.g., linagliptin, saxagliptin, sitagliptin, wildagliptin), 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 diseases or after organ transplantation (e.g., cyclosporine and tacrolimus), allopurinol (used to treat gout), trimethoprim and co-trimoxazole (used to treat 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 that occurs 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 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 (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 reduce 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. The patient should 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 intensification of the blood pressure-lowering effect of Vilpin Combi.

Pregnancy, breastfeeding, and fertility

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 suspected (or planned) pregnancy. Usually, the doctor will advise stopping Vilpin Combi before becoming pregnant or as soon as the patient finds out they are pregnant and will prescribe another medicine instead of Vilpin Combi. Vilpin Combi should not be taken during early pregnancy and should not be taken after 3 months of pregnancy, as it may cause serious harm to the baby if taken during this period. Breastfeeding It has been shown that small amounts of amlodipine pass into human milk. The patient should inform their doctor about breastfeeding or intending to breastfeed. Vilpin Combi should not be taken during breastfeeding. The doctor may choose another medicine if the patient intends to breastfeed, especially in the case of breastfeeding a newborn or premature baby.

Driving and using machines

Vilpin Combi may impair the ability to drive and use machines. If the patient experiences nausea, dizziness, weakness, fatigue, or headache after taking the tablets, they should not drive or use machines and should contact their 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 the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Vilpin Combi

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 in the morning, at the same time every day, before a meal. The doctor will determine the dose suitable for the patient. Usually, it 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

Vilpin Combi should not be used in children and adolescents.

Taking a higher dose of Vilpin Combi than recommended

In case of taking too many tablets, the patient should contact their doctor or go to the emergency department of the nearest hospital immediately. The most common symptom of overdose is low blood pressure, which can cause dizziness or fainting. If such symptoms occur, it may be helpful to lie down with elevated 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.

Missing a dose of Vilpin Combi

It is important to take the medicine every day, as regular use ensures its effectiveness. However, if a dose of Vilpin Combi 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 treatment with Vilpin Combi

Treatment with Vilpin Combi is usually long-term, so before stopping the treatment, the patient should consult their doctor. 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, Vilpin Combi 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: 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 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), weakness of the arms or legs, or speech disturbances, which may be a sign of a stroke, excessively rapid or irregular heartbeat, chest pain (angina pectoris), or heart attack, pancreatitis, which can cause severe abdominal pain radiating to the back, accompanied by very poor general condition, yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation. The following common side effectshave been reported. If any of the followingsymptoms are troublesome for the patient or last longer than one week, they should contact their doctor. Very common side effects(may occur in more than 1 in 10 people): swelling (water retention). Common side effects(may occur in up to 1 in 10 people): headache, dizziness of central origin, drowsiness (especially at the beginning of treatment), dizziness of labyrinthine origin, feeling of tingling and numbness of limbs, vision disturbances (including double vision), ringing in the ears (feeling of noise in the ears), palpitations (awareness of heart function), sudden flushing (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 disorders, 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 reported side effects are listed below. If the patient experiences any side effectsnot listed in the leaflet, they should tell their doctor or pharmacist. Uncommon side effects(may occur in up to 1 in 100 people): mood changes, anxiety, depression, insomnia, sleep disturbances, tremors, loss of consciousness, loss of pain sensation, inflammation of the nasal mucosa (nasal congestion or discharge), heart rhythm disturbances, hair loss, red spots or discoloration of the skin, back pain, muscle or joint pain, chest pain, urinary disturbances, nocturia (need to urinate at night), increased frequency of urination, pain, poor general condition, 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, discomfort or breast enlargement in men, weight gain or loss, rapid heartbeat, fever, falls, vasculitis (inflammation of blood vessels), hypersensitivity reactions to light (increased skin sensitivity to sunlight), changes in laboratory test results: high potassium levels in the blood, low sodium levels, hypoglycemia (very low blood sugar levels) in patients with diabetes, increased urea levels in the blood. Rare side effects(may occur in up to 1 in 1,000 people): disorientation (feeling of confusion), worsening of psoriasis, abnormal laboratory test results: increased liver enzyme activity, increased bilirubin levels in serum. 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 occur in up to 1 in 10,000 people): cardiovascular disorders (angina pectoris and stroke), 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 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), skin rash, often starting with the appearance of red, itchy spots on the face, arms, or legs (erythema multiforme), 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, accompanied by very poor general condition, liver function disorders, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect some laboratory test results, abdominal bloating (gastritis), nerve disorders, which can cause weakness, tingling, or numbness, increased muscle tone, gum hypertrophy, increased blood sugar levels (hyperglycemia). Frequency not known(frequency cannot be estimated from available data): tremors, stiffness of posture, mask-like face, slow movements, and shuffling gait, cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon), very severe skin reaction (toxic epidermal necrolysis). If the patient experiences any of these symptoms, they should contact their doctor as soon as possible.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, more information can be gathered on the safety of the medicine.

5. How to store Vilpin Combi

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging and label of the bottle after the "Expiry date" or "EXP" marking. The expiry date refers to the last day of the month stated. There are no special storage temperature requirements. Store in the original packaging to protect from light and moisture. Store the container tightly closed. 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 Vilpin Combi contains

• The active substances of Vilpin Combi are perindopril tosilate and amlodipine. Each tablet contains 5 mg of perindopril tosilate, which corresponds to 3.4 mg of perindopril, and 6.935 mg of amlodipine besylate, which corresponds to 5 mg of amlodipine. Each tablet contains 5 mg of perindopril tosilate, which corresponds to 3.4 mg of perindopril, and 13.87 mg of amlodipine besylate, which corresponds to 10 mg of amlodipine. Each tablet contains 10 mg of perindopril tosilate, which corresponds to 6.8 mg of perindopril, and 6.935 mg of amlodipine besylate, which corresponds to 5 mg of amlodipine. Each tablet contains 10 mg of perindopril tosilate, which corresponds to 6.8 mg of perindopril, and 13.87 mg of amlodipine besylate, which corresponds 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 packaging

Vilpin Combi, 5 mg + 5 mg, tablets are white, oval, biconvex tablets with the marking "5/5" on one side and smooth on the other. Vilpin Combi, 5 mg + 10 mg, tablets are white, round, biconvex tablets with the marking "5/10" on one side and smooth on the other. Vilpin Combi, 10 mg + 5 mg, tablets are white, oval, biconvex tablets with the marking "10/5" on one side and smooth on the other. Vilpin Combi, 10 mg + 10 mg, tablets are white, round, biconvex tablets with the marking "10/10" on one side and smooth on the other. Vilpin Combi, stored in tablet containers (polypropylene (PP) containers with a desiccant in the cap), is available in packages containing: 5 mg + 5 mg: 10, 30, and collective packaging of 90 (3 x 30) tablets, 5 mg + 10 mg, 10 mg + 5 mg, and 10 mg + 10 mg: 30 and collective packaging 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 about the medicine, the patient should contact the representative of 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 leaflet:November 2023