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 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, tell your 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 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 heart 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 a single tablet of 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 class of drugs known as dihydropyridines). 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 for more than 3 months (it is also recommended to avoid taking Vilpin Combi in early pregnancy - see section 2 "Pregnancy and breast-feeding"),
• if you have had symptoms while taking an ACE inhibitor in the past, such as wheezing, swelling of the face or tongue, intense itching or severe skin rash, or if such symptoms have occurred in you or a family member in any other circumstances (a condition called angioedema),

if you have narrowing of the aortic valve (aortic stenosis)

• 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 containing 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 disease of the heart muscle) or renal artery stenosis (narrowing of the blood vessel supplying the kidney), heart failure, significantly increased 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 (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma, diabetes, you are taking a low-salt diet or taking salt substitutes containing potassium (it is necessary to adjust the potassium level 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:

• angiotensin II receptor antagonist (AIIRA), also known as 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 "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,

in combination with Vilpin Combi.

• 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.

Angioedema has been reported in patients treated with ACE inhibitors, including Vilpin Combi. This reaction can occur at any time during treatment. If you experience such symptoms, stop taking Vilpin Combi 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. Vilpin Combi should not be taken during pregnancy, and it is not recommended to take it in early pregnancy, as it may cause serious harm to the baby if taken during this period (see section "Pregnancy"). You should also inform your doctor or healthcare professional if you are taking Vilpin Combi and:

Children and adolescents

Vilpin Combi should not be used in children and adolescents.

Vilpin Combi with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take. Do not take Vilpin Combi with::
lithium (used to treat mania or depression),
estradiol (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),
with 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 treatment with Vilpin Combi. Tell your doctor if you are taking any of the following medicines, as they may require

special caution:
medicines commonly used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors, tacrolimus, and wildagliptin), as they may increase the risk of a serious allergic reaction. See "Warnings and precautions",
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 high 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),
immunosuppressants (medicines that 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 (used to treat muscle stiffness, which occurs in diseases such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia during anesthesia),
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.
Do not eat grapefruits or drink grapefruit juice while taking Vilpin Combi, as this may increase the level of the active substance amlodipine in the blood, which may cause unpredictable enhancement of the blood pressure-lowering effect of Vilpin Combi.

Pregnancy, breast-feeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Vilpin Combi before you become pregnant or as soon as you find out that you are pregnant, and will advise you to take a different medicine instead of Vilpin Combi. Vilpin Combi should not be taken in early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the baby if taken during this period.
Breast-feeding
It has been shown that small amounts of amlodipine pass into human milk. Inform your doctor if you are breast-feeding or plan to breast-feed. Vilpin Combi is not recommended during breast-feeding. Your doctor may choose a different medicine if you are going to breast-feed, especially if you are breast-feeding a newborn or premature baby.

Driving and using machines

Vilpin Combi may affect your ability to drive or operate machines. If you experience nausea, dizziness, weakness, fatigue, or headache after taking the tablets, do not drive or operate 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 diagnosed with intolerance to some sugars, you should consult 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.
Swallow the tablet with a glass of water, preferably in the morning, at the same time every day, before meals. Your doctor will determine the dose that is right for you. It is usually 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.

Overdose of Vilpin Combi

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 such symptoms, it may be helpful to lie down with your legs raised.

Missing a dose of Vilpin Combi

It is important to take the medicine every day to ensure its effectiveness. However, if you miss a dose of Vilpin Combi, take the next dose at the usual time. Do 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, consult 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 severe rash, itching, 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,
weakness of the arms or legs, or speech disturbances, which may be a sign of stroke,
abnormally fast or irregular heart rhythm, chest pain (angina pectoris), or heart attack,
pancreatitis, which may cause severe abdominal pain, radiating to the back, accompanied by a very bad feeling,
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 following symptoms are troublesomeor last longer than one week, you should consult your doctor.
Very common side effects (may affect more than 1 in 10 people): swelling (water 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 tingling and numbness of limbs, visual disturbances (including double vision), ringing in the ears (feeling of noise in the ears), palpitations (awareness of heart rhythm), 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, change 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 that have been reported are listed below. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Uncommon side effects (may affect up to 1 in 100 people): mood changes, anxiety, depression, insomnia, sleep disturbances, tremors, loss of consciousness, loss of pain sensation, inflammation of the nasal mucosa (nasal congestion or runny nose), 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, 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 problems, impotence, increased sweating, weight gain or loss, increased heart rate, 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, increased creatinine levels in the blood.
Rare side effects (may affect 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 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 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, itching, 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 may cause severe abdominal pain, radiating to the back, accompanied by a very bad feeling, liver function disorders, liver inflammation, jaundice, increased liver enzyme activity, which may affect some laboratory test results, abdominal bloating (gastritis), nerve disorders, which may cause weakness, tingling, or numbness, increased muscle tension, gum hypertrophy, increased blood sugar levels (hyperglycemia).
Frequency not known (frequency cannot be estimated from the available data): tremors, stiffness of posture, 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), very severe skin reaction (toxic epidermal necrolysis).
If you experience any of these symptoms, contact your doctor as soon as possible

Reporting side effects

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

5. How to store Vilpin Combi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and label after the "Expiry date" or "EXP":. The expiry date refers to the last day of the month stated.
There are no special storage instructions for the medicine.
Store in the original packaging to protect from light and moisture.
Keep 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 of Vilpin Combi 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 the inscription "5/5" on one side and smooth on the other side.
Vilpin Combi, 5 mg + 10 mg, tablets are white, round, biconvex tablets with the inscription "5/10" on one side and smooth on the other side.
Vilpin Combi, 10 mg + 5 mg, tablets are white, oval, biconvex tablets with the inscription "10/5" on one side and smooth on the other side.
Vilpin Combi, 10 mg + 10 mg, tablets are white, round, biconvex tablets with the inscription "10/10" on one side and smooth on the other side.
Vilpin Combi, stored in tablet containers (propylene containers (PP) with a desiccant in the cap), is available in packs containing:
5 mg + 5 mg: 10, 30, and collective packaging 90 (3 x 30) tablets
5 mg + 10 mg, 10 mg + 5 mg, and 10 mg + 10 mg: 30, and collective packaging 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
To obtain more detailed information on this medicine, contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53,
00-113 Warsaw
Phone: (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