Vilpin combi

Patient Information Leaflet

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 tosylate + Amlodipine
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm others even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Vilpin Combi is and what it is used for
2. What you need to know 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 Vilpin Combi is and what it is 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 previously treated with perindopril and amlodipine as separate tablets may instead be prescribed a single tablet of Vilpin Combi, which contains both active substances.
Vilpin Combi is a combination medicine containing two active substances: perindopril and amlodipine.
Perindopril is an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine is a calcium antagonist (belonging to a group of medicines called dihydropyridines). Both active substances work by relaxing and widening blood vessels, which improves blood flow and helps the heart pump blood more easily throughout the body.

2. Important information before using Vilpin Combi

When not to use 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 more than 3 months pregnant (it is also better to avoid using Vilpin Combi in early pregnancy - see section 2 "Pregnancy and breastfeeding"),
• if the patient has previously experienced symptoms while taking an ACE inhibitor,

such as wheezing, facial or tongue swelling, intense itching, or severe skin rashes,
or if such symptoms occurred in the patient or in any family member under
any circumstances (a condition called angioedema),

• if the patient has aortic valve stenosis (narrowing of the aortic valve),

• if the patient is suffering from cardiogenic shock (a condition in which the heart is unable to supply the body with adequate blood flow), if the patient has significantly low blood pressure (hypotension), if the patient has heart failure following myocardial infarction, 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 using sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure, because the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) increases (see "Warnings and precautions" and "Vilpin Combi with other medicines"),

• if the patient is undergoing dialysis or other blood filtration methods. Depending on the device used, Vilpin Combi may not be suitable for the patient,

• if the patient has kidney disorders causing reduced blood supply to the kidneys (renal artery stenosis).

Warnings and precautions
Before starting treatment with Vilpin Combi, discuss with your doctor or pharmacist if
the patient has any of the following conditions:
hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis
(narrowing of the blood vessel supplying blood to the kidney),
heart failure,
severe 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 hyperaldosteronism),
collagenosis (connective tissue disease), such as systemic lupus erythematosus or scleroderma,
diabetes,
the patient is on a low-salt diet or uses salt substitutes containing
potassium (monitoring of blood potassium levels is necessary),
dose adjustment may be required 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 blood electrolyte levels (e.g. potassium). See also the section "When not to use Vilpin Combi". The patient is taking any of the following medicines, as the risk of angioedema increases:
• racecadotril (used to treat diarrhoea),
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of drugs called mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment),
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used
  in the treatment of chronic heart failure,
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of drugs called gliptins (used in diabetes treatment),
  the patient is of Black race - in this case, there may be a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure than in other patients.

Angioedema
In patients treated with ACE inhibitors, including Vilpin Combi, cases of
angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat,
and difficulty swallowing or breathing) have been reported. This reaction may occur at
any time during treatment. If such symptoms occur, stop taking Vilpin Combi immediately and
contact your doctor without delay. See also section 4.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Vilpin Combi is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the unborn child if used during this period (see section "Pregnancy").
You should also inform your doctor or medical staff that you are taking Vilpin Combi if:
the patient is to undergo general anaesthesia and/or major surgery,
the patient has recently experienced diarrhoea or vomiting,
an LDL apheresis procedure (removal of cholesterol from blood using a special
device) is planned,
desensitisation treatment is planned to reduce allergic reactions to bee or wasp stings.

Children and adolescents
Vilpin Combi is not recommended for use in children and adolescents.

Vilpin Combi with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Avoid using 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 blood potassium levels (e.g.
trimethoprim and co-trimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used in bacterial infections),
potassium-sparing medicines used in heart failure treatment: eplerenone
and spironolactone at doses of 12.5 mg to 50 mg per day.

The use of other medicines may affect treatment with Vilpin Combi. Inform your doctor if you are taking any of the following medicines, as special precautions may be required:
medicines most commonly used to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the group of mTOR inhibitors, tacrolimus and vildagliptin), as they may increase the risk of severe allergic reactions. See section "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 volume produced by the kidneys),
non-steroidal anti-inflammatory drugs (e.g. ibuprofen), used to relieve pain or high doses of aspirin (acetylsalicylic acid), a substance found in many medicines used for pain relief, fever reduction, and prevention of blood clots,
medicines used to treat diabetes (such as insulin and gliptins, e.g. linagliptin,
saxagliptin, sitagliptin, vildagliptin),
medicines used to treat mental disorders, such as depression, anxiety,
schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics),
immunosuppressive medicines (suppressing the immune system), used in 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),
vasodilating medicines, including nitrates,
ephedrine, noradrenaline or adrenaline (medicines used to treat low blood pressure, shock, or asthma),
baclofen or dantrolene (intravenous) used to treat muscle stiffness occurring in diseases such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia during anaesthesia (symptoms include very high fever and muscle rigidity),
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-adrenolytic medicines, used to treat enlarged prostate, such as prazosin,
alfuzosin, doxazosin, tamsulosin, terazosin,
amifostine (used to prevent or reduce side effects caused by other medicines or radiotherapy, used in cancer treatment),
corticosteroids (used to treat various diseases, including severe asthma and rheumatoid arthritis),
gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis),
ritonavir, indinavir, nelfinavir (so-called protease inhibitors, used in HIV infection treatment),
simvastatin (used to reduce cholesterol levels),
sacubitril (available in a combination medicine containing sacubitril and valsartan), used
in the treatment of 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 meals.
Do not consume grapefruit or grapefruit juice while taking Vilpin Combi, as this may increase blood levels of the active substance - amlodipine, which could lead to unpredictable intensification of the blood pressure-lowering effect of Vilpin Combi.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. Usually, your doctor will advise stopping Vilpin Combi before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine. Vilpin Combi is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the unborn child if used during this period.

Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. Inform your doctor if you are breastfeeding or plan to breastfeed. Vilpin Combi is not recommended during breastfeeding. Your doctor may choose another medicine if you plan to breastfeed, especially if breastfeeding a newborn or premature infant.

Driving and using machines
Vilpin Combi may impair the ability to drive and operate machinery. If nausea, dizziness, weakness, fatigue or headache occur after taking the tablets, do not drive or operate machinery and immediately contact your doctor.

Vilpin Combi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

Vilpin Combi contains isomalt
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking this medicine.

3. How to take Vilpin Combi

This medicine should always be taken as directed by the doctor. If in doubt, consult your
doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably in the morning, at the same time each day, before
a meal. The doctor will determine the dose appropriate for the patient. Usually, the dose is one tablet per day.
Vilpin Combi is generally recommended for patients who are already taking perindopril and amlodipine in
separate tablets.
Use in children and adolescents
Use in children and adolescents is not recommended.
Taking more Vilpin Combi than prescribed
If too many tablets are taken, contact a doctor immediately or go to the nearest hospital emergency department.
The most common symptom of overdose is low blood pressure, which may cause dizziness or fainting.
If such symptoms occur, lying down with legs raised may be helpful.
Breathlessness due to fluid accumulation in the lungs (pulmonary edema) may occur within 24–48 hours after taking the medicine.
Missing a dose of Vilpin Combi
It is important to take the medicine every day, as regular use ensures effectiveness. However, if a dose of Vilpin Combi is missed, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Vilpin Combi treatment
Treatment with Vilpin Combi is usually long-term, so you should contact your doctor before stopping the medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur in a patient, stop taking the medicine immediately and contact a doctor without delay:

• 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 in breathing,
• severe skin reactions, including severe skin rash, urticaria, redness of the skin over the entire body, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions,
• weakness in arms or legs, or speech disturbances, which may be signs of stroke,
• abnormally fast or irregular heartbeat, chest pain (angina) or heart attack,
• pancreatitis, which may cause severe upper abdominal pain radiating to the back, accompanied by a general feeling of severe illness,
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation.

The following common adverse reactions have been reported. If any of the following symptoms are troublesome to the patient or last longer than one week, contact a doctor.
Very common adverse reactions (may occur in more than 1 in 10 people):

• swelling (fluid retention)

Common adverse reactions (may occur in up to 1 in 10 people):

• headache,
• central dizziness,
• drowsiness (especially at the beginning of treatment),
• labyrinthine dizziness,
• tingling or numbness in the limbs,
• visual disturbances (including double vision),
• tinnitus (sensation of noise in the ears),
• palpitations (awareness of heartbeat),
• sudden flushing (especially of the face),
• sensation 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 rhythm,
• diarrhoea,
• constipation,
• allergic reactions (such as skin rash, itching),
• muscle cramps,
• feeling of fatigue,
• weakness,
• swollen ankles (oedema).

Other reported adverse reactions are listed below. If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• mood changes,
• anxiety,
• depression,
• insomnia,
• sleep disturbances,
• tremor,
• loss of consciousness,
• loss of pain sensation,
• nasal mucosal inflammation (nasal congestion or discharge),
• heart rhythm disturbances,
• hair loss,
• red spots or skin discoloration,
• back, muscle or joint pain,
• chest pain,
• urinary disorders,
• nocturnal urge to urinate,
• increased frequency of urination,
• pain,
• malaise,
• bronchospasm (feeling of tightness in the chest, wheezing and shortness of breath),
• dryness of the oral mucosa,
• angioedema (symptoms such as wheezing, swelling of the face or tongue),
• formation of skin blisters,
• kidney-related disorders,
• impotence,
• increased sweating,
• discomfort or enlargement of the breasts in men,
• weight gain or weight loss,
• rapid heartbeat,
• fever,
• falls,
• vasculitis (inflammation of blood vessels),
• photosensitivity reactions (increased skin sensitivity to sunlight),
• changes in laboratory test results:
  • high potassium levels in blood (transient and resolves after discontinuation of treatment),
  • low sodium levels,
  • hypoglycaemia (very low blood sugar levels) in diabetic patients,
  • increased blood urea levels,
  • increased blood creatinine levels.

Rare adverse reactions (may occur in up to 1 in 1,000 people):

• disorientation (confusion),
• exacerbation of psoriasis,
• abnormal laboratory test results: increased liver enzyme activity, increased serum bilirubin levels.
• dark urine,
• nausea or vomiting,
• muscle cramps,
• disorientation and seizures – these may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion),
• reduced urine output or absence of urine output, acute kidney failure.

Very rare adverse reactions (may occur in up to 1 in 10,000 people):

• cardiovascular disorders (angina and stroke),
• eosinophilic pneumonia (a rare form of pneumonia),
• swelling of the eyelids, face or lips,
• swelling of the tongue and throat causing significant breathing difficulties,
• severe skin reactions, including severe skin rash, urticaria, redness of the skin over the entire body, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome),
• skin rash, often beginning with red, itchy spots on the face, arms or legs (erythema multiforme),
• blood parameter changes such as decreased white blood cell and red blood cell counts, decreased haemoglobin levels, decreased platelet count, blood disorders,
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and a general feeling of severe illness,
• liver function disorders, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity (which may affect certain test results),
• abdominal distension (dyspepsia),
• nerve disorders causing weakness, tingling or numbness,
• increased muscle tension,
• gingival hyperplasia (swollen gums),
• increased blood sugar levels (hyperglycaemia).

Frequency not known (frequency cannot be estimated from available data):

• tremor,
• muscle rigidity,
• facial masking,
• slowed movements and dragging gait,
• unsteady gait,
• cyanosis,
• numbness and pain in fingers or toes (Raynaud's phenomenon),
• very severe skin reaction (toxic epidermal necrolysis).

If any of these symptoms occur, contact a doctor as soon as possible.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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

Adverse reactions can also be reported to the responsible entity.

By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Vilpin Combi

Keep this medicine 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 following the terms "Expiry date (EXP):" or "EXP:". The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine.
Store in the original packaging to protect from light and moisture.
Keep the container tightly closed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Vilpin Combi contains

• The active substances in this medicine are: perindopril tosylate and amlodipine. Each tablet contains 5 mg of perindopril tosylate, 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 tosylate, 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 tosylate, 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 tosylate, 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 carboxymethyl starch (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 an embossing “5/5” on one side and smooth on the other side.
Vilpin Combi 5 mg + 10 mg tablets are white, round, biconvex tablets with an embossing “5/10” on one side and smooth on the other side.
Vilpin Combi 10 mg + 5 mg tablets are white, oval, biconvex tablets with an embossing “10/5” on one side and smooth on the other side.
Vilpin Combi 10 mg + 10 mg tablets are white, round, biconvex tablets with an embossing “10/10” on one side and smooth on the other side.
Vilpin Combi, stored in tablet containers (polypropylene (PP) containers with a moisture-absorbing cap insert), is available in packs containing:
5 mg + 5 mg: 10, 30 tablets, and multipacks of 90 (3 x 30) tablets
5 mg + 10 mg, 10 mg + 5 mg and 10 mg + 10 mg: 30 tablets and multipacks of 90 (3 x 30) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer:
TEVA Gyógyszergyár Zrt.
Pallagi út 13
4042 Debrecen
Hungary
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Tel.: (22) 345 93 00

This medicine is authorised in 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