Pricoron

Package leaflet: Information for the patient

Pricoron, 5 mg coated tablets
Pricoron, 10 mg coated tablets
Perindopril with arginine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Contents of the leaflet:

1. What Pricoron is and what it is used for
2. What you need to know before taking Pricoron
3. How to take Pricoron
4. Possible side effects
5. How to store Pricoron
6. Contents of the pack and other information

1. What Pricoron is and what it is used for

Pricoron is an angiotensin-converting enzyme (ACE) inhibitor. It works by dilating blood vessels, which helps the heart pump blood more easily.

Pricoron is used:

• in the treatment of high blood pressure (hypertension).
• in the treatment of heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs) (Pricoron 2.5 mg and 5 mg only).
• to reduce the risk of cardiac events such as heart attack in patients with stable coronary artery disease (a condition in which blood supply to the heart is reduced or blocked), who have previously had a heart attack and/or undergone a procedure to improve blood supply to the heart by widening the blood vessels.

2. Important information before using Pricoron

When not to use Pricoron

• if the patient is allergic to perindopril, to any other angiotensin-converting enzyme (ACE) inhibitor, or to any of the other ingredients of this medicine (listed in section 6).
• if during previous treatment with an ACE inhibitor the patient experienced symptoms such as: wheezing, facial, tongue or throat swelling, severe itching, or severe skin rashes, or if the patient or a family member has ever had such symptoms under other circumstances (a condition called angioedema).
• if the patient is more than 3 months pregnant. (It is also advisable to avoid using Pricoron during early pregnancy – see section on pregnancy).
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.
• if the patient is undergoing dialysis or other blood filtration methods. Depending on the device used, Pricoron may not be suitable for the patient.
• if the patient has kidney disorders that reduce blood supply to the kidneys (renal artery stenosis).
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used to treat heart failure, because this increases the risk of angioedema (rapid swelling of tissues under the skin around the throat) (see "Warnings and precautions" and "Pricoron with other medicines").

Warnings and precautions
Before starting Pricoron, discuss with your doctor or pharmacist if:

• the patient has been diagnosed with aortic stenosis (narrowing of the main blood vessel leaving the heart), hypertrophic cardiomyopathy (a heart muscle disorder), or renal artery stenosis (narrowing of the artery supplying blood to the kidney).
• the patient has any other heart conditions.
• the patient has liver disease.
• the patient has kidney disease or is undergoing dialysis.
• the patient has abnormally high levels of a hormone called aldosterone in the blood (primary hyperaldosteronism).
• the patient has a connective tissue disease such as systemic lupus erythematosus or scleroderma.
• the patient has diabetes.
• the patient is on a low-sodium diet or uses potassium-containing salt substitutes.
• the patient is undergoing anaesthesia and/or surgery.
• the patient is undergoing LDL apheresis (removal of cholesterol from the blood using a special device).
• the patient is undergoing desensitisation therapy to reduce allergic reactions to bee or wasp stings.
• the patient has recently had diarrhoea or vomiting, or is dehydrated.
• the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARB) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes.
• aliskiren. The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading "When not to use Pricoron".
• patients of Black race have a higher risk of developing angioedema, and this medicine may be less effective in lowering blood pressure compared to patients of other races.
• if the patient is taking any of the following medicines, which increase the risk of angioedema:
• racecadotril (used to treat diarrhoea).
• medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus) and other medicines belonging to the class of mTOR inhibitors.
• vildagliptin, a medicine used to treat diabetes.
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure.

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril arginine. This reaction may occur at any time during treatment. If such symptoms occur, stop taking Pricoron immediately and contact your doctor without delay. See also section 4.
Inform your doctor if you think you are (or might be) pregnant. Pricoron is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child (see section on pregnancy).

Children and adolescents
The use of perindopril in children and adolescents under 18 years of age is not recommended.

Pricoron 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 use. Other medicines may affect treatment with Pricoron. The treating doctor may need to adjust the dose and/or take additional precautions. These include:

• Other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (ARBs), aliskiren (see also information under "When not to use Pricoron" and "Warnings and precautions"), or diuretics (medicines that increase urine production by the kidneys).
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole used for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots).
• Potassium-sparing medicines used in heart failure treatment: eplerenone and spironolactone at doses from 12.5 mg to 50 mg per day.
• Lithium, used in the treatment of mania or depression.
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen) used to relieve pain, or high-dose aspirin.
• Medicines used to treat diabetes (such as insulin, vildagliptin or metformin).
• Baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis).
• Medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics).
• Immunosuppressive medicines (which reduce the body's immune response) used to treat autoimmune disorders or after organ transplantation (e.g. tacrolimus).
• Estramustine (used in anticancer therapy).
• Medicines most commonly used to treat diarrhoea (racecadotril).
• Medicines most commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other mTOR inhibitors). See section "Warnings and precautions".
• A medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "Do not take Pricoron" and "Warnings and precautions".
• Allopurinol (used to treat gout).
• Procainamide (used to treat heart rhythm disorders).
• Vasodilators, including nitrates.
• Medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline or adrenaline).
• Gold salts, particularly when administered intravenously (used to treat symptoms of rheumatoid arthritis).

Pricoron with food and drink
It is recommended to take Pricoron before a meal.

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

Pregnancy
The patient must inform her doctor if she thinks she is (or might be) pregnant. Usually, the doctor will advise stopping Pricoron before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Pricoron is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if used after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Pricoron is not recommended for breastfeeding mothers, and the doctor may choose an alternative treatment if the patient wishes to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
Perindopril arginine generally does not affect alertness, but some patients may experience dizziness or weakness due to low blood pressure. If such symptoms occur, the ability to drive or operate machinery may be impaired.

Pricoron contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Pricoron

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably at the same time each day, in the morning before a meal. The appropriate dose is determined by the doctor.

Recommended doses are as follows:
Hypertension: the usual initial and maintenance dose is 5 mg, taken once daily. After one month of treatment, if necessary, the dose may be increased to 10 mg once daily. A dose of 10 mg daily is the maximum recommended dose for hypertension.
In patients aged 65 years or older, the usual starting dose is 2.5 mg once daily. After one month of treatment, the dose may be increased to 5 mg once daily, and then, if necessary, to 10 mg once daily.

Heart failure (Pricoron 5 mg only): the usual initial dose is 2.5 mg once daily. After 2 weeks, the dose may be increased to 5 mg once daily, which is the maximum recommended dose for heart failure.

Stable angina pectoris: the usual initial dose is 5 mg once daily. After two weeks of treatment, the dose may be increased to 10 mg once daily. This is the maximum recommended dose for this indication.
In patients aged 65 years or older, the usual starting dose is 2.5 mg once daily. After one week of treatment, the dose may be increased to 5 mg once daily, and after another week, to 10 mg once daily.

Use in children and adolescents
Pricoron is not recommended for use in children and adolescents.

Taking more Pricoron than recommended
If too many tablets are taken, contact a doctor immediately or go to the nearest hospital emergency department. The most likely symptom of overdose is low blood pressure, which may cause dizziness and fainting. In such a case, it is helpful to lay the patient down with elevated legs.

If a dose of Pricoron is missed
It is important to take the medicine regularly, as this ensures optimal effectiveness.
If a dose of Pricoron is missed, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Pricoron treatment
Since treatment with Pricoron is long-term, you should consult your doctor before stopping the medication.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking this medicine and contact your doctor immediately if any of the following
adverse reactions occur, as they may be serious:

• Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema; see section 2 "Warnings and precautions") (not common – may occur in up to 1 in 100 patients).
• Severe dizziness or fainting due to low blood pressure (common – may occur in up to 1 in 10 patients).
• Extremely rapid or irregular heartbeat, chest pain (angina) or heart attack (very rare – may occur in up to 1 in 10,000 patients).
• Sudden weakness in the arms or legs, or difficulty speaking, which may be signs of stroke (very rare – may occur in up to 1 in 10,000 patients).
• Sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm; not common – may occur in up to 1 in 100 patients).
• Pancreatitis, which may cause severe upper abdominal pain radiating to the back and general malaise (very rare – may occur in up to 1 in 10,000 patients).
• Yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare – may occur in up to 1 in 10,000 patients).
• Skin rash, often beginning with red, itchy spots on the face, arms or legs (erythema multiforme; very rare – may occur in up to 1 in 10,000 patients).

You should inform your doctor if any of the following adverse reactions occur:
Common (may occur in up to 1 in 10 patients):

• Headache.
• Dizziness.
• Vertigo (dizziness with a spinning sensation).
• Tingling and numbness.
• Visual disturbances.
• Tinnitus (sensation of hearing sounds).
• Cough.
• Dyspnea.
• Gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, indigestion or difficulty digesting, diarrhea, constipation).
• Allergic reactions (such as rashes, itching).
• Muscle cramps.
• Feeling of weakness.

Not common (may occur in up to 1 in 100 patients):

• Mood changes.
• Sleep disturbances.
• Depression.
• Dry mouth.
• Intense itching or severe rash.
• Formation of clusters of blisters on the skin.
• Kidney function disorders.
• Impotence.
• Sweating.
• Increased eosinophil count (a type of white blood cells).
• Somnolence.
• Fainting.
• Palpitations.
• Tachycardia (rapid heartbeat).
• Vasculitis (inflammation of blood vessels).
• Photosensitivity reaction (increased skin sensitivity to sunlight).
• Joint pain.
• Muscle pain.
• Chest pain.
• Malaise.
• Peripheral edema (swelling of hands or feet).
• Fever.
• Falls.
• Abnormal laboratory test results: high blood potassium levels, transient and resolving after discontinuation of treatment, low sodium levels, hypoglycemia (very low blood sugar levels) in diabetic patients, increased blood urea levels, increased blood creatinine levels.

Rare (may occur in up to 1 in 1,000 patients):

• 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).
• Sudden redness of the face and neck.
• Worsening of psoriasis.
• Reduced or absent urine output.
• Acute kidney failure.
• Changes in laboratory test results: increased liver enzyme activity, elevated serum bilirubin levels.

Very rare (may occur in up to 1 in 10,000 patients):

• Disorientation.
• Eosinophilic pneumonia (a rare type of lung inflammation).
• Rhinitis (nasal mucosa inflammation; nasal swelling or discharge).
• Blood count abnormalities, such as decreased white blood cell and red blood cell counts, decreased hemoglobin concentration, decreased platelet count.

Frequency not known (based on available data, frequency cannot be estimated):

• Bluish discoloration, numbness and pain in fingers or toes (Raynaud's phenomenon).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder or its representative.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pricoron

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/blister pack after the word
"EXP". The expiry date refers to the last day of the stated month.
Pricoron 5 mg and 10 mg: Store below 25 °C in the original packaging to protect from light.
Medicines must 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 Pricoron contains

• The active substance is perindopril with arginine.
  Pricoron 5 mg: Each coated tablet contains 5 mg of perindopril arginine, equivalent to 3.395 mg of perindopril.
  Pricoron 10 mg: Each coated tablet contains 10 mg of perindopril arginine, equivalent to 6.790 mg of perindopril.

• Other ingredients are: monohydrate lactose, pregelatinized starch, sodium carboxymethyl starch, hydrophobic colloidal anhydrous silica, magnesium stearate, hypromellose, calcium carbonate, macrogol 3350, medium-chain triglycerides, talc.
  Pricoron 5 mg and 10 mg: quinoline yellow (E104), yellow iron oxide (E172), brilliant blue (E133), black iron oxide (E172).

What Pricoron looks like and contents of the pack
Pricoron 5 mg: Light green, oval, biconvex coated tablet, 10.0 ± 0.50 mm in length and 4.75 ± 0.24 mm in width, with a score line on both sides. The tablet can be divided into equal doses.
Pricoron 10 mg: Green to marbled-green, round, biconvex coated tablets, 9.0 ± 0.45 mm in diameter, with the imprint "10" on one side.
Pricoron is packed in OPA/Alu/PVC//Alu or PVC/PVDC white//Alu blisters in a cardboard box.
Pack sizes:
Pricoron 5 mg: 15, 30 or 90 coated tablets.
Pricoron 10 mg: 30 or 90 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Zentiva k.s.,
U kabelovny 130,
Dolní Měcholupy, 102 37 Prague 10,
Czech Republic

Manufacturer:
Zentiva k.s.,
U kabelovny 130,
Dolní Měcholupy, 102 37 Prague 10,
Czech Republic
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola PLA3000
Malta

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Pricoron Neo
Poland, Romania, Slovakia: Pricoron
Estonia, Italy, Latvia, Portugal: Perindopril Zentiva
France: Perindopril Arginine Zentiva

For further information, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.,
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00