Pricoron

Leaflet accompanying the packaging: patient information

Pricoron, 5 mg coated tablets

Pricoron, 10 mg coated tablets

Perindopril arginine

You should carefully read the contents of this 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 further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Pricoron and what is it used for

Pricoron is an angiotensin-converting enzyme (ACE) inhibitor. It works by widening the blood vessels, making it easier for the heart to pump blood.

Pricoron is used

• to treat high blood pressure(hypertension).
• to treat heart failure(a condition where the heart is not able to pump enough blood to meet the body's needs) (only Pricoron 2.5 mg and 5 mg).
• to reduce the risk of heart attacks in patients with stable coronary artery disease(a condition where the blood supply to the heart is reduced or blocked), and who have had a heart attack and/or a procedure to improve blood flow to the heart.

2. Important information before taking Pricoron

When not to take Pricoron

• if you are allergic to perindopril, any other ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6).
• if you have had symptoms such as wheezing, swelling of the face, lips, tongue, or throat, intense itching, or severe skin rashes during previous treatment with an ACE inhibitor, or if you or a member of your family has had these symptoms in other circumstances (a condition called angioedema).
• if you are pregnant over 3 months (it is also recommended to avoid taking Pricoron in early pregnancy - see section on pregnancy).

in the first trimester of pregnancy - see section on pregnancy).

• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.
• if you are undergoing dialysis or blood filtration using a different method. Depending on the device used, Pricoron may not be suitable for you.
• if you have kidney problems that reduce blood flow to the kidneys (renal artery stenosis).
• if you have taken or are currently taking a combination medicine containing sacubitril and valsartan, used to treat heart failure, as the risk of angioedema (rapid swelling of the tissues under the skin in the area of the throat) increases (see "Warnings and precautions" and "Pricoron and other medicines").

Warnings and precautions

Before taking Pricoron, you should discuss with your doctor or pharmacist if

• you have a narrowing of the aorta (the main blood vessel leaving the heart), hypertrophic cardiomyopathy (a disease of the heart muscle), or renal artery stenosis (narrowing of the artery supplying the kidney with blood).
• you have any other heart disease.
• you have liver disease.
• you have kidney disease or are undergoing dialysis.
• you have an abnormally high level of a hormone called aldosterone in your blood (primary aldosteronism).
• you have collagen disease (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma.
• you have diabetes.
• you are on a low-sodium diet or using salt substitutes that contain potassium.
• you are undergoing anesthesia and/or surgery.
• you are undergoing LDL apheresis (removal of cholesterol from the blood using a special device).
• you are undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings.
• you have recently had diarrhea or vomiting or are dehydrated.
• you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin receptor blocker (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals. See also the information under "When not to take Pricoron" and "Pricoron and other medicines".
• if you are of black African origin, there is a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure than in patients of other races.
• if you are taking any of the following medicines, the risk of angioedema increases:
• Racecadotril (used to treat diarrhea).
• Medicines used to prevent transplant rejection and treat cancer (e.g., temsirolimus, sirolimus, everolimus) and other medicines belonging to the class of mTOR inhibitors. See section "Warnings and precautions".
• Wildagliptin, a medicine used to treat diabetes.
• Sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure. See sections "Do not take Pricoron" and "Warnings and precautions".

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, with difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril arginine. This reaction can occur at any time during treatment. If you experience these symptoms, you should stop taking Pricoron and contact your doctor immediately. See also section 4.
You should inform your doctor if you think you are (or might become) pregnant. Pricoron is not recommended in early pregnancy and must not be taken if you are pregnant over 3 months, as it may cause serious harm to your baby if used after the third month of pregnancy.

Children and adolescents

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

Pricoron and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take. Other medicines may affect the treatment with Pricoron. Your doctor may need to change the dose and/or take other precautions. These include:

• Other medicines used to treat high blood pressure, including an angiotensin receptor blocker (ARB), aliskiren (see also the information under "When not to take Pricoron" and "Warnings and precautions"), or diuretics (medicines that increase the amount of urine produced 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 in the case of bacterial infections; cyclosporin, an immunosuppressant used to prevent transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in doses of 12.5 mg to 50 mg per day.
• Lithium used to treat mania or depression.
• Non-steroidal anti-inflammatory drugs (e.g., ibuprofen) used to relieve pain or aspirin in high doses.
• Medicines used to treat diabetes (such as insulin, wildagliptin, or metformin).
• Baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis).
• Medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (e.g., tricyclic antidepressants, antipsychotics).
• Immunosuppressants (medicines that reduce the body's immune response) used to treat autoimmune disorders or used after transplants (e.g., tacrolimus).
• Estramustine (used in cancer therapy).
• Medicines commonly used to treat diarrhea (racecadotril).
• Medicines commonly used to prevent transplant rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of 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 irregular heart rhythms).
• Vasodilators, including nitrates.
• Medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, noradrenaline, or adrenaline).
• Gold salts, especially when given 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Pricoron before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Pricoron. Pricoron is not recommended in early pregnancy and must not be taken if you are pregnant over 3 months, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding
You should tell your doctor if you are breastfeeding or plan to breastfeed. Pricoron is not recommended for mothers who are breastfeeding, and your doctor may choose a different treatment if you want to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

Perindopril arginine usually does not affect alertness, but some patients may experience dizziness or weakness due to low blood pressure. If you experience these symptoms, your ability to drive or operate machinery may be impaired.

Pricoron contains lactose and sodium

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

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

3. How to take Pricoron

This medicine should always be taken exactly as your doctor or pharmacist has told you.

In case of doubt, you should ask 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 breakfast. The dose will be decided by your doctor.

The recommended doses are as follows:

Hypertension: the usual starting and maintenance dose is 5 mg, taken once a day. After one month of treatment, the dose may be increased to 10 mg, taken once a day. The dose of 10 mg per day is the maximum recommended dose for hypertension.

In patients over 65 years of age, the usual starting dose is 2.5 mg, taken once a day. After one month of treatment, the dose may be increased to 5 mg, taken once a day, and then to 10 mg, taken once a day if necessary.

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

Stable coronary artery disease: the usual starting dose is 5 mg, taken once a day. After 2 weeks of treatment, the dose may be increased to 10 mg, taken once a day. This is the maximum recommended dose for this indication.

In patients over 65 years of age, the usual starting dose is 2.5 mg, taken once a day. After one week of treatment, the dose may be increased to 5 mg, taken once a day, and then to 10 mg, taken once a day after another week.

Use in children and adolescents

Pricoron is not recommended for use in children and adolescents.

Taking too much Pricoron

If you have taken too many tablets, you should contact your doctor or go to the hospital immediately. The most likely symptom of overdose is low blood pressure, which can cause dizziness and fainting. In this case, it is helpful to lay the patient down with their legs raised.

Missing a dose of Pricoron

It is important to take the medicine regularly for it to work best.

If you forget to take a dose of Pricoron, you should take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Pricoron

Since treatment with Pricoron is long-term, you should consult your doctor before stopping treatment.

If you have any further questions on the use of this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking this medicine and contact your doctor immediately if you experience any of the following serious side effects:

• Swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema; see section 2 "Warnings and precautions") (uncommon - may affect up to 1 in 100 people).
• Severe dizziness or fainting due to low blood pressure (common - may affect up to 1 in 10 people).
• Very fast or irregular heartbeat, chest pain (angina pectoris), or heart attack (very rare - may affect up to 1 in 10,000 people).
• Muscle weakness or difficulty speaking, which may be a sign of a stroke (very rare - may affect up to 1 in 10,000 people).
• Sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm; uncommon - may affect up to 1 in 100 people).
• Pancreatitis, which can cause severe abdominal pain and very bad overall condition (very rare - may affect up to 1 in 10,000 people).
• Yellowing of the skin or eyes (jaundice), which can be a sign of liver inflammation (very rare - may affect up to 1 in 10,000 people).
• Rash, often starting with the appearance of red, itchy patches on the face, arms, or legs (erythema multiforme; very rare - may affect up to 1 in 10,000 people).

You should tell your doctor if you experience any of the following side effects:

Common(may affect up to 1 in 10 people):

• Headache.
• Dizziness.
• Vertigo (dizziness with a feeling of spinning).
• Pins and needles.
• Visual disturbances.
• Tinnitus (a feeling of hearing sounds).
• Cough.
• Shortness of breath.
• Gastrointestinal disorders (nausea, vomiting, abdominal pain, taste disturbances, indigestion, or difficulty digesting, diarrhea, constipation).
• Allergic reactions (such as rash, itching).
• Muscle cramps.
• Feeling weak.

Uncommon(may affect up to 1 in 100 people):

• Mood changes.
• Sleep disturbances.
• Depression.
• Dry mouth.
• Intense itching or severe rash
• Formation of blisters on the skin.
• Kidney problems.
• Impotence.
• Sweating.
• Increased eosinophil count (a type of white blood cell).
• Drowsiness.
• Fainting.
• Palpitations.
• Tachycardia (fast heartbeat).
• Vasculitis (inflammation of blood vessels).
• Photosensitivity reaction (increased skin sensitivity to sunlight).
• Joint pain.
• Muscle pain.
• Chest pain.
• Bad overall condition.
• Peripheral edema (swelling of the hands or feet).
• Fever.
• Falls.
• Abnormal laboratory test results: high potassium levels in the blood, transient after stopping treatment, low sodium levels, hypoglycemia (very low blood sugar) in patients with diabetes, increased urea levels in the blood, increased creatinine levels in the blood.

Rare(may affect up to 1 in 1,000 people):

• Dark urine, nausea, or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate secretion of antidiuretic hormone).
• Sudden reddening of the face and neck.
• Worsening of psoriasis.
• Reduced or absent urine production.
• Acute kidney failure.
• Changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood.

Very rare(may affect up to 1 in 10,000 people):

• Disorientation.
• Eosinophilic pneumonia (a rare type of pneumonia).
• Nasal mucositis (inflammation or ulceration of the nasal mucosa).
• Changes in blood counts, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin levels, decreased platelet count.

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

• -Cyanosis, numbness, and pain in the fingers or toes (Raynaud's phenomenon).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring 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
You can also report side effects to the marketing authorization holder or its representative.

By reporting side effects, you can help provide more information on the safety of this 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/blisters after the "EXP" label. The expiry date refers to the last day of the month stated.

Pricoron 5 mg and 10 mg: Store in a temperature below 25°C in the original packaging to protect from light.

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 packaging and other information

What Pricoron contains

• The active substance is perindopril 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.

• The other ingredients are: lactose monohydrate, maize starch, carboxymethyl starch sodium, 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 double 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 a single-sided embossing "10".

Pricoron is packaged in OPA/Alu/PVC//Alu or PVC/PVDC white//Alu blisters in a cardboard box.

Package 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 authorization 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 authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Pricoron Neo
Poland, Romania, Slovakia: Pricoron
Estonia, Italy, Latvia, Portugal: Perindopril Zentiva
France: Perindopril Arginine Zentiva

For more information, please contact the local representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z.o.o.,
Bonifraterska 17
00-203 Warsaw, Poland
Phone: +48 22 375 92 00

Date of last revision of the leaflet: