Pricoron

Leaflet accompanying the packaging: patient information

Pricoron, 5 mg coated tablets

Pricoron, 10 mg coated tablets

Perindopril arginine

Read the 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, pharmacist, or nurse.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in the leaflet, 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 pack 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 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 undergone surgery to improve blood flow to the heart.

2. Important information before taking Pricoron

When not to take Pricoron

in early pregnancy - see section on pregnancy).

Warnings and precautions

Before taking Pricoron, 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 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:
• angiotensin receptor blockers (ARBs) (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) regularly. See also the information under "When not to take Pricoron" and "Pricoron with other medicines".
• 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, stop taking Pricoron and contact your doctor immediately. See also section 4.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, 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. Normally, your doctor will advise you to stop taking Pricoron before you become pregnant or as soon as you know you are pregnant, and will prescribe 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
Tell your doctor if you are breastfeeding or about to start breastfeeding. 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 disturbances, your ability to drive or operate machinery may be impaired.

Pricoron contains lactose monohydrate and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially 'sodium-free'.

3. How to take Pricoron

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
Swallow the tablet 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.

Use in children and adolescents

Pricoron is not recommended for use in children and adolescents.

If you take more Pricoron than you should

If you have taken too many tablets, 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.

If you forget to take Pricoron

It is important to take the medicine regularly for it to work best.
If you forget to take a dose of Pricoron, 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, do not stop taking the medicine without consulting your doctor.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Stop taking the 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 serious illness (very rare - may affect up to 1 in 10,000 people).
• Yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare - may affect up to 1 in 10,000 people).
• Rash, often starting with red, itchy patches on the face, arms, or legs (erythema multiforme; very rare - may affect up to 1 in 10,000 people).

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 (ringing in the ears).
• 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 skin 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 heart rate).
• Vasculitis (inflammation of blood vessels).
• Photosensitivity reaction (increased skin sensitivity to sunlight).
• Joint pain.
• Muscle pain.
• Chest pain.
• Feeling unwell.
• Peripheral edema (swelling of 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 levels) in diabetic patients, 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 congestion or runny nose (nasal mucositis).
• Changes in blood cell 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 the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety 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 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 which is stated on the carton/blisters after "EXP". The expiry date refers to the last day of that month.
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 pack 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, carboxymethylcellulose sodium, hydrophobic colloidal 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 bisecting 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 one-sided engraving "10".
Pricoron is packaged 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 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, contact your local representative of the marketing authorization holder in Poland:
Zentiva Polska Sp. z.o.o.,
ul. Bonifraterska 17
00-203 Warsaw, Poland
phone: +48 22 375 92 00

Date of last revision of the leaflet: