PRESTOZEK 8 mg + 10 Mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Prestozek Combi, 4 mg + 5 mg, tablets
3. Prestozek Combi, 4 mg + 10 mg, tablets
4. Prestozek Combi, 8 mg + 5 mg, tablets
5. Prestozek Combi, 8 mg + 10 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
6. What is Prestozek Combi and what is it used for
7. Important information before taking Prestozek Combi
   1. When not to take Prestozek Combi:
   2. Warnings and precautions
   3. Children and adolescents
   4. Prestozek Combi and other medicines
   5. Prestozek Combi with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Prestozek Combi contains sodium.
8. How to take Prestozek Combi
   1. Use in children and adolescents
   2. Taking a higher dose of Prestozek Combi than recommended
   3. Missing a dose of Prestozek Combi
   4. Stopping Prestozek Combi
9. Possible side effects
   1. Reporting side effects
10. How to store Prestozek Combi
11. Contents of the packaging and other information
    1. What Prestozek Combi contains
    2. What Prestozek Combi looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

Prestozek Combi, 4 mg + 5 mg, tablets

Prestozek Combi, 4 mg + 10 mg, tablets

Prestozek Combi, 8 mg + 5 mg, tablets

Prestozek Combi, 8 mg + 10 mg, tablets

tert-Butylamine perindopril + Amlodipine

You should carefully read the contents of the 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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Prestozek Combi and what is it used for

Prestozek 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 taking perindopril and amlodipine in separate tablets may instead take one tablet of Prestozek Combi, which contains both ingredients.
Prestozek Combi is a combination medicine containing two active substances: perindopril and amlodipine.
Perindopril is an ACE inhibitor (angiotensin-converting enzyme). Amlodipine is a calcium antagonist (which belongs to a group of medicines called dihydropyridines). Together, these medicines cause the blood vessels to dilate and relax, resulting in a decrease in blood pressure. Blood flow in the body is facilitated, so the heart does not have to work as hard.

2. Important information before taking Prestozek Combi

When not to take Prestozek Combi:

• if the patient is allergic to perindopril with tert-butylamine or any other ACE inhibitor, to amlodipine or other dihydropyridines, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant over 3 months (it is also recommended to avoid taking Prestozek Combi in early pregnancy - see the section on pregnancy);
• if the patient has previously experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rash when taking an ACE inhibitor, or if such symptoms have occurred in the patient or a relative in any circumstances (a condition called angioedema);
• if the patient has cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body) or aortic stenosis (narrowing of the main blood vessel leading from the heart);
• if the patient has very low blood pressure (severe hypotension);
• if the patient has heart failure (a condition in which the heart is unable to pump enough blood, resulting in shortness of breath or swelling of the legs, ankles, or feet) after a recent heart attack;
• if the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine containing aliskiren;
• if the patient has taken or is currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling of tissues under the skin, such as the throat).

Warnings and precautions

Before starting to take Prestozek Combi, the patient should discuss this with their doctor or pharmacist if:

• the patient has hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the artery supplying blood to the kidney);
• the patient has any other heart disease;
• the patient has liver function disorders;
• the patient has kidney disease or is undergoing dialysis;
• the patient has collagenosis (a disease of connective tissue), such as systemic lupus erythematosus or scleroderma;
• the patient has diabetes;
• the patient is on a low-salt diet or uses salt substitutes containing potassium (it is essential to have the right level of potassium in the blood);
• the patient is taking any of the following medicines for high blood pressure:
• an angiotensin II receptor antagonist (AIIRA), also known as a sartan - for example, valsartan, telmisartan, irbesartan, especially if the patient has diabetic kidney disease;
• aliskiren.
• if the patient is taking any of the following medicines, there is an increased risk of angioedema (rapid swelling of tissues under the skin, such as the throat):
• racecadotril (used to treat diarrhea);
• medicines used to prevent the rejection of transplanted organs and to treat cancer

(e.g., temsirolimus, sirolimus, everolimus);

• sildenafil, a medicine used to treat erectile dysfunction.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the section "When not to take Prestozek Combi".
The patient should inform their doctor if they are pregnant, think they may be pregnant, or plan to become pregnant.
Prestozek Combi should not be taken during pregnancy, and it is not recommended during early pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby if taken during this period (see the section on pregnancy).
When taking Prestozek Combi, the patient should also inform their doctor or healthcare professional if:

• the patient is to undergo general anesthesia and/or surgery;
• the patient has recently experienced diarrhea or vomiting;
• the patient is to undergo LDL apheresis (removal of cholesterol from the blood using a special device);
• the patient is to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings.

Children and adolescents

Prestozek Combi should not be used in children and adolescents.

Prestozek Combi and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should avoid taking Prestozek Combi with:

• lithium (used to treat mania or depression),
• estradiol (used to treat cancer),
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection, and heparin, a medicine used to thin the blood to prevent clots).

Taking Prestozek Combi may be affected by other medicines. The doctor may recommend changing the dose and/or taking other precautions.
The patient should tell their doctor if they are taking any of the following medicines, as this may require special precautions:

• other medicines for high blood pressure, including angiotensin II receptor antagonists (AIIRA), aliskiren (see also the sections "When not to take Prestozek Combi" and "Warnings and precautions"), and diuretics (medicines that increase urine production);
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen), used to relieve pain or high doses of acetylsalicylic acid;
• medicines for diabetes (such as insulin);
• medicines for mental disorders, such as depression, anxiety, schizophrenia, etc.

(e.g., tricyclic antidepressants, antipsychotics, antidepressants similar to imipramine, neuroleptics);

• immunosuppressive medicines (which weaken the body's defense mechanisms), used to treat autoimmune diseases or after organ transplantation (e.g., cyclosporine);
• allopurinol (used to treat gout);
• procainamide (used to treat irregular heart rhythms);
• vasodilators, including nitrates;
• heparin (a medicine used to thin the blood to prevent clots);
• ephedrine, noradrenaline, or adrenaline (medicines used to treat low blood pressure, shock, or asthma);
• baclofen, used to treat muscle stiffness in diseases such as multiple sclerosis;
• rifampicin, erythromycin, clarithromycin (antibiotics);
• antiepileptic medicines, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone;
• itraconazole, ketoconazole (medicines used to treat fungal infections);
• medicines that block alpha-adrenergic receptors, used to treat prostate enlargement, such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin;
• amifostine (used to prevent or reduce the severity of side effects associated with the use of other medicines or radiation therapy for cancer);
• corticosteroids (used to treat various diseases, including severe asthma and rheumatoid arthritis);
• gold salts, especially those given intravenously (used to treat symptoms of rheumatoid arthritis).
• simvastatin (a medicine used to lower cholesterol levels)
• medicines commonly used to treat diarrhea (racecadotril) or to prevent the rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See the section "Warnings and precautions".

If the patient is taking any of the following medicines, they should tell their doctor. These medicines, when taken with Prestozek Combi, may increase the risk of side effects:

• tacrolimus (used to control the body's immune response, allowing the body to accept a transplanted organ);
• clarithromycin (used to treat bacterial infections).

Prestozek Combi with food and drink

Prestozek Combi should be taken before a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.
Prestozek Combi should not be taken during early pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby if taken after 3 months of pregnancy.
Breastfeeding: it has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or plans to breastfeed, they should tell their doctor before taking Prestozek Combi.

Driving and using machines

Prestozek Combi does not affect the ability to concentrate, but the patient may experience dizziness or weakness due to low blood pressure, which may affect the ability to drive or operate machinery. Therefore, it is not recommended to drive or operate machinery until the patient is sure how Prestozek Combi affects them.

Prestozek Combi contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Prestozek Combi

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably at the same time every day, in the morning, before a meal. The doctor will determine the dose suitable for the patient. The usual dose is one tablet per day. Prestozek Combi is usually prescribed to patients who are already taking perindopril and amlodipine in separate tablets.

Use in children and adolescents

Prestozek Combi should not be used in children and adolescents.

Taking a higher dose of Prestozek Combi than recommended

In case of taking too many tablets, the patient should immediately go to the emergency department of the nearest hospital or consult a doctor. The most likely symptoms of overdose are low blood pressure, which can cause dizziness or fainting.
In such a case, it may be helpful to lie on your back with your legs raised.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Prestozek Combi

It is essential to take the medicine every day, as regular use is most effective.
If a dose of Prestozek Combi is missed, the next dose should be taken at the usual time. A double dose should not be taken to make up for the missed tablet.

Stopping Prestozek Combi

Since Prestozek Combi is usually taken for life, the patient should discuss stopping the tablets with their doctor before doing so.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Prestozek Combi can cause side effects, although not everybody gets them.
Side effects are grouped by frequency as follows:

Very common:
occur in more than 1 in 10 patients
Common:
occur in 1 to 10 in 100 patients
Uncommon:
occur in 1 to 10 in 1,000 patients
Rare:
occur in 1 to 10 in 10,000 patients
Very rare:
occur in less than 1 in 10,000 patients
Unknown:
frequency cannot be estimated from available data
If any of the following side effects occur, the patient should stop taking the medicine and consult their doctor immediately:

• symptoms of an allergic reaction, such as swelling of the face, lips, mouth, tongue, or throat, difficulty breathing;
• severe dizziness or fainting;
• abnormally fast or irregular heartbeat;
• severe skin reactions, including severe rash, hives, redness of the skin all over the body, intense itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.

Other side effects include:
Common side effects:headache, dizziness of central origin, dizziness of labyrinthine origin, feeling of numbness or tingling, drowsiness, vision disturbances, tinnitus (feeling of sound in the ears), palpitations (very rapid heartbeat), sudden flushing of the face (feeling of heat or warmth on 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 difficulty digesting, diarrhea, constipation, allergic reactions (such as skin rashes, itching), swelling of the ankles, muscle cramps, feeling of fatigue, swelling (swelling of the legs or ankles).
Uncommon side effects:mood swings, sleep disturbances, tremors, fainting (temporary loss of consciousness), loss of pain sensation, inflammation of the nasal mucosa (nasal congestion or discharge), changes in bowel movements, hair loss, red spots or discoloration on the skin, back pain, muscle or joint pain, chest pain, increased frequency of urination, especially at night, general feeling of being unwell, 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), kidney disorders, impotence, increased sweating, gynecomastia (enlargement of the breasts in men), weight gain or loss, depression.
Rare side effects:disorientation, increased levels of bilirubin and liver enzymes in the blood, worsening of psoriasis, 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 or absent urine production, sudden flushing of the face and neck, acute kidney failure.
Very rare side effects:cardiovascular disorders (arrhythmias, angina pectoris, myocardial infarction, and stroke), eosinophilic pneumonia (a rare type of pneumonia), erythema multiforme (a skin rash, often starting with the appearance of red, itchy spots on the face, arms, or legs), blood disorders, disorders of the pancreas, stomach, or liver, peripheral neuropathy (a disease that causes loss of sensation, pain, and uncontrolled muscle movements), hypertension (increased muscle tension), vasculitis (inflammation of blood vessels, especially of the skin), gum hypertrophy, high blood sugar levels.
Unknown frequency: tremors, stiffness of posture, mask-like face, slow movements, and dragging of the feet when walking, cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon).
Patients taking Prestozek Combi have also reported the following side effects:
hypoglycemia (very low blood sugar levels), increased levels of urea and creatinine in the blood, hyperkalemia (increased potassium levels in the blood).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Prestozek Combi

Store in the original packaging to protect from light and moisture.
There are no special recommendations for the storage temperature of the medicine.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Prestozek Combi contains

• The active substances of the medicine are: perindopril with tert-butylamine and amlodipine. Prestozek Combi, 4 mg + 5 mg, tablets Each tablet contains 4 mg of perindopril with tert-butylamine and 5 mg of amlodipine, which corresponds to 6.94 mg of amlodipine besylate. Prestozek Combi, 4 mg + 10 mg, tablets Each tablet contains 4 mg of perindopril with tert-butylamine and 10 mg of amlodipine, which corresponds to 13.87 mg of amlodipine besylate. Prestozek Combi, 8 mg + 5 mg, tablets Each tablet contains 8 mg of perindopril with tert-butylamine and 5 mg of amlodipine, which corresponds to 6.94 mg of amlodipine besylate. Prestozek Combi, 8 mg + 10 mg, tablets Each tablet contains 8 mg of perindopril with tert-butylamine and 10 mg of amlodipine, which corresponds to 13.87 mg of amlodipine besylate.
• Other ingredients are: microcrystalline cellulose (type 200XLM), microcrystalline cellulose (type 112), sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate.

What Prestozek Combi looks like and contents of the pack

Prestozek Combi, 4 mg + 5 mg, tablets
White or almost white, round, biconvex tablets without coating, 7 mm in diameter.
Prestozek Combi, 4 mg + 10 mg, tablets
White or almost white, round, flat tablets without coating, with the marking "15" on one side, 9 mm in diameter.
Prestozek Combi, 8 mg + 5 mg, tablets
White or almost white, round, biconvex tablets without coating, with the marking "100" on one side and "
" on the other side, 9 mm in diameter.
Prestozek Combi, 8 mg + 10 mg, tablets
White or almost white, round, biconvex tablets without coating, with the marking "5" on one side, 9.5 mm in diameter.
Pack sizes: 30, 60, 90 tablets in blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer/Importer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland
Prestozek Combi
Bulgaria
Prestozek Combi
Latvia
Prestozek
Date of last revision of the leaflet:April 2024