Prestozek combi

Package leaflet: Information for the patient

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

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

Leaflet contents:

1. What Prestozek Combi is and what it is 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 pack and other information

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

Prestozek Combi is used to treat high blood pressure (hypertension) and/or
stable angina (a condition in which blood flow to the heart is reduced or
blocked).
Patients currently taking perindopril and amlodipine as separate tablets may instead take
one tablet of Prestozek Combi, which contains both active substances.
Prestozek Combi is a combination medicine containing two active ingredients: perindopril and
amlodipine.
Perindopril is an ACE inhibitor (angiotensin-converting enzyme inhibitor). Amlodipine is a
calcium antagonist (belonging to a class of medicines known as dihydropyridines). Together, these medicines cause the blood vessels to widen and relax, resulting in lowered blood pressure. Blood flow throughout the body improves, 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 more than 3 months pregnant (it is also better to avoid using Prestozek Combi in early pregnancy – see section on pregnancy);
• if the patient previously experienced symptoms during treatment with 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 a blood relative under any circumstances (a condition called angioedema);
• if the patient has cardiogenic shock (a condition in which the heart cannot deliver sufficient 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 cannot adequately pump blood, resulting in breathlessness or peripheral swelling, e.g. in legs, ankles, or feet) following acute myocardial infarction;
• if the patient has diabetes or kidney function disorders and is taking a blood pressure-lowering medicine containing aliskiren;
• if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, because the risk of angioedema (rapid swelling of tissues under the skin, e.g. in the throat) increases.

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

• the patient has hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidney);
• the patient has any other heart diseases;
• the patient has liver function disorders;
• the patient has kidney disease or is undergoing dialysis;
• the patient has a collagen vascular disease (connective tissue disease), 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 (maintaining appropriate blood potassium levels is important);
• 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, particularly if the patient has kidney disorders related to diabetes;
  • aliskiren.
• if the patient is taking any of the following medicines, there is an increased risk of angioedema (rapid swelling of the skin in areas such as the throat):
  • racecadotril (used to treat diarrhoea);
  • medicines used to prevent organ transplant rejection or to treat cancer

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

• vildagliptin, a medicine used to treat diabetes.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section “When not to take Prestozek Combi”.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Use of Prestozek Combi is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child if used during this period (see section on pregnancy).
When taking Prestozek Combi, you should also inform your doctor or medical staff if:

• the patient is to undergo general anaesthesia and/or surgery;
• the patient has recently experienced diarrhoea or vomiting;
• the patient is scheduled for LDL apheresis (removal of cholesterol from the blood using a special device);
• the patient is to undergo allergen immunotherapy to reduce allergic reactions to bee or wasp venom.

Children and adolescents
Prestozek Combi is not recommended for use in children and adolescents.
Prestozek Combi and 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 taking Prestozek Combi together with:

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

Other medicines may affect treatment with Prestozek Combi. Your doctor may recommend dose adjustments and/or additional precautions.
Tell your doctor if the patient is taking any of the following medicines, as this may require special precautions:

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

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

• immunosuppressive medicines (weakening the body's immune defences), used to treat autoimmune diseases or after organ transplantation (e.g. cyclosporine);
• allopurinol (used to treat gout);
• procainamide (used to treat heart rhythm disorders);
• vasodilators, including nitrates;
• heparin (a medicine used to thin the blood);
• ephedrine, noradrenaline, or adrenaline (medicines used to treat low blood pressure, shock, or asthma);
• baclofen, used to treat muscle stiffness in conditions 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);
• alpha-adrenergic receptor blockers, used to treat benign prostatic hyperplasia, such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin;
• amifostine (used to prevent or reduce the severity of adverse effects associated with other cancer treatments or radiotherapy);
• corticosteroids (used to treat various conditions, including severe asthma and rheumatoid arthritis);
• gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis);
• simvastatin (a cholesterol-lowering medicine);
• 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 drugs called mTOR inhibitors). See section “Warnings and precautions”.

If the patient is taking any of the following medicines, inform the treating doctor. These medicines, when used together with Prestozek Combi, may increase the likelihood of adverse effects:

• tacrolimus (used to control the 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, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Use of Prestozek Combi is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child if used after this time.
Breastfeeding: Small amounts of amlodipine have been shown to pass into human milk. If the patient is breastfeeding or planning to breastfeed, she should inform her doctor before starting Prestozek Combi.
Driving and operating machinery
Prestozek Combi does not affect concentration, but the patient may experience dizziness or weakness due to low blood pressure, which could impair the ability to drive or operate machinery. Therefore, driving or operating machinery is not recommended until the patient knows how Prestozek Combi affects them.
Prestozek Combi contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Prestozek Combi

This medicine should always be taken exactly as prescribed by your doctor. In case of any doubts,
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. Your doctor will determine the dose appropriate for you. The usual dose is
one tablet daily. Prestozek Combi is generally prescribed to patients who are already taking
perindopril and amlodipine as separate tablets.

Use in children and adolescents
Prestozek Combi is not recommended for use in children and adolescents.

If you take more Prestozek Combi than recommended
If you take too many tablets, seek immediate medical attention at the nearest hospital emergency
department or contact your doctor. The most likely symptoms of overdose are low blood pressure,
which may cause dizziness or fainting. In such a case, lying down with legs raised may be helpful.
Breathing difficulty due to fluid accumulation in the lungs (pulmonary edema) may occur even
24–48 hours after taking the medicine.

If you miss a dose of Prestozek Combi
It is important to take the medicine every day, as regular use is most effective. However, if you
miss a dose of Prestozek Combi, take the next dose at your usual time. Do not take a double dose
to make up for the missed tablet.

Stopping Prestozek Combi
Since Prestozek Combi is usually taken for life, you should discuss with your doctor before
stopping the tablets.

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 experiences them.
Adverse reactions are grouped below according to their frequency of occurrence:
Very common: affects more than 1 in 10 patients
Common: affects 1 to 10 in 100 patients
Uncommon: affects 1 to 10 in 1,000 patients
Rare: affects 1 to 10 in 10,000 patients
Very rare: affects fewer than 1 in 10,000 patients
Not known: frequency cannot be estimated from available data

If any of the following adverse symptoms occur, stop taking the medicine immediately and contact your doctor without delay:

• 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 or swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.

Other adverse reactions include:
Common adverse reactions: headache, central dizziness, labyrinthine dizziness, tingling or numbness, drowsiness, visual disturbances, tinnitus (ringing or noise in the ears), palpitations (very fast heartbeat), sudden flushing of the face (feeling of warmth or heat in 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 difficulty digesting, diarrhoea, constipation, allergic reactions (such as skin rashes, itching), ankle swelling, muscle cramps, feeling of fatigue, oedema (swelling of legs or ankles).
Uncommon adverse reactions: mood swings, sleep disturbances, tremor, fainting (temporary loss of consciousness), lack of pain sensation, nasal mucosal inflammation (nasal congestion or runny nose), changes in bowel habits, hair loss, red spots or discolouration of the skin, back, muscle or joint pain, chest pain, increased frequency of urination, especially at night, general 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), kidney disorders, impotence, increased sweating, breast enlargement in males, weight gain or weight loss, depression.
Rare adverse reactions: disorientation, increased bilirubin levels and liver enzyme activity in serum, exacerbation of psoriasis, dark-coloured 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 or no urine output, sudden redness of the face and neck, acute kidney failure.
Very rare adverse reactions: cardiovascular disorders (heart rhythm disturbances, angina pectoris, myocardial infarction and stroke), eosinophilic pneumonia (a rare type of lung inflammation), erythema multiforme (skin rash, often starting with red, itchy spots on the face, arms or legs), blood disorders, pancreas, stomach or liver disorders, peripheral neuropathy (a condition causing loss of sensation, pain and uncontrolled muscle movements), hypertonia (increased muscle tension), vasculitis (especially of the skin), gum hyperplasia, high blood sugar levels.
Frequency not known: tremor, muscle rigidity, mask-like facial expression, slowed movements and shuffling gait, cyanosis, numbness, pain and bluish discolouration of fingers or toes (Raynaud's phenomenon).

Patients taking Prestozek Combi have also reported the following adverse reactions:
hypoglycaemia (very low blood sugar levels), increased blood urea levels and increased serum creatinine levels, hyperkalaemia (increased potassium levels in blood).

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 for Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-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 marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Prestozek Combi

Keep in the original packaging to protect from light and moisture.
There are no special requirements regarding storage temperature.
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 mentioned month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Prestozek Combi contains

• The active substances 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, equivalent 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, equivalent 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, equivalent 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, equivalent to 13.87 mg of amlodipine besylate.
• Other ingredients are: microcrystalline cellulose (type 200XLM), microcrystalline cellulose (type 112), sodium carboxymethyl starch (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, uncoated tablets, 7 mm in diameter.
Prestozek Combi 4 mg + 10 mg, tablets
White or almost white, round, flat, uncoated tablets with the imprint "15" on one side, 9 mm in diameter.
Prestozek Combi 8 mg + 5 mg, tablets
White or almost white, round, biconvex, uncoated tablets with the imprint "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, uncoated tablets with the imprint "5" on one side, 9.5 mm in diameter.
Pack sizes: 30, 60, 90 tablets in blisters packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer/Importer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Prestozek Combi
Bulgaria: Prestozek Combi
Latvia: Prestozek