Prestarium A, 10 mg 30 pcs

Perindopril is an inhibitor of the enzyme that converts angiotensin I to angiotensin II (ACE inhibitor). ACE both converts angiotensin I into the vasoconstrictor angiotensin II and degrades bradykinin, which has a vasodilator effect, into an inactive heptapeptide. Perindopril reduces total peripheral vascular resistance, which leads to a decrease in blood pressure, normalizes heart function by reducing preload and postload.

Indications

The drug Prestarium® A is indicated in adult patients:
• for the treatment of high blood pressure (arterial hypertension);
• to treat chronic heart failure (a condition in which the heart cannot pump enough blood to meet the body’s needs);
• to reduce the risk of recurrent stroke (when used together with the drug indapamide) in patients who have had a stroke or transient disorder

cerebral circulation of the ischemic type (a condition associated with a disruption in the blood supply to the brain, but a milder course than a stroke);
• to reduce the risk of heart complications in patients with stable coronary artery disease (a condition in which the blood supply to the heart is reduced or blocked).

If there is no improvement or you feel worse, you should consult a doctor.

Pharmacological effect

Perindopril is an inhibitor of the enzyme that converts angiotensin I into angiotensin II (ACE inhibitor). ACE carries out both the conversion of angiotensin I into the vasoconstrictor substance angiotensin II, and the destruction of bradykinin, which has a vasodilator effect, into an inactive heptapeptide. Perindopril reduces total peripheral vascular resistance, which leads to a decrease in blood pressure, normalizes heart function, reducing preload and afterload.

Special instructions

Before using Prestarium® A, consult your doctor or pharmacist. Be sure to tell your doctor if any of the following applies to you:

if you have aortic stenosis (a narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (a narrowing of the artery that supplies blood to the kidneys)
if you have other cardiovascular diseases;
if you have liver dysfunction;
if you have kidney disease or are undergoing dialysis or other type of blood filtration;
if you are taking allopurinol, cytotoxic drugs (cancer drugs) or immunosuppressants, or are receiving procainamide therapy (a drug used to treat heart rhythm problems);
if you have had a serious allergic reaction with swelling of the face, lips, mouth, tongue and throat, which may be accompanied by difficulty swallowing or breathing (angioedema). This can occur at any time during treatment. If you develop such symptoms, you should stop treatment and consult a doctor immediately;
if you have a significant increase in the level of the hormone aldosterone in the blood (primary hyperaldosteronism);
if you have a systemic connective tissue disease (a group of diseases characterized by damage to connective tissue), such as systemic lupus erythematosus or scleroderma;
if you have diabetes;
if you follow a salt-free diet or take nutritional supplements, use salt substitutes containing potassium;
if you are undergoing major surgery and/or anesthesia;
if you are undergoing low-density lipoprotein apheresis (a procedure to remove cholesterol from the blood);
if you are undergoing treatment that is intended to further reduce your sensitivity to the allergic effects of bee or wasp stings (desensitization therapy);
if you have recently had diarrhea (diarrhoea), vomiting or dehydration;
if your doctor has told you that you have an intolerance to certain types of sugars;
if your doctor told you that you have phenylketonuria;
if you are taking any of the following medicines to treat high blood pressure:
angiotensin II receptor blockers (also known as sartans, such as valsartan, telmisartan, irbersartan and other drugs in this group), especially if you have kidney disease caused by diabetes;
medicines containing aliskiren;

Your doctor may regularly check your kidney function, blood pressure, and the amount of electrolytes (such as potassium) in your blood.

See also the information provided in the subsection “Do not take Prestarium® A.”

if you are of black race, as you may be at higher risk of angioedema, and this drug may be less effective in lowering blood pressure compared to patients of other races;
If you take any of the following medications, your risk of developing angioedema may be increased:
racecadotril (used to treat diarrhea);
sirolimus, everolimus, temsirolimus and other drugs belonging to the group of so-called mTOR inhibitors (used to prevent organ transplant rejection);
sacubitril (in fixed combination with valsartan), used to treat chronic heart failure.
if you have angina (a condition in which the blood supply to the heart is reduced or blocked, resulting in attacks of pain in the chest);
if you have a persistent dry cough, which may occur while taking other ACE inhibitors;
if you have had a kidney transplant.
Angioedema (allergic reaction)

When taking ACE inhibitors, including Prestarium® A, a severe allergic reaction may occur with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing (angioedema). This reaction can occur at any time during treatment.

If you experience these symptoms (also listed in section 4), stop taking Prestarium® A immediately and contact your doctor.

You should tell your doctor if you think you are (or are planning to become) pregnant. Prestarium® A should not be taken during pregnancy as it may cause serious harm to the baby (see section “Pregnancy and breastfeeding”).

Children and teenagers

Do not give the drug to children from 0 to 18 years of age, since the safety and effectiveness of the drug Prestarium® A in children and adolescents have not been established. Prestarium® A is not intended for use in children and adolescents under 18 years of age.

Driving vehicles and working with machinery

As a rule, Prestarium® A does not affect alertness, but in some patients dizziness or weakness may occur due to low blood pressure. In this case, the ability to drive vehicles and operate machinery may be reduced.

The drug Prestarium® A contains lactose monohydrate

The drug Prestarium® A contains lactose monohydrate. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

The drug Prestarium® A contains aspartame

If you have phenylketonuria, talk to your doctor before taking this drug. The aspartame contained in this medicine may be harmful to you.

Active ingredient

Perindopril

Composition

Prestarium® A, 5 mg, orally dispersible tablets
The active ingredient is perindopril arginine. Each orally dispersible tablet contains 5 mg perindopril arginine (corresponding to 3.395 mg perindopril).

Other ingredients (excipients) are: Acesulfame potassium
Aspartame Magnesium stearate
Silicon dioxide colloidal anhydrous
Dry mixture of lactose and starch (lactose monohydrate 85%, corn starch 15%)

Prestarium® A, 10 mg, tablets, orally dispersible
The active ingredient is perindopril arginine. Each orally dispersible tablet contains 10 mg perindopril arginine (corresponding to 6.790 mg perindopril).
Other ingredients (excipients) are: Acesulfame potassium
Aspartame Magnesium stearate
Silicon dioxide colloidal anhydrous
Dry mixture of lactose and starch (lactose monohydrate 85%, corn starch 15%)

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before using this medicine.

The use of ACE inhibitors (such as perindopril arginine) in the second and third trimesters of pregnancy can lead to fetal development disorders (decreased renal function, oligohydramnios, delayed skull ossification, arterial hypertension, hyperkalemia).

Pregnancy
You should tell your doctor if you think you are (or may become) pregnant. Typically, your doctor will advise you to stop taking Prestarium® A before you become pregnant or as soon as you find out you are pregnant. The doctor will advise you to take another drug instead of Prestarium® A. Prestarium® A is contraindicated during pregnancy, as its use can cause serious harm to the health of the child.

Breastfeeding
You should not take Prestarium® A if you are breastfeeding.
Tell your healthcare provider right away if you are breastfeeding or plan to breastfeed.
Contact your healthcare provider immediately.

Fertility
No effect on reproductive function or fertility has been established.

Contraindications

Do not take Prestarium® A:

if you are allergic to perindopril, or other drugs related to ACE inhibitors, or any other ingredients of the drug (listed in section 6 of the leaflet);
if you or one of your relatives have previously experienced symptoms such as wheezing, swelling of the face, tongue or larynx, intense itching or severe skin rash (angioedema) while taking other ACE inhibitors or under other circumstances;
if you are pregnant or breastfeeding;
if you have diabetes and/or impaired renal function and are taking a blood pressure medicine containing aliskiren;
if you have kidney disease associated with diabetes and are taking angiotensin II receptor blockers;
if you are taking medications containing valsartan + sacubitril – drugs for the treatment of heart failure (see the information provided in the section “Special instructions and precautions” and “Other drugs and Prestarium® A”);
if you are undergoing dialysis or another type of blood filtration. Depending on the equipment used, the drug Prestarium® A may not be suitable for your treatment;
if you have a kidney disease that reduces blood flow to the kidneys (renal artery stenosis).

If you think any of the above applies to you, tell your doctor.

Side Effects

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

Stop taking the drug and call your doctor immediately if any of the following side effects occur, which may be serious:

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

severe dizziness or loss of consciousness caused by low blood pressure,

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

swelling of the face, lips, tongue and throat, difficulty breathing (angioedema) (see section 2 “Special instructions and precautions”)
sudden wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm),

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

unusually fast or irregular heartbeat, chest pain (angina) or heart attack,
weakness in arms, legs or speech problems, which may be symptoms of a stroke,
inflammation of the pancreas (pancreatitis), which can cause back pain accompanied by very poor health,
yellowing of the skin or whites of the eyes (jaundice), which may be symptoms of hepatitis,
skin rash starting with red, itchy patches on the face, arms or legs (erythema multiforme),
acute renal failure (acute renal dysfunction),
agranulocytosis (low white blood cell count) or pancytopenia (low red blood cell, white blood cell, and platelet count).
Contact your doctor if you experience any of the following side effects:

Common (may affect up to 1 in 10 people)

headache,
dizziness,
vertigo,
spontaneously occurring sensations of burning, tingling, crawling,
visual impairment,
tinnitus,
cough,
dyspnea,
disorders of the gastrointestinal tract (abdominal pain, constipation, diarrhea, taste disorder (dysgeusia), dyspepsia, nausea, vomiting),
allergic reactions (skin itching, skin rash), muscle spasms,
fatigue.

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

mood swings,
sleep disorder,
dry mouth,
severe itching or severe skin rash (urticaria),
focal blistering of the skin (pemphigoid),
renal failure,
impotence (erectile dysfunction),
increased sweating,
increased levels of eosinphils (a type of white blood cell) (eosinphilia),
drowsiness,
loss of consciousness,
feeling of heartbeat,
tachycardia,
vasculitis (inflammation of blood vessels),
photosensitivity reactions (increased sensitivity of the skin to sun exposure),
arthralgia (joint pain),
myalgia (muscle pain),
chest pain,
general malaise,
peripheral edema,
fever,
fall,
changes in laboratory parameters (based on blood test results):
an increase in potassium concentration in the blood, reversible after cessation of treatment,
low sodium concentration in the blood,
hypoglycemia (very low blood sugar concentration) in patients with diabetes,
increased concentration of urea in the blood,
increase in creatinine concentration in the blood.

Rare (may affect up to 1 in 1000 people):

exacerbation of psoriasis,
changes in laboratory parameters (based on blood test results):
increased activity of “liver” enzymes in the blood,
increased concentration of bilirubin in the blood.

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

confusion,
eosinophilic pneumonia (a rare type of pneumonia),
rhinitis (nasal congestion),
acute renal failure,
change in blood test results: decrease in the concentration of leukocytes and red blood cells, decrease in hemoglobin, decrease in the number of platelets in the blood.
Increased concentration (darkening) of urine, nausea or vomiting, muscle spasms, confusion and seizures can be caused by inadequate secretion of ADH (antidiuretic hormone) when taking ACE inhibitors. If these symptoms occur, consult your doctor immediately.

Frequency unknown (cannot be estimated from available data):

Raynaud’s syndrome, characterized by changes in skin color (pallor), numbness and pain in the fingers and toes.

Interaction

Tell your doctor or pharmacist if you are taking, have recently taken, or may start taking any other medications. Treatment with Prestarium® A may be affected by taking other medications. Your doctor may decide to change your dose and/or take other precautions.
Be sure to tell your doctor if you are taking any of the following medications:
• other drugs to treat high blood pressure, including ACE inhibitors, angiotensin II receptor blockers, aliskiren (see

also section 2), diuretics (drugs that increase the volume of urine excreted by the kidneys);
• potassium-sparing drugs (such as triamterene, amiloride), potassium supplements or salt substitutes containing potassium, and other drugs that can increase the amount of potassium in the body (such as heparin and co-trimoxazole, also known as a combination drug containing sulfamethoxazole and trimethoprim);
• lithium preparations (used for mania or depression);
• nonsteroidal anti-inflammatory drugs (eg, ibuprofen), cyclooxygenase-2 inhibitors (eg, valdecoxib, etoricoxib) for pain, or acetylsalicylic acid (aspirin) in high doses (3000 mg per day or more);
• drugs for the treatment of diabetes (such as insulin, metformin or gliptins (linagliptin, saxagliptin, sitagliptin, vildagliptin));
• baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis);
• drugs for the treatment of mental disorders such as depression, anxiety, schizophrenia, etc. (for example, tricyclic antidepressants, antipsychotics);
• immunosuppressants that are used to treat autoimmune disorders or after transplant surgery to prevent rejection (eg, cyclosporine, tacrolimus);
• trimethoprim (to treat infections);
• estramustine (used in the treatment of cancer);
• drugs that are most often used to treat diarrhea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTOR inhibitors). See section “Special instructions and precautions”;
• combination of valsartan + sacubitril (used for the treatment of chronic heart failure). See subsections “Do not take Prestarium® A” and
“Special instructions and precautions”;
• allopurinol (for the treatment of gout);
• procainamide (to treat irregular heart rhythm);
• vasodilators, including nitrates (drugs that cause blood vessels to dilate);
• drugs that are used to treat low blood pressure, shock or asthma (for example, ephedrine, norepinephrine or epinephrine);
• gold preparations for intravenous administration (used to treat symptoms of rheumatoid arthritis).

Storage conditions

Keep the drug out of the reach of children and so that the child cannot see it.

Do not use the drug after the expiration date (shelf life) indicated on the carton and on the bottle after the words “Best before”. The expiration date is the last day of the specified month.

Store at a temperature not exceeding 25 °C.

Do not dispose of the drug down the drain or with household waste. Ask your pharmacist how to dispose of (destroy) a drug that is no longer needed. These measures will protect the environment.

Shelf life

3 years

Manufacturer

Servier Rus LLC, Russia