Vidotin

Leaflet accompanying the packaging: information for the user

Vidotin, 4 mg, tablets

Vidotin, 8 mg, tablets

(Tert-butylamine perindopril)

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 you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. 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 Vidotin and what is it used for
• 2. Important information before taking Vidotin
• 3. How to take Vidotin
• 4. Possible side effects
• 5. How to store Vidotin
• 6. Contents of the pack and other information

1. What is Vidotin and what is it used for

Vidotin belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). These medicines work by widening the blood vessels, making it easier for the heart to pump blood to the body.
Vidotin is used:

• to treat high blood pressure (hypertension);
• to reduce the risk of heart attacks, such as myocardial infarction, in patients with stable coronary artery disease (a condition in which the heart muscle's blood supply is reduced or blocked) or in patients who have already had a myocardial infarction and/or undergone surgical procedures to improve blood flow to the heart muscle by widening the blood vessels. This only applies to 4 mg tablets:
• to treat symptomatic heart failure (a condition in which the heart is unable to pump enough blood to meet the body's needs).

2. Important information before taking Vidotin

When not to take Vidotin

• if the patient is allergic to perindopril or other ACE inhibitors, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced a hypersensitivity reaction with sudden swelling of the lips and face, neck, and possibly hands and feet or difficulty breathing or wheezing (angioedema) after taking an ACE inhibitor;
• if angioedema has occurred in a relative or the patient has been diagnosed with angioedema for any reason;
• after the third month of pregnancy (it is also recommended to avoid taking Vidotin in early pregnancy - see section Pregnancy);
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren; if the patient is undergoing dialysis or blood filtration of another type - depending on the type of device used, Vidotin may not be suitable for the patient;
• if the patient has severe kidney problems, with reduced blood flow to the kidneys (significant narrowing of the renal artery);
• if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat a certain type of chronic (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) increases.

In case of doubt, consult a doctor.

Warnings and precautions

There is a possibility that taking Vidotin may not be suitable or may require increased monitoring. Before starting to take Vidotin, the patient should discuss this with their doctor, pharmacist, or nurse if:

• the patient has reduced or blocked blood flow to the heart (stable coronary artery disease);
• the patient has an enlarged heart muscle or heart valve problems;
• the patient has narrowing of the artery that supplies blood to the kidney (renal artery stenosis);
• the patient has diabetes;
• the patient has any other kidney, liver, or heart problems;
• the patient has excessive levels of a hormone called aldosterone in the blood (primary hyperaldosteronism); if the patient has collagen vascular disease (a connective tissue disease), such as systemic lupus erythematosus or scleroderma;
• the patient is undergoing dialysis or has recently undergone a kidney transplant;
• the patient is on a low-salt diet, has severe vomiting or diarrhea, or is taking diuretics (medicines that increase urine production);
• the patient is taking lithium, used to treat mania or depression;
• the patient is taking potassium supplements or salt substitutes containing potassium;
• the patient is taking any of the following medicines, used to treat high blood pressure:
• an angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g., valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes,
• aliskiren; The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
• the patient is taking any of the following medicines, as the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) may increase
• racecadotril (a medicine used to treat diarrhea),
• wildagliptin (a medicine used to treat diabetes),
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of so-called mTOR inhibitors (used to prevent the rejection of transplanted organs and to treat cancer).

The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Vidotin in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby (see section Pregnancy).
See also subsection "When not to take Vidotin."
During treatment with Vidotin
The patient should immediately inform their doctor if they experience any of the following symptoms:

• Dizziness after taking the first dose. In a small number of patients, dizziness, weakness, fainting, and nausea occur after taking the first dose or increasing the dose.
• Sudden swelling of the lips and face, neck, and possibly hands and feet or difficulty breathing or wheezing. This condition is called angioedema. It can occur at any time during treatment. ACE inhibitors more frequently cause angioedema in black patients than in patients of other races.
• High body temperature, sore throat, or mouth ulcers (may be symptoms of an infection caused by a decrease in white blood cell count).
• Yellowing of the skin and whites of the eyes (jaundice), which may be a sign of liver disease.
• Persistent dry cough. There have been reports of a link between cough and ACE inhibitors, but it may also be a symptom of upper respiratory tract diseases.
• Abdominal pain with or without nausea and vomiting may be a symptom of a condition called angioedema of the intestine, which has been observed in patients taking this type of medicine (ACE inhibitors).

At the beginning of treatment and/or during dose adjustment, more frequent check-ups with the doctor may be necessary. The patient should not miss these check-ups, even if they feel better. The doctor will determine the frequency of check-ups.
To prevent possible complications during treatment with Vidotin, the patient should also inform their doctor if:
they are undergoing anesthesia and/or surgery (including dental surgery),

• the patient is undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings,
• the patient is undergoing hemodialysis or LDL cholesterol apheresis (removal of cholesterol from the body using a special device).

Children and adolescents(under 18 years of age)
Vidotin is not recommended for use in children and adolescents.

Vidotin 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 not take medicines available without a prescription without consulting a doctor. This is especially true for:

• medicines used to treat colds, containing pseudoephedrine or phenylephrine as active substances;
• painkillers, including gold preparations and acetylsalicylic acid (a substance found in many painkillers and antipyretics, as well as blood thinners);
• potassium supplements;
• salt substitutes containing potassium. Other medicines may affect the action of Vidotin. The doctor may recommend changing the dose and/or taking other precautions if the patient is taking:
• an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also subsections "When not to take Vidotin" and "Warnings and precautions"); medicines that are most commonly used to treat diarrhea (racecadotril) or diabetes (wildagliptin) or to prevent the rejection of transplanted organs and to treat cancer (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of so-called mTOR inhibitors). See section "Warnings and precautions".

The patient should inform their doctor about taking any of the following medicines to ensure that taking Vidotin at the same time is safe:

• other medicines used to treat high blood pressure and/or heart failure, including diuretics;
• potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride); potassium supplements and salt substitutes containing potassium;
• medicines used to treat diabetes (insulin or oral medicines), which lower blood sugar levels;
• lithium, used to treat mania or depression;
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, or other psychoses;
• baclofen (used to treat muscle stiffness, such as in multiple sclerosis);
• allopurinol, used to treat gout;
• immunosuppressive medicines used to treat autoimmune diseases (e.g., rheumatoid arthritis) or given after organ transplantation;
• estramustine (used to treat cancer);
• procainamide, used to treat heart rhythm disorders;
• non-steroidal anti-inflammatory medicines (NSAIDs) used to relieve pain, including aspirin;
• medicines used to treat low blood pressure, shock, or asthma (e.g., ephedrine, norepinephrine, or adrenaline);
• vasodilators, including nitrates;
• medicines that can increase potassium levels in the body, such as heparin (used to reduce blood density to prevent clot formation), cyclosporine (an immunosuppressive medicine used to prevent organ rejection), trimetoprim, cotrimoxazole (also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections);
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Vidotin" and "Warnings and precautions".

Vidotin with food, drink, and alcohol

Vidotin should be taken before a meal to reduce the effect of food on the action of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Vidotin before becoming pregnant or as soon as the patient finds out they are pregnant and recommend taking a different medicine instead of Vidotin. It is not recommended to take Vidotin in early pregnancy and it should not be taken after the third month of pregnancy, as it may be very harmful to the baby.
Breastfeeding
The patient should inform their doctor if they are breastfeeding or plan to breastfeed.
It is not recommended to take Vidotin while breastfeeding. If the patient decides to breastfeed, especially if the baby is a newborn or premature, the doctor may choose a different treatment.
Fertility
This medicine does not affect fertility.

Driving and using machines

Vidotin usually does not affect concentration, but some patients may experience dizziness or weakness due to low blood pressure, especially at the beginning of treatment or when taking combined treatment with another medicine for high blood pressure. If the patient experiences such symptoms, their ability to drive and operate machines may be impaired.

Vidotin contains lactose

The tablets contain lactose monohydrate. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Vidotin

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
High blood pressure: the usual initial and maintenance dose is 4 mg once daily. After one month of treatment, the dose can be increased to 8 mg once daily, depending on the response to treatment. The maximum daily dose is 8 mg once daily.
This only applies to 4 mg tablets!
Heart failure: the usual initial dose is 2 mg once daily. If necessary, the dose can be increased to a maximum of 4 mg once daily. Treatment of heart failure is carried out under close medical supervision, and the patient should always follow the doctor's instructions.
Stable coronary artery disease: the usual initial dose is 4 mg once daily. After 2 weeks, the dose can be increased to a maximum of 8 mg once daily, depending on the response to treatment.
The initial and maintenance doses may be lower than the usual doses and will be determined by the doctor:

• in elderly patients;
• in patients with kidney problems;
• in patients with kidney problems, including high blood pressure caused by narrowing of the arteries that supply blood to the kidneys (renal artery stenosis);
• in patients taking diuretics (medicines that increase urine production) at the same time;
• in patients with heart problems, including severe heart failure;
• in patients taking diuretics that cannot be discontinued;
• in patients taking vasodilators.

The doctor may adjust the dose based on the treatment outcome and the patient's needs.

Use in children and adolescents

The efficacy and safety of Vidotin in children and adolescents have not been established. Therefore, it is not recommended to give this medicine to children and adolescents.
Method and route of administration
The tablet(s) should be swallowed with a glass of water, preferably at the same time every day, in the morning, before a meal.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.

Overdose of Vidotin

In case of taking too many tablets, the patient should immediately consult their doctor.
The most likely symptom of overdose is a sudden drop in blood pressure (hypotension). Other possible symptoms include: rapid or slow heart rate, palpitations, shortness of breath, dizziness, anxiety, and/or cough.
In case of significant hypotension, the patient should be placed with their legs raised, and only a small pillow should be used as a headrest.

Missing a dose of Vidotin

It is important to take the medicine every day. If the patient misses one or more doses, they should take them as soon as they remember and then return to their normal dosing schedule.
The patient should not take a double dose to make up for a missed dose and should take the next dose at the usual time.

Stopping treatment with Vidotin

After stopping treatment, blood pressure may rise again, increasing the risk of complications caused by high blood pressure, particularly affecting the heart, brain, and kidneys.
The condition of patients with heart failure may worsen to the point where hospitalization is necessary.
Therefore, if the patient is considering stopping treatment with Vidotin, they should consult their doctor first.
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, Vidotin can cause side effects, although not everybody gets them.

If the patient experiences any of the following symptoms, they should stop taking Vidotin and immediately consult their doctor:

• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing or swallowing (angioedema) (see section 2 "Warnings and precautions") (uncommon - may affect less than 1 in 100 people);
• severe dizziness or fainting due to low blood pressure (common - may affect less than 1 in 10 people);
• very rapid or irregular heartbeat, chest pain (angina pectoris), or heart attack (very rare - may affect less than 1 in 10,000 people);
• muscle weakness or difficulty speaking, which may be symptoms of a stroke (very rare - may affect less than 1 in 10,000 people);
• sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm) (uncommon - may affect less than 1 in 100 people);
• pancreatitis, which can cause severe abdominal pain radiating to the back and very poor general condition (very rare - may affect less than 1 in 10,000 people);
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (very rare - may affect less than 1 in 10,000 people);
• rash, often starting with the appearance of red, itchy spots on the face, arms, or legs (erythema multiforme) (very rare - may affect less than 1 in 10,000 people).

The patient should tell their doctor if they experience any of the following side effects:
Common (may affect less than 1 in 10 people):

• headache,
• dizziness of central origin, feeling of spinning (vertigo),
• tingling or numbness of the hands or feet (paresthesia),
• vision disturbances,
• feeling of ringing, buzzing, roaring, clicking in the ears, etc. (tinnitus),
• low blood pressure (hypotension) and symptoms related to hypotension,
• cough, shortness of breath,
• nausea, vomiting,
• abdominal pain,
• taste disturbances,
• feeling of fullness in the stomach (indigestion),
• diarrhea and constipation,
• rash, itching (pruritus),
• muscle cramps,
• weakness (asthenia).

Uncommon (may affect less than 1 in 100 people):

• high levels of eosinophils (a type of white blood cell),
• low blood sugar levels (hypoglycemia), high potassium levels (hyperkalemia) reversible after stopping treatment, low sodium levels,
• mood swings, sleep disturbances,
• depression,
• drowsiness, fainting,
• feeling of rapid and strong heartbeat,
• vasculitis, inflammation of blood vessels, often with skin rash,
• dryness of the mucous membranes of the mouth,
• hives, allergic reactions to light (increased skin sensitivity to the sun), formation of blisters on the skin, excessive sweating,
• joint pain, muscle pain,
• kidney problems,
• impotence (inability to achieve or maintain an erection),
• chest pain, poor general condition, peripheral edema, fever, falls,
• increased levels of metabolites in the blood (urea and creatinine in serum). Rare (may affect less than 1 in 1,000 people):
• worsening of psoriasis,
• dark urine, nausea, or vomiting, muscle cramps, confusion, and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion),
• reduced or absent urine production,
• sudden reddening of the face and neck
• acute kidney failure
• increased activity of liver enzymes and bilirubin levels in serum (orange-yellow pigment in bile).

Very rare (may affect less than 1 in 10,000 people):

• decrease in hemoglobin levels (a substance in red blood cells responsible for transporting oxygen in the body) and hematocrit values (the ratio of red blood cell volume to blood volume),
• significant decrease in platelet count (thrombocytopenia), significant decrease in white blood cell count (leukopenia), decrease in neutrophil count (a type of white blood cell), and cases of agranulocytosis (a decrease in neutrophil count) or pancytopenia (a decrease in all blood cell types),
• in patients with a congenital deficiency of an enzyme (glucose-6-phosphate dehydrogenase - G-6PDH), very rare cases of anemia (insufficient red blood cell count) have been reported, resulting from the breakdown of red blood cells (hemolytic anemia),
• disorientation,
• inflammation of the lungs associated with the accumulation of certain white blood cells (eosinophils) in lung tissue (eosinophilic pneumonia),
• inflammation of the nasal mucosa (rhinitis).

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

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Vidotin

Do not store above 30°C.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton. 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 they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vidotin contains

• The active substance is perindopril tert-butylamine.

Vidotin, 4 mg, tablets:
Each tablet contains 4 mg of perindopril tert-butylamine, equivalent to 3.338 mg of perindopril.
Vidotin, 8 mg, tablets:
Each tablet contains 8 mg of perindopril tert-butylamine, equivalent to 6.676 mg of perindopril.

• Other ingredients are: microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, magnesium stearate.

What Vidotin looks like and contents of the pack

Vidotin 4 mg tablets:
Oval, flat tablets, white in color. The tablet can be divided into two halves. On one side of the tablet, there is a score line, and on the other side, the marking C53 is embossed.
Vidotin 8 mg tablets:
Round, white tablets with the marking C54 embossed on one side.
Pack sizes: 30 tablets

Marketing authorization holder:

GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

Manufacturer:

GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
To obtain more detailed information about the medicine and its names in other EU member states, the patient should contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22) 755 96 48
[email protected]
Fax: +48 (22) 755 96 24
Date of last revision of the leaflet:October 2021
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