Vidotin

Package Leaflet: Information for the User

Vidotin, 4 mg, tablets

Vidotin, 8 mg, tablets

(Tert-butylamine perindopril)

Read the package 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 where the blood supply to the heart is reduced or blocked) or in patients who have already had a heart attack and/or have undergone surgical procedures to improve blood flow to the heart by widening the blood vessels. This only applies to 4 mg tablets:
• to treat symptomatic heart failure (a condition where the heart is not able to pump enough blood to meet the body's needs).

2. Important information before taking Vidotin

When not to take Vidotin

• after the third month of pregnancy (it is also recommended to avoid taking Vidotin during early pregnancy - see section Pregnancy);

In case of doubt, consult your 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, discuss this with your doctor, pharmacist, or nurse if:

• you have a reduced or blocked blood flow to the heart (stable coronary artery disease);
• you have an enlarged heart muscle or heart valve problems;
• you have a narrowing of the artery that supplies blood to the kidney (renal artery stenosis);
• you have diabetes;
• you have any other kidney, liver, or heart problems;
• you have an excessive increase in the level of a hormone called aldosterone in your blood (primary hyperaldosteronism); if you have a connective tissue disease, such as systemic lupus erythematosus or scleroderma;
• you are undergoing dialysis or have recently had a kidney transplant;
• you are on a low-salt diet, have severe vomiting or diarrhea, or are taking diuretics (water pills);
• you are taking lithium, used to treat mania or depression;
• you are taking potassium supplements or salt substitutes that contain potassium;
• you are taking any of the following medicines, used to treat high blood pressure:
• an angiotensin II receptor antagonist (AIIRA), also known as a sartan - for example, valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes,
• aliskiren; Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood.
• you are taking any of the following medicines, as they may increase the risk of angioedema (rapid swelling of the skin and mucous membranes)
• 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).

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. It is not recommended to take Vidotin during early pregnancy and it must not be taken after the third month of pregnancy, as it may cause serious harm to the baby (see section Pregnancy).
Also, see the section "When not to take Vidotin".
While taking Vidotin
Tell your doctor immediately if you experience any of the following symptoms:

• Dizziness after taking the first dose. In a small number of patients, dizziness, weakness, fainting, and nausea may occur after taking the first dose or increasing the dose.
• Sudden swelling of the lips, face, neck, and/or hands and feet, or difficulty breathing or swallowing (angioedema). This can occur at any time during treatment. ACE inhibitors are more likely to cause angioedema in black patients than in patients of other races.
• High fever, sore throat, or mouth ulcers (may be signs of an infection caused by a low white blood cell count).
• Yellowing of the skin and eyes (jaundice), which may be a sign of liver disease.
• Persistent dry cough. There have been reports of a cough associated with 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 sign of a condition called angioedema of the intestine, which has been observed in patients taking this type of medicine (ACE inhibitors).

At the start of treatment and/or when adjusting the dose, more frequent check-ups with your doctor may be necessary. Do not miss these check-ups, even if you feel better. Your doctor will determine the frequency of the check-ups.
To prevent possible complications when taking Vidotin, also inform your doctor if:

• you are going to have an operation or receive anesthesia (including dental surgery),
• you are going to have a treatment to reduce allergic reactions to bee or wasp stings (desensitization),
• you are going to have hemodialysis or LDL 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 with food, drink, and alcohol

Vidotin should be taken before meals to reduce the effect of food on the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking Vidotin before you become pregnant or as soon as you find out you are pregnant, and will prescribe a different medicine instead of Vidotin. It is not recommended to take Vidotin during early pregnancy and it must not be taken after the third month of pregnancy, as it may cause serious harm to the baby.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Vidotin while breastfeeding. If you decide to breastfeed, especially if your baby is a newborn or premature, your 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 start of treatment or when taking other blood pressure-lowering medicines. If you experience these symptoms, your ability to drive or operate machinery may be impaired.

Vidotin contains lactose

The tablets contain lactose monohydrate. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Vidotin

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
High blood pressure: the usual starting 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 starting dose is 2 mg once daily. If necessary, the dose can be increased up to 4 mg once daily. Treatment of heart failure is under close medical supervision, always follow your doctor's instructions.
Stable coronary artery disease: the usual starting dose is 4 mg once daily. After 2 weeks, the dose can be increased up to 8 mg once daily, depending on the response to treatment.

• The starting and maintenance doses may be lower than the usual doses and will be determined by your 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 (water pills);
• in patients with heart problems, including severe heart failure;
• in patients taking diuretics that cannot be stopped;
• in patients taking vasodilators.

Your doctor may adjust the dose according to the treatment outcome and your 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
Swallow the tablet(s) with a glass of water, preferably at the same time every day, in the morning, before meals.
If you feel that the effect of Vidotin is too strong or too weak, consult your doctor or pharmacist.

Overdose of Vidotin

If you have taken too many tablets, contact your doctor immediately.
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.
If you experience a significant drop in blood pressure, lie down with your legs raised and use a small pillow as a headrest.

Missed dose of Vidotin

It is important to take the medicine every day. If you miss one or more doses, take them as soon as you remember and then return to your normal dosing schedule.
Do not take a double dose to make up for a missed dose, and 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, requiring hospitalization.
Therefore, if you are considering stopping treatment with Vidotin, consult your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following symptoms, stop taking Vidotin and contact your doctor immediately:

• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing or swallowing (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);
• weakness of the arms or legs, or difficulty speaking, which may be symptoms 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 may cause severe abdominal pain and a very bad feeling (very rare - may affect up to 1 in 10,000 people);
• yellowing of the skin and eyes (jaundice), which may be a sign of liver disease (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, feeling of spinning (vertigo),
• tingling or numbness of the hands or feet (paresthesia),
• visual disturbances,
• ringing, buzzing, roaring, clicking, etc. in the ears (tinnitus),
• low blood pressure and symptoms related to low blood pressure,
• cough, shortness of breath,
• nausea, vomiting,
• abdominal pain,
• taste disturbances,
• feeling of indigestion (dyspepsia),
• diarrhea and constipation,
• rash, itching (pruritus),
• muscle cramps,
• weakness (asthenia).

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

• increased eosinophils (a type of white blood cell),
• low blood sugar (hypoglycemia), high potassium levels (hyperkalemia) reversible after stopping treatment, low sodium levels,
• mood changes, sleep disturbances,
• depression,
• drowsiness, fainting,
• feeling of a rapid or strong heartbeat,
• vasculitis, inflammation of blood vessels, often with a rash,
• dryness of the mucous membranes of the mouth,
• hives, allergic reactions to sunlight (increased sensitivity of the skin to the sun), formation of blisters on the skin, increased sweating,
• joint pain, muscle pain,
• kidney problems,
• impotence,
• chest pain, malaise, peripheral edema, fever, falls,
• increased levels of metabolites in the blood (urea and creatinine in serum).

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

• decreased 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 a type of white blood cell called neutrophils (neutropenia), and cases of a lack of white blood cells (agranulocytosis) or a lack of all blood cell types (pancytopenia),
• in patients with a congenital deficiency of an enzyme (glucose-6-phosphate dehydrogenase - G6PD), very rare cases of anemia (insufficient red blood cells) have been reported, resulting from the breakdown of red blood cells (hemolytic anemia),
• disorientation,
• inflammation of the lungs associated with an accumulation of certain white blood cells (eosinophils) in lung tissue (eosinophilic pneumonia),
• inflammation of the nasal mucous membranes (rhinitis).

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

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects 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
Tel.: +48 22 49 21 301,
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vidotin

Do not store above 30°C.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
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 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.

• The other ingredients are: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous 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 equal halves. On one side of the tablet, there is a score line, and on the other side, the code C53 is embossed.
Vidotin 8 mg tablets:
Round, white tablets with the code 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 on this medicine and its names in other EU member states, contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
lekalert@grodzisk.rgnet.org
Fax: +48 (22) 755 96 24
Date of last revision of the leaflet:October 2021
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