Vidotin

Package leaflet: Information for the user

Vidotin, 4 mg, tablets
Vidotin, 8 mg, tablets
(tert-Butylamine perindoprilum)
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific patient. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Vidotin is and what it is used for
2. What you need to know 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 Vidotin is and what it is used for

Vidotin belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. These medicines work by widening blood vessels, which helps the heart pump blood through the body more easily.
Vidotin is used:

• to treat high blood pressure (hypertension);
• to reduce the risk of cardiovascular events, such as heart attack, in patients with stable coronary artery disease (a condition in which blood supply to the heart muscle is reduced or blocked), or in patients who have previously had a heart attack and/or undergone a surgical procedure to improve blood flow to the heart muscle by widening the blood vessels.
  For 4 mg tablets only:
• 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 using Vidotin

When not to use Vidotin

• if the patient is allergic to perindopril or to any other ACE inhibitor, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced a hypersensitivity reaction with sudden swelling of the lips and face, neck, possibly including swelling of the hands and feet, or with shortness of breath or hoarseness (angioedema) after taking an ACE inhibitor;
• if angioedema has occurred in a relative or if the patient has ever been diagnosed with angioedema for any reason;
• after the third month of pregnancy (it is also recommended to avoid using Vidotin in early pregnancy – see Pregnancy section);
• 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 other types of blood filtration – depending on the type of equipment used, Vidotin may not be suitable for the patient;
• if the patient has severe kidney problems with reduced blood flow to the kidneys (significant renal artery stenosis);
• 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, such as in the throat) increases.

If in doubt, consult a doctor.
Warnings and precautions
There is a possibility that treatment with Vidotin may not be suitable or may require increased monitoring. Before starting Vidotin, discuss with your doctor, pharmacist, or nurse if:

• the patient has reduced or blocked blood flow to the heart (stable coronary artery disease);
• the patient has been diagnosed with thickening of the heart muscle or heart valve disorders;
• the patient has narrowing of the artery supplying blood to the kidney (renal artery stenosis);
• the patient has diabetes;
• the patient has any other kidney, liver, or heart conditions;
• the patient has excessive increase in the level of a hormone called aldosterone in the blood (primary hyperaldosteronism);
• the patient has vascular collagenosis (connective tissue disease), such as systemic lupus erythematosus or scleroderma;
• the patient is undergoing dialysis or has recently undergone kidney transplantation;
• the patient is on a low-salt diet, has severe vomiting or diarrhea, or is taking medicines that increase urine output (diuretics);
• 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 – for example, 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 blood electrolyte levels (e.g. potassium).
• the patient is taking any of the following medicines, as they may increase the risk of angioedema (rapid swelling of the skin in areas such as the throat):
  • racecadotril (a medicine used to treat diarrhea),
  • vildagliptin (a medicine used to treat diabetes),
  • sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of so-called mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment).

Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Use of Vidotin is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child (see Pregnancy section).
See also the section "When not to use Vidotin."
While taking Vidotin
Inform your doctor immediately if any of the following symptoms occur:

• Dizziness after taking the first dose. A small number of patients may experience dizziness, weakness, fainting, or nausea after taking the first dose or increasing the dose.
• Sudden swelling of the lips and face, neck, possibly including swelling of the hands and feet, or wheezing or hoarseness. This condition is called angioedema and may 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 (which may be signs of infection due to reduced white blood cell count).
• Yellowing of the skin or whites of the eyes (jaundice), which may indicate liver disease.
• Persistent dry cough. Cough has been reported with ACE inhibitors, but it may also be a symptom of upper respiratory tract diseases.
• Abdominal pain with or without nausea and vomiting, which may be a sign of a condition called intestinal angioedema, 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. Do not skip these visits even if the patient feels better. The doctor will determine the frequency of follow-up examinations.
To prevent possible complications while taking Vidotin, inform your doctor if:

• the patient is undergoing anesthesia and/or surgery (including dental procedures),
• the patient is scheduled for treatment aimed at reducing allergic reactions after bee or wasp stings (desensitization),
• the patient is to undergo 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 with 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.
Do not take over-the-counter medicines without consulting a doctor. This particularly applies to:

• cold remedies containing pseudoephedrine or phenylephrine as active ingredients;
• painkillers, including gold preparations and acetylsalicylic acid (a substance found in many painkillers, antipyretics, and blood-thinning medicines);
• potassium supplements;
• salt substitutes containing potassium.

Other medicines may affect the action of Vidotin. The doctor may recommend changing the dose and/or taking additional precautions if the patient is taking:

• an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to use Vidotin" and "Warnings and precautions");
• medicines commonly used to treat diarrhea (racecadotril) or medicines used to treat diabetes (vildagliptin), or medicines used to prevent organ transplant rejection and in cancer treatment (sirolimus, everolimus, temsirolimus, and other mTOR inhibitors). See section "Warnings and precautions".

Inform your doctor if you are 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 (water pills) that increase urine output;
• potassium-sparing diuretics (e.g. spironolactone, triamterene, or amiloride); potassium supplements and salt substitutes containing potassium;
• medicines used to treat diabetes (insulin or oral antidiabetic drugs) that lower blood sugar;
• 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 in conditions such as 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 drugs (NSAIDs) used to relieve pain, including aspirin;
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline, or adrenaline);
• vasodilators, including nitrates;
• medicines that may increase potassium levels in the body, such as heparin (used to reduce blood viscosity to prevent clot formation), cyclosporine (an immunosuppressive medicine used to prevent organ transplant rejection), trimethoprim, cotrimoxazole (also known as trimethoprim/sulfamethoxazole) (used to treat bacterial infections);
• a medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to use Vidotin" and "Warnings and precautions".

Vidotin with food, drink, and alcohol
Vidotin should be taken before meals to minimize the effect of food on the medicine's action.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. The doctor will usually advise stopping Vidotin before becoming pregnant or immediately upon learning of pregnancy and will recommend an alternative medicine. Vidotin is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may be highly harmful to the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Vidotin is not recommended for use in breastfeeding mothers. If the patient decides to breastfeed, especially if the baby is a newborn or was born prematurely, the doctor may choose an alternative treatment.
Fertility
This medicine has no effect on 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 used in combination with other blood pressure-lowering medicines. If such symptoms occur, the ability to drive or operate machinery may be impaired.
Vidotin contains lactose
The tablets contain monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

3. How to use Vidotin

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult 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 may be increased to 8 mg once daily, depending on the response to treatment. The maximum daily dose is 8 mg once daily.
Applies only to 4 mg tablets!
Heart failure: the usual starting dose is 2 mg once daily. If necessary, the dose may be increased up to a maximum of 4 mg once daily. Treatment of heart failure must be conducted under strict medical supervision; always follow your doctor's instructions.
Stable angina pectoris: the usual starting dose is 4 mg once daily. After 2 weeks, the dose may be increased up to a maximum of 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 the doctor:

• in elderly patients;
• in patients with impaired kidney function;
• in patients with kidney disorders, including high blood pressure caused by narrowing of the arteries supplying blood to the kidneys (renovascular hypertension);
• in patients taking diuretics (water tablets);
• in patients with heart disorders, including severe heart failure;
• in patients taking diuretics that cannot be discontinued;
• in patients taking vasodilating medicines.

Your doctor may adjust the dose according to treatment response and individual needs.
Use in children and adolescents
The efficacy and safety of Vidotin in children and adolescents have not been established. Therefore, this medicine is not recommended for use in children and adolescents.
Method and route of administration
The tablet(s) should be swallowed with a glass of water, preferably at the same time each day, in the morning, before a meal.
If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.
Taking more Vidotin than recommended
If you have taken too many tablets, seek medical advice immediately.
The most likely symptom of overdose is a sudden drop in blood pressure (hypotension). Other possible symptoms include: rapid or slow heartbeat, palpitations, shortness of breath, dizziness, anxiety, and (or) cough.
If significant hypotension occurs, the patient should be laid down with legs elevated, using only a small pillow under the head.
Missing a 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, then continue with your regular dosing schedule.
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Vidotin treatment
After stopping treatment, blood pressure may rise again, increasing the risk of complications related to high blood pressure, particularly affecting the heart, brain, and kidneys. The condition of patients with heart failure may worsen to the extent that hospitalization is required. Therefore, if you are considering stopping Vidotin, you should first consult your doctor.
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.
If any of the following symptoms occur, stop taking the medicine
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 occur in less than 1 in 100 patients);
• severe dizziness or fainting caused by low blood pressure (Common - may occur in less than 1 in 10 patients);
• very fast or irregular heartbeat, chest pain (angina) or heart attack (Very rare - may occur in less than 1 in 10,000 patients);
• weakness of the arms or legs, or difficulty speaking, which may be signs of stroke (Very rare - may occur in less than 1 in 10,000 patients);
• sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm) (Uncommon - may occur in less than 1 in 100 patients);
• inflammation of the pancreas, which may cause severe upper abdominal pain radiating to the back and general malaise (Very rare - may occur in less than 1 in 10,000 patients);
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation (Very rare - may occur in less than 1 in 10,000 patients);
• skin rash, often starting with red, itchy spots on the face, arms or legs (erythema multiforme) (Very rare - may occur in less than 1 in 10,000 patients).

Tell your doctor if you experience any of the following adverse reactions:
Common (may occur in less than 1 in 10 people):

• headache,
• central dizziness, sensation of spinning (vestibular dizziness),
• tingling or numbness of hands or feet (paresthesia),
• visual disturbances,
• 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,
• sensation of stomach churning (dyspepsia),
• diarrhea and constipation,
• rash, itching (pruritus),
• muscle cramps,
• weakness (asthenia).

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

• increased number of eosinophils (a type of white blood cells),
• low blood sugar (hypoglycemia), high potassium levels (hyperkalemia) reversible upon discontinuation of treatment, low sodium levels,
• mood swings, sleep disturbances,
• depression,
• drowsiness, fainting,
• sensation of rapid or strong heartbeat,
• vasculitis, inflammation of blood vessels, often with skin rash,
• dryness of the oral mucosa,
• urticaria, photosensitivity reactions (increased skin sensitivity to sunlight), formation of clusters of blisters on the skin, excessive sweating,
• joint pain, muscle pain,
• impaired kidney function,
• inability to achieve or maintain penile erection (impotence),
• chest pain, malaise, peripheral edema, fever, falls,
• increased levels of metabolites in blood (blood urea nitrogen and plasma creatinine).

Rare (may occur in less than 1 in 1,000 people):

• exacerbation 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),
• decreased urine output or absence of urine,
• sudden redness of the face and neck,
• acute kidney failure,
• increased activity of liver enzymes and increased serum bilirubin levels (an orange-yellow pigment in bile).

Very rare (may occur in less than 1 in 10,000 patients):

• decreased hemoglobin concentration (a substance in red blood cells responsible for oxygen transport) and hematocrit values (ratio of red blood cell volume to total blood volume),
• significant decrease in platelet count (cells responsible for blood clotting) (thrombocytopenia),
• significant decrease in white blood cell count (leukopenia), decreased number of a specific type of white blood cells - neutrophils (neutropenia), and cases of absence of a certain type of white blood cells - granulocytes (agranulocytosis), or absence of all types of blood cells (red blood cells, white blood cells and platelets - pancytopenia),
• in patients with congenital deficiency of one of the enzymes (glucose-6-phosphate dehydrogenase - G-6PDH), very rare cases of anemia (insufficient number of red blood cells) resulting from red blood cell breakdown (hemolytic anemia) have been reported,
• disorientation,
• lung inflammation associated with accumulation of certain blood cells (eosinophils) in lung tissue (eosinophilic pneumonia),
• inflammation of the nasal mucosa (rhinitis).

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

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

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 of Monitoring Adverse Reactions of Medicinal Products
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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vidotin

Do not store above 30ºC.
Keep in a place inaccessible and out of sight 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Vidotin contains

• The active substance is perindopril with tert-butylamine.

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

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

What Vidotin looks like and contents of the pack
Vidotin 4 mg tablets:
Oval, flat, white tablets. The tablet can be divided into halves. One side of the tablet has a division line, and on the opposite side is the imprint C53.
Vidotin 8 mg tablets:
Round, white tablets with the imprint C54 on one side.
Available pack: 30 tablets

Marketing Authorisation 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

For further information about this medicinal product and its names in other European Economic Area countries, please 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
[email protected]
fax: +48 (22) 755 96 24
((logo of the marketing authorisation holder))
((pharmacode))