Enalapril Vitabalans

Leaflet attached to the packaging: information for the user

Enalapril Vitabalans, 5 mg, tablets

Enalapril Vitabalans, 10 mg, tablets

Enalapril Vitabalans, 20 mg, tablets

Enalapril maleate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 Enalapril Vitabalans and what is it used for
• 2. Important information before taking Enalapril Vitabalans
• 3. How to take Enalapril Vitabalans
• 4. Possible side effects
• 5. How to store Enalapril Vitabalans
• 6. Contents of the packaging and other information

1. What is Enalapril Vitabalans and what is it used for

Enalapril Vitabalans belongs to a group of medicines called ACE inhibitors. This medicine works by widening the blood vessels, making it easier for the heart to pump blood through the vessels to all parts of the body. This leads to a decrease in high blood pressure.

Enalapril Vitabalans is used:

• to treat high blood pressure (hypertension)
• to treat symptomatic heart failure (a condition in which the heart is not able to pump enough blood to meet the body's needs)
• to prevent symptomatic heart failure in patients whose heart function is impaired but who do not yet have symptoms of the disease

2. Important information before taking Enalapril Vitabalans

When not to take Enalapril Vitabalans

• if the patient is allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6)
• in case of previous allergic reactions caused by taking an ACE inhibitor, known as angioedema, which is characterized by swelling of the skin of the hands, feet, face, or swelling of the lips, tongue, or throat, causing difficulty swallowing or breathing
• if the patient has previously experienced angioedema of unknown origin or has a family history of angioedema - the tendency to such a reaction may be inherited
• if the patient has taken or is currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as it increases the risk of angioedema

the risk of angioedema (rapid swelling of tissues under the skin, such as the throat)

• after the 3rd month of pregnancy (it is also recommended to avoid taking Enalapril Vitabalans in early pregnancy - see "Pregnancy")
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting treatment with Enalapril Vitabalans, the patient should discuss it with their doctor or pharmacist.

• in case of prolonged and severe diarrhea and vomiting
• if the patient is taking diuretics (medicines that increase urine production)
• if the patient is on a low-salt diet
• if the patient has other heart and blood vessel diseases, such as coronary artery disease (angina pectoris), cerebrovascular disorders, heart valve disorders, aortic stenosis, or cardiomyopathy
• in case of kidney problems that require hemodialysis or if the patient has had a kidney transplant
• in case of narrowing of the renal artery, causing high blood pressure
• if the patient has liver problems
• in case of connective tissue diseases that affect blood vessels, such as Raynaud's disease or systemic sclerosis
• if the patient has previously experienced a prolonged, dry cough while taking an ACE inhibitor (see section 4 "Possible side effects")
• if the patient has undergone desensitization, for example, to bee or wasp venom
• in case of LDL apheresis (a way of removing cholesterol from the blood using a special device) for diabetes (see section 2 "Taking other medicines")
• in patients with collagen vascular disease, taking immunosuppressive medicines (used to treat autoimmune disorders such as rheumatoid arthritis or after organ transplantation), taking allopurinol (used to treat gout), or procainamide (used to treat heart rhythm disorders). The doctor may periodically take a blood sample to check the white blood cell count. If such patients experience symptoms of infection (e.g., elevated temperature, fever), they should immediately inform their doctor
• in case of taking potassium supplements or potassium-sparing diuretics
• in case of taking lithium, used to treat certain mental disorders
• in black patients, as the effect of enalapril may be weaker
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes.
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under "When not to take Enalapril Vitabalans" and "Warnings and precautions".

If the patient is taking any of the following medicines, the risk of angioedema may increase:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent organ rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

During treatment with Enalapril Vitabalans, the patient should immediately inform their doctor if they experience any of the following symptoms:

• dizziness after taking the first dose. Some people may react to the first dose or an increase in dose with dizziness, weakness, fainting, and/or vomiting
• sudden swelling of the lips and face, tongue, larynx, throat, and sometimes hands and feet, or a wheezing cough. This condition is called angioedema. It can occur at any time during treatment. ACE inhibitors more frequently cause angioedema in black patients than in other races
• high fever, sore throat, or mouth ulcers (these may be symptoms of an infection caused by a low white blood cell count)
• yellowing of the skin and whites of the eyes (jaundice), which can be symptoms of liver disease.

If any of the above situations apply to the patient, they should consult their doctor before starting treatment with Enalapril Vitabalans tablets.

Enalapril Vitabalans 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.

In particular, the doctor should be informed about the use of the following medicines:

• diuretics
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ rejection; heparin, a medicine used to thin the blood to prevent blood clots)
• other medicines used to treat high blood pressure
• other medicines that may lower blood pressure, such as nitrates used to treat angina, tricyclic antidepressants, medicines used to treat mental disorders (phenothiazines), or barbiturates used to treat epilepsy, narcotics, and anesthetics
• lithium (used to treat manic-depressive disorders)
• oral antidiabetic medicines (both insulin and oral antidiabetic medicines) - the dosage of these medicines may need to be adjusted
• allopurinol (used to treat gout) or procainamide (used to treat heart rhythm disorders)
• immunosuppressive medicines, used, for example, after organ transplantation
• non-steroidal anti-inflammatory medicines (NSAIDs), such as acetylsalicylic acid, ibuprofen, or ketoprofen, used regularly or for a long time - Note: While taking Enalapril Vitabalans tablets, it is safe to use small doses of acetylsalicylic acid (e.g., 50 mg or 100 mg per day) to prevent blood clots.
• sympathomimetic medicines
• concomitant treatment with gold preparations may cause flushing, nausea, vomiting, and low blood pressure

The doctor may need to adjust the dose and/or take other precautions:

If the patient is taking an angiotensin receptor antagonist (ARB) or aliskiren (see also the information under "When not to take Enalapril Vitabalans" and "Warnings and precautions").

Enalapril Vitabalans with food and drink

Meals and drinks do not affect the absorption of enalapril. The tablets can be taken on an empty stomach or with a meal with a sufficient amount of liquid, such as a glass of water.

Consuming large amounts of salt (sodium chloride) may reduce the effect of Enalapril Vitabalans.

Consuming foods high in potassium and salt substitutes while taking Enalapril Vitabalans is not recommended, as potassium levels in the blood may become too high.

Alcohol may enhance the effect of Enalapril Vitabalans on blood pressure.

Pregnancy and breastfeeding

Pregnancy

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. The doctor will usually recommend stopping Enalapril Vitabalans before planned pregnancy or as soon as pregnancy is confirmed and recommend taking a different medicine instead of Enalapril Vitabalans. It is not recommended to take Enalapril Vitabalans in early pregnancy and it must not be taken after the 3rd month of pregnancy, as it may seriously harm the baby (see "Pregnancy").

Breastfeeding

The patient should inform their doctor about breastfeeding or intending to breastfeed. It is not recommended to breastfeed newborns (the first few weeks after birth), especially premature babies, while taking Enalapril Vitabalans.

In the case of older infants, the doctor will inform about the benefits and risks of taking Enalapril Vitabalans during breastfeeding, compared to other treatment options.

Driving and using machines

While driving vehicles or operating machines, it should be taken into account that dizziness or fatigue may occur.

Enalapril Vitabalans may cause side effects related to low blood pressure, such as dizziness, fainting, or blurred vision (see section 4 "Possible side effects"). These usually occur at the beginning of treatment or after a dose increase; their occurrence is unlikely during long-term treatment. If such symptoms occur, the patient should avoid driving vehicles and performing other tasks that require concentration.

3. How to take Enalapril Vitabalans

This medicine should always be taken as directed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.

Enalapril Vitabalans can be taken with or without food, with a sufficient amount of liquid, such as a glass of water.

Adults:

Treatment of high blood pressure:

The initial dose is usually 5 mg to 20 mg once daily, and the maintenance dose is 20 mg once daily.

Treatment of heart failure:

The initial dose is 2.5 mg daily. The dose should be gradually increased until the maintenance dose is reached. This dose is usually 20 mg daily, given in one dose or in two divided doses.

Elderly patients and patients with renal impairment:

The dose should be adjusted according to the patient's renal function.

Use in children

The appropriate dose is determined based on the child's body weight.

If the patient thinks that the effect of Enalapril Vitabalans is too strong or too weak, they should inform their doctor.

Taking a higher dose of Enalapril Vitabalans than recommended

In case of overdose, the patient should immediately contact their doctor, emergency department, or the nearest hospital. The most common signs and symptoms of overdose are low blood pressure and drowsiness (a state of near-total loss of consciousness). Other symptoms include dizziness or lightheadedness caused by low blood pressure, rapid heartbeat, palpitations, anxiety, cough, kidney failure, and rapid breathing.

Missing a dose of Enalapril Vitabalans

The patient should not take a double (or increased) dose to make up for missed doses. They should take the next tablet at the usual time.

Stopping treatment with Enalapril Vitabalans

If treatment is stopped, blood pressure may increase. If blood pressure is too high, it can affect heart and kidney function. The patient should not stop taking the medicine unless their doctor tells them to.

If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Enalapril Vitabalans can cause side effects, although not everybody gets them.

Very common (occurring in more than 1 in 10 patients):

• visual disturbances
• dizziness, weakness
• dry cough (the patient should contact their doctor if a persistent cough develops while taking Enalapril Vitabalans)
• nausea

Common (occurring in 1 to 10 patients in 100):

• headache, depression, fatigue
• excessive lowering of blood pressure or lowering of blood pressure when standing up (which can cause dizziness or fainting)
• chest pain, heart rhythm disorders, rapid heartbeat (tachycardia)
• shortness of breath
• diarrhea, abdominal pain, taste disturbances
• rash and other allergic reactions (see below "Angioedema")
• increased potassium and creatinine levels in the blood

Uncommon (occurring in 1 to 10 patients in 1,000):

• anemia
• excessive lowering of blood sugar (hypoglycemia) in patients with diabetes
• fainting, nervousness, sensory disturbances such as tingling or numbness (paresthesia), dizziness, drowsiness, insomnia
• palpitations
• runny nose, sore throat, hoarseness, shortness of breath
• ringing in the ears
• dry mouth, vomiting, heartburn, stomach upset, constipation, weight loss
• stomach or duodenal ulcer, intestinal obstruction, pancreatitis (which can cause abdominal pain)
• excessive sweating, itching, hives, hair loss, flushing
• kidney problems, protein in the urine
• impotence
• muscle cramps, general feeling of being unwell, fever (see below "Fever of unknown origin")

Rare (occurring in 1 to 10 patients in 10,000):

• low white blood cell count (see below "Fever of unknown origin")
• low platelet count (which can cause nosebleeds and a tendency to bruise)
• enlarged lymph nodes, development of an autoimmune disease
• nightmares, sleep disturbances
• worsening of Raynaud's syndrome (pain in the fingers and toes, which initially turn white, then blue, and finally red)
• lung infiltrates, allergic alveolitis, eosinophilic pneumonia
• mouth ulcers, aphthous ulcers in the mouth, tongue inflammation
• liver problems, hepatitis, bile duct obstruction with jaundice (yellowing of the skin and whites of the eyes)
• severe blistering or peeling skin or mucous membrane disorders (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, lupus erythematosus)
• a syndrome involving fever, muscle or blood vessel inflammation, muscle and joint pain (see below "Fever of unknown origin")
• decreased urine output
• breast enlargement (in men)
• increased liver enzyme activity, increased bilirubin levels in the blood

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

• intestinal angioedema (angioedema of the intestines)

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

• syndrome of inappropriate antidiuretic hormone secretion

Angioedema

The patient should immediately contact their doctor if they experience any of the following symptoms while taking Enalapril Vitabalans:

swelling of the hands, feet, face, or swelling of the tongue or throat, which can cause difficulty swallowing or breathing

Fever of unknown origin

The patient should immediately contact their doctor if they experience a fever of unknown origin with accompanying symptoms such as a sore throat.

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, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Jerozolimskie Avenue 181C

02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Email: [[email protected]](mailto:[email protected])

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Enalapril Vitabalans

The medicine should be stored out of sight and reach of children.

Store in a temperature below 25°C.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Enalapril Vitabalans contains

The active substance is enalapril maleate. Each tablet contains 5 mg, 10 mg, or 20 mg of enalapril maleate.

Other ingredients: maize starch, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, povidone K-29/32, sodium hydrogen carbonate, magnesium stearate, talc.

Enalapril Vitabalans 10 mg tablets also contain a coloring agent (iron oxide red, E172).

Enalapril Vitabalans 20 mg tablets also contain a coloring agent (iron oxide red and iron oxide yellow, E172).

What Enalapril Vitabalans looks like and contents of the pack

What Enalapril Vitabalans looks like

Enalapril Vitabalans 5 mg: The tablets are white, round, flat, and have a notch on one side. The diameter is 8 mm.

Enalapril Vitabalans 10 mg: The tablets are reddish-brown, round, flat, and have a notch on one side. The diameter is 8 mm.

Enalapril Vitabalans 20 mg: The tablets are light orange, round, flat, and have a notch on one side. The diameter is 8 mm.

The tablet can be divided into equal doses.

Package sizes:

28, 30, 56, 60, 98, 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Vitabalans Oy

Varastokatu 8

13500 Hämeenlinna

FINLAND

Phone: +358 (3) 615600

Fax: +358 (3) 6183130

This medicinal product is authorized in the Member States of the European Economic Area under the following names

Enalapril Vitabalans (FI, SE, PL, CZ, SK, SI, DE, DK, EE, LV, LT, HU)

Date of last revision of the leaflet:28.03.2019