Enalapril vitabalans

Package leaflet: Information for the user

Enalapril Vitabalans, 5 mg, tablets
Enalapril Vitabalans, 10 mg, tablets
Enalapril Vitabalans, 20 mg, tablets
Enalapril maleate
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 someone else, even if their symptoms are the same as yours.
• 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 Enalapril Vitabalans is and what it is 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 pack and other information

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

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

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

2. Important information before taking Enalapril Vitabalans

When not to take Enalapril Vitabalans

• if you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced allergic reactions to an ACE inhibitor, known as angioedema, which involves swelling of the skin of the hands, feet, face, or swelling of the lips, tongue, or throat, causing difficulty in swallowing or breathing
• if you have previously experienced angioedema of unknown cause or if you have a family history of angioedema – susceptibility to such a reaction may be hereditary
• if you are taking or have recently taken sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, because this increases the risk of angioedema (rapid swelling of tissues beneath the skin, such as in the throat)
• after the 3rd month of pregnancy (you should also avoid using Enalapril Vitabalans early in pregnancy – see section “Pregnancy”)
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren

Warnings and precautions
Before starting Enalapril Vitabalans, discuss this with your doctor or pharmacist if:

• you have prolonged and severe diarrhoea and vomiting
• you are taking diuretics (medicines that increase urine production)
• you are on a low-salt diet
• you have other heart or blood vessel conditions, such as coronary artery disease (angina pectoris), cerebrovascular disorders, heart valve disorders, aortic stenosis, or a heart muscle disease called cardiomyopathy
• you have kidney problems requiring haemodialysis or have had a kidney transplant
• you have renal artery stenosis causing high blood pressure
• you have liver function disorders
• you have connective tissue diseases affecting blood vessels, such as Raynaud's disease or systemic sclerosis
• you previously experienced a persistent, dry cough while taking ACE inhibitors (see section 4 “Possible side effects”)
• you have undergone desensitisation treatment, for example to bee or ant venom
• you are undergoing LDL apheresis (a method of removing cholesterol from the blood using a special device)
• you have diabetes (see section 2 “Taking other medicines”)
• you have collagen vascular disease and are taking immunosuppressive medicines (used to treat autoimmune disorders such as rheumatoid arthritis or after organ transplant), allopurinol (used to treat gout) or procainamide (used to treat heart rhythm disorders). Your doctor may periodically take blood samples to check your white blood cell count. If you develop signs of infection (e.g. high temperature, fever), inform your doctor immediately
• you are taking potassium supplements or potassium-containing salt substitutes
• you are taking lithium, used to treat certain mental health conditions
• you are of Black race, as enalapril may be less effective in this group
• you are taking any of the following medicines used to treat high blood pressure:
  • an angiotensin II receptor antagonist (Angiotensin Receptor Blockers, ARBs), also known as sartans (e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes
  • aliskiren. Your doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading “When not to take Enalapril Vitabalans”.

The risk of angioedema may increase if you are taking any of the following medicines:

• racecadotril, a medicine used to treat diarrhoea
• medicines used to prevent organ transplant rejection or to treat cancer (e.g. temsirolimus, sirolimus, everolimus)
• vildagliptin, a medicine used to treat diabetes

During treatment with Enalapril Vitabalans, inform your doctor immediately if any of the following occur:

• dizziness after the first dose. Some people may experience dizziness, weakness, fainting, and/or vomiting after the first dose or after an increase in dose
• sudden swelling of the lips and face, tongue, larynx, trachea, neck, sometimes also of the hands and feet, or wheezing or hoarseness. This condition is called angioedema. It may occur at any time during treatment. ACE inhibitors more frequently cause angioedema in people of Black race than in other races
• high fever, sore throat, or mouth ulcers (these may be symptoms of infection due to reduced white blood cell count)
• yellowing of the skin or whites of the eyes (jaundice), which may be signs of liver disease

If any of the above situations apply to you, you should consult your doctor before starting treatment with Enalapril Vitabalans tablets.
If you are scheduled for surgery or an operation under general or spinal anaesthesia, inform the anaesthetist that you are taking Enalapril Vitabalans.
Inform your doctor if you suspect (or are planning) pregnancy. Use of Enalapril Vitabalans is not recommended early in pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy”).

Enalapril Vitabalans and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, inform your doctor if you are taking any of the following medicines:

• diuretics (water tablets)
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase blood potassium levels (e.g. trimethoprim and co-trimoxazole, used for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots)
• other medicines used to treat high blood pressure
• other medicines that may lower blood pressure, such as nitrates used for ischaemic heart disease, tricyclic antidepressants, medicines used to treat mental illnesses (phenothiazines), or barbiturates used for epilepsy, narcotic painkillers, and anaesthetics
• lithium (used to treat bipolar disorder)
• antidiabetic medicines (both insulin and oral antidiabetic medicines) – dosage adjustments may be needed
• allopurinol (used to treat gout) or procainamide (used for heart rhythm disorders)
• immunosuppressive medicines, for example after organ transplantation
• non-steroidal anti-inflammatory drugs (NSAIDs) with analgesic effect, such as acetylsalicylic acid, ibuprofen, or ketoprofen, taken regularly or chronically – Note: While taking Enalapril Vitabalans tablets, low-dose acetylsalicylic acid (e.g. 50 mg or 100 mg per day) may be safely used for prevention of blood clots.
• sympathomimetic medicines
• concurrent treatment with gold preparations may cause facial flushing, nausea, vomiting, and low blood pressure

Your doctor may need to adjust your dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also 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. Tablets may be taken on an empty stomach or with food, with sufficient liquid, for example a glass of water.
Consuming large amounts of salt (sodium chloride) may weaken the effect of Enalapril Vitabalans.
Eating foods high in potassium or using potassium-containing salt substitutes during treatment with Enalapril Vitabalans is not recommended, as blood potassium levels may rise excessively.
Alcohol may enhance the effect of Enalapril Vitabalans on blood pressure.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine. Your doctor will usually recommend stopping Enalapril Vitabalans before a planned pregnancy or immediately after pregnancy is confirmed, and will advise you to take an alternative medicine instead. Use of Enalapril Vitabalans is not recommended early in pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Breastfeeding is not recommended for newborns (the first few weeks after birth), especially premature infants, while taking Enalapril Vitabalans.
For older infants, your doctor will advise you on the benefits and risks of taking Enalapril Vitabalans during breastfeeding compared to other treatment options.

Driving and using machines
When driving or operating machinery, bear in mind that dizziness or fatigue may occasionally occur.
Enalapril Vitabalans may cause side effects related to low blood pressure in some patients, 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; they are unlikely to occur during long-term treatment. If such symptoms occur, avoid driving motor vehicles and performing other tasks requiring concentration.

3. How to use Enalapril Vitabalans

This medicine should always be taken as prescribed by your doctor. In case of doubt, consult your
doctor or pharmacist.
Enalapril Vitabalans may be taken during meals or between meals, with sufficient fluid, for example
with a glass of water.
Adults:
Treatment of high blood pressure:
The usual starting dose is 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 per day. The dose should be gradually increased until the maintenance dose
is reached. This dose is usually 20 mg per day, administered as a single dose or divided into two 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 feels that the effect of Enalapril Vitabalans is too strong or too weak, they should
inform their doctor.
Taking more Enalapril Vitabalans than prescribed
If an overdose is taken, contact your doctor, emergency department, or nearest hospital immediately.
The most common signs and symptoms of overdose include low blood pressure and dizziness (a state close to
complete loss of consciousness). Other symptoms may include vertigo or lightheadedness due to low blood
pressure, strong or rapid heartbeat, anxiety, cough, renal failure, and rapid breathing.
Missing a dose of Enalapril Vitabalans
Do not take a double (or increased) dose to make up for a missed dose. Take the next tablet at the
usual time.
Stopping Enalapril Vitabalans
If treatment is stopped, blood pressure may rise. High blood pressure may affect heart and kidney
function. Do not stop taking this medicine unless advised by 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 everybody gets them.

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

• visual disturbances
• dizziness, weakness
• dry cough (if a persistent cough develops during treatment with Enalapril Vitabalans, contact your doctor)
• nausea

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

• headache, depression, fatigue
• excessive lowering of blood pressure or drop in blood pressure upon standing (which may cause dizziness or fainting)
• chest pain, heart rhythm disturbances, rapid heartbeat (tachycardia)
• shortness of breath
• diarrhoea, abdominal pain, disturbances in taste perception
• rash and other hypersensitivity reactions (see below "Angioedema")
• increased serum potassium and creatinine levels

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

• anaemia
• excessive lowering of blood sugar (hypoglycaemia) in diabetic patients
• drowsiness, nervousness, sensory disturbances such as tingling or numbness (paraesthesiae), dizziness, somnolence, insomnia
• sensation of rapid or irregular heartbeat (palpitations)
• nasal inflammation, sore throat, hoarseness, respiratory tract obstruction
• ringing in the ears (tinnitus)
• dry mouth, vomiting, heartburn, gastric irritation, constipation, weight loss
• gastric or duodenal ulcer, intestinal obstruction, pancreatitis (may cause abdominal pain)
• excessive sweating, itching, urticaria, alopecia, redness
• impaired kidney function, presence of protein in urine
• impotence
• muscle cramps, general malaise, fever (see below "Fever of unknown origin")

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

• decrease in white blood cell count (see below "Fever of unknown origin")
• decrease in platelet count (may cause nosebleeds and tendency to bruise)
• swollen lymph nodes, development of autoimmune disease
• nightmares, sleep disturbances
• worsening of Raynaud's phenomenon (pain in fingers and toes, which initially turn white, then blue, and finally red)
• pulmonary infiltrates, allergic alveolitis, eosinophilic pneumonia
• stomatitis, aphthous ulcers in the mouth, glossitis
• impaired liver function, hepatitis, biliary obstruction with jaundice (yellowing of the skin and yellowing of the whites of the eyes)
• severe blistering or exfoliative skin or mucosal lesions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous eruption, erythema)
• syndrome including fever, myositis or vasculitis, muscle and joint pain (see below "Fever of unknown origin")
• reduced urine output
• breast gland enlargement (in males)
• increased liver enzyme activity, increased serum bilirubin levels

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

• intestinal wall angioedema (intestinal angioedema)

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

• syndrome of inappropriate antidiuretic hormone secretion

Angioedema
Seek immediate medical advice if, during treatment with Enalapril Vitabalans, you experience swelling of the hands, feet, face, or swelling of the tongue or throat, which may lead to difficulty in swallowing or breathing.

Fever of unknown origin
Seek immediate medical advice if, during treatment with Enalapril Vitabalans, you develop a fever of unknown origin accompanied by flu-like symptoms such as sore throat.

Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to:
Department for Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Enalapril Vitabalans

Keep the medicine out of the sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater 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 Enalapril Vitabalans contains
The active substance is enalapril maleate. Each tablet contains 5 mg, 10 mg or 20 mg of enalapril maleate.
Other ingredients: Gelatinised starch, corn 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 colouring agent (iron oxide red, E172).
Enalapril Vitabalans 20 mg tablets also contain colouring agents (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: Tablets are white, round, flat, with a score line on one side of the tablet. Diameter is 8 mm.
Enalapril Vitabalans 10 mg: Tablets are red-brown, round, flat, with a score line on one side of the tablet. Diameter is 8 mm.
Enalapril Vitabalans 20 mg: Tablets are light orange, round, flat, with a score line on one side of the tablet. Diameter is 8 mm.
The tablet can be divided into equal doses.

Pack sizes:
28, 30, 56, 60, 98, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
FINLAND
Tel: +358 (3) 615600
Fax: +358 (3) 6183130

This medicinal product is authorised in the European Economic Area countries under the following names:
Enalapril Vitabalans (FI, SE, PL, CZ, SK, SI, DE, DK, EE, LV, LT, HU)