Enarenal

Leaflet attached to the packaging: patient information

Enarenal, 5 mg, tablets

Enarenal, 10 mg, tablets

Enarenal, 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 Enarenal and what is it used for
• 2. Important information before taking Enarenal
• 3. How to take Enarenal
• 4. Possible side effects
• 5. How to store Enarenal
• 6. Package contents and other information

1. What is Enarenal and what is it used for

Enarenal is a medicine from the group of angiotensin-converting enzyme inhibitors (ACE inhibitors) used to treat high blood pressure, symptomatic heart failure, and to prevent symptomatic heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 35%).

2. Important information before taking Enarenal

When not to take Enarenal:

• if the patient is allergic to enalapril maleate, another ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has ever had angioedema after taking other ACE inhibitors;
• if the patient or a family member has ever had angioedema for any reason (hereditary or idiopathic angioedema);
• after the third month of pregnancy (Enarenal should be avoided in early pregnancy - see subsection on pregnancy);
• 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 this increases the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat).

Warnings and precautions

Before starting Enarenal, the patient should discuss the following with their doctor or pharmacist:

• taking any of the following medicines for 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
• experiencing dizziness, lightheadedness, or fainting, especially at the start of treatment or after a dose increase, or when changing body position from sitting or lying to standing
• having heart failure (insufficient pumping power of the heart), as excessive lowering of blood pressure may occur. The risk is higher in patients with severe heart failure taking high doses of loop diuretics, patients with low sodium levels in the blood, or impaired kidney function.
• having coronary heart disease caused by reduced blood flow or cerebrovascular disease. Treatment of this group of patients requires special caution, as a significant decrease in blood pressure may cause a heart attack or stroke.
• following a low-salt diet, having recently had severe vomiting or diarrhea, or taking diuretics
• having diseases such as aortic stenosis (narrowing of the aorta), hypertrophic cardiomyopathy, or left ventricular outflow tract obstruction
• having kidney disease, having had a kidney transplant, or undergoing dialysis (using high-flux dialysis membranes with enalapril may cause severe allergic reactions), or having high blood pressure due to kidney artery narrowing (renal artery stenosis)
• having liver function disorders
• having collagen diseases, taking immunosuppressive medicines (used to treat autoimmune diseases such as rheumatoid arthritis or post-transplant conditions), taking allopurinol (used to treat gout), or procainamide (used to treat heart rhythm disorders). In these patients, the doctor may order more frequent white blood cell counts. If these patients experience symptoms of infection (such as high fever, chills), they should inform their doctor immediately.
• having a history of angioedema (symptoms such as itching, hives, wheezing, or swelling of the hands, throat, mouth, or eyelids) when taking other medicines
• taking antidiabetic medicines or insulin; during the first month of enalapril treatment, blood glucose levels should be closely monitored
• taking potassium-sparing diuretics, potassium-containing medicines, or salt substitutes containing potassium, or medicines that increase potassium levels in the blood
• taking lithium-containing medicines (used to treat certain mental illnesses).

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

• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors (used to prevent rejection of transplanted organs and to treat cancer);
• vildagliptin (used to treat diabetes).

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
See also the subsection "When not to take Enarenal".

The patient must contact their doctor if they experience any of the following symptoms while taking Enarenal:

• jaundice (yellowing of the skin and whites of the eyes)
• persistent dry cough.

The patient should inform their doctor about taking Enarenal if they are planning any of the following procedures:

• LDL apheresis, which involves removing cholesterol from the blood
• desensitization, which reduces the effect of allergies to bee or wasp stings
• any surgery or administration of anesthetics.

In case of pregnancy (or suspected pregnancy), the patient should consult their doctor. Enarenal is not recommended in early pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to the fetus (see the subsection on pregnancy).
At the start of treatment, the doctor will closely monitor blood pressure to ensure the patient is receiving the correct dose. In addition, in some patients, the doctor may recommend blood tests to assess potassium and creatinine levels or liver enzyme activity.

Children and adolescents

In children and adolescents, enalapril is used only for high blood pressure. The dose is determined by the doctor based on the patient's condition and blood pressure.

Enarenal 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.
Certain medicines should not be taken at the same time.
In other cases, the doctor may recommend changing the dosage of medicines if they are taken with other medicines. This is especially important if the patient is taking:

• potassium-sparing diuretics, such as spironolactone, triamterene, or amiloride; potassium-containing medicines or salt substitutes containing potassium. Enalapril may increase potassium levels in the blood, leading to hyperkalemia. Mild hyperkalemia may cause few or no symptoms and is usually detected by blood tests or electrocardiogram.
• diuretics, such as furosemide, other antihypertensive medicines, glyceryl trinitrate (nitroglycerin), or other nitrates, as well as other vasodilators. Their concurrent use with enalapril may cause hypotension.
• sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults (see also the information under the heading "When not to take Enarenal"),
• 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, and heparin, a medicine used to thin the blood to prevent clots),
• lithium salts, used to treat certain mental illnesses. Enarenal should not be taken with lithium salts.
• tricyclic antidepressants, such as amitriptyline (used to treat depression),

medicines used to treat psychosis, such as phenazine derivatives (which calm significant agitation),
narcotics, such as morphine (used to treat moderate to severe pain), and anesthetics. Taking these medicines with Enarenal may enhance the blood pressure-lowering effect.

• nonsteroidal anti-inflammatory medicines (NSAIDs), such as diflunisal or diclofenac, used to relieve pain and inflammation. These medicines reduce the blood pressure-lowering effect of enalapril and increase potassium levels in the blood.
• gold salts (used to treat arthritis).
• sympathomimetics, such as ephedrine, noradrenaline, and adrenaline, used to treat low blood pressure, shock, circulatory failure, asthma, or allergies. Taking these medicines with enalapril may cause persistent high blood pressure.
• medicines used to treat diabetes (e.g., insulin, glibenclamide, or metformin). When taken with enalapril, they may cause excessive lowering of blood glucose levels.

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

• if the patient is taking an angiotensin receptor antagonist (ARB) or aliskiren (see also the subsections "When not to take Enarenal" and "Warnings and precautions").

Enarenal with food and alcohol

Enarenal can be taken with or without food.
Drinking alcohol while taking Enarenal may enhance the blood pressure-lowering effect and cause dizziness, lightheadedness, or fainting. Alcohol consumption should be kept to a minimum.

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
In case of pregnancy (or suspected pregnancy), the patient should consult their doctor. The doctor should recommend stopping Enarenal before becoming pregnant or until pregnancy is confirmed and may advise taking a different medicine instead of Enarenal.
Enarenal is not recommended in early pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to the fetus.
Breastfeeding
During breastfeeding or before starting breastfeeding, the patient should consult their doctor. Breastfeeding is not recommended for newborns (the first few weeks after birth), especially premature babies, while taking Enarenal.
In the case of older children, the doctor should inform the patient about the benefits and risks of taking Enarenal during breastfeeding compared to other medicines.

Driving and using machines

Individual responses to the medicine may vary. Some side effects of enalapril, such as dizziness or fatigue, may affect the ability to drive or operate machinery in some patients.

Enarenal contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially "sodium-free".

3. How to take Enarenal

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The dose of the medicine is determined by the doctor based on the patient's condition and the effect of the medicine on blood pressure. The patient should not change the dose of the medicine or stop taking it without consulting their doctor.
Usually, the following dosing is recommended:
Adults
Hypertension
The initial dose is 5 mg to a maximum of 20 mg, depending on the degree of hypertension and the patient's condition. The medicine is taken once a day. In mild hypertension, the recommended dose is 5-10 mg. In patients with increased activity of the renin-angiotensin-aldosterone system (e.g., with renal artery stenosis, excessive loss of salt and/or water, cardiac decompensation, or severe hypertension), a marked decrease in blood pressure may occur after the initial dose. In these patients, an initial dose of 5 mg or less is recommended, and treatment should be started under medical supervision.

Overdose of Enarenal

If the patient has taken more than the recommended dose of the medicine, they should immediately contact their doctor, who will provide appropriate treatment.
The most common symptoms of overdose are low blood pressure and fainting (a state of near-total loss of consciousness). Other symptoms may include dizziness or lightheadedness due to low blood pressure, rapid or forceful heartbeat, palpitations, anxiety, cough, kidney failure, and rapid breathing.

Missed dose of Enarenal

If the patient misses a dose, they should take it as soon as possible. If it is already time for the next dose, they should not take the missed dose. The patient should not take a double dose to make up for the missed dose.

Stopping Enarenal

The patient should not stop taking the medicine without consulting their doctor first.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking Enarenal and consult their doctor immediately if they experience any of the following symptoms:

• low blood pressure (too low blood pressure), dizziness, lightheadedness, or fainting, especially at the start of treatment or after a dose increase, or when changing body position from sitting or lying to standing
• itching, shortness of breath, or wheezing
• throat inflammation or pain, fever, swollen lymph nodes
• symptoms of angioedema (swelling of the hands, tongue, lips, throat, face, or eyes)
• severe skin reactions, such as sudden onset of rash, burning of the skin, or peeling of the skin
• jaundice (yellowing of the skin and whites of the eyes)

The following is a list of side effects that have occurred in patients taking enalapril, classified by frequency:

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

• dizziness, blurred vision, weakness
• cough
• nausea

Common(occurring in less than 1 in 10 patients)

• headache, depression, fainting, low blood pressure, feeling of tiredness
• shortness of breath, chest pain, irregular heartbeat, angina pectoris, rapid heartbeat
• diarrhea, abdominal pain, taste disturbances
• rash, allergic reactions, angioedema
• high potassium levels in the blood
• increased creatinine levels in the blood

Uncommon(occurring in less than 1 in 100 patients)

• disorientation, drowsiness, nervousness, insomnia
• paresthesia (tingling, numbness, or burning sensation)
• palpitations, myocardial infarction, or stroke
• anemia
• sore throat and hoarseness, nasal discharge, difficulty breathing, or asthma
• abdominal distension or pain (which may be caused by intestinal obstruction), severe abdominal pain (which may be caused by pancreatitis), vomiting, indigestion, constipation, loss of appetite, stomach upset, dry mouth, gastric ulcer (a piercing pain and feeling of hunger, especially when the stomach is empty)
• excessive sweating, itching, hives, hair loss
• kidney problems, kidney failure, presence of protein in the urine
• impotence (sexual dysfunction)
• muscle cramps, flushing, tinnitus, malaise, fever
• low sodium levels in the blood
• high urea levels in the blood
• low blood glucose levels

Rare(occurring in less than 1 in 1,000 patients)

• dreams, sleep disturbances
• poor circulation in the fingers and toes, causing redness and pain (Raynaud's phenomenon)
• fluid accumulation in the lungs, runny nose or nasal pain, eosinophilic pneumonia (a lung disease caused by an allergic reaction)
• blood disorders (with symptoms such as fatigue, weakness, shortness of breath, feeling of exhaustion, persistent or recurrent colds, prolonged bleeding, unexplained bruising), swollen lymph nodes, autoimmune diseases (diseases in which the immune system treats the body's own cells as foreign and produces antibodies against them)
• mouth ulcers, inflammation, or pain and swelling of the tongue
• liver failure, hepatitis, bile duct obstruction (including jaundice)
• severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, erythroderma), with symptoms such as skin redness, blisters, inflammation, and peeling
• breast enlargement in men
• oliguria (reduced urine production)

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

• syndrome of inappropriate antidiuretic hormone secretion, with symptoms such as headache, weakness, nausea, vomiting, disorientation, and seizures

During enalapril treatment, the following symptoms have also been reported: fever, vasculitis, muscle and joint pain, blood disorders, rash, hypersensitivity to sunlight, or other skin symptoms.
Enarenal may cause:

• increased creatinine and urea levels in the blood (indicating kidney function)
• increased liver enzyme activity and bilirubin levels in the blood (indicating liver function)
• decreased platelet count, which may affect blood clotting. If the patient experiences bruising or red or purple spots on the skin for no apparent reason, they should inform their doctor.
• decreased red and white blood cell count
• decreased blood glucose levels in patients with diabetes. At the start of treatment, blood glucose levels should be closely monitored.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this 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 gather more information on the safety of the medicine.

5. How to store Enarenal

The medicine should be stored out of sight and reach of children.
Store in a temperature not exceeding 25°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.
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. Package contents and other information

What Enarenal contains

• The active substance of the medicine is enalapril maleate. Each tablet contains 5 mg, 10 mg, or 20 mg of enalapril maleate.
• The other ingredients are lactose monohydrate, modified cornstarch, sodium carboxymethylcellulose, sodium bicarbonate, and magnesium stearate.

What Enarenal looks like and contents of the pack

Enarenal 5 mg is a white, oval, biconvex tablet with a score line. The tablets can be divided into two halves.
Enarenal 10 mg and 20 mg are white, round, flat tablets.
One pack contains 30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the leaflet: