Benalapril 5

Leaflet attached to the packaging: patient information

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

1. What is Benalapril 5 and what is it used for

Benalapril 5 contains the active substance enalapril maleate. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Benalapril 5 is used

• to treat high blood pressure (hypertension);
• to treat heart failure (reduced heart function). The medicine may reduce the need for hospitalization and may prolong life for some patients;
• to prevent symptoms of heart failure. These symptoms include: shortness of breath, feeling tired after minimal physical activity, such as walking or swelling of the ankles and feet.

This medicine works by widening the patient's blood vessels. This leads to a decrease in blood pressure. The effect of the medicine usually starts within an hour of taking it and lasts for at least 24 hours. In some patients, the desired blood pressure control is achieved after several weeks of treatment.

2. Important information before taking Benalapril 5

When not to take Benalapril 5

if the patient is allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6);
if the patient has ever had an allergic reaction to medicines similar to this one, called ACE inhibitors;
if the patient has ever had swelling of the face, lips, mouth, tongue, or throat, which made swallowing or breathing difficult (angioedema) for unknown reasons or due to genetic conditions;
if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
after the third month of pregnancy (it is also recommended to avoid taking Benalapril 5 in early pregnancy - see section 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).
Do not take this medicine if any of the above conditions apply to the patient. In case of doubts, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting to take Benalapril 5, discuss it with a doctor or pharmacist.

Inform your doctor

• in case of heart disease
• in case of vascular disorders in the brain
• in case of blood disorders, such as a low or lack of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or reduced red blood cell count (anemia)
• in case of liver disease
• in case of kidney disease (including post-kidney transplant). These may lead to a significant increase in potassium levels in the blood. The doctor may adjust the dose of Benalapril 5 or monitor potassium levels in the blood.
• in case of dialysis therapy
• in case of recent severe vomiting or diarrhea
• in case of a low-salt diet, taking potassium supplements, potassium-sparing diuretics, or salt substitutes containing potassium
• in case of patients over 70 years old
• in case of diabetes. Blood glucose levels should be monitored, as they may be low, especially during the first month of treatment. Potassium levels in the blood may be elevated. Taking Benalapril 5 with glucose-lowering medicines containing metformin may increase the risk of lactic acidosis (possibly due to kidney function disorders). Therefore, metformin should be used with caution in patients at risk, and kidney function should be closely monitored.
• in case of persistent dry cough
• in case of a history of allergic reactions with swelling of the face, lips, tongue, or throat, which made swallowing or breathing difficult. Be aware that in patients of black race, the risk of this type of reaction to ACE inhibitors is increased.
• in case of low blood pressure (which may cause dizziness or fainting, especially when standing up)
• in case of collagen diseases (e.g., lupus erythematosus, rheumatoid arthritis, scleroderma), during immunosuppressive treatment, during treatment with allopurinol (a medicine used to treat gout) or procainamide (a medicine used to treat heart rhythm disorders) or lithium (a medicine used to treat certain types of depression), or if several of the above risk factors occur at the same time
• 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 rejection of a transplanted organ and to treat cancer (e.g., temsirolimus, sirolimus, everolimus, and other mTOR inhibitors). See section Warnings and precautions
• Wildagliptin, a medicine used to treat diabetes
• Alteplase (a medicine used to dissolve blood clots)
• if the patient is taking any of the following medicines used to treat high blood pressure:
• Angiotensin II receptor antagonist (AIIRA), also known as sartan - e.g., 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 electrolyte levels (e.g., potassium) in the blood.
See also subsection "When not to take Benalapril 5".
Inform your doctor about pregnancy, suspected pregnancy, or planning pregnancy. It is not recommended to take this medicine during early pregnancy, and it should not be taken after 3 months of pregnancy, as it may seriously harm the baby (see section Pregnancy).
Be aware that this medicine lowers blood pressure less effectively in patients of black race than in patients of other races.
In case of doubts about any of the above conditions, consult a doctor or pharmacist before taking this medicine.

In case of scheduled procedures

In case of scheduled procedures, inform your doctor about taking Benalapril 5:

• any surgical procedure or administration of general anesthetics (also during dental procedures),
• treatment to remove cholesterol from the blood, called LDL apheresis,
• desensitization to reduce allergic reactions to bee or wasp stings. If any of the above conditions apply to the patient, inform the doctor or dentist before the procedure.

Children and adolescents

There is limited experience with the use of enalapril maleate in children with high blood pressure. There is no experience with the use of enalapril in children for other indications.
Data on the efficacy and tolerance of enalapril are available only for the treatment of children over 6 years old with high blood pressure.
Therefore, Benalapril 5 is recommended for use in children only for the treatment of high blood pressure.
Do not give Benalapril 5 to newborns, children, and adolescents with kidney disease.

Benalapril 5 and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Benalapril 5 may affect the action of other medicines, and other medicines may affect the action of Benalapril 5.
The attending doctor may need to change the dose and/or take other precautions.
In particular, inform your doctor or pharmacistif you are taking:

• sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, which should not be taken with Benalapril 5 (see section "When not to take Benalapril 5")
• racecadotril, a medicine used to treat diarrhea
• medicines used to prevent rejection of a transplanted organ and to treat cancer (e.g., temsirolimus, sirolimus, everolimus, and other mTOR inhibitors). See section Warnings and precautions
• potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamterene, or amiloride), 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 rejection of a transplanted organ, and heparin, a medicine used to thin the blood to prevent clots)
• wildagliptin, a medicine used to treat diabetes
• medicines used to dissolve blood clots (thrombolytic medicines). See section Warnings and precautions
• other blood pressure-lowering medicines, such as beta-blockers or other diuretics. If you are taking angiotensin II receptor antagonists (AIIRA) or aliskiren, also see subsections "When not to take Benalapril 5" and "Warnings and precautions".
• nitroglycerin and other nitrates (medicines used to treat chest pain or angina pectoris)
• antidiabetic medicines, including oral antidiabetic medicines, such as metformin (see section Warnings and precautions), and insulin
• lithium (a medicine used to treat a certain type of depression)
• tricyclic antidepressants
• medicines used to treat mental disorders, called antipsychotics
• certain medicines used to treat cough and cold, and weight loss medicines containing sympathomimetics
• certain painkillers and medicines used to treat arthritis, including gold salts
• non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and are used to relieve pain)
• aspirin (acetylsalicylic acid)
• alcohol

In case of doubts about any of the above conditions, discuss it with a doctor or pharmacist before taking Benalapril 5.

Benalapril 5 with food, drink, and alcohol

Benalapril 5 can be taken with or without food. Most people take Benalapril 5 with a glass of water.
Alcohol enhances the blood pressure-lowering effect of ACE inhibitors.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor about suspected or planned pregnancy. The doctor will usually recommend stopping Benalapril 5 before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Benalapril 5. It is not recommended to take this medicine during early pregnancy, and it should not be taken after 3 months of pregnancy, as it may seriously harm the baby (see section Pregnancy).
Breastfeeding
Inform your 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 this medicine. For older infants, the doctor will inform you about the benefits and risks of taking Benalapril 5 during breastfeeding compared to other treatment options.

Driving and using machines

While taking this medicine, dizziness or drowsiness may occur. In such cases, do not drive vehicles, use tools, or operate machines.

Benalapril 5 contains lactose

Benalapril 5 contains lactose, a type of sugar. If you have been diagnosed with intolerance to some sugars, consult a doctor before taking this medicine.

Benalapril 5 contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Benalapril 5

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult a doctor or pharmacist.

• It is very important to continue taking this medicine for as long as your doctor recommends.
• Do not take more tablets than prescribed.

Swallow the tablet whole (do not chew or crush), with a sufficient amount of liquid (e.g., a glass of water). Benalapril 5 can be taken with or without food. The daily dose is usually taken in the morning or, if necessary, can be divided into two doses taken in the morning and evening.

Dividing the tablet

• The tablet can be divided into two equal doses. Place the tablet on a flat, hard surface, with the dividing line facing up. Then, break the tablet along the dividing line, as shown in the pictures (1 and 2), by pressing the surface of the tablet with two index fingers.

Fig. 1 and 2: Dividing the tablet of Benalapril 5

Hypertension

• The usual initial dose is 5 mg to 20 mg of enalapril maleate once a day.
• Some patients may need a lower initial dose.
• The usual maintenance dose is 20 mg of enalapril maleate once a day.
• The maximum maintenance dose is 40 mg of enalapril maleate once a day.

Heart failure

• The usual initial dose is 2.5 mg of enalapril maleate once a day.
• The doctor will gradually increase the dose to achieve the optimal dose for the patient.
• The usual maintenance dose is 20 mg of enalapril maleate per day, given in one or two divided doses.
• The maximum maintenance dose is 40 mg of enalapril maleate per day, given in two divided doses.

Patients with kidney problems

The dose of the medicine will be adjusted according to the patient's kidney function:

• mild kidney problems - 5 mg to 10 mg of enalapril maleate per day
• severe kidney problems - 2.5 mg of enalapril maleate per day
• in case of dialysis therapy - 2.5 mg of enalapril maleate per day on dialysis days. The dose on non-dialysis days should be adjusted according to blood pressure values.

Patients over 65 years old

The doctor will determine the appropriate dose based on kidney function.

Use in children and adolescents

There is limited experience with the use of Benalapril 5 in children with high blood pressure. If the child can swallow the tablet, the doctor will adjust the dose based on the child's body weight and blood pressure.
The usual initial dose is:

• body weight from 20 kg to 50 kg - 2.5 mg of enalapril maleate per day.
• body weight over 50 kg - 5 mg of enalapril maleate per day.

The dose can be adjusted according to the child's needs:

• the maximum dose for children with a body weight from 20 kg to 50 kg is 20 mg of enalapril maleate per day.
• the maximum dose for children with a body weight over 50 kg is 40 mg of enalapril maleate per day.

Do not give this medicine to newborns (in the first few weeks after birth) and children with kidney problems.

Taking a higher dose of Benalapril 5 than recommended

In case of taking a higher dose of Benalapril 5 than recommended, immediately contact a doctor or go to the nearest hospital. Take the medicine packaging with you.
The following symptoms may occur: dizziness or fainting due to sudden or excessive lowering of blood pressure.

Missing a dose of Benalapril 5

• If you miss a dose, skip it.
• Take the next dose as scheduled.
• Do not take a double dose to make up for the missed dose.

Stopping treatment with Benalapril 5

Do not stop treatment with this medicine without consulting your doctor first.
In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur after taking this medicine:

Stop taking Benalapril 5 and consult a doctor immediately if you notice any of the following symptoms:

• swelling of the face, lips, tongue, or throat, which makes swallowing or breathing difficult
• swelling of the hands, feet, or ankles
• raised, red skin rash (hives).

Be aware that patients of black race are more prone to these types of reactions. If you experience any of the above symptoms, stop taking Benalapril 5 and consult a doctor immediately.
At the beginning of treatment, fainting or dizziness may occur. In such cases, lying down can help. These symptoms are caused by a decrease in blood pressure and should subside as treatment continues. In case of doubts, consult a doctor.
Other side effects include:

Very common(may affect more than 1 in 10 people)

• dizziness, weakness, or nausea
• blurred vision
• cough

Common(may affect up to 1 in 10 people)

• low blood pressure, irregular heartbeat, rapid heartbeat, angina pectoris, or chest pain
• headache, fainting
• taste disorders, shortness of breath
• diarrhea or abdominal pain, rash
• fatigue (tiredness), depression
• allergic reactions with swelling of the limbs, face, lips, tongue, or throat with difficulty swallowing or breathing
• increased potassium levels in the blood, increased creatinine levels in the blood (detected in a blood test)

Uncommon(may affect up to 1 in 100 people)

• sudden drop in blood pressure when changing position from lying down to standing up (orthostatic hypotension)
• rapid or irregular heartbeat (palpitations)
• heart attack (possibly due to excessive lowering of blood pressure in patients at high risk, including those with impaired blood flow to the heart or brain)
• anemia (including aplastic or hemolytic anemia)
• stroke (possibly due to excessive lowering of blood pressure in patients at high risk)
• confusion, insomnia, or excessive sleepiness, nervousness
• tingling or numbness of the skin
• vertigo
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthmatic bronchial spasm/bronchospasm
• slow movement of the intestines (including intestinal obstruction), pancreatitis
• vomiting, nausea, constipation, loss of appetite (anorexia), stomach upset, dry mouth, stomach ulcers (peptic ulcers)
• excessive sweating
• kidney problems, kidney failure
• itching or hives
• hair loss
• muscle cramps, flushing (especially of the face), general feeling of being unwell, high temperature (fever), impotence
• increased protein levels in the urine (detected in a test)
• decreased glucose and sodium levels in the blood, increased urea levels in the blood (detected in a blood test)

Rare(may affect up to 1 in 1,000 people)

• Raynaud's phenomenon, in which the hands and feet become very cold and pale due to reduced blood flow
• blood count changes, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin levels, decreased hematocrit values, decreased platelet count
• bone marrow suppression, lymph node swelling
• autoimmune diseases
• strange dreams or sleep disorders
• abnormalities in lung tissue (pulmonary infiltrates)
• nasal passage inflammation
• pneumonia causing breathing difficulties (allergic alveolitis/eosinophilic pneumonia)
• inflammation of the cheeks, gums, tongue, lips, or throat
• decreased urine output
• rash resembling target-like lesions (erythema multiforme)
• Stevens-Johnson syndrome and toxic epidermal necrolysis, severe skin disease with redness and peeling of the skin, blistering, or painful ulcers, or separation of the outer layer of the skin from the deeper layers, exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin)
• liver problems, such as impaired liver function, liver failure, hepatitis, jaundice (yellowing of the skin or eyes), elevated liver enzyme levels or bilirubin levels (detected in a blood test)
• breast enlargement in men Very rare(may affect up to 1 in 10,000 people)
• intestinal angioedema (angioedema of the intestines)

Frequency not known(cannot be estimated from available data)

• syndrome of inappropriate antidiuretic hormone secretion (SIADH), which can lead to low sodium levels in the blood (symptoms such as fatigue, headache, nausea, vomiting).
• a syndrome of symptoms that may include several or all of the following side effects: fever, serositis, vasculitis, muscle and joint pain/arthritis, and changes in the results of some laboratory tests (positive antinuclear antibody titer - ANA, accelerated ESR, eosinophilia, and leukocytosis). Skin rash, photosensitivity, or other skin reactions may also occur.
• excessive acidification of the blood with lactic acid (lactic acidosis) when taken with metformin. Symptoms of lactic acidosis include vomiting, abdominal pain with muscle cramps, general feeling of being unwell, accompanied by severe fatigue and breathing difficulties. Other symptoms include decreased body temperature and slowed heart rate (see also section 2. "Important information before taking Benalapril 5").

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse.
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
Glienicker Weg 125
12489 Berlin, Germany
Tel.: + 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 to gather more information on the safety of this medicine.

5. How to store Benalapril 5

Keep the medicine out of the sight and reach of children.
Do not take this medicine after the expiry date stated on the blister packs and carton after "EXP". The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Benalapril 5 contains

Active substance: each tablet contains 5 mg of enalapril maleate.
Other ingredients are: gelatin, lactose monohydrate, magnesium stearate, magnesium carbonate, colloidal silica anhydrous, sodium carboxymethylcellulose (type A).

What Benalapril 5 looks like and contents of the pack

Almost white tablets, slightly convex on both sides, with beveled edges and a dividing line on one side.
Packaging of 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
BERLIN-CHEMIE AG
Glienicker Weg 125
12489 Berlin, Germany
Manufacturer
BERLIN-CHEMIE AG
Glienicker Weg 125
12489 Berlin, Germany
Menarini - Von Heyden GmbH
Leipziger Strasse 7-13
01097 Dresden
Germany
For more information about this medicine, contact the representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: + 48 22566 21 00
Fax: + 48 22 566 21 01

Date of last revision of the leaflet: