Benalapril 10

Leaflet accompanying the packaging: patient information

Benalapril 10, 10 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 those 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 10 and what is it used for
• 2. Important information before taking Benalapril 10
• 3. How to take Benalapril 10
• 4. Possible side effects
• 5. How to store Benalapril 10
• 6. Package contents and other information

1. What is Benalapril 10 and what is it used for

Benalapril 10 contains the active substance enalapril maleate. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Benalapril 10 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 10

When not to take Benalapril 10

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, making it difficult to swallow or breathe (angioedema) of unknown or hereditary origin;
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 10 in early pregnancy – see section Pregnancy);
if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat a certain type of chronic (long-term) heart failure in adults, as this increases the risk of angioedema (rapid swelling of tissues under the skin, such as the throat).
Do not take this medicine if any of the above conditions apply to the patient. If in doubt, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting to take Benalapril 10, discuss it with your 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 absent white blood cell count (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or reduced red blood cell count (anemia)
• in case of liver disease
• in case of kidney disease (including after kidney transplantation). These may lead to a significant increase in potassium levels in the blood. The doctor may adjust the dose of Benalapril 10 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 increased. Taking Benalapril 10 with glucose-lowering medicines containing metformin may increase the risk of lactic acidosis (probably 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 the risk of this type of reaction to ACE inhibitors is increased in black patients.
• 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 the 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 a 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 10".
Inform your doctor about pregnancy, suspected pregnancy, or planning pregnancy. It is not recommended to take this medicine in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see section Pregnancy).
Be aware that this medicine lowers blood pressure less effectively in black patients than in patients of other races.
If in doubt whether any of the above conditions apply to the patient, consult a doctor or pharmacist before taking this medicine.

In case of planned procedures

In case of a planned procedure, inform your doctor about taking Benalapril 10:

• any surgical procedure or administration of general anesthesia (also during dental procedures),
• treatment to remove cholesterol from the blood, called LDL apheresis,
• desensitization aimed at reducing the allergic reaction 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 10 is recommended for use in children only for the treatment of high blood pressure.
Do not give Benalapril 10 to newborns, children, and adolescents with kidney disease.

Benalapril 10 with 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. Benalapril 10 may affect the action of other medicines, and other medicines may affect the action of Benalapril 10.

• 10.

Your doctor may need to change the dose and/or take other precautions.
In particular, inform your doctor or pharmacistif you are taking:

• sacubitril with valsartan, a medicine used to treat a certain type of chronic (long-term) heart failure in adults, which should not be taken with Benalapril 10 (see section "When not to take Benalapril 10")
• racecadotril, a medicine used to treat diarrhea
• medicines used to prevent the 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 organ rejection, 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, see also subsections "When not to take Benalapril 10" 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
• nonsteroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and are used to relieve pain)
• aspirin (acetylsalicylic acid)
• alcohol

If in doubt whether any of the above conditions apply to you, discuss it with your doctor or pharmacist before taking Benalapril 10.

Benalapril 10 with food, drink, and alcohol

Benalapril 10 can be taken with or without food. Most people take Benalapril 10 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Inform your doctor about suspected or planned pregnancy. Your doctor will usually recommend stopping Benalapril 10 before planned pregnancy or as soon as possible after confirming pregnancy and will recommend taking another medicine instead of Benalapril 10. It is not recommended to take this medicine in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus.
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 10 during breastfeeding, compared to other treatment options.

Driving and using machines

While taking this medicine, dizziness or drowsiness may occur. In this case, do not drive, use tools, or operate machinery.

Benalapril 10 contains lactose

Benalapril 10 contains lactose, a type of sugar. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Benalapril 10 contains sodium

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

3. How to take Benalapril 10

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your 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 10 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 Benalapril 10 tablet

Hypertension

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

Heart failure

• The usual initial dose is 2.5 mg of enalapril maleate once daily.
• 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 10 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 changed 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 10 than recommended

If a higher dose of Benalapril 10 than recommended is taken, contact a doctor or go to the nearest hospital immediately. 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 10

• 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 10

Do not stop taking this medicine without consulting your doctor first.
If you have any further doubts about taking this medicine, consult your 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 10 and consult your doctor immediately if you notice any of the following symptoms:

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

Be aware that black patients are more likely to experience these types of reactions. If you experience any of the above symptoms, stop taking Benalapril 10 and consult your doctor immediately.
At the beginning of treatment, fainting or dizziness may occur. In this case, lying down may help. These symptoms are caused by low blood pressure and should disappear as treatment continues. If in doubt, consult your 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 disturbances, 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
• asthma/bronchospasm
• slow movement of the intestines (including intestinal obstruction), pancreatitis
• vomiting, nausea, constipation, loss of appetite (anorexia), stomach upset, dry mouth
• 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 disturbances
• 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
• reduced urine output
• rash resembling target 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

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

• syndrome of inappropriate antidiuretic hormone secretion (SIADH), which leads 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, inflammation of the serous membrane, 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 difficulty breathing. Other symptoms include decreased body temperature and slowed heart rate (see also section 2. "Important information before taking Benalapril 10").

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 to gather more information on the safety of this medicine.

5. How to store Benalapril 10

Keep this 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 10 contains

Active substance: each tablet contains 10 mg of enalapril maleate.
Other ingredients are: gelatin, lactose monohydrate, magnesium stearate, magnesium carbonate, colloidal anhydrous silica, sodium carboxymethylcellulose (type A), iron oxide (II, III) (brown, E 172).

What Benalapril 10 looks like and contents of the pack

Light brown tablets, slightly convex on both sides, with beveled edges and a dividing line on one side.
Pack sizes: 30, 50, or 100 tablets.
Not all pack sizes may be marketed.

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
To obtain more detailed information on this medicine, contact the representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: +48 22 566 21 00
Fax: +48 22 566 21 01

Date of last revision of the leaflet: