Benalapril 20

Patient Information Leaflet

Benalapril 20, 20 mg, tablets
Enalapril maleate
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, 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.

Leaflet Contents

1. What Benalapril 20 is and what it is used for
2. What you need to know before taking Benalapril 20
3. How to take Benalapril 20
4. Possible side effects
5. How to store Benalapril 20
6. Contents of the pack and other information

1. What Benalapril 20 is and what it is used for

Benalapril 20 contains the active substance enalapril maleate. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Benalapril 20 is used:

• to treat high blood pressure (hypertension);
• to treat heart failure (weakened heart function). The medicine may reduce the need for hospitalisation and may prolong life in some patients;
• to prevent symptoms of heart failure. These symptoms include: breathlessness, feeling tired after only mild physical activity such as walking, or swelling around the ankles and feet.

This medicine works by widening the patient's blood vessels, thereby lowering blood pressure. The effect usually begins within one hour of taking the medicine 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 using Benalapril 20

When not to use Benalapril 20
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,
known as ACE inhibitors;
if the patient has ever experienced swelling of the face, lips, mouth, tongue or throat,
making swallowing or breathing difficult (angioedema) of unknown cause 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 best to avoid using Benalapril 20 in early
pregnancy – see section Pregnancy);
if the patient has taken or is currently taking sacubitril with valsartan, a medicine used in
the treatment of certain types of chronic (long-term) heart failure in adults,
because the risk of angioedema (rapid swelling of tissues beneath the skin,
such as in the throat) increases.
Do not take this medicine if any of the above conditions apply to the patient.
If in doubt, discuss this with a doctor or pharmacist before using this medicine.

Warnings and precautions
Before starting to take Benalapril 20, discuss this with your doctor or pharmacist.
Tell your doctor

• if you have heart disease
• if you have blood vessel disorders in the brain
• if you have blood disorders such as low or absent white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or reduced red blood cells (anaemia)
• if you have liver disease
• if you have kidney disease (including after kidney transplant). These may lead to a significant increase in serum potassium levels. Your doctor may adjust the dose of Benalapril 20 or monitor serum potassium levels.
• if you are undergoing dialysis
• if you have recently had severe vomiting or diarrhoea
• if you are on a low-salt diet, taking potassium supplements, potassium-sparing medicines, or potassium-containing salt substitutes
• if you are over 70 years of age
• if you have diabetes. Blood glucose levels should be monitored, which may be low, especially during the first month of treatment. Serum potassium levels may be increased. Concomitant use of Benalapril 20 with glucose-lowering medicines containing metformin may increase the risk of lactic acidosis (likely due to impaired kidney function). Therefore, metformin should be used cautiously in patients at risk, and kidney function must be closely monitored.
• if you develop a persistent, dry cough
• if you have ever had an allergic reaction with swelling of the face, lips, tongue or throat that made swallowing or breathing difficult. Be aware that black patients have an increased risk of such reactions to ACE inhibitors.
• if you have low blood pressure (which may cause fainting or dizziness, especially when standing)
• if you have collagenosis (e.g. systemic lupus erythematosus, rheumatoid arthritis, scleroderma), during immunosuppressive treatment, when taking medicines containing allopurinol (used in gout), propranolol (used in heart rhythm disorders), or lithium (used in certain types of depression), or if several of these risk factors occur simultaneously
• if you are taking any of the following medicines, the risk of angioedema may increase:
• Racecadotril, a medicine used to treat diarrhoea
• Medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus)
• Vildagliptin, a medicine used to treat diabetes
• Alteplase (a medicine used to dissolve blood clots)
• if you are taking any of the following medicines used to treat high blood pressure:
• An angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes.
• Aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood
electrolyte levels (e.g. potassium).
See also the section "When not to use Benalapril 20".
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Use of
this medicine is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section Pregnancy).
Be aware that this medicine is less effective in lowering blood pressure in black patients compared to patients of other races.
If in doubt whether any of the above conditions apply to you, consult your doctor or pharmacist before starting treatment with Benalapril 20.

In case of planned procedures
If any of the following procedures are planned, inform your doctor that you are taking Benalapril 20:

• any surgical procedure or administration of general anaesthesia (including during dental procedures),
• treatment involving removal of cholesterol from the blood, known as LDL apheresis,
• desensitisation to reduce allergic reactions to bee or wasp stings. If any of the above conditions apply, inform your doctor or dentist before the procedure.

Children and adolescents
There is limited data on the use of enalapril maleate in children with high blood pressure. There is no data on the use of enalapril in children for other indications. Data on the efficacy and tolerability of enalapril are available only for the treatment of children over 6 years of age with hypertension. Therefore, Benalapril 20 is recommended for use in children only for the treatment of hypertension.
Do not administer Benalapril 20 to newborns, children, or adolescents with kidney disease.

Benalapril 20 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Benalapril 20 may affect the action of other medicines, and other medicines may affect the action of Benalapril 20.
Your doctor may need to adjust the dose and/or take other precautions.

In particular, inform your doctor or pharmacist if you are taking:

• sacubitril with valsartan, a medicine used in the treatment of certain types of chronic (long-term) heart failure in adults, which must not be used together with Benalapril 20 (see section "When not to use Benalapril 20")
• racecadotril, a medicine used to treat diarrhoea
• medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus and other drugs belonging to the class of 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 blood potassium levels (e.g. trimethoprim and co-trimoxazole, used in bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots)
• vildagliptin, a medicine used to treat diabetes
• medicines used to dissolve blood clots (thrombolytics). See section "Warnings and precautions"
• other medicines that lower blood pressure, such as beta-blockers or other medicines that increase urine output (diuretics)
• nitrates such as nitroglycerin (medicines used to treat chest pain or tightness known as angina)
• 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)
• antidepressants known as tricyclic antidepressants
• medicines used for mental disorders, known as antipsychotics
• some cough and cold medicines and weight-reducing medicines containing sympathomimetic substances
• certain painkillers and medicines used for joint inflammation, including gold salts
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and relieve pain)
• aspirin (acetylsalicylic acid)
• alcohol

If in doubt whether any of the above conditions apply, discuss this with your
doctor or pharmacist before starting treatment with Benalapril 20.

Benalapril 20 with food, drink and alcohol
Benalapril 20 can be taken with or without food. Most people take Benalapril 20 with water.
Alcohol enhances the antihypertensive effect of ACE inhibitors.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a
child, consult your doctor or pharmacist before using this medicine.

Pregnancy
Inform your doctor if you suspect (or are planning) pregnancy. Your doctor will usually recommend
discontinuing Benalapril 20 before planning pregnancy or immediately after confirming
pregnancy and will recommend an alternative medicine. Use of this medicine is not recommended during early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section Pregnancy).

Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Breastfeeding is not recommended for newborns (first few weeks after birth), especially premature infants, while taking this medicine. For older infants, your doctor will inform you about the benefits and risks of using Benalapril 20 during breastfeeding compared to other treatment options.

Driving and using machines
Dizziness or drowsiness may occur while taking this medicine. In such cases, do not drive, use tools, or operate machinery.

Benalapril 20 contains lactose
Benalapril 20 contains lactose, a type of sugar. If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

Benalapril 20 contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Benalapril 20

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult 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.

The tablet should be swallowed whole (do not crush or chew), with an adequate amount of liquid
(e.g. a glass of water). Benalapril 20 may be taken with or without food. The daily dose is usually taken in the morning, or, if necessary, it may be divided into two halves and taken in the morning and evening.
Special caution should be observed when starting treatment or increasing the dose of the medicine.
If dizziness or vertigo occurs, you should contact your doctor immediately.
Your doctor will closely monitor your blood pressure and kidney function both before and after
starting treatment with Benalapril 20 mg, as hypotension and (less commonly) renal failure have been observed. If the patient is taking medicines that increase urine output (diuretics), the doctor will decide whether to reduce their dose—if possible—before starting treatment with Benalapril 20.
The occurrence of hypotension after the initial dose of Benalapril 20 does not mean that such reactions will continue during long-term treatment with Benalapril 20, and does not preclude further use of the medicine. Your doctor will monitor serum potassium levels and kidney function.

Tablet splitting

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

Fig. 1 and 2: Splitting the Benalapril 20 tablet
Hypertension

• The usual initial dose ranges from 5 mg of enalapril maleate to 20 mg of enalapril maleate once daily.
• Some patients may require 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.
• Your doctor will gradually increase the dose until the optimal dose for the patient is reached.
• The usual maintenance dose is 20 mg of enalapril maleate per day, given as a single dose or divided into two doses.
• The maximum maintenance dose is 40 mg of enalapril maleate per day, given in two divided doses.

Patients with impaired kidney function
The dose will be adjusted according to the degree of kidney function:

• moderate kidney impairment - 5 mg to 10 mg of enalapril maleate per day.
• severe kidney impairment - 2.5 mg of enalapril maleate per day.
• in patients undergoing dialysis - 2.5 mg of enalapril maleate per day on dialysis days. Dosing on non-dialysis days should be adjusted according to blood pressure values.

Elderly patients
Your doctor will determine the appropriate dose based on kidney function.
Use in children and adolescents
Experience with the use of Benalapril 20 in children with high blood pressure is limited. If a child is able to 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 above 50 kg - 5 mg of enalapril maleate per day.

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

• maximum dose for children weighing from 20 kg to 50 kg is 20 mg of enalapril maleate per day.
• maximum dose for children weighing above 50 kg is 40 mg of enalapril maleate per day.

This medicine is not recommended for use in neonates (during the first weeks after birth) or in children with impaired kidney function.
Taking more Benalapril 20 than prescribed
If you take more Benalapril 20 than prescribed, contact your doctor immediately or go to the nearest hospital. Bring the medicine packaging with you.
The following symptoms may occur: dizziness or vertigo caused by sudden or excessive lowering of blood pressure.
If you miss a dose of Benalapril 20

• If you forget to take a tablet, skip that dose.
• Take the next dose as scheduled.
• Do not take a double dose to make up for a missed dose. Stopping Benalapril 20 Do not stop treatment with this medicine without first consulting 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 everyone will experience them.
The following adverse reactions may occur after using this medicine:
Stop taking Benalapril 20 and consult a doctor immediately if
the patient notices any of the following symptoms:

• swelling of the face, lips, tongue or throat, causing difficulty in breathing or swallowing
• swelling of the hands, feet or ankles
• raised, red skin rash (urticaria).

It should be noted that black patients are more likely to experience such reactions.
If any of the above symptoms occur, treatment with Benalapril 20 must be discontinued immediately and medical advice must be sought without delay.
Dizziness or fainting may occur at the beginning of treatment. In such cases, lying down may be helpful. These symptoms are caused by low blood pressure and should gradually subside as treatment continues. If in doubt, consult your doctor.
Other adverse reactions include:
Very common (may affect at least 1 in 10 patients)

• dizziness, feeling weak or nauseous
• blurred vision
• cough

Common (may affect less than 1 in 10 patients)

• low blood pressure, heart rhythm disturbances, rapid heartbeat, angina or chest pain
• headache, fainting
• taste disturbances, shortness of breath
• diarrhoea or abdominal pain, rash
• fatigue (tiredness), depression
• allergic reactions with swelling of limbs, face, lips, tongue or throat, causing difficulty in swallowing or breathing
• increased potassium levels in blood, increased creatinine levels in blood (detected in blood tests)

Uncommon (may affect less than 1 in 100 patients)

• sudden drop in blood pressure when changing from lying to standing position (orthostatic hypotension)
• rapid or irregular heartbeat (palpitations)
• heart attack (possibly due to excessive lowering of blood pressure in certain high-risk patients, including those with impaired blood flow to the heart or brain)
• anaemia (including aplastic or haemolytic)
• stroke (possibly due to excessive lowering of blood pressure in high-risk patients)
• confusion, insomnia or excessive drowsiness, nervousness
• skin prickling or numbness
• vertigo of labyrinthine origin
• ringing in the ears (tinnitus)
• nasal congestion, sore throat or hoarseness
• spasmodic narrowing of the bronchi (bronchospasm)/asthma
• slow intestinal peristalsis (including intestinal obstruction), pancreatitis
• vomiting, indigestion, constipation, loss of appetite (anorexia), stomach irritation, dryness of the oral mucosa, stomach ulcer (peptic ulcer)
• increased sweating
• kidney function disorders, kidney failure
• itching or urticaria
• hair loss
• muscle cramps, sudden flushing (especially of the face), general malaise, high temperature (fever), impotence
• increased protein in urine (detected in urine test)
• decreased glucose and sodium levels in blood, increased urea levels in blood (detected in blood tests)

Rare (may affect less than 1 in 1000 patients)

• Raynaud's phenomenon, in which hands and feet may become very cold and pale due to reduced blood flow
• blood count changes such as reduced numbers of white and red blood cells, reduced haemoglobin levels, reduced haematocrit values, reduced platelet count
• bone marrow suppression, swelling of lymph nodes
• autoimmune diseases
• unusual dreams or sleep disturbances
• lung tissue abnormalities (pulmonary infiltrates)
• inflammation of the nasal mucosa
• lung inflammation causing breathing difficulties (allergic alveolitis/eosinophilic pneumonia)
• inflammation of cheeks, gums, tongue, lips, throat
• reduced urine output
• skin rash resembling a target (erythema multiforme)
• Stevens-Johnson syndrome and toxic epidermal necrolysis, severe skin disease with redness and skin peeling, formation of blisters or painful ulcers, or separation of the outer skin layer from deeper layers, exfoliative dermatitis/erythroderma (severe skin rash with peeling or flaking of the skin), bullous eruption (small fluid-filled bumps on the skin)
• liver disorders such as impaired liver function, liver failure, hepatitis, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin levels (detected in blood tests)
• breast enlargement in men

Very rare (may affect less than 1 in 10,000 patients)

• intestinal angioedema (intestinal swelling)

Frequency not known (cannot be estimated from available data)

• syndrome of inappropriate antidiuretic hormone secretion (SIADH), resulting in low sodium levels in blood (symptoms such as fatigue, headache, nausea, vomiting)
• a syndrome of symptoms has been observed, which may include one or more of the following adverse reactions: fever, serositis, vasculitis, muscle and joint pain/arthritis, and changes in certain laboratory test results (positive antinuclear antibody titre - ANA, elevated ESR, eosinophilia and leukocytosis). Skin rash, photosensitivity or other skin reactions may also occur.
• excessive lactic acidosis in blood during concomitant use with metformin. Symptoms of lactic acidosis include vomiting, abdominal pain (abdominal pain) with muscle cramps, general malaise accompanied by severe fatigue and difficulty breathing. Other symptoms include decreased body temperature and slowed heart rate (see also section 2. "Important information before using Benalapril 20").

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Benalapril 20

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister packs and the outer
cardboard box following the abbreviation "EXP". The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging to protect from moisture.
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 packaging and other information

What Benalapril 20 contains
Active substance: Each tablet contains 20 mg of enalapril maleate.
Other ingredients: gelatin, monohydrate lactose, magnesium stearate, magnesium carbonate,
anhydrous colloidal silicon dioxide, sodium carboxymethyl starch (type A), iron(III) oxide
(red, E 172).

What Benalapril 20 looks like and contents of the pack
Pale red tablets, slightly convex on both sides, with bevelled edges and a division line on one side.
Packs of 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
BERLIN-CHEMIE AG
Glienicker Weg 125
12489 Berlin, Germany

Manufacturer
BERLIN-CHEMIE AG
Glienicker Weg 125
12489 Berlin, Germany

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: +48 22 566 21 00
Fax: +48 22 566 21 01