Benalapril 10

Package leaflet: Information for the patient

Benalapril 10, 10 mg, tablets
Enalapril maleate
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Benalapril 10 is and what it is 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. Contents of the pack and other information

1. What Benalapril 10 is and what it is 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 (weakened heart function). The medicine may reduce the need for hospitalization and may prolong life in some patients;
• to prevent symptoms of heart failure. Such symptoms include: shortness of breath, feeling tired after minimal physical activity such as walking, or swelling around the ankles and feet.

This medicine works by widening the patient's blood vessels. This leads to a reduction in
blood pressure. The effect usually begins within one hour after 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 10

When not to use 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 experienced swelling of the face, lips, mouth, tongue or throat,
making swallowing or breathing difficult (angioedema) of unknown cause or
hereditary angioedema;
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 10 in early
pregnancy – see section Pregnancy);
if the patient has taken or is currently using 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 under the skin, for example 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 10, discuss this with a 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 number or absence of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia) or reduced number of 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 10 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 salt substitutes containing potassium
• 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. Taking Benalapril 10 together with glucose-lowering medicines containing metformin may increase the risk of lactic acidosis (probably due to impaired kidney function). Therefore, in patients at risk, metformin should be used cautiously 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, making swallowing or breathing difficult. Be aware that in patients of black race, the risk of such a reaction to ACE inhibitors is increased.
• if you have low blood pressure (which may cause fainting or dizziness, especially when standing)
• if you have collagen diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, scleroderma), during immunosuppressive treatment, during treatment with medicines containing allopurinol (a medicine used for gout), propranolol (a medicine used for heart rhythm disorders) or lithium (a medicine used for certain types of depression), or if you have several of the above risk factors at the same time
• 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 to treat cancer (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 called 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 10”.
Inform your doctor if you are pregnant, suspect you may be pregnant or are planning pregnancy. It is not recommended to use
this medicine in early pregnancy and it 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 patients of black race 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
to take this medicine.
Planned procedures
If any of the following procedures are planned, inform your doctor that you are taking Benalapril 10:

• any surgical procedure or administration of general anaesthesia (including during dental procedures),
• treatment involving removal of cholesterol from the blood, called LDL apheresis,
• desensitisation to reduce allergic reactions to bee or wasp stings. If any of the above conditions apply to you, 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 are no data on the use of enalapril in children for other indications.
Data on the efficacy and safety of enalapril are available only for the treatment of children over 6 years of age
with hypertension. Therefore, Benalapril 10 is recommended for use in children only for the treatment of hypertension.
Do not give Benalapril 10 to newborns, children or adolescents with kidney disease.
Benalapril 10 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. Benalapril 10 may
affect the action of other medicines, and other medicines may affect the action of Benalapril 10.
Your doctor may need to change 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 10 (see section “When not to use Benalapril 10”)
• racecadotril, a medicine used to treat diarrhoea
• medicines used to prevent organ transplant rejection and to treat cancer (e.g. temsirolimus, sirolimus, everolimus and other medicines belonging to the mTOR inhibitor group). 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 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)
• vildagliptin, a medicine used to treat diabetes
• medicines used to dissolve blood clots (thrombolytic medicines). See section “Warnings and precautions”
• other medicines that lower blood pressure, such as beta-blockers or other medicines that increase urine output (diuretics, also called water tablets). If you are taking angiotensin II receptor antagonists (AIIRAs) or aliskiren, see also sections “When not to use Benalapril 10” and “Warnings and precautions”.
• nitroglycerin and other nitrates (medicines used to treat chest tightness or chest pain, called 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 called tricyclic antidepressants
• medicines used for mental disorders, called antipsychotics
• some medicines used for cough and colds and weight-loss medicines containing substances called sympathomimetics
• some painkillers and medicines used for arthritis, including gold salts
• non-steroidal anti-inflammatory drugs, 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 this with your
doctor or pharmacist before starting to take Benalapril 10.
Benalapril 10 with food, drink and alcohol
Benalapril 10 can be taken during or independently of meals. Most people
take Benalapril 10 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 plan to have a
child, you should 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 10 before planned pregnancy or immediately after confirming
pregnancy and will recommend taking another medicine instead of Benalapril 10. It is not recommended to use
this medicine in early pregnancy and it 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 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 taking Benalapril 10 during breastfeeding compared to other treatment options.
Driving and operating machinery
Dizziness or drowsiness may occur while taking this medicine. In such a
case, do not drive, use tools or operate machinery.
Benalapril 10 contains lactose
Benalapril 10 contains lactose, which is a type of sugar. If you have been previously diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.
Benalapril 10 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 10

This medicine should always be taken exactly as prescribed 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 10 may be taken with or without food. The daily dose is usually taken in the morning, or, if necessary, it may be divided and 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 score line facing upwards. Then break the tablet along the score line as shown in the illustrations (1 and 2) by pressing down on both sides of the tablet with two index fingers.

Fig. 1 and 2: Dividing the Benalapril 10 tablet
Arterial hypertension

• The usual starting dose is from 5 mg enalapril maleate to 20 mg enalapril maleate once daily.
• Some patients may require a lower starting dose.
• The usual maintenance dose is 20 mg enalapril maleate once daily.
• The maximum maintenance dose is 40 mg enalapril maleate once daily.

Heart failure

• The usual starting dose is 2.5 mg enalapril maleate once daily.
• Your doctor will gradually increase the dose until the optimal dose for you is reached.
• The usual maintenance dose is 20 mg enalapril maleate daily, given as a single dose or divided into two doses.
• The maximum maintenance dose is 40 mg enalapril maleate daily, given in two divided doses.

Patients with impaired renal function
The dose will be adjusted depending on the degree of kidney function:

• moderate renal impairment - 5 mg enalapril maleate to 10 mg enalapril maleate daily.
• severe renal impairment - 2.5 mg enalapril maleate daily.
• during dialysis therapy - 2.5 mg enalapril maleate daily 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 10 in children with high blood pressure is limited. If the 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 starting doses are:

• body weight from 20 kg to 50 kg - 2.5 mg enalapril maleate daily.
• body weight above 50 kg - 5 mg enalapril maleate daily.

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 enalapril maleate daily.
• maximum dose for children weighing above 50 kg is 40 mg enalapril maleate daily.

Use of this medicine is not recommended in newborns (during the first weeks of life) or in children with impaired kidney function.
Taking more Benalapril 10 than prescribed
If you take more Benalapril 10 than prescribed, contact your doctor immediately or go to the nearest hospital. Take the medicine packaging with you.
The following symptoms may occur: dizziness or vertigo caused by sudden or excessive drop in blood pressure.
Missing a dose of Benalapril 10

• If you forget to take a tablet, skip that dose.
• Take the next dose according to your regular dosing schedule.
• Do not take a double dose to make up for a missed dose. Stopping treatment with Benalapril 10 Do not stop taking this medicine without first consulting your doctor. If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following adverse effects may occur after using this medicine:
Benalapril 10 must be discontinued and immediate medical advice sought 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, itchy rash (urticaria).

It should be noted that patients of African descent are more prone to such reactions.
If any of the above symptoms occur, Benalapril 10 must be discontinued immediately and medical advice sought without delay.
Dizziness or fainting may occur at the beginning of treatment. In such cases, lying down may help.
These symptoms are due to low blood pressure and usually resolve as treatment continues.
If in any doubt, consult your doctor.
Other adverse effects include:

Very common (may affect at least 1 in 10 people)

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

Common (may affect less than 1 in 10 people)

• low blood pressure, irregular heartbeat, 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 people)

• 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
• tingling or numbness of the skin
• vertigo (dizziness 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, gastric 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 1,000 people)

• Raynaud's phenomenon, in which hands and feet may become very cold and pale due to reduced blood flow
• blood count abnormalities such as reduced white blood cell and red blood cell counts, reduced haemoglobin levels, reduced haematocrit, reduced platelet count
• bone marrow suppression, lymph node swelling
• 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 target-like lesions (erythema multiforme)
• Stevens-Johnson syndrome and toxic epidermal necrolysis, severe skin disease with redness and skin peeling, blister formation or painful ulcers, or separation of the outer skin layer from deeper layers, exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of skin flakes), bullae (small fluid-filled blisters 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 people)

• 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 include fatigue, headache, nausea, vomiting)
• a syndrome has been observed which may include one or more of the following adverse effects: 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 when used concomitantly with metformin. Symptoms of lactic acidosis include vomiting, abdominal pain (abdominal discomfort) 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 taking Benalapril 10”).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Benalapril 10

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blisters and the outer carton 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 pack and other information

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

What Benalapril 10 looks like and contents of the pack
Pale brown tablets, slightly convex on both sides, with bevelled edges and a division line on one side.
Pack sizes: 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 regarding this medicinal product, 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