Patient Information Leaflet

LOTENSIN 20 mg, coated tablets
Benazepril hydrochloride
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 only. Do not pass it on to others. It may harm other people, 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.

Contents of the leaflet

What Lotensin is and what it is used for
What you need to know before you take Lotensin
How to take Lotensin
Possible side effects
How to store Lotensin
Contents of the pack and other information

1. What Lotensin is and what it is used for

Lotensin is available in three strengths: 5 mg, 10 mg and 20 mg.
Lotensin belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors, which help control high blood pressure. These medicines work by blocking the activity of a substance responsible for narrowing blood vessels. As a result, blood vessels relax and blood pressure decreases.
High blood pressure is often asymptomatic. Many patients with high blood pressure feel perfectly well.
However, high blood pressure increases the strain on the heart and blood vessels. If left untreated over a long period, it may damage blood vessels in the brain, heart, or kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure also increases the risk of heart attack. The likelihood of these conditions is reduced if blood pressure is kept under control.

Indications

Treatment of hypertension.
Adjunctive treatment of congestive heart failure (classes II–IV according to the New York Heart Association - NYHA).

2. Important information before using Lotensin

Lotensin should only be used after a medical examination, as it is not suitable for all patients.
When not to use Lotensin

if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
if the patient currently has or has previously had angioedema associated with the use of other ACE inhibitors, manifesting as swelling of the face, lips, tongue, hands or feet, or sudden breathing difficulties,
if the patient currently has or has previously had hereditary (congenital) or idiopathic (of unknown cause) angioedema,
during the third trimester of pregnancy (Lotensin should also be avoided in early pregnancy – see pregnancy section), if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren, if the patient has taken or is currently taking sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, as this increases the risk of angioedema (rapid swelling of tissues beneath the skin in areas such as the throat), if the patient is 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.

Warnings and precautions
Before starting treatment with Lotensin, discuss this with your doctor or pharmacist.
If you are pregnant (or suspect you may be), consult your doctor. Lotensin is not recommended
during early pregnancy and must not be taken after the third month of pregnancy, as its use at this
stage may cause serious harm to the unborn child (see pregnancy section).
If, during treatment, the patient experiences hypersensitivity reactions, such as swelling of the face,
lips, tongue, difficulty breathing and/or itching and rash, often as a result of an allergic reaction
(angioedema), treatment must be stopped immediately and the patient should contact their doctor.
Exercise particular caution when using Lotensin:

if the patient has severe kidney disease,
if the patient has heart or blood vessel disorders, such as:
heart failure (inadequate pumping of blood),
heart disease caused by poor blood supply to the heart or cerebrovascular disease,
narrowing of the main artery or certain heart defects. The drug should be avoided in cases of shock due to heart dysfunction or restricted blood flow.
if the patient is to undergo surgery under anaesthesia (including dental surgery); before any planned procedure, inform the anaesthetist or dentist that the patient is taking Lotensin,
if the patient experiences diarrhoea or vomiting,
if the patient is undergoing or planned for desensitisation therapy with Hymenoptera venom (venom used in allergy testing or treatment of insect sting allergies),
if the patient is undergoing or currently receiving dialysis,
if the patient has liver dysfunction, such as:
impaired liver function; even minor disturbances in water and electrolyte balance may lead to hepatic coma,
liver cirrhosis; in patients who produce large amounts of urine and are treated with corticosteroids or ACTH, the risk of low blood potassium levels increases. If jaundice occurs during treatment with Lotensin, treatment must be stopped immediately and the patient must consult a doctor without delay.
if the patient has diabetes,
if the patient has high blood cholesterol levels and is scheduled for cholesterol removal from the blood (plasmapheresis),
if the patient is on a low-salt diet,
if the patient is taking diuretics; the doctor may advise stopping them 2 to 3 days before starting Lotensin,
if the patient has been diagnosed with overproduction of hormones by the adrenal glands,
if the patient has a vascular disease called collagenosis or is taking immunosuppressive medicines, medicines used in gout (allopurinol) or antiarrhythmics (procainamide); severe infections may occur,
if, during treatment, the patient experiences hypersensitivity reactions or sudden accumulation of fluid under the skin or mucous membranes (e.g. throat or tongue), breathing difficulties and/or itching and rash, often as a result of an allergic reaction (angioedema), contact your doctor,
if the patient has kidney failure or diabetes and is also taking potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes or other medicines that increase blood potassium levels, elevated blood potassium levels may occur,
in black patients, there is an increased risk of sudden fluid accumulation under the skin or mucous membranes (e.g. throat or tongue), breathing difficulties and/or itching and rash, often as a result of an allergic reaction, and additionally, the effect of Lotensin may be weaker,
if the patient currently has or has previously had an allergy or a sudden severe condition due to painful contraction of respiratory muscles and swelling of the respiratory mucosa, often with cough and sputum production,
if the patient is 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 dysfunction related to diabetes,
aliskiren.

The 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 Lotensin”.
Regular follow-up visits are necessary during treatment so that the treating doctor can assess the effectiveness of therapy.
Contact your doctor immediately if gastrointestinal disturbances occur, such as nausea, vomiting or diarrhoea, especially if they are severe or persistent. These conditions may lead to excessive fluid loss and result in excessive lowering of blood pressure.
Dizziness (lightheadedness) or fainting may occur during physical exertion and in hot weather. Excessive sweating may lead to excessive fluid loss and may result in low blood pressure. Exercise caution during physical activity and in hot weather, and maintain adequate fluid intake by drinking sufficient water.
Lotensin and other medicines
Inform your doctor about all medicines currently used or recently taken, as well as any medicines the patient plans to take. The doctor may recommend dose adjustments and/or additional precautions. This applies to both prescription and over-the-counter medicines.
In particular, speak with your doctor or pharmacist if the patient is currently taking, has recently taken, or may take any of the following medicines:

antihypertensive medicines, diuretics, tricyclic antidepressants, antipsychotics, anaesthetics,
potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that increase blood potassium levels (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),
sympathomimetics,
allopurinol, procainamide, cytostatics, immunosuppressive agents, systemic corticosteroids and other medicinal products affecting blood parameters,
lithium-containing medicines,
antidiabetic medicines (e.g. insulin, oral antidiabetics),
non-steroidal anti-inflammatory drugs (NSAIDs) used to relieve pain and inflammation (e.g. ibuprofen, indomethacin),
acetylsalicylic acid (aspirin), used to relieve pain and inflammation (benazepril may be used with aspirin when taken to prevent heart attack and stroke),
medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus),
angiotensin II receptor antagonists (AIIRAs) or aliskiren (see also sections “When not to use Lotensin” and “Warnings and precautions”),
racecadotril, a medicine used to treat diarrhoea.

Taking Lotensin with food, drink and alcohol
Drinking alcohol while taking Lotensin may intensify its blood pressure-lowering effect and/or increase the risk of dizziness or fainting.
Children and adolescents
Lotensin may be used in children over 7 years of age and weighing more than 25 kg.
Elderly patients
Lotensin may be used in patients aged 65 years and older.
Pregnancy and breastfeeding
Pregnancy
Pregnant women should not take Lotensin. Use of ACE inhibitors (including Lotensin) during pregnancy may cause serious harm to the unborn child. Therefore, if pregnancy is suspected, contact your doctor immediately.
If you are pregnant (or suspect you may be), consult your doctor. Your doctor should advise stopping Lotensin before becoming pregnant or until pregnancy is confirmed and may recommend using another medicine instead of Lotensin.
Lotensin is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as its use after this time may cause serious harm to the unborn child.
Breastfeeding
During breastfeeding or before starting breastfeeding, consult your doctor.
Breastfeeding is not recommended for newborns (first weeks after birth), especially premature infants, while taking Lotensin.
For older infants, the doctor should inform the patient about the benefits and risks of taking Lotensin during breastfeeding compared to other medicines.
Driving and using machines
Like many other medicines that lower blood pressure, Lotensin may cause dizziness and affect concentration. Assess your response to Lotensin before driving, operating machinery or performing tasks requiring concentration.
Lotensin contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Lotensin

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist. Do not exceed the recommended dose.
Take this medicine strictly according to your doctor's instructions. Do not change the dose or stop taking the medicine without your doctor's consent.
High blood pressure often occurs without symptoms. Many patients with high blood pressure feel perfectly well.
Keep in mind that this medicine does not eliminate the cause of high blood pressure, but only controls it. Therefore, to lower blood pressure and maintain appropriate levels, you must continue taking the medicine as directed.

Dosage

Hypertension
For patients not taking thiazide diuretics, the recommended initial dose is 10 mg once daily. Your doctor may increase the dose to 20 mg daily. Dosage should be adjusted according to blood pressure response, usually every 1 to 2 weeks.
In some patients, the antihypertensive effect may weaken toward the end of the dosing interval. In such cases, your doctor may recommend dividing the total daily dose into two equal doses. The maximum recommended daily dose of Lotensin in patients with hypertension is 40 mg. This may be taken as a single dose or divided into two doses.
If Lotensin does not provide sufficient reduction in blood pressure, your doctor may prescribe another antihypertensive medicine to be used concomitantly, such as a thiazide diuretic or a calcium antagonist (initially in low doses). If you were previously treated with diuretics, your doctor may advise discontinuing them 2–3 days before starting Lotensin. Diuretics may then be restarted if necessary. If discontinuation of diuretics is not possible, your doctor may reduce the initial dose of Lotensin (to 5 mg instead of 10 mg) to avoid excessive lowering of blood pressure.
For patients with creatinine clearance ≥ 30 ml/min, the usual doses of Lotensin are generally recommended.

Patients with creatinine clearance < 30 ml/min
The initial dose is 5 mg. Your doctor may increase the dose up to the maximum dose of 10 mg daily. To achieve additional hypotensive effect, your doctor may recommend adding a diuretic other than a thiazide diuretic or another antihypertensive medicine.

Congestive heart failure (CHF)
The recommended initial dose is 2.5 mg once daily. Due to the risk of a sudden drop in blood pressure after the first dose, your doctor will closely monitor patients taking Lotensin for the first time. If, after 2–4 weeks of treatment, there is no satisfactory improvement in heart failure symptoms, your doctor may increase the dose to 5 mg once daily, provided that symptomatic hypotension or other significant adverse effects have not occurred. Depending on the clinical response, your doctor may further increase the dose to 10 mg or up to the maximum dose of 20 mg once daily, at appropriate intervals.
Once-daily dosing is usually effective. Some patients may respond better when taking the medicine twice daily. Controlled clinical studies indicate that patients with more advanced heart failure (NYHA class IV) usually require lower doses of Lotensin than patients with mild to moderate heart failure (NYHA classes II and III).
For patients with CHF and creatinine clearance < 30 ml/min, your doctor may increase the daily dose up to 10 mg; however, it may turn out that the initial low dose (2.5 mg once daily) is the most appropriate.

How to take the medicine
It is recommended to take the medicine in the morning at the same time each day.
Lotensin may be taken independently of meals.
In the treatment of heart conditions, Lotensin should be used under medical supervision. Lotensin is used as an additional treatment in heart failure (usually in combination with digitalis glycosides or diuretics). The first dose should be taken in the presence of a doctor, who should then monitor blood pressure for at least one hour.

Taking more than the recommended dose of Lotensin
Contact your doctor immediately if you experience:

severe dizziness and/or fainting;
persistent or severe nausea, vomiting, or diarrhea;
severe fatigue, weakness, or muscle cramps;
irregular heartbeat.

Missed dose of Lotensin
If you miss a dose at the usual time, take it as soon as you remember, unless it is almost time for the next dose. In that case, skip the missed dose and take the next dose at the regular time.
If you have any further doubts about using this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Although not all of these adverse reactions occur frequently, medical intervention may be necessary if they occur.
Common (in more than 1 in 100 treated patients but less than 1 in 10 treated patients):
palpitations, orthostatic symptoms (dizziness or fainting due to a drop in blood pressure upon changing to an upright position), non-specific gastrointestinal disorders, rash, sudden flushing of the face, itching, photosensitivity, frequent urination, cough, respiratory tract symptoms, headache, dizziness, feeling of fatigue, decreased hemoglobin concentration, hematocrit values, white blood cell count, and platelet count.
Uncommon (in more than 1 in 10,000 treated patients but less than 1 in 1,000 treated patients):
orthostatic hypotension (drop in blood pressure upon standing), chest pain, angina pectoris, arrhythmia, diarrhea, constipation, nausea, vomiting, abdominal pain, bullous eruption, urticaria, hepatitis (mainly cholestatic), cholestatic jaundice, increased blood urea, increased serum creatinine concentration, somnolence, insomnia, nervousness, sensation of pricking, tingling and burning, angioedema, swelling of the lips or face, joint pain, arthritis, muscle pain.
Rare (in less than 1 in 10,000 treated patients):
myocardial infarction or cerebral ischemic episode, pancreatitis, intestinal obstruction, Stevens-Johnson syndrome, renal function impairment, tinnitus, taste disturbances, hemolytic anemia, thrombocytopenia.
Frequency unknown (cannot be estimated from available data):
agranulocytosis, neutropenia, pseudoanaphylactic reactions, hyperkalemia, angioedema of the small intestine, exacerbation of psoriasis (a skin disease causing red, itchy, scaly patches, most commonly on knees, elbows, trunk, and scalp).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
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 Lotensin

Store at a temperature not exceeding 30 °C and protect from moisture.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: Expiry
date. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask
your pharmacist how to dispose of medicines no longer required. This will help
protect the environment.

6. Contents of the pack and other information

What Lotensin contains
The active substance is benazepril hydrochloride. One tablet contains 20 mg of benazepril hydrochloride.
Other ingredients are:

Tablet core: colloidal anhydrous silica, microcrystalline cellulose, hydrogenated castor oil, lactose monohydrate, pregelatinized corn starch, crospovidone.
Coating: hypromellose, yellow iron oxide, macrogol 8000, talc, titanium dioxide, red iron oxide.

What Lotensin looks like and contents of the pack
Lotensin 20 mg film-coated tablets are round, light orange-coloured, scored tablets:
pack containing 28 tablets in blisters.
Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Manufacturer:
Madaus GmbH
51101 Cologne
Germany
For further information, please contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel.: 22 546 64 00