Lotensin

Package leaflet: Information for the patient

LOTENSIN, 10 mg, film-coated tablets
Benazepril hydrochloride
Please read this leaflet carefully before using the 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 consult 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 Lotensin is and what it is used for
2. Important information before taking Lotensin
3. How to take Lotensin
4. Possible side effects
5. How to store Lotensin
6. 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 called angiotensin-converting enzyme inhibitors (ACE inhibitors), which help control high blood pressure. These medicines work by inhibiting the activity of a substance responsible for narrowing blood vessels. As a result, blood vessels relax and blood pressure is lowered.
Lotensin is used to treat high blood pressure. Elevated blood pressure is often asymptomatic. Many patients with high blood pressure feel perfectly well. However, high blood pressure increases the workload on the heart and blood vessels. If this condition persists over time, it may damage the blood vessels of the brain, heart, or kidneys, potentially leading to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. The likelihood of these conditions is reduced when blood pressure is maintained at normal levels.

Indications

• Treatment of hypertension.
• Adjunctive treatment of congestive heart failure (in NYHA class II-IV).
• Progressive chronic renal insufficiency (creatinine clearance 30–60 mL/min).

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 to any of the other ingredients of this medicine (listed in section 6),
• if the patient has or has had in the past angioedema (a type of swelling) related to treatment with other ACE inhibitors or sulfonamide derivatives, manifesting as swelling of the face, lips, tongue, hands or feet, or sudden breathing difficulties,
• if the patient has or has had in the past hereditary (congenital) or idiopathic (of unknown cause) angioedema,
• after the 3rd month of pregnancy (Lotensin should also be avoided during early pregnancy – see section on pregnancy), if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren, if the patient has taken or is currently using sacubitril with valsartan, a medicine used to treat 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) may increase. If the patient is taking any of the following medicines, the risk of angioedema may be increased:
  • 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 3rd month of pregnancy, as it may cause serious harm to the unborn child (see section on pregnancy).
If during treatment the patient experiences hypersensitivity reactions, such as swelling of the face, lips, tongue, difficulty in breathing and/or itching and rash, often due to an allergic reaction (angioedema), treatment must be stopped immediately and medical advice sought without delay.
Exercise particular caution:

• if the patient has kidney problems or is undergoing dialysis; Lotensin is not recommended for patients who have recently undergone kidney transplantation,
• if the patient has heart or blood vessel disorders such as:
• heart failure (inadequate pumping of blood),
• heart disease caused by reduced blood supply or cerebrovascular disease,
• aortic valve stenosis or certain other heart defects,
• if the patient is to undergo surgery under anaesthesia (including dental procedures); 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 scheduled for desensitisation therapy with Hymenoptera venom (venom used in allergy testing or treatment of insect sting allergies),
• if the patient has liver disorders or progressive liver disease, e.g. cirrhosis of the liver. If jaundice occurs during treatment with Lotensin, treatment must be stopped immediately and medical advice sought without delay.
• if the patient has diabetes,
• if the patient has high blood cholesterol levels and is scheduled for plasmapheresis,
• if the patient is on a low-salt diet,
• if the patient is taking diuretics; your doctor may advise stopping them 2 to 3 days before starting Lotensin,
• if the patient has an adrenal gland disorder called Conn's syndrome (also known as primary hyperaldosteronism),
• if the patient has a blood vessel disorder called collagenosis or is taking immunosuppressive medicines, medicines used in gout (allopurinol) or antiarrhythmics (procainamide); severe infections may occur. In such patients, the doctor may recommend regular monitoring of white blood cell counts and advise reporting any signs of infection (e.g. fever, sore throat, mouth ulcers).
• if the patient has kidney impairment or diabetes and is also taking potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicines that increase blood potassium levels, elevated blood potassium levels may occur,
• in black patients, there is an increased risk of allergic reactions – angioedema – and reduced effectiveness of Lotensin,
• 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 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 Lotensin”.
Regular follow-up visits are necessary during treatment so that your doctor can assess the effectiveness of the treatment.
Contact your doctor immediately if nausea, vomiting or diarrhoea occur, especially if they are severe or persistent. These conditions may lead to excessive fluid loss and cause 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.
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.
Lotensin and other medicines
Inform your doctor about all medicines you are currently taking, have recently taken or plan to take. Your doctor may recommend adjusting the dose and/or taking additional precautions. This applies to both prescription and over-the-counter medicines.
In particular, speak with your doctor or pharmacist if you are currently taking, have 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 in bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots),
• sympathomimetics,
• allopurinol, procainamide, cytostatics, immunosuppressants, systemic corticosteroids and other medicines affecting blood parameters,
• medicines containing lithium,
• antidiabetic medicines (e.g. insulin, oral antidiabetic agents),
• 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 given 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 enhance its blood pressure-lowering effect and/or increase the risk of dizziness or fainting.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant (or suspect you may be), consult your doctor. Your doctor should advise stopping Lotensin before becoming pregnant or as soon as pregnancy is suspected, and may recommend using an alternative medicine.
Lotensin is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it 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, your doctor should inform you about the benefits and risks of taking Lotensin during breastfeeding compared with 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, the patient 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. In case of 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.

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 once daily. Dosage should be adjusted according to the blood pressure response, usually every 1 to 2 weeks.
In some patients, the antihypertensive effect may be reduced towards 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, which may be taken as a single dose or divided into two doses.

If Lotensin does not provide sufficient blood pressure reduction, your doctor may prescribe an additional antihypertensive medicine, e.g. a thiazide diuretic or a calcium antagonist (initially in low doses). If diuretic treatment was previously used, your doctor may recommend discontinuing it 2–3 days before starting Lotensin. If necessary, diuretic treatment may be resumed later. If discontinuation of diuretics is not possible, your doctor may recommend reducing the initial dose of Lotensin (5 mg instead of 10 mg) to avoid excessive lowering of blood pressure.

For patients with creatinine clearance ≥ 30 ml/min, the usual recommended doses of Lotensin are advised.

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 once daily. To achieve additional antihypertensive effect, your doctor may recommend adding a non-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 the patient has not experienced symptomatic hypotension or other significant adverse effects. 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 to twice-daily dosing. 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).

In patients with CHF and creatinine clearance < 30 ml/min, your doctor may increase the daily dose up to 10 mg; however, a low initial dose (2.5 mg once daily) may prove most appropriate.

Progressive chronic renal failure (PCRF)
To slow the progression of chronic renal failure, with or without concomitant hypertension, long-term treatment with Lotensin at a dose of 10 mg once daily is recommended. If further blood pressure reduction is needed, other antihypertensive medicines may be used in combination with Lotensin.

Use in children
Children with hypertension (aged 7–16 years, body weight ≥ 25 kg)
The usual recommended initial dose of Lotensin is 0.2 mg/kg body weight (up to a maximum of 10 mg) once daily. Your doctor will adjust the dose according to the blood pressure response. Doses higher than 0.6 mg/kg body weight (or exceeding 40 mg daily) have not been studied in children. Long-term effects of Lotensin on growth and development have not been evaluated.

Lotensin is not recommended for children under 7 years of age, for older children who cannot swallow tablets, or when the calculated dose (mg/kg body weight) does not correspond to the available tablet strengths. Lotensin is not recommended for children with a glomerular filtration rate < 30 ml/min due to insufficient data to recommend a dosing regimen in this patient group.

The efficacy and safety of Lotensin in children with CHF or progressive chronic renal failure have not been studied.

It is recommended to take the medicine in the morning at the same time each day.
Lotensin may be taken with or without food.
Lotensin should be used under medical supervision. Lotensin is used as an add-on therapy in the treatment of heart failure (usually in combination with digitalis glycosides or diuretics).

Taking more Lotensin than prescribed
Seek immediate medical advice if any of the following occur:

• Severe dizziness and/or fainting;
• Persistent or severe nausea, vomiting, or diarrhoea;
• Marked fatigue, weakness, or muscle cramps;
• Irregular heartbeat.

If you miss a dose of Lotensin
If you forget to take a dose at your usual time, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicinal product, this medicine can cause adverse reactions, although not everyone experiences them.
Even though not all of these adverse reactions occur frequently, appropriate medical action may be required if they occur.

Common (affects more than 1 in 100 but less than 1 in 10 treated patients):
palpitations, orthostatic symptoms (dizziness or fainting due to a drop in blood pressure upon changing body position to standing), hot flushes, non-specific gastrointestinal disturbances, rash, sudden flushing of the face, itching, photosensitivity, frequent urination, cough, respiratory tract symptoms, headache, dizziness, feeling of fatigue, decreased haemoglobin concentration, haematocrit values, white blood cell count, and platelet count.

Uncommon (affects more than 1 in 10,000 but less than 1 in 1,000 treated patients):
orthostatic hypotension (drop in blood pressure upon standing), chest pain, angina pectoris, arrhythmia, diarrhoea, constipation, nausea, vomiting, abdominal pain, bullous eruption, urticaria, hepatitis (mainly due to cholestasis), cholestatic jaundice (due to bile stasis), increased blood urea concentration, 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 (affects less than 1 in 10,000 treated patients):
myocardial infarction or cerebral ischaemic episode, pancreatitis, intestinal obstruction, Stevens-Johnson syndrome, renal dysfunction, tinnitus, taste disturbances, haemolytic anaemia, thrombocytopenia.

Frequency not known (cannot be estimated from available data):
agranulocytosis, neutropenia, leukopenia, anaphylactoid reactions, hyperkalaemia, angioedema of the small intestine, exacerbation of psoriasis (a skin disease causing red, itchy, scaly patches, most commonly on knees, elbows, torso, 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, 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 authorisation holder.
Reporting adverse reactions helps to 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 out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: Expiry
date. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater 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 10 mg of benazepril hydrochloride.
• The other ingredients are: colloidal anhydrous silica, microcrystalline cellulose, hydrogenated castor oil, lactose monohydrate, pregelatinized corn starch, crospovidone, hypromellose, yellow iron oxide, macrogol 8000, talc, titanium dioxide.

What Lotensin looks like and contents of the pack
Lotensin 10 mg film-coated tablets are round, dark yellow, scored tablets.
The pack contains 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, contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel.: 22 546 64 00