Lotensin

Package Leaflet: Information for the Patient

LOTENSIN, 10 mg, Film-Coated Tablets

Benazepril Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Lotensin and what is it 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 is Lotensin and what is it 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 blocking the action of a substance that causes blood vessels to constrict. As a result, the blood vessels relax, and blood pressure is lowered.
Lotensin is used to treat high blood pressure. High blood pressure often has no symptoms. Many patients with high blood pressure feel perfectly well.
However, high blood pressure increases the workload on the heart and arteries. If this condition continues over time, it can lead to damage to the blood vessels in the brain, heart, or kidneys, which can result in a stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attack. The likelihood of these conditions is lower if blood pressure is kept under control.

Indications for Use

• Treatment of high blood pressure.
• Supportive treatment in congestive heart failure (in NYHA class II-IV).
• Progressive chronic renal failure (creatinine clearance 30-60 ml/min).

2. Important information before taking Lotensin

Lotensin should only be taken after a medical examination, as it is not suitable for all patients.

When Not to Take Lotensin

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if you have had angioedema (a condition that causes swelling of the face, lips, tongue, hands, or feet, or difficulty breathing) in the past, related to the use of other ACE inhibitors or sulfonamide derivatives,
• if you have had hereditary (inborn) or idiopathic (of unknown cause) angioedema,
• after the third month of pregnancy (you should also avoid taking Lotensin in early pregnancy - see section on pregnancy), if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren, if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat) increases,
• racecadotril, a medicine used to treat diarrhea
• medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus)
• saxagliptin, a medicine used to treat diabetes

Warnings and Precautions

Before starting treatment with Lotensin, discuss it with your doctor or pharmacist.
In case of pregnancy (or suspected pregnancy), consult your doctor. Lotensin is not recommended in early pregnancy and should not be taken after the third month of pregnancy, as it may harm the baby (see section on pregnancy).
If you experience an allergic reaction during treatment, characterized by swelling of the face, lips, tongue, difficulty breathing, and/or itching and rash, discontinue treatment and contact your doctor immediately.
Particular caution is required:

• if you have kidney problems or are undergoing dialysis; in patients who have recently undergone kidney transplantation, Lotensin is not recommended,
• if you have heart or blood vessel problems, such as:
• heart failure (insufficient pumping power of the heart),
• heart disease caused by poor blood supply or blood vessel disease in the brain,
• narrowing of the aortic valve or certain heart defects,
• if you are to undergo surgery under anesthesia (including dental surgery); before planned surgery, inform the anesthesiologist or dentist about taking Lotensin,
• if you experience diarrhea or vomiting,
• if you are to undergo desensitization treatment with hymenoptera venom (venom used in allergy tests or to treat allergies to insect stings),
• if you have liver problems or progressive liver disease, such as liver cirrhosis. If jaundice occurs during treatment with Lotensin, discontinue treatment and consult your doctor immediately.
• if you have diabetes,
• if you have high cholesterol and are to undergo plasmapheresis,
• if you are on a low-salt diet,
• if you are taking diuretics; your doctor will advise you to stop taking them 2 to 3 days before starting Lotensin.
• if you have adrenal gland disease, known as Conn's syndrome (also known as primary hyperaldosteronism),
• if you have a blood vessel disease called collagenosis or are taking immunosuppressive medicines, gout medicines (allopurinol), or anti-arrhythmic medicines (procainamide); severe infections may occur. In these patients, your doctor will recommend regular monitoring of white blood cell count and inform you about the need to report any signs of infection (e.g., fever, sore throat, mouth ulcers).
• if you have kidney failure or diabetes and are taking potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium, or are taking other medicines that increase potassium levels in the blood, high potassium levels in the blood may occur,
• in black patients, there is an increased risk of angioedema and reduced efficacy of Lotensin,
• if you are 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 you have kidney problems related to diabetes,
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also the section "When Not to Take Lotensin".
During treatment, regular check-ups are necessary to allow your doctor to assess the effectiveness of the treatment.
Consult your doctor immediately if you experience nausea, vomiting, or diarrhea, especially if they are severe or persistent. These conditions may lead to excessive fluid loss and result in low blood pressure.
Dizziness (feeling of dizziness) or fainting may occur during physical exertion and in hot weather. Excessive sweating may lead to excessive fluid loss and result in low blood pressure. Be cautious during physical exertion and in hot weather, and drink plenty of water.

Children and Adolescents

Lotensin can be used in children over 7 years old, with a body weight of more than 25 kg.

Elderly Patients

Lotensin can be used in patients over 65 years old.

Lotensin and Other Medicines

Tell your doctor about all medicines you are taking, have recently taken, or might take, and your doctor may recommend a dose change and/or take other precautions. This applies to both prescription and non-prescription medicines.
In particular, inform your doctor or pharmacist if you are taking or have recently taken any of the following medicines:

• blood pressure-lowering medicines, diuretics, tricyclic antidepressants, antipsychotics, anesthetics
• potassium supplements (including salt substitutes), potassium-sparing diuretics, 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 transplant rejection; heparin, a medicine used to thin the blood and prevent clots)

and

• sympathomimetics;
• allopurinol, procainamide, cytostatics, immunosuppressants, corticosteroids used systemically, and other medicines that affect blood counts
• lithium-containing medicines
• antidiabetic medicines (e.g., insulin, oral antidiabetic medicines)
• non-steroidal anti-inflammatory medicines 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 given to prevent heart attack and stroke)
• medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus)
• angiotensin II receptor antagonists (AIIRA) or aliskiren (see also sections "When Not to Take Lotensin" and "Warnings and Precautions")
• racecadotril, a medicine used to treat diarrhea.

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 think you may be pregnant, consult your doctor. Your doctor will advise you to stop taking Lotensin before becoming pregnant or as soon as pregnancy is confirmed, and may recommend an alternative medicine.
Lotensin is not recommended in early pregnancy and should not be taken after the third month of pregnancy, as it may harm the baby.

Breastfeeding

Before breastfeeding or starting breastfeeding, consult your doctor.
Breastfeeding is not recommended in newborns (first weeks after birth), especially in premature babies, while taking Lotensin.
In older children, your doctor will inform you about the benefits and risks of taking Lotensin during breastfeeding compared to other medicines.

Driving and Using Machines

Lotensin, like many other blood pressure-lowering medicines, may cause dizziness and affect your ability to concentrate. Assess your reaction to Lotensin before driving, operating machinery, or performing activities that require concentration.

Lotensin Contains Lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

3. How to Take Lotensin

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Do not exceed the recommended dose.
Take the medicine exactly as prescribed by your doctor. Do not change the dose or stop taking the medicine without consulting your doctor.

Dosage

Hypertension

In 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. The dosage should be adjusted according to the blood pressure response, usually every 1 to 2 weeks.
In some patients, the antihypertensive effect may be attenuated at the end of the dosing interval. Your doctor may then recommend dividing the total daily dose into two equal doses. The maximum recommended daily dose of Lotensin is 40 mg in patients with hypertension. It can be taken in one dose or divided into two doses.
If Lotensin does not provide sufficient blood pressure reduction, your doctor may prescribe another antihypertensive medicine, e.g., a thiazide diuretic or a calcium antagonist (initially in low doses). If you were previously treated with diuretics, your doctor will advise you to stop taking them 2 to 3 days before starting Lotensin, and may then resume them if necessary. If it is not possible to stop taking diuretics, your doctor will recommend reducing the initial dose of Lotensin (5 mg instead of 10 mg) to avoid excessive blood pressure reduction.
In patients with creatinine clearance ≥ 30 ml/min, the usual doses of Lotensin are recommended.

Patients with Creatinine Clearance <30 ml min< h4>

The initial dose is 5 mg. Your doctor may increase the dose to a maximum of 10 mg once daily. To achieve additional blood pressure reduction, your doctor may recommend another 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 pronounced decrease 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 reduction in symptoms of heart failure, your doctor may increase the dose of Lotensin to 5 mg once daily, provided that the patient has not experienced symptomatic hypotension or other significant adverse effects. Depending on the clinical response to the medicine, your doctor may increase the dose to 10 mg or a maximum of 20 mg once daily, at appropriate intervals.
Once-daily dosing is usually effective. Some patients respond better when taking the medicine twice daily. Controlled clinical trials indicate that in patients with more severe heart failure (NYHA class IV), lower doses of Lotensin are usually used than in patients with mild to moderate heart failure (NYHA class II and III).
In patients with CHF and creatinine clearance <30 ml min, your doctor may increase the daily dose to 10 mg, but it be found that a small initial (2.5 mg once daily) is most appropriate.< p>

Progressive Chronic Renal Failure (PCRF)

To slow the progression of chronic renal failure with or without hypertension, long-term treatment with Lotensin is recommended at a dose of 10 mg once daily. If additional blood pressure reduction is required, other antihypertensive medicines can be used in combination with Lotensin.

Use in Children

Children with hypertension (aged 7-16 years, body weight ≥ 25 kg)
Lotensin is usually given at an initial dose of 0.2 mg/kg body weight (up to 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 higher than 40 mg daily) have not been studied in children. No studies have been conducted on the long-term effects of Lotensin on growth and development.
Lotensin is not recommended in children under 7 years old, in older children who cannot swallow tablets, or for whom the calculated dose (mg/kg body weight) does not correspond to the available tablet strength. The use of Lotensin is not recommended in children with a glomerular filtration rate of <30 ml min, due to insufficient data recommend a dosing regimen in this patient group.
No studies have been conducted on the efficacy and safety of Lotensin in children with CHF or progressive chronic renal failure.
It is recommended to take the medicine in the morning at the same time every day.
Lotensin can be taken with or without food.
Lotensin should be taken under medical supervision. Lotensin is given as an adjunct in the treatment of heart failure (usually in combination with digitalis glycosides or diuretics).

Overdose of Lotensin

In case of overdose, 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, take the missed dose as soon as you remember, unless it is almost time for your next dose. In this case, skip the missed dose and take the next dose at the usual time.
If you have any further questions on the use of this medicine, ask your doctor.

4. Possible Side Effects

Like all medicines, Lotensin can cause side effects, although not everybody gets them.
Although not all of these side effects may occur, if they do occur, medical attention may be required.

Common (in more than 1 in 100 patients, but less than 1 in 10 patients):

palpitations, orthostatic effects (dizziness or fainting due to a drop in blood pressure when changing body position), flushing, non-specific gastrointestinal disorders, rash, sudden reddening of the face, itching, photosensitivity, frequent urination, cough, respiratory symptoms, headache, dizziness, feeling of tiredness, decreased hemoglobin, hematocrit, white blood cell count, and platelet count.

Rare (in more than 1 in 10,000 patients, but less than 1 in 1,000 patients):

orthostatic hypotension (drop in blood pressure when standing up), chest pain, angina pectoris, irregular heartbeat, diarrhea, constipation, nausea, vomiting, abdominal pain, pellagra, hives, hepatitis (mainly due to bile stasis), cholestatic jaundice (due to bile stasis), increased urea levels in the blood, increased creatinine levels in the blood, drowsiness, insomnia, nervousness, feeling of tingling, numbness, and burning, angioedema, swelling of the lips or face, joint pain, arthritis, muscle pain.
Very Rare (in less than 1 in 10,000 patients):myocardial infarction or ischemic episode, pancreatitis, intestinal obstruction, Stevens-Johnson syndrome, kidney dysfunction, tinnitus, taste disorders, hemolytic anemia, thrombocytopenia.
Frequency Not Known (cannot be estimated from the available data):agranulocytosis, neutropenia, leukopenia, pseudoanaphylactic reactions, hyperkalemia, angioedema of the small intestine, exacerbation of psoriasis (a skin disease that causes red, itchy, scaly patches, usually on the knees, elbows, trunk, and scalp).

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Lotensin

Store in a temperature not exceeding 30°C, protect from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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: anhydrous colloidal silica, microcrystalline cellulose, hydrogenated castor oil, lactose monohydrate, maize starch paste, crospovidone, hypromellose, yellow iron oxide, macrogol 8000, talc, titanium dioxide.

What Lotensin Looks Like and Contents of the Pack

Lotensin, film-coated tablets, 10 mg are dark yellow, round, non-divisible tablets.
The pack contains 28 tablets in blisters.

Marketing Authorization Holder:

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw

Manufacturer:

Madaus GmbH
51101 Cologne
Germany

For More Information

Contact the marketing authorization holder: Viatris Healthcare Sp. z o.o., tel.: 22 546 64 00
Date of Last Revision of the Leaflet:02/2024