Lotensin

Package Leaflet: Information for the Patient

LOTENSIN, 5 mg, coated tablets

Benazepril hydrochloride

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

• 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 those 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, blood vessels relax, and blood pressure decreases.
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 persists for a long time, it may cause damage to the blood vessels in the brain, heart, or kidneys, which can lead to 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).

2. Important Information Before Taking Lotensin

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

When Not to Take 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 has or has had a history of angioedema related to the use of other ACE inhibitors or sulfonamide derivatives, characterized by swelling of the face, lips, tongue, hands, or feet, or sudden breathing difficulties,
• if the patient has or has had a history of hereditary (inborn) or idiopathic (of unknown cause) angioedema,
• after the 3rd month of pregnancy (it is also recommended to avoid taking Lotensin in 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 taking sacubitril with valsartan, a medicine used to treat a certain type of chronic heart failure in adults, as the risk of angioedema increases,
• racecadotril, a medicine used to treat diarrhea
• medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus)
• wildagliptin, 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 a doctor. Lotensin is not recommended in early pregnancy and should not be taken after the 3rd month of pregnancy, as it may cause serious harm to the fetus (see section on pregnancy).
If a hypersensitivity reaction occurs during treatment, characterized by swelling of the face, lips, tongue, difficulty breathing, and/or itching and rash, often as a result of an allergic reaction (angioedema), discontinue the medicine and consult a doctor immediately.
Particular caution is required:

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

The 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 the doctor to assess the effectiveness of the treatment.
Consult a doctor immediately if nausea, vomiting, or diarrhea occur, especially if they are severe or persistent. These conditions may cause excessive fluid loss and lead to excessive blood pressure decrease.
Dizziness (feeling of dizziness) or fainting may occur during physical exertion and in hot weather. Excessive sweating may cause excessive fluid loss and lead to decreased 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 greater 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, or have recently taken, and about any medicines you plan to take. The doctor may advise to change the dose and/or take other precautions. This applies to both prescription and non-prescription medicines.
In particular, discuss with your doctor or pharmacist if you are taking, have recently taken, or might take 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, and heparin, a medicine used to thin the blood to prevent blood 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.

Using Lotensin with Food, Drink, and Alcohol

Drinking alcohol during treatment with Lotensin may enhance its blood pressure-lowering effect and/or increase the risk of dizziness or fainting.

Pregnancy and Breastfeeding

Pregnancy

In case of pregnancy (or suspected pregnancy), consult a doctor. The doctor will advise to stop taking Lotensin before becoming pregnant or until pregnancy is confirmed, and may recommend an alternative medicine.
Lotensin is not recommended in early pregnancy and should not be taken after the 3rd month of pregnancy, as it may cause serious harm to the fetus.

Breastfeeding

Before breastfeeding or starting to breastfeed, consult a doctor.
It is not recommended to breastfeed newborns (first weeks after birth), especially premature babies, while taking Lotensin.
In the case of older children, the doctor will inform the patient 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 concentration. Assess your reaction to the medicine before driving, using machines, or performing activities that require concentration.

Lotensin Contains Lactose

If you have been diagnosed with an intolerance to some sugars, consult 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.
The medicine should be taken strictly according to the doctor's instructions. Without the doctor's consent, the dose or treatment should not be changed or discontinued.

Dosage

Hypertension

In patients not taking thiazide diuretics, the recommended initial dose is 10 mg once daily. The 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. The doctor will then recommend dividing the total daily dose into two equal doses. The maximum recommended daily dose of Lotensin in patients with hypertension is 40 mg. It can be taken in one dose or divided into two doses.
If Lotensin does not cause sufficient blood pressure decrease, the doctor may use another antihypertensive medicine, e.g., a thiazide diuretic or a calcium antagonist (initially in small doses). If diuretic treatment was used previously, the doctor will advise to discontinue it 2-3 days before starting Lotensin, and may then resume it if necessary. If it is not possible to discontinue diuretic treatment, the doctor will recommend reducing the initial dose of Lotensin (5 mg instead of 10 mg) to avoid excessive blood pressure decrease.

Patients with Renal Impairment

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. The doctor may increase the dose to the maximum dose, i.e., 10 mg once daily. To achieve additional hypotensive effect, the doctor may recommend using another diuretic, other than a thiazide diuretic, or another hypotensive medicine.

Congestive Heart Failure (CHF)

The recommended initial dose is 2.5 mg once daily. Due to the risk of severe hypotension after the first dose, the 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, the doctor may increase the dose of Lotensin to 5 mg once daily, provided that the patient has not developed symptomatic hypotension or other significant adverse effects. Depending on the clinical response to the medicine, the doctor may increase the dose to 10 mg or the maximum dose, i.e., 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 advanced heart failure (NYHA class IV), smaller 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, the doctor may increase daily dose to 10 mg, but it be found that a small initial (2.5 mg once daily) is most appropriate.< p>

Use in Children

Children with hypertension (aged 7-16 years, body weight ≥ 25 kg)
Usually, the recommended initial dose of Lotensin is 0.2 mg/kg body weight (up to 10 mg) once daily. The doctor will adjust the dose according to the blood pressure response. The use of a dose higher than 0.6 mg/kg body weight (or higher than 40 mg once daily) has not been studied in children. No studies have been conducted on the long-term effects of Lotensin on growth and development.
It is not recommended to use Lotensin 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 <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 with progressive chronic kidney disease.
It is recommended to take the medicine in the morning at the same time every day.
Lotensin can be taken independently of meals.
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

Consult a doctor immediately if the following occur:

• 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 a dose is missed at the usual time, take the missed dose as soon as you remember, unless it is close to the time for the 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 are common, if they occur, medical attention may be necessary.

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

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

Uncommon (in more than 1 in 1,000 patients, but less than 1 in 100 patients):

orthostatic hypotension (blood pressure drop when standing up), chest pain, angina pectoris, irregular heartbeat, diarrhea, constipation, nausea, vomiting, abdominal pain, gastritis, hives, hepatitis (mainly due to bile stasis), cholestatic jaundice (due to bile stasis), increased blood urea levels, increased serum creatinine levels, drowsiness, insomnia, nervousness, tingling, numbness, and burning sensation, angioedema, swelling of lips or face, joint pain, arthritis, muscle pain.

Rare (in more than 1 in 10,000 patients, but less than 1 in 1,000 patients):myocardial infarction or ischemic cerebral episode, pancreatitis, intestinal obstruction, Stevens-Johnson syndrome, kidney dysfunction, tinnitus, taste disorders, hemolytic anemia, thrombocytopenia.
Very rare (in less than 1 in 10,000 patients):agranulocytosis, neutropenia, leukopenia, pseudoanaphylactic reactions, hyperkalemia, small intestine angioedema, exacerbation of psoriasis (a skin disease that causes red, itchy, scaly patches, most often on the knees, elbows, trunk, and scalp).

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction 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 the 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. 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 5 mg of benazepril hydrochloride.
• The other ingredients are: colloidal anhydrous silica, microcrystalline cellulose, hydrogenated castor oil, lactose monohydrate, maize starch, crospovidone, hypromellose, yellow iron oxide, macrogol 8000, talc, titanium dioxide.

What Lotensin Looks Like and Contents of the Pack

Lotensin, 5 mg, coated tablets are oval, light yellow tablets with a score line on both sides. 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