Lotensin

Patient Information Leaflet: Important Information

LOTENSIN, 20 mg, film-coated tablets

Benazepril hydrochloride

Read the 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 any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents

• 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.
High blood pressure often has no symptoms. Many patients with high blood pressure feel fine.
However, high blood pressure can increase the workload on the heart and arteries. If this condition continues for a long 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 also increases the risk of heart attack. The likelihood of these complications is lower if blood pressure is kept under control.

Indications

• Treatment of high blood pressure.
• Supportive treatment of congestive heart failure (NYHA class II-IV).

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 ever had angioedema (a condition that causes swelling of the face, lips, tongue, hands, or feet, or difficulty breathing) related to the use of other ACE inhibitors,
• if you have ever had hereditary or idiopathic angioedema,
• after the third month of pregnancy (you should also avoid taking Lotensin during 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)
• wildagliptin, a medicine used to treat diabetes

Warnings and precautions

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

• if you have severe kidney disease,
• if you have heart or blood vessel problems, such as:
• heart failure (insufficient pumping power),
• heart disease caused by poor blood supply or blood vessel disease in the brain,
• narrowing of the main artery or certain heart defects. Avoid taking the medicine in case of shock caused by heart problems or impaired blood flow.
• if you are to undergo surgery with anesthesia (including dental surgery); inform the anesthesiologist or dentist about taking Lotensin before the planned surgery,
• if you experience diarrhea or vomiting,
• if you are to undergo desensitization with insect venom (venom used in allergy tests or to treat insect sting allergies),
• if you are to undergo dialysis treatments,
• if you have liver problems, such as:
• liver dysfunction; minor changes in water and electrolyte balance can lead to hepatic coma,
• liver cirrhosis; in patients who rapidly excrete urine and are treated with corticosteroids or ACTH, the risk of decreased potassium levels in the blood increases. If jaundice occurs during treatment with Lotensin, discontinue the medicine and consult your doctor immediately.
• if you have diabetes,
• if you have high cholesterol and are to undergo a procedure to remove cholesterol from the blood (plasmapheresis),
• if you are on a low-salt diet,
• if you are taking diuretics; your doctor may advise you to stop taking them 2 to 3 days before starting Lotensin, and then may resume them if necessary. If it is not possible to stop taking diuretics, your doctor may reduce the initial dose of Lotensin (5 mg instead of 10 mg) to avoid excessive lowering of blood pressure.
• if you have been found to have increased production of hormones by the adrenal glands,
• 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,
• if you experience allergic reactions or sudden fluid accumulation in the skin or mucous membranes (e.g., throat or tongue), difficulty breathing, and/or itching and rash, often as a result of an allergic reaction (angioedema), consult your doctor,
• if you have kidney failure or diabetes and are taking potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes, or other medicines that increase potassium levels in the blood, as increased potassium levels in the blood may occur,
• in black patients, there is a higher risk of angioedema (rapid swelling of tissues under the skin, such as in the throat), and the effect of Lotensin may be weaker,
• if you have ever had an allergy or a severe condition caused by a painful contraction of the respiratory muscles and swelling of the mucous membranes of the airways, often with coughing and expectoration,
• 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).
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 gastrointestinal disorders, 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.

Lotensin and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, and those you plan to take.
Your doctor may need to adjust the dose 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, 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 clots)
• sympathomimetics
• allopurinol, procainamide, cytostatics, immunosuppressive agents, corticosteroids used systemically, and other medicines that affect blood counts
• lithium-containing medicines
• antidiabetic medicines (e.g., insulin, oral antidiabetics)
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen, indomethacin) used to relieve pain and inflammation
• acetylsalicylic acid (aspirin) used to relieve pain and inflammation (benazepril may be taken 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.

Children and adolescents

Lotensin can be used in children over 7 years old and with a body weight above 25 kg.

Elderly patients

Lotensin can be used in patients over 65 years old.

Pregnancy and breastfeeding

Pregnancy

Pregnant women should not take Lotensin. The use of ACE inhibitors (including Lotensin) during pregnancy may cause serious harm to the unborn baby. Therefore, if you suspect you are pregnant, consult your doctor immediately.
In case of pregnancy (or suspected pregnancy), consult your doctor. Your doctor may advise you to stop taking Lotensin before becoming pregnant or until pregnancy is confirmed, and may recommend an alternative medicine.
Lotensin is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to the baby.

Breastfeeding

Before breastfeeding or starting to breastfeed, consult your doctor.
Breastfeeding is not recommended for newborns (first few weeks after birth), especially premature babies, while taking Lotensin.
For 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 the medicine before driving, operating machinery, 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.
Take the medicine exactly as prescribed by your doctor. Do not change the dose or stop taking the medicine without consulting your doctor.
High blood pressure often has no symptoms. Many patients with high blood pressure feel fine.
Remember that the medicine does not cure the cause of high blood pressure, but only controls it. Therefore, to lower and maintain blood pressure, you should continue taking the medicine as prescribed.

Dosage

High blood pressure

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. 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 diminished towards the end of the dosing interval. Your doctor may then advise dividing the total daily dose into two equal doses.
The maximum recommended daily dose of Lotensin for patients with high blood pressure is 40 mg. It can be taken in one dose or divided into two doses.
If Lotensin does not sufficiently lower blood pressure, your doctor may prescribe another antihypertensive medicine, such as a thiazide diuretic or a calcium antagonist (initially in low doses). If you were previously treated with diuretics, your doctor may advise stopping them for 2-3 days before starting Lotensin, and then may resume them if necessary. If it is not possible to stop taking diuretics, your doctor may reduce the initial dose of Lotensin (5 mg instead of 10 mg) to avoid excessive lowering of blood pressure.
For patients with a creatinine clearance of ≥ 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 hypotensive effect, your doctor may advise taking 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 you when 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 you have 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 to 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 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, your doctor may increase the daily dose to 10 mg, but it be found that a low initial (2.5 mg once daily) is most appropriate.< p>

How to take the medicine

It is recommended to take the medicine in the morning, at the same time every day.
Lotensin can be taken with or without food.
In the treatment of heart diseases, 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). The first dose of the medicine should be taken in the presence of a doctor, who will then monitor your blood pressure for at least one hour.

Overdose

In case of overdose, consult 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

If you miss a dose, take it as soon as you remember, unless it is close to the time for your next dose. In this case, skip the missed dose and take the next one 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, medical attention may be required.

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

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

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

Uncommon:orthostatic hypotension (drop in blood pressure when standing up), chest pain, angina pectoris, irregular heartbeat, diarrhea, constipation, nausea, vomiting, abdominal pain, gastritis, urticaria, hepatitis (mainly cholestatic), cholestatic jaundice, increased urea in the blood, increased creatinine levels in the blood, drowsiness, insomnia, nervousness, tingling, numbness, and burning sensation, angioedema, swelling of the lips or face, joint pain, arthritis, muscle pain.
Very rare (affects less than 1 in 10,000 people):myocardial infarction or ischemic stroke, 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, pseudo-anaphylactic 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 those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Monitoring of the 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
You can also report side effects 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 20 mg of benazepril hydrochloride.
The other ingredients are:

• tablet core: colloidal anhydrous silica, microcrystalline cellulose, hydrogenated castor oil, lactose monohydrate, maize 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 light orange, round, non-divisible tablets:
packaging containing 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