What Lerdapril is and what it is used for:
Lerdapril is a fixed combination of an ACE inhibitor (enalapril) and a calcium channel blocker (lercanidipine) and lowers arterial blood pressure.
Lerdapril is used for the treatment of high arterial blood pressure (hypertension) in adult patients whose blood pressure is not adequately controlled with lercanidipine 10 mg alone.
Lerdapril is not used for the initial treatment of hypertension.

Active substances: enalapril and lercanidipine.
Each tablet contains 10 mg enalapril maleate, equivalent to 7.64 mg enalapril, and 10 mg lercanidipine hydrochloride, equivalent to 9.44 mg lercanidipine.

Other ingredients:
Core: microcrystalline cellulose, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate type A, sodium bicarbonate
Coating: white Opadry II 85F18422, composition: polyvinyl alcohol, titanium dioxide (E171), macrogol PEG 3350, talc

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Do not take Lerdapril:
• if you are allergic to enalapril or lercanidipine or any of the other ingredients of this medicine.
• if you are allergic to medicines similar to those contained in Lerdapril, e.g. ACE inhibitors or calcium channel blockers.
• if you have ever experienced swelling of the face, lips, mouth, tongue, or throat after taking ACE inhibitors, causing difficulty swallowing or breathing (angioedema), or when the cause was unknown.
• if you have diabetes or serious kidney problems and are taking blood-pressure-lowering medicines containing aliskiren.
• if you are more than three months pregnant (it is better to avoid Lerdapril also in early pregnancy).
• if you suffer from heart diseases:

- obstruction of blood flow from the heart, including narrowing of the aortic valve.

- untreated heart failure.
• discomfort in the chest at rest or worsening or more frequent attacks (unstable angina).
• within one month after a heart attack (myocardial infarction).
• if you have severe kidney problems or are on dialysis.
• if you have severe liver problems.
• if you are taking inhibitors of liver metabolism such as:

- antifungal medicines (e.g. ketoconazole, itraconazole).

- macrolide antibiotics (e.g. erythromycin, troleandomycin).

- antiviral medicines (e.g. ritonavir).
• if you are taking ciclosporin at the same time.
• together with grapefruit or grapefruit juice.

Warnings and precautions:
Before taking Lerdapril, talk to your doctor or pharmacist. Tell your doctor or pharmacist:
• if you have low blood pressure (if you experience fainting or dizziness when standing up).
• if you have recently had vomiting or diarrhea.
• if you are on a low-salt diet, take potassium supplements, potassium-sparing medicines, or potassium-containing salt substitutes.
• if you are over 70 years of age.
• if you suffer from heart disease.
• if you have impaired blood flow to the brain.
• if you have kidney problems (including kidney transplantation).
• if you are treated with dialysis.
• if you have liver problems.
• if there is a reduction in white blood cells of various degrees (leukopenia, agranulocytosis), a reduction in platelets (thrombocytopenia), or a reduction in red blood cells (anemia).
• if you have a collagen vascular disease (e.g. lupus erythematosus, rheumatoid arthritis, or scleroderma), are undergoing immunosuppressive therapy, or are taking medicines such as allopurinol or procainamide, or any combination of these.
• if you are Black, you should know that in Black patients the risk of allergic reactions after taking ACE inhibitors is higher, accompanied by swelling of the face, lips, mouth, tongue, or throat, causing difficulty swallowing or breathing.
• if you have diabetes.
• if you develop a persistent dry cough.
• if you think you are pregnant (or might become pregnant); Lerdapril is not recommended in early pregnancy and must not be used from the third month of pregnancy, as it may cause serious harm to the fetus.
• if you are taking medicines for high blood pressure:
• angiotensin II receptor blockers (ARBs) (also known as “sartans” – e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems due to diabetes;
• aliskiren.
• if you are taking the following medicines, the risk of angioedema (swelling of the subcutaneous tissues in the throat area) increases:
• sirolimus, everolimus, and other medicines of the mTOR inhibitor class (used to prevent rejection of transplanted organs).

Your doctor may regularly order tests to check kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).

You should know that this medicine lowers blood pressure less effectively in Black patients compared with white patients.

If you are planning to undergo any of the following procedures in the near future, tell your doctor that you are taking Lerdapril:
• surgery or anesthesia (including dental anesthesia)
• mechanical removal of cholesterol from the blood (LDL apheresis)
• a desensitization course to reduce allergic reactions to bee or wasp stings.

Contact your doctor immediately if the following symptoms occur:
• yellowing of the skin and mucous membranes
In this case, stop taking Lerdapril and consult your doctor.

Children and adolescents: Not used in children under 18 years of age, as the safety and effectiveness of the medicine have not been established.

Using Lerdapril with other medicines:
Tell your doctor or pharmacist if you are currently taking, have recently taken, or plan to take any other medicines. When Lerdapril is used together with other medicines, the effects of Lerdapril or other medicines may be increased or decreased, or certain side effects may occur more frequently.

Tell your doctor if you are taking any of the following medicines:
• potassium-containing products (including salt substitutes).
• blood-pressure-lowering medicines such as diuretics, angiotensin II receptor blockers (ARBs), or aliskiren.
• lithium (a medicine used to treat certain types of depression).
• tricyclic antidepressants.
• medicines used to relieve severe pain (narcotic medicines such as morphine).
• antipsychotic medicines.
• non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and are used to relieve pain).
• certain medicines for pain and arthritis.
• cough and cold medicines and slimming medicines containing sympathomimetic substances.
• medicines for the treatment of diabetes (including antidiabetic medicines and insulin).
• astemizole or terfenadine (antiallergic medicines).
• amiodarone or quinidine (antiarrhythmic medicines).
• phenytoin or carbamazepine (used in the treatment of epilepsy).
• rifampicin (used to treat tuberculosis).
• digoxin (used for heart problems).
• midazolam (used for sleep disorders).
• beta-blockers (used to treat high blood pressure and heart problems).
• the anti-ulcer medicine cimetidine at daily doses above 800 mg.
• medicines used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See subsection “Warnings and precautions”.
• potassium supplements or potassium-containing salt substitutes, diuretics (especially potassium-sparing ones), and other medicines that may increase potassium levels in your body (such as heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole).

Your doctor may change your dose and/or take additional precautions:
• if you are taking angiotensin II receptor blockers (ARBs) or aliskiren (see sections “Do not take Lerdapril” and “Warnings and precautions”).

Taking Lerdapril with food, drink, and alcohol: Lerdapril must not be taken with grapefruit or grapefruit juice. Alcohol may increase the effect of Lerdapril; therefore, do not take it with alcohol and strictly limit alcohol consumption.

Pregnancy:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will usually advise you to stop taking Lerdapril before becoming pregnant or as soon as you know you are pregnant and will prescribe another medicine instead. Lerdapril is not recommended in early pregnancy and must not be used from the third month of pregnancy, as its use during this period may affect the fetus.

Breastfeeding:
Tell your doctor if you are breastfeeding or plan to start breastfeeding. Breastfeeding newborns (the first few weeks after birth), especially premature infants, is not recommended during Lerdapril use. For older infants, your doctor will inform you about the benefits and risks of using Lerdapril during breastfeeding compared with other treatments.

Driving and using machines: If dizziness, weakness, fatigue, or drowsiness occurs during treatment with this medicine, do not drive or operate machinery.

Lerdapril contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Method of administration: Always use exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults:
Unless your doctor prescribes otherwise, the usual dose is one tablet once daily at the same time each day. It is preferable to take the tablet at least 15 minutes before breakfast. Tablets should be swallowed with water.

Patients with kidney disease / elderly patients: The dose will be selected by the doctor depending on kidney function.

Overdose:
If you accidentally take more Lerdapril than prescribed, contact your doctor or a medical facility immediately. Take the medicine with you. Overdose may cause a significant drop in blood pressure and irregular or rapid heartbeat.

Missed dose: Do not take a double dose to make up for a missed dose. If you forget to take Lerdapril, skip the missed dose and continue with the usual dosing schedule.

Stopping Lerdapril: Do not stop treatment with Lerdapril on your own initiative without consulting your doctor.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

Possible side effects:
If any of the following side effects occur during treatment, contact your doctor immediately:
• allergic reaction accompanied by swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing.
• allergic skin reactions, including rash, mouth ulcers, worsening of existing skin disease, redness, blistering of the skin (such as Stevens–Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
• fainting, dizziness, or blurred vision may occur due to a rapid drop in blood pressure; lying down is recommended.

Side effects observed during treatment with Lerdapril
Common: cough, dizziness, headache.
Uncommon: changes in blood such as reduced platelet count, increased potassium level, anxiety, dizziness on standing, vertigo, increased heart rate, rapid or irregular heartbeat (palpitations), sudden flushing of the face, neck, or upper chest, low blood pressure, abdominal pain, constipation, nausea, increased liver enzymes, skin redness, joint pain, frequent urination, weakness, fatigue, hot flushes, ankle swelling.
Rare: anemia, allergic reactions, ringing in the ears, collapse due to very low blood pressure, dry throat, sore throat, dyspepsia, salty taste on the tongue, diarrhea, dry mouth, swelling of lips and gums, skin rash, urticaria, nighttime urination, increased urine output, impotence.

Additional side effects observed when taking enalapril or lercanidipine alone

Enalapril
Very common: blurred vision, dizziness, cough, nausea, weakness.
Common: depression, fainting, chest pain, changes in heart rhythm, angina, shortness of breath, diarrhea, abdominal pain, taste disturbance, skin rash, fatigue, increased potassium level, increased creatinine level (usually detected by blood tests).
Uncommon: anemia (including aplastic and hemolytic), sudden drop in blood pressure, confusion, insomnia or drowsiness, numbness or tingling sensations, heart attack (due to very low blood pressure in certain high-risk patients, including those with heart or cerebral circulation problems), stroke (for the same reason), runny nose, sore throat, hoarseness, asthma, slowed intestinal movement, pancreatitis, dyspepsia, gastric irritation, dry mouth, ulcer, anorexia, increased sweating, itching, urticaria, hair loss, impaired kidney function, kidney failure, high levels of protein in urine, impotence, muscle cramps, malaise, fever, low blood sugar and sodium levels, high blood urea levels (detected by blood tests).
Rare: blood disorders such as reduced platelet count, bone marrow suppression, autoimmune diseases, abnormal dreams or sleep problems, Raynaud’s phenomenon (whitening of fingers and toes with coldness due to reduced blood flow), lung infiltrates, inflammation of the nasal cavity, pneumonia, swelling of the tongue, liver problems such as impaired liver function, hepatitis, jaundice (yellowing of the skin or eyes), increased bilirubin levels (detected by blood tests), reduced urine output, enlargement of breast tissue in male patients.
Very rare: intestinal swelling (intestinal angioedema).
Unknown: excessive secretion of antidiuretic hormone leading to fluid retention, resulting in weakness, fatigue, or confusion. Reported symptoms include fever, inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Rash, photosensitivity, or other skin disorders may occur.

Lercanidipine
Rare: angina pectoris (chest pain), nausea, heartburn, muscle pain.
Very rare: chest pain.
In patients with angina pectoris, an increase in frequency, duration, or severity of attacks may occur. Isolated cases of heart attack may be observed.

If you notice any side effects, including those not listed in this leaflet, inform your doctor or pharmacist.

Storage conditions:

- Store out of sight and reach of children.

- Do not use after the expiry date. The expiry date refers to the last day of the indicated month.

- Store at temperatures below 30°C.

- Store in the original package to protect from light and moisture.

- Do not dispose of medicines via wastewater or household waste. Ask your pharmacist about proper disposal. These measures will help protect the environment.

Dispensing conditions: Pharmaceutical product group II, dispensed with prescription form N3.

Marketing authorization holder:
New Pharma LLC
Georgia, Tbilisi, 0154, 18 I. Evdoshvili St.
Stamped

Manufacturer:
Balkanpharma – Dupnitsa AD
Bulgaria, Dupnitsa 2600, 3 Samokovsko Shosse St.