Trandolapril Aurobindo

Package Leaflet: Information for the User

Trandolapril Aurobindo, 2 mg, hard capsules

Trandolapril

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

• Keep this package 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.

Contents of the package leaflet:

• 1. What Trandolapril Aurobindo is and what it is used for
• 2. Important information before taking Trandolapril Aurobindo
• 3. How to take Trandolapril Aurobindo
• 4. Possible side effects
• 5. How to store Trandolapril Aurobindo
• 6. Contents of the pack and other information

1. What Trandolapril Aurobindo is and what it is used for

Trandolapril Aurobindo contains trandolapril, which belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). Their action is to widen blood vessels, making it easier for the heart to pump blood to the entire body. This helps to lower blood pressure.

Trandolapril Aurobindo is used to treat mild or moderate high blood pressure and heart failure after a heart attack.

2. Important information before taking Trandolapril Aurobindo

When not to take Trandolapril Aurobindo

• if you are allergic (hypersensitive) to trandolapril or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to other ACE inhibitors,
• after the third month of pregnancy (also avoid taking the medicine during early pregnancy; see section "Pregnancy and breastfeeding"),
• if you have ever had symptoms such as swelling of the face, tongue, or throat, intense itching, skin rash, difficulty swallowing, and/or breathing during previous treatment with an ACE inhibitor or in any other circumstances (this condition is called angioedema),
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren,
• if you are taking a medicine that combines sacubitril and valsartan (used to treat long-term (chronic) heart failure in adults), as the risk of angioedema increases.

In case of doubt, consult your doctor.

Warnings and precautions

Before starting treatment with Trandolapril Aurobindo, discuss it with your doctor or pharmacist if:

• you are taking any of the following medicines, as the risk of angioedema may increase:
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent the rejection of a transplanted organ and to treat cancer (e.g., temsirolimus, sirolimus, everolimus),
• vildagliptin, a medicine used to treat diabetes,
• you have heart problems (heart failure) or any kidney or liver disease
• your doctor may closely monitor you and recommend a dose change,
• you have ever had an allergic reaction (called Quincke's edema or angioedema) when taking other ACE inhibitors (e.g., perindopril or ramipril), with swelling of the face, lips, tongue, or throat, causing difficulty swallowing or breathing),
• you have kidney problems caused by narrowing of the renal artery,
• you are on a low-sodium diet,
• you are undergoing dialysis therapy - your doctor may recommend taking a different medicine,
• you experience coughing - your doctor may decide to use a different medicine,
• you have recently had severe vomiting or diarrhea,
• you have narrowing of the aortic valve (narrowing of one of the heart valves) or other heart problems that make it difficult for blood to flow out of the heart,
• you have a disease called primary hyperaldosteronism,
• you are undergoing desensitization treatment for insect venom (bees or wasps),
• you have diabetes,
• you are undergoing mechanical removal of cholesterol from the blood,
• a surgical procedure is planned or anesthesia is to be administered - inform your doctor or dentist that you are taking trandolapril,
• you have collagenosis, such as scleroderma or lupus - inform your doctor immediately if you experience any signs of infection while taking trandolapril,
• 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 Trandolapril Aurobindo"

Inform your doctor if you have previously taken trandolapril and experienced side effects.

Your doctor may recommend a kidney function test before starting Trandolapril Aurobindo and periodically during treatment.

Trandolapril Aurobindo should not be used in children.

Trandolapril Aurobindo and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take:

• other medicines used to treat high blood pressure, including diuretics, such as bendroflumethiazide
• anti-inflammatory painkillers (NSAIDs - non-steroidal anti-inflammatory drugs, e.g., ibuprofen, diclofenac, indomethacin, acetylsalicylic acid, and COX-2 inhibitors)
• lithium or tricyclic antidepressants (e.g., amitriptyline, doxepin)
• medicines used to treat diabetes (such as insulin, glibenclamide, or gliclazide)
• antacids
• allopurinol (used to treat gout) or procainamide (used to treat heart rhythm disorders)
• immunosuppressants (e.g., cyclosporine), corticosteroids (e.g., prednisolone, hydrocortisone), or anticancer drugs
• antipsychotic drugs, such as chlorpromazine, thioridazine, flupentixol
• medicines used to treat low blood pressure, shock, colds, and asthma (e.g., (pseudo)ephedrine and (nor)adrenaline)
• medicines most commonly used to prevent the rejection of a transplanted organ (sirolimus, everolimus, and other mTOR kinase inhibitors) - see the section "Warnings and precautions"
• racecadotril,
• vildagliptin, potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to thin the blood to prevent clots).

Your doctor may recommend a dose change and/or take other precautions:

• if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "When not to take Trandolapril Aurobindo" and "Warnings and precautions").

Trandolapril Aurobindo with food and drink

The medicine can be taken before, during, or after a meal, with a glass of water.

It is not recommended to consume alcohol while taking Trandolapril Aurobindo.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Your doctor will usually recommend stopping Trandolapril Aurobindo before planned pregnancy or immediately after confirming pregnancy and recommend taking a different medicine instead of Trandolapril Aurobindo.

It is not recommended to take Trandolapril Aurobindo during early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby.

Inform your doctor about breastfeeding or intention to breastfeed.

It is not recommended to take Trandolapril Aurobindo during breastfeeding.

Your doctor may recommend taking a different medicine.

Driving and using machines

Trandolapril Aurobindo may cause dizziness or fainting, especially when starting treatment.

Alcohol, even in small amounts, can enhance these effects.

Do not drive, operate machinery, or perform other activities that require increased attention for a few hours after taking the first dose or after each dose increase.

Wait and observe how the capsules affect you.

In case of doubt, always consult your doctor or pharmacist.

Trandolapril Aurobindo contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Trandolapril Aurobindo

Always take this medicine exactly as your doctor or pharmacist has told you.

In case of doubt, consult your doctor or pharmacist.

Swallow the capsules whole with a small amount of water.

Do not crush or chew the capsules.

Trandolapril Aurobindo can be taken before, during, or after a meal, but try to take the capsules at the same time every day.

The number of capsules to take depends on your disease.

If you are already taking diuretics (water pills), your doctor may recommend reducing their dose or stopping them before starting Trandolapril Aurobindo.

Always follow your doctor's instructions.

High blood pressure (hypertension)

The recommended initial dose is 0.5 mg of trandolapril once a day.

The usual maintenance dose is 1 mg or 2 mg of trandolapril once a day.

Doses of 0.5 mg and 1 mg cannot be obtained using Trandolapril Aurobindo capsules.

The maximum dose of Trandolapril Aurobindo is 4 mg per day.

Patient with heart failure after a heart attack

Treatment will be started in a hospital setting.

The usual initial dose is 0.5 mg once a day, given 3-7 days after the heart attack.

The dose will be increased the next day to 1 mg and gradually increased to a maximum of 4 mg per day.

Doses of 0.5 mg and 1 mg cannot be obtained using Trandolapril Aurobindo capsules.

Patient with kidney problems

Your doctor will adjust the dose based on laboratory test results.

In patients with severe kidney problems, the maximum dose of Trandolapril Aurobindo is 2 mg once a day.

Patient with liver problems

The initial dose is 0.5 mg per day.

Then, your doctor may adjust the dose if necessary.

In patients with severe liver problems, the maximum dose of Trandolapril Aurobindo is one 2 mg capsule per day.

Dosing in adult patients previously treated with diuretics

Diuretic treatment should be stopped at least 72 hours (3 days) before starting Trandolapril Aurobindo and/or treatment may be started with a dose of 0.5 mg once a day.

Then, the dose will be adjusted based on the treatment results.

Overdose of Trandolapril Aurobindo

Possible symptoms include increased coughing, dizziness, anxiety, or fainting, significantly low blood pressure, shock, slowed mental processes (lethargy), slow heart rate, electrolyte disturbances, and worsening kidney function.

Immediately contact your doctor or go to the emergency department of the nearest hospital.

Remember to take the packaging and remaining capsules with you.

Missed dose of Trandolapril Aurobindo

If you miss a dose, take it as soon as possible.

However, if it is almost time for the next dose, do not take the missed dose.

Do not take a double dose to make up for the missed dose.

Stopping treatment with Trandolapril Aurobindo

Initial symptoms may return after stopping treatment.

It is important to take the capsules for as long as your doctor has prescribed.

Do not stop treatment because you feel better.

In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Trandolapril Aurobindo can cause side effects, although not everybody gets them.

If you experience a rash, blisters, or other skin symptoms, itching, or a high temperature, stop taking Trandolapril Aurobindo and contact your doctor immediately.

Immediately inform your doctor if you experience:

• swelling of the face, tongue, and/or throat, intense redness of the skin (hives) and/or difficulty swallowing and/or breathing (angioedema),
• feeling unwell after the first dose (some patients may react to the first dose with dizziness, weakness, fainting, and nausea),
• infection with throat pain or mouth ulcers during treatment with the medicine,
• increased tendency to bleeding and bruising while taking the medicine.

The following side effects have also been reported:

Frequent(occurring in less than 1 in 10 treated patients)

• dizziness
• headache
• low blood pressure
• cough
• weakness

Uncommon(occurring in less than 1 in 100 treated patients)

• upper respiratory tract infection
• insomnia, decreased libido
• drowsiness
• palpitations (feeling of irregular or rapid heartbeat)
• redness of the skin with a feeling of heat
• upper respiratory tract inflammation, nasal congestion
• nausea, diarrhea, abdominal pain, constipation, gastrointestinal disorder
• itching, rash
• back pain, muscle cramps, limb pain
• erectile dysfunction
• malaise, chest pain, peripheral edema, feeling of abnormal condition

Rare(occurring in less than 1 in 1000 treated patients)

• urinary tract infection, bronchitis, pharyngitis
• leukopenia, anemia, blood platelet disorders, white blood cell disorders
• hypersensitivity
• abnormal laboratory test results: increased blood glucose levels (hyperglycemia), decreased sodium levels in the blood (hyponatremia), increased cholesterol levels in the blood (hypercholesterolemia), increased triglyceride and cholesterol levels in the blood (hyperlipidemia), increased uric acid levels in the blood (hyperuricemia)
• gout, loss of appetite, increased appetite, abnormal enzyme activity
• hallucinations, depression, sleep disorders, anxiety, agitation, apathy
• stroke, fainting, clonic muscle spasms, paresthesia (feeling of numbness, tingling), migraine, migraine without aura, taste disorders
• blepharitis, conjunctivitis, vision disorders, eye disorders
• tinnitus
• myocardial infarction, myocardial ischemia, angina pectoris, heart failure, ventricular tachycardia, tachycardia, bradycardia
• hypertension, vascular changes (angiopathy), orthostatic hypotension (sudden drop in blood pressure when changing position from lying to standing), peripheral vascular disorders, varicose veins
• dyspnea, epistaxis, throat pain, cough with expectoration, breathing disorders
• hematemesis, gastritis, vomiting, nausea, gastrointestinal disorders, dry mouth, flatulence
• hepatitis, increased bilirubin levels (bile pigment)
• angioedema, psoriasis, excessive sweating, rash, acne, dry skin, skin disorders
• arthralgia, myalgia, osteoarthritis
• renal failure, azotemia (elevated levels of nitrogen compounds in the blood), polyuria, frequent urination
• congenital vascular malformation, fish scales
• edema, feeling of fatigue
• injury

After the medicine was placed on the market, the following side effects were reported:

• agranulocytosis (significant, rapidly progressing decrease in granulocyte count), pancytopenia (decrease in red, white blood cells, and platelets)
• increased potassium levels in the blood (hyperkalemia)
• transient ischemic attack, cerebral hemorrhage, balance disorders
• atrioventricular block, cardiac arrest, arrhythmia
• bronchospasm
• intestinal obstruction, pancreatitis
• jaundice
• alopecia, urticaria, severe form of erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis
• myalgia
• fever
• abnormal laboratory test results (increased creatinine and urea levels in the blood, increased alkaline phosphatase and lactate dehydrogenase activity, abnormal ECG, decreased platelet count, abnormal liver function tests, increased transaminase activity, decreased hemoglobin levels, decreased hematocrit values).

The following side effects have been observed in patients taking other medicines in the same therapeutic group as Trandolapril Aurobindo:

• hemolytic anemia,
• confusion,
• blurred vision,
• sinusitis, rhinitis, glossitis,
• angioedema of the intestines,
• erythema multiforme, psoriasis-like skin inflammation.

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 Monitoring of Adverse Reactions to Medicinal Products

Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

Al. Jerozolimskie 181C, PL-02 222 Warszawa

Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309

e-mail: ndl@urpl.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 Trandolapril Aurobindo

Keep the medicine out of the sight and reach of children.

No special storage precautions are required.

Do not use this medicine after the expiry date stated on the carton and blister/bottle after "Expiry date:".

The expiry date refers to the last day of that 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 Trandolapril Aurobindo contains

• The active substance is trandolapril. One hard capsule contains 2 mg of trandolapril. Other ingredients are lactose monohydrate, cornstarch, sodium stearyl fumarate, iron oxide black (E 172), iron oxide yellow (E 172), erythrosine (E 127), titanium dioxide (E 171), sodium lauryl sulfate, gelatin, shellac
• and other ingredients.

What Trandolapril Aurobindo looks like and contents of the pack

Hard gelatin capsules filled with white or almost white granules, with a black ink print of the symbol "F" on the opaque red cap and the symbol "06" on the opaque red body, size "4".

• Transparent PVC/PE/PVDC/Aluminum blisters containing 14, 20, 24, 28, 30, 40, 50, 56, 60, 84, 90, 98, or 100 capsules, in a cardboard box.
• HDPE bottles with PP cap and desiccant, containing 30 or 1000 capsules, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront,

Floriana FRN 1913,

Malta

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000.

Malta

Date of last revision of the package leaflet: