Tanatril

Package Leaflet: Information for the Patient

TANATRIL, 5 mg, tablets

TANATRIL, 10 mg, tablets

TANATRIL, 20 mg, tablets

(Imidapril hydrochloride)

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, pharmacist, or nurse.
• 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 inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Tanatril and what is it used for

The active substance of Tanatril is imidapril. It belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). ACE inhibitors work by widening blood vessels, making it easier for the heart to pump blood and reducing blood pressure.

Tanatril is used to treat high blood pressure.

2. Important information before taking Tanatril

When not to take Tanatril:

• If you are allergic to imidapril or any other ACE inhibitor or any of the other ingredients of this medicine (listed in section 6);
• If you have ever had angioedema (a severe allergic reaction with symptoms such as rash, itching, swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing) associated with previous ACE inhibitor treatment;
• If you are taking a medicine containing sacubitril/valsartan (used to treat a certain type of long-term heart failure in adults), as the risk of angioedema (rapid swelling of the skin and mucous membranes, e.g., around the throat) is increased;
• If you have hereditary or idiopathic angioedema;
• In the second and third trimesters of pregnancy (see also "Pregnancy and breastfeeding");
• During breastfeeding;
• If you have renovascular hypertension;
• If you have kidney disease or are on dialysis;
• If you have diabetes and are treated with aliskiren.

Warnings and precautions

Before taking Tanatril, discuss it with your doctor, pharmacist, or nurse.

• If you are taking diuretics (water pills), including potassium-sparing diuretics (e.g., spironolactone, canrenone, amiloride, eplerenone);
• If you are on a low-salt diet;
• If you are taking potassium or lithium supplements;
• If you have recently experienced severe vomiting or diarrhea;
• If you have ever had facial, lip, tongue, or throat swelling;
• If you have heart failure;
• If you have atherosclerosis (hardening of the arteries), angina pectoris (chest pain due to insufficient blood supply to the heart), or cerebrovascular disease (caused by reduced blood flow in the brain's blood vessels);
• If you have valvular heart disease or cardiac muscle disease;
• If you have kidney problems;
• If you have renal artery stenosis (narrowing of the arteries supplying blood to the kidneys) or have only one functioning kidney, or have recently undergone kidney transplantation;
• If you are to undergo dialysis or LDL apheresis (removal of cholesterol from the blood using a special device);
• If you have liver problems;
• If you have diabetes;
• If you have psoriasis;
• If you are allergic to insect venom and are to undergo desensitization treatment;
• If you are scheduled for anesthesia (even dental) or surgery;
• If you experience a dry, persistent cough, worsening at night, inform your doctor;
• If you have aortic stenosis (narrowing of the aortic valve);
• If you have connective tissue disease;
• If you are taking any of the following medicines used to treat high blood pressure:
• angiotensin receptor blockers (ARBs) (also known as sartans, e.g., valsartan, telmisartan, irbesartan), especially if you have diabetic kidney disease.
• aliskiren.
• If you are taking any of the following medicines, there is an increased risk of angioedema (rapid swelling of the skin and mucous membranes, e.g., around the throat):
• 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.

Tell your doctor if you think you might be pregnant or are planning to have a baby. Tanatril is not recommended during early pregnancy and must not be taken during the second and third trimesters of pregnancy, as it may cause serious harm to the baby.

Tanatril and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

• Medicines used to prevent transplant rejection (e.g., sirolimus, everolimus, and other mTOR inhibitors); see "Warnings and precautions";
• ACE inhibitors, such as sacubitril/valsartan (used in heart failure) and racecadotril (used as an anti-diarrheal medicine); see "When not to take Tanatril";
• Potassium supplements (including potassium-sparing diuretics, e.g., spironolactone, amiloride, triamterene) and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, 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);
• Lithium (used to treat certain mental illnesses);
• Anesthetics (used for general anesthesia);
• Opioids (used to treat severe pain);
• Other medicines used to treat high blood pressure;
• Allopurinol (used to treat gout);
• Cytostatics (used to treat cancer);
• Immunosuppressants (used to treat autoimmune diseases or after transplant surgery to prevent rejection);
• Corticosteroids (used to treat various conditions, including severe asthma and rheumatoid arthritis);
• Procainamide (used to treat irregular heart rhythms);
• Non-steroidal anti-inflammatory medicines;
• Gold salts given intravenously (used to treat rheumatoid arthritis) during concomitant ACE inhibitor therapy;
• Tricyclic antidepressants, neuroleptics (used to treat mental disorders, such as depression, anxiety, schizophrenia);
• Rifampicin (used to treat tuberculosis);
• Insulin and oral anti-diabetic medicines (used to treat diabetes);
• Medicines that reduce stomach acid (used to treat heartburn or stomach ulcers);
• Amines (used to increase blood pressure, such as adrenaline or used to treat low blood pressure, shock, heart failure, asthma, or allergy);
• racecadotril, a medicine used to treat diarrhea;
• wildagliptin, a medicine used to treat diabetes.

Your doctor may need to change the dose and/or take other precautions:

• If you are taking an angiotensin receptor blocker (ARB) or aliskiren (see also "When not to take Tanatril" and "Warnings and precautions").

Taking Tanatril with food, drink, and alcohol

It is recommended to take Tanatril before a meal.

Alcohol may enhance the blood pressure-lowering effect of Tanatril.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Tanatril if you are pregnant or breastfeeding. Your doctor will choose an alternative treatment for you if you are planning to breastfeed, especially if you are breastfeeding newborns or premature babies.

Driving and using machines

Some patients may experience side effects such as excessive tiredness and dizziness, which may affect their ability to drive or operate machinery.

Tanatril contains lactose monohydrate

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

Tanatril contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Tanatril

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

Recommended dose:

Adults

For most patients, the doctor recommends an initial dose of 5 mg, taken once daily, preferably at the same time of day, about 15 minutes before a meal. Swallow the tablet with a sufficient amount of liquid.

Treatment with the initial dose lasts for at least three weeks, after which the doctor may recommend a higher dose, adjusting it according to the patient's response to treatment.

Elderly patients (over 65 years)

The initial dose for elderly patients is usually 2.5 mg, taken once daily.

Patients with renal and hepatic impairment

For these patients, the doctor usually recommends a lower initial dose of 2.5 mg per day.

Patients with an increased risk of symptomatic hypotension

For these patients, the recommended initial dose is 2.5 mg of imidapril per day, taken under close medical supervision.

Children and adolescents

Do not give Tanatril to children and adolescents.

Overdose

If you have taken more than the prescribed dose, you may experience excessive lowering of blood pressure, which can cause dizziness, fainting, or slow heart rate. In this case, lie down with your legs elevated and call your doctor immediately, who will provide appropriate treatment.

If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately.

Missed dose

Take the missed dose as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a forgotten dose or take two tablets in a short period.

Stopping treatment with Tanatril

Do not stop taking Tanatril without consulting your doctor, as this may worsen your condition. Your doctor will decide how to stop treatment, usually by gradually reducing the dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects

If you experience a severe reaction, known as angioedema, stop taking Tanatril and consult your doctor or go to the nearest hospital immediately. You may need urgent medical attention or hospitalization.

• Swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing.

Other possible side effects

Common (may affect up to 1 in 10 people)

• Excessive tiredness
• Cough

Uncommon (may affect up to 1 in 100 people)

• Headache
• Low blood pressure. This can cause weakness, dizziness, or lightheadedness, blurred vision, and fainting.
• Rash, itching

Rare (may affect up to 1 in 1,000 people)

• Decreased white or red blood cell count, found in blood tests
• Allergic reactions, hypersensitivity reactions
• Insomnia
• Fatigue
• Depression
• Taste disturbances
• Swelling
• Balance disorders
• Disorientation
• Ringing, buzzing, or other noises in the ears (tinnitus)
• Palpitations (feeling of rapid or irregular heartbeat)
• Bronchospasm (constriction of the airways, causing wheezing and shortness of breath)
• Sinusitis
• Rhinitis (stuffy or runny nose)
• Glossitis (inflammation of the tongue)
• Bronchitis
• Shortness of breath
• Angioedema of the upper airways
• Nausea
• Vomiting
• Diarrhea
• Gastritis (inflammation of the stomach lining)
• Abdominal pain
• Constipation
• Dry mouth
• Bowel obstruction (blockage of the intestine)
• Pancreatitis (inflammation of the pancreas)
• Hepatitis (inflammation of the liver)
• Kidney problems
• Proteinuria (excess protein in the urine)

Frequency not known (cannot be estimated from the available data)

• Decreased platelet count or certain white blood cell count, anemia due to bone marrow disorders
• Urticaria
• Pruritus
• Somnolence
• Angioedema (rapid swelling of the skin and mucous membranes, e.g., around the throat)
• Severe skin reactions, including erythema multiforme (a condition characterized by red, target-like rashes), Stevens-Johnson syndrome (a widespread rash with blisters and peeling skin, mainly on the lips, eyes, mouth, and genitals), and toxic epidermal necrolysis (a severe skin reaction with peeling of the skin over more than 30% of the body surface)
• Psoriasis-like rash
• Photosensitivity
• Visual disturbances
• Dizziness
• Palpitations (feeling of rapid or irregular heartbeat)
• Chest pain or discomfort (angina pectoris)
• Myocardial infarction (heart attack)
• Transient ischemic attack (temporary lack of blood flow to the brain)
• Stroke
• Alopecia (hair loss)
• Acute kidney failure
• Changes in blood test results, including those indicating kidney and liver function
• Impotence
• Discomfort in the mouth and throat
• Hyperkalemia (elevated potassium levels in the blood)
• Jaundice (yellowing of the skin and eyes)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: 22 49 21 301, Fax: 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 Tanatril

Store the medicine at a temperature not exceeding 30°C, protected 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 carton after "Expiry date". The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tanatril contains

The active substance is imidapril hydrochloride.

The other ingredients are calcium hydrogen phosphate anhydrous, maize starch, lactose monohydrate, sodium carmellose, glycerol distearate (type I).

What Tanatril looks like and contents of the pack

Almost white, oblong, biconvex tablet with a score line on both sides.

The pack contains 2 blisters of 14 tablets each.

Marketing authorization holder

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Tel.: +48 17 865 51 00

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA

ul. Wincentego Pola 21

58-500 Jelenia Góra

Bausch Health Poland sp. z o.o.

ul. Przemysłowa 2

35-959 Rzeszów

Poland

Date of last revision of the leaflet: