Tanatril

Leaflet accompanying the packaging: patient information

TANATRIL, 5 mg, tablets

TANATRIL, 10 mg, tablets

TANATRIL, 20 mg, tablets

(Imidapril hydrochloride)

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the 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 packaging 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.

2. Important information before taking Tanatril

When not to take Tanatril:

• If the patient is allergic to imidapril or any other ACE inhibitor or any of the other ingredients of this medicine (listed in section 6);
• If the patient has 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 the patient is 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., in the throat) increases;
• If the patient has hereditary or idiopathic angioedema;
• In the second and third trimesters of pregnancy (it is also recommended to avoid taking Tanatril in early pregnancy, see also the section "Pregnancy and breastfeeding");
• During breastfeeding;
• If the patient has arterial hypertension caused by renal artery stenosis;
• If the patient has kidney disease or is undergoing dialysis;
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting treatment with Tanatril, the patient should discuss it with their doctor, pharmacist, or nurse.

• If the patient is taking diuretics (including potassium-sparing diuretics such as spironolactone, canrenone, amiloride, eplerenone);
• If the patient is on a low-salt diet;
• If the patient is taking potassium or lithium supplements;
• If the patient has recently experienced severe vomiting and/or diarrhea;
• If the patient has ever had facial, lip, tongue, or throat swelling;
• If the patient has heart failure;
• If the patient has 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 the patient has valvular heart disease or heart muscle disease;
• If the patient has kidney problems;
• If the patient has renal artery stenosis or has only one functioning kidney, or if the patient has recently undergone kidney transplantation;
• If the patient is to undergo dialysis or LDL apheresis (removal of cholesterol from the blood using a special device);
• If the patient has liver problems;
• If the patient has diabetes;
• If the patient has psoriasis;
• If the patient is allergic to insect venom and is to undergo desensitization treatment;
• If anesthesia (even dental) or surgery is planned;
• If the patient experiences a dry, persistent cough, worsening at night, they should inform their doctor;
• If the patient has aortic stenosis (narrowing of the aortic valve);
• If the patient has connective tissue disease;
• If the patient is 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 the patient has diabetic kidney disease.
• aliskiren.
• If the patient is taking any of the following medicines, there is an increased risk of angioedema (rapid swelling of the skin and mucous membranes, e.g., in 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.

The patient should inform their doctor if they suspect they are (or may be) pregnant. Tanatril is not recommended during early pregnancy and should not be taken during the second and third trimesters of pregnancy, as it may cause serious harm to the fetus.

Tanatril and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• Medicines commonly used to prevent transplant rejection (e.g., sirolimus, everolimus, and other mTOR inhibitors); see the section "Warnings and precautions";
• ACE inhibitors, such as sacubitril/valsartan (used in heart failure) and racecadotril (used as an anti-diarrheal medicine); see the section "When not to take Tanatril";
• Potassium supplements (including salt substitutes), 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 immunosuppressant used to prevent transplant rejection, and heparin, a medicine used to thin the blood to prevent clots);
• Lithium (used to treat certain types of mental illness);
• 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 heart rhythm disorders);
• Non-steroidal anti-inflammatory drugs;
• Intravenous gold salts (used to treat rheumatoid arthritis) during concomitant treatment with ACE inhibitors;
• 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 (which increase blood pressure, such as adrenaline or used to treat low blood pressure, shock, heart failure, asthma, or allergies);
• Racecadotril, a medicine used to treat diarrhea;
• Wildagliptin, a medicine used to treat diabetes.

The doctor may need to adjust the dose and/or take other precautions:

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

Taking Tanatril with food, drink, and alcohol

Tanatril should be taken before a meal.

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

The doctor will usually advise the patient to stop taking Tanatril before becoming pregnant or as soon as pregnancy is confirmed and recommend an alternative medicine instead of Tanatril, unless the doctor considers it necessary to continue treatment with an ACE inhibitor.

Tanatril should not be taken during the second and third trimesters of pregnancy, as it may cause serious harm to the baby if taken after the third month of pregnancy.

Tanatril should not be taken by breastfeeding mothers. The doctor may choose an alternative treatment for the patient who plans to breastfeed, especially when breastfeeding newborns or premature babies.

Driving and using machines

Some patients may experience side effects such as excessive tiredness and dizziness, which may impair their ability to drive and use machines.

Tanatril contains lactose monohydrate

If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medicine.

Tanatril contains sodium

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

3. How to take Tanatril

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

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. The tablet should be swallowed with a sufficient amount of liquid.

Treatment with the initial dose usually lasts for at least three weeks, after which the doctor may recommend a higher dose, adjusting its size according to the effectiveness of the treatment for the individual patient.

Elderly patients (over 65 years old)

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

Patients with kidney and liver problems

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 once daily, taken under close medical supervision.

Children and adolescents

Tanatril should not be taken by children and adolescents.

Overdose of Tanatril

In case of overdose, excessive lowering of blood pressure may occur, manifested by dizziness, fainting, or slow heart rate. In such cases, the patient should be placed on their back with their legs elevated and a doctor should be called immediately to provide appropriate treatment.

If the patient has taken more than the recommended dose, they should consult their doctor or pharmacist immediately.

Missing a dose of Tanatril

A missed dose should be taken as soon as possible, unless it is almost time for the next dose. The patient should not take a double dose to make up for a missed dose or take two tablets in a short period.

Stopping treatment with Tanatril

The patient should not stop taking the medicine without consulting their doctor, as this may worsen the symptoms of the disease. The doctor will decide how to stop the treatment, usually by gradually reducing the dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

Severe side effects

In case of a severe reaction, known as angioedema, the patient should stop taking Tanatril and consult their doctor or go to the nearest hospital immediately. Immediate medical attention or hospitalization may be necessary.

• 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 may cause weakness, dizziness, or a feeling of "emptiness" in the head, 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 strong, fast, or irregular heartbeat)
• Constriction of the airways (bronchospasm)
• Sinusitis
• Nasal congestion (stuffy or runny nose)
• Tongue inflammation
• Bronchitis
• Shortness of breath (dyspnea)
• Angioedema of the upper airways
• Nausea
• Vomiting
• Diarrhea
• Gastritis (inflammation of the stomach lining)
• Abdominal pain
• Constipation
• Dry mouth
• Bowel obstruction (intestinal obstruction)
• 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
• Rash
• Hives
• Drowsiness
• Sudden swelling of the skin or mucous membranes (angioedema)
• Severe skin reactions, including erythema multiforme (a disease characterized by the appearance of red blisters that can develop into skin blisters, mainly in the mouth, eyes, nose, and genital areas), Stevens-Johnson syndrome (a widespread rash with blisters and peeling skin, mainly in the mouth, eyes, nose, and genital areas), and toxic epidermal necrolysis (a severe form of skin rash causing skin peeling over more than 30% of the body surface)
• Psoriasis-like rash
• Photosensitivity
• Visual disturbances
• Dizziness
• Fast or irregular heartbeat
• Chest pain or feeling of pressure in the chest (angina pectoris)
• Myocardial infarction (heart attack)
• Transient ischemic attack (temporary lack of blood flow to the brain)
• Stroke
• Hair loss (alopecia)
• Acute kidney failure
• Changes in blood test results, including those indicating kidney and liver function
• Impotence
• Discomfort in the mouth and throat
• Increased potassium levels in the blood
• Jaundice (yellowing of the skin and whites of the eyes)

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Tanatril

Store the medicine at a temperature not exceeding 30°C, protected from moisture.

Keep the medicine out of 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 the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tanatril contains

The active substance of Tanatril is imidapril hydrochloride.

The other ingredients are calcium phosphate anhydrous, maize starch, lactose monohydrate, sodium croscarmellose, 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: