Tanatril

Patient Information Leaflet

TANATRIL, 5 mg, tablets
TANATRIL, 10 mg, tablets
TANATRIL, 20 mg, tablets
(Imidapril hydrochloride)
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What Tanatril is and what it is used for
2. What you need to know 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 Tanatril is and what it is used for

The active substance in Tanatril is imidapril. It belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors. ACE inhibitors work by relaxing blood vessels, which makes it easier for the heart to pump blood and leads to a reduction in blood pressure.
Tanatril is indicated for the treatment of high blood pressure (hypertension).

2. Important information before using Tanatril

When not to use Tanatril:

• If the patient is allergic to imidapril or any other angiotensin-converting enzyme (ACE) inhibitor, or any of the other ingredients of this medicine (listed in section 6);
• If the patient has previously experienced angioedema (a serious allergic reaction with symptoms such as rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing) related to previous treatment with an ACE inhibitor;
• If the patient is taking or has recently taken a medication containing sacubitril and valsartan (used to treat certain types of chronic heart failure in adults), as this increases the risk of angioedema (rapid swelling of subcutaneous tissue, e.g. in the throat area);
• If the patient has hereditary or idiopathic angioedema;
• During the second and third trimesters of pregnancy (Tanatril should also be avoided in early pregnancy; see section "Pregnancy and breastfeeding");
• During breastfeeding;
• If the patient has hypertension caused by renal artery stenosis;
• If the patient has kidney disease or is undergoing dialysis;
• If the patient has diabetes or impaired kidney function and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Tanatril, discuss this with your doctor, pharmacist, or nurse.

• If the patient is taking diuretics (water tablets), including potassium-sparing diuretics (e.g. spironolactone, canrenone, amiloride, eplerenone);
• If the patient is on a low-salt diet;
• If the patient is taking potassium supplements or lithium;
• If the patient has had or recently experienced severe vomiting and/or diarrhoea;
• If the patient has ever had swelling of the face, lips, throat, or tongue;
• If the patient has heart failure;
• If the patient has arterial narrowing (arteriosclerosis), angina pectoris (chest pain due to insufficient oxygen supply to the heart), or cerebrovascular disease (caused by reduced blood flow in brain vessels);
• If the patient has heart valve disease or cardiomyopathy;
• If the patient has impaired kidney function;
• If the patient has narrowing of the arteries supplying blood to the kidneys (renal artery stenosis), has only one functioning kidney, or has recently received a kidney transplant;
• If dialysis or LDL apheresis (removal of cholesterol from blood using a special device) is planned;
• If the patient has impaired liver function;
• If the patient has diabetes;
• If the patient has psoriasis;
• If the patient is allergic to insect venom and is undergoing desensitization therapy;
• If general anaesthesia (even dental anaesthesia) or surgery is planned;
• If the patient develops a dry, persistent cough, especially worsening at night, inform the doctor;
• If the patient has aortic stenosis (narrowing of the outflow tract from the left ventricle of the heart);
• If the patient has connective tissue disease;
• If the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonists (AT receptor blockers, ARBs), also known as sartans (e.g. valsartan, telmisartan, irbesartan), particularly if the patient has kidney problems related to diabetes;
• aliskiren.
• If the patient is taking any of the following medicines, the risk of angioedema (rapid swelling of the skin, e.g. in the throat area) is increased:
• racecadotril, a medicine used to treat diarrhoea;
• medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

Inform your doctor if you suspect you are (or might be) pregnant. Tanatril is not recommended during early pregnancy and must not be used during the second and third trimesters of pregnancy, as it may cause severe harm to the unborn child.
Your doctor may monitor kidney function, blood pressure, electrolyte levels (e.g. potassium), and white blood cell count at regular intervals.
See also information under the heading “When not to use Tanatril”.

Tanatril and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Other medicines may affect treatment with Tanatril, especially:

• Medicines most commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors); see section “Warnings and precautions”;
• Neprilysin inhibitors, e.g. sacubitril/valsartan (used in heart failure) and racecadotril (used as an antidiarrhoeal); see section “When not to use Tanatril”;
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (spironolactone, amiloride, triamterene), and other medicines that increase blood potassium levels (e.g. trimethoprim and co-trimoxazole, used for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection; and heparin, an anticoagulant used to prevent blood clots);
• Lithium (used to treat certain psychiatric disorders);
• Anaesthetics (used in general anaesthesia);
• Opioids (used to treat severe pain);
• Other medicines used to treat high blood pressure;
• Allopurinol (used to treat gout);
• Cytostatic agents (used in cancer treatment);
• Immunosuppressants (used to treat autoimmune diseases or to prevent transplant rejection);
• Glucocorticoids (used to treat various conditions, including severe asthma and rheumatoid arthritis);
• Procainamide (used to treat cardiac arrhythmias);
• Non-steroidal anti-inflammatory drugs (NSAIDs);
• Intravenous gold salts (used to treat rheumatoid arthritis) when used concomitantly with ACE inhibitors;
• Tricyclic antidepressants and neuroleptics (used to treat psychiatric disorders such as depression, anxiety, schizophrenia);
• Rifampicin (used to treat tuberculosis);
• Insulin and oral antidiabetic medicines (used to treat diabetes);
• Medicines reducing gastric acidity (used to treat heartburn or peptic ulcer disease);
• Amines (used to increase blood pressure, such as adrenaline, or used to treat hypotension, shock, heart failure, asthma, or allergic reactions);
• Racecadotril, a medicine used to treat diarrhoea;
• Vildagliptin, a medicine used to treat diabetes.

Your doctor may need to adjust the dose and/or take additional precautions:

• If the patient is taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also information under “When not to use Tanatril” and “Warnings and precautions”).

Taking Tanatril with food, drink and alcohol
It is recommended to take Tanatril before meals.
Alcohol may enhance the antihypertensive effect of Tanatril.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Your doctor will usually advise stopping Tanatril before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative treatment unless continued treatment with an ACE inhibitor is considered essential. Tanatril is not recommended during early pregnancy and must not be used during the second and third trimesters of pregnancy, as it may seriously harm the unborn child if used after the third month of pregnancy.
Tanatril must not be used by breastfeeding mothers. Your doctor may choose a different treatment for patients who plan to breastfeed, especially when feeding newborns or premature infants.

Driving and using machines
Some patients may experience adverse effects such as excessive tiredness or dizziness, which may impair the ability to drive or operate machinery.

Tanatril contains lactose monohydrate
If the patient has been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Tanatril contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Tanatril

This medicine should always be used according to the recommendations of a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Recommended dose:
Adults
For most patients, the doctor usually recommends an initial dose of 5 mg taken once daily, preferably at the same time each day, approximately 15 minutes before a meal. The tablet should be taken with an adequate amount of fluid.
Treatment with the initial dose lasts for at least three weeks. Afterwards, if necessary, the doctor may recommend a higher dose, adjusted according to the treatment response in the individual patient.
Use in elderly patients (over 65 years of age)
The initial dose for elderly patients is usually 2.5 mg once daily.
Use in patients with renal or hepatic impairment
In these patients, the doctor usually recommends a lower initial dose of 2.5 mg per day.
Use in patients with increased risk of symptomatic hypotension
In these patients, the recommended initial dose is 2.5 mg of imidapryl once daily, administered under strict medical supervision.
Use in children and adolescents
Tanatril should not be used in children and adolescents.
Taking more than the recommended dose of Tanatril
Overdose may result in excessive lowering of blood pressure, manifesting, among others, as dizziness, fainting, and abnormally slow heart rate. In such a case, the patient should be laid down on their back with legs elevated, and a doctor should be contacted as quickly as possible. The doctor will administer appropriate treatment.
If a dose higher than recommended has been taken, consult a doctor or pharmacist immediately.
Missed dose of Tanatril
A missed dose should be taken as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose, or take two tablets in close succession.
Stopping Tanatril treatment
Do not discontinue imidapryl treatment without consulting a doctor, as this may lead to worsening of disease symptoms. The decision on how to discontinue the medicine is made by the doctor, who usually recommends gradual dose reduction.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Serious adverse reactions
If a serious reaction called angioedema occurs, stop taking Tanatril immediately and consult a doctor or go to the nearest hospital emergency department straight away. Immediate medical assistance or hospitalization may be necessary.
Symptoms include:

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

Other possible adverse reactions
Common (may occur in up to 1 in 10 people)

• Feeling of excessive tiredness
• Cough

Uncommon (may occur in up to 1 in 100 people)

• Headache
• Low blood pressure. This may cause weakness, dizziness, a sensation of "emptiness" in the head, blurred vision and fainting
• Rash, itching

Rare (may occur in up to 1 in 1000 people)

• Decreased number of white blood cells (leukopenia) or red blood cells (anemia), detected in blood tests
• Allergic reactions, hypersensitivity reactions
• Insomnia
• Fatigue
• Depression
• Disturbances in taste perception
• Swelling
• Balance disorders
• Disorientation
• Ringing, buzzing, humming or crackling sounds in the ears (tinnitus)
• Palpitations (sensation of strong, fast or irregular heartbeat)
• Bronchospasm (feeling of tightness in the chest, wheezing and shortness of breath)
• Sinusitis
• Rhinitis (nasal congestion or runny nose)
• Glossitis (inflammation of the tongue)
• Bronchitis
• Shortness of breath (dyspnea)
• Angioedema of the upper respiratory tract
• Nausea
• Vomiting
• Diarrhea
• Gastritis (inflammation of the stomach lining)
• Abdominal pain
• Constipation
• Dry mouth
• Intestinal obstruction
• Pancreatitis
• Hepatitis
• Kidney function disorders
• Proteinuria

Frequency not known (cannot be estimated from available data)

• Decreased number of platelets (thrombocytopenia) or certain white blood cells (agranulocytosis), anemia due to impaired bone marrow function
• Skin rash
• Urticaria
• Somnolence
• Sudden swelling of the skin or mucous membranes (angioedema)
• Severe skin reactions, including erythema multiforme (a disease characterized by red spots which may develop into skin blisters), Stevens-Johnson syndrome (widespread rash with blisters and peeling skin, mainly affecting the area around the mouth, eyes, nose and genital organs), and toxic epidermal necrolysis (a more severe form of rash causing skin peeling from over 30% of the body surface)
• Psoriasis-like rash
• Photosensitivity
• Visual disturbances
• Dizziness
• Sensation of rapid heartbeat, irregular heartbeat
• Pain and pressure in the chest during exertion or due to stress (angina pectoris)
• Myocardial infarction
• Transient ischaemic attack (transient ischaemic attacks)
• Cerebral haemorrhage
• Hair loss (alopecia)
• Acute kidney failure
• Changes in blood test results, including tests indicating kidney and liver function
• Impotence
• Discomfort in the mouth and throat
• Increased potassium levels in blood
• Yellowing of the skin and whites of the eyes (jaundice)

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Tanatril

Store the medicine at a temperature not exceeding 30°C and protect 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 stated month.
Medicines must 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 packaging and other information

What Tanatril contains
The active substance is imidapril hydrochloride.
The other ingredients are: calcium hydrogen phosphate anhydrous, pregelatinized corn starch, lactose monohydrate, sodium croscarmellose, glycerol distearate (type I).
What Tanatril looks like and contents of the pack
Almost white, oblong, biconvex tablet with straight edges, marked with a central break line on both sides.
The pack contains 2 blisters with 14 tablets each.
Marketing Authorisation 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