Tritace 5

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Tritace 5 (Zenra 5 mg), 5 mg, tablets

Ramipril
Tritace 5 and Zenra 5 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Tritace 5 and what is it used for

Tritace 5 contains the active substance ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Tritace 5 works by:

• reducing the production of substances in the body that increase blood pressure,
• reducing tension and dilating blood vessels,
• making it easier for the heart to pump blood throughout the body.

Tritace 5 can be used to:

• treat high blood pressure (hypertension),
• reduce the risk of heart attack or stroke,
• reduce the risk of or delay the progression of kidney problems (regardless of whether the patient has diabetes),
• treat heart failure when the heart is not pumping enough blood to the rest of the body,
• treat heart failure after a heart attack.

2. Important information before taking Tritace 5

When not to take Tritace 5

• If the patient is allergic to ramipril, another ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If the patient has ever had a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red spots on the palms, soles, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If the patient is taking or has taken sacubitril in combination with valsartan, a medicine used to treat chronic (long-term) heart failure in adults.
• If the patient is undergoing dialysis or other types of blood filtration. Depending on the type of equipment used, Tritace 5 may not be a suitable medicine.
• If the patient has kidney problems related to reduced blood flow to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see below "Pregnancy and breastfeeding").
• If blood pressure is very low or unstable - the doctor will recommend frequent blood pressure checks.
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to the patient, they should not take Tritace 5.
In case of doubts about taking this medicine, the patient should consult a doctor before starting to take Tritace 5.

Warnings and precautions

Before starting to take Tritace 5, the patient should discuss it with their doctor or pharmacist.

• If the patient has heart, liver, or kidney disease.
• If the patient has recently lost a significant amount of electrolytes or fluids (through vomiting, diarrhea, excessive sweating, a low-sodium diet, or long-term use of diuretics or dialysis).
• If the patient is to undergo desensitization treatment for bee or wasp stings (allergy shots).
• If the patient is to receive medicines used to reduce allergic reactions. They may be used during surgical or dental procedures. It may be necessary to stop taking Tritace 5 on the day before the procedure, in case of doubts, the patient should consult their doctor.
• If the patient has high levels of potassium in the blood (as shown by blood tests).
• If the patient is taking medicines or has conditions that may lower sodium levels in the blood. The doctor may recommend regular blood tests, especially to check sodium levels in the blood, particularly in elderly patients.
• If the patient is taking medicines that may increase the risk of angioedema (severe allergic reaction), such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), wildagliptin, neprilysin inhibitors (NEP) (e.g., racecadotril), or sacubitril in combination with valsartan (see section 2 "When not to take Tritace 5").
• If the patient has collagenosis, such as scleroderma or systemic lupus erythematosus.
• The patient should tell their doctor if they are pregnant, think they may be pregnant, or plan to become pregnant. Tritace 5 should not be taken during the first 12 weeks of pregnancy and should not be taken from the 13th week of pregnancy, as it may harm the baby. If the patient becomes pregnant while taking Tritace 5, they should inform their doctor immediately. Before planned pregnancy, the patient should switch to a suitable alternative treatment.
  Breastfeeding
  The patient should not take Tritace 5 if they are breastfeeding.
  Before taking any medicine, the patient should consult their doctor or pharmacist.

  Children and adolescents

  Tritace 5 should not be taken by children and adolescents under 18 years of age, as the safety and efficacy of Tritace 5 have not been established.
  If any of the above situations apply to the patient (or the patient has doubts), before taking Tritace 5, they should consult their doctor.

  Tritace 5 and other medicines

  The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. Tritace 5 may affect the action of other medicines, and other medicines may affect the action of Tritace 5.
  The patient should tell their doctor about taking the following medicines, as they may reduce the effect of Tritace 5:

  • Pain-relieving and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin).
  • Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. The doctor will check the patient's blood pressure.

  The patient should tell their doctor about taking the following medicines, as they may increase the risk of side effects when taken with Tritace 5:

  • sacubitril in combination with valsartan - used to treat chronic (long-term) heart failure in adults (see section 2 "When not to take Tritace 5"),
  • pain-relieving and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin),
  • cancer medicines (chemotherapy),
  • medicines used to prevent organ rejection, such as cyclosporine,
  • diuretics (water pills), such as furosemide,
  • medicines that increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim used alone or in combination with sulfamethoxazole (used to treat bacterial infections), and heparin (a blood thinner),
  • corticosteroids, such as prednisolone,
  • allopurinol (used to reduce uric acid levels in the blood),
  • procainamide (used to treat irregular heart rhythms),
  • temsirolimus (used to treat cancer),
  • sirolimus, everolimus (used to prevent organ rejection);
  • wildagliptin (used to treat type 2 diabetes),
  • racecadotril (used to treat diarrhea),
  • the doctor may recommend changing the dose and/or taking other precautions if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to take Tritace 5" and "Warnings and precautions"). The patient should tell their doctor about taking the following medicines, as their action may be affected when taken with Tritace 5:
    • anti-diabetic medicines, such as oral glucose-lowering medicines and insulin. Tritace 5 may lower blood glucose levels. During treatment with Tritace 5, the patient should regularly check their blood glucose levels;
    • lithium (used to treat mental illnesses). Tritace 5 may increase lithium levels in the blood. The doctor will recommend monitoring lithium levels in the blood.

    If any of the above situations apply to the patient (or the patient has doubts), before taking Tritace 5, they should consult their doctor.

    Tritace 5 with food and drink

    • Drinking alcohol while taking Tritace 5 may cause dizziness and drowsiness. In case of doubts about the amount of alcohol allowed while taking Tritace 5, the patient should discuss it with their doctor regarding the potential interaction between blood pressure-lowering medicines and alcohol.
    • Tritace 5 can be taken with or without food.

    Pregnancy and breastfeeding

    Pregnancy
    If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor before taking this medicine. Tritace 5 should not be taken during the first 12 weeks of pregnancy and should not be taken from the 13th week of pregnancy, as it may harm the baby. If the patient becomes pregnant while taking Tritace 5, they should inform their doctor immediately. Before planned pregnancy, the patient should switch to a suitable alternative treatment.
    Breastfeeding
    The patient should not take Tritace 5 if they are breastfeeding.
    Before taking any medicine, the patient should consult their doctor or pharmacist.

    Driving and using machines

    While taking Tritace 5, the patient may experience dizziness. The risk of dizziness is higher at the beginning of treatment with Tritace 5 and after increasing the dose. If the patient experiences dizziness, they should not drive, use tools, or operate machines.

    Tritace 5 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 Tritace 5

    This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
    Tritace 2.5 (2.5 mg), Tritace 5 (5 mg), and Tritace 10 (10 mg) are available on the market.

    Dosage

    Treatment of high blood pressure

    • The initial dose is usually 1.25 mg or 2.5 mg once a day.
    • The doctor may adjust the dose of Tritace 5 until blood pressure is adequately controlled.
    • The maximum dose is 10 mg once a day.
    • If the patient is taking diuretics (water pills), the doctor may stop or reduce the dose of the diuretic before starting treatment with Tritace 5. Prevention of heart attack or stroke
    • The initial dose is usually 2.5 mg once a day.
    • The doctor may decide to increase the dose.
    • The usual dose is 10 mg once a day. Reducing or delaying kidney problems
    • The initial dose is usually 1.25 mg or 2.5 mg once a day.
    • The doctor may adjust the dose of Tritace 5.
    • The usual dose is 5 mg or 10 mg once a day. Treatment of heart failure
    • The initial dose is usually 1.25 mg once a day.
    • The doctor may adjust the dose of Tritace 5.
    • The maximum dose is 10 mg per day. It is recommended to take the medicine in two divided doses. Treatment after a heart attack
    • The initial dose is usually 1.25 mg to 2.5 mg once a day.
    • The doctor may adjust the dose of Tritace 5.
    • The usual dose is 10 mg per day. It is recommended to take the medicine in two divided doses. Elderly patientsThe doctor will recommend a lower-than-usual initial dose, which will then be gradually increased.

    Taking the medicine

    • The medicine should be taken orally, once a day, at the same time.
    • The patient should take the tablets with a drink of water.
    • The tablets should not be crushed or chewed.

    Taking a higher dose of Tritace 5 than recommended

    The patient should contact their doctor or go to the nearest hospital emergency department.
    The patient should not drive themselves, but ask someone to take them to the hospital or call an ambulance. The patient should take the packaging of the medicine with them, so the doctor knows what medicine was taken.

    Missing a dose of Tritace 5

    • If a dose is missed, the patient should take the next planned dose at the usual time.
    • The patient should not take a double dose to make up for the missed dose.

    In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

    4. Possible side effects

    Like all medicines, Tritace 5 can cause side effects, although not everybody gets them.

    If the patient notices any of the following serious side effects, they should stop taking Tritace 5 and contact their doctor immediately – they may need urgent medical attention:

    • Swelling of the face, lips, or throat, making it difficult to swallow or breathe, as well as itching and rash. These may be symptoms of a severe allergic reaction to Tritace 5.
    • Severe skin reactions, including rash, mouth ulcers, exacerbation of existing skin conditions, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

    If the patient experiences any of the following, they should tell their doctor promptly:

    • Rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, feeling of pressure in the chest, or worsening of existing conditions, including heart attack or stroke.
    • Shortness of breath or cough. These may indicate lung problems.
    • Easy bruising, prolonged bleeding, or any signs of bleeding (e.g., bleeding gums), purple spots on the skin, or more frequent infections, sore throat, and fever, fatigue, weakness, dizziness, or pale skin. These may indicate blood or bone marrow disorders.
    • Severe abdominal pain, which may radiate to the back. These may be symptoms of pancreatitis.
    • Fever, chills, weakness, loss of appetite, abdominal pain, nausea, or vomiting, yellowing of the skin or whites of the eyes (jaundice). These may be symptoms of liver problems, such as inflammation or liver damage.

    Other side effects

    The patient should tell their doctor if any of the following symptoms worsen or persist for more than a few days.
    Common(may affect up to 1 in 10 people)

    • Headache or feeling tired,
    • Dizziness; the risk is higher at the beginning of treatment with Tritace 5 and after increasing the dose,
    • Fainting, hypotension (abnormally low blood pressure), especially after sudden changes from lying to sitting or standing,
    • Dry, persistent cough, sinusitis, or bronchitis, shortness of breath,
    • Abdominal or intestinal pain, diarrhea, nausea, or vomiting,
    • Rash with or without raised patches,
    • Chest pain,
    • Muscle cramps or pain,
    • High levels of potassium in the blood, as shown by laboratory tests.

    Uncommon(may affect up to 1 in 100 people)

    • Balance disorders (dizziness),
    • Itching of the skin and sensory disturbances, such as numbness, tingling, prickling, burning, or crawling sensation on the skin (paresthesia),
    • Loss or disturbance of taste,
    • Sleep disorders,
    • Depression, anxiety, nervousness, or restlessness,
    • Feeling of nasal congestion, difficulty breathing, or worsening of asthma,
    • Intestinal angioedema, which may cause abdominal pain, vomiting, and diarrhea,
    • Heartburn, constipation, or dry mouth,
    • Increased urination during the day,
    • Excessive sweating,
    • Loss or decreased appetite (anorexia),
    • Fast or irregular heartbeat,
    • Swelling of the hands and feet; may be a sign of water retention,
    • Sudden flushing of the face,
    • Blurred vision,
    • Joint pain,
    • Fever,
    • Impotence, decreased libido in men and women,
    • Increased levels of certain white blood cells (eosinophilia) in blood tests,
    • Blood test results indicating changes in the liver, pancreas, or kidneys.

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

    • Feeling of uncertainty, confusion, or disorientation,
    • Red, swollen tongue,
    • Excessive peeling of the skin, itchy papular rash,
    • Nail disorders (e.g., loosening or separation of the nail from the nail bed),
    • Rash or bruising of the skin,
    • Spots on the skin and cold extremities,
    • Redness, itching, swelling, and tearing of the eyes,
    • Hearing or ringing in the ears,
    • Weakness,
    • Decreased levels of red blood cells, white blood cells, or platelets, or hemoglobin levels in blood tests.

    Very rare(may affect up to 1 in 10,000 people)

    • Sensitivity to sunlight.

    Other reported side effects:

    If any of the following symptoms worsen or persist for more than a few days, the patient should tell their doctor.

    • Difficulty concentrating,
    • Swelling of the lips,
    • Low levels of blood cells, as shown by blood tests,
    • Low levels of sodium in the blood, as shown by blood tests,
    • Dark-colored urine, nausea, or vomiting, muscle cramps, feeling of confusion, and seizures, which may be due to abnormal antidiuretic hormone (ADH) secretion (SIADH).

    If the above symptoms occur, the patient should immediately consult their doctor.

    • Changes in finger color upon cooling and feeling of tingling or pain upon warming (Raynaud's phenomenon),
    • Breast enlargement in men,
    • Slowed or impaired reactions,
    • Burning sensation,
    • Disturbances of smell,
    • Hair loss.

    Reporting side effects

    If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
    By reporting side effects, more information can be collected on the safety of this medicine.

    5. How to store Tritace 5

    The medicine should be stored out of sight and reach of children.
    The patient should not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
    There are no special storage precautions.
    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 Tritace 5 contains

    The active substance of Tritace 5 is ramipril. Each tablet contains 5 mg of ramipril.
    The other ingredients are: hypromellose, maize starch, microcrystalline cellulose, sodium stearyl fumarate, red iron oxide (E 172).

    What Tritace 5 looks like and contents of the pack

    The tablets are pale red, oval, divisible, 8 x 4 mm in size, with "5" and "company logo" engraved on one side and "5" and "HMP" on the other side. The tablet can be divided into equal doses.
    Tritace 5 tablets are packaged in packs containing 28 tablets in PVC/Aluminum blisters.
    For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

    Marketing authorization holder in Romania, the country of export:

    ZENTIVA S.A.
    Bulevardul Theodor Pallady nr. 50, sector 3
    Bucharest, 020334
    Romania

    Manufacturer:

    Sanofi S.p.A., Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy
    Delpharm Dijon, 6, Boulevard de l’Europe, 21800 Quetigny, France
    S.C. Zentiva S.A., Bulevardul Theodor Pallady nr. 50, Sector 3, Bucharest, 032266, Romania

    Parallel importer:

    InPharm Sp. z o.o.
    ul. Strumykowa 28/11
    03-138 Warsaw

    Repackaged by:

    InPharm Sp. z o.o. Services sp. k.
    ul. Chełmżyńska 249
    04-458 Warsaw
    Marketing authorization number in Romania, the country of export:9237/2016/01

    Parallel import authorization number: 171/22 Date of approval of the leaflet: 13.04.2022

    [Information about the trademark]