Tritace 2,5

Leaflet accompanying the packaging: information for the user

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

Tritace 2.5 (Zenra 2.5 mg)

2.5 mg, tablets

Ramipril
Tritace 2.5 and Zenra 2.5 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.
• In case of 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 2.5 and what is it used for
• 2. Important information before taking Tritace 2.5
• 3. How to take Tritace 2.5
• 4. Possible side effects
• 5. How to store Tritace 2.5
• 6. Contents of the packaging and other information

1. What is Tritace 2.5 and what is it used for

Tritace 2.5 contains the active substance ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Tritace 2.5 works by:

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

Tritace 2.5 can be used to:

• treat high blood pressure (hypertension),
• reduce the risk of heart attack or stroke,
• reduce the risk or slow 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 attack complicated by heart failure.

2. Important information before taking Tritace 2.5

When not to take Tritace 2.5

• 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". Its symptoms include: itching, hives, red spots on the palms of the hands,

feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.

• If the patient has taken or is taking 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 type of blood filtration. Depending on the type of equipment used, Tritace 2.5 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 2.5.
In case of doubts about taking this medicine, the patient should consult a doctor before starting to take Tritace 2.5.

Warnings and precautions

Before starting to take Tritace 2.5, 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 to reduce allergic reactions to bee or wasp stings.
• If the patient is to receive medicines used for anesthesia. They may be used during surgical or dental procedures. It may be necessary to stop taking Tritace 2.5 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 order 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 (a severe allergic reaction), such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), wildagliptin, neprilysin inhibitors (NEP) (such as racecadotril), or sacubitril in combination with valsartan (see section 2 "When not to take Tritace 2.5").
• 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 2.5 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 2.5, they should inform their doctor immediately. Before planned pregnancy, the therapy should be changed to a suitable alternative treatment.
  Breastfeeding
  The patient should not take Tritace 2.5 if they are breastfeeding.
  Before taking any medicine, the patient should consult their doctor or pharmacist.

  Driving and using machines

  While taking Tritace 2.5, the patient may experience dizziness. The risk of dizziness is higher at the beginning of treatment with Tritace 2.5 and after increasing the dose. If the patient experiences dizziness, they should not drive, use tools, or operate machines.

  Tritace 2.5 contains sodium

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

  3. How to take Tritace 2.5

  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 hypertension

  • The initial dose is usually 1.25 mg or 2.5 mg once a day.
  • The doctor may adjust the dose of the medicine until adequate blood pressure control is achieved.
  • The maximum dose is 10 mg once a day.
  • In case of diuretic use (diuretic medicines), the doctor may discontinue or reduce the dose of the diuretic before starting treatment with Tritace 2.5.

  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 slowing the progression of kidney problems

  • The initial dose is usually 1.25 mg or 2.5 mg once a day.
  • The doctor may modify the dosing of the medicine.
  • 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 modify the dosing of the medicine.
  • The maximum dose is 10 mg per day. It is recommended to administer the medicine in two divided doses.

  Treatment after heart attack

  • The initial dose is usually 1.25 mg to 2.5 mg once a day.
  • The doctor may modify the dosing of the medicine.
  • The usual dose is 10 mg per day. It is recommended to administer the medicine in two divided doses.

  Elderly patients
  The doctor will recommend a lower-than-usual initial dose, which will then be gradually increased.

  Taking the medicine

  • This medicine should be taken orally, once a day, at the same time.
  • The patient should take the tablets with a liquid.
  • The patient should not crush or chew the tablets.

  Taking a higher dose of Tritace 2.5 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 drive them to the hospital or call an ambulance. The patient should take the packaging of the medicine with them, so that the doctor knows which medicine was taken.

  Missing a dose of Tritace 2.5

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

  4. Possible side effects

  Like all medicines, Tritace 2.5 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 2.5 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 2.5.
  • Severe skin changes, including rash, mouth ulcers, worsening 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 more severe, serious conditions, including heart attack or stroke.
  • Shortness of breath or cough. These may indicate lung problems.
  • Easy bruising, longer-than-usual bleeding time, 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, vomiting, yellowing of the skin or whites of the eyes (jaundice). These may be symptoms of liver problems, such as inflammation or damage to the liver.

  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 2.5 and after increasing the dose,
  • Fainting, hypotension (abnormally low blood pressure), especially after sudden change from lying to sitting or standing,
  • Dry, persistent cough, sinusitis or bronchitis, shortness of breath,
  • Abdominal or intestinal pain, diarrhea, indigestion, 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 disturbances,
  • Depression, anxiety, nervousness, or restlessness,
  • Nasal congestion, difficulty breathing, or worsening of asthma,
  • Intestinal angioedema, characterized by abdominal pain, vomiting, and diarrhea,
  • Heartburn, constipation, or dry mouth,
  • Increased urine production during the day,
  • Excessive sweating,
  • Loss or decreased appetite (anorexia),
  • Rapid or irregular heartbeat,
  • Swelling of the hands and feet; may be a sign of excessive 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 laboratory tests,
  • Laboratory test results indicating changes in the liver, pancreas, or kidneys.

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

  • Feeling of uncertainty, confusion, 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 disturbances and ringing in the ears,
  • Weakness,
  • Decreased levels of red blood cells, white blood cells, or platelets, or hemoglobin levels in laboratory 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,
  • Lip swelling,
  • Low levels of blood cells, as shown by laboratory tests,
  • Low levels of sodium in the blood, as shown by laboratory tests,
  • Dark-colored urine (concentrated urine), nausea, or vomiting, muscle cramps, confusion, and seizures, which may be due to abnormal secretion of antidiuretic hormone (ADH). If these 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 disturbed 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 gathered on the safety of the medicine.

  5. How to store Tritace 2.5

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

  The active substance of the medicine is ramipril.
  Each tablet contains 2.5 mg of ramipril.
  The other ingredients are: hypromellose, cornstarch, microcrystalline cellulose, sodium stearylfumarate, yellow iron oxide (E 172).

  What Tritace 2.5 looks like and what the packaging contains

  The tablets are yellow or yellowish, oblong, scored, 8 x 4 mm in size, with "2.5" and the company logo engraved on one side and "2.5" and "HMR" on the other side. The tablet can be divided into equal doses.
  Tritace 2.5 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:9236/2016/01

  Parallel import authorization number: 200/22 Date of leaflet approval: 10.05.2022

  [Information about the trademark]