Tritace 10

Leaflet accompanying the packaging: information for the user

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

TRITACE 10, 10 mg, tablets

Ramipril

You should carefully read the contents of the leaflet before using 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 as yours.
• 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 10 and what is it used for
• 2. Important information before taking Tritace 10
• 3. How to take Tritace 10
• 4. Possible side effects
• 5. How to store Tritace 10
• 6. Contents of the packaging and other information

1. What is Tritace 10 and what is it used for

Tritace 10 contains the active substance ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Tritace 10 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 10 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 10

When not to take Tritace 10

• 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 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 10 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 10.
In case of doubts about taking this medicine, the patient should consult a doctor before starting to take Tritace 10.

Warnings and precautions

Before starting to take Tritace 10, 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 10 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), vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril), or sacubitril in combination with valsartan (see section 2 "When not to take Tritace 10").
• 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 10 should not be used during the first 12 weeks of pregnancy and should not be used from the 13th week of pregnancy, as it may harm the baby. If the patient becomes pregnant while taking Tritace 10, 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 10 if they are breastfeeding.
  Before taking any medicine, the patient should consult their doctor or pharmacist.

  Children and adolescents

  Tritace 10 should not be used in children and adolescents under 18 years of age, as the safety and efficacy of Tritace 10 have not been established.
  If any of the above situations apply to the patient (or the patient has doubts), before starting to take Tritace 10, they should consult their doctor.

  Tritace 10 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 10 may affect the action of other medicines, and other medicines may affect the action of Tritace 10.
  The patient should tell their doctor about taking the following medicines, as they may reduce the effect of Tritace 10:

  • 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 10:

  • Sacubitril in combination with valsartan - used to treat chronic (long-term) heart failure in adults (see section 2 "When not to take Tritace 10"),
  • 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 for the treatment of bacterial infections), and heparin (a blood thinner),
  • Steroidal anti-inflammatory medicines, such as prednisolone,
  • Allopurinol (used to reduce uric acid levels in the blood),
  • Procainamide (used to treat heart rhythm disorders),
  • Temsirolimus (used to treat cancer),
  • Sirolimus, everolimus (used to prevent organ rejection);
  • Vildagliptin (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 10" and "Warnings and precautions").

  The patient should tell their doctor about taking the following medicines, as their effect may be altered when taken with Tritace 10:

  • Medicines used to treat diabetes, such as oral glucose-lowering medicines and insulin. Tritace 10 may lower blood glucose levels. The patient should regularly check their blood glucose levels while taking Tritace 10;
  • Lithium (used to treat mental illnesses). Tritace 10 may increase lithium levels in the blood. The doctor will order regular blood tests to check lithium levels.

  If any of the above situations apply to the patient (or the patient has doubts), before starting to take Tritace 10, they should consult their doctor.

  Tritace 10 with food and drink

  • Drinking alcohol while taking Tritace 10 may cause dizziness and drowsiness. In case of doubts about the amount of alcohol allowed while taking Tritace 10, the patient should discuss it with their doctor regarding the potential interaction between blood pressure-lowering medicines and alcohol.

  Tritace 10 can be taken with or without food.

  • Tritace 10 should be taken independently of meals.

  Pregnancy and breastfeeding

  Pregnancy
  If the patient is pregnant, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor before taking this medicine. Tritace 10 should not be used during the first 12 weeks of pregnancy and should not be used from the 13th week of pregnancy, as it may harm the baby. If the patient becomes pregnant while taking Tritace 10, 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 10 if they are breastfeeding.
  Before taking any medicine, the patient should consult their doctor or pharmacist.

  Driving and using machines

  While taking Tritace 10, the patient may experience dizziness. The risk of dizziness is higher at the beginning of treatment with Tritace 10 and after increasing the dose. If the patient experiences dizziness, they should not drive, use tools, or operate machinery.

  Tritace 10 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 10

  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 10 until blood pressure is adequately controlled.
  • The maximum dose is 10 mg once a day.
  • In case of diuretic use (water pills), the doctor may discontinue or reduce the dose of the diuretic before starting treatment with Tritace 10. 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 10.
  • 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 10.
  • 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 10.
  • The usual dose is 10 mg per day. It is recommended to take the medicine in two divided doses.

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

  How to take the medicine

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

  Overdose of Tritace 10

  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 the doctor knows what medicine was taken.

  Missed dose of Tritace 10

  • 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 a 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 10 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 10 and contact their doctor immediately – urgent medical attention may be required:

  • 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 10.
  • Severe skin reactions, including rash, ulcers in the mouth, 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 conditions, they should inform their doctor promptly:

  • Rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, feeling of pressure in the chest, or more severe, serious illnesses, 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.
  Frequently(may affect up to 1 in 10 people)

  • Headache or feeling tired,
  • Dizziness; the risk is higher at the beginning of treatment with Tritace 10 and after increasing the dose,
  • Fainting, low blood pressure (hypotension), 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 blood tests).

  Less frequently(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 sensations 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 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 blood tests,
  • Blood test results indicating changes in the liver, pancreas, or kidneys.

  Rarely(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 rarely(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 blood cell count (as shown by blood tests),
  • Low sodium levels in the blood (as shown by blood tests),
  • Dark-colored urine, nausea, or vomiting, muscle cramps, confusion, and seizures, which may be due to abnormal antidiuretic hormone (ADH) secretion. If the patient experiences any of these symptoms, they 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,
  • Smell disorders,
  • 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 10

  The medicine should be stored out of sight and reach of children.
  The patient should not use 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 they no longer use. This will help protect the environment.

  6. Contents of the packaging and other information

  What Tritace 10 contains

  The active substance of Tritace 10 is ramipril.
  Each tablet contains 10 mg of ramipril.
  The other ingredients are hypromellose, modified cornstarch, microcrystalline cellulose, and sodium stearyl fumarate.

  What Tritace 10 looks like and contents of the pack

  The tablets are white or almost white, oblong, scored, and measure 7 x 4.5 mm, with "HMO/HMO" embossed on one side. The tablet can be divided into equal doses.
  Tritace 10 tablets are packaged in blisters of PVC/Aluminum, containing 28 tablets.
  For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

  Marketing authorization holder in Romania, the country of export:

  Sanofi Romania SRL
  Str. Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9
  Sector 2, Bucharest, 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., B-dul 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:

  Pharma Innovations Sp. z o.o.
  ul. Jagiellońska 76
  03-301 Warsaw
  InPharm Sp. z o.o. Services sp. k.
  ul. Chełmżyńska 249
  04-458 Warsaw
  Romanian marketing authorization number:9228/2016/01
  Parallel import authorization number:145/19

  Date of leaflet approval: 04.03.2024

  [Information about the trademark]