Tritace 5

Leaflet accompanying the packaging: information for the user

2.5, 2.5 mg, tablets

5, 5 mg, tablets

10, 10 mg, tablets

Ramipril

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

1. What is Tritace and what is it used for

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

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

2. Important information before taking Tritace

When not to take Tritace

• 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, soles of the feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If the patient is taking sacubitril/valsartan, a medicine used to treat long-term (chronic) heart failure in adults.
• If the patient is undergoing dialysis or other types of blood filtration. Depending on the type of equipment used, Tritace 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.
In case of doubts about taking this medicine, the patient should consult a doctor before starting to take Tritace.

Warnings and precautions

Before starting to take Tritace, 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.
If the patient is to receive medicines used in anesthesia. They may be used during surgical or dental procedures. It may be necessary to stop taking Tritace 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 (a severe allergic reaction), such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP) (e.g., racecadotril), or sacubitril/valsartan (see section 2 "When not to take Tritace").
If the patient has collagenosis, such as scleroderma or systemic lupus erythematosus.
The patient should tell their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Tritace during the first three months of pregnancy, and if taken after 3 months of pregnancy, this medicine may harm the baby (see below "Pregnancy and breastfeeding").

• If the patient is taking any of the following medicines used to treat high blood pressure: an angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g., valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes, or aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also subsection "When not to take Tritace".

Children and adolescents

Tritace should not be used in children and adolescents under 18 years of age, as the safety and efficacy of Tritace have not been established.
If any of the above situations apply (or if there are doubts), the patient should consult a doctor before taking Tritace.

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

• 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. They may increase the risk of side effects when taken with Tritace:

• sacubitril/valsartan - used to treat long-term (chronic) heart failure in adults (see section 2 "When not to take Tritace"),
• 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),
• corticosteroid anti-inflammatory medicines, 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);
• vildagliptin (used to treat type 2 diabetes),
• racecadotril (used to treat diarrhea),
• the doctor may recommend a dose change and/or take other precautions if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also subsections "When not to take Tritace" and "Warnings and precautions").

The patient should tell their doctor about taking the following medicines. Their action may be altered when taken with Tritace:

• anti-diabetic medicines, such as oral glucose-lowering medicines and insulin. Tritace may lower blood glucose levels. During treatment with Tritace, blood glucose levels should be regularly checked;
• lithium (used to treat mental illnesses). Tritace may increase lithium levels in the blood. The doctor will recommend monitoring lithium levels in the blood. If any of the above conditions apply to the patient (or if the patient has doubts), they should consult a doctor before taking Tritace.

Tritace with food and drink

• Drinking alcohol while taking Tritace may cause dizziness and lightheadedness. In case of doubts about the amount of alcohol allowed during treatment with Tritace, the patient should discuss it with their doctor regarding the potential additive effect of blood pressure-lowering medicines and alcohol.
• Tritace 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 have a baby, they should consult a doctor before taking this medicine. Tritace 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, they should immediately inform their doctor. Before planned pregnancy, the treatment should be changed to a suitable alternative.
Breastfeeding
The patient should not take Tritace if they are breastfeeding.
Before taking any medicine, the patient should consult a doctor or pharmacist.

Driving and using machines

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

Tritace 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

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.

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 until adequate blood pressure control is achieved.
• 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. 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 adjust the dose of Tritace.
• 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.
• 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.
• 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

• 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 tablets should not be crushed or chewed.

Overdose of Tritace

The patient should contact a 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

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 a doctor or pharmacist.

4. Possible side effects

Like all medicines, Tritace 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 and immediately consult a doctor – urgent medical attention may be required:

• Swelling of the face, lips, or throat, which may cause difficulty swallowing or breathing, as well as itching and rash. These may be symptoms of a severe allergic reaction to Tritace.
• Severe skin reactions, including rash, ulcers in the mouth, 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 conditions, they should promptly inform their doctor:

• 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. They may indicate lung problems.
• Easy bruising, prolonged 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 paleness of the skin. They may indicate blood or bone marrow disorders.
• Severe abdominal pain, which may radiate to the back. They 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). They 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 and after increasing the dose,
• fainting, hypotension (abnormally low blood pressure), especially after sudden changes from a lying to a sitting or standing position,
• 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 sensation, or feeling of crawling under the skin (paresthesia),
• loss or disturbance of taste,
• sleep disorders,
• depression, anxiety, nervousness, or restlessness,
• stuffy nose, difficulty breathing, or worsening of asthma,
• intestinal angioedema, which may cause 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 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, 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 secretion of ADH (antidiuretic hormone). 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,
• 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, pharmacist, or nurse. Side effects can be reported directly to
the Department of Drug Safety Monitoring
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181 C

• 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Tritace

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging, blister, or bottle after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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 contains

The active substance of Tritace is ramipril.
Tablets
2.5: each tablet contains 2.5 mg of ramipril.
5:
each tablet contains 5 mg of ramipril.
10:
each tablet contains 10 mg of ramipril.
Other ingredients are:
2.5, 2.5 mg tablets
hypromellose
modified cornstarch
microcrystalline cellulose
sodium stearyl fumarate
yellow iron oxide (E172).
5, 5 mg tablets
hypromellose
modified cornstarch
microcrystalline cellulose
sodium stearyl fumarate
red iron oxide (E172).
10, 10 mg tablets
hypromellose
modified cornstarch
microcrystalline cellulose
sodium stearyl fumarate.

What Tritace looks like and contents of the pack

2.5, 2.5 mg tablets
The tablets are yellow or yellowish, oblong, scored, 8 x 4 mm in size, with "2.5" and "company logo" engraved on one side and "2.5" and "HMR" on the other side. The tablet can be divided into equal doses.
5, 5 mg tablets
The tablets are pale red, oblong, scored, 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.
10, 10 mg tablets
The tablets are white or off-white, oblong, scored, 7 x 4.5 mm in size, with "HMO/HMO" engraved on one side. The tablet can be divided into equal doses.
Tritace 2.5 tablets are packaged in packs containing 28 tablets in PVC/Aluminum blisters and packs containing 500 tablets in a type III brown glass bottle with an HDPE cap.
Tritace 5 tablets are packaged in packs containing 28 tablets in PVC/Aluminum blisters and packs containing 500 tablets in a type III brown glass bottle with an HDPE cap.
Tritace 10 tablets are packaged in packs containing 28 tablets in PVC/Aluminum blisters and packs containing 500 tablets in a type III brown glass bottle with an HDPE cap.
Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi-Aventis Deutschland GmbH
Brüningstrasse 50

• D-65926 Frankfurt am Main, Germany

Manufacturer

Sanofi S.r.l.
Strada Statale 17, Km 22
67019 Scoppito (L'Aquila)
Italy
Delpharm Dijon
6 boulevard de l'Europe
21800 Quetigny
France
S.C. ZENTIVA S.A.
B-dul Theodor Pallady nr. 50,
Sector 3, Bucuresti, 032266,
Romania
Sanofi Aventis Deutschland GmbH
Industriepark Höechst Brüningstrasse 50
D-65926 Frankfurt am Main
Germany

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder in Poland:

Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
tel.: +48 22 280 00 00

Date of last revision of the leaflet: