Tritace 2,5

Leaflet accompanying the packaging: information for the user

2.5, 2.5 mg, tablets

5, 5 mg, tablets

10, 10 mg, tablets

Ramipril

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to you by a doctor, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including those not listed in this leaflet, tell your 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 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

When not to take Tritace

• If you are 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 face, lips, tongue, or throat.
• If you have 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 you are taking sacubitril/valsartan, a medicine used to treat long-term (chronic) heart failure in adults (see section 2 "When not to take Tritace").
• If you are undergoing dialysis or other type of blood filtration. Depending on the type of equipment used, Tritace may not be suitable for you.
• If you have 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 your blood pressure is very low or unstable - your doctor will monitor your blood pressure closely.
• If you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, do not take Tritace.
In case of doubts about taking this medicine, consult a doctor before starting treatment with Tritace.

Warnings and precautions

Before starting treatment with Tritace, discuss it with your doctor or pharmacist.
If you have heart, liver, or kidney disease.
If you have 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 you are going to undergo desensitization treatment for bee or wasp stings.
If you are going to receive 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, consult a doctor.
If you have high levels of potassium in your blood (as shown by blood tests).
If you are taking medicines or have conditions that may lower your sodium levels. Your doctor may order regular blood tests, especially to check your sodium levels, particularly in elderly patients.
If you are taking medicines that may increase the risk of angioedema (a severe allergic reaction), such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), vildagliptin, NEP inhibitors (e.g., racecadotril), or sacubitril/valsartan (see section 2 "When not to take Tritace").
If you have collagenosis, such as scleroderma or systemic lupus erythematosus.
Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Do not take Tritace during the first 12 weeks of pregnancy and do not take it from the 13th week of pregnancy, as it may harm your baby. If you become pregnant while taking Tritace, tell your doctor immediately. Before planned pregnancy, change your treatment to a suitable alternative.

• If you are taking any of the following medicines for high blood pressure: an angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g., valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes, or aliskiren. Your doctor may order regular checks of your kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also section "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 yet.
If any of the above situations apply to you (or you have doubts), consult a doctor before starting treatment with Tritace.

Tritace and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Tritace may affect the way other medicines work, and other medicines may affect the way Tritace works.
Tell your doctor about the following medicines. They may reduce the effect of Tritace:

• Pain 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. Your doctor will check your blood pressure.

Tell your doctor about the following medicines. They may increase the risk of side effects when taken with Tritace:

• sacubitril/valsartan - used to treat chronic heart failure in adults (see section 2 "When not to take Tritace"),
• pain 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 transplant 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 transplant rejection);
• vildagliptin (used to treat type 2 diabetes),
• racecadotril (used to treat diarrhea),
• your doctor may order a change in dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to take Tritace" and "Warnings and precautions").

Tell your doctor about the following medicines. Their effect may be altered when taken with Tritace:

• medicines used to treat diabetes, such as oral glucose-lowering medicines and insulin. Tritace may lower your blood sugar levels. While taking Tritace, you should regularly check your blood sugar levels;
• lithium (used to treat mental illnesses). Tritace may increase lithium levels in your blood. Your doctor will order regular checks of your lithium levels. If any of the above conditions apply to you (or you have doubts), consult a doctor before starting treatment with Tritace.

Tritace with food and drink

• Drinking alcohol while taking Tritace may cause dizziness and fainting. If you have doubts about the amount of alcohol allowed while taking Tritace, talk to your doctor about the possibility of combining the effects of blood pressure-lowering medicines and alcohol.
• Tritace can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, think you may be pregnant, or plan to become pregnant, consult a doctor before taking this medicine. Do not take Tritace during the first 12 weeks of pregnancy and do not take it from the 13th week of pregnancy, as it may harm your baby. If you become pregnant while taking Tritace, tell your doctor immediately. Before planned pregnancy, change your treatment to a suitable alternative.
Breastfeeding
Do not take Tritace if you are breastfeeding.
Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

While taking Tritace, you may experience dizziness. The risk of dizziness is higher at the beginning of treatment with Tritace and after increasing the dose. If you feel dizzy, do 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

Always take this medicine exactly as your doctor has told you. If you are not sure, consult a doctor or pharmacist.

Dosage

Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once a day.
• Your doctor may adjust the dose of Tritace until you reach adequate blood pressure control.
• The maximum dose is 10 mg once a day.
• If you are taking diuretics (water pills), your doctor may stop or reduce the dose of the diuretic before starting treatment with Tritace. Prevention of heart attack or stroke
• The usual starting dose is 2.5 mg once a day.
• Your doctor may decide to increase the dose.
• The usual dose is 10 mg once a day. Reducing or delaying kidney problems
• The usual starting dose is 1.25 mg or 2.5 mg once a day.
• Your doctor may adjust the dose of Tritace.
• The usual dose is 5 mg or 10 mg once a day. Treatment of heart failure
• The usual starting dose is 1.25 mg once a day.
• Your 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 usual starting dose is 1.25 mg to 2.5 mg once a day.
• Your 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 patientsYour doctor will prescribe a lower than usual starting dose, which will then be gradually increased.

How to take the medicine

• Take this medicine orally, once a day, at the same time.
• Swallow the tablets with a liquid.
• Do not crush or chew the tablets.

What to do if you take more Tritace than you should

Contact a doctor or go to the nearest hospital emergency department immediately.
Do not drive yourself, ask someone to drive you to the hospital or call an ambulance. Take the packaging of the medicine with you, so the doctor knows what medicine you have taken.

What to do if you forget to take a dose of Tritace

If you miss a dose, take the next planned dose at the usual time.
Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking Tritace and contact a doctor immediately – you may need urgent medical attention:

• 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, 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 you experience any of the following, tell your doctor immediately:

• Rapid heartbeat, irregular heartbeat, chest pain, feeling of pressure in the chest, or worsening of existing conditions, including heart attack or stroke.
• Shortness of breath or cough. They may indicate lung problems.
• Easy bruising, prolonged bleeding, any signs of bleeding (e.g., bleeding gums), purple spots on the skin, or frequent infections, sore throat, and fever, fatigue, weakness, dizziness, or pale 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 damage to the liver.

Other side effects

Tell your doctor if any of the following symptoms get worse or last 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, low blood pressure, especially after sudden changes in position from lying down 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 sensation, or crawling sensation on the skin (paresthesia),
• loss or alteration 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 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,
• reduced 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 get worse or last more than a few days, tell your 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 urine (concentrated urine), nausea, or vomiting, muscle cramps, confusion, and seizures, which may be due to abnormal antidiuretic hormone (ADH) secretion. If you experience any of these symptoms, consult your doctor immediately,
• changes in finger color after cooling and a feeling of tingling or pain after warming (Raynaud's phenomenon),
• breast enlargement in men,
• slowed or impaired reactions,
• burning sensation,
• disturbances of smell,
• hair loss.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to
the Department of Drug Safety Monitoring
National Institute of Medicines
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 Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tritace

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, blister, and bottle after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should 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 Tritace contains

The active substance 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
Yellow or yellowish tablets, oblong, scored, 8 x 4mm 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
Pale red tablets, 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
White or off-white tablets, 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, 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: