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 (Tritace 10 mg tablets), 10 mg, tablets

Ramipril
Tritace 10 and Tritace 10 mg tablets are different trade names for the same medicine.

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 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 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 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 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 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 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 (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 alternative therapy.
• If the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as sartan - e.g., valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also section 2 "When not to take Tritace 10".

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 (or if there are doubts), the patient should consult a doctor before starting to take Tritace 10.

Tritace 10 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 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 the following medicines, as they may reduce the effect of Tritace 10:

• 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. The doctor will check the patient's blood pressure.

The patient should tell their doctor about 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 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);
• 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 2 "When not to take Tritace 10" and "Warnings and precautions").

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

• antidiabetic medicines, such as oral glucose-lowering medicines and insulin. Tritace 10 may lower blood glucose levels. During treatment with Tritace 10, the patient should regularly check their blood glucose levels;
• lithium (used to treat mental illnesses). Tritace 10 may increase lithium levels in the blood. The doctor will order regular monitoring of lithium levels in the blood.

If any of the above conditions apply to the patient (or if they have doubts), they should consult a doctor before starting to take Tritace 10.

Tritace 10 with food and drink

• Drinking alcohol while taking Tritace 10 may cause dizziness and fainting. 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.

Pregnancy and breastfeeding

Pregnancy
If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult a 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 alternative therapy.
Breastfeeding
The patient should not take Tritace 10 if they are breastfeeding.
Before taking any medicine, the patient should consult a 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 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 a 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 daily.
• The doctor may adjust the dose of Tritace 10 until adequate blood pressure control is achieved.
• The maximum dose is 10 mg once daily.
• In patients taking diuretics (water pills), the doctor may stop 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 daily.
• The doctor may decide to increase the dose.
• The usual dose is 10 mg once daily. Reducing or slowing the progression of kidney problems
• The initial dose is usually 1.25 mg or 2.5 mg once daily.
• The doctor may adjust the dose of Tritace 10.
• The usual dose is 5 mg or 10 mg once daily. Treatment of heart failure
• The initial dose is usually 1.25 mg once daily.
• The doctor may adjust the dose of Tritace 10.
• The maximum dose is 10 mg daily. 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 daily.
• The doctor may adjust the dose of Tritace 10.
• The usual dose is 10 mg daily. 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

• The medicine should be taken orally, once daily, at the same time.
• The patient should swallow the tablets with a drink.
• The patient should not crush or chew the tablets.

Overdose of Tritace 10

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.

Missing a 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 a 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, and itching and rash. These may be symptoms of a severe allergic reaction to Tritace 10.
• 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, any signs of bleeding (e.g., bleeding from the 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 10 and after increasing the dose,
• Fainting, low blood pressure, especially when changing 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 and skin disorders, such as numbness, tingling, prickling, burning, or crawling sensations (paresthesia),
• Loss or disturbance of taste,
• Sleep disorders,
• 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,
• Abnormal laboratory test results indicating changes in liver, pancreas, or kidney function.

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

• Feeling of uncertainty, confusion, or disorientation,
• Red, swollen tongue,
• Excessive skin peeling, 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 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,
• Swelling of the lips,
• Low blood cell count, as shown by laboratory tests,
• Low sodium levels in the blood, as shown by laboratory tests,
• Dark urine (concentrated urine), nausea, or vomiting, muscle cramps, confusion, and seizures, which may be due to abnormal antidiuretic hormone (ADH) secretion. If these symptoms occur, the patient should immediately consult their doctor,
• Changes in finger color upon cooling and 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 Medicines Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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 stated.
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 is ramipril.
Each tablet contains 10 mg of ramipril.
The other ingredients are hypromellose, cornstarch, microcrystalline cellulose, sodium stearyl fumarate.

What Tritace 10 looks like and contents of the pack

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

Marketing authorization holder in Ireland, the country of export:

sanofi-aventis Ireland Ltd. T/A SANOFI
Citywest Business Campus
Dublin 24
Ireland

Manufacturer:

Sanofi S.r.l., Strada Statale 17km: 22, 67019 Scoppito (AQ), Italy
S.C. ZENTIVA S.A., B-dul Theodor Pallady nr. 50, Sector 3, Bucharest, 032266, Romania
Delpharm Dijon, 6, Boulevard de l’Europe, 21800 Quetigny, France

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 Ireland, the country of export:PA 540/84/8
Parallel import authorization number:237/21
Translation of day abbreviations on the packaging:
MON– Monday, TUE– Tuesday, WED– Wednesday, THU– Thursday, FRI– Friday, SAT– Saturday, SUN– Sunday.
Date of leaflet approval: 22.03.2022
[Information about the trademark]