Tritace 5

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Tritace 5(Zenra 5 mg)

5 mg, tablets

Ramipril
Tritace 5 and Zenra 5 mg 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 you need to.
• If you have 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 them, 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Tritace 5 and what is it used for

Tritace 5 contains the active substance ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Tritace 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 around the body.

Tritace 5 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 (whether or not 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 5

When not to take Tritace 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 face, lips, 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 or has taken 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 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 5. If there are any doubts about taking this medicine, the patient should consult a doctor before starting to take Tritace 5.

Warnings and precautions

Before starting to take Tritace 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 lot of electrolytes or fluids (through vomiting, diarrhea, excessive sweating, a low-sodium diet, taking diuretics for a long time, or dialysis).
• If the patient is going to undergo desensitization treatment to prevent allergic reactions to bee or wasp stings.
• If the patient is going to receive anesthesia. These may be used during surgical or dental procedures. It may be necessary to stop taking Tritace 5 on the day before the procedure, and if there are any 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), wildagliptin, neprilysin inhibitors (NEP) (such as racecadotril), or sacubitril/valsartan (see section 2 "When not to take Tritace 5").
• If the patient has collagen vascular disease, 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 5 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 5, they should inform their doctor immediately. Before planned pregnancy, the treatment should be changed to a suitable alternative.
• 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,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also section 2 "When not to take Tritace 5".

Children and adolescents

Tritace 5 should not be used in children and adolescents under 18 years of age, as the safety and efficacy of Tritace 5 have not been established.
If any of the above situations apply (or if there are any doubts), the patient should consult a doctor before starting to take Tritace 5.

Tritace 5 and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.
Tritace 5 may affect the way other medicines work, and other medicines may affect the way Tritace 5 works.
The patient should tell their doctor about the following medicines. They may reduce the effect of Tritace 5:

• Pain-relieving and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacin, 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. They may increase the risk of side effects when taken with Tritace 5:

• sacubitril/valsartan - used to treat long-term (chronic) heart failure in adults (see section 2 "When not to take Tritace 5"),
• pain-relieving and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacin, and aspirin),
• cancer medicines (chemotherapy),
• medicines used to prevent organ rejection, such as cyclosporin,
• diuretics (water tablets), 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-thinning medicine),
• 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);
• wildagliptin (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 sections 2 "When not to take Tritace 5" and "Warnings and precautions").

The patient should tell their doctor about the following medicines. Their effect may be altered when taken with Tritace 5:

• medicines used to treat diabetes, such as oral glucose-lowering medicines and insulin. Tritace 5 may lower blood sugar levels. Blood sugar levels should be regularly monitored while taking Tritace 5;
• lithium (used to treat mental illnesses). Tritace 5 may increase lithium levels in the blood. The doctor will monitor lithium levels in the blood.

If any of the above conditions apply to the patient (or if they have any doubts), they should consult a doctor before starting to take Tritace 5.

Tritace 5 with food and drink

• Drinking alcohol while taking Tritace 5 may cause dizziness and fainting. If there are any doubts about the amount of alcohol that can be consumed while taking Tritace 5, the patient should talk to their doctor about the possibility of the effects of blood pressure-lowering medicines and alcohol adding up.
• Tritace 5 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 5 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 5, they should inform their doctor immediately. Before planned pregnancy, the treatment should be changed to a suitable alternative.
Breastfeeding
The patient should not take Tritace 5 if they are breastfeeding.
Before taking any medicine, the patient should consult a doctor or pharmacist.

Driving and using machines

While taking Tritace 5, the patient may experience dizziness. The risk of dizziness is greater at the start of treatment with Tritace 5 and after increasing the dose. If the patient experiences dizziness, they should not drive, use tools, or operate machinery.

Tritace 5 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 5

This medicine should always be taken exactly as prescribed by the doctor. If there are any 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.

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 to achieve adequate blood pressure control.
• The maximum dose is 10 mg once a day.
• If the patient is taking diuretics, the doctor may stop or reduce the dose of the diuretic before starting Tritace 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 delaying 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.
• 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.
• 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.
• 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

• The medicine should be taken orally, once a day, at the same time every day.
• The patient should swallow the tablets with a drink.
• The tablets should not be crushed or chewed.

Overdose of Tritace 5

The patient should contact a doctor or go to the nearest hospital emergency department. They should not drive themselves, but ask someone to drive them to the hospital or call an ambulance. They should take the packaging of the medicine with them, so the doctor knows what medicine has been taken.

Missed dose of Tritace 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 a missed dose.

If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 5 and contact a doctor immediately - 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 5.
• 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 immediately:

• Rapid heartbeat, irregular heartbeat, 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, or any signs of bleeding (e.g., bleeding from the gums), purpura, or 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. This may be a symptom 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 get worse 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 greater at the start of treatment with Tritace 5 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 pain or intestinal problems, 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 sensory disturbances, such as numbness, tingling, prickling, burning, or crawling sensations (paresthesia),
• loss or disturbance of taste,
• sleep disturbances,
• 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 urination during the day,
• excessive sweating,
• loss of appetite (anorexia),
• rapid or irregular heartbeat,
• swelling of the hands and feet; this 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 laboratory tests,
• abnormal 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, 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 disturbances and ringing in the ears,
• weakness,
• reduced 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 get worse 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-colored urine, nausea, or vomiting, muscle cramps, confusion, and convulsions, which may be symptoms of inappropriate antidiuretic hormone secretion (SIADH). If these symptoms occur, the patient should consult their doctor immediately,
• 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,
• disturbances of smell,
• hair loss.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, 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 parallel importer. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Tritace 5

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 need. This will help protect the environment.

6. Contents of the packaging and other information

What Tritace 5 contains

The active substance is ramipril. Each tablet contains 5 mg of ramipril.
The other ingredients are:
hypromellose
cornstarch
microcrystalline cellulose
sodium stearyl fumarate
red iron oxide (E 172)

What Tritace 5 looks like and contents of the pack

The tablets are pale red, oblong, scored, 8 x 4 mm in size, with "5" and the company logo on one side and "5" and "HMP" on the other side. The tablet can be divided into equal doses.
The tablets are packaged in PVC/Al blisters containing 28 tablets.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Zentiva S.A.
Bulevardul Theodor Pallady, nr. 50, sector 3
020334 Bucharest
Romania

Manufacturer:

Sanofi S.r.l.
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
032266 Bucharest
Romania

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

Marketing authorization number in Romania, the country of export: 9237/2016/01, 9237/2016/03, 9237/2016/11

Parallel import authorization number: 227/23

Date of leaflet approval: 11.10.2023

[Information about the trademark]