TRITACE 5

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
TRITACE 5 (Cardace 5 mg)
5 mg, tablets
Ramiprilum
Tritace 5 and Cardace 5 mg are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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

1. What Tritace 5 is and what it is 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 in the body of substances that increase blood pressure,
• reducing tension and widening blood vessels,
• helping the heart pump blood around the body.

Tritace 5 may be used to:

• treat high blood pressure (hypertension),
• reduce the risk of heart attack or stroke,
• reduce the risk of or delay worsening of kidney function disorders (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 patients after a heart attack complicated by heart failure.

2. Information before using Tritace 5

When not to use Tritace 5

• If the patient is allergic to ramipril, any other medicine in the class of ACE inhibitors, 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 experienced a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red spots on the hands, 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 in combination with valsartan, a medicine used to treat chronic (long-term) 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 suitable.
• If the patient has kidney function disorders due to reduced blood flow to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see section below "Pregnancy and breastfeeding").
• If the patient has very low or unstable blood pressure – the doctor will recommend frequent blood pressure monitoring.
• If the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply, Tritace 5 should not be used. In case of doubt about using this medicine, consult a doctor before starting treatment with Tritace 5.

Warnings and precautions

Before starting treatment with Tritace 5, discuss this with your 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 (due to vomiting, diarrhoea, excessive sweating, a low-sodium diet, long-term use of diuretics (water tablets), or dialysis).
• If the patient is undergoing treatment to reduce allergic reactions to bee or wasp venom (desensitisation).
• If the patient is to receive medicines used in anaesthesia. These may be used during surgical or dental procedures. It may be necessary to stop taking Tritace 5 one day before the procedure; consult your doctor if in doubt.
• If the patient has high levels of potassium in the blood (shown in 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 blood sodium levels, 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 (NEP) inhibitors (such as racecadotril), or sacubitril in combination with valsartan (sacubitril with valsartan – see section 2 "When not to use Tritace 5").
• If the patient has collagenosis, such as scleroderma or systemic lupus erythematosus.
• Inform the doctor if the patient is pregnant, suspects pregnancy, or plans to become pregnant. Use of Tritace 5 is not recommended during the first three months of pregnancy, and use after the third month of pregnancy may harm the unborn child (see section 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 – for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney disorders related to diabetes,
  • Aliskiren.
• The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also section "When not to use Tritace 5".

Children and adolescents

Tritace 5 is not recommended for use 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 is any uncertainty), consult a doctor before starting treatment with Tritace 5.

Tritace 5 and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. Tritace 5 may affect the action of other medicines, and other medicines may affect the action of Tritace 5.

Tell your doctor if the patient is taking any of the following medicines. These may reduce the effectiveness of Tritace 5:

• Painkillers 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 monitor the patient's blood pressure.

Tell your doctor if the patient is taking any of the following medicines. These may increase the risk of adverse effects when used together with Tritace 5:

• Sacubitril in combination with valsartan – used to treat chronic (long-term) heart failure in adults (see section 2 "When not to use Tritace 5"),
• Painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs [NSAIDs], such as: ibuprofen or indomethacin, and aspirin),
• Medicines used to treat cancer (chemotherapy),
• Medicines used to prevent organ transplant rejection, such as cyclosporine,
• Diuretics (water tablets), such as furosemide,
• Medicines that increase potassium levels in the blood, such as: spironolactone, triamterene, amiloride, potassium salts, trimethoprim used as monotherapy or in combination with sulfamethoxazole (used to treat bacterial infections), and heparin (a blood-thinning medicine),
• Steroidal anti-inflammatory medicines, such as prednisolone,
• Allopurinol (used to reduce uric acid levels in the blood),
• Procaïnamide (used for heart rhythm disorders),
• Temsirolimus (used to treat cancer),
• Sirolimus, everolimus (used to prevent transplant rejection),
• Wildagliptin (used to treat type 2 diabetes),
• Racecadotril (used to treat diarrhoea),
• The doctor may recommend dose adjustments and/or additional precautions if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to use Tritace 5" and "Warnings and precautions").

Tell your doctor if the patient is taking any of the following medicines. Their effect may be altered when taking Tritace 5:

• Antidiabetic medicines, such as oral glucose-lowering agents and insulin. Tritace 5 may lower blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Tritace 5.
• Lithium (used for psychiatric disorders). Tritace 5 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 any doubts), consult a doctor before starting treatment with Tritace 5.

Tritace 5 with food and alcohol

• Drinking alcohol while taking Tritace 5 may cause dizziness and a feeling of lightheadedness. If in doubt about the amount of alcohol allowed while taking Tritace 5, discuss with your doctor the possible additive effects of blood pressure-lowering medicines and alcohol.

• Tritace 5 can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine. Tritace 5 should not be used during the first 12 weeks of pregnancy and must not be used from week 13 of pregnancy onwards, as its use during pregnancy may harm the unborn child. If the patient becomes pregnant while taking Tritace 5, she should inform her doctor immediately. Before planning a pregnancy, therapy should be changed to an appropriate alternative treatment.

Breastfeeding

The patient should not use Tritace 5 if she is breastfeeding.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Dizziness may occur while taking Tritace 5. The risk of dizziness is higher at the beginning of treatment with Tritace 5 and after an increase in dose. If the patient experiences dizziness, driving, using tools, or operating machinery should be avoided.

Tritace 5 contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tritace 5

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The following are available on the market: Tritace 2.5 (2.5 mg), Tritace 5 (5 mg), and Tritace 10 (10 mg).
Dosage
Treatment of arterial hypertension

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor may adjust the dose until adequate blood pressure control is achieved.
• The maximum dose is 10 mg once daily.
• If you are taking diuretics (water pills), your doctor may discontinue or reduce the dose of the diuretic before starting Tritace 5.

Prevention of myocardial infarction or stroke

• The usual starting dose is 2.5 mg once daily.
• Your doctor may decide to increase the dose.
• The usual dose is 10 mg once daily.

Reduction or delay of worsening kidney function

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor may modify the dosage.
• The usual dose is 5 mg or 10 mg once daily.

Treatment of heart failure

• The usual starting dose is 1.25 mg once daily.
• Your doctor may modify the dosage.
• The maximum dose is 10 mg per day. It is recommended to administer the medicine in two divided doses.

Treatment after myocardial infarction

• The usual starting dose is 1.25 mg to 2.5 mg once daily.
• Your doctor may modify the dosage.
• The usual dose is 10 mg per day. It is recommended to administer the medicine in two divided doses.

Elderly patients
Your doctor will recommend a lower than usual starting dose, which will then be gradually increased.
How to take the medicine

• This medicine should be taken orally, at the same time each day.
• Tablets should be taken with fluid.
• Do not crush or chew the tablets.

Taking more Tritace 5 than prescribed
Contact your doctor or go to the nearest hospital emergency department immediately.
Do not drive yourself—ask someone to take you to the hospital or call an ambulance. Bring the
medication packaging with you so the doctor knows which medicine was taken.
If you miss a dose of Tritace 5

• If you miss a dose, take the next scheduled dose at the usual time.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient notices any of the following serious adverse reactions, treatment with Tritace 5 must be discontinued and the patient should contact a doctor immediately – urgent medical care may be required:

• Swelling of the face, lips, or throat causing difficulty in swallowing or breathing, together with itching and rash. These may be symptoms of a severe hypersensitivity reaction to Tritace 5.
• Severe skin reactions, including rash, oral mucosal ulcers, worsening of pre-existing skin disorders, redness, blisters, or skin detachment (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

If any of the following conditions occur, the doctor should be informed promptly:

• Rapid heartbeat, irregular or stronger heartbeats (palpitations), chest pain, feeling of chest tightness, or worsening, severe conditions including myocardial infarction or stroke.
• Shortness of breath or cough. These may indicate lung disorders.
• Easy bruising, longer than usual bleeding time, any signs of bleeding (e.g. bleeding gums), purpuric skin spots, or increased frequency of 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 jaundice (yellowing of the skin or whites of the eyes). These may be symptoms of liver disorders, such as hepatitis or liver damage.

Other adverse reactions
Tell your doctor if any of the following symptoms become severe or persist for more than a few days.
Common (may affect less than 1 in 10 patients)

• Headache or feeling of fatigue,
• Dizziness; risk is higher at the beginning of treatment with Tritace 5 and after dose increase,
• Fainting, hypotension (abnormally low blood pressure), especially after sudden change from lying to sitting or standing position,
• Dry, persistent cough, sinusitis or bronchitis, shortness of breath,
• Abdominal or intestinal pain, diarrhea, indigestion, nausea or vomiting,
• Rash with or without raised lesions,
• Chest pain,
• Muscle cramps or pain,
• Increased potassium levels in blood tests.

Uncommon (may affect less than 1 in 100 patients)

• Balance disorders (dizziness),
• Itching of the skin and sensory disturbances such as numbness, tingling, pricking, burning sensation, or crawling sensation on the skin (paresthesia),
• Loss or disturbances of taste,
• Sleep disturbances,
• Depression, anxiety, nervousness or restlessness,
• Nasal congestion, breathing difficulties, or worsening of asthma,
• Intestinal swelling known as "intestinal angioedema", presenting with abdominal pain, vomiting, and diarrhea,
• Heartburn, constipation, or dry mouth,
• Increased urine output during the day,
• Excessive sweating,
• Loss or decrease in appetite (anorexia),
• Rapid or irregular heartbeat,
• Swelling of hands and feet; may indicate retention of larger than normal amounts of fluid,
• Sudden flushing of the face,
• Blurred vision,
• Joint pain,
• Fever,
• Impotence, decreased libido in men and women,
• Increased number of certain white blood cells (eosinophilia) in blood tests,
• Blood test results indicating changes in liver, pancreas, or kidneys.

Rare (may affect less than 1 in 1000 patients)

• Feeling of uneasiness, disorientation, confusion,
• Red, swollen tongue,
• Excessive skin peeling, itchy nodular rash,
• Nail disorders (e.g. loosening or separation of the nail from the nail bed),
• Rash or skin bruising,
• Skin spots and cold extremities,
• Redness, itching, swelling, and tearing of the eyes,
• Hearing disturbances and tinnitus,
• Weakness,
• Decreased number of red blood cells, white blood cells, or platelets, or decreased hemoglobin levels in blood tests.

Very rare (may affect less than 1 in 10,000 patients)

• Photosensitivity (hypersensitivity to sunlight).

Other reported adverse reactions
If any of the symptoms listed below become severe or persist for more than a few days, inform your doctor.

• Difficulty concentrating,
• Swelling of the lips,
• Detection of low blood cell counts in blood tests,
• Detection of lower than normal sodium levels in blood tests,
• Concentrated (dark-colored) urine, nausea or vomiting, muscle cramps, confusion, and seizures, which may result from inappropriate ADH secretion (antidiuretic hormone – vasopressin). If any of the above symptoms occur, contact your doctor immediately,
• Color changes in fingers upon cold exposure, 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 of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store TRITACE 5

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Tritace 5 contains
The active substance is ramipril. Each tablet contains 5 mg of ramipril.
The other ingredients are: hypromellose, pregelatinized corn starch, microcrystalline cellulose,
sodium stearyl fumarate, iron oxide red (E 172).
What Tritace 5 looks like and contents of the pack
Pale red, elongated, scored tablets measuring 8 x 4 mm, with "5" and "company logo" embossed on one side and "5" and "HMP" on the other side. The tablet can be divided into equal doses.
Tritace 5 tablets are packed in packs containing 28 tablets in PVC/Aluminium blisters, in a cardboard box.
For further information, contact the responsible party or the parallel importer.
Responsible party in Lithuania, country of export:
sanofi-aventis groupe, 54, rue La Boétie, 75008 Paris, France
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, Bucharest, 032266, Romania
Sanofi Aventis Deutschland GmbH, Industriepark Hoechst Bruningstrasse 50, D-65926 Frankfurt am Main, Germany
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Authorisation number in Lithuania, country of export: LT/1/97/1617/003
Parallel import authorisation number: 189/22