Tritace 2.5

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Tritace 2.5 (Zenra 2.5 mg)
2.5 mg, tablets
Ramipril
Tritace 2.5 and Zenra 2.5 mg are different trade names for the same medicine.
Please read this leaflet carefully before taking 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Tritace 2.5 is and what it is used for
2. Important information before taking Tritace 2.5
3. How to take Tritace 2.5
4. Possible side effects
5. How to store Tritace 2.5
6. Contents of the pack and other information

1. What Tritace 2.5 is and what it is used for

Tritace 2.5 contains the active substance ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).

Tritace 2.5 works by:

• reducing the body's production of substances that increase blood pressure,
• reducing tension and widening blood vessels,
• helping the heart pump blood through the body more easily.

Tritace 2.5 may be used:

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

2. Important information before using Tritace 2.5

When not to use Tritace 2.5

• If the patient is allergic to ramipril, to any other medicine in the ACE inhibitor class, or to 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, urticaria, 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 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 types of blood filtration. Depending on the type of equipment used, Tritace 2.5 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 blood pressure is very low or unstable – the doctor may 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 2.5 must not be used.
If in doubt about using this medicine, consult a doctor before starting Tritace 2.5.
Warnings and precautions
Before starting Tritace 2.5, 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 scheduled for allergen immunotherapy (desensitisation) to bee or wasp venom.
• If the patient is to receive medicines used for anaesthesia. These may be used during surgical or dental procedures. It may be necessary to stop taking Tritace 2.5 one day before the procedure; if in doubt, contact your doctor.
• If the patient has high potassium levels in the blood (as shown in 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, particularly to monitor blood sodium levels, especially 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 (sacubitril with valsartan – see section 2 "When not to use Tritace 2.5").
• 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 2.5 is not recommended during the first three months of pregnancy, and after the third month of pregnancy this medicine may harm the unborn child (see section below "Pregnancy and breastfeeding").
• If the patient is taking any of the following medicines for 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 the section "When not to use Tritace 2.5".

Children and adolescents
Tritace 2.5 is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of Tritace 2.5 have not been established.
If any of the above situations apply (or if there is any uncertainty), consult a doctor before starting Tritace 2.5.
Tritace 2.5 and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take. Tritace 2.5 may affect the action of other medicines, and other medicines may affect the action of Tritace 2.5.
Inform your doctor if you are taking the following medicines. They may reduce the effect of Tritace 2.5:

• 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.

Inform your doctor if you are taking the following medicines. They may increase the risk of adverse effects when used together with Tritace 2.5:

• sacubitril in combination with valsartan – used to treat chronic (long-term) heart failure in adults (see section 2 "When not to use Tritace 2.5"),
• painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs [NSAIDs], such as: ibuprofen or indomethacin, and aspirin),
• anticancer medicines (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 alone or in combination with sulfamethoxazole (used to treat bacterial infections), and heparin (a blood-thinning medicine),
• corticosteroid anti-inflammatory medicines, such as prednisolone,
• allopurinol (used to reduce uric acid levels in the blood),
• procainamide (used for heart rhythm disorders),
• temsirolimus (used to treat cancer),
• sirolimus, everolimus (used to prevent transplant rejection);
• vildagliptin (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 2.5" and "Warnings and precautions").

Inform your doctor if you are taking the following medicines. Their effects may be altered when taking Tritace 2.5:

• antidiabetic medicines, such as oral glucose-lowering agents and insulin. Tritace 2.5 may lower blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Tritace 2.5;
• lithium (used for psychiatric disorders). Tritace 2.5 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 (or if there is any uncertainty), consult your doctor before starting Tritace 2.5.
Tritace 2.5 with food and alcohol

• Drinking alcohol while taking Tritace 2.5 may cause dizziness and drowsiness. If in doubt about the amount of alcohol allowed during treatment with Tritace 2.5, discuss with your doctor the potential additive effects of blood pressure-lowering medicines and alcohol.
• Tritace 2.5 can be taken independently of meals.

Pregnancy and breastfeeding
Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult her doctor before using this medicine. Tritace 2.5 must 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 pregnancy occurs while taking Tritace 2.5, inform the doctor immediately. Before planning a pregnancy, therapy should be changed to an appropriate alternative treatment.
Breastfeeding
The patient should not use Tritace 2.5 if she is breastfeeding.
Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
Dizziness may occur while taking Tritace 2.5. The risk of dizziness is higher at the beginning of treatment with Tritace 2.5 and after dose increases. If the patient experiences dizziness, he or she should not drive, operate tools, or use machinery.
Tritace 2.5 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 2.5

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

• The usual initial 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 treatment with Tritace 2.5.

Prevention of myocardial infarction or stroke

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

Reduction or delay of kidney function deterioration

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

Treatment of heart failure

• The usual initial dose is 1.25 mg once daily.
• Your doctor may modify the dosage.
• The maximum dose is 10 mg per day. Administration in two divided doses is recommended.

Treatment after myocardial infarction

• The usual initial 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. Administration in two divided doses is recommended.

Elderly patients
Your doctor will recommend a lower than usual initial 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 swallowed with liquid.
• Do not crush or chew the tablets.

Taking more Tritace 2.5 than prescribed
Contact your doctor or go immediately to the nearest hospital emergency department.
Do not drive yourself; ask someone to take you to the hospital or call an ambulance. Take the medicine packaging with you so the doctor knows which medicine has been taken.
If you miss a dose of Tritace 2.5

• 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 2.5 must be
discontinued and the patient should contact a doctor immediately – urgent medical attention 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 allergic reaction to Tritace 2.5.
• Severe skin reactions, including rash, mouth ulcers, worsening of pre-existing skin disorders, redness, blisters or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

If any of the following conditions occur, inform a doctor promptly:

• Rapid heartbeat, irregular or stronger heartbeats (palpitations), chest pain, feeling of pressure in the chest, or more severe conditions including heart attack 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), 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, yellowing of the skin or whites of the eyes (jaundice). These may be symptoms of liver disorders such as hepatitis or liver damage.

Other adverse reactions
Inform 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 tired,
• Dizziness; risk is higher at the beginning of treatment with Tritace 2.5 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, diarrhoea, 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 and sensory disturbances such as numbness, tingling, pricking, burning sensation or crawling sensation on the skin (paraesthesiae),
• Loss or disturbance of taste,
• Sleep disturbances,
• Depression, anxiety, nervousness or restlessness,
• Nasal congestion, difficulty breathing or worsening of asthma,
• Intestinal angioedema, characterized by abdominal pain, vomiting and diarrhoea,
• Heartburn, constipation or dry mouth,
• Increased urine output during the day,
• Excessive sweating,
• Loss or decrease of appetite (anorexia),
• Rapid or irregular heartbeat,
• Swelling of hands and feet; may indicate fluid retention,
• 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 uncertainty, 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 purpura of the skin,
• Skin spots and cold extremities,
• Redness, itching, swelling and watering of the eyes,
• Hearing disturbances and tinnitus,
• Weakness,
• Decreased number of red blood cells, white blood cells or platelets, or decreased haemoglobin levels in blood tests.

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

• 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-coloured) 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,
• Smell disturbances,
• Hair loss.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 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 to provide more information on the safety of the medicine.

5. How to store Tritace 2.5

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

6. Contents of the package and other information

What Tritace 2.5 contains
The active substance in this medicine is ramipril.
Each tablet contains 2.5 mg of ramipril.
The other ingredients are: hypromellose, pregelatinized corn starch, microcrystalline cellulose,
sodium stearyl fumarate, yellow iron oxide (E 172).

What Tritace 2.5 looks like and contents of the pack
Yellow or yellowish, elongated, divisible tablets measuring 8 x 4 mm, with "2.5" and "company logo" embossed on one side and "2.5" and "HMR" on the other side. The tablet can be divided into equal doses.
Tritace 2.5 tablets are packed in packs containing 28 tablets in PVC/Aluminium blisters.

For further detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Romania, the country of export:
ZENTIVA S.A., Bulevardul Theodor Pallady nr. 50, sector 3, Bucharest, 020334, Romania

Manufacturer:
Sanofi S.p.A., Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy
Delpharm Dijon, 6, Boulevard de l’Europe, 21800 Quetigny, France
S.C. Zentiva S.A., Bulevardul Theodor Pallady nr. 50, Sector 3, Bucharest, 032266, Romania

Parallel Importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing Authorisation Number in Romania, the country of export: 9236/2016/01
Parallel Import Authorisation Number: 200/22