TRITACE 5

Package leaflet: 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
Ramiprilum
Tritace 5 and Zenra 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. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet contents

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 raise blood pressure,
• reducing tension and widening blood vessels,
• helping the heart to pump blood around the body.

Tritace 5 may be used:

• to treat high blood pressure (hypertension),
• to reduce the risk of heart attack or stroke,
• to reduce the risk of or delay worsening of kidney function (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 5

When not to use Tritace 5

• If the patient is allergic to ramipril, to any other medicine in the class of ACE inhibitors, 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, hives, red patches on the palms, soles, 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 blood pressure is very low or unstable – the doctor will advise frequent monitoring of blood pressure.
• 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 must not be used. If in doubt about using this medicine, consult a doctor before starting Tritace 5.

Warnings and precautions

Before starting 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 due to undergo 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; 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 reduce sodium levels in the blood. The doctor may recommend regular blood tests, particularly to check 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), wildagliptin, neprilysin inhibitors (NEP) (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 is planning pregnancy. Tritace 5 is not recommended during the first three months of pregnancy, and if used after the third month of pregnancy, this medicine may cause harm to 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 function 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 doubt), consult a doctor before starting Tritace 5.

Tritace 5 and other medicines

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

Tell the 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 the 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 indometacin, 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 alone or in combination with sulfamethoxazole (used to treat bacterial infections), and heparin (a blood thinner),
• 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);
• 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 the doctor if the patient is taking any of the following medicines. Their effects 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 Tritace 5.

Tritace 5 with food and alcohol

• Drinking alcohol while taking Tritace 5 may cause dizziness and lightheadedness. If in doubt about the amount of alcohol allowed while taking Tritace 5, discuss with your doctor the potential additive effects of blood pressure-lowering medicines and alcohol.
• Tritace 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 to have a baby, she should consult her doctor before using this medicine. Tritace 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 the patient becomes pregnant while taking Tritace 5, she should inform her doctor immediately. Before planning a pregnancy, therapy should be changed to appropriate alternative treatment.

Breast-feeding

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 increasing the dose. If the patient experiences dizziness, driving, using tools, or operating machinery should be avoided.

Tritace 5 contains sodium

The 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 your doctor has instructed. If you are unsure, you should consult your doctor or pharmacist.
Available on the market are: 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 tablets), your doctor may discontinue or reduce the dose of the diuretic before starting treatment with 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.
  Reducing or delaying worsening of 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. Administration in two divided doses is recommended.
  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. Administration in two divided doses is recommended.

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 liquid.
• 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. Take the medicine packaging with you so the doctor knows which medicine has been taken.
Missed 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 severe adverse reactions, treatment with Tritace 5 must be discontinued immediately and the patient should contact a doctor without delay – 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 hypersensitivity reaction to Tritace 5.
• Severe skin changes, 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 the doctor promptly:

• Rapid heartbeat, irregular or forceful heartbeats (palpitations), chest pain, sensation of chest pressure, or more severe conditions including heart attack or stroke.
• Shortness of breath or cough. These may indicate lung disorders.
• Easy bruising, prolonged bleeding time, any signs of bleeding (e.g. bleeding gums), purplish 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. 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
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, diarrhoea, indigestion, nausea or vomiting,
• Rash with or without raised lesions,
• Chest pain,
• Muscle cramps or muscle pain,
• Elevated 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 (paresthesia),
• Loss or disturbances of taste sensation,
• Sleep disturbances,
• Depression, anxiety, nervousness or restlessness,
• Nasal congestion, difficulty breathing or worsening of asthma,
• Intestinal swelling known as "intestinal angioedema", presenting with abdominal pain, vomiting and diarrhoea,
• 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 abnormally large 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 watering of the eyes,
• Hearing disturbances and tinnitus,
• Weakness,
• Decreased number of red blood cells, white blood cells or platelets, or decreased haemoglobin concentration in blood tests.

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

• Photosensitivity (increased sensitivity 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,
• Low blood cell count detected in blood tests,
• Lower than normal sodium levels detected 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 these symptoms occur, contact your doctor immediately,
• Changes in finger colour upon cold exposure, accompanied by 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 those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Tritace 5

Keep this medicine out of 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 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 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, divisible tablets measuring 8 x 4 mm, embossed 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 packed in packs containing 28 tablets in PVC/Al blisters.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation 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
Poland

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

Marketing Authorisation numbers in Romania, the country of export: 9237/2016/01
9237/2016/03
9237/2016/11

Parallel Import Authorisation number: 227/23