Tritace 10

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Tritace 10 (Zenra 10 mg), 10 mg, tablets
Ramiprilum
Tritace 10 and Zenra 10 mg are different trade names of the same medicine.
Please read this leaflet carefully before taking this 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Tritace 10 is and what it is used for
2. What you need to know before taking Tritace 10
3. How to take Tritace 10
4. Possible side effects
5. How to store Tritace 10
6. Contents of the pack and other information

1. What Tritace 10 is and what it is 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 in the body of substances that increase blood pressure,
• reducing tension and widening blood vessels,
• helping the heart to pump blood around the body.

Tritace 10 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 10

When not to use Tritace 10

• If the patient is allergic to ramipril, any other medicine in the ACE inhibitor class, 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 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 another type of blood filtration. Depending on the type of equipment used, Tritace 10 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 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, do not use Tritace 10. If in doubt about using this medicine, consult a doctor before starting treatment with Tritace 10.

Warnings and precautions

Before starting treatment with Tritace 10, 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 for anaesthesia. These may be used during surgical or dental procedures. It may be necessary to stop taking Tritace 10 one day before the procedure; if in doubt, contact your doctor.
• If the patient has high potassium levels in the blood (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 (a 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 10").
• 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 to become pregnant. Use of Tritace 10 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, particularly 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 the section "When not to use Tritace 10".

Children and adolescents

Tritace 10 is not recommended for use 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 there is any doubt), consult a doctor before starting treatment with Tritace 10.

Tritace 10 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 10 may affect the action of other medicines, and other medicines may affect the action of Tritace 10.

Tell your doctor if the patient is taking any of the following medicines. These may reduce the effect of Tritace 10:

• 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 10:

• sacubitril in combination with valsartan – used to treat chronic (long-term) heart failure in adults (see section 2 "When not to use Tritace 10"),
• 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 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),
• 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 10" and "Warnings and precautions").

Tell your doctor if the patient is taking any of the following medicines. Their effects may be altered when taking Tritace 10:

• antidiabetic medicines, such as oral glucose-lowering medicines and insulin. Tritace 10 may lower blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Tritace 10.
• lithium (used for psychiatric disorders). Tritace 10 may increase lithium levels in the blood. The doctor will recommend monitoring lithium levels in the blood.

If any of the above conditions apply (or if there is any doubt), consult a doctor before starting treatment with Tritace 10.

Tritace 10 with food and alcohol

• Drinking alcohol while taking Tritace 10 may cause dizziness and drowsiness. If in doubt about the amount of alcohol allowed during treatment with Tritace 10, discuss with your doctor the potential additive effects of blood pressure-lowering medicines and alcohol.
• Tritace 10 may 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 become pregnant, she should consult a doctor before using this medicine. Tritace 10 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 10, she should inform her doctor immediately. Prior to planned pregnancy, therapy should be switched to appropriate alternative treatment.

Breast-feeding

The patient should not use Tritace 10 if she is breast-feeding.

Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery

Dizziness may occur while taking Tritace 10. The risk of dizziness is higher at the beginning of treatment with Tritace 10 and after dose increases. If the patient experiences dizziness, driving, using tools or operating machinery should be avoided.

Tritace 10 contains sodium

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

3. How to use Tritace 10

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The following products are available on the market: 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 10.
  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.
  Reducing or delaying worsening of kidney function

• The usual initial 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 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 usually recommend a lower initial dose, which will then be gradually increased.
How to take the medicine

• This medicine is for oral use and should be taken at the same time each day.
• Tablets should be swallowed with liquid.
• Do not crush or chew the tablets.

Taking more Tritace 10 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. Bring the medicine packaging with you so the doctor knows which medicine has been taken.
If you miss a dose of Tritace 10

• If you miss a dose, take the next dose at your usual time.
• Do not take a double dose to make up for the 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 10 must be discontinued and medical advice must be sought immediately – urgent medical assistance 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 10.
• Severe skin reactions, including rash, mouth 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, contact a doctor promptly:

• Rapid heartbeat, irregular or stronger-than-normal heartbeats (palpitations), chest pain, sensation of pressure in the chest, 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), purplish skin spots, 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 up to 1 in 10 patients)

• Headache or feeling tired,
• Dizziness; the risk is higher at the beginning of treatment with Tritace 10 and after dose increase,
• Fainting, hypotension (abnormally low blood pressure), especially upon 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 up to 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 disturbance of taste,
• Sleep disturbances,
• Depression, anxiety, nervousness or restlessness,
• Nasal congestion, difficulty breathing or worsening of asthma,
• Intestinal swelling known as "intestinal angioedema", with symptoms including abdominal pain, vomiting and diarrhoea,
• Heartburn, constipation or dry mouth,
• Increased urine output during the day,
• Excessive sweating,
• Loss of or reduced 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 levels of certain white blood cells (eosinophilia) in blood tests,
• Blood test results indicating changes in liver, pancreas or kidneys.

Rare (may affect up to 1 in 1,000 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 purpura (skin bruising),
• Skin spots and cold extremities,
• Redness, itching, swelling and tearing of the eyes,
• Hearing disturbances and tinnitus (ringing in the ears),
• Weakness,
• Decreased red blood cells, white blood cells or platelets, or decreased hemoglobin levels in blood tests.

Very rare (may affect up to 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,
• 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 these symptoms occur, contact your doctor immediately,
• Changes in finger colour upon cold exposure, and tingling or pain upon warming (Raynaud's phenomenon),
• Breast enlargement in men,
• Slowed or impaired reactions,
• Burning sensation,
• Olfactory 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 of Adverse Drug Reactions at 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 provide more information on the safety of this medicine.

5. How to store Tritace 10

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 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 5 mPas (type 2910), pregelatinized corn starch, microcrystalline cellulose, sodium stearyl fumarate.

What Tritace 10 looks like and contents of the pack
White or almost white, elongated, scored tablets, 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 packed in blisters made of PVC/Aluminum foil, containing 28 tablets.

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

Responsible entity in Romania, country of export:
Zentiva S.A.
Bulevardul Theodor Pallady nr. 50, sector 3
020334 Bucharest
Romania

Manufacturer:
S.C. Zentiva S.A., Bulevardul Theodor Pallady nr. 50, Sector 3, 032266 Bucharest, Romania
Sanofi S.r.l., Strada Statale 17, Km 22, 67019 Scoppito (AQ), Italy
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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw

Marketing Authorization number in Romania, country of export: 9238/2016/01
Parallel import licence number: 342/24