Tritace 10

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
TRITACE 10, 10 mg, tablets
Ramiprilum
Please read the following information 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 questions, please 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 other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 raise 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),
• reduce the risk of heart attack or stroke,
• reduce the risk or delay the progression 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 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 group 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 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 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 type of blood filtration. Depending on the type of equipment used, Tritace 10 may not be suitable.
• If the patient has been diagnosed with 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, 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 it 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 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 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 (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 pregnancy. 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 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 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 if 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:

• Pain-relieving 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"),
• Pain-relieving 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 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 adjustment 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 agents 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 to the patient (or if the patient has any doubts), 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 while taking Tritace 10, discuss with your doctor the potential combined effects of blood pressure-lowering medicines and alcohol.

• Tritace 10 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 10 should not be used during the first 12 weeks of pregnancy and must not be used from week 13 of pregnancy, as its use during pregnancy may harm the unborn child. If the patient becomes pregnant while taking Tritace 10, she must inform her doctor immediately. Before planning a pregnancy, therapy should be changed 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 using machines
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, do not drive, operate tools or machinery.

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

3. How to use Tritace 10

This medicine should always be taken exactly as prescribed 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), and 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 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 maintenance dose is 10 mg per day. Administration in two divided doses is recommended.

Elderly patients
Your doctor will usually 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.
• Swallow the tablets with liquid.
• Do not crush or chew the tablets.

Taking more Tritace 10 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.
If you miss a dose of Tritace 10

• 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 10 must be discontinued and medical advice must be sought 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 10.
• Severe skin reactions, including rash, mouth ulcers, worsening of pre-existing skin disorders, redness, blisters or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

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

• Increased heart rate, irregular or forceful heartbeat (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, prolonged bleeding time, any signs of bleeding (e.g. bleeding gums), purplish 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 up to 1 in 10 patients)

• Headache or feeling of fatigue,
• Dizziness; risk is higher at the beginning of treatment with Tritace 10 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,
• Laboratory finding of higher than normal potassium levels in blood.

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 (paraesthesiae),
• Loss or disturbances of taste,
• Sleep disturbances,
• Depression, anxiety, nervousness or restlessness,
• Nasal congestion, difficulty in breathing or worsening of asthma,
• Intestinal swelling known as "intestinal angioedema", with symptoms such as abdominal pain, vomiting and diarrhoea,
• Heartburn, constipation or dry mouth,
• Increased urine output during the day,
• Excessive sweating,
• Loss of or decreased appetite (anorexia),
• Rapid or irregular heartbeat,
• Swelling of hands and feet; may be a sign of increased 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 up to 1 in 1,000 patients)

• Feeling of uneasiness, disorientation, confusion,
• Red, swollen tongue,
• Excessive skin scaling, 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 ringing in the ears (tinnitus),
• Weakness,
• Decreased number of red blood cells, white blood cells or platelets, or decreased haemoglobin concentration in blood tests.

Very rare (may affect up to 1 in 10,000 patients)

• Hypersensitivity to sunlight.

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

• Difficulty concentrating,
• Swelling of the lips,
• Finding of low blood cell counts in blood tests,
• Finding of lower than normal sodium levels in blood tests,
• Concentrated urine (dark in colour), nausea or vomiting, muscle cramps, confusion and seizures, which may be due to inappropriate ADH secretion (antidiuretic hormone - vasopressin). If any of these symptoms occur, contact your doctor immediately,
• Changes in finger colour upon exposure to cold, together with 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 effects 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, 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 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 required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Tritace 10 contains
The active substance is ramipril.
Each tablet contains 10 mg of ramipril.
The other ingredients are: hypromellose, modified maize 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 blister packs made of PVC/Aluminium, containing 28 tablets.

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

Responsible party in Romania, the country of export:
Sanofi Romania SRL
Str. Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9
Sector 2, Bucharest, 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., B-dul 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 in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw, Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorization number in Romania, the country of export: 9228/2016/01
Parallel import authorization number: 145/19