Tritace 10

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Tritace 10 (Cardace 10 mg), 10 mg, tablets
Ramipril
Tritace 10 and Cardace 10 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. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any 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. Important information 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 a substance that increases 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 of or delay the progression of kidney dysfunction (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. Important information before using Tritace 10

When not to use Tritace 10

• 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 spots on the palms,
  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 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 blood pressure is very low or unstable – 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.

Do not use Tritace 10 if any of the above situations apply. If in doubt about using this medicine, consult a doctor before starting Tritace 10.
Warnings and precautions
Before starting Tritace 10, discuss this with your doctor or pharmacist.

• If the patient has heart, liver or kidney diseases.
• If the patient has recently lost a significant amount of electrolytes or fluids (through 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 the doctor.
• If the patient has high potassium levels in the blood (shown in blood test results).
• If the patient is taking medicines or has conditions that may reduce sodium levels in the blood. The doctor may order 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 plans to become pregnant. 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 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 Tritace 10.
Tritace 10 and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken. Tritace 10 may affect the action of other medicines, and other medicines may affect the action of Tritace 10.
Inform the doctor if the patient is taking any of the following medicines. They 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.

Inform the doctor if the patient is taking any of the following medicines. They 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),
• 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),
• 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").

Inform the doctor if the patient is taking any of the following medicines. Their effect 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 order monitoring of blood lithium levels.

If any of the above conditions apply (or if the patient has any doubts), consult a doctor before starting Tritace 10.
Tritace 10 with food and alcohol

• Drinking alcohol while taking Tritace 10 may cause dizziness and lightheadedness. If in doubt about the amount of alcohol allowed while taking Tritace 10, discuss with the doctor the possibility of additive effects between 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 plans to have a child, she should consult a 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 onwards, as its use during pregnancy may harm the unborn child. If the patient becomes pregnant while taking Tritace 10, she should inform the doctor immediately. Before planning a pregnancy, therapy should be changed to appropriate alternative treatment.
Breastfeeding
The patient should not use Tritace 10 if she is breastfeeding.
Before using 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 the medicine is considered "sodium-free".

3. How to use Tritace 10

This medicine should always be taken as directed by your doctor. If you have any doubts, you should
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 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 your diuretic before starting treatment with Tritace 10.
  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 maintenance dose is 10 mg once daily.
  Slowing or delaying the progression of kidney dysfunction
• The usual starting 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 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.
  Post-myocardial infarction treatment
• 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 fluid.
• 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. 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 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient notices any of the following serious adverse effects, treatment with Tritace 10 must be stopped and the doctor must be contacted immediately – urgent medical care may be necessary:

• 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 10.
• Severe skin reactions, including rash, mouth ulcers, worsening of pre-existing skin diseases, redness, blisters or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

If any of the following conditions occur, contact the doctor quickly:

• Rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, feeling of pressure in the chest, or more 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), 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 effects
Tell your doctor if any of the following symptoms worsen significantly 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 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 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, prickling, burning sensation or crawling sensation on the skin (paraesthesiae),
• Loss or disturbance of taste,
• Sleep disturbances,
• Depression, anxiety, nervousness or restlessness,
• Nasal congestion, breathing difficulties 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 or decrease in appetite (anorexia),
• Rapid or irregular heartbeat,
• Swelling of hands and feet; may indicate retention of larger than usual 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 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 less than 1 in 10,000 patients)

• Hypersensitivity to sunlight.

Other reported adverse effects:
If any of the symptoms listed below worsen or persist for more than a few days, inform your doctor.

• Difficulty concentrating,
• Swelling of the lips,
• Finding low blood cell counts in blood tests,
• Finding lower than normal sodium levels in blood tests,
• Concentrated urine (dark in colour), 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,
• Colour changes in fingers upon exposure to cold, 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects helps to provide more information on the safety of the 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 are required.
Medicines must 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 pack and other information

What Tritace 10 contains
The active substance is ramipril.
Each tablet contains 10 mg of ramipril.
Other components are: hypromellose, pregelatinized starch, corn starch, microcrystalline cellulose,
sodium stearyl fumarate.

What Tritace 10 looks like and contents of the pack
White or almost white, elongated, divisible 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 foil containing 28 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Latvia, country of export:
Sanofi Winthrop Industrie
82, avenue Raspail
94250 Gentilly, France

Manufacturer:
Sanofi S.r.l.
Strada Statale 17, Km 22, 67019 Scoppito, 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
Sanofi Aventis Deutschland GmbH
Industriepark Höchst Brüningstraße 50, D-65926 Frankfurt am Main, Germany

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 Latvia, country of export: 03-0067
Parallel Import Licence Number: 443/24