Triatec

Package leaflet: Information for the user

TRIATEC 2.5 mg tablets, 5 mg tablets, 10 mg tablets

ramipril
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What TRIATEC is and what it is used for

TRIATEC contains a medicine called ramipril, which belongs to a group of medicines
known as ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).
TRIATEC works by:

• Decreasing the body's production of substances that can cause an increase in blood pressure
• Relaxing and widening your blood vessels
• Helping your heart pump blood more easily throughout the body.

TRIATEC may be used:

• To treat high blood pressure (hypertension)
• To reduce the risk of heart attack or stroke
• To reduce the risk or delay the worsening of kidney problems (with or without diabetes)
• To treat heart failure (when the heart is unable to pump enough blood to the rest of the body)
• As a treatment after a heart attack (myocardial infarction), when associated with heart failure.

2. What you should know before taking TRIATEC

Do not take TRIATEC:

• If you are allergic to ramipril, other ACE inhibitors, or any of the other ingredients of this medicine listed in section 6. Signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have previously had a severe allergic reaction called "angioedema". Signs include itching, skin rash (urticaria), red spots on hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing or swallowing.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults.
• If you are on dialysis or undergoing another type of blood filtration. Depending on the equipment used, TRIATEC may not be suitable for you.
• If you have kidney problems due to reduced blood flow to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see below “Pregnancy and breastfeeding”).
• If your blood pressure is excessively low or unstable. Your doctor must assess this.
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take TRIATEC if any of the above conditions apply to you. If you are unsure,
ask your doctor before taking TRIATEC.
Warnings and precautions
Talk to your doctor or pharmacist before taking TRIATEC:

• If you have heart, liver, or kidney problems.
• If you have lost significant amounts of body salts or fluids (due to illness such as vomiting, diarrhea, excessive sweating, following a low-salt diet, prolonged use of diuretics, or after dialysis).
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization).
• If you are about to receive an anesthetic, which may be given during surgery or dental procedures. You may need to stop taking TRIATEC the day before; consult your doctor.
• If you have high levels of potassium in your blood (shown by a blood test).
• If you are taking medicines or have conditions that may lower sodium levels in your blood. Your doctor may order regular blood tests, especially to monitor blood sodium levels, particularly if you are elderly.
• If you are taking medicines that may increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin (NEP) inhibitors (e.g., racecadotril), or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take TRIATEC”.
• If you have a vascular collagen disorder such as scleroderma or systemic lupus erythematosus.
• You must inform your doctor if you think you are pregnant (or could become pregnant). TRIATEC is not recommended during the first 3 months of pregnancy and may cause severe harm to the unborn child after 3 months of pregnancy (see below “Pregnancy and breastfeeding”).
• If you are taking any of the following medicines for high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA), also known as sartans (e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also the section “Do not take TRIATEC”.

Children and adolescents
The use of TRIATEC is not recommended in children and adolescents under 18 years of age
because the safety and efficacy of TRIATEC in children have not yet been established.
If any of the above conditions apply (or if you are unsure), ask your doctor before taking TRIATEC.
Other medicines and TRIATEC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because TRIATEC may affect how some other medicines work. Also, some medicines may affect how TRIATEC works.
Inform your doctor if you are taking any of the following medicines. These medicines may interfere with TRIATEC and alter its effect:

• Medicines used to relieve pain and inflammation (e.g., Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, aspirin).
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor will need to monitor your blood pressure.

Inform your doctor if you are taking any of the following medicines. Taking these with TRIATEC may increase the risk of side effects:

• Sacubitril/valsartan – used to treat chronic heart failure in adults (see section 2 “Do not take TRIATEC”).
• Medicines used to relieve pain and inflammation (e.g., Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, aspirin).
• Medicines for cancer (chemotherapy).
• Medicines to prevent organ rejection after transplant, such as cyclosporine.
• Diuretics such as furosemide.
• Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections), and heparin (used to thin the blood).
• Steroid medicines used to treat inflammation, such as prednisolone.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent transplant rejection).
• Vildagliptin (for treatment of type 2 diabetes).
• Racecadotril (used to treat diarrhea).
• Your doctor may consider it necessary to adjust the dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take TRIATEC” and “Warnings and precautions”).

Inform your doctor if you are taking any of the following medicines. The action of these medicines may be affected by TRIATEC:

• Medicines for diabetes such as oral hypoglycemics and insulin. TRIATEC may lower blood sugar levels. Monitor your blood sugar levels carefully when taking TRIATEC.
• Lithium (for psychiatric conditions). TRIATEC may increase lithium levels in the blood. Your doctor must closely monitor your blood lithium levels. If any of the above conditions apply (or if you are unsure), ask your doctor before taking TRIATEC.

TRIATEC with food and alcohol

• Drinking alcoholic beverages together with TRIATEC may cause dizziness or lightheadedness. Discuss with your doctor how much alcohol you can drink while taking TRIATEC, as blood pressure-lowering medicines and alcohol may have additive effects.
• TRIATEC can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or could become pregnant).
You must not take TRIATEC during the first 12 weeks of pregnancy and must absolutely avoid it from week 13 onwards, as its use during pregnancy may harm the unborn child. If you become pregnant while taking TRIATEC, inform your doctor immediately. Before planning a pregnancy, you should switch to another medicine more suitable for use in pregnancy.
Breastfeeding
You must not take TRIATEC if you are breastfeeding. Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
You may experience dizziness while taking TRIATEC. This is more likely when you first start taking TRIATEC or when your dose has just been increased. If this occurs, do not drive or operate tools or machinery.

3. How to take TRIATEC

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.

How much you should take

Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust your dose until your blood pressure is under control.
• The maximum daily dose is 10 mg.
• If you are already taking diuretics, your doctor may stop or reduce them before starting your treatment with TRIATEC.

To reduce the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once daily.
• Your doctor may decide to increase your dose.
• The usual dose is 10 mg once daily.

Treatment to reduce or delay worsening of kidney problems

• You may be started on a dose of 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust your dose.
• 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 will adjust your dose.
• The maximum dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.

Treatment after a heart attack

• The usual starting dose ranges from 1.25 mg once daily to 2.5 mg twice daily.
• Your doctor will adjust your dose.
• The usual dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.

Elderly population
Your doctor will reduce the starting dose and adjust treatment more slowly.

Taking this medicine

• Take this medicine by mouth, at the same time each day.
• Swallow the tablets whole with liquid.
• Do not break or chew the tablets.

If you take more TRIATEC than you should
Inform your doctor or go to the nearest hospital emergency department. Do not drive to the hospital; have someone accompany you or call an ambulance. Bring the medicine pack with you, as the doctor needs to know what you have taken.

If you forget to take TRIATEC

• If you forget a dose, take your usual dose at the next scheduled time.
• Do not take a double dose to make up for the forgotten tablet.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking TRIATEC and contact your doctor immediately if you notice any of the following serious side effects – you may need urgent medical treatment:

• Swelling of the face, lips, or throat causing difficulty swallowing or breathing, as well as itching or skin rash. This could be a sign of a severe allergic reaction to TRIATEC.
• Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin conditions, redness, blistering, and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Contact your doctor immediately if you experience:

• Rapid heartbeat, irregular or forceful heartbeat (palpitations), chest pain, tightness in the chest, or more serious problems including heart attack and stroke.
• Shortness of breath or cough. These may be signs of lung problems.
• Easy bruising, prolonged bleeding longer than normal, any sign of bleeding (e.g., bleeding gums), purple spots on the skin, or increased susceptibility to infections, sore throat, fever, feeling tired, weakness, dizziness, or pale appearance. These may be signs of blood or bone marrow problems.
• Severe stomach pain that may extend to the back. This could be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (liver inflammation) or liver damage.

Other side effects include:
Inform your doctor if any of the following conditions become severe or persist for more than a few days:
Common (may affect up to 1 in 10 people)

• Headache or feeling tired
• Dizziness. This is more likely to occur when starting treatment with TRIATEC or shortly after increasing the dose
• Weakness, hypotension (unusually low blood pressure), especially when standing up or getting up quickly
• Dry, persistent cough, sinus inflammation (sinusitis), or bronchitis, shortness of breath
• Stomach or intestinal pain, diarrhea, indigestion, nausea, or feeling unwell
• Rash with or without swelling
• Chest pain
• Muscle cramps or muscle pain
• Blood tests show higher than normal potassium levels.

Uncommon (may affect up to 1 in 100 people)

• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling, or scratching sensations (paresthesia)
• Loss or change in taste
• Sleep disturbances
• Depressed mood, anxiety, increased nervousness, or irritability
• Stuffy nose, breathing difficulties, or worsening of asthma
• Intestinal swelling called "intestinal angioedema" presenting with symptoms such as abdominal pain, vomiting, and diarrhea
• Heartburn, constipation, or dry mouth
• Increased amount of urine during the day
• Increased sweating
• Loss of appetite or reduced appetite (anorexia)
• Rapid or irregular heartbeat
• Swollen arms and legs. This may be a sign that your body is retaining more fluid than usual
• Hot flushes
• Blurred vision
• Joint pain
• Fever
• Impotence in men, reduced sexual desire in men and women
• Increase in white blood cells (eosinophilia) detected during blood tests
• Changes in liver, pancreas, or kidney function as shown by blood tests.

Rare (may affect up to 1 in 1,000 people)

• Feeling faint or confused
• Swollen and red tongue
• Severe peeling or shedding of the skin, itching, rash with pustules
• Nail problems (such as nail loss or separation of the nail from its bed)
• Skin rash or bruising
• Spots on the skin and cold extremities
• Red, swollen, watery, or itchy eyes
• Hearing disturbances and ringing in the ears
• Feeling weak
• Decreased number of red blood cells, white blood cells, and platelets, or reduced hemoglobin concentration, as shown by blood tests.

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

• Increased sensitivity to sunlight.

Other side effects reported:
Inform your doctor if any of the following conditions become severe or persist for more than a few days.

• Difficulty concentrating
• Mouth swelling
• Blood tests showing too low a number of blood cells
• Blood tests showing low sodium levels in the blood
• Concentrated (dark-colored) urine, feeling unwell, muscle cramps, confusion, and seizures that may be due to inappropriate antidiuretic hormone (ADH) secretion. If you experience these symptoms, contact your doctor promptly
• Fingers of hands and feet changing color when cold, and tingling or painful when warmed (Raynaud's phenomenon)
• Breast enlargement in men
• Slowed or altered reactions
• Burning sensation
• Changes in sense of smell
• Hair loss.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TRIATEC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cartons, blisters, and bottles after Exp. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the Pack and Other Information

What TRIATEC Contains
The active substance is ramipril.
2.5 mg: Each tablet contains ramipril 2.5 mg
5 mg: Each tablet contains ramipril 5 mg
10 mg: Each tablet contains ramipril 10 mg

The other components of the tablets are:
2.5 mg tablets
hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate,
yellow iron oxide E172.

5 mg tablets
hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate,
red iron oxide E172.

10 mg tablets
hypromellose, pregelatinized maize starch, microcrystalline cellulose, sodium stearyl fumarate.

Description of the Appearance of TRIATEC and Pack Contents
2.5 mg tablets
Oblong tablets of 8 x 4 mm, yellow to yellowish, with a score line, marked on the upper side with "2.5" and the company logo, and on the lower side with "HMR" and "2.5". The tablet can be divided into equal doses.

5 mg tablets
Oblong tablets of 8 x 4 mm, light red, with a score line, marked on the upper side with "5" and the company logo, and on the lower side with "HMP" and "5". The tablet can be divided into equal doses.

10 mg tablets
Oblong tablets of 7 x 4.5 mm, white to almost white, with a score line, marked on the upper side with "HMO/HMO". The tablet can be divided into equal doses.

TRIATEC 2.5 mg tablets are available in packs of 7, 10, 14, 15, 18, 20, 28, 30, 45, 50, 60, 90, 98, 99, 100, 300, 320, 500 tablets in PVC/aluminum blisters and in bottles of 500 tablets made of dark glass with a closure cap.

TRIATEC 5 mg tablets are available in packs of 10, 14, 15, 18, 20, 21, 28, 30, 45, 50, 56, 90, 98, 99, 100, 300, 320, 500 tablets in PVC/aluminum blisters and in bottles of 500 tablets made of dark glass with a closure cap.

TRIATEC 10 mg tablets are available in packs of 7, 10, 14, 15, 18, 20, 28, 30, 45, 50, 56, 90, 98, 99, 100, 300, 320, 500 tablets in PVC/aluminum blisters and in bottles of 28, 56, 500 tablets made of dark glass with a closure cap.

Not all pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sanofi S.r.l. - Viale L. Bodio, 37/B - 20158 Milan, Italy

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

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Austria:
Tritace 1.25 mg Tabletten, Tritace 2.5 mg Tabletten, Tritace 5 mg Tabletten, Tritace 10 mg Tabletten

Belgium:
Tritace 2.5 mg tabletten/comprimés/tabletten,
Tritace 5 mg tabletten/comprimés/tabletten, Tritace 10 mg tabletten/comprimés/tabletten

Bulgaria:
Tritace 5 mg таблетки, Tritace 10 mg таблетки

Cyprus:
Triatec 2.5 mg δισκία, Triatec 5 mg δισκία

Czech Republic:
Tritace 1.25 mg tablety, Tritace 2.5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety

Denmark:
Triatec 5 mg tabletter

Estonia:
Cardace 2.5 mg tabletid, Cardace 5 mg tabletid, Cardace 10 mg tabletid

Finland:
Cardace 2.5 mg tabletit, Cardace 5 mg tabletit, Cardace 10 mg tabletit

France:
Triatec 1.25 mg comprimé, Triatec 2.5 mg comprimé sécable, Triatec 5 mg comprimé sécable, Triatec 10 mg comprimé sécable
Ramipril Zentiva 2.5 mg comprimés sécables, Ramipril Zentiva 5 mg comprimés sécables, Ramipril Zentiva 10 mg comprimés sécables

Germany:
Delix 2.5 mg Tabletten, Delix 5 mg Tabletten, Delix Protect 10 mg Tabletten
Delix Protect Startset
Ramilich 2.5 mg Tabletten, Ramilich 5 mg Tabletten, Ramilich 10 mg Tabletten
Delix 1.25 mg Tabletten
Delix 1.25 mg Kapseln, Delix P 2.5 mg Kapseln, Delix P 5 mg Kapseln, Delix P 10 mg Kapseln

Greece:
Triatec 2.5 mg δισκία, Triatec 5 mg δισκία

Hungary:
Tritace Mite 1.25 mg tabletta
Tritace 2.5 mg tabletta, Tritace 5 mg tabletta, Tritace 10 mg tabletta
Ramipril – Zentiva 5 mg tabletta
Ramipril – Zentiva 10 mg tabletta

Ireland:
Tritace 1.25 mg tabs, Tritace 2.5 mg tabs, Tritace 5 mg tabs, Tritace 10 mg tabs

Italy:
Triatec 2.5 mg compresse, Triatec 5 mg compresse, Triatec 10 mg compresse
Ramipril Zentiva 2.5 mg compresse, Ramipril Zentiva 5 mg compresse, Ramipril Zentiva 10 mg compresse

Latvia:
Cardace 2.5 mg tabletes, Cardace 5 mg tabletes, Cardace 10 mg tabletes

Lithuania:
Cardace 5 mg tabletės, Cardace 10 mg tabletės

Luxembourg:
Tritace 2.5 mg tabletten/comprimés/tabletten
Tritace 5 mg tabletten/comprimés/tabletten, Tritace 10 mg tabletten/comprimés/tabletten

Norway:
Triatec 2.5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg tabletter

Poland:
Tritace 2.5 mg tabletki, Tritace 5 mg tabletki, Tritace 10 mg tabletki

Portugal:
Triatec 1.25 mg cápsulas, Triatec 2.5 mg cápsulas, Triatec 5 mg cápsulas, Triatec 10 mg cápsulas

Romania:
Tritace 2.5 mg comprimate, Tritace 5 mg comprimate, Tritace 10 mg comprimate
Zenra 2.5 mg comprimate, Zenra 5 mg comprimate, Zenra 10 mg comprimate

Slovakia:
Tritace 1.25 mg tablety, Tritace 2.5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety

Slovenia:
Tritace 1.25 mg tablete, Tritace 2.5 mg tablete, Tritace 5 mg tablete, Tritace 10 mg tablete

Spain:
Acovil 2.5 mg comprimidos, Acovil 5 mg comprimidos, Acovil 10 mg comprimidos

Sweden:
Triatec 2.5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg tabletter

United Kingdom:
Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets,
Tritace Titration Pack tablets