TRIATEC <2.5 MG Tablet

Зміст інструкції

1. TRIATEC 2.5 mg tablets, 5 mg tablets, 10 mg tablets
   1. What is TRIATEC and what is it 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. Content of the pack and other information

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

ramipril

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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is TRIATEC and what is it used for

TRIATEC contains a medicine called ramipril which belongs to the group of medicines
called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
TRIATEC works by:

• Decreasing the production, by the body, of substances that can cause an increase in blood pressure
• Relaxing and widening its blood vessels
• Making it easier for its heart to pump blood around the body.

TRIATEC can be used:

• To treat high blood pressure (hypertension)
• To reduce the risk of a heart attack or stroke
• To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes)
• To treat your heart when it cannot pump enough blood around the rest of the body (heart failure)
• As treatment after a heart attack (myocardial infarction) if associated with heart failure.

2. What you need to know before taking TRIATEC

Do not take TRIATEC:

• If you are allergic to ramipril, to other ACE inhibitor medicines or to any of the other ingredients of this medicine listed in section 6. Signs of an allergic reaction can include skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
• If you have had a serious allergic reaction called “angioedema”. The signs include itching, rash (urticaria), red patches on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.
• If you are on dialysis or having any other type of blood filtration. Depending on the machine that is used, TRIATEC may not be suitable for you
• If you have kidney problems caused by insufficient blood supply to the kidney (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 will need to make this assessment
• If you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Do not take TRIATEC if any of the above conditions apply to you. If you are not sure,
ask your doctor before taking TRIATEC.

Warnings and precautions
Talk to your doctor or pharmacist before taking TRIATEC:

• If you have problems with your heart, liver or kidneys
• If you have lost a lot of salts or fluids from your body (due to an illness such as vomiting, diarrhoea, excessive sweating, or following a low-salt diet, or after taking diuretics for a long time or having undergone dialysis)
• If you are about to undergo treatment to reduce your allergy to bee or wasp stings (desensitisation)
• If you are going to receive an anaesthetic. This may be given for surgery or dental treatment. You may need to stop taking TRIATEC the day before; ask your doctor for advice
• If you have a high amount of potassium in your blood (shown by a blood test)
• If you are taking medicines or are in conditions where the levels of sodium in your blood may decrease. Your doctor may prescribe blood tests at regular intervals, particularly to check the levels of sodium in your blood, especially if you are elderly
• If you are taking medicines that can increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril) or sacubitril/valsartan. See section 2 “Do not take TRIATEC” for sacubitril/valsartan.
• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus.
• You must tell your doctor if you think you might be pregnant (or might become pregnant). TRIATEC is not recommended in the first 3 months of pregnancy and can cause serious harm to the baby after 3 months of pregnancy (see below “Pregnancy and breastfeeding”)
• If you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes
• aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood 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 the age of 18 years
because the safety and efficacy of TRIATEC in children have not yet been established.
If any of the above conditions apply to you (or you are not sure), 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 medicines. This is because TRIATEC can affect the mechanism
of action of some other medicines. Also some medicines can affect the
mechanism of action of TRIATEC.
Tell your doctor if you are taking any of the following medicines. These medicines can
interfere with TRIATEC by altering its action:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indometacin, 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 check your blood pressure.

Tell your doctor if you are taking any of the following medicines. These medicines, if taken
with TRIATEC, can increase the likelihood of side effects:

• Sacubitril/valsartan - used to treat a type of long-term (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, indometacin, aspirin)
• Cancer medicines (chemotherapy)
• Medicines to prevent organ rejection after a transplant such as ciclosporin
• Diuretics such as furosemide
• Medicines that can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections) and heparin (used to make the blood more fluid)
• Steroid medicines for treating inflammation such as prednisolone
• Allopurinol (used to lower the amount of uric acid in the blood)
• Procainamide (for heart rhythm problems)
• Temsirolimus (for cancer)
• Sirolimus, everolimus (to prevent transplant rejection)
• Vildagliptin (for the treatment of type 2 diabetes)
• Racecadotril (used to treat diarrhoea)
• Your doctor may need to change the dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections “Do not take TRIATEC” and “Warnings and precautions”).

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

• Diabetes medicines such as oral hypoglycaemics and insulin. TRIATEC can lower the amount of sugar in your blood. Check your blood sugar levels carefully when taking TRIATEC.
• Lithium (for psychiatric problems). TRIATEC can increase the amount of lithium in your blood. Your doctor must check the level of lithium in your blood carefully. If any of the above conditions apply to you (or you are not sure), ask your doctor before taking TRIATEC.

TRIATEC with food and alcohol

• Drinking alcoholic beverages together with TRIATEC can cause dizziness or lightheadedness. If you want to know how much alcohol you can drink when taking TRIATEC, discuss this with your doctor, as medicines used to lower blood pressure and alcohol can have additive effects.
• TRIATEC can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you might be pregnant (or might become pregnant).
You must not take TRIATEC in the first 12 weeks of pregnancy and must not
take it at all after the 13th week because its use during pregnancy can
be harmful to the baby. If you become pregnant while taking TRIATEC, tell
your doctor immediately. Before planning a pregnancy, you should switch to another medicine that is more suitable.
Breastfeeding
You must not take TRIATEC if you are breastfeeding. Ask your doctor or pharmacist before
taking any medicine.

Driving and using machines
You may feel dizzy while taking TRIATEC. This is more likely
when you first start taking TRIATEC or have just increased the dose. If this
happens, do not drive or use tools or machines.

3. How to take TRIATEC

Take this medicine following exactly the instructions of your doctor. If you have
any doubts, consult your doctor or pharmacist.

How much to take

Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once a day.
• Your doctor will adjust the amount you take until your blood pressure is under control.
• The maximum daily dose is 10 mg.
• If you are already taking diuretics, your doctor may stop them or reduce the amount before starting you on TRIATEC. To reduce the risk of a heart attack or stroke
• The usual starting dose is 2.5 mg once a day.
• Your doctor may decide to increase the dosage you take.
• The usual dose is 10 mg once a day. Treatment to reduce or delay the worsening of kidney problems
• You may be given to start a dose of 1.25 mg or 2.5 mg once a day.
• Your doctor will adjust the amount you are taking.
• The usual dose is 5 mg or 10 mg once a day. Treatment of heart failure
• The usual starting dose is 1.25 mg once a day.
• Your doctor will adjust the amount you take.
• 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 is from 1.25 mg once a day to 2.5 mg twice a day.
• Your doctor will adjust the amount you take.
• 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 the treatment more slowly.

Taking this medicine

• Take this medicine by mouth, at the same time of day, every 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 emergency room of the nearest hospital. Do not drive to
the hospital, have someone accompany you or call an ambulance. Bring with you the
medicine packaging. This is because the doctor needs to know what you have taken.

If you forget to take TRIATEC

• If you forget a dose, take your normal dose when it is time.
• Do not take a double dose to make up for a forgotten tablet.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking TRIATEC and contact your doctor immediately if you notice the onset of any serious side effect – you may need urgent medical treatment:

• Swelling of the face, lips or throat making it difficult to swallow or breathe, as well as itching or rash. This could be a sign of a severe allergic reaction to TRIATEC.
• Severe skin reactions including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering and peeling skin (such as Stevens-Johnson Syndrome, toxic epidermal necrolysis or erythema multiforme).

Inform your doctor immediately if you experience:

• Increased heart rate, irregular or strengthened heartbeat (palpitations), chest pain, feeling of 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
• Easier bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums) purple spots on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, weak, dizzy or pale skin. These may be signs of problems with blood circulation or the bone marrow
• Severe abdominal pain that may extend to the back. This may 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 (inflammation of the liver) or liver damage.

Other side effects include:
Inform your doctor if any of the following conditions becomes severe or persists for more than a few days:

Common(may affect up to 1 in 10 people)

• Headache or feeling tired
• Feeling dizzy. This is more likely to happen when treatment with TRIATEC is first started or the dose has just been increased
• Weakness, low blood pressure (unusually low blood pressure), especially when standing up or rising quickly
• Dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
• Stomach or intestinal pain, diarrhea, indigestion, feeling unwell or generally unwell
• Rash with or without swelling
• Chest pain
• Cramps or muscle pain
• Blood tests show a higher than normal level of potassium.

Uncommon(may affect up to 1 in 100 people)

• Problems with balance (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or chafing (paresthesia)
• Loss or change of taste
• Sleep problems
• Depressed mood, anxiety, increased nervousness than usual or irritability
• Nasal congestion, difficulty breathing or worsening of asthma
• Swelling of the intestine called “intestinal angioedema” and which presents with symptoms such as abdominal pain, vomiting and diarrhea
• Heartburn, constipation or dry mouth
• Increased amount of urine during the day
• Increased sweating than usual
• Loss or decrease of appetite (anorexia)
• Fast or irregular heartbeat
• Swollen arms and legs. This may be a sign that your body is retaining more water than usual
• Hot flushes
• Blurred vision
• Joint pain
• Fever
• Impotence in men, reduced sexual desire in men and women
• Increased number of white blood cells (eosinophilia) found during blood tests
• Changes in liver, pancreas or kidney function as highlighted by blood tests.

Rare(may affect up to 1 in 1000 people)

• Feeling faint or confused
• Swollen and red tongue
• Severe flaking or peeling of the skin, itching, rash characterized by pustules
• Problems with nails (such as loss or separation of the nail from its bed)
• Rash or bruising
• Spots on the skin and cold extremities
• Red, swollen, watery or itchy eyes
• Hearing disorders and ringing in the ears
• Feeling weak
• Decrease in the number of red blood cells, white blood cells and platelets in the blood or hemoglobin concentration, highlighted by blood tests.

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

• Increased sensitivity to the sun.

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

• Difficulty concentrating
• Swelling of the mouth
• Blood tests showing a low number of blood cells
• Blood tests showing a low level of sodium in the blood
• Concentrated urine (dark in color), feeling unwell or sick, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor promptly
• Fingers of the hands and feet that change color when cooled and tingle or hurt when warmed (Raynaud's phenomenon)
• Increased breast volume in men
• Slowed or altered reactions
• Burning sensation
• Change in the perception of smells
• Hair loss.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.Reporting side effects 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 which is stated on the packs, 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 in waste water or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Content of the pack and other information

What TRIATEC contains
The active ingredient 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 corn starch, microcrystalline cellulose, sodium stearylfumarate,
yellow iron oxide E172.

5 mg tablets
hypromellose, pregelatinized corn starch, microcrystalline cellulose, sodium stearylfumarate,
red iron oxide E172.

10 mg tablets
hypromellose, pregelatinized corn starch, microcrystalline cellulose, sodium stearylfumarate.

Description of the appearance of TRIATEC and content of the pack
2.5 mg tablets
Oblong tablets 8 x 4 mm, from yellow to yellowish, with a breaking notch, marked
on the upper side with 2.5 and 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 8 x 4 mm, light red, with a breaking notch, marked on the upper
side with 5 and company logo and on the lower side with HMP and 5. The tablet can
be divided into equal doses.
10 mg tablets
Oblong tablets 7 x 4.5 mm, from white to almost white, with a breaking notch,
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 packs of
500 tablets in dark glass bottles with a closing 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 packs of
500 tablets in dark glass bottles with a closing 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 packs of
28, 56, 500 tablets in dark glass bottles with a closing cap.
It is possible that not all packs are on the market

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

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, Bucuresti, 032266 (Romania)
Sanofi Aventis Deutschland GmbH
Industriepark Höechst, Brüningstraβe 50, D-65926 Frankfurt am Main (Germany)

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:
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,
C
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