Triamterene and hydrochlorothiazide Roche

Patient Information Leaflet: Information for the User

Triatec HCT 2.5 mg + 12.5 mg tablets, 5 mg + 25 mg tablets

ramipril/hydrochlorothiazide
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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Triatec HCT is and what it is used for

Triatec HCT is a combination of two medicines called ramipril and hydrochlorothiazide.
Ramipril belongs to a group of medicines known as “ACE inhibitors” (Angiotensin-Converting Enzyme inhibitors). It works by:

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

Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics” or oral diuretics. It works by increasing the amount of water (urine) produced. This lowers blood pressure.
Triatec HCT is used to treat high blood pressure (hypertension). The two active substances work together to lower blood pressure. They are used in combination when treatment with either component alone is not effective.

2. What you should know before taking Triatec HCT

Do not take Triatec HCT:

• If you are allergic to ramipril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines similar to Triatec HCT (other ACE inhibitors or medicines derived from sulfonamides). Signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have ever had a severe allergic reaction called "angioedema." Symptoms 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 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 undergoing any other type of blood filtration. Depending on the equipment used, Triatec HCT may not be suitable for you.
• If you have severe liver problems.
• If you have abnormal levels of salts (calcium, potassium, sodium) in your blood.
• If you have kidney problems due to reduced blood flow to the kidney (renal artery stenosis).
• During the last 6 months of pregnancy (see section below “Pregnancy and breastfeeding”).
• If you are breastfeeding (see section below “Pregnancy and breastfeeding”).
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take Triatec HCT if any of the above conditions apply to you. If you are unsure, consult your doctor before taking Triatec HCT.

Warnings and precautions

Talk to your doctor or pharmacist before taking Triatec HCT:

• 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, diarrhoea, excessive sweating, following a low-salt diet, prolonged use of oral diuretics, or after dialysis).
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
• If you are due to receive an anaesthetic that may be administered during surgery or dental procedures. You may need to stop taking Triatec HCT 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 reduce sodium levels in your blood. Your doctor may prescribe regular blood tests, particularly to monitor sodium levels, especially 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 inhibitors (NEP) (such as racecadotril), or sacubitril/valsartan. For sacubitril/valsartan, see also section “Do not take Triatec HCT”.
• 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 HCT is not recommended during the first trimester of pregnancy and may cause severe harm to the unborn child after the first three months of pregnancy (see section “Pregnancy and breastfeeding”).
• If you experience vision loss or eye pain, especially if you are at risk of developing a condition called glaucoma or have an allergy to penicillin- or sulfonamide-containing medicines.
• 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 – e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • aliskiren. Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also section “Do not take Triatec HCT”.
• If you have previously had skin cancer or develop unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV radiation while taking Triatec HCT.

Children and adolescents

Triatec HCT is not recommended for children and adolescents under 18 years of age, as this medicine has never been used in this age group.

If any of the conditions listed above apply to you or you are unsure, consult your doctor before taking Triatec HCT.

Other medicines and Triatec HCT

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Triatec HCT may affect how some other medicines work. Also, some medicines may affect how Triatec HCT works.

Inform your doctor if you are taking any of the following medicines. These medicines may interfere with Triatec HCT, reducing its effectiveness:

• 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 monitor your blood pressure.

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

• Sacubitril/valsartan – used to treat a type of long-term (chronic) heart failure in adults (see also section “Do not take Triatec HCT”).
• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacin, aspirin).
• Medicines that may lower potassium levels in the blood. These include medicines for constipation, diuretics, amphotericin B (used for fungal infections), and adrenocorticotropic hormone (used to check if your adrenal glands are functioning properly).
• Medicines for cancer (chemotherapy).
• Medicines for heart problems, including heart rhythm disorders.
• Medicines to prevent organ rejection after transplantation, such as ciclosporin.
• 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 for treating inflammation, such as prednisolone.
• Calcium supplements.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Cholestyramine (to reduce blood fat levels).
• Carbamazepine (for treating epilepsy).
• Heparin (to thin the blood).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent transplant rejection).
• Vildagliptin (for treating type 2 diabetes).
• Racecadotril (used to treat diarrhoea).
• 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 HCT” 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 HCT:

• Medicines for diabetes such as oral hypoglycaemics and insulin. Triatec HCT may lower blood sugar levels. Monitor your blood sugar levels carefully when taking Triatec HCT.
• Lithium (for psychiatric conditions). Triatec HCT may increase lithium levels in the blood. Your doctor must monitor your blood lithium levels closely.
• Muscle relaxants.
• Quinine (for treating malaria).
• Medicines containing iodine, which may be used in hospital before X-ray or scanning procedures.
• Penicillin (for treating infections).
• Oral medicines that thin the blood (oral anticoagulants) such as warfarin.

If any of the above conditions apply to you (or you are unsure), consult your doctor before taking Triatec HCT.

Tests

Inform your doctor or pharmacist before taking this medicine:

• If you are having a test to check parathyroid function. Triatec HCT may alter test results.
• If you are an athlete undergoing anti-doping control. Triatec HCT may give a positive result.

Triatec HCT with food and alcohol

• Drinking alcohol while taking Triatec HCT may cause dizziness or lightheadedness. Discuss with your doctor how much alcohol you may drink while taking Triatec HCT, as alcohol increases the effects of blood pressure medicines.
• Triatec HCT 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 HCT during the first 12 weeks of pregnancy and must not take it at all from week 13 onwards, as it may harm the unborn child.
If you become pregnant while taking Triatec HCT, inform your doctor immediately. Before planning a pregnancy, you should switch to another, more suitable medicine.

Breastfeeding

You must not take Triatec HCT while breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

Effects on ability to drive and use machines

You may feel dizzy while taking Triatec HCT. This is more likely when you first start taking Triatec HCT or when you start taking a higher dose. If this occurs, do not drive or operate tools or machinery.

3. How to take Triatec HCT

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How much should you take?
Treatment of high blood pressure
Your doctor will adjust your dose until your blood pressure is under control.
Elderly population
Your doctor will reduce the initial dose and adjust treatment more slowly.

Taking this medicine

• Take this medicine orally at the same time each day, usually in the morning.
• Swallow the tablets with liquid.
• Do not crush the tablets or chew them.

If you take more Triatec HCT 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. Take the medicine pack with you. This is because the doctor needs to know what you have taken.

If you forget to take Triatec HCT

• 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Triatec HCT can cause side effects, although not everyone experiences them.
Stop taking Triatec HCT 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 may be a sign of a severe allergic reaction to Triatec HCT.
• 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 heartbeats (palpitations), chest pain, chest tightness, or more serious problems including heart attack and stroke.
• Shortness of breath, cough, fever lasting 2 to 3 days, and reduced appetite. These may be signs of lung problems, including inflammation.
• Easy bruising, prolonged bleeding more than usual, any signs of bleeding (e.g. bleeding gums), purple spots on the skin, or increased susceptibility to infections, sore throat, fever, fatigue, weakness, dizziness, or pale appearance. These may be signs of blood or bone marrow problems.
• Severe stomach pain that may radiate 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 (liver inflammation) or liver damage.
• Severe eye pain, blurred vision or seeing halos around lights, headache, excessive tearing, nausea, and vomiting – these may indicate a condition called glaucoma; reduced vision or difficulty seeing at a distance may indicate myopia.

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

• Headache or feeling weak or tired
• Dizziness – this is more likely when treatment with Triatec HCT has just started or the dose has recently been increased
• Dry, irritating cough or bronchitis
• Blood tests show higher than normal blood sugar levels. If you have diabetes, this may worsen it
• Blood tests show higher than normal levels of uric acid or fats
• Painful, red, and swollen joints

Uncommon (may affect up to 1 in 100 people)

• Skin rash with or without swelling
• Flushing, weakness, hypotension (unusually low blood pressure), especially when standing up or rising quickly
• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, prickling, burning, or crawling sensations (paresthesia)
• Loss or change in taste
• Sleep disturbances
• Depressed, anxious, or unusually nervous or irritable mood
• Stuffy nose, sinus inflammation (sinusitis), shortness of breath
• Inflammation of the gums (gingivitis), mouth swelling
• Red, swollen, watery, or itchy eyes
• Ringing in the ears (tinnitus)
• Blurred vision
• Hair loss
• Chest pain
• Muscle pain
• Constipation, stomach or intestinal pain
• Indigestion or feeling unwell
• Increased urine output during the day
• Increased sweating or thirst
• Loss or decrease in appetite (anorexia), reduced sense of hunger
• Rapid or irregular heartbeat
• Swollen arms and legs – this may indicate your body is retaining more fluid than usual
• Fever
• Impotence in men
• Decreased number of red blood cells, white blood cells, platelets, or hemoglobin concentration, as shown by blood tests
• Changes in liver, pancreas, or kidney function as shown by blood tests
• Blood tests show lower than normal potassium levels

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

• Feeling unwell, causing diarrhea or stomach burning
• Swollen and red tongue or dry mouth
• Blood tests show higher than normal potassium levels

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

• Difficulty concentrating, feeling restless or confused
• Fingers of hands and feet changing color when cold, and tingling or hurting when warmed (Raynaud's phenomenon)
• Breast enlargement in men
• Blood clots
• Hearing disorders
• Eyes less moist than usual
• Objects appear yellow in color
• Dehydration
• Swelling, pain, and redness of the cheeks (inflammation of a salivary gland)
• Intestinal swelling called "intestinal angioedema" presenting with symptoms such as abdominal pain, vomiting, and diarrhea
• Increased sensitivity to sunlight
• Severe peeling or shedding of the skin, itching, rash, or other skin reactions such as facial or forehead redness
• Skin rash or bruising
• Skin spots and cold extremities
• Nail problems (such as nail loss or separation of the nail from its bed)
• Musculoskeletal stiffness or inability to move the jaw (tetany)
• Muscle weakness or cramps
• Reduced sexual desire in men and women
• Presence of blood in the urine – this may indicate a kidney problem (interstitial nephritis)
• Higher than normal sugar levels in the urine
• Increased number of certain white blood cells (eosinophilia) detected in blood tests
• Too low number of blood cells shown by blood tests (pancytopenia)
• Changes in blood levels of electrolytes such as sodium, calcium, magnesium, and chloride, shown by blood tests
• Concentrated urine (dark-colored), feeling unwell, muscle cramps, confusion, and seizures that may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible
• Slowed or altered reactions
• Changes in smell perception
• Breathing difficulties or worsening of asthma
• Skin and lip cancer (non-melanoma skin cancer)

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 HCT

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

6. Package Contents and Other Information

What Triatec HCT Contains
Each tablet contains 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide.
Each tablet contains 5 mg of ramipril and 25 mg of hydrochlorothiazide.
The other ingredients are hypromellose, pregelatinized corn starch, microcrystalline cellulose and sodium stearyl fumarate.

Description of the Appearance of Triatec HCT and Contents of the Pack
The 2.5 mg + 12.5 mg tablets are oblong, 8 x 4.4 mm in size, white to almost white, with a score line, marked on both sides with “HNV and company logo”. The tablet can be divided into equal doses.
Triatec HCT 2.5 mg + 12.5 mg tablets are available in packs of 10, 14, 18, 20, 28, 30, 45, 50, 56, 60, 98, 99, 100, 300, 320 tablets in PVC/aluminum blisters.

The 5 mg + 25 mg tablets are oblong, 10 x 5.6 mm in size, white to almost white, with a score line, marked on both sides with “HNW and company logo”. The tablet can be divided into equal doses.
Triatec HCT 5 mg + 25 mg tablets are available in packs of 10, 14, 18, 20, 28, 30, 45, 50, 56, 98, 99, 100, 300, 320 tablets in PVC/aluminum blisters.
Not all pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sanofi S.p.A.
Viale L. Bodio, 37/B – Milan

Manufacturers
Sanofi S.p.A.
S.S. n. 17, km. 22 – 67019 Scoppito (AQ)
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:
Tritazide 2.5 mg/12.5 mg Tabletten, Tritazide 5 mg/25 mg Tabletten

Belgium:
Tritazide 5 mg/25 mg tabletten/comprimés/Tabletten

Bulgaria:
Tritace Plus 5 mg/25 mg таблетки

Cyprus:
Triatec Plus 5 mg/25 mg δισκία

Czech Republic:
Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety

Estonia:
Cardace Comp 2.5 mg/12.5 mg tabletid
Cardace Plus 5 mg/25 mg tabletid

Finland:
Cardace Comp 2.5 mg/12.5 mg tabletit

Germany:
Delix 2.5 Plus 2.5 mg/12.5 mg Tabletten, Delix 5 Plus 5 mg/25 mg Tabletten
Ramilich Comp 2.5 mg/12.5 mg Tabletten, Ramilich Comp 5 mg/25 mg Tabletten

Greece:
Triatec Plus 5 mg/25 mg δισκία

Hungary:
Tritace HCT 2.5 mg/12.5 mg tabletta, Tritace HCT 5 mg/25 mg tabletta
Ramipril HCT – ZENTIVA 5 mg/25 mg tabletta

Italy:
Triatec HCT 2.5 mg/12.5 mg compresse, Triatec HCT 5 mg/25 mg compresse
Ramipril e Idroclorotiazide Zentiva 2.5 mg/12.5 mg compresse
Ramipril e Idroclorotiazide Zentiva 5 mg/25 mg compresse

Luxembourg:
Tritazide 5/25 mg tabletten/comprimés/Tabletten

Poland:
Tritace 2.5 Comb 2.5 mg/12.5 mg tabletki, Tritace 5 Comb 5 mg/25 mg tabletki

Portugal:
Triatec Composto 2.5 mg/12.5 mg comprimidos, Triatec Composto Forte 5 mg/25 mg comprimidos

Romania:
Tritace Plus 5 mg/25 mg comprimate

Slovakia:
Tritazide 2.5 mg/12.5 mg tablety, Tritazide 5 mg/25 mg tablety

Slovenia:
Tritazide 2.5 mg/12.5 mg tablete, Tritazide 5 mg/25 mg tablete

Package leaflet: information for the user

Triatec HCT 10 mg + 12.5 mg tablets, 25 mg tablets

ramipril/hydrochlorothiazide
Please read this entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Triatec HCT is and what it is used for
2. What you need to know before taking Triatec HCT
3. How to take Triatec HCT
4. Possible side effects
5. How to store Triatec HCT
6. Package contents and other information

1. What Triatec HCT is and what it is used for

Triatec HCT is a combination of two medicines called ramipril and hydrochlorothiazide.
Ramipril belongs to a group of medicines known as "ACE inhibitors" (Angiotensin Converting Enzyme inhibitors). It works by:

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

Hydrochlorothiazide belongs to a group of medicines called "thiazide diuretics" or oral diuretics. It works by increasing the amount of water (urine) produced. This lowers blood pressure.
Triatec HCT is used to treat high blood pressure (hypertension). The two active substances work together to lower blood pressure. They are used in combination when treatment with either component alone is not effective.

2. What you should know before taking Triatec HCT

Do not take Triatec HCT:

• If you are allergic to ramipril, hydrochlorothiazide, or any of the other ingredients of this medicine (see section 6).
• If you are allergic to medicines similar to Triatec HCT (other ACE inhibitors or sulfonamide-derived medicines). Signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have ever had a severe allergic reaction called “angioedema.” These signs include itching, skin rash (urticaria), red spots 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 undergoing any other type of blood filtration. Depending on the equipment used, Triatec HCT may not be suitable for you.
• If you have severe liver problems.
• If you have abnormal levels of salts (calcium, potassium, sodium) in your blood.
• If you have kidney problems due to inadequate blood supply to the kidney (renal artery stenosis).
• During the last 6 months of pregnancy (see section below “Pregnancy and breastfeeding”).
• If you are breastfeeding (see section below “Pregnancy and breastfeeding”).
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren. Do not take Triatec HCT if any of the above conditions apply to you. If you are unsure, ask your doctor before taking Triatec HCT.

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

• If you have heart problems
• If you have lost significant amounts of body salts or fluids (due to illness such as vomiting, diarrhoea, excessive sweating, or due to a low-salt diet, or from long-term use of oral diuretics, or following dialysis)
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation)
• If you are about to receive an anaesthetic that may be administered for surgery or dental procedures. You may need to stop taking Triatec HCT 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 reduce sodium levels in your blood. Your doctor may perform regular blood tests, particularly to monitor blood sodium levels, especially if you are elderly
• If you are taking medicines that may increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin (NEP) inhibitors (such as racecadotril), or sacubitril/valsartan. For sacubitril/valsartan, see section “Do not take Triatec HCT”.
• If you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus
• You must inform your doctor if you think you are pregnant (or could become pregnant). Triatec HCT is not recommended during the first trimester of pregnancy and may cause severe harm to the unborn child after the first three months of pregnancy (see section “Pregnancy and breastfeeding”)
• If you experience vision loss or eye pain, especially if you are at risk of developing a condition called glaucoma or have an allergy to penicillin- or sulfonamide-containing medicines
• 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 – e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes
• aliskiren. Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also section “Do not take Triatec HCT”.
• If you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV radiation while taking Triatec HCT.

If any of these conditions apply to you (or you are unsure), talk to your doctor before taking Triatec HCT.
Children and adolescents
Triatec HCT is not recommended for children and adolescents under 18 years of age, as this medicine has never been studied in this age group.
Other medicines and Triatec HCT
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Triatec HCT may affect the action of some other medicines. Also, some medicines may affect the action of Triatec HCT.
Inform your doctor if you are taking any of the following medicines. These medicines may interfere with Triatec HCT, reducing its effectiveness:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacin, and 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 medicines with Triatec HCT may increase the likelihood of side effects:

• Sacubitril/valsartan – used to treat a type of long-term (chronic) heart failure in adults (see also section “Do not take Triatec HCT”)
• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacin, and aspirin)
• Medicines that may lower potassium levels in the blood. These include medicines for constipation, diuretics, amphotericin B (used for fungal infections), and ACTH hormone (used to test whether your adrenal glands are functioning properly)
• Medicines for cancer treatment (chemotherapy)
• Medicines for heart problems, including heart rhythm disorders
• Medicines to prevent organ rejection after transplantation, 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 make blood less sticky)
• Steroid medicines for treating inflammation, such as prednisolone
• Calcium supplements
• Allopurinol (used to lower uric acid levels in the blood)
• Procainamide (for heart rhythm problems)
• Cholestyramine (to reduce fat levels in the blood)
• Carbamazepine (for treatment of epilepsy)
• Heparin (to thin the blood)
• Temsirolimus (for cancer)
• Sirolimus, everolimus (to prevent transplant rejection)
• Vildagliptin (for treatment of type 2 diabetes)
• Racecadotril (used to treat diarrhoea)
• Your doctor may consider it necessary to adjust the dose and/or take additional precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “Do not take Triatec HCT” and “Take special care with Triatec HCT”).

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

• Medicines for diabetes such as oral hypoglycaemics and insulin. Triatec HCT may lower blood sugar levels. Monitor your blood sugar levels carefully when taking Triatec HCT
• Lithium (for psychiatric conditions). Triatec HCT may increase lithium levels in the blood. Your doctor must monitor your blood lithium levels carefully
• Medicines to relax muscles
• Quinine (for treatment of malaria)
• Medicines containing iodine, which may be used in hospital before X-ray or scanning procedures
• Penicillin (for treatment of infections)
• Oral anticoagulant medicines (blood thinners) such as warfarin.

If any of the above conditions apply to you (or you are unsure), consult your doctor before taking Triatec HCT.
Tests
Inform your doctor or pharmacist before taking this medicine:

• If you are having a test for parathyroid function. Triatec HCT may alter test results
• If you are an athlete undergoing anti-doping testing. Triatec HCT may produce a positive result.

Triatec HCT with food and drinks

• Drinking alcohol with Triatec HCT may cause dizziness or lightheadedness. If you want to know how much alcohol you can drink while taking Triatec HCT, discuss this with your doctor. Alcohol increases the effects of medicines used to lower blood pressure.
• Triatec HCT can be taken with or without food.

Pregnancy and breastfeeding
You must inform your doctor if you think you are pregnant (or could become pregnant).
You must not take Triatec HCT during the first 12 weeks of pregnancy and must not take it at all from week 13 onwards, as it may harm the unborn child.
If you become pregnant while taking Triatec HCT, inform your doctor immediately. Before planning a pregnancy, you should switch to another medicine more suitable for use during pregnancy.
You must not take Triatec HCT if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.
Effects on ability to drive and use machines
Some adverse effects (e.g. symptoms of low blood pressure such as dizziness) may impair your ability to concentrate and react. This may be a risk in situations where your abilities are particularly important (e.g. when driving or operating machinery). You may feel dizzy while taking Triatec HCT. This is more likely when you first start taking Triatec HCT or when you start taking a higher dose. If this occurs, do not drive or operate tools or machines.

3. How to take Triatec HCT

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
How much to take
High blood pressure treatment
Your doctor will adjust your dose until your blood pressure is under control.
Elderly population
Your doctor will reduce the initial dose and adjust treatment more slowly.
Taking this medicine

• Take the medicine orally at the same time each day, usually in the morning.
• Swallow the tablets with a liquid.
• Do not crush or chew the tablets.

If you take more Triatec HCT than you should
Contact your doctor or go to the nearest hospital emergency department. Do not drive to the hospital; have someone drive you or call an ambulance. Take the medicine pack with you, as the doctor needs to know what you have taken.
If you forget to take Triatec HCT

• 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Triatec HCT 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 in swallowing or breathing, as well as itching or skin rash. This could be a sign of a serious allergic reaction to Triatec HCT.
• Severe skin reactions including rash, mouth ulcers, worsening of a pre-existing skin condition, 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 heartbeats (palpitations), chest pain, tightness in the chest, or more serious problems including heart attack and stroke.
• Shortness of breath, cough, fever lasting for 2 to 3 days, and reduced appetite. These may be signs of lung problems, including inflammation.
• Easy bruising, prolonged bleeding more than usual, any signs of bleeding (e.g. bleeding gums), purple spots, skin patches, or increased susceptibility to infections, sore throat and fever, feeling tired, fainting, dizziness or pale appearance. These may be signs of blood or bone marrow problems.
• Severe stomach pain that may spread 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.
• Severe eye pain, blurred vision or seeing halos around lights, headache, excessive tearing, nausea and vomiting – these may indicate a condition called glaucoma; reduced vision, difficulty seeing distant objects – these may indicate a condition called myopia.

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

• Headache or feeling weak or tired
• Dizziness – this is more likely when treatment with Triatec HCT has just started or the dose has recently been increased
• Dry, irritating cough or bronchitis
• Blood tests show higher than normal blood sugar levels. If you have diabetes, this may worsen
• Blood tests show higher than normal levels of uric acid or fats
• Painful, red and swollen joints

Uncommon (may affect up to 1 in 100 people)

• Rash with or without swelling
• Flushing, weakness, hypotension (unusually low blood pressure), especially when standing up or getting up quickly
• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, pricking, burning or crawling sensations (paresthesia)
• Loss or change in taste
• Sleep problems
• Depressed mood, anxiety, increased nervousness or irritability
• Stuffy nose, inflammation of the sinuses (sinusitis), shortness of breath
• Inflammation of the gums (gingivitis), swelling of the mouth
• Red, swollen, watery or itchy eyes
• Ringing in the ears
• Blurred vision
• Hair loss
• Chest pain
• Muscle pain
• Constipation, stomach or intestinal pain
• Indigestion or feeling unwell
• Increased amount of urine during the day
• Increased sweating or thirst
• Loss or decrease in appetite (anorexia), reduced feeling of hunger
• Fast or irregular heartbeat
• Swollen arms and legs – this may indicate your body is retaining more fluid than usual
• Fever
• Impotence in men
• Decrease in the number of red blood cells, white blood cells, platelets or hemoglobin concentration, shown by blood tests
• Changes in liver, pancreas or kidney function shown by blood tests
• Blood tests show lower than normal potassium levels

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

• Feeling unwell, causing diarrhea or heartburn
• Swollen and red tongue or dry mouth
• Blood tests show higher than normal potassium levels

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

• Difficulty concentrating, feeling restless or confused
• Fingers of hands and feet changing color when cold, and tingling or pain when warmed (Raynaud's phenomenon)
• Breast enlargement in men
• Blood clots
• Hearing disturbances
• Eyes less moist than usual
• Objects appearing yellow in color
• Dehydration
• Swelling, pain and redness of the cheeks (inflammation of a salivary gland)
• Swelling of the intestine called "intestinal angioedema" presenting with symptoms such as abdominal pain, vomiting and diarrhea
• Increased sensitivity to sunlight
• Severe peeling or shedding of the skin, itching, rash or other skin reactions such as facial or forehead redness
• Rash or bruising
• Skin spots and cold extremities
• Nail problems (such as nail loss or separation of the nail from its bed)
• Musculoskeletal stiffness or inability to move the jaw (tetany)
• Muscle weakness or cramps
• Reduced sexual desire in men and women
• Blood in the urine – this could be a sign of a kidney problem (interstitial nephritis)
• Increased amount of sugar in the urine
• Increased number of certain white blood cells in the blood (eosinophilia), detected during blood tests
• Too low number of blood cells shown by blood tests (pancytopenia)
• Changes in blood levels of electrolytes such as sodium, calcium, magnesium and chloride, shown by blood tests
• Concentrated urine (dark-colored), feeling unwell, muscle cramps, confusion and seizures – these may be due to inappropriate antidiuretic hormone (ADH) secretion. If you experience these symptoms, contact your doctor as soon as possible.
• Slowed or altered reactions
• Changes in smell perception
• Breathing difficulties or worsening of asthma
• Skin and lip cancer (non-melanoma skin cancer)

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 HCT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp.) stated on the cartons and blisters. The expiry date refers to the last day of that month.
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. Pack contents and other information

What Triatec HCT contains
The active substances are ramipril and hydrochlorothiazide.
Each tablet contains 10 mg of ramipril and 12.5 mg of hydrochlorothiazide.
Each tablet contains 10 mg of ramipril and 25 mg of hydrochlorothiazide.
10 mg/12.5 mg tablet
The other ingredients are hypromellose 5mPa.s, pregelatinized corn starch, microcrystalline cellulose, sodium stearyl fumarate, red iron oxide and yellow iron oxide or E172.
10 mg/25 mg tablet
The other ingredients are hypromellose 5mPa.s, pregelatinized corn starch, microcrystalline cellulose, red iron oxide (E172) and sodium stearyl fumarate.

Description of the appearance of Triatec HCT and pack contents
The 10 mg/12.5 mg tablets are oblong, 8 mm x 4.4 mm, biconvex, orange in colour, marked on one side with "42/AV" and a breakline on both sides. The breakline is intended only to facilitate swallowing and is not intended for dividing the tablet into equal doses.
Triatec HCT 10 mg/12.5 mg tablets are available in packs of 10, 14, 28, 30, 56, 60 and 100 tablets in white opaque PVC/aluminium blisters.
The 10 mg/25 mg tablets are oblong, 10 mm x 5.6 mm, biconvex, pink in colour, marked on one side with "39/AV" and a breakline on both sides. The breakline is intended only to facilitate swallowing and is not intended for dividing the tablet into equal doses.
Triatec HCT 10 mg/25 mg tablets are available in packs of 10, 14, 28, 30, 56, 60 and 100 tablets in white opaque PVC/aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sanofi S.p.A.
Viale L. Bodio, 37/B
20158 – Milan, Italy

Manufacturer
Sanofi S.p.A.
S.S. n. 17, km. 22 – 67019 Scoppito (AQ), Italy

This medicinal product has been authorized in the European Economic Area Member States under the following names:
Bulgaria:
Tritace Plus 10 mg/12.5 mg tablets
Tritace Plus 10 mg/25 mg tablets
Estonia:
Cardace Forte 10 mg/12.5 mg tablets
Cardace Forte 10 mg/25 mg tablets
Germany:
Delix Plus 10 mg/12.5 mg tablets
Delix Plus 10 mg/25 mg tablets
Hungary:
Tritace HCT 10 mg/12.5 mg tablets
Tritace HCT 10 mg/25 mg tablets
Italy:
Triatec HCT 10 mg/12.5 mg tablets
Triatec HCT 10 mg/25 mg tablets

This leaflet was last approved on: