2.5 mg, 5 mg, 10 mg tablets
Ramipril
What Triatec is and what it is used for
Triatec contains a medicine called ramipril. It belongs to a group of medicines called ACE inhibitors ( Angiotensin Converting Enzyme inhibitors).
Triatec works by:
- Reduce the body’s production of substances that could increase your blood pressure
- Make your blood vessels dilate and relax
- Make it easier for your heart to pump the blood around your body
Triatec can be used:
- To treat high blood pressure ( hypertension )
- To reduce the risk of heart attack or stroke
- To reduce or delay the worsening of kidney problems (regardless of whether you have diabetes or not)
- For treating the heart when it cannot pump enough blood around to the rest of the body ( heart failure )
- As treatment after a heart attack complicated by heart failure
The ramipril contained in Triatec may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Triatec
Do not take Triatec:
- If you are allergic to ramipril or any other ACE inhibitor or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include rash, difficulty swallowing or breathing, swelling of your face, lips, throat, or tongue
- If you have ever had a severe allergic reaction called ‘angioedema’. Signs of this include itching, hives ( urticaria ), red marks on the hands, feet, and neck, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing
- If you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term ( chronic ) heart failure in adults
- If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Triatec may not be suitable for you
- If you have kidney problems which means that the blood supply to your kidneys is reduced ( renal artery stenosis )
- During the second and third trimesters of pregnancy (see the section below “Pregnancy and breast-feeding”)
- If your blood pressure is abnormally low or unstable. Your doctor will make this assessment
- 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 applies to you. If you are not sure, talk to your doctor before taking Triatec.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine:
- If you have heart, liver, or kidney problems
- If you have lost a lot of body salts or body fluids (through vomiting, diarrhea, abnormal sweating, a very low salt diet, treatment with diuretics for a long time, or have undergone dialysis )
- If you are going to undergo a treatment to reduce your allergy to wasp or bee stings ( hyposensitization )
- If you will receive an anesthetic. This may be given to you before an operation or dental treatment. You may need to stop taking Triatec one day before surgery; ask your doctor for advice
- If you have high levels of potassium in your blood (shown by a blood test)
- You are taking medication or have a condition that can reduce sodium levels in your blood. Your doctor may carry out regular blood tests, especially to check the levels of sodium in your blood, 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 (eg temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin (NEP) inhibitors (such as racecadotril) or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take Triatec”.
- If you have a connective tissue disease such as scleroderma or SLE (systemic lupus erythematosus)
- If you think you are pregnant or become pregnant during treatment, contact your doctor. Triatec is not recommended during the first three months of pregnancy and can cause serious birth defects after three months of pregnancy (see the section below “Pregnancy and breast-feeding”)
- If you are taking any of the following medicines that can be used to treat high blood pressure:
- an angiotensin II receptor blocker (ARB) (also called sartans – for example, valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems
- the aliskiren.
Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals. See also the information under the heading “Do not take Triatec”
Children and young people
Triatec is not recommended for children and adolescents under the age of 18, as the safety and effectiveness of Triatec for children have not yet been established.
If any of the above apply to you (or if you are not sure), talk to 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 how other medicines work. Some medicines can also affect how Triatec works.
Tell your doctor if you are using any of the following medicines. They can make Triatec work less well:
- Medicines used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs such as ibuprofen or indomethacin and aspirin )
- Medicines are used in the treatment of low blood pressure, shock, heart failure, asthma, or allergies such as ephedrine, norepinephrine, or adrenaline. Your doctor will check your blood pressure.
Tell your doctor if you are using any of the following medicines. They may increase the risk of side effects if you take them with Triatec:
- 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 (non-steroidal anti-inflammatory drugs such as ibuprofen or indomethacin and aspirin )
- Medicines for cancer ( chemotherapy )
- Medicines that prevent rejection of transplanted organs 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 (anti-infection ) and heparin (blood thinner)
- Steroids used in inflammation such as prednisolone
- Allopurinol (used to reduce the amount of uric acid in your blood)
- Procainamide (used for heart rhythm disorders)
- Temsirolimus (for cancer)
- Sirolimus, everolimus (for prevention of transplant rejection)
- Vildagliptin (used to treat type 2 diabetes )
- Racecadotril (used for diarrhea)
- Your doctor may need to change your dose and/or take other precautions: If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information under the headings “Do not take Triatec” and “Warnings and precautions”).
Tell your doctor if you are using any of the following medicines. They may be affected by Triatec:
- Medicines for diabetes such as oral glucose-lowering medicines and insulin. Triatec may lower your blood sugar levels. Monitor your blood sugar levels closely while taking Triatec.
- Lithium (used in mental illnesses). Triatec may increase the amount of lithium in your blood. Your lithium levels will need to be closely monitored by your doctor.
If any of the above apply to you (or if you are not sure), talk to your doctor before taking Triatec.
Triatec with food and alcohol
- If you drink alcohol while taking Triatec, you may feel dizzy. If you are worried about how much you can drink while taking Triatec, discuss it with your doctor as alcohol can increase the effect of blood pressure lowering medicines.
- Triatec can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
You should not take Triatec during the first 12 weeks of pregnancy and you should especially not take Triatec from the 13th week of pregnancy as this may harm the fetus. If you become pregnant while taking Triatec, tell your doctor immediately. Switching to a suitable alternative treatment should take place before a planned pregnancy.
Breast-feeding
You should not take Triatec if you are breastfeeding.
Driving ability and use of machinery
You may feel dizzy while taking Triatec. This is more likely to happen when you start taking Triatec or if you take a higher dose. If this happens, do not drive or use any tools or machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Triatec contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.
How to take Triatec
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
What dose to take
Treatment of high blood pressure
- The usual starting dose is 1.25 mg or 2.5 mg once daily
- Your doctor will adjust the dose until your blood pressure is under control
- The maximum dose is 10 mg once daily
- If you are already taking diuretics ( diuretics ), your doctor may ask you to stop taking or reduce the dose of one of the diuretics before starting treatment with Triatec
To reduce the risk of heart attack and stroke
- The usual starting dose is 2.5 mg once daily
- Your doctor may then decide to increase this dose
- The usual dose is 10 mg once daily
To reduce or delay the worsening of kidney problems
- Your starting dose may be 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 daily. Two dosing occasions per day are preferred
Treatment after a heart attack
- The usual starting dose is 1.25 mg once daily up to 2.5 mg twice daily
- Your doctor will adjust your dose
- The maximum dose is 10 mg daily. Two dosing occasions per day are preferred
Elderly patients
Your doctor will reduce the starting dose and adjust your treatment at a slower rate.
Dosage
- To be swallowed. Taken at the same time each day.
- Swallow the tablets whole with liquid.
- Do not crush or chew the tablets.
If you have taken too much Triatec
Tell your doctor or visit the emergency department of the nearest hospital as soon as possible. Do not drive to the hospital, ask someone else to drive you, or call an ambulance. Bring your medicine pack. This is so that the doctor knows what you have taken.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Triatec
Do not take a double dose to make up for a missed tablet.
If you have forgotten to take a dose, take your normal dose at the next dosing time.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Triatec and see a doctor immediately if you notice any of the following serious side effects – you may need emergency medical attention:
- Swelling of the face, lips, or throat which makes it difficult to swallow or breathe, but also itching and rash. This could be a sign of a serious allergic reaction to Triatec
- Serious skin reactions including rash, mouth sores, worsening of skin conditions, redness, blistering, or peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme)
Tell your doctor immediately if you feel that you have received:
- Increased heart rate, irregular or strong heartbeats ( palpitations ), chest pain, chest tightness, or more serious problems including heart attack and stroke
- Shortness of breath or cough. This could be a sign of lung problems
- Bruising that comes on more easily than usual, prolonged bleeding time, signs of bleeding (eg bleeding gums), purple spots on the skin or increased susceptibility to infection, sore throat and fever, tiredness, weakness, dizziness, or pale skin. This may be a sign of blood or bone marrow problems.
- Severe stomach pain can be felt in the back. This may be a sign of pancreatitis ( inflammation of the pancreas).
- Fever, chills, tiredness, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). This can be a sign of liver problems such as hepatitis ( inflammation of the liver) or other liver damage.
Other side effects include:
Tell your doctor if any of the following side effects become serious or persist for more than a few days.
Common (may affect up to 1 in 10 people):
- Headache or fatigue
- Dizziness. This is more likely to happen when you start taking Triatec or if you start taking a higher dose.
- Fainting, abnormally low blood pressure ( hypotension ), especially when standing or standing up quickly
- Dry cough, sinusitis or bronchitis, shortness of breath
- Stomach pain, diarrhea, heartburn, nausea, or vomiting
- Skin rash with or without swelling
- Chest pain
- Cramp or muscle pain
- Blood tests showed more potassium than normal
Uncommon (may affect up to 1 in 100 people):
- Balance problems (vertigo)
- Itching and abnormal sensations in the skin such as numbness, tingling, burning, or tingling ( paresthesia )
- Changed or lost sense of taste
- Sleep disorders
- Depression, anxiety, increased nervousness or restlessness
- Stuffy nose, difficulty breathing, or worsening of asthma
- Swelling of the stomach is called “intestinal angioedema” which causes symptoms such as stomach pain, vomiting, and diarrhea
- Heartburn, constipation, or dry mouth
- Increased urination
- Increased sweating
- Loss or decreased appetite ( anorexia )
- Increased or irregular heartbeat. Swollen arms and legs. This could be a sign that your body is storing more water than usual
- Flushing
- Blurred vision
- Joint pain
- Fever
- Sexual impotence in men reduced sexual desire in men or women
- Increased number of certain white blood cells ( eosinophilia ) detected via blood tests
- Blood tests that show changes in your liver, pancreas, or kidney function
Rare (may affect up to 1 in 1,000 people):
- Tremors or confusion
- Red and swollen tongue
- Severe skin peeling, itchy nodular rash
- Nail problems (e.g. loose nails or the nail loosening from its attachment)
- Skin rash or bruising
- Spots on the skin and cold limbs
- Red, itchy, swollen, or watery eyes
- Affected hearing and ringing in the ears
- Feeling of weakness
- Blood tests show a decrease in the number of red blood cells, white blood cells, or platelets or a decrease in the level of hemoglobin
Very rare (may affect up to 1 in 10,000 people):
- Increased sun sensitivity
Other reported side effects:
Tell your doctor if any of the following side effects become serious or persist for more than a few days.
- Concentration difficulties
- Swelling of the mouth
- Blood tests that show too few blood cells in your blood
- Blood tests that show less sodium in your blood than normal
- Concentrated urine (dark color), nausea or vomiting, muscle cramps, confusion, and seizures may be caused by improper secretion of ADH ( antidiuretic hormone ). If you get these symptoms, you should contact your doctor as soon as possible
- Discoloration of fingers and toes when cold, then pain and crawling when warmed (Raynaud’s phenomenon)
- Enlarged breasts in men
- Delayed or impaired reactions
- Burning sensation
- Change in the sense of smell
- Hair loss
How Triatec should be stored
Keep this medicine out of the sight and reach of children.
Do not use Triatec after the expiry date stated on the cartons, blisters, and glass jars. The expiration date is the last day of the specified month.
The medicine does not require any special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is ramipril.
2.5 mg: Each tablet contains 2.5 mg of ramipril
5 mg: Each tablet contains 5 mg of ramipril
10 mg: Each tablet contains 10 mg of ramipril
Other ingredients in the tablets are
Tablets 2.5 mg
Hypromellose
Pregelatinized maize starch
Microcrystalline cellulose
Sodium stearyl fumarate
Yellow iron oxide (E 172) Tablets 5 mg
Hypromellose Pregelatinized
maize starch
Microcrystalline cellulose
Sodium stearyl fumarate
Iron oxide red (E 172)
Tablets 10 mg
Hypromellose
Pregelatinized corn starch
Microcrystalline cellulose
Sodium stearyl fumarate.
Appearance and package sizes of the medicine
Tablets 2.5 mg
Yellowish to yellow, oblong tablet 8 x 4 mm, scored upper stamp 2.5 and company logo, lower stamp HMR and 2.5. The tablet can be divided into equal halves.
Tablets 5 mg
Pale red, oblong tablet 8 x 4 mm, scored upper stamp 5 and company logo, lower stamp HMP and 5. The tablet can be divided into equal doses.
Tablets 10 mg
White to almost white, oblong tablet 7 x 4.5 mm, scored upper stamp HMO/HMO. The tablet can be divided into equal doses.
Triatec 2.5 mg tablets are supplied in packs of 7, 10, 14, 15, 18, 20, 28, 30, 45, 50, 60, 90, 98, 99, 100, 300, 320, 500 tablets in PVC/Alu blister and in a pack of 500 tablets in a brown glass jar with a lid.
Triatec 5 mg tablets are supplied in packs of 10, 14, 15, 18, 20, 21, 28, 30, 45, 50, 56, 90, 98, 99, 100, 300, 320, 500 tablets in PVC/Alu blisters and in packs of 500 tablets in a brown glass jar with a lid.
Triatec 10 mg tablets are supplied in packs of 7, 10, 14, 15, 18, 20, 28, 30, 45, 50, 56, 90, 98, 99, 100, 300, 320, 500 tablets in PVC/Alu blisters and in packages of 28, 56, 500 tablets in a brown glass jar with a lid.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi AB
Box 30052
104 25 Stockholm
Manufacturer
Sanofi-Aventis Deutschland GmbH
Brüningsstrasse 50
D-65926 Frankfurt am Main
Germany
Sanofi Srl
Strada Statale 17, Km 22
67019 Scoppito (L´Aquila)
Italy
Delpharm Dijon
6 boulevard de l´Europé
21800 Quétigny
France
SC ZENTIVA SA
B flat Theodor Pallady no. 50, Sector 3
Bucharest, 032266
Romania
This medicine is approved in the European Economic Area under the names:
Austria:
Tritace 1.25 mg Tablet, Tritace 2.5 mg Tablet, Tritace 5 mg Tablet, Tritace 10 mg Tablet
Belgium:
Tritace 2.5 mg tabletten/comprimés/ Tabletten, Tritace 5 mg tabletten/comprimés/ Tabletten, Tritace 10 mg tabletten/comprimés/ Tabletten
Bulgaria:
Tritace 5 mg tablets, Tritace 10 mg tablets
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 2.5 mg tablets, Triatec 5 mg tablets
Estonia:
Cardace 2.5 mg tabletid, Cardace 5 mg tabletid, Cardace 10 mg tabletid
Finland:
Cardace 2.5 mg tabletite, Cardace 5 mg tabletite, Cardace 10 mg tabletite
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 Tablet, Delix 5 mg Tablet, Delix Protect 10 mg Tablet
Delix Protect Starter Set
Ramilich 2.5 mg Tablet, Ramilich 5 mg Tablet, Ramilich 10 mg Tablet
Delix 1.25 mg Tablet
Delix 1.25 mg Capsule, Delix P 2.5 mg Capsule, Delix P 5 mg Capsule, Delix P 10 mg Capsule
Greece:
Triatec 2.5 mg δισκία, Triatec 5 mg δισκία
Hungary:
Tritace Mite 1.25 mg tablet
Tritace 2.5 mg tablet, Tritace 5 mg tablet, Tritace 10 mg tablet
Ramipril – Zentiva 5 mg tablet
Ramipril – Zentiva 10 mg tablet
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 tablets, Cardace 5 mg tablets, Cardace 10 mg tablets
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 tablets, Triatec 5 mg tablets, Triatec 10 mg tablets
Poland:
Tritace 2.5 mg tabletki, Tritace 5 mg tabletki, Tritace 10 mg tabletki
Portugal:
Triatec 1.25 mg capsules, Triatec 2.5 mg capsules, Triatec 5 mg capsules, Triatec 10 mg capsules
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:
Triatec 2.5 mg tablets, Triatec 5 mg tablets, Triatec 10 mg tablets
United Kingdom:
Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets
Tritace Titration Pack tablets