Triveram

Leaflet accompanying the packaging: patient information

Triveram, 10 mg + 5 mg + 5 mg, film-coated tablets

Triveram, 20 mg + 5 mg + 5 mg, film-coated tablets

Triveram, 20 mg + 10 mg + 5 mg, film-coated tablets

Triveram, 20 mg + 10 mg + 10 mg, film-coated tablets

Triveram, 40 mg + 10 mg + 10 mg, film-coated tablets

Atorvastatin + Perindopril arginine + Amlodipine

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What Triveram is and what it is used for
• 2. Important information before taking Triveram
• 3. How to take Triveram
• 4. Possible side effects
• 5. How to store Triveram
• 6. Contents of the packaging and other information

1. What Triveram is and what it is used for

Triveram contains three active substances in one tablet: atorvastatin, perindopril arginine, and amlodipine.
Atorvastatin belongs to a group of medicines called statins, which are used to regulate blood lipid levels.
Perindopril arginine is an angiotensin-converting enzyme inhibitor (ACE inhibitor). In patients with high blood pressure, it works by dilating blood vessels, making it easier for the heart to pump blood.
Amlodipine belongs to a group of medicines called calcium antagonists. In patients with high blood pressure, it works by relaxing blood vessels, making it easier for blood to flow through them. In patients with angina pectoris (causing chest pain), it works by improving blood flow to the heart muscle, which then receives more oxygen, resulting in the prevention of chest pain.
Triveram is used to treat high blood pressure (hypertension) and/or stable coronary artery disease (a disease in which the heart's blood supply is reduced or blocked) in adults who also have one of the following conditions:

• high cholesterol levels (primary hypercholesterolemia) or
• high cholesterol and triglyceride levels at the same time (combined or mixed hyperlipidemia).

Triveram is intended for patients who are already being treated with atorvastatin, perindopril arginine, and amlodipine in separate tablets. Instead of taking atorvastatin, perindopril arginine, and amlodipine in separate tablets, the patient can take one Triveram tablet, which contains the three active substances in the same doses.

2. Important information before taking Triveram

When not to take Triveram:

• if the patient is allergic to atorvastatin or any other statin, to perindopril or any other ACE inhibitor, to amlodipine or any other calcium antagonist, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has a disease that affects the liver;
• if the patient has unexplained, abnormal liver function test results;
• if the patient has very low blood pressure (hypotension);
• if the patient has cardiogenic shock (a condition where the heart is unable to supply the body with enough blood);
• if the patient has a blockage of blood flow from the left ventricle of the heart (e.g., hypertrophic cardiomyopathy with outflow obstruction and high-grade aortic stenosis);
• if the patient has heart failure after a heart attack;
• if the patient has had symptoms such as wheezing, swelling of the face, lips, tongue, or throat, intense itching, or severe rash when taking an ACE inhibitor in the past, or if such symptoms have occurred in relatives under any circumstances (a condition called angioedema);
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine that contains aliskiren;
• if the patient is undergoing dialysis or blood filtration by another method. Depending on the device used, Triveram may not be suitable for the patient;
• if the patient has kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used to treat heart failure, as the risk of angioedema (rapid swelling of tissues under the skin in the throat area) increases (see "Warnings and precautions" and "Triveram and other medicines");
• if the patient is taking glecaprevir with pibrentasvir to treat hepatitis C virus infection;
• if the patient is pregnant or trying to become pregnant, or is of childbearing age and not using adequate contraception;
• if the patient is breastfeeding.

Warnings and precautions

Before starting Triveram, the patient should discuss the following with their doctor or pharmacist:

• if the patient has liver problems or has had liver disease in the past;
• if the patient has moderate or severe kidney disease;
• if the patient regularly drinks large amounts of alcohol;
• if the patient is taking or has taken a medicine called fusidic acid (used to treat bacterial infections) orally or by injection within the last 7 days. Taking fusidic acid and Triveram at the same time may lead to severe muscle problems (rhabdomyolysis);
• if the patient has recurring or unexplained muscle pain, has had muscle problems in the past, or if such problems have occurred in relatives;
• if the patient or a close relative has muscle disorders that have occurred in the family;
• if the patient has had muscle problems while being treated with other medicines that lower lipid levels (e.g., other statins or fibrates);
• if the patient has hypothyroidism;
• if the patient's condition leads to increased atorvastatin levels in the blood;
• if severe respiratory failure occurs during treatment;
• if the patient has diabetes (high blood sugar levels);
• if the patient has heart failure or any other heart problems;
• if the patient has had a heart attack or has recently had a heart attack;
• if the patient has recently had diarrhea or vomiting, or is dehydrated;
• if the patient has mild aortic or mitral stenosis (narrowing of the main blood vessel leading from the heart or the mitral valve of the heart);
• if the patient has kidney problems, has recently had a kidney transplant, or is undergoing dialysis;
• if the patient has high levels of a hormone called aldosterone in the blood (primary aldosteronism);
• if the patient is elderly;
• if the patient has a severe allergic reaction with swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing (angioedema). This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Triveram and contact their doctor immediately.
• if the patient is of black race, as there is a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure than in patients of other races;
• if the patient is taking any of the following medicines, which increase the risk of angioedema: racecadotril (used to treat diarrhea); sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors (used to prevent organ rejection and treat cancer); sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure; linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes);
• if the patient is undergoing LDL apheresis (removal of cholesterol from the blood using a special device);
• if the patient is undergoing desensitization treatment to reduce the effects of allergies to bee or wasp stings;
• if the patient is undergoing anesthesia and/or surgery;
• if the patient has collagenosis (a disease of connective tissue), such as systemic lupus erythematosus or scleroderma;
• if the patient is on a low-salt diet or uses salt substitutes containing potassium;
• if the patient has been informed by their doctor that they have intolerance to certain sugars;
• if the patient is taking any of the following medicines used to treat high blood pressure: angiotensin receptor blockers (ARBs) (also known as sartans, e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes; aliskiren;
• if the patient is taking any of the following medicines: immunosuppressants (which reduce the body's defense mechanism), used to treat autoimmune diseases or after organ transplantation (e.g., cyclosporine, tacrolimus); ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (antifungal medicines); rifampicin, erythromycin, clarithromycin, telithromycin, fusidic acid*, trimethoprim (antibiotics used to treat bacterial infections); colchicine (used to treat gout, a disease in which joint pain and swelling are caused by uric acid crystals); other medicines that regulate lipid levels, e.g., gemfibrozil, other fibrates, colestyramine, ezetimibe; certain calcium antagonists used to treat angina or high blood pressure, e.g., diltiazem; medicines that regulate heart rhythm, e.g., digoxin, verapamil, amiodarone; letermovir, a medicine that helps prevent disease caused by cytomegalovirus; medicines used to treat HIV or liver disease, such as hepatitis C, e.g., delavirdine, efavirenz, ritonavir, lopinavir, atazanavir, indinavir, darunavir, telaprevir, boceprevir, and a combination medicine containing elbasvir with grazoprevir, ledipasvir with sofosbuvir; warfarin (which reduces blood clotting); oral contraceptives; stiripentol (an antiepileptic medicine used to treat epilepsy); cimetidine (used to treat heartburn and stomach ulcers); phenazon (a pain reliever); antacids (medicines that neutralize stomach acid, containing aluminum or magnesium); over-the-counter medicines containing Hypericum perforatum (St. John's Wort, used to treat depression); dantrolene (used to treat severe body temperature disorders);
• other medicines used to treat high blood pressure, including aliskiren, angiotensin receptor blockers (e.g., valsartan) - see also the information in "When not to take Triveram" and "Warnings and precautions";
• potassium-sparing medicines (e.g., triamterene, amiloride, eplerenone, spironolactone), potassium supplements, or salt substitutes containing potassium, other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood and prevent clotting, trimethoprim, and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• estramustine (used to treat cancer);
• lithium (used to treat mania or depression);
• medicines that are most commonly used to treat diarrhea or to prevent organ rejection (racecadotril, sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See "Warnings and precautions";

*If the patient must take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Triveram. The doctor will decide when it is safe to resume taking Triveram. Taking Triveram with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Triveram with food and drink

It is recommended to take Triveram before a meal.

Grapefruit juice and grapefruit

Grapefruit juice and grapefruit should not be consumed by patients taking Triveram, as grapefruit and grapefruit juice can increase the levels of the active substance amlodipine in the blood, which may lead to unexpected increases in the blood pressure-lowering effect of Triveram.
If the patient is taking Triveram, they should not drink more than one or two small glasses of grapefruit juice per day, as large amounts of juice may increase the effect of the active substance atorvastatin.

Alcohol

The patient should avoid drinking large amounts of alcohol while taking this medicine. More information is provided in section 2 "Warnings and precautions".

Pregnancy

Triveram should not be taken if the patient is pregnant, trying to become pregnant, or of childbearing age, unless they are using adequate contraception (see "When not to take Triveram").
If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
This medicine is contraindicated during pregnancy.

Breastfeeding

Triveram should not be taken if the patient is breastfeeding. The patient should immediately tell their doctor if they are breastfeeding or start breastfeeding.

Driving and using machines

Triveram may cause dizziness, headache, fatigue, or nausea. If the medicine affects the patient in this way, their ability to drive or operate machines may be impaired, especially at the start of treatment.

Triveram contains lactose

If the patient has been told that they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

Triveram contains sodium

Triveram contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Triveram

Triveram should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose is one tablet per day. The tablet should be swallowed with a glass of water, preferably at the same time every day, in the morning before a meal.

Use in children and adolescents

Triveram is not recommended for use in children and adolescents under 18 years of age.

Overdose

If the patient has taken more tablets than prescribed, they should immediately contact their doctor or go to the emergency department. Taking too many tablets may cause low or even dangerously low blood pressure. This may lead to dizziness, a feeling of "emptiness" in the head, fainting, or weakness. In such a situation, lying down with elevated legs may help.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missed dose

It is important to take the medicine regularly every day, as its effect is better. However, if a dose of Triveram is missed, the next dose should be taken at the usual time. A double dose should not be taken to make up for a missed dose.

Stopping Triveram

Treatment with Triveram is usually long-term, so the patient should consult their doctor before stopping the medicine.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Triveram can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects or symptoms, they should stop taking Triveram and contact their doctor immediately:

• swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing (angioedema) (see section 2 "Warnings and precautions");
• severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• muscle weakness, tenderness, pain, or muscle rupture, especially if the patient also has a high fever or feels unwell, which may be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems;
• weakness or numbness of the arms or legs, or difficulty speaking, which may be a sign of a stroke;
• severe dizziness or fainting due to low blood pressure;
• very fast or irregular heartbeat;
• chest pain (angina pectoris) or heart attack;
• sudden wheezing, chest pain, shortness of breath, or difficulty breathing (bronchospasm);
• pancreatitis, which can cause severe abdominal pain radiating to the back and severe illness;
• if the patient experiences unexpected or unusual bleeding or bruising, which may indicate liver problems;
• yellowing of the skin or eyes (jaundice), which may be a sign of liver inflammation;
• rash, often starting with red, itchy patches on the face, arms, or legs (erythema multiforme);
• lupus-like syndrome (including rash, joint pain, and effects on blood cells).

The patient should tell their doctor if they experience any of the following side effects:

very common(may affect more than 1 in 10 people):

• edema (fluid retention).

common(may affect up to 1 in 10 people):

• inflammation of the nasal passages, sore throat, nosebleeds;
• allergic reactions (such as rash, itching);
• increased blood sugar levels (if the patient has diabetes, they should closely monitor their blood sugar levels), increased creatine kinase levels in the blood;
• headache, dizziness, central or peripheral vertigo, paresthesia, fatigue;
• visual disturbances, double vision;
• tinnitus (ringing or other sounds in the ears);
• cough, shortness of breath;
• gastrointestinal disorders: nausea, vomiting, constipation, flatulence, dyspepsia, altered bowel habits, diarrhea, abdominal pain, gastrointestinal disturbances, indigestion;
• joint pain, muscle pain, muscle cramps, back pain;
• fatigue, weakness;
• edema of the ankles, palpitations (feeling of heartbeat), sudden flushing of the face and neck;
• abnormal liver function tests.

uncommon(may affect up to 1 in 100 people):

• loss of appetite (anorexia), weight gain or loss;
• nightmares, insomnia, sleep disturbances, mood changes, anxiety, depression;
• numbness or tingling in the fingers or toes or in the limbs, decreased sensation of pain or touch, memory loss;
• blurred vision;
• rhinitis or sinusitis, sneezing;
• belching, dry mouth;
• severe itching or severe rash, red patches on the skin, skin discoloration, formation of blisters on the skin, peeling, and swelling of the skin, photosensitivity reaction (increased skin sensitivity to sunlight), hair loss;
• kidney problems, difficulty urinating, nocturia, increased frequency of urination;
• erectile dysfunction, impotence, discomfort or enlargement of the breasts in men;
• neck pain, muscle weakness;
• malaise, tremors, fainting, falls, fatigue, fever, sweating, pain;
• tachycardia (fast heartbeat);
• purpura (purple spots on the skin);
• increased eosinophil count (a type of white blood cell);
• urine tests showing the presence of white blood cells;
• changes in laboratory test results: high potassium levels in the blood, transient and disappearing after treatment discontinuation, low sodium levels in the blood, hypoglycemia (very low blood sugar levels) in diabetic patients, increased urea levels in the blood, increased creatinine levels in the blood.

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

• acute kidney failure;
• dark urine, nausea, or vomiting, muscle cramps, confusion, and seizures. These may be symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion);
• decreased or absent urine production;
• worsening of psoriasis;
• confusion (disorientation);
• unexpected bleeding or bruising;
• cholestasis (yellowing of the skin and eyes);
• tendon damage;
• changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood;
• nerve disorders that can cause weakness, numbness, or tingling;
• rash that can occur on the skin or ulcers in the mouth (drug rash).

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

• eosinophilic pneumonia (a rare type of pneumonia);
• hearing loss;
• increased muscle tone;
• gum hypertrophy;
• abdominal distension (gastritis);
• abnormal liver function, jaundice, increased liver enzyme activity, which may affect some medical tests;
• changes in blood composition, such as decreased white blood cell count, decreased red blood cell count, decreased hemoglobin levels, decreased platelet count, which can cause unusual bruising or bleeding (red blood cell damage), a disease resulting from red blood cell damage.

frequency not known

• permanent muscle weakness;
• tremors, stiff body posture, mask-like face, slow movements, and shuffling gait;
• discoloration, numbness, and pain in the fingers or toes (Raynaud's phenomenon);
• myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing);
• ocular myasthenia (a disease that causes muscle weakness in the eyes).
• The patient should talk to their doctor if they experience any of the following: muscle weakness in the arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing or shortness of breath.

If such symptoms occur, the patient should contact their doctor as soon as possible.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Triveram

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP" (the expiry date stated on the packaging). The expiry date refers to the last day of the month stated.
The word "Lot" on the packaging means the batch number of the medicine.
The container should be kept tightly closed to protect it from moisture.
There are no special storage temperature requirements for the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Triveram contains

• The active substances of Triveram are: atorvastatin, perindopril arginine, and amlodipine besylate.
• Each Triveram 10 mg + 5 mg + 5 mg tablet contains 10.82 mg of atorvastatin calcium trihydrate, equivalent to 10 mg of atorvastatin, 5 mg of perindopril arginine, equivalent to 3.40 mg of perindopril, and 6.94 mg of amlodipine besylate, equivalent to 5 mg of amlodipine.
• Each Triveram 20 mg + 5 mg + 5 mg tablet contains 21.64 mg of atorvastatin calcium trihydrate, equivalent to 20 mg of atorvastatin, 5 mg of perindopril arginine, equivalent to 3.40 mg of perindopril, and 6.94 mg of amlodipine besylate, equivalent to 5 mg of amlodipine.
• Each Triveram 20 mg + 10 mg + 5 mg tablet contains 21.64 mg of atorvastatin calcium trihydrate, equivalent to 20 mg of atorvastatin, 10 mg of perindopril arginine, equivalent to 6.79 mg of perindopril, and 6.94 mg of amlodipine besylate, equivalent to 5 mg of amlodipine.
• Each Triveram 20 mg + 10 mg + 10 mg tablet contains 21.64 mg of atorvastatin calcium trihydrate, equivalent to 20 mg of atorvastatin, 10 mg of perindopril arginine, equivalent to 6.79 mg of perindopril, and 13.87 mg of amlodipine besylate, equivalent to 10 mg of amlodipine.
• Each Triveram 40 mg + 10 mg + 10 mg tablet contains 43.28 mg of atorvastatin calcium trihydrate, equivalent to 40 mg of atorvastatin, 10 mg of perindopril arginine, equivalent to 6.79 mg of perindopril, and 13.87 mg of amlodipine besylate, equivalent to 10 mg of amlodipine.
• The other ingredients are:
• tablet core: lactose monohydrate, calcium carbonate, hydroxypropyl cellulose, sodium carboxymethyl cellulose (type A), microcrystalline cellulose, maltodextrin, magnesium stearate.
• coating: glycerol, hypromellose, macrogol 6000, magnesium stearate, titanium dioxide (E 171), yellow iron oxide (E 172).

What Triveram looks like and contents of the pack

Triveram 10 mg + 5 mg + 5 mg: yellow, round, film-coated tablets with a diameter of 7 mm, a radius of curvature of 25 mm, with the imprint "" on one side and "" on the other side.
Triveram 20 mg + 5 mg + 5 mg: yellow, round, film-coated tablets with a diameter of 8.8 mm, a radius of curvature of 32 mm, with the imprint "" on one side and "" on the other side.
Triveram 20 mg + 10 mg + 5 mg: yellow, square, film-coated tablets with a side length of 9 mm, a radius of curvature of 16 mm, with the imprint "" on one side and "" on the other side.
Triveram 20 mg + 10 mg + 10 mg: yellow, oval, film-coated tablets with a length of 12.7 mm and a width of 6.35 mm, with the imprint "" on one side and "" on the other side.
Triveram 40 mg + 10 mg + 10 mg: yellow, oval, film-coated tablets with a length of 16 mm and a width of 8 mm, with the imprint "" on one side and "" on the other side.
The tablets are available in containers containing 30 tablets. There are also packs containing 90 tablets (3 containers of 30 tablets each).
The container is closed with a cap. The cap contains a desiccant.
Not all pack sizes may be marketed.

Marketing authorization holder

Servier Laboratories
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer

Servier Industries
905 route de Saran
45520 Gidy
France
Anpharm Pharmaceutical Company S.A.
Annopol 6B
03-236 Warsaw
Poland
Egis Pharmaceuticals PLC
H-9900, Körmend
Mátyás király u. 65.
Hungary

Servier (Ireland) Industries Ltd (SII)
Moneylans - Gorey Road
Arklow – Co. Wicklow
Ireland
To obtain detailed information, the patient should contact the representative of the marketing authorization holder:
Servier Polska Sp. z o.o.
Phone: (22) 594 90 00

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

Belgium
Lipertance
Bulgaria
Lipertance
Croatia
Lipertance
Czech Republic
Lipertance
Cyprus
Triveram
Estonia
Triveram
Finland
Triveram
France
Triveram
Germany
Triveram
Greece
Triveram
Ireland
Lipertance
Italy
Triveram
Latvia
Triveram
Lithuania
Triveram
Luxembourg
Lipertance
Poland
Triveram
Portugal
Triveram
Romania
Lipertance
Slovakia
Lipertance

Date of last revision of the leaflet: 05/2025