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 this 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 further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 other statins, to perindopril or other ACE inhibitors, to amlodipine or other calcium antagonists, 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 obstruction of blood flow from the left ventricle of the heart (e.g., hypertrophic cardiomyopathy with outflow tract 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, facial swelling, tongue or throat swelling, intense itching, or severe rash when taking an ACE inhibitor in the past, or if such symptoms have occurred in relatives under any other circumstances (a condition called angioedema);
• if the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine containing aliskiren;
• if the patient is undergoing dialysis or blood filtration by other methods. 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 with other medicines");
• if the patient is taking glecaprevir with pibrentasvir for the treatment of 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, you should discuss it with your doctor or pharmacist if:

• you have liver problems or have had liver disease in the past;
• you have moderate or severe kidney disease;
• you regularly drink large amounts of alcohol;
• you are taking or have taken within the last 7 days a medicine called fusidic acid (used to treat bacterial infections), orally or by injection. Taking fusidic acid and Triveram at the same time may lead to severe muscle disorders (rhabdomyolysis);
• you have recurring or unexplained muscle pain, have had muscle problems in the past, or have similar problems in your family;
• you or a close relative have muscle disorders that have occurred in the family;
• you have had muscle disorders while being treated with other medicines that lower lipid levels (e.g., other statins or fibrates);
• you have hypothyroidism;
• your condition leads to increased atorvastatin levels in the blood;
• severe respiratory failure occurs during treatment;
• you have diabetes (high blood sugar levels);
• you have heart failure or other heart problems;
• you have had a heart attack or have recently had a heart attack;
• you have recently had diarrhea or vomiting, or are dehydrated;
• you have mild aortic or mitral stenosis (narrowing of the main blood vessel leading from the heart or the mitral valve of the heart);
• you have kidney problems, have recently had a kidney transplant, or are undergoing dialysis;
• you have a condition with high levels of a hormone called aldosterone in the blood (primary aldosteronism);
• you are elderly;
• you have a severe allergic reaction with swelling of the face, lips, tongue, or throat, with difficulty swallowing or breathing (angioedema). This reaction can occur at any time during treatment. If you experience such symptoms, you should stop taking Triveram and contact your doctor immediately.
• if you are of black race, there is a greater risk of angioedema, and the medicine may be less effective in lowering blood pressure than in patients of other races;
• you are 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, wildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes);
• you are undergoing LDL apheresis (removal of cholesterol from the blood using a special device);
• you are undergoing desensitization treatment to reduce the effects of allergies to bee or wasp stings;
• you are undergoing anesthesia and/or surgery;
• you have collagenosis (a disease of connective tissue), such as systemic lupus erythematosus or scleroderma;
• you are on a low-salt diet or are taking salt substitutes containing potassium;
• you have been informed by your doctor that you have an intolerance to certain sugars;
• you are 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 you have kidney problems related to diabetes; aliskiren;
• you are 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 in infusion 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 the "When not to take Triveram" and "Warnings and precautions" sections;
• 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 commonly used to treat diarrhea or to prevent organ rejection (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See the "Warnings and precautions" section;

*If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking Triveram. Your 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 about 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 people 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 you are taking Triveram, you 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

While taking this medicine, you should avoid drinking too much alcohol. More information is provided in section 2 "Warnings and precautions".

Pregnancy

You should not take Triveram if you are pregnant, trying to become pregnant, or are of childbearing age, unless you are using adequate contraception (see "When not to take Triveram").
If you are pregnant, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.
This medicine is contraindicated during pregnancy.

Breastfeeding

You should not take Triveram if you are breastfeeding. You should immediately tell your doctor if you are breastfeeding or start breastfeeding.

Driving and using machines

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

Triveram contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your 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 your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
The recommended dose is one tablet per day. You should swallow the tablet 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.

Taking a higher dose of Triveram than recommended

If you have taken more tablets than recommended, you should immediately contact your doctor or go to the emergency room. Taking too many tablets may cause your blood pressure to be too low or even dangerously low. This may cause dizziness, a feeling of "emptiness" in the head, fainting, or weakness. In such a situation, lying down with your legs raised 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.

Missing a dose of Triveram

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

Stopping Triveram treatment

Treatment with Triveram is usually long-term, so before stopping the medicine, you should consult your doctor.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects or symptoms, you should stop taking Triveram and contact your 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 you also feel unwell or have a high fever, which may be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems;
• weakness or numbness in 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 onset of 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 you experience unexpected or unusual bleeding or bruising, it 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 problems, and effects on the kidneys).

You should tell your doctor if you 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 you have diabetes, you should closely monitor your blood sugar levels), increased creatine kinase activity in the blood;
• headache, dizziness, central or peripheral vertigo, feeling of tingling, fatigue;
• vision disturbances, double vision;
• tinnitus (ringing or other sounds in the ears);
• cough, shortness of breath;
• gastrointestinal disorders: nausea, vomiting, constipation, flatulence, digestive disorders, changes in bowel movements, diarrhea, abdominal pain, changes in taste, indigestion;
• joint pain, muscle pain, muscle cramps, and back pain;
• fatigue, weakness;
• swelling of the ankles, palpitations (feeling of heartbeat), sudden flushing of the face and neck;
• blood test results indicating liver function disorders.

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

• loss of appetite (anorexia), weight gain or loss;
• nightmares, insomnia, sleep disorders, 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, dryness of the oral mucosa;
• intense itching or severe rash, red patches on the skin, skin discoloration, formation of blisters on the skin, hives, hypersensitivity to light (increased skin sensitivity to sunlight), hair loss;
• kidney problems, urinary disorders, nocturia, increased frequency of urination;
• erectile dysfunction, impotence, discomfort or breast enlargement in men;
• neck pain, muscle weakness;
• general malaise, tremors, fainting, falls, fatigue, fever, increased sweating, pain;
• tachycardia (fast heartbeat);
• purple spots on the skin (a sign of vasculitis);
• 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 after stopping treatment, 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 urination;
• exacerbation 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 serum;
• nerve disorders, which can cause weakness, numbness, or tingling;
• rash, which 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, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect some medical tests;
• changes in blood composition, such as decreased white blood cell count and red blood cell count, decreased hemoglobin levels, decreased platelet count, which can cause unusual bruising or bleeding (hemolytic anemia), 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 in some cases muscles involved in breathing);
• ocular myasthenia (a disease that causes muscle weakness in the eyes).
• You should talk to your doctor if you experience muscle weakness in your arms or legs, worsening over time, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

If you experience such symptoms, you should contact your doctor as soon as possible.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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, you can help provide more information on the safety of this 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 "Lot" number on the packaging refers to the batch number of the medicine.
Store the container tightly closed to protect from moisture.
There are no special storage temperature requirements for the medicinal product.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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.
• 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

Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France

Manufacturer

Les Laboratoires Servier Industrie, 905 route de Saran, 45520 Gidy, France
Anpharm Pharmaceutical Company S.A., ul. 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
In order to obtain detailed information, you should contact the representative of the marketing authorization holder:
Servier Polska Sp. z o.o., phone number: (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