Triveram

Package leaflet: Information for the patient

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
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents:

1. What Triveram is and what it is used for
2. What you need to know before taking Triveram
3. How to take Triveram
4. Possible side effects
5. How to store Triveram
6. Contents of the pack 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 lipid-regulating agents (lowering blood fats).
Perindopril arginine is an angiotensin-converting enzyme (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 known as calcium channel blockers. In patients with high blood pressure, it works by relaxing blood vessels, thus improving blood flow. In patients with angina pectoris (causing chest pain), it improves blood supply to the heart muscle, delivering more oxygen and thereby preventing chest pain.
Triveram is used to treat high blood pressure (hypertension) and/or stable coronary artery disease (a condition in which blood supply to the heart is reduced or blocked), in adults who also have one of the following conditions:

• elevated cholesterol levels (primary hypercholesterolemia), or
• elevated cholesterol and fat (triglyceride) levels simultaneously (combined or mixed hyperlipidemia).

Triveram is intended for patients already being treated with atorvastatin, perindopril arginine, and amlodipine in separate tablets. Instead of taking atorvastatin, perindopril arginine, and amlodipine as separate tablets, the patient may take one Triveram tablet containing the three active substances at the same doses.

2. Important information before using Triveram

When not to use Triveram:

• if the patient is allergic to atorvastatin or another statin, to perindopril or another ACE inhibitor, to amlodipine or another calcium channel blocker, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has a liver disease;
• 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 in which the heart is unable to deliver sufficient blood to the body);
• if the patient has obstruction of blood flow from the left ventricle of the heart (e.g. hypertrophic obstructive cardiomyopathy or high-grade aortic valve stenosis);
• if the patient has heart failure following a heart attack;
• if the patient previously experienced symptoms such as wheezing, facial, tongue or throat swelling, intense itching, or severe rash while taking an ACE inhibitor, or if such symptoms occurred in blood 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 containing aliskiren;
• if the patient is undergoing dialysis or another form of blood filtration. Depending on the device used, Triveram may not be suitable for the patient;
• if the patient has kidney disorders causing reduced 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 this increases the risk of angioedema (rapid swelling of tissues under the skin, particularly in the throat area) (see "Warnings and precautions" and "Triveram with other medicines");
• if the patient is simultaneously using glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection;
• if the patient is pregnant, trying to become pregnant, or is of childbearing age and not using appropriate contraceptive methods;
• if the patient is breastfeeding.

Warnings and precautions
Before starting Triveram, discuss with your doctor or pharmacist if:

• the patient has liver disorders or a history of liver disease;
• the patient has moderate to severe kidney disease;
• the patient regularly drinks large amounts of alcohol;
• the patient is taking or has taken within the last 7 days the medicine fusidic acid (used for bacterial infections), either orally or by injection. Concomitant use of fusidic acid and Triveram may lead to severe muscle disorders (rhabdomyolysis);
• the patient has recurrent or unexplained muscle pain, a history of muscle problems, or if such symptoms occurred in blood relatives;
• the patient or a close relative has a family history of muscle disorders;
• the patient previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g. other statins or fibrates);
• the patient has hypothyroidism;
• the patient's condition leads to increased atorvastatin blood levels;
• symptoms of severe respiratory failure develop during treatment;
• the patient has diabetes (high blood glucose levels);
• the patient has heart failure or any other heart disorders;
• the patient has had a heart attack or recently suffered a heart attack;
• the patient has recently experienced diarrhoea or vomiting, or is dehydrated;
• the patient has mild stenosis of the aortic or mitral valve (narrowing of the main blood vessel leaving the heart or of the mitral heart valve);
• the patient has kidney disorders, recently received a kidney transplant, or has undergone dialysis;
• the patient has abnormally high blood levels of a hormone called aldosterone (primary hyperaldosteronism);
• the patient is elderly;
• the patient develops a severe allergic reaction with swelling of the face, lips, tongue or throat, difficulty swallowing or breathing (angioedema). This reaction may occur at any time during treatment. If such symptoms occur, stop taking Triveram immediately and contact your doctor without delay;
• patients of Black African origin have a higher risk of developing angioedema, and the medicine may be less effective in lowering blood pressure compared to patients of other races;
• the patient is taking any of the following medicines, which increase the risk of angioedema: racecadotril (used to treat diarrhoea); sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of mTOR inhibitors (used to prevent organ transplant rejection and in cancer treatment); 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 gliptins (used to treat diabetes);
• the patient is undergoing LDL apheresis (removal of cholesterol from the blood using a special device);
• the patient is undergoing desensitisation therapy to reduce the effects of allergy to bee or wasp stings;
• the patient is undergoing anaesthesia and/or surgery;
• the patient has a collagenosis (connective tissue disease) such as systemic lupus erythematosus or scleroderma;
• the patient is on a low-salt diet or uses salt substitutes containing potassium;
• the patient has been informed by a doctor of an intolerance to certain sugars;
• the patient is taking any of the following medicines used to treat high blood pressure: an angiotensin II receptor antagonist (ARB) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes; aliskiren;
• the patient has or has had myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms or trigger myasthenia (see section 4).

If any of the above situations apply to the patient, speak with your doctor before taking Triveram.
During treatment, your doctor may recommend blood tests to check muscle function (see section 2 "Triveram with other medicines").
Also inform your doctor or pharmacist if muscle weakness persists. Additional tests and medicines may be needed to diagnose and treat this condition.
Your doctor may recommend monitoring kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium). See also information in the section "When not to use Triveram".
While taking this medicine, your doctor will closely monitor you for the development of diabetes or risk of diabetes. Patients with high blood levels of glucose and lipids, overweight patients, and those with high blood pressure may be at increased risk of developing diabetes.

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

Triveram with other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
Some medicines may alter the effect of Triveram, or their effect may be altered by Triveram. This type of interaction could make one or both medicines less effective. It may also increase the risk or severity of adverse effects, including the risk of muscle damage known as rhabdomyolysis, described in section 4. Ensure your doctor is informed if you are taking any of the following medicines:

• immunosuppressive medicines (which reduce the body's immune response), 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 for bacterial infections);
• colchicine (used to treat gout, a condition where joint pain and swelling are caused by uric acid crystals);
• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, colestipol, ezetimibe;
• certain calcium channel blockers used for angina or hypertension, e.g. diltiazem;
• medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone;
• letermovir, a medicine helping to prevent cytomegalovirus disease;
• medicines used to treat HIV or liver disease such as hepatitis C virus infection, e.g. delavirdine, efavirenz, ritonavir, lopinavir, atazanavir, indinavir, darunavir, telaprevir, boceprevir, and combination medicines containing elbasvir with grazoprevir, ledipasvir with sofosbuvir;
• warfarin (reduces blood clot formation);
• oral contraceptives;
• stiripentol (an anticonvulsant used in epilepsy);
• cimetidine (used to treat heartburn and peptic ulcers);
• phenazone (a pain-relieving medicine);
• medicines that neutralise gastric acid (indigestion remedies containing aluminium or magnesium);
• over-the-counter medicines containing Hypericum perforatum (St. John's wort, used to treat depression);
• dantrolene (used intravenously to treat severe body temperature disorders);
• other medicines used to treat high blood pressure, including aliskiren, angiotensin II receptor antagonists (e.g. valsartan) – see also information in section "When not to use Triveram" and "Warnings and precautions";
• potassium-sparing medicines (e.g. triamterene, amiloride, eplerenone, spironolactone), potassium supplements, or salt substitutes containing potassium, and other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent clots, trimethoprim and co-trimoxazole, also known as a combination of trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• estramustine (used to treat cancer);
• lithium (used to treat mania or depression);
• medicines most commonly used to treat diarrhoea (racecadotril) or to prevent

organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the group of mTOR inhibitors). See section "Warnings and precautions";

• combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to use Triveram" and "Warnings and precautions";
• medicines used to treat diabetes (such as insulin, metformin or gliptins);
• baclofen (used to treat muscle stiffness in conditions such as multiple sclerosis);
• non-steroidal anti-inflammatory medicines (e.g. ibuprofen), used to relieve pain or treat inflammatory conditions (e.g. rheumatoid arthritis), or high doses of acetylsalicylic acid, a substance found in many medicines used for pain relief, fever reduction, and prevention of blood clots;
• vasodilating medicines, including nitrates;
• medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics);
• medicines used to treat low blood pressure, shock, or asthma (e.g. ephedrine, noradrenaline or adrenaline);
• gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis);
• allopurinol (used to treat gout);
• procainamide (used to treat heart rhythm disorders);
• daptomycin (a medicine used to treat complicated skin and skin structure infections and to combat bacteria present in the blood).

*If the patient needs to 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 Triveram. Using Triveram with fusidic acid may 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 grapefruits
Grapefruit juice and grapefruits should not be consumed by people taking Triveram, as grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, potentially causing an unexpected increase in Triveram's blood pressure-lowering effect.
If you are taking Triveram, you should not drink more than one or two small glasses of grapefruit juice per day, as large amounts may intensify the effect of the active substance atorvastatin.

Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. Detailed information is provided in section 2 "Warnings and precautions".

Pregnancy
Do not take Triveram if you are pregnant, trying to become pregnant, or if you are of childbearing age unless you are using appropriate contraceptive methods (see "When not to use Triveram").
If you are pregnant, suspect you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
This medicine is contraindicated during pregnancy.

Breast-feeding
Do not take Triveram if you are breastfeeding. Inform your doctor immediately if you are breastfeeding or start breastfeeding.

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

Triveram contains lactose
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

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

3. How to use Triveram

Triveram should always be used as directed by the physician or pharmacist. If in doubt,
consult a physician 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 each 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 more Triveram than recommended
If more tablets are taken than recommended, contact a physician immediately or go to the emergency room.
Taking too many tablets may cause blood pressure to become low or even dangerously low. This may lead to dizziness,
a sensation of "emptiness" in the head, fainting, or weakness. In such a situation, lying down with elevated legs may help.
If arterial blood pressure drop is significant, shock may occur. The patient may feel that the skin is cold and moist, and may lose consciousness.
Breathlessness due to excess fluid accumulating in the lungs (pulmonary edema) may occur even within 24–48 hours after taking the medication.
Missing a dose of Triveram
It is important to take the medicine regularly every day, as this ensures better effectiveness. However, if a dose of Triveram is missed,
the next dose should be taken 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; therefore, contact your physician before discontinuing the medication.
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the following severe adverse reactions or symptoms,
treatment must be discontinued and medical advice must be sought 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, urticaria, generalized redness of the skin, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• muscle weakness, tenderness, pain, muscle rupture or red-brown discoloration of urine, especially if accompanied by malaise or high fever, which may be due to abnormal muscle breakdown, potentially life-threatening and leading to kidney problems;
• weakness of the arms or legs, or difficulty speaking, which may be signs of stroke;
• severe dizziness or fainting due to low blood pressure;
• extremely rapid or irregular heartbeat;
• chest pain (angina) or heart attack;
• sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing (bronchospasm);
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and severe malaise;
• unexpected or unusual bleeding or bruising, which may indicate liver abnormalities;
• yellowing of the skin or eyes (jaundice), which may be a sign of hepatitis;
• rash, often starting with red, itchy spots on the face, arms or legs (erythema multiforme);
• lupus-like syndrome (including rash, joint disorders and effects on blood cells).

The patient should inform the doctor if any of the following adverse reactions occur:
Very common (may occur in more than 1 in 10 patients):

• swelling (fluid retention).

Common (may occur in up to 1 in 10 patients):

• inflammation of the nasal passages, sore throat, nosebleeds;
• allergic reactions (such as rashes, itching);
• increased blood glucose levels (if the patient has diabetes, blood glucose levels should be closely monitored), increased creatine kinase activity in blood;
• headache, central or vestibular dizziness, tingling or prickling sensations, feeling of fatigue;
• visual disturbances, double vision;
• tinnitus (ringing or noises in the ears);
• cough, shortness of breath;
• gastrointestinal disorders: nausea, vomiting, constipation, flatulence, indigestion, altered bowel function, diarrhoea, abdominal pain, taste disturbances, dyspepsia;
• joint pain, muscle pain, muscle cramps and back pain;
• fatigue, weakness;
• swollen ankles, palpitations (awareness of heartbeat), sudden flushing of the face and neck;
• blood test results indicating impaired liver function.

Uncommon (may occur in up to 1 in 100 patients):

• loss of appetite, weight gain or weight loss;
• nightmares, insomnia, sleep disturbances, mood changes, anxiety, depression;
• numbness or tingling in fingers or toes or limbs, reduced sensation to pain or touch, memory loss;
• blurred vision;
• sneezing or runny nose due to inflammation of the nasal mucosa;
• belching, dryness of the oral mucosa;
• intense itching or severe rash, red skin spots, skin discoloration, skin blistering, urticaria, photosensitivity reaction (increased skin sensitivity to sunlight), hair loss;
• kidney disorders, urinary disorders, nocturnal urge to urinate, increased frequency of urination;
• inability to achieve erection, impotence, discomfort or enlargement of the breasts in men;
• neck pain, muscle weakness;
• malaise, tremor, fainting, falls, tiredness, elevated temperature (fever), excessive sweating, pain;
• tachycardia (rapid heartbeat);
• purple skin lesions (sign of vasculitis);
• increased eosinophil count (a type of white blood cell);
• urine tests showing presence of white blood cells;
• changes in laboratory test results: high potassium levels in blood, transient after discontinuation of treatment, low sodium levels in blood, hypoglycaemia (very low blood sugar levels) in diabetic patients, increased blood urea levels, increased blood creatinine levels.

Rare (may occur in up to 1 in 1,000 patients):

• acute kidney failure;
• dark urine, nausea or vomiting, muscle cramps, disorientation and seizures. These may be symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion);
• reduced or absent urine output;
• worsening of psoriasis;
• confusion (disorientation);
• unexpected bleeding or bruising;
• cholestasis (yellowing of the skin and whites of the eyes);
• tendon damage;
• changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in serum;
• nerve disorders, which may cause weakness, tingling or numbness;
• rash, which may appear on the skin or cause oral ulcers (drug-induced lichenoid reaction).

Very rare (may occur in up to 1 in 10,000 patients):

• eosinophilic pneumonia (a rare type of lung inflammation);
• hearing loss;
• increased muscle tone;
• gum swelling;
• abdominal distension (inflammation of the gastric mucosa);
• abnormal liver function, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect certain medical tests;
• changes in blood composition, such as reduced white and red blood cell counts, reduced haemoglobin levels, reduced platelet count, which may cause unusual bruising or bleeding (damage to red blood cells), disease resulting from damage to red blood cells.

Frequency not known

• persistent muscle weakness;
• tremor, rigid posture, mask-like face, slowed movements and shuffling gait, unbalanced walking;
• bluish discoloration, numbness and pain in fingers or toes (Raynaud's phenomenon);
• myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing);
• ocular myasthenia (a disease causing weakness of the eye muscles).
• The patient should consult a doctor if they experience weakness in the arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

If any of these symptoms occur, medical advice should be sought immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Triveram

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP" (abbreviation used to describe the expiry date). The expiry date refers to the last day
of the stated month. The word "Lot" on the packaging indicates the batch number of the medicine.
Store the container tightly closed to protect it from moisture.
There are no special storage temperature requirements for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Triveram contains

• The active substances are: atorvastatin, perindopril with arginine, and amlodipine besylate.
• Each tablet of Triveram 10 mg + 5 mg + 5 mg 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 tablet of Triveram 20 mg + 5 mg + 5 mg 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 tablet of Triveram 20 mg + 10 mg + 5 mg 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 tablet of Triveram 20 mg + 10 mg + 10 mg 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 tablet of Triveram 40 mg + 10 mg + 10 mg 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:
• Core of the tablet: monohydrate lactose, calcium carbonate, hydroxypropylcellulose, sodium carboxymethyl starch (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 coated tablets with a diameter of 7 mm and curvature radius of 25 mm, embossed with " " on one side and " " on the other side.

Triveram 20 mg + 5 mg + 5 mg: yellow, round coated tablets with a diameter of 8.8 mm and curvature radius of 32 mm, embossed with " " on one side and " " on the other side.

Triveram 20 mg + 10 mg + 5 mg: yellow, square coated tablets with a side length of 9 mm and curvature radius of 16 mm, embossed with " " on one side and " " on the other side.

Triveram 20 mg + 10 mg + 10 mg: yellow, oblong coated tablets with a length of 12.7 mm and width of 6.35 mm, embossed with " " on one side and " " on the other side.

Triveram 40 mg + 10 mg + 10 mg: yellow, oblong coated tablets with a length of 16 mm and width of 8 mm, embossed with " " on one side and " " on the other side.

Tablets are available in containers containing 30 tablets. Also available are packs containing 90 tablets (3 containers of 30 tablets each).
The tablet container is closed with a screw cap. The cap contains a desiccant.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex
France

Manufacturer
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy
France
Anpharm Przedsiębiorstwo Farmaceutyczne S.A.
Annopol 6B
03-236 Warszawa
Poland
Egis Pharmaceuticals PLC
H-9900, Körmend
Mátyás király u. 65.
Hungary
Servier (Ireland) Industries Ltd (SII)
Moneylans - Gorey Road
Arklow – Co. Wicklow
Ireland

For further information, contact the local representative of the Marketing Authorisation Holder:
Servier Polska Sp. z o.o.
Telephone number: (22) 594 90 00

This medicinal product is authorised for marketing in 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