Patient Information Leaflet

Trinocard 5 mg/5 mg/10 mg tablets, 5 mg/5 mg/20 mg tablets, 10 mg/5 mg/20 mg tablets, 10 mg/10 mg/20 mg tablets, 10 mg/10 mg/40 mg tablets

ramipril + amlodipine + atorvastatin
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Trinocard is and what it is used for
What you need to know before taking Trinocard
How to take Trinocard
Possible side effects
How to store Trinocard
Contents of the pack and other information

1. What Trinocard is and what it is used for

Trinocard tablets contain three active substances called ramipril, amlodipine, and atorvastatin.
Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). In patients with high blood pressure, it works by dilating blood vessels, thereby making it easier for the heart to pump blood around the body.
Amlodipine belongs to a group of medicines called calcium antagonists. In patients with high blood pressure, it works by relaxing blood vessels, allowing blood to flow more easily.
Atorvastatin belongs to a class of medicines known as statins, which regulate lipid (fat) levels. It is used to reduce lipid levels in the blood, known as cholesterol and triglycerides.
Trinocard is used to treat high blood pressure (hypertension) associated with elevated cholesterol levels (primary hypercholesterolemia) or elevated levels of cholesterol and fats (triglycerides) simultaneously (combined or mixed hyperlipidemia) in adult patients.
Instead of taking ramipril, amlodipine, and atorvastatin as separate tablets, you will take one tablet of Trinocard containing the three active substances at the same dosage.

2. What you should know before taking Trinocard

Do not take Trinocard

if you are allergic to ramipril or any other ACE inhibitor, to amlodipine or any other calcium channel blockers, to atorvastatin or to any of the other ingredients of this medicine (listed in section 6).

Signs of an allergic reaction may include a skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

if your blood pressure is excessively low or unstable. Your doctor will need to assess this.
if you suffer from heart failure following a heart attack.
if you have narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body).
if you or a family member has ever had a severe allergic reaction called "angioedema". Signs include itching, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.
if you are on dialysis or undergoing any other type of blood filtration. Depending on the machine used, Trinocard may not be suitable for you.
if you have kidney problems caused by reduced blood flow to the kidneys (renal artery stenosis).
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
if you have a liver disease, if you have liver problems (hepatic insufficiency), or if liver function tests have shown unexplained abnormal results.
if you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.
if you are pregnant or planning to become pregnant, or if you are a woman of childbearing age and not using a reliable method of contraception.
if you are breastfeeding.

Do not take Trinocard if any of the conditions listed above apply to you. If you are unsure, consult your doctor or pharmacist before taking Trinocard.

Warnings and precautions

Talk to your doctor or pharmacist before taking Trinocard.

Inform your doctor if you have or have had any of the following conditions:

If you suffer from heart failure or other heart problems.
If you have had or recently had a heart attack.
If you have kidney problems or kidney disease.
If you have or have had a liver disease.
If you have lost significant amounts of salts or body fluids (due to illness such as vomiting, diarrhoea, excessive sweating, or following a low-salt diet, or from long-term use of oral diuretics, or after undergoing dialysis).
If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
If you are about to undergo anaesthesia that may be administered for surgery or dental procedures. You may need to stop taking Trinocard the day before; consult your doctor.
If you have high levels of potassium in your blood (shown by a blood test) or if you use salt substitutes containing potassium.
If you are taking medicines or are in conditions where sodium levels in your blood may decrease. Your doctor may prescribe regular blood tests, particularly to monitor sodium levels, especially if you are elderly.
If you have experienced a severe allergic reaction with swelling of the face, lips, tongue, or throat, with difficulty breathing or swallowing (angioedema). This may occur at any time during treatment. If you develop such symptoms, you must stop taking this medicine and consult a doctor immediately.
If you are taking any of the following medicines, as they may increase the risk of angioedema:
- mTOR inhibitors (used to prevent organ transplant rejection), e.g. temsirolimus, everolimus, sirolimus,
- vildagliptin (used to treat diabetes),
- neprilysin inhibitors (NEP), such as racecadotril (used to treat diarrhoea),
- or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take Trinocard”.
If you suffer from collagen vascular diseases such as scleroderma or systemic lupus erythematosus.
If you are of Black origin, as you may have a higher risk of angioedema, and this medicine may be less effective in lowering blood pressure in Black populations compared to non-Black populations.
If you are taking any of the following medicines for hypertension:
- an angiotensin II receptor blocker (ARBs) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes,
- or aliskiren.
If you suffer from severe respiratory failure or develop symptoms of severe respiratory failure during treatment.
If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used for bacterial infections). The combination of fusidic acid and Trinocard may cause serious muscle problems (rhabdomyolysis).
If you have an underactive thyroid gland (hypothyroidism).
If you have had repeated or unexplained muscle pain or tenderness, or a personal or family history of muscle problems.
If you have previously experienced muscle problems while being treated with lipid-lowering medicines (e.g. other statins or fibrates).
If you regularly consume large amounts of alcohol.

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

Your doctor will perform blood tests before and possibly during treatment with Trinocard to assess the risk of muscle-related side effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section “Other medicines and Trinocard”).

Also inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medicines may be needed to diagnose and treat this condition.

During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high blood sugar levels, are overweight, and have high blood pressure.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals. See also the section “Do not take Trinocard”.

Children and adolescents

Trinocard is not recommended for children and adolescents under 18 years of age.

Other medicines and Trinocard

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines (including herbal medicines).

Some medicines may alter the effect of Trinocard or may have their effect altered by Trinocard. This type of interaction could make one or both medicines less effective. Alternatively, it could increase the risk or severity of adverse effects, including the serious condition of muscle breakdown known as rhabdomyolysis, described in section 4:

Sacubitril/valsartan – used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Trinocard”).
Other medicines for high blood pressure, including aliskiren, angiotensin II receptor antagonists (e.g. valsartan). See also the sections “Do not take Trinocard” and “Warnings and precautions”.
Verapamil, diltiazem (for the treatment of certain heart conditions and hypertension).
Medicines used to regulate heart rhythm (procainamide, digoxin, amiodarone).
Diuretics.
Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies such as isoproterenol, dobutamine, dopamine, epinephrine, noradrenaline, or adrenaline. Your doctor will need to monitor your blood pressure.
Potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride), or other medicines that may increase potassium levels in your blood, such as trimethoprim alone or in combination with sulfamethoxazole (for bacterial infections), and heparin (a medicine used to thin the blood and prevent clots).
Medicines used to relieve pain and inflammation (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or phenazone, and acetylsalicylic acid).
Rifampicin (an antibiotic used to treat tuberculosis).
Hypericum perforatum (St. John’s wort – a herbal treatment for depression).
Cancer medicines (cytostatics).
Immunosuppressants (medicines that reduce the body’s defence mechanisms) used to treat autoimmune diseases or after organ transplantation (e.g. cyclosporine, tacrolimus).
Steroid medicines for inflammation such as prednisolone.
Allopurinol, colchicine (medicines for the treatment of gout).
Ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (used to treat fungal infections).
Erythromycin, clarithromycin, telithromycin, fusidic acid* (antibiotics used to treat certain bacterial infections).
Medicines used to treat HIV or liver diseases such as hepatitis C, e.g. delavirdine, efavirenz; ritonavir, lopinavir, atazanavir, indinavir, nelfinavir, darunavir, the combination tipranavir/ritonavir, telaprevir, boceprevir, the combination elbasvir/grazoprevir, ledipasvir/sofosbuvir (so-called protease inhibitors).
Letermovir, a medicine that helps prevent cytomegalovirus infection.
Dantrolene (infusion for severe disturbances in body temperature).
Medicines belonging to the class of so-called mTOR inhibitors or neprilysin inhibitors (NEP), e.g.:
- Temsirolimus (for cancer).
- Sirolimus, everolimus (to prevent transplant rejection).
- Vildagliptin (used to treat type 2 diabetes).
- Racecadotril (for the treatment of diarrhoea). See also section “Warnings and precautions”.
Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol, ezetimibe.
Warfarin (which reduces blood clotting).
Oral contraceptives.
Stiripentol (an anticonvulsant for epilepsy).
Cimetidine (used for heartburn and peptic ulcer).
Antacids (indigestion remedies containing aluminium or magnesium).
Medicines for diabetes such as oral hypoglycaemics and insulin. Trinocard may lower blood sugar levels. Monitor your blood sugar levels carefully while taking Trinocard.
Medicines for mental disorders such as depression (tricyclic antidepressants, lithium). Trinocard may increase lithium levels in the blood. Your doctor must closely monitor your blood lithium levels.
Baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis).
Medicines that dilate blood vessels (e.g. nitrates, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin).

* If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart Trinocard. Taking Trinocard with fusidic acid may rarely cause fatigue, weakness, or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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

Trinocard with food, drinks, and alcohol

See section 3. How to take Trinocard.

People taking Trinocard must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can increase blood levels of the active substance amlodipine, which may cause an unpredictable increase in blood pressure, reducing the effectiveness of Trinocard. Large amounts of grapefruit juice will also increase the effect of the active substance atorvastatin.

Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, refer to section 2 “Warnings and precautions”.

Drinking alcohol with Trinocard may cause dizziness or confusion. If you are concerned about how much alcohol you can drink while taking Trinocard, discuss this with your doctor, as blood pressure-lowering medicines and alcohol may have additional sedative effects.

Pregnancy and breastfeeding

Pregnancy

Do not take Trinocard if you are pregnant or planning to become pregnant, or if you are a woman of childbearing age and not using a reliable method of contraception (see “Do not take Trinocard”).

This medicine must not be used during pregnancy.

Breastfeeding

Do not take Trinocard if you are breastfeeding. You must inform your doctor if you are breastfeeding or planning to start breastfeeding.

Driving and using machines

Trinocard may affect your ability to drive or operate machinery. If this medicine causes you discomfort, dizziness or fatigue, or headache, do not drive or operate machinery.

Trinocard contains lactose.

If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Trinocard contains sodium.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Trinocard

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet per day.
The maximum daily dose is one tablet of the 10 mg/10 mg/40 mg strength taken once daily.
You must follow a cholesterol-lowering diet during treatment with Trinocard.
The tablets must be swallowed whole with a glass of water, with or without food. However, try to take the tablets at the same time each day.
Do not split or chew the tablets.
Do not take Trinocard with grapefruit juice.

If you take more Trinocard than you should
Taking too many tablets may cause a lowering or a dangerously low drop in blood pressure. You may experience dizziness, lightheadedness, fainting, or weakness. If the drop in blood pressure is severe, shock may occur. Your skin may become cold and clammy, and you may lose consciousness.
Contact your doctor immediately or go immediately to the nearest hospital. Do not drive yourself to the hospital—have someone drive you or call an ambulance. Take the medicine’s packaging with you so the doctor knows what you have taken.

If you forget to take Trinocard
If you forget to take a tablet, skip that dose completely and take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Trinocard
Your doctor will advise you on how long you should take this medicine. If you stop treatment before being told to do so, your condition may return.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects or serious symptoms, stop taking Trinocard and consult your doctor immediately or go to the nearest emergency room.

Swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing, together with itching and skin rashes. This could be a sign of a severe allergic reaction (angioedema) to Trinocard. (See section “Warnings and precautions”).
Severe skin reactions including rash, hives, worsening of a pre-existing skin disease, redness of the skin all over the body, intense itching, blisters or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme) or other allergic reactions.
Skin rash, which often begins with itchy red spots on the face, arms and legs that may turn into blisters and look like small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (bullous dermatitis, erythema multiforme).
Muscle weakness, tenderness, pain, muscle breakdown or red-coloured urine, and especially if you also feel unwell or have a high fever, which may be due to abnormal muscle deterioration (rhabdomyolysis) that can be life-threatening and may lead to kidney problems.
Lupus-like disease syndrome (including skin rash, joint disorders and effects on blood cells).
Weakness in arms or legs, or speech problems which could be signs of a possible stroke.
Severe dizziness or fainting due to low blood pressure.
Fast or irregular heartbeat (arrhythmia, including bradycardia, ventricular tachycardia and atrial fibrillation), chest pain, chest tightness (angina pectoris, myocardial ischemia) or heart attack (myocardial infarction).
Shortness of breath, sudden wheezing, cough or difficulty breathing. These could be signs of lung problems.
Easy bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums), purple spots on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, weak, dizzy or pale appearance. These may be signs of circulatory or bone marrow problems.
Severe stomach pain that may extend to the back. This could be a sign of pancreatitis (inflammation of the pancreas).
Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (liver inflammation) or liver damage, or acute liver failure.
If you have problems with unexpected or unusual bleeding or bruising, this could be signs of liver problems. Consult your doctor as soon as possible.

Other side effects include:
Tell your doctor if you notice any of the following side effects.
Very common (may affect more than 1 in 10 people):

Swelling due to fluid retention (edema)

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

Inflammation of the nasal passages (rhinopharyngitis)
Higher than normal potassium levels
Higher than normal sugar levels (hyperglycaemia; if you have diabetes, monitor your blood sugar levels carefully)
Headache, dizziness, feeling weak or drowsy
Visual disturbances (including double and blurred vision)
Increased heart rate (palpitations)
Joint swelling, including in the ankles
Low blood pressure (hypotension), especially when standing up or sitting down quickly (orthostatic hypotension), fainting (syncope), hot flushes, dry irritating cough, bronchitis, inflammation of the sinuses (sinusitis), shortness of breath (dyspnea), chest pain, nosebleeds
Abdominal pain, diarrhoea, gastrointestinal inflammation, digestive disorders and abdominal discomfort, dyspnea, nausea, vomiting, changes in bowel habits, constipation, flatulence
Skin rash with or without swelling
Muscle spasms, cramps or muscle pain (myalgia), ankle swelling, joint pain (arthralgia), back pain, limb pain
Chest pain, feeling of tiredness (fatigue)
Feeling of weakness (asthenia)
Blood test results showing abnormal liver function, increased creatine kinase in the blood

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

Increase in certain white blood cells (eosinophilia) found during blood tests
Decreased appetite, loss of appetite (anorexia)
Decreased blood sugar levels (hypoglycaemia; if you have diabetes, continue to monitor your blood sugar levels carefully)
Weight gain
Mood changes, depressed mood, depression, anxiety, nervousness, restlessness, sleep disturbances (including drowsiness), insomnia, nightmares
Dizziness, tremor, syncope
Unusual skin sensations such as numbness, tingling, pricking, burning or crawling on the skin (paresthesia), reduced skin sensitivity (hypoesthesia), loss of taste (ageusia) or altered taste (dysgeusia)
Memory loss (amnesia)
Ringing in the ears and/or head (tinnitus)
Sneezing/runny nose (rhinitis), nasal congestion, cough
Difficulty breathing (bronchospasm or worsening of asthma)
Increased pancreatic enzymes
Swelling of the intestine called "intestinal angioedema" presenting with symptoms such as abdominal pain, vomiting and diarrhoea
Dry mouth, upper (including gastritis) and lower abdominal pain, heartburn
Blood tests showing changes in liver function (increased liver enzymes and/or conjugated bilirubin)
Excessive sweating (hyperhidrosis)
Hair loss (alopecia)
Itching, small bleeding spots or bleeding areas on the skin (purpura), skin discoloration, rash, hives, skin eruption
Neck pain, muscle fatigue
Kidney problems including acute kidney failure, urinary disorders, increased urine volume compared to normal during the day and/or increased frequency, increased need to urinate at night (nocturia)
Worsening of pre-existing proteinuria (more protein than usual in urine), white blood cells in urine, increased blood urea, increased blood creatinine
Inability to achieve an erection (impotence), reduced sexual desire in men or women, enlargement of male breast (gynecomastia)
Increased body temperature (pyrexia)
Feeling unwell
Weight gain or weight loss

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

Blood tests showing a decrease in red blood cells, white blood cells (including neutropenia or agranulocytosis, leukopenia) or platelets (thrombocytopenia) or hemoglobin levels
Confusion
Balance problems
Nerve disorder which may cause weakness, numbness or tingling (peripheral neuropathy), red, itchy, swollen or watery eyes (conjunctivitis)
Hearing disorder
Narrowing of blood vessels (vascular stenosis)
Blood flow disorders (hypoperfusion)
Inflammation of blood vessels (vasculitis)
Red and swollen tongue (glossitis)
Nail problems, e.g. loosening or separation of a nail from its bed (onycholysis)
Muscle disorders or inflammation: myopathy, myositis, muscle rupture
Tendon injury, sometimes complicated by rupture

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

Anaphylactic or anaphylactoid reactions (anaphylaxis)
Increased muscle tension (hypertonia)
Hearing loss
Enlargement of gum tissue (gingival hyperplasia)
Liver failure
Sensitivity to light or sun (photosensitivity)

Not known (frequency cannot be estimated from available data):

Too low number of blood cells shown by blood tests (pancytopenia)
Blood tests showing an excessive number of damaged red blood cells (hemolytic anemia)
Increased antinuclear antibodies
Concentrated (dark-coloured) urine, feeling unwell, muscle cramps, confusion and seizures which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you have these symptoms, contact your doctor as soon as possible
Reduced sodium in the blood
Attention disorder
Psychomotor impairment
Burning sensation
Change in the smell of things (parosmia)
Tremor, rigid posture, mask-like face, slow movements and shuffling, unbalanced gait (extrapyramidal disorder)
Fingers of hands and feet changing colour (turning pale) when cold, followed by tingling or painful sensation when warming up (Raynaud's phenomenon)
Inflammation of the oral mucosa with small ulcers (aphthous stomatitis)
Lumpy skin (pemphigus)
Skin inflammation (psoriasiform dermatitis), acute skin rash (pemphigoid or lichenoid rash), worsening of skin peeling or desquamation (worsening psoriasis), mucosal rash (enanthema)
Persistent muscle weakness (immune-mediated necrotizing myopathy)

Possible side effects reported with some statins (medicines of the same type as atorvastatin):

Sexual difficulties
Depression
Breathing difficulties including persistent cough and/or shortness of breath or fever
Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Trinocard

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

6. Package contents and other information

What Trinocard contains
The active substances are:
Trinocard 5 mg/5 mg/10 mg tablets:
Each tablet contains: 5 mg ramipril, 5 mg amlodipine (as amlodipine besilate), 10 mg atorvastatin (as atorvastatin calcium trihydrate).
Trinocard 5 mg/5 mg/20 mg tablets:
Each tablet contains: 5 mg ramipril, 5 mg amlodipine (as amlodipine besilate), 20 mg atorvastatin (as atorvastatin calcium trihydrate).
Trinocard 10 mg/5 mg/20 mg tablets:
Each tablet contains: 10 mg ramipril, 5 mg amlodipine (as amlodipine besilate), 20 mg atorvastatin (as atorvastatin calcium trihydrate).
Trinocard 10 mg/10 mg/20 mg tablets:
Each tablet contains: 10 mg ramipril, 10 mg amlodipine (as amlodipine besilate), 20 mg atorvastatin (as atorvastatin calcium trihydrate).
Trinocard 10 mg/10 mg/40 mg tablets:
Each tablet contains: 10 mg ramipril, 10 mg amlodipine (as amlodipine besilate), 40 mg atorvastatin (as atorvastatin calcium trihydrate).
The other components are: microcrystalline cellulose, monohydrate lactose, pregelatinized starch, calcium carbonate, croscarmellose sodium, glyceryl dibehenate, hypromellose, hydroxypropylcellulose, polysorbate 80, sodium stearyl fumarate.

Description of the appearance of Trinocard and contents of the pack
Trinocard 5 mg/5 mg/10 mg tablets:
White to off-white, round, biconvex tablets, imprinted with "A" on one side (size: approx. 8.5 mm in diameter).
Trinocard 5 mg/5 mg/20 mg tablets:
White to off-white, round, biconvex tablets, imprinted with "B" on one side (size: approx. 9.9 mm in diameter).
Trinocard 10 mg/5 mg/20 mg tablets:
White to off-white, oval, biconvex tablets, imprinted with "C" on one side and "5" on the other side (size: approx. 15.5 mm x 8 mm).
Trinocard 10 mg/10 mg/20 mg tablets:
White to off-white, oval, biconvex tablets, imprinted with "D" on one side and "10" on the other side (size: approx. 15.5 mm x 8 mm).
Trinocard 10 mg/10 mg/40 mg tablets:
White to off-white, oval, biconvex tablets, imprinted with "E" on one side (size: approx. 16.8 mm x 8 mm).
30 tablets packed in blisters made of OPA/aluminum/PVC film coated with an aluminum foil, in a cardboard box.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Medinitaly Pharma Progress S.r.l.
Viale di Villa Massimo, 37
00161 Rome
Italy
Manufacturer
Bluepharma Industria Farmaceutica S.A.
S. Martinho do Bispo
Coimbra - Portugal
January 2022