TRINOCARD 5 mg/5 mg /10 Mg Coated Tablet

Зміст інструкції

1. 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
   1. What is Trinocard and what is it used for
   2. What you need to know before taking Trinocard
   3. How to take Trinocard
   4. Possible side effects
   5. How to store Trinocard
   6. Package Contents and Other Information

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

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Trinocard is and what it is used for
• 2. What you need to know before you take Trinocard
• 3. How to take Trinocard
• 4. Possible side effects
• 5. How to store Trinocard
• 6. Contents of the pack and other information

1. What is Trinocard and what is it used for

Trinocard tablets contains three active ingredients 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, which makes 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, so that blood can flow more easily.
Atorvastatin belongs to the class of medicines called 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 high levels of cholesterol (primary hypercholesterolemia) or high 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 Trinocard tablet that contains the three active ingredients in the same dosage.

2. What you need to 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 any of the other ingredients of this medicine (listed in section 6).

The signs of an allergic reaction can 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 make this assessment.
• if you suffer from heart failure following a heart attack.
• if you have a narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to provide enough blood to the body).
• if you or a member of your family has ever had a serious allergic reaction called “angioedema”. The 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 are taking 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 being 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 suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers your blood pressure, containing aliskiren.
• if you have a disease affecting the liver, if you have a liver problem (hepatic insufficiency) or if the results of liver function tests have shown inexplicably altered values.
• if you are using glecaprevir/pibrentasvir combination in the treatment of hepatitis C.
• if you are pregnant or planning a pregnancy, or if you are a woman of childbearing potential and not using a reliable method of contraception.
• if you are breastfeeding.

Do not take Trinocard if any of the above cases apply to you. If you are not sure, ask your doctor
or pharmacist before taking Trinocard.

Warnings and precautions
Talk to your doctor or pharmacist before taking Trinocard.
Tell 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 a recent heart attack.
• If you have kidney problems or kidney disease.
• If you have or have had a disease affecting the liver.
• If you have lost a lot of salts or body fluids (due to an illness such as vomiting, diarrhea, excessive sweating, or following a low-salt diet, or after taking oral diuretics for a long time or having undergone dialysis).
• If you are about to undergo treatment to reduce the allergy to bee or wasp stings (desensitization).
• If you are about to undergo anesthesia that may be administered for surgery or dental treatment. It may be necessary to stop treatment with Trinocard the day before; ask your doctor for advice.
• If you have a high amount of potassium in your blood (shown by a blood test) or use potassium-containing salt substitutes.
• If you are taking medicines or are in conditions that may decrease sodium levels in your blood. Your doctor may prescribe blood tests at regular intervals, especially to check sodium levels in your blood, particularly if you are elderly.
• If you have had a severe allergic reaction with swelling of the face, lips, tongue or throat with difficulty breathing and swallowing (angioedema). This can occur at any time during treatment. If you develop such symptoms, you should stop taking this medicine and consult a doctor immediately.
• If you are taking any of the following medicines, these may increase the risk of angioedema: or mTOR inhibitors (used to prevent organ rejection after transplantation, e.g. temsirolimus, everolimus, sirolimus), or vildagliptin (used to treat diabetes), or neprilysin (NEP) inhibitors such as racecadotril (used to treat diarrhea) or

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 one of the following medicines used to treat hypertension: or an Angiotensin II receptor blocker (ARB) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes. or aliskiren.
• If you suffer from severe respiratory failure or if you develop symptoms of severe respiratory failure during treatment.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic used for bacterial infections) orally or by injection. 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 recurrent or unexplained muscle pain or soreness, a personal or family history of muscle problems.
• If you have had previous muscle problems while taking medicines for lowering blood lipids (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 not sure), talk to your doctor before taking
Trinocard.
Your doctor will need to perform a blood test before and possibly during treatment with
Trinocard to predict the risk of muscle-related side effects. It is known that the risk of muscle-related
side effects, such as rhabdomyolysis, increases when certain medicines are
taken together (see section “Other medicines and Trinocard”).
Also tell your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines
may be needed to diagnose and treat this problem.
During treatment with this medicine, your doctor will carefully monitor that you do not have
diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high
blood sugar levels, if you are overweight and have high blood pressure.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals. See also what is reported under “Do not
take Trinocard”.

Children and adolescents
Trinocard is not recommended in children and adolescents under the age of 18 years.

Other medicines and Trinocard
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including herbal remedies.
There are some medicines that can alter the effect of Trinocard or whose effect may be altered
by Trinocard. This type of interaction could make one or both medicines less effective. In
alternative it may increase the risk or severity of side effects, including the important
condition of muscle breakdown known as rhabdomyolysis, described in paragraph 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 the treatment of high blood pressure, including aliskiren, angiotensin II receptor antagonists (ARBs) (e.g. valsartan). See also what is reported under “Do not take Trinocard” and “Warnings and precautions”.
• Verapamil, diltiazem (for the treatment of some heart diseases 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, norepinephrine 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 can increase the amount of potassium in your blood such as trimethoprim alone or in combination with sulfamethoxazole (for infections caused by bacteria) 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 (antibiotic agent used to treat tuberculosis).
• Hypericum perforatum (St. John's wort - herbal remedy for depression).
• Cancer medicines (cytostatics).
• Immunosuppressants (medicines that reduce the body's defenses) used to treat autoimmune diseases or following 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 some bacterial infections).
• Medicines used in the treatment of 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 to avoid cytomegalovirus disease.
• Dantrolene (infusion for severe alterations of body temperature).
• Medicines belonging to the class of so-called mTor inhibitors or neprilysin (NEP) inhibitors, e.g.:
• Temsirolimus (for cancer).
• Sirolimus, everolimus (for transplant rejection prevention).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (for the treatment of diarrhea). See also the 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 products containing aluminum or magnesium).
• Medicines for diabetes such as oral hypoglycemic agents and insulin. Trinocard may lower blood sugar levels. Carefully monitor your blood sugar levels while taking Trinocard.
• Medicines for the treatment of mental disorders such as depression (tricyclic antidepressants, lithium). Trinocard may increase the amount of lithium in your blood. The amount of lithium in your blood will need to be carefully monitored by your doctor.
• Baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis)
• Medicines that widen blood vessels (e.g. nitrates, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin)

* If you need to take oral fusidic acid to treat a bacterial infection, you will temporarily need to stop taking this medicine. Your doctor will tell you when it is safe to resume taking Trinocard. Taking Trinocard with fusidic acid may rarely lead to fatigue, weakness or muscle pain (rhabdomyolysis). For more information about rhabdomyolysis see paragraph 4.
If any of the above conditions apply to you (or you are not sure), tell your doctor before
taking Trinocard.

Trinocard with food, drinks and alcohol
See what is reported in paragraph 3. How to take Trinocard.
People taking Trinocard should not consume grapefruit or grapefruit juice.
This is because grapefruit and its juice can lead to an increase in the levels of the
active ingredient amlodipine in the blood, which can cause an unpredictable increase in blood
pressure reducing the effect of Trinocard. Large amounts of grapefruit juice will lead to an
increase in the effect of the active ingredient atorvastatin.
Avoid drinking excessive amounts of alcohol when taking this medicine. For further
details see paragraph 2 “Warnings and precautions”.
Drinking alcohol with Trinocard can cause dizziness or confusion. If you are concerned about how much
you can drink while taking Trinocard, talk to your doctor, as medicines used to
lower blood pressure and alcohol can have other sedative effects.

Pregnancy and breastfeeding

Pregnancy
Do not take Trinocard if you are pregnant or planning a pregnancy, or if you are a woman of childbearing
potential and not using a reliable method of contraception (see “Do not take Trinocard”).
This medicine should not be used during pregnancy.

Breastfeeding
Do not take Trinocard if you are breastfeeding. You should inform your doctor if you are breastfeeding or are about to start
breastfeeding.

Driving and using machines
Trinocard may affect your ability to drive vehicles or use machines. If this medicine
causes you to feel unwell, dizzy or tired, or headache, do not drive vehicles or use machines.

Trinocard contains lactose.
If your doctor has diagnosed you with intolerance to certain sugars, contact them 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet a day.
The maximum daily dose is 1 tablet of the 10 mg/10 mg/40 mg dosage once a day.
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 every day at the same time.
Do not break 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 decrease or a dangerous decrease in blood
pressure. You may experience dizziness, lightheadedness, fainting or weakness. If the drop in blood pressure is so severe,
shock may occur. The skin may become cold and clammy and you may lose
consciousness.
Inform your doctor immediately or go to the nearest hospital immediately. Do not drive to
go to the hospital, but have someone drive you or call an ambulance. Bring the packaging of the
medicine with you, so that the doctor knows what you have taken.

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

If you stop taking Trinocard
Your doctor will tell you how long you should take this medicine. If you stop treatment
before you are told to do so, your condition may recur.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following side effects or serious symptoms, stop taking Trinocard and immediately consult your doctor or go to the nearest emergency room.

• Swelling of the face, lips, mouth or throat that can cause difficulty swallowing or breathing, as well as 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, , urticaria, worsening of a pre-existing skin condition, redness of the skin all over the body, intense itching, blisters or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme) or other allergic reactions.
• Skin rash, which often starts with itchy red spots on the face, arms and legs that may turn into blisters and look like small targets (dark central areas surrounded by a lighter area, with a dark ring around the edge) (bullous dermatitis, erythema multiforme).
• Muscle weakness, tenderness, pain, muscle breakdown or reddish urine, and especially if you do not feel well or have a high fever at the same time, this may be caused by abnormal muscle deterioration (rhabdomyolysis) which can be life-threatening and can lead to kidney problems.
• Syndrome with illness-like symptoms similar to Lupus (including rash, joint disorders and effects on blood cells).
• Weakness of the arms or legs, or difficulty speaking, which may be a sign 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, tightness in the chest (angina pectoris, myocardial ischemia) or heart attack (myocardial infarction).
• Shortness of breath, sudden wheezing, coughing or difficulty breathing. These may be signs of lung problems.
• Easier bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums) purple spots on the skin or easy onset of infections, sore throat and fever, feeling tired, weak, dizzy or pale skin. These can be signs of problems with blood circulation or the bone marrow.
• Severe stomach pain that can extend to the back. This may 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 can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage, or acute liver failure.
• If you experience problems with unexpected or unusual bleeding or bruising, this could be a sign of a liver problem. Consult your doctor as soon as possible.

Other side effects include:
Inform 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 (nasopharyngitis)
• A higher than normal level of potassium
• A higher than normal level of sugars (hyperglycemia; If you have diabetes, monitor your blood sugar levels carefully)
• Headache, dizziness, feeling weak or sleepy
• Visual disturbances (including double and blurred vision)
• Fast heartbeat (palpitations)
• Joint swelling, including ankles
• Low blood pressure (hypotension), especially when getting up or sitting quickly (orthostatic hypotension), fainting (syncope), hot flashes Dry, irritating cough, bronchitis, inflammation of the sinuses (sinusitis), shortness of breath (dyspnea), chest pain, nosebleeds
• Abdominal pain, diarrhea, 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), swelling of the ankles, joint pain (arthralgia), back pain, pain in the limbs
• Chest pain, feeling tired (fatigue)
• Feeling of weakness (asthenia)
• Blood tests showing abnormal liver function. increased creatine kinase in the blood

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

• Increase in the number of certain white blood cells (eosinophilia) detected during blood tests
• Loss of appetite, decreased appetite (anorexia)
• Decrease in blood sugar levels (hypoglycemia; if you suffer from diabetes you should continue to monitor your blood sugar levels carefully)
• Weight gain
• Mood changes, depressed mood, depression, anxiety, nervousness, restlessness, sleep disorders (including drowsiness), insomnia, nightmares
• Dizziness, tremor (tremor), syncope
• Unusual skin sensations such as numbness, tingling, prickling, burning or creeping on the skin (paresthesia), reduced skin sensitivity (hypoesthesia) loss (ageusia) or change in the sense of taste of things (dysgeusia);
• Memory loss (amnesia)
• Ringing in the ears and/or head (tinnitus)
• Sneezing/runny nose (rhinitis), stuffy nose, cough
• Difficulty breathing (bronchospasm or worsening of asthma
• Increased pancreatic enzymes
• An inflammation of the intestine called "intestinal angioedema" which presents with symptoms such as abdominal pain, vomiting and diarrhea
• Dry mouth, upper abdominal pain (including gastritis) and lower abdominal pain, heartburn
• Blood tests showing changes in how the liver works (increased liver enzymes and/or conjugated bilirubin)
• Excessive sweating (hyperhidrosis)
• Hair loss (Alopecia)
• Itching, small bleeding or bleeding areas on the skin (purpura), skin discoloration, rash, urticaria, skin rash
• Neck pain, muscle fatigue
• Kidney problems including acute renal failure, urination disorders, increased amount of urine 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 the urine), white blood cells in the urine, increased urea in the blood, increased creatinine in the blood
• Inability to get an erection (impotence), decreased sexual desire in men or women, enlargement of male breasts (gynecomastia)
• Increased body temperature (pyrexia)
• Feeling unwell
• Weight gain or loss

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

• Blood tests showing a decrease in the number of red blood cells, white blood cells (including neutropenia or agranulocytosis, leucopenia) or platelets (thrombocytopenia) or the amount of hemoglobin
• Confusion
• Balance problems
• Nerve disorder that can cause weakness, numbness or tingling (peripheral neuropathy Red eyes, itchy, swollen or watery (conjunctivitis);
• Hearing impairment
• 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 and inflammatory disorders: myopathy, myositis, muscle breakdown
• Tendon injury, sometimes complicated by rupture

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

• 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 few blood cells highlighted by blood tests (pancytopenia)
• Blood tests showing an excessive number of damaged red blood cells (hemolytic anemia)
• Increased antinuclear antibodies
• Concentrated urine (dark in color), feeling unwell, muscle cramps, confusion and convulsions which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you have these symptoms contact your doctor as soon as possible
• Decreased 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 unsteady gait (extrapyramidal disorder)
• Fingers and toes changing color (turning pale) when cold and then tingling or feeling pain when warming up (Raynaud's phenomenon)
• Inflammation of the oral mucosa with small ulcers (aphthous stomatitis)
• Blistered skin (pemphigus)
• Inflammation of the skin (psoriasiform dermatitis), acute skin rash (pemphigoid or lichenoid rash), worsening of scaling or peeling of the skin (aggravated psoriasis), rash of the mucous membranes (enanthem)
• Persistent muscle weakness (immune-mediated necrotizing myopathy)

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 that is stated on the pack after Exp. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in 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 ingredients are:
Trinocard 5 mg/5 mg/10 mg tablets:
Each tablet contains: 5 mg ramipril, 5 mg amlodipine (as amlodipine besylate), 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 besylate), 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 besylate), 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 besylate), 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 besylate), 40 mg
atorvastatin (as atorvastatin calcium trihydrate).
The other ingredients are: Microcrystalline cellulose, lactose monohydrate, pregelatinized starch,
croscarmellose sodium, glycerol dibehenate, hypromellose, hydroxypropyl cellulose,
polysorbate 80, sodium stearyl fumarate.

Description of the appearance of Trinocard and package contents
Trinocard 5 mg/5 mg/10 mg tablets:
Tablets of colour from white to off-white, round in shape, biconvex, with imprinted “A” on one side
(dimensions: diameter approx. 8.5 mm).
Trinocard 5 mg/5 mg/20 mg tablets:
Tablets of colour from white to off-white, round in shape, biconvex, with imprinted “B” on one side
(dimensions: diameter approx. 9.9 mm).
Trinocard 10 mg/5 mg/20 mg tablets:
Tablets of colour from white to off-white, oval in shape, biconvex, with imprinted “C” on one side and
“5” on the other side (dimensions: approx. 15.5 mm x 8 mm).
Trinocard 10 mg/10 mg/20 mg tablets:
Tablets of colour from white to off-white, oval in shape, biconvex, with imprinted “D” on one side and
“10” on the other side (dimensions: approx. 15.5 mm x 8 mm).
Trinocard 10 mg/10 mg/40 mg tablets:
Tablets of colour from white to off-white, oval in shape, biconvex, with imprinted “E” on one side
(dimensions: approx. 16.8 mm x 8 mm).
30 tablets packaged in blisters made of OPA/aluminium/PVC foil covered with an aluminium foil in a
cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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