TRICUAL 20 mg/5 mg/5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

TRICUAL 10 mg/5 mg/5 mg tablets

TRICUAL 20 mg/5 mg/5 mg tablets

TRICUAL 20 mg/5 mg/10 mg tablets

TRICUAL 20 mg/10 mg/10 mg tablets

TRICUAL 40 mg/10 mg/10 mg tablets

atorvastatin/amlodipine/ramipril

Read all of 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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tricual and what is it used for
2. What you need to know before you take Tricual
3. How to take Tricual
4. Possible side effects

5 Conservation of Tricual

1. Contents of the pack and further information

1. What is Tricual and what is it used for

Tricual tablets contain three active substances called atorvastatin, amlodipine, and ramipril.

Atorvastatin belongs to a group of medicines known as statins, which are lipid-modifying medicines. It works by reducing the lipids such as cholesterol and triglycerides in the blood.

Amlodipine belongs to a group of medicines called calcium channel blockers. In patients with high blood pressure, it works by relaxing the blood vessels, so that blood passes through them more easily.

Ramipril belongs to a group of medicines called ACE inhibitors. In patients with high blood pressure, it works by widening the blood vessels, making it easier for the heart to pump blood to the rest of the body.

Tricual is used to treat high blood pressure (hypertension) associated with high levels of cholesterol (primary hypercholesterolemia) or high levels of cholesterol and fats (triglycerides) at the same time (combined or mixed hyperlipidemia) in adult patients.

Tricual is intended for patients who are already being treated with atorvastatin, amlodipine, and ramipril in separate tablets. Instead of taking atorvastatin, amlodipine, and ramipril in separate tablets, you will receive one Tricual tablet that contains the three active substances in the same concentration.

2. What you need to know before you take Tricual

Do not takeTricual

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

The signs of an allergic reaction can include rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

• if your blood pressure is abnormally low or unstable. Your doctor will need to assess this.
• if you have heart failure after a heart attack.
• if you have an obstruction of the blood flow from the left ventricle of the heart (e.g., high-grade aortic stenosis) or shock (including cardiogenic shock, a condition where the heart is unable to supply enough blood to the body).
• if you or a member of your family has ever had a severe allergic reaction called "angioedema".

The signs include itching, hives, red marks on 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 taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults (see section 2 'Do not take Tricual').
• if you are undergoing dialysis or any other type of blood filtration procedure. Depending on the device used, Tricual may not be suitable for you.
• if you have kidney problems that involve a reduction in blood supply to the kidneys (renal artery stenosis).
• if you have diabetes or kidney impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• if you have a liver disease, if you have a liver problem (liver failure) or if you have had unexplained abnormal results of liver function tests.
• if you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.
• if you are pregnant or trying to become pregnant, or if you are a woman of childbearing age and are not using a reliable contraceptive method.
• if you are breast-feeding.

Do not take Tricual if any of the above applies to you. If you are not sure, consult your doctor before taking Tricual.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tricual.

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

• if you have very high blood pressure.
• if you have heart failure or any other heart problem.
• if you have recently had a heart attack.
• if you have kidney problems or kidney disease.
• if you have liver problems or a history of liver disease.
• if you have lost a large amount of body salts or fluids (due to vomiting, diarrhea, excessive sweating, low-salt diet, taking diuretics for a long time, or dialysis treatment).
• if you are going to have a treatment to reduce your allergic reactions to bee or wasp stings (desensitization).
• if you are going to have an anesthesia and/or major surgery. You may be given anesthesia for an operation or any dental procedure. You may need to stop taking Tricual one day before; consult your doctor.
• if you have high levels of potassium in your blood (hyperkalemia, shown in blood test results) or use salt substitutes that contain potassium.
• if you are taking medicines or have a disease that may decrease the levels of sodium in your blood. Your doctor may perform periodic blood tests, especially to check the levels of sodium in your blood, especially if you are an elderly patient.
• if you experience a severe allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing (angioedema). This can occur at any time during treatment. If you experience these symptoms, stop taking this medicine and go to the doctor immediately.
• if you are taking any of the following medicines, the risk of angioedema increases:
• 1. - mTOR inhibitors (used to prevent organ rejection), e.g., temsirolimus, everolimus, sirolimus,
  2. - vildagliptin (used to treat diabetes),
  3. - neprilysin inhibitors (NEP) such as racecadotril (used to treat diarrhea) or
  4. - sacubitril/valsartan. For sacubitril/valsartan, see section 2 "Do not take Tricual".
• if you have a vascular disease of the collagen such as scleroderma or systemic lupus erythematosus.
• if you are black, as you may have a higher risk of angioedema and this medicine may be less effective in reducing your blood pressure than in patients who are not black.
• if you are taking any of the following medicines used to treat high blood pressure:
• 1. - an angiotensin II receptor antagonist (ARA) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  2. - aliskiren.
• if you have severe respiratory failure or if you develop symptoms of severe respiratory failure while taking this medicine.
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Tricual can cause serious muscle problems (rhabdomyolysis).
• if you have an underactive thyroid gland (hypothyroidism).
• if you have had repeated or unexplained muscle pain, personal or family history of muscle problems.
• if you have had muscle problems before while taking other cholesterol-lowering medicines (e.g., other "-statin" or "-fibrate" medicines).
• if you regularly drink large amounts of alcohol.

If any of the above applies to you (or you are not sure), talk to your doctor before taking Tricual.

Your doctor will need to perform a blood test before and possibly during your treatment with this medicine to assess the risk of you experiencing muscle-related side effects. It is known that the risk of muscle-related side effects, e.g., rhabdomyolysis, increases when certain medicines are taken at the same time (see section 2 "Other medicines and Tricual").

Also, inform your doctor or pharmacist if you have constant muscle weakness. Further tests and medicines may be needed to diagnose and treat it.

While taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight, and have high blood pressure.

Your doctor may periodically check your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood. See also the information under the heading "Do not take Tricual".

Children and adolescents

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

Other medicines and Tricual

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

There are some medicines that can affect the way Tricual works or their effect can be altered by Tricual. This type of interaction can make one or both medicines less effective. Alternatively, it could increase the risk or severity of side effects, including the important muscle damage known as rhabdomyolysis described in section 4:

• Sacubitril/valsartan - used for the treatment of a type of long-term (chronic) heart failure in adults (see section 2 'Do not take Tricual').
• Other medicines for treating high blood pressure, including aliskiren, angiotensin II receptor antagonists (e.g., valsartan). See also the information under the headings "Do not take Tricual" and "Warnings and precautions").
• Verapamil, diltiazem (for the treatment of certain heart diseases and high blood pressure).
• Medicines for regulating your heart rhythm (procainamide, digoxin, amiodarone).
• Diuretics.
• Medicines used for treating 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), and other medicines that can increase the amount of potassium in the blood, such as trimethoprim alone or in combination with sulfamethoxazole (for bacterial infections) and heparin (a medicine used to thin the blood and prevent blood 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 defense mechanism) used for the treatment of autoimmune disorders or after a transplant operation (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 in the treatment of HIV or liver diseases such as hepatitis C, e.g., delavirdine, efavirenz; ritonavir, lopinavir, atazanavir, indinavir, nelfinavir, darunavir, the combination of tipranavir/ritonavir, telaprevir, boceprevir, the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir (the so-called protease inhibitors).
• Letermovir, a medicine that helps prevent you from getting sick with cytomegalovirus.
• Dantrolene (in infusion for severe body temperature abnormalities).
• Medicines belonging to the class of so-called mTOR inhibitors or neprilysin inhibitors (NEP), e.g.:

• Temsirolimus (for cancer).
• Sirolimus, everolimus (for the prevention of graft rejection).
• Vildagliptin (for the treatment of type 2 diabetes).
• Racecadotril (for the treatment of diarrhea).

See also the section "Warnings and precautions".

• Other medicines for regulating lipid levels, e.g., gemfibrozil, other fibrates, colestipol, ezetimibe.
• Warfarin (which reduces blood clotting).
• Oral contraceptives.
• Stiripentol (an anticonvulsant for epilepsy).
• Cimetidine (for heartburn and peptic ulcers).
• Antacids (indigestion products containing aluminum or magnesium).
• Medicines for diabetes such as oral hypoglycemics and insulin. Tricual may reduce your blood sugar levels. Monitor your blood sugar levels closely while taking Tricual.
• Medicines for treating mental disorders such as depression (tricyclic antidepressants, lithium). Tricual may increase the amount of lithium in your blood. Your lithium levels should be closely monitored by your doctor.
• Baclofen (used to treat muscle stiffness in diseases such as multiple sclerosis).
• Medicines that make blood vessels widen (e.g., nitrates, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin).

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when it is safe to start taking Tricual again. Taking Tricual with fusidic acid can rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

If any of the above applies to you (or you are not sure), consult your doctor before taking Tricual.

Taking Tricual with food, drinks, and alcohol

See section 3 for instructions on how to take Tricual.

Grapefruit juice and grapefruit should not be consumed by people taking Tricual. This is because grapefruit and grapefruit juice can cause an increase in the levels of the active substance amlodipine in the blood, which can cause an unpredictable increase in the blood-pressure-lowering effect of Tricual. Large amounts of grapefruit juice will increase the effect of the active substance atorvastatin.

Avoid drinking too much alcohol while taking this medicine. See section 2 "Warnings and precautions" for more details.

Drinking alcohol during treatment with this medicine can make you feel dizzy or drowsy. If you are concerned about how much you can drink while taking Tricual, talk to your doctor, as the medicines used to lower blood pressure and alcohol can reinforce each other's sedative effects.

Pregnancy and breast-feeding

Pregnancy

Do not take Tricual if you are pregnant, if you are trying to become pregnant, or if you are of childbearing age and are not using a reliable contraceptive method (see "Do not take Tricual").

This medicine should not be used during pregnancy.

Breast-feeding

Do not take Tricual if you are breast-feeding. Inform your doctor immediately if you are breast-feeding or are about to start breast-feeding.

Driving and using machines

Tricual may affect your ability to drive or use machines. If you feel unwell, dizzy, tired, or have a headache while taking this medicine, do not drive or use machines. This is more likely to happen when you start taking this medicine or when you start taking a higher dose.

Tricual contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Tricual contains sodium

This medicine contains less than 1mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to Take Tricual

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet per day.

The maximum dose is 1 tablet of the 40 mg/10 mg/10 mg dose once a day.

You should continue with the diet to reduce cholesterol during treatment with Tricual.

Swallow the tablet whole with a glass of water at the same time each day, with or without food.

Do not crush or chew the tablet.

Do not take Tricual with grapefruit juice.

If You Take More Tricual Than You Should

Inform your doctor immediately or contact the nearest emergency service. Do not drive to the hospital, ask someone else to take you or call an ambulance. Bring the medication packaging with you. This way, the doctor will know what you have taken.

Taking too many tablets can cause your blood pressure to drop or even drop dangerously. You may feel dizzy, dazed, or weak. If the drop in blood pressure is severe enough, it can cause shock. You may feel cold and damp skin and may lose consciousness.

Excess fluid can accumulate in the lungs (pulmonary edema), causing difficulty breathing that can appear up to 24-48 hours after ingestion.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Miss a Dose of Tricual

If you forget to take a tablet, leave that dose completely. Take the next dose at the usual time. Do not take a double dose to make up for missed doses.

If You Interrupt Treatment with Tricual

Your doctor will indicate how long you should take this medication. Your condition may recur if you interrupt treatment with this medication.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not all people experience them.

If You Experience Any of the Following Serious Side Effects or Symptoms, Stop Taking Tricual and Inform Your Doctor Immediately or Go to the Nearest Hospital Emergency Service.

• Swelling of the face, lips, mouth, tongue, or throat, which makes swallowing or breathing difficult, as well as itching and skin rashes. This could be a sign of a severe allergic reaction (angioedema) to Tricual (See section 2 "Warnings and Precautions").
• Severe skin reactions, including intense skin rash, hives, worsening of a pre-existing skin disease, redness of the skin all over the body, intense itching, blistering, or peeling of the skin, inflammation of the mucous membranes (such as Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.
• Skin rash, which usually starts with red spots that itch on the face, arms, or legs, can form blisters, and looks like small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (bullous dermatitis, erythema multiforme).
• Muscle weakness, sensitivity, pain, rupture, or brownish discoloration of the urine, and especially if you feel unwell or have a fever, may be due to abnormal muscle breakdown (rhabdomyolysis) that can be potentially fatal and cause kidney problems.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).
• Weakness in the arms or legs, or problems speaking, which could be a sign of a possible stroke.
• Severe dizziness or fainting due to low blood pressure.
• Fast or irregular heartbeats (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, coughing, or difficulty breathing. These can be signs of lung problems.
• Bruising more easily than usual, prolonged bleeding, any sign of bleeding (e.g., bleeding gums), purple spots on the skin, or getting infections more easily than usual, sore throat, and fever, feeling of tiredness, weakness, dizziness, or paleness. These can be symptoms of blood or bone marrow problems.
• Severe stomach pain that can extend to the back. This can be a sign of pancreas inflammation (pancreatitis).
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). These can be signs of liver problems, such as liver inflammation (hepatitis) or liver damage or acute liver failure.
• If you experience unexpected bleeding or bruising problems, this may indicate a liver problem. You should consult your doctor as soon as possible.

Other Side Effects:

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 (nasopharyngitis).
• Allergic reactions.
• Increased potassium in the blood.
• Increased blood sugar levels (hyperglycemia; if you have diabetes, continue to monitor your blood sugar levels closely).
• Headache, dizziness, numbness, drowsiness.
• Vision problems (including double vision and blurred vision).
• Heartbeat sensations (palpitations).
• Joint swelling, including ankle swelling.
• Low blood pressure (hypotension), especially when standing up or sitting down quickly (orthostatic blood pressure decrease), fainting (syncope), hot flashes.
• Dry cough with tickling, bronchitis, inflammation of the paranasal sinuses (sinusitis), difficulty breathing (dyspnea), sore throat, nasal bleeding.
• Abdominal pain, diarrhea, gastrointestinal inflammation, digestive disorders, and abdominal discomfort, dyspepsia, nausea, vomiting, alteration of bowel habits, constipation, flatulence.
• Skin rash with or without inflammation.
• Muscle spasms, cramps, or muscle pain (myalgia), joint pain (arthralgia), back pain, pain in the limbs.
• Chest pain, feeling of exhaustion (fatigue).
• Feeling of weakness and powerlessness (asthenia).
• Blood tests showing abnormal liver function, increased creatine kinase in the blood.

Uncommon: May Affect Up to 1 in 100 People

• Increased number of certain white blood cells (eosinophilia) in a blood test.
• Decreased appetite, loss of appetite (anorexia).
• Decreased blood sugar levels (hypoglycemia; if you have diabetes, you should continue to monitor your blood sugar levels closely).
• Weight gain.
• Mood changes, depressive mood, depression, anxiety, nervousness, restlessness, sleep disorders (including drowsiness), insomnia, nightmares.
• Dizziness, tremors, fainting.
• Unusual skin sensations such as numbness, tingling, pinching, burning, or tingling in the skin (paresthesia), decreased skin sensitivity (hypoesthesia).
• Loss (ageusia) or change in the taste of things (dysgeusia).
• Memory loss (amnesia).
• Ringing in the ears and/or head (tinnitus).
• Swelling of the arms and legs (peripheral edema).
• Sneezing/nasal dripping (rhinitis), nasal congestion, cough.
• Breathing difficulties (bronchospasm), including worsening of asthma.
• Increased pancreatic enzymes.
• Intestinal inflammation called "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea.
• Dry mouth, upper abdominal pain (including gastritis) and lower, heartburn, belching.
• Blood tests showing changes in liver function (increased liver enzymes and/or conjugated bilirubin).
• Excessive sweating (hyperhidrosis).
• Hair loss (alopecia).
• Itching (pruritus), small bleeding spots or bleeding area on the skin (purpura), skin discoloration, exanthema, urticaria, skin rash.
• Neck pain, muscle fatigue.
• Kidney problems including acute kidney failure, urinary disorders, urinating more often 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.
• Impotence, decreased sexual desire in men or women, increased male breast tissue (gynecomastia).
• Increased body temperature/fever (pyrexia).
• Feeling of discomfort (general malaise).
• Weight gain or loss.

Rare: May Affect Up to 1 in 1,000 People

• 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 disorders.
• Nerve disorders that can cause weakness, tingling, or numbness (peripheral neuropathy).
• Redness, itching, swelling, or tearing of the eyes (conjunctivitis).
• Hearing impairment.
• Narrowing of blood vessels (vascular stenosis).
• Alteration of blood flow (hypoperfusion).
• Inflammation of blood vessels (vasculitis).
• Red and swollen tongue (glossitis).
• Cholestasis.
• Nail problems, such as weakness or separation of the nail from its bed (onycholysis).
• Muscle disorders: myopathy, myositis.
• Tendon disorders, 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.
• Gingival hyperplasia.
• Liver failure.
• Sensitivity to light or sun (photosensitivity).

Frequency Not Known: Frequency Cannot Be Estimated from Available Data

• Blood tests showing very few red and white blood cells and platelets (pancytopenia).
• Blood tests showing too many damaged red blood cells (hemolytic anemia).
• Increased antinuclear antibodies.
• Concentrated urine (dark color), feeling of discomfort or nausea, muscle cramps, confusion, and convulsions that may be due to inadequate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible.
• Decreased sodium in the blood.
• Attention disorder.
• Psychomotor impairment.
• Burning sensation.
• Change in the way things smell (parosmia).
• Tremors, rigid posture, "mask-like" face, slow movements, and unsteady gait (extrapyramidal disorder).
• Fingers on hands and feet change color (pale) when cold and then tingle or hurt when warm (Raynaud's phenomenon).
• Inflammation of the oral mucosa with small ulcers (aphthous stomatitis).
• Grainy skin (pemphigus).
• Skin inflammation (psoriasiform dermatitis), acute skin rash (pemphigoid or lichenoid exanthema), worsening of skin scaling or skin scaling (psoriasis aggravation), mucosal eruption (enanthema).
• Constant muscle weakness (immune-mediated necrotizing myopathy).

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

• Sexual difficulties.
• Depression.
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.
• Diabetes. This is more likely if you have high sugar and fat levels in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tricual

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions. Keep in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging and blister, after EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tricual

• The active ingredients are atorvastatin (as atorvastatin calcium trihydrate), amlodipine (as amlodipine besylate), and ramipril.

Tricual 10 mg/5 mg/5 mg tablets:

Each tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate), 5 mg amlodipine (as amlodipine besylate), 5 mg ramipril.

Tricual 20 mg/5 mg/5 mg tablets

Each tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate), 5 mg amlodipine (as amlodipine besylate), 5 mg ramipril.

Tricual 20 mg/5 mg/10 mg tablets

Each tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate), 5 mg amlodipine (as amlodipine besylate), 10 mg ramipril.

Tricual 20 mg/10 mg/10 mg tablets

Each tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate), 10 mg amlodipine (as amlodipine besylate), 10 mg ramipril.

Tricual 40 mg/10 mg/10 mg tablets

Each tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate), 10 mg amlodipine (as amlodipine besylate), 10 mg ramipril.

Other Components

• The other components are microcrystalline cellulose, lactose monohydrate, pregelatinized starch, calcium carbonate, sodium croscarmellose, glycerol dibehenate, hypromellose, hydroxypropylcellulose, polysorbate 80, and sodium fumarate and stearate.

Appearance of the Product and Package Contents

Tricual 10 mg/5 mg/5 mg tablets:

Tablets are white to off-white, round, biconvex, with the letter "A" engraved on one side (approximate dimensions: diameter 8.5 mm).

Tricual 20 mg/5 mg/5 mg tablets:

Tablets are white to off-white, round, biconvex, with the letter "B" engraved on one side (approximate dimensions: diameter 9.9 mm).

Tricual 20 mg/5 mg/10 mg tablets:

Tablets are white to off-white, oval, biconvex, with the letter "C" on one side and "5" on the other (approximate dimensions: 15.5 mm x 8 mm).

Tricual 20 mg/10 mg/10 mg tablets:

Tablets are white to off-white, oval, biconvex, with the letter "D" on one side and "10" on the other (approximate dimensions: 15.5 mm x 8 mm).

Tricual 40 mg/10 mg/10 mg tablets:

Tablets are white to off-white, oval, biconvex, with the letter "E" engraved on one side (approximate dimensions: 16.8 mm x 8 mm).

Packaging with 10, 14, 28, 30 tablets packaged in OPA/Aluminum/PVC blister packs covered with an aluminum foil sheet in a cardboard box.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios BIAL, S.A.

C/ Alcalá 265, Edificio 2, Planta 2ª

28027 Madrid

Spain

Manufacturer

Bluepharma Industria Farmaceutica S.A.

Sao Martinho Do Bispo

3045-016 Coimbra

Portugal

This Medication is Authorized in the Member States of the European Economic Area with the Following Names:

Austria and Spain

Tricual 10 mg/5 mg/5 mg tablets

Tricual 20 mg/5 mg/5 mg tablets

Tricual 20 mg/5 mg/10 mg tablets

Tricual 20 mg/10 mg/10 mg tablets

Tricual 40 mg/10 mg/10 mg tablets

Portugal

Polipres 10 mg/5 mg/5 mg tablets

Polipres 20 mg/5 mg/5 mg tablets

Polipres 20 mg/5 mg/10 mg tablets

Polipres 20 mg/10 mg/10 mg tablets

Polipres 40 mg/10 mg/10 mg tablets

Date of the Last Revision of this Leaflet:05/2024.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)