Olmesartan/amlodipine/hydrochlorothiazide Viatris 40 mg/10 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 20 mg/5 mg/12.5 mg film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40 mg/5 mg/12.5 mg film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40 mg/5 mg/25 mg film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40 mg/10 mg/12.5 mg film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40 mg/10 mg/25 mg film-coated tablets EFG

olmesartan medoxomil/amlodipine/hydrochlorothiazide

Read the entire leaflet carefully before you start using 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Olmesartan/Amlodipine/Hydrochlorothiazide Viatris is and what it is used for
2. What you need to know before taking Olmesartan/Amlodipine/Hydrochlorothiazide Viatris
3. How to take Olmesartan/Amlodipine/Hydrochlorothiazide Viatris
4. Possible side effects
5. How to store Olmesartan/Amlodipine/Hydrochlorothiazide Viatris
6. Contents of the pack and other information

1. What Olmesartan/Amlodipine/Hydrochlorothiazide Viatris is and what it is used for

This medicine contains three active substances: olmesartan medoxomil, amlodipine (as amlodipine besilate), and hydrochlorothiazide. These three substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called "angiotensin II receptor antagonists", which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called "calcium channel blockers". Amlodipine also lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

The combined action of these substances helps reduce your blood pressure. Olmesartan/Amlodipine/Hydrochlorothiazide Viatris is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled with a fixed-dose combination of olmesartan medoxomil and amlodipine, or
• in adult patients who are already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide together with tablets containing amlodipine alone, or a fixed-dose combination of olmesartan medoxomil and amlodipine together with tablets containing hydrochlorothiazide alone.

2. What you need to know before taking Olmesartan/Amlodipine/Hydrochlorothiazide Viatris

Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Viatris

• If you are allergic to olmesartan medoxomil, amlodipine, or a special group of calcium channel blockers (dihydropyridines), hydrochlorothiazide, or substances similar to hydrochlorothiazide (sulfonamides), or to any of the other components of this medicine (listed in section 6).
• If you think you may be allergic, inform your doctor before taking olmesartan/amlodipine/hydrochlorothiazide.
• If you have severe kidney problems.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have low levels of potassium or sodium in your blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in your blood, which do not improve with treatment.
• If you are more than 3 months pregnant. (It is also advisable to avoid olmesartan/amlodipine/hydrochlorothiazide early in pregnancy – see section “Pregnancy and breastfeeding”).
• If you have severe liver problems, bile secretion disorders, or obstruction of bile drainage from the gallbladder (e.g., due to gallstones), or have jaundice (yellowing of the skin and eyes).
• If you have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, meaning shock due to serious heart problems).
• If your blood pressure is very low.
• If blood flow from your heart is slow or blocked. This may occur if blood vessels or heart valves that carry blood away from the heart are narrowed (aortic stenosis).
• If you have low cardiac output following a heart attack (acute myocardial infarction). Low cardiac output may make you feel short of breath or have swelling in your feet and ankles.

Do not take olmesartan/amlodipine/hydrochlorothiazide if any of these apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting Olmesartan/Amlodipine/Hydrochlorothiazide Viatris if you:

• Have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Olmesartan/Amlodipine/Hydrochlorothiazide Viatris, seek medical attention immediately.

Tell your doctor if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking olmesartan/amlodipine/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking olmesartan/amlodipine/hydrochlorothiazide on your own.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Viatris”.

Tell your doctor if you have any of the following health conditions:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medicines that increase urine output (diuretics), or if you are on a low-salt diet.
• High levels of potassium in your blood.
• Problems with your adrenal glands (hormone-producing glands located above the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Skin reactions such as sunburns or rash after sun exposure or use of tanning beds.
• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking this medicine.

Contact your doctor if you experience any of the following symptoms:

• Severe, persistent diarrhea causing significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.
• Decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from hours to weeks after taking olmesartan/amlodipine/hydrochlorothiazide. This may lead to permanent vision loss if not treated.

As with any other medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

Olmesartan/amlodipine/hydrochlorothiazide may cause increased levels of lipids and uric acid (which causes gout – painful joint swelling) in the blood. Your doctor may want to perform blood tests periodically to monitor these potential changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor may want to perform blood tests periodically to monitor this possible change. Some signs of electrolyte imbalances are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, drowsy, restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

If you are scheduled for parathyroid function tests, you should stop taking olmesartan/amlodipine/hydrochlorothiazide before the tests are performed.

Information for athletes

Athletes should be aware that this medicine contains a component that may result in a positive analytical finding in doping control tests.

Inform your doctor if you are pregnant (or think you might be). Use of olmesartan/amlodipine/hydrochlorothiazide is not recommended early in pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years of age)

Use of olmesartan/amlodipine/hydrochlorothiazide is not recommended in children and adolescents under 18 years of age.

Taking Olmesartan/Amlodipine/Hydrochlorothiazide Viatris with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines:

• Other blood pressure-lowering medicines, as they may increase the effect of olmesartan/amlodipine/hydrochlorothiazide.

Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Viatris” and “Warnings and precautions”).
• Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used together with olmesartan/amlodipine/hydrochlorothiazide. If you must take lithium, your doctor will monitor lithium blood levels.
• Diltiazem, verapamil, used for heart rhythm problems and high blood pressure.
• Rifampicin, erythromycin, clarithromycin, tetracyclines or sparfloxacin, antibiotics used for tuberculosis and other infections.
• St. John’s wort (Hypericum perforatum), a herbal remedy for depression.
• Cisapride, used to increase movement of food through the stomach and intestines.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve blood circulation in the nervous system.
• Amantadine, used for Parkinson’s disease.
• Potassium supplements, potassium-containing salt substitutes, medicines that increase urine output (diuretics), heparin (to thin the blood and prevent blood clots), angiotensin-converting enzyme (ACE) inhibitors (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine for mouth and stomach ulcers), sodium penicillin G (an antibiotic also called sodium benzylpenicillin), some painkillers such as acetylsalicylic acid (“aspirin”) or salicylates. Using these medicines together with olmesartan/amlodipine/hydrochlorothiazide may alter potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with olmesartan/amlodipine/hydrochlorothiazide, may increase the risk of kidney failure. The effect of olmesartan/amlodipine/hydrochlorothiazide may be reduced by NSAIDs. High doses of salicylates may increase the toxic effect on the central nervous system.
• Sleep-inducing medicines, sedatives, and antidepressants, when used with olmesartan/amlodipine/hydrochlorothiazide, may cause a sudden drop in blood pressure when standing up.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of olmesartan/amlodipine/hydrochlorothiazide. Your doctor may advise you to take olmesartan/amlodipine/hydrochlorothiazide at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion and heartburn), as they may slightly reduce the effect of olmesartan/amlodipine/hydrochlorothiazide.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene (by infusion for serious body temperature abnormalities).
• Simvastatin, used to lower cholesterol and fat (triglyceride) levels in the blood.
• Medicines used to control the body’s immune response (e.g., tacrolimus, cyclosporine), which help the body accept a transplanted organ.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines for:

• Treating certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• Treating low blood sugar (e.g., diazoxide) or high blood pressure (e.g., beta-blockers, methyldopa), since olmesartan/amlodipine/hydrochlorothiazide may affect the mechanism of action of these medicines.
• Treating heart rhythm problems, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections.
• Treating HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir).
• Treating fungal infections (e.g., ketoconazole, itraconazole, amphotericin).
• Treating heart problems, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis.
• Treating cancer, such as amifostine, cyclophosphamide, or methotrexate.
• Increasing blood pressure and decreasing heart rate, such as noradrenaline.
• Treating gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Lowering blood fat levels, such as colestyramine and colestipol.
• Lowering blood sugar levels, such as metformin or insulin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Taking Olmesartan/Amlodipine/Hydrochlorothiazide Viatris with food and drinks

This medicine can be taken with or without food.

People taking olmesartan/amlodipine/hydrochlorothiazide should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of olmesartan/amlodipine/hydrochlorothiazide.

Be cautious when drinking alcohol while taking this medicine, as some people may feel faint or dizzy. If this happens, avoid alcohol.

Elderly patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure each time your dose is increased, to ensure your blood pressure does not drop too much.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking olmesartan/amlodipine/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of this medicine is not recommended during pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

If you become pregnant while being treated with olmesartan/amlodipine/hydrochlorothiazide, inform and see your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. This medicine is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may feel drowsy, unwell, dizzy, or have a headache while being treated for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartan/Amlodipine/Hydrochlorothiazide Viatris contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Olmesartan/Amlodipine/Hydrochlorothiazide Viatris

Follow exactly the instructions for use of this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet per day.
• The tablets can be taken with or without food. Swallow the tablets with some liquid (such as a glass of water). Do not chew the tablet. Do not take the tablets with grapefruit juice.
• If possible, take your daily dose at the same time each day, for example at breakfast time.

If you take more Olmesartan/Amlodipine/Hydrochlorothiazide Viatris than you should

If you take more tablets than you should, you are likely to experience a drop in blood pressure, accompanied by symptoms such as dizziness, and fast or slow heartbeat.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop 24–48 hours after ingestion.

If you take more tablets than you should, or if a child accidentally swallows any tablets, contact your doctor immediately or go to the nearest emergency department, and take the medicine packaging or this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Poison Information Service at telephone number 91 562 04 20.

If you forget to take Olmesartan/Amlodipine/Hydrochlorothiazide Viatris

If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Olmesartan/Amlodipine/Hydrochlorothiazide Viatris

It is important to continue taking this medicine unless your doctor tells you to stop.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If they do occur, they are often mild and do not require stopping treatment.

The following adverse effects may be serious, although they affect only a small number of people:

During treatment with olmesartan/amlodipine/hydrochlorothiazide, allergic reactions may occur, with swelling of the face, mouth and/or larynx (vocal cords), together with itching and skin rash. If this happens to you, stop taking this medicine and consult your doctor immediately.

Olmesartan/amlodipine/hydrochlorothiazide may cause a marked drop in blood pressure in susceptible patients. This may lead to fainting or severe dizziness. If this happens to you, stop taking this medicine, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with Olmesartan/Amlodipine/Hydrochlorothiazide Viatris some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

Olmesartan/amlodipine/hydrochlorothiazide is a combination of three active substances. The information below first describes the adverse effects reported so far with the combination olmesartan/amlodipine/hydrochlorothiazide (in addition to those already mentioned), and secondly, the known adverse effects of each active substance individually, or when two of the substances are taken together.

To give you an idea of how many patients may experience adverse effects, these have been classified as very common, common, uncommon, rare, and very rare.

These are other known adverse effects reported so far with olmesartan/amlodipine/hydrochlorothiazide:

If these effects occur, they are often mild and you do not need to stop treatment.

Common (may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat and nasal symptoms, urinary tract infection, dizziness, headache, awareness of heartbeat, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, feeling of urgency to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test results.

Uncommon (may affect up to 1 in 100 people)

Dizziness upon standing, vertigo, rapid heartbeat, feeling faint, flushing and sensation of warmth in the face, cough, dry mouth, muscle weakness, inability to achieve or maintain an erection.

These are the known adverse effects for each of the active substances individually or when two of the substances are taken together:

These may be adverse effects due to olmesartan/amlodipine/hydrochlorothiazide, even if they have not yet been observed with olmesartan/amlodipine/hydrochlorothiazide.

Very common (may affect more than 1 in 10 people)

Edema (fluid retention).

Common (may affect up to 1 in 10 people)

Bronchitis, stomach and intestinal infection, vomiting, increased blood glucose, glucose in urine, confusion, drowsiness, visual disturbances (including double vision and blurred vision), nasal discharge or congestion, sore throat, difficulty breathing, cough, abdominal pain, heartburn, stomach discomfort, flatulence, joint or bone pain, back pain, bone pain, blood in urine, flu-like symptoms, chest pain, pain.

Uncommon (may affect up to 1 in 100 people)

Reduction in the number of a type of blood cells called platelets, which may lead to easy bruising or prolonged bleeding time, anaphylactic reactions, abnormally decreased appetite (anorexia), sleep problems, irritability, mood changes including anxiety, feeling of depression, chills, sleep disorders, altered sense of taste, loss of consciousness, reduced sense of touch, tingling sensation, worsening of myopia, ringing in the ears (tinnitus), angina (chest pain or discomfort, known as angina pectoris), irregular heartbeat, rash, hair loss, allergic skin inflammation, skin redness, purple spots or patches on the skin due to minor bleeding (purpura), skin discoloration, itchy red welts (urticaria), increased sweating, pruritus, skin rash, skin reactions to light such as sunburn or skin eruption, muscle pain, difficulty urinating, feeling of needing to urinate at night, breast enlargement in men, decreased sex drive, facial swelling, feeling of malaise, weight gain or loss, exhaustion.

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

Inflammation and pain of the salivary glands, decreased number of white blood cells in the blood, which could increase the risk of infections, decreased number of red blood cells (anemia), bone marrow damage, restlessness, feeling of loss of interest (apathy), seizures, yellowish perception of objects when looking at them, dry eyes, blood clots (thrombosis, embolism), fluid accumulation in the lungs, pneumonia, inflammation of blood vessels and small blood vessels in the skin, inflammation of the pancreas, yellowing of the skin and eyes, acute inflammation of the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pains, and coldness in hands and fingers, severe skin reactions including intense skin rash, urticaria, redness of the skin of the body, severe itching, blisters, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe, impaired movement, acute renal failure, non-infectious inflammation of the kidney, reduced kidney function, fever, intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion), high muscle tension, numbness of hands or feet, heart attack, stomach inflammation, gum overgrowth, intestinal obstruction, liver inflammation.

Adverse effects with unknown frequency (cannot be estimated from available data)

Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma). Tremors, rigid posture, mask-like face, slow movements, and unbalanced gait with shuffling of the feet.

Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan/Amlodipine/Hydrochlorothiazide Viatris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack following “EXP”. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to your local pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Amlodipine/Hydrochlorothiazide Viatris

The active substances are olmesartan medoxomil, amlodipine (as amlodipine besilate) and hydrochlorothiazide.

• Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 20 mg/5 mg/12.5 mg: Each film-coated tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as besilate) and 12.5 mg of hydrochlorothiazide.
• Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40 mg/5 mg/12.5 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as besilate) and 12.5 mg of hydrochlorothiazide.
• Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40 mg/5 mg/25 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as besilate) and 25 mg of hydrochlorothiazide.
• Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40 mg/10 mg/12.5 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as besilate) and 12.5 mg of hydrochlorothiazide.
• Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40 mg/10 mg/25 mg: Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as besilate) and 25 mg of hydrochlorothiazide.

The other components are:

• Tablet core: Povidone; pregelatinized maize starch; microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate; magnesium stearate.

Film coating: Polyvinyl alcohol (E1203); titanium dioxide (E171); macrogol (E1521); talc (E553b); yellow iron oxide (E172); black iron oxide (E172) (only in film-coated tablets of 20 mg/5 mg/12.5 mg); red iron oxide (E172) (only in film-coated tablets of 20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, 40 mg/10 mg/25 mg).

Appearance of the product and contents of the pack

Film-coated EFG tablets of Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 20 mg/5 mg/12.5 mg are between white and light orange in colour, approximately 8.00 mm in diameter, round, with bevelled edges, marked with "OC1" on one side and plain on the other.

Film-coated EFG tablets of Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40 mg/5 mg/12.5 mg are light yellow in colour, approximately 9.50 mm in diameter, round, with bevelled edges, marked with "OC2" on one side and plain on the other.

Film-coated EFG tablets of Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40 mg/5 mg/25 mg are light yellow in colour, approximately 15.00 mm long and 7.00 mm wide, oval, with bevelled edges, marked with "OC3" on one side and plain on the other.

Film-coated EFG tablets of Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40 mg/10 mg/12.5 mg are terracotta red in colour, approximately 9.50 mm in diameter, round, with bevelled edges, marked with "OC4" on one side and plain on the other.

Film-coated EFG tablets of Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40 mg/10 mg/25 mg are terracotta red in colour, approximately 15.00 mm long, 7.00 mm wide, oval, with bevelled edges, marked with "OC5" on one side and plain on the other.

Aluminium-aluminium blisters containing:

28 film-coated tablets

28 × 1 film-coated tablets

98 film-coated tablets

98 × 1 film-coated tablets

in a cardboard box.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona,
08040 Barcelona, Spain

Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzedz
Poland

Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany	Olmesartan/Amlodipine/HCT Mylan plus 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, 40 mg/5 mg/25 mg, 40 mg/10 mg/25 mg film-coated tablets
Belgium	Olmesartan/Amlodipine/HCT Viatris 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, 40 mg/5 mg/25 mg, 40 mg/10 mg/25 mg film-coated tablets
Cyprus	Olmedipin Plus 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, 40 mg/5 mg/25 mg, 40 mg/10 mg/25 mg film-coated tablets
Spain	Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, 40 mg/5 mg/25 mg, 40 mg/10 mg/25 mg film-coated tablets (EP)
Greece	Olmedipin Plus 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, 40 mg/5 mg/25 mg, 40 mg/10 mg/25 mg film-coated tablets
Italy	Olmesartan / Amlodipine / Hydrochlorothiazide Mylan
Luxembourg	Olmesartan/Amlodipine/HCT Viatris 20 mg/5 mg/12.5 mg, 40 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, 40 mg/5 mg/25 mg, 40 mg/10 mg/25 mg film-coated tablets

Date of the most recent review of this leaflet: January 2025

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