Package Leaflet: Information for the User

Olmesartán/Amlodipino/Hidroclorotiazida Viatris 20 mg/5 mg/12,5 mg Film-Coated Tablets

Olmesartán/Amlodipino/Hidroclorotiazida Viatris 40 mg/5 mg/12,5 mg Film-Coated Tablets

Olmesartán/Amlodipino/Hidroclorotiazida Viatris 40 mg/5 mg/25 mg Film-Coated Tablets

Olmesartán/Amlodipino/Hidroclorotiazida Viatris 40 mg/10 mg/12,5 mg Film-Coated Tablets

Olmesartán/Amlodipino/Hidroclorotiazida Viatris 40 mg/10 mg/25 mg Film-Coated Tablets

olmesartán medoxomilo/amlodipino/hidroclorotiazida

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Olmesartán/Amlodipino/Hidroclorotiazida Viatris and what it is used for

2.What you need to know before taking Olmesartán/Amlodipino/Hidroclorotiazida Viatris

3.How to take Olmesartán/Amlodipino/Hidroclorotiazida Viatris

4.Possible side effects

5.Storage of Olmesartán/Amlodipino/Hidroclorotiazida Viatris

6.Contents of the pack and additional information

This medication contains three active substances called olmesartan medoxomil, amlodipine (as amlodipine besylate) and hydrochlorothiazide. The three substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medications called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medications called “calcium channel blockers”. Amlodipine also decreases blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medications called thiazide diuretics. It decreases blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

The action of these substances contributes to lowering blood pressure. Olmesartán/amlodipino/hidroclorotiazida Viatris is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled with the combination of olmesartan medoxomil and amlodipine, taken as a fixed-dose combination, or
• in patients already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide, along with tablets containing only amlodipine, or a fixed-dose combination of olmesartan medoxomil and amlodipine, along with tablets containing only hydrochlorothiazide.

Do not take Olmesartán/Amlodipino/Hidroclorotiazida Viatris

• If you are allergic to olmesartan medoxomil, amlodipine, or a group of calcium channel blockers (dihydropyridines), to hydrochlorothiazide or to substances similar to hydrochlorothiazide (sulfonamides), or to any of the other components of this medication (listed in section 6).
• If you think you may be allergic, inform your doctor before taking olmesartán/amlodipino/hidroclorotiazida.
• If you have severe kidney problems.
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure medication that contains aliskirén.
• 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, that do not improve with treatment.
• If you are more than 3 months pregnant. (It is also best to avoid olmesartán/amlodipino/hidroclorotiazida at the beginning of pregnancy - see section “Pregnancy and breastfeeding”).
• If you have severe liver problems, bile secretion problems, or obstruction of bile duct drainage from the gallbladder (e.g., due to gallstones), or have jaundice (yellow skin and eyes).
• If you have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate, or shock (including cardiogenic shock, which means shock due to severe heart problems).
• If you have very low blood pressure.
• If the blood flow to your heart is slow or blocked. This can occur if the blood vessels or heart valves that capture blood from the heart become narrowed (aortic stenosis).
• If you have low cardiac output after a heart attack (acute myocardial infarction). Low cardiac output can make you feel short of breath or have swelling in your feet and ankles.

Do not take olmesartán/amlodipino/hidroclorotiazida if any of these cases occur.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartán/Amlodipino/Hidroclorotiazida Viatris if you:

• Have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Olmesartán/Amlodipino/Hidroclorotiazida Viatris, see your doctor immediately.

Tell your doctorif you are taking any of the following medications used to treat high blood pressure (hypertension):

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after takingolmesartán/amlodipino/hidroclorotiazida. Your doctor will decide whether to continue treatment. Do not stop takingolmesartán/amlodipino/hidroclorotiazidaon your own.

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

See also the information under the heading “Do not take Olmesartán/Amlodipino/Hidroclorotiazida Viatris”.

Tell your doctorif you have any of the following health problems:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Intense vomiting, diarrhea, treatment with high doses of medications that increase urine elimination (diuretics), or if you are on a low-sodium diet.
• Elevated potassium levels in your blood.
• Problems with the adrenal glands (glands that produce hormones located above the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Skin reactions such as sunburn or rash after being in the sun or in a tanning bed.
• If you have had skin cancer or if a skin lesion appears unexpectedly during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking this medication.

Contact your doctorif you experience any of the following symptoms:

• Severe, persistent diarrhea that causes 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 may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage)or increased eye pressure, which can occur from a few hours to several weeks after taking olmesartán/amlodipino/hidroclorotiazida. This can lead to permanent vision loss if not treated.

Like any other medication that lowers blood pressure, excessive blood pressure reduction in patients with heart or brain blood flow abnormalities can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

Olmesartán/amlodipino/hidroclorotiazida may cause an increase in lipid and uric acid levels in your blood. Your doctor will likely want to perform blood tests from time to time to monitor these possible changes.

You may experience changes in the levels of certain substances in your blood called electrolytes. Your doctor will likely want to perform blood tests from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

If you are undergoing parathyroid function tests, you should stop taking olmesartán/amlodipino/hidroclorotiazida before the tests are performed.

Information for athletes

It is reported to athletes that this medication contains a component that can result in a positive analytical control for doping as positive.

Inform your doctor if you are pregnant (or think you might be). Do not use olmesartán/amlodipino/hidroclorotiazida at the beginning of pregnancy, and do not take it if you are more than 3 months pregnant, as it can cause severe harm to your baby if taken at this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years)

Olmesartán/amlodipino/hidroclorotiazida is not recommended for use in children and adolescents under 18 years.

Taking Olmesartán/Amlodipino/Hidroclorotiazida Viatris with other medications

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

• Other blood pressure-lowering medications, as they may increase the effect of olmesartán/amlodipino/hidroclorotiazida.

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

• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskirén (see also the information under the headings “Do not take Olmesartán/Amlodipino/Hidroclorotiazida Viatris” and “Warnings and precautions”).
• Thelithium(medication used to treat mood changes and some types of depression) if used at the same time as olmesartán/amlodipino/hidroclorotiazida may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in your blood.
• Diltiazem,verapamil,used for heart rhythm and high blood pressure problems.
• Rifampicin,erythromycin, clarithromycin, tetracyclines, or ciprofloxacin,antibiotics used for tuberculosis and other infections.
• St. John's Wort(Hypericum perforatum), herbal remedy for depression treatment.
• Cisapride, used to increase stomach and intestinal movement.
• Difemanil, used for slow heart rate or to 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, salt substitutes containing potassium, medications that increase urine elimination(diuretics),heparin(to thin the blood and prevent blood clots), ACE inhibitors (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (medication for mouth and stomach ulcers), penicillin G sodium (antibiotic also called benzylpenicillin sodium), some pain relievers such as aspirin or salicylates. Using these medications at the same time as olmesartán/amlodipino/hidroclorotiazida may alter potassium levels in your blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs)(medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartán/amlodipino/hidroclorotiazida may increase the risk of kidney failure. The effect of olmesartán/amlodipino/hidroclorotiazida may be reduced by NSAIDs. High doses of salicylates may increase the toxic effect on the central nervous system.
• Sedatives, hypnotics, and antidepressants, used with olmesartán/amlodipino/hidroclorotiazida may cause a sudden drop in blood pressure when standing.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartán/amlodipino/hidroclorotiazida. Your doctor may advise you to take olmesartán/amlodipino/hidroclorotiazida at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of olmesartán/amlodipino/hidroclorotiazida.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medications, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, used to lower cholesterol and triglyceride levels in the blood.
• Medications used to control the body's immune response(e.g., tacrolimus, cyclosporine), which allows your body to accept the transplanted organ.

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

• Treating certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• Treating low blood sugar(e.g., diazoxide) orhigh blood pressure(e.g., beta-blockers, methyldopa), as olmesartán/amlodipino/hidroclorotiazida may affect the mechanism of action of these medications.
• 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 digital.
• Treating cancer, such as amifostine, cyclophosphamide, or methotrexate.
• Increasing blood pressureanddecreasing heart rate, such as norepinephrine.
• Treating gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Lowering cholesterol levels in the blood, such as cholestyramine and colestipol.
• Lowering blood sugar levels, such as metformin or insulin.

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

Taking Olmesartán/Amlodipino/Hidroclorotiazida Viatris with food and drinks

This medication can be taken with or without food.

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

Be careful when drinking alcohol while taking this medication, as some people may feel dizzy, nauseous, or experience headaches. If this happens, do not drink any alcohol.

Older patients

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, or if you think you might be. Your doctor will advise you to stop taking olmesartán/amlodipino/hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of olmesartán/amlodipino/hidroclorotiazida. Do not use this medication during pregnancy, and do not take it if you are more than 3 months pregnant, as it can cause severe harm to your baby if used from the third month of pregnancy.

If you become pregnant while taking olmesartán/amlodipino/hidroclorotiazida, inform and see your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. Do not use this medication in mothers who are breastfeeding, and your doctor may choose another treatment if you want to breastfeed.

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

Driving and operating machinery

You may feel drowsy, nauseous, or experience headaches while taking this medication for high blood pressure. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

Olmesartán/Amlodipino/Hidroclorotiazida Viatris contains lactose

If your doctor has informed you that you have intolerance to certain sugars, contact them before taking this medication.

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

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

If you take more Olmesartán/Amlodipino/Hidroclorotiazida 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 a rapid or slow heart rate.

Excess fluid may accumulate in the lungs (pulmonary edema) causing breathing difficulties that may develop up to 24-48 hours after ingestion.

If you take more tablets than you should or if a child accidentally ingests a tablet, contact your doctor immediately or go to the nearest emergency center and bring the medication packaging or this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Olmesartán/Amlodipino/Hidroclorotiazida Viatris

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

If you interrupt treatment with Olmesartán/Amlodipino/Hidroclorotiazida Viatris

It is essential to continue taking this medication, unless your doctor tells you to stop treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If they occur, they are often mild and do not require interrupting treatment.

The following side effects can be serious, although they may affect only a small group of people:

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

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

Unknown frequency: If you experience yellowish discoloration of the whites of the eyes, dark urine, skin itching, even if you started treatment withOlmesartan/Amlodipine/Hydrochlorothiazide Viatrissome time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

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

To give you an idea of the number of patients who may experience side effects, they have been classified as frequent, infrequent, rare, and very rare.

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

If these side effects occur, they are often mild andit is not necessary to interrupt treatment.

Frequent(may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat, and runny nose, urinary tract infection, dizziness, headache, perception of heartbeats, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, sensation of urgency to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test results.

Infrequent(may affect up to 1 in 100 people)

Dizziness when standing up, vertigo, rapid heartbeat, sensation of fainting, flushing and sensation of heat in the face, cough, dry mouth, muscle weakness, inability to have or maintain an erection.

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

They may be side effects due to olmesartan/amlodipine/hydrochlorothiazide, even if they have not been observed so far with olmesartan/amlodipine/hydrochlorothiazide.

Frequent(may affect up to 1 in 10 people)

Edema (fluid retention).

Infrequent(may affect up to 1 in 10 people)

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

Infrequent(may affect up to 1 in 100 people)

Reduced number of a type of blood cell, called platelets, which can cause easy bruising or prolong bleeding time, anaphylactic reactions, abnormal decrease in appetite (anorexia), sleep problems, irritability, mood changes including anxiety, sensation of depression, chills, sleep disorders, alteration of taste, loss of consciousness, decreased sense of touch, sensation of numbness, worsening of myopia, ringing in the ears (tinnitus), angina (chest pain or discomfort), irregular heartbeat, rash, hair loss, allergic skin inflammation, skin redness, purple patches or spots on the skin due to small hemorrhages (purpura), skin discoloration, red itchy patches (urticaria), increased sweating, pruritus, skin rash, skin reactions to light, such as sunburn or skin eruption, muscle pain, urination problems, sensation of needing to urinate at night, breast enlargement in men, decreased libido, swelling of the face, feeling unwell, weight gain or loss, fatigue.

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

Salivary gland inflammation and pain, 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, sensation of loss of interest (apathy), seizures (convulsions), yellowish perception of objects when looking at them, dry eyes, blood clots (thrombosis, embolism), fluid accumulation in the lungs, pneumonia, inflammation of small blood vessels and skin blood vessels, pancreatitis, yellowish discoloration of the skin and eyes, acute inflammation of the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, severe skin reactions including intense skin eruption, urticaria, skin redness, severe itching, blisters, skin peeling, and inflammation, Stevens-Johnson syndrome, toxic epidermal necrolysis, sometimes very severe, movement impairment, acute kidney failure, non-infectious kidney inflammation, decreased kidney function, fever,intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion), high muscle tension, numbness of hands or feet, heart attack, stomach inflammation, gum thickening, intestinal obstruction, liver inflammation.

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 hemorrhage) oracute angle-closure glaucoma). Tremors, rigid posture, mask-like face, slow movements, and unsteady gait dragging the feet.

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

Reporting of 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 System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Olmesartan/Amlodipine/Hydrochlorothiazide Viatris

The active ingredients are olmesartan medoxomil, amlodipine (as amlodipine besylate), and hydrochlorothiazide.

• Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 20mg/5mg/12,5mg: Each film-coated tablet contains 20mg of olmesartan medoxomil, 5mg of amlodipine (in the form of besylate), and 12,5mg of hydrochlorothiazide.
• Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40mg/5mg/12,5mg: Each film-coated tablet contains 40mg of olmesartan medoxomil, 5mg of amlodipine (in the form of besylate), and 12,5mg of hydrochlorothiazide.
• Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40mg/5mg/25mg: Each film-coated tablet contains 40mg of olmesartan medoxomil, 5mg of amlodipine (in the form of besylate), and 25mg of hydrochlorothiazide.
• Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40mg/10mg/12,5mg: Each film-coated tablet contains 40mg of olmesartan medoxomil, 10mg of amlodipine (in the form of besylate), and 12,5mg of hydrochlorothiazide.
• Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40mg/10mg/25mg: Each film-coated tablet contains 40mg of olmesartan medoxomil, 10mg of amlodipine (in the form of besylate), and 25mg of hydrochlorothiazide.

The other components are:

• Core of the tablet: Povidone; pregelatinized cornstarch; microcrystalline cellulose; anhydrous colloidal silica; lactose monohydrate; magnesium stearate.

Coating of the tablet: Polyvinyl alcohol (E1203); titanium dioxide (E171); macrogol (E1521); talc (E553b); yellow iron oxide (E172); black iron oxide (E172) (only in 20mg/5mg /12,5mg film-coated tablets); red iron oxide (E172) (only in 20mg/5mg/12,5mg, 40mg/10mg 12,5mg, 40mg/10mg/25mg film-coated tablets)

Appearance of the product and contents of the package

The EFG film-coated tablets of Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 20mg/5mg/12,5mg are white to light orange in color, approximately 8,00mm in diameter, round, with a bisected edge, with the inscription “OC1” on one face and smooth on the other face.

The EFG film-coated tablets of Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40mg/5mg/12,5mg are light yellow in color, approximately 9,50mm in diameter, round, with a bisected edge, with the inscription “OC2” on one face and smooth on the other face.

The EFG film-coated tablets of Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40mg/5mg/25mg are light yellow in color, approximately 15,00mm in length and 7,00mm in width, oval, with a bisected edge, with the inscription “OC3” on one face and smooth on the other face.

The EFG film-coated tablets of Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40mg/10mg/12,5mg are terracotta in color, approximately 9,50mm in diameter, round, with a bisected edge, with the inscription “OC4” on one face and smooth on the other face.

The EFG film-coated tablets of Olmesartan/Amlodipine/Hydrochlorothiazide Viatris 40mg/10mg/25mg are terracotta in color, approximately 15,00mm in length, 7,00mm in width, oval, with a bisected edge, with the inscription “OC5” on one face and smooth on the other face.

Aluminum blisters – aluminum containing:

28 film-coated tablets

28× 1 film-coated tablet

98 film-coated tablets

98× 1 film-coated tablet

in a cardboard box.

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

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 more information about this medicine, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:January 2025

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).