Product Information for the User

Olmesartán/Amlodipino Viatris 40 mg/10 mg Film-Coated Tablets EFG

olmesartán medoxomilo/amlodipino

Read this entire 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 Olmesartán/Amlodipino Viatris is and what it is used for

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

3. How to take Olmesartán/Amlodipino Viatris

4. Possible side effects

5. Storage of Olmesartán/Amlodipino Viatris

6. Contents of the pack and additional information

Olmesartán/Amlodipino Viatris contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besylate). The two substances help control high blood pressure.

• Olmesartan belongs to a group of medicines called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called “calcium channel blockers”. Amlodipine prevents calcium from entering the blood vessel wall, which prevents blood vessel constriction, thereby also decreasing blood pressure.

The action of both substances contributes to preventing blood vessel constriction, so that these vessels relax and blood pressure decreases.

Olmesartán/Amlodipino Viatrisis used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartan or amlodipine alone.

Do not take Olmesartán/Amlodipino Viatris

• If you are allergic to olmesartán, or to amlodipino, or to a group of special calcium channel blockers called dihidropiridinas, or to any of the other components of this medication (listed in section 6).

Inform your doctor before taking Olmesartán/Amlodipino Viatris if you think you may be allergic.

• If you are more than 3 months pregnant. It is best to avoid Olmesartán/Amlodipino Viatris at the beginning of pregnancy (see section “Pregnancy and breastfeeding”).
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskirén.
• If you have severe liver problems, if your bile secretion is altered, or if your bile release is blocked (for example, by gallstones), or if you have jaundice (yellow skin and eyes).
• If you have very low blood pressure.
• If you have inadequate blood flow to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate (shock, including cardiogenic shock). Cardiogenic shock means shock due to severe heart problems.
• If your heart's blood flow is blocked (for example, due to aortic stenosis).
• If you have poor heart function (producing difficulty breathing or peripheral edema) after a heart attack (acute myocardial infarction).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Olmesartán/Amlodipino Viatris.

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) (for example, 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. Your doctor will decide whether to continue treatment. Do not stop takingolmesartán/amlodipinoon your own.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (for example, potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartán/Amlodipino 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 the blood.
• Problems with the adrenal glands (glands that produce hormones located above the kidneys).

Contact your doctor if you experience severe, persistent diarrhea, and significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.

Like any other medication that lowers blood pressure, excessive lowering of blood pressure 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.

Inform your doctor if you are pregnant or think you may be pregnant. Olmesartán/Amlodipino Viatris is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years)

Olmesartán/Amlodipino Viatris is not recommended for children and adolescents under 18 years.

Other medications and Olmesartán/Amlodipino Viatris

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 Viatris.

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

If you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Olmesartán/Amlodipino Viatris” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medications that increase urine elimination(diuretics), orheparin(to thin the blood and prevent blood clots). The use of these medications with Olmesartán/Amlodipino Viatris may elevate potassium levels in the blood.
• Lithium(a medication used to treat mood changes and some types of depression) used at the same time as Olmesartán/Amlodipino Viatris may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in the 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 Viatris may increase the risk of kidney failure. The effect of Olmesartán/Amlodipino Viatris may be reduced by NSAIDs.
• Colesevelam hydrochloride,a medication that lowers cholesterol levels in the blood, as it may reduce the effect of Olmesartán/Amlodipino Viatris. Your doctor may advise you to take Olmesartán/Amlodipino Viatris at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of Olmesartán/Amlodipino Viatris.
• Medications used to treat HIV/AIDS(for example, ritonavir, indinavir, nelfinavir)or fungal infections(for example, ketoconazole, itraconazole).
• Diltiazem, verapamil (medications used to treat heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin (antibiotics), medications used to treat tuberculosis or other infections.
• St. John's Wort(Hypericum perforatum), herbal remedy.
• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, a medication used to lower cholesterol and triglyceride levels in the blood.
• Tacrolimus,sirolimus, temsirolimus, everolimus, andciclosporin,used to control the body's immune response, making it possible for 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 other medication.

Taking Olmesartán/Amlodipino Viatris with food and drinks

Olmesartán/Amlodipino Viatris can be taken with or without food. Take the tablets with a little liquid (such as a glass of water). If possible, take the daily dose at the same time each day, for example, at breakfast time.

People taking Olmesartán/Amlodipino Viatris 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 amlodipino, which may cause an unpredictable increase in the blood pressure-lowering effect of Olmesartán/Amlodipino Viatris.

Older patients

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

Black patients

Like other similar medications, the blood pressure-lowering effect of Olmesartán/Amlodipino Mylan is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you may be pregnant.

Your doctor will advise you to stop taking Olmesartán/Amlodipino Viatris before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of Olmesartán/Amlodipino Viatris. Olmesartán/Amlodipino Viatris is not recommended for use at the beginning of pregnancy, and it should not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used during the third month of pregnancy.

If you become pregnant while taking Olmesartán/Amlodipino Viatris, inform and visit your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to startbreastfeeding.Amlodipino has been shown to pass into breast milk in small amounts.Olmesartán/Amlodipino Viatris is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

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

Driving and operating machines

During blood pressure treatment, you may experience drowsiness, nausea, dizziness, or headaches. If this occurs, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet; it is essentially “sodium-free”.

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 of Olmesartán/Amlodipino Viatris 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 Olmesartán/Amlodipino Viatris 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 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 difficulty breathing that may develop up to 24-48 hours after ingestion.

If you take more tablets than you should or a child accidentally ingests some tablets, 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 the Toxicological Information Service. Phone 91 562 04 20.

If you forget to take Olmesartán/Amlodipino 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 Viatris

It is essential to continue taking Olmesartán/Amlodipino Viatris, 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 number of people:

During treatment with Olmesartán/Amlodipino Viatris, allergic reactions may occur, which can affect the entire body, with inflammation of the face, mouth, and/or larynx (vocal cords), along with pruritus and skin rash.If this happens, stop taking Olmesartán/Amlodipino Viatris and consult your doctor immediately.

Olmesartán/Amlodipino Viatris can cause a pronounced drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This can cause severe dizziness or fainting.If this happens, stop taking Olmesartán/Amlodipino Viatris, consult your doctor immediately, and remain lying down in a horizontal position.

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

Other possible side effects with Olmesartán/Amlodipino Viatris:

Frequent (can affect up to 1 in 10 people):

Dizziness; headache; swelling of the ankles, feet, legs, hands, or arms; fatigue.

Infrequent (can affect up to 1 in 100 people):

Dizziness when standing up; lack of energy; tingling or numbness of the hands or feet; vertigo; feeling heartbeats; rapid heartbeats; low blood pressure with symptoms such as dizziness, fainting; difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; abdominal pain; skin rash; cramps; arm and leg pain; back pain; sensation of urgency to urinate; sexual inactivity; inability to achieve or maintain an erection; weakness.

Also, some changes have been observed in the results of certain blood tests:

Increased, as well as decreased, levels of potassium in the blood, increased levels of creatinine in the blood, increased levels of uric acid, increased values of liver function tests (gamma-glutamyl transferase levels).

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

Medication hypersensitivity; fainting; flushing and sensation of heat in the face; red itchy rash (urticaria); facial inflammation.

Side effects reported with the use of olmesartan medoxomil or amlodipine alone, but not with Olmesartán/Amlodipino Viatris, or with a higher frequency:

Olmesartan medoxomil

Frequent (can affect up to 1 in 10 people):

Bronchitis; sore throat; congestion and nasal secretion; cough; abdominal pain; viral gastroenteritis; diarrhea; indigestion; nausea; joint and bone pain; back pain; blood in the urine; urinary tract infection; chest pain; flu-like symptoms; pain. Changes in blood test results, such as increased levels of a type of fat (hypertriglyceridemia); increased uric acid and urea in the blood, and increased values of liver and muscle function tests.

Infrequent (can affect up to 1 in 100 people):

Reduction in the number of a type of blood cell, called platelets, which can cause easy bruising or prolong bleeding time; rapid allergic reactions, which can affect the entire body and cause respiratory problems, as well as rapid drop in blood pressure, which can even cause fainting (anaphylactic reactions);angina (chest pain or discomfort, known as angina pectoris); itching;skin rash; allergic skin rash;urticaria rash;facial swelling;muscle pain;discomfort.

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

Facial, mouth, and/or laryngeal (vocal cord) inflammation; acute renal failure and renal insufficiency;lethargy,intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Amlodipine

Very frequent (can affect more than 1 in 10 people):

Edema (fluid retention).

Frequent (can affect up to 1 in 10 people):

Abdominal pain; nausea; swelling of the ankles; feeling sleepy; flushing and sensation of heat in the face, visual disturbances (including double vision and blurred vision), feeling heartbeats, diarrhea, constipation, indigestion, cramps, weakness, difficulty breathing.

Infrequent (can affect up to 1 in 100 people):

Difficulty sleeping; sleep disorders; mood changes, including anxiety;depression;irritability;shakiness;alterations in taste; fainting;ringing in the ears(tinnitus);emergenceofangina pectoris(chest pain or discomfort); irregular heartbeat;nasal secretion or congestion; hair loss;purple spotsor patcheson the skin due to small hemorrhages(purpura);skin discoloration;excessive sweating;skin rash; itching; red itchy rash (urticaria);joint or muscle pain;urinary problems;need to urinate at night;increased need to urinate,enlargement of the breastsin men,chest pain;pain; feeling unwell;weight gain or loss.

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

Confusion.

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

Reduction in the number of white blood cells, which could increase the risk of infections; reduction in the number of a type of blood cell called platelets, which could cause bruising and prolong bleeding time; increased glucose in the blood; increased muscle tension or increased resistance to passive movement (hypertonia);tingling or numbness of the hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach wall; gum thickening; elevated liver enzymes; yellow skin and eyes; increased skin sensitivity to light; severe allergic reactions, itching, rash, facial, mouth, and/or laryngeal (vocal cord) inflammation, along with itching and rash, severe skin reactions, including intense skin rash, urticaria, skin redness, severe itching, blisters, peeling, and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis),sometimes very severe.

Unknown frequency (cannot be estimated from available data):

Tremors, rigid posture, mask-like face, slow movements, and unsteady gait dragging the feet.

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 Vigilance 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 usethis medicationafter the expiration date that appears onthe packagingafter CAD or EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofOlmesartán/Amlodipino Viatris

The active principles are olmesartan and amlodipine (as amlodipine besylate).

Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besylate).

The other components are:

Tablet core:

microcrystalline cellulose (E-460i), sodium lauryl sulfate (E-487), citric acid monohydrate (E-330), hydroxypropyl cellulose (E-463), sodium croscarmellose (E-466), maltose, mannitol (E-421), hydroxypropyl cellulose of low substitution (E-463), magnesium stearate (E-572).

Tablet coating (Opadry II Brown 85F565125):

partially hydrolyzed polyvinyl alcohol (E-1203), titanium dioxide (E-171), macrogol/PEG (E-1521), talc (E-553b), yellow iron oxide (E-172), red iron oxide (E-172).

Product appearance and packaging contents

Olmesartán/Amlodipino Viatris are brown film-coated tablets, round, biconvex, marked with "M" on one face and "OA3" on the other.

PVC/Alu/OPA-Alu blister pack containing 28 film-coated tablets.

PVC/Alu/OPA-Alu calendar blister pack containing 28 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories T/A Mylan Dublin

Unit 35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13, D17 XC99, Ireland

Mylan Hungary Kft.

H-2900Komárom

Mylan útca 1

Hungary

Last review date of this leaflet:February 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/