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Patient Information Leaflet: Package Insert

Olmesartan Viatris 40mg Film-Coated Tablets

Olmesartan medoxomil

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 Olmesartan Viatris and what is it used for

2.What you need to know before taking Olmesartan Viatris

3.How to take Olmesartan Viatris

4.Possible side effects

5.Storage of Olmesartan Viatris

6. Contents of the pack and additional information

Olmesartán belongs to a group of medicines known as angiotensin II receptor antagonists. It reduces blood pressure by relaxing blood vessels.

This medicine is used to treat high blood pressure (also known as hypertension) in adults and in children and adolescents from 6 years to less than 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this can lead to a heart attack, heart failure, or kidney failure, stroke, or blindness. High blood pressure usually does not present symptoms. It is essential to control blood pressure to prevent damage.

High blood pressure can be controlled with medicines like Olmesartán Viatris. Your doctor may also have recommended that you make some lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing the amount of alcohol you drink, and reducing the amount of salt in your diet). Your doctor may also recommend that you exercise regularly, such as walking or swimming. It is essential to follow your doctor's advice.

Do not take Olmesartán Viatris:

-If you are allergic to olmesartan medoxomilo or to any of the other ingredients of this medicine (listed in section 6).

-If you are more than 3 months pregnant. (It is also best to avoid this medicine at the beginning of pregnancy - see Pregnancy section).

-If you have a yellowish discoloration of the skin (jaundice) or problems with bile drainage from the gallbladder (biliary obstruction such as gallstones).

-If you have diabetes or kidney function impairment and are being treated with an antihypertensive that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartán Viatris.

·If you have kidney problems.

·If you have liver disease.

·If you have heart failure or problems with heart valves or heart muscle.

·If you have diabetes, have intense vomiting, diarrhea, are receiving high doses of medications that increase urine elimination (diuretics), or are following a low-sodium diet.

·If you have high levels of potassium in your blood.

·If you have problems with the adrenal glands.

·If you are taking any of the following medications to treat high blood pressure:

-An angiotensin-converting enzyme (ACE) inhibitor (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems due to diabetes.

-Aliskiren.

Your doctor may check your kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not takeOlmesartán Viatris”

During treatment

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

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

You must inform your doctor if you are pregnant or think you may be pregnant. This medicine 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 Pregnancy section).

Children and adolescents

Olmesartán has been studied in children and adolescents. For more information, consult your doctor. This medicine is not recommended for children between 1 and 6 years old, and it should not be used in children under 1 year old as there is no data available.

Older adults

If you are over 65 years old and your doctor decides to increase the dose of olmesartan medoxomilo to 40 mg per day, your doctor will regularly check your blood pressure to ensure it does not drop too low.

Black patients

As with other similar medications, the blood pressure-lowering effect of this medicine is somewhat less in black patients.

Other medications and Olmesartán Viatris

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

• Supplements of potassium, salt substitutes containing potassium, diuretics, or heparin (to thin the blood). The use of these medications with Olmesartán may elevate potassium levels in the blood.
• Lithium (a medication used to treat mood changes and some types of depression), as used with Olmesartán 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 to relieve pain, swelling, and other symptoms of inflammation, including arthritis, such as ibuprofen or aceclofenac), as used with Olmesartán may increase the risk of kidney failure and reduce the effect of Olmesartán Viatris.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of Olmesartán. Your doctor may advise you to take Olmesartán at least 4 hours before colesevelam hydrochloride.

• Other blood pressure-lowering medications, as they may increase the effect of Olmesartán.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of Olmesartán.

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

• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not takeOlmesartán Viatris” and “Warnings and precautions”).

Pregnancy and breastfeeding

Inform your doctor or pharmacist if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant.

Pregnancy

You must inform your doctor if you are pregnant, or if you think you may be pregnant or plan to become pregnant. Your doctor will advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend another medication in place of Olmesartán Viatris.

This medicine 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.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. This medicine 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.

Driving and operating machinery

You may feel drowsy or dizzy during blood pressure treatment. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

Olmesartán Viatris contains sodium

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

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

Adults

The recommended initial dose is 1 tablet of 10 mg per day. If blood pressure is not adequately controlled, your doctor may increase the dose up to 20 mg or 40 mg per day or prescribe additional treatment.

In patients with mild to moderate renal insufficiency, the maximum dose is 20 mg once a day.

Tablets can be taken with or without food. Take the tablets with a sufficient amount of water (for example, a glass). Do not chew the tablets. If possible, take your dose at the same time each day, for example, at breakfast time.

Children and adolescents from 6 to less than 18 years of age:

The recommended initial dose is 10 mg once a day. If the patient's blood pressure is not adequately controlled, the doctor may decide to change the dose up to a maximum of 20 or 40 mg once a day. In children weighing less than 35 kg, the dose should not exceed 20 mg once a day.

If you take more Olmesartán Viatris than you should

If you accidentally take too many tablets, contact your doctor or pharmacist immediately, call the Toxicological Information Service (Tel. 91 562 04 20), indicating the medication and the amount ingested, or go to the nearest hospital emergency department.

If you forget to take Olmesartán Viatris

If you forget to take a dose, take the usual dose the next day.Do nottake a double dose to make up for the missed doses.

If you interrupt treatment with Olmesartán 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.

Although many people may not experience them, the following side effects can be serious. If you observe any of the following side effects, contact your doctor or the nearest hospital emergency department immediately.

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

·Severe allergic reactions that can affect the whole body and cause breathing problems, as well as a rapid decrease in blood pressure that can lead to fainting (anaphylactic reactions).

·Feeling of oppression or heaviness in the chest, especially when exercising. They may be signs of heart problems (angina pectoris).

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

·During treatment with this medicine, swelling of the face, mouth, and/or larynx may occur along with itching and rash.If this occurs, discontinue treatment with this medicine and contact your doctor immediately.

·Rarely (but slightly more frequently in older patients), this medicine can cause blood pressure to drop too low in susceptible individuals or due to an allergic reaction. This can cause intense dizziness or fainting.If this occurs, discontinue treatment with this medicine, contact your doctor immediately, and lie down.

·Difficulty or pain urinating, with changes in urine color and volume. Pain in the lower back, nausea, or vomiting, feeling of general discomfort. They may be signs of severe kidney problems.

Unknown frequency

• If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started olmesartan treatment a long time ago, contact your doctor immediately who will evaluate your symptoms and decide how to continue treatment for high blood pressure.

These are the other side effects known with the use ofOlmesartan Viatris:

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

·Dizziness, headache.

·Nausea, indigestion, diarrhea, stomach pain, gastroenteritis.

·Fatigue.

·Throat pain, congestion, and nasal discharge, bronchitis, flu-like symptoms, cough.

·Pain, especially back pain, bone pain, joint pain.

·Urinary tract infection.

·Blood in urine.

·Swelling of ankles, feet, legs, hands, or arms.

Some changes in the results of certain blood tests:

·Increased levels of fat (hypertriglyceridemia).

·Increased levels of uric acid (hyperuricemia).

·Increased levels of urea in the blood.

·Increases in liver and muscle function test values.

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

·Feeling of spinning (dizziness).

·Vomiting, weakness, feeling of discomfort.

·Muscle pain.

·Rash, allergic rash, itching, exanthema (skin rash), skin swelling (hives).

Some changes in the results of certain blood tests:

·Decreased number of a type of blood cell called platelets (thrombocytopenia).

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

·Lack of energy.

·Muscle cramps.

·Worsening of kidney function, which can cause more frequent urination, especially at night, and will be observed in the blood test.

·Low blood pressure, which can cause dizziness or fatigue.

Some changes in the results of certain blood tests:

·Increased levels of potassium in the blood (hyperkalemia).

·Increased levels of components related to kidney function.

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

• Severe persistent diarrhea and significant weight loss.

Other side effects in children and adolescents:

In children, side effects are similar to those observed in adults. However, dizziness and headache were more frequent in children, and nosebleeds are a frequent side effect observed only in children.

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 store at a temperature above 25°C. Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging and in the blister (after “CAD”). The expiration date is the last day of the month indicated.

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

Olmesartan Viatris Composition

-The active ingredient is olmesartan medoxomil.

-Each film-coated tablet contains 40 mg of olmesartan medoxomil.

-The other components of the tablet core are croscarmellose sodium, mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulfate

-The film coating contains hypromellose, titanium dioxide (E171), macrogol, and talc.

Appearance of the product and contents of the pack

Olmesartan Viatris are film-coated tablets, white, oval, biconvex, and with a beveled edge, with the inscription 'M' on one side and 'O4' on the other.

Olmesartan Viatris is available in blisters of 14, 28, 28 x 1, 30, 50 x 1, 56, 90, and 98 film-coated tablets and in plastic bottles of 500 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Generics [UK] Ltd,

Potters Bar, Hertfordshire,

EN6 1TL,

UK

O

McDermott Laboratories Ltd t/a Gerard Laboratories,

35/36 Grange Road,

Baldoyle Industrial Estate,

Dublin 13, Ireland

O

Mylan Hungary Kft,

H-2900 Komárom,

Mylan útca 1,

Hungary

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 European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Spain:Olmesartan Viatris 40 mg film-coated tablets EFG

Greece:Olmesartan / Mylan 40 mg

Ireland:Olmesartan medoxomil 40 mg Film-coated tablets

Italy:Olmesartan medoxomil Mylan 40 mg

Portugal:Olmesartan medoxomilo Mylan

United Kingdom (Northern Ireland):Olmesartan medoxomil 40 mg Film-coated tablets

Last review date of this leaflet:February 2022.

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