Package Leaflet: Information for the User

Olmesartan Vir 10 mg Film-Coated Tablets EFG

olmesartan medoxomilo

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 pass it on to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Contents of the package leaflet

1.What Olmesartan Vir is and what it is used for

2.What you need to know before you start taking Olmesartan Vir

3.How to take Olmesartan Vir

4.Possible side effects

5.Storage of Olmesartan Vir

6.Contents of the pack and additional information

Olmesartan Vir belongs to a group of medications called angiotensin II receptor antagonists. It reduces blood pressure by relaxing blood vessels.

Olmesartan Vir is used in the treatment of high blood pressure(also known as "hypertension"). High blood pressure can cause damage to organs such as the heart, kidneys, brain, and eyes. In some cases, it can cause a heart attack, heart failure, or kidney failure, stroke, or blindness. Normally, high blood pressure does not have symptoms. It is very important to check your blood pressure to prevent damage.

High blood pressure can be controlled with medications such asOlmesartan Vir. Your doctor probably recommended making lifestyle changes to help you lower your blood pressure(for example, losing weight, quitting smoking, reducing the amount of alcohol you consume, and reducing the amount of salt in your diet). Your doctor may also recommend regular exercise, such as walking or swimming. It is very important to follow your doctor's recommendations.

Do not take Olmesartan Vir

• If you are allergic to olmesartan medoxomilo or any of the other components of this medication (including those listed in section 6);

• If you are more than 3 months pregnant. (It is also best not to take Olmesartan Vir at the beginning of pregnancy – see Pregnancy section).

• If you have yellow skin and eyes (jaundice) or problems with bile drainage from the gallbladder (biliary obstruction, e.g., gallstones).

• If you have diabetes or kidney problems (problems with your kidney function) and are being treated to lower your blood pressure with medications that contain aliskiren.

If you have any of these conditions, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor before taking this medication if you have or have had any of the following diseases or conditions:

• Kidney problems;

• Liver disease;

• Heart failure, or problems with heart valves or heart muscle;

• Severe vomiting, diarrhea, treatment with high doses of medications to remove fluids (diuretics) or if you are on a low-sodium diet;

• Elevated potassium levels in your blood;

• Problems with your adrenal glands;

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

− An ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

− Aliskiren.

• Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking olmesartan. Your doctor will decide whether to continue treatment. Do not stop taking olmesartan in monotherapy.

Your doctor may want to review your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood regularly.

See also the information under the heading “Do not take Olmesartan”

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 treating high blood pressure.

Like any other medication for reducing blood pressure, excessive reduction of blood pressure in patients with alterations in blood flow to the heart or brain can cause a stroke or heart attack. Therefore, your doctor will carefully review your blood pressure.

You must inform your doctor if you think you are (or may be) pregnant.Olmesartan Vir is not recommended at the beginning of pregnancy, and should not be taken if you are more than 3 months pregnant, as it could cause severe damage to your baby (see Pregnancy section).

Children and adolescents

Olmesartan Vir is not recommended for children and adolescents under 18 years old.

Older adults

If you are over 65 years old and your doctor decides to increase your dose of olmesartan medoxomilo to 40 mg daily, your blood pressure should be monitored regularly by your doctor to ensure it does not drop too low.

Black patients

Like other similar medications, the blood pressure-lowering effect of Olmesartan Vir is less in patients of African descent.

Taking Olmesartan Vir with other medications

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

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

• If you are taking an ACE inhibitor or aliskiren (see the information under the heading “Do not take Olmesartan Vir” and “Warnings and precautions”).

Particularly, inform your doctor or pharmacist about any of the following medications:

• Potassium supplements, a salt substitute containing potassium, diuretics, or heparin (to thin the blood). Using these medications at the same time as Olmesartan Vir could elevate potassium levels in your blood.

• Lithium (a medication used to treat mood changes and some types of depression), used at the same time as Olmesartan Vir could increase lithium toxicity. If you take lithium, your doctor will measure the level of lithium in your blood.

• Nonsteroidal anti-inflammatory drugs (NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) if used at the same time as Olmesartan Vir, could increase the risk of kidney failure and the effect of Olmesartan Vir could decrease due to NSAIDs.

• Other medications that lower blood pressure, as they may increase the effect of Olmesartan Vir;

• Cholestyramine, a medication that lowers cholesterol in the blood, as it may decrease the effect of Olmesartan Vir. Your doctor may instruct you to take Olmesartan Vir at least 4 hours after cholestyramine;

• Certain antacids (remedies for indigestion), as the effect of Olmesartan Vir may decrease slightly.

Taking Olmesartan Vir with food and drinks

Olmesartan Vir can be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

You must inform your doctor if you think you are (or may be) pregnant. Your doctor will advise you to stop taking Olmesartan Vir before becoming pregnant or as soon as you find out you are pregnant and recommend that you take another medication instead of Olmesartan Vir.This medication is not recommended at the beginning of pregnancy, and should not be taken if you are more than 3 months pregnant, as it could cause severe damage to your baby.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding.Olmesartan Vir is not recommended for mothers who are breastfeeding and your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

While being treated for high blood pressure, you may experience drowsiness or dizziness. If this occurs, do not drive or operate machinery until the symptoms disappear. Consult your doctor.

Olmesartan Vir contains lactose

This medication contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain types of sugar, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist.

The recommended initial dose is one 10 mg tablet once a day. However, if your blood pressure is not controlled, your doctor may decide to change your dose to 20 or 40 mg per day, or prescribe additional medications.

For patients with mild or moderate kidney problems, the dose should not exceed 20 mg per day.

Tablets can be taken with or without food. Swallow the tablets with a sufficient amount of water (e.g., a glass). If possible, take your daily dose at the same time every day, for example, at breakfast time.

If you take more Olmesartan Vir than you should

If you take more tablets than prescribed or if a child accidentally ingests one or more tablets, go immediately to your doctor or the nearest emergency room, and bring your medication with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forget to take Olmesartan Vir

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

If you interrupt treatment with Olmesartan Vir

It is essential that you continue taking the Olmesartan Vir tablets until your doctor tells you to stop treatment.

If you have any doubts about the use of this medication, consult your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.If they occur, they are usually mild and will not require the treatment to be interrupted.

The following side effects may be serious, although not many people may experience them:

In rare cases (affecting up to 1 in 1,000 people), the following allergic reactions, which can affect the whole body, have been reported:

Swelling of the mouth and/or larynx (voice box), along with itching and skin rash, may occur during treatment with Olmesartan Vir. If this happens, stop taking Olmesartan Vir and contact your doctor immediately.

•Rarely (but slightly more often in elderly patients)

Olmesartan Vir may cause blood pressure to drop too low in susceptible individuals, or as a result of an allergic reaction. This can cause severe dizziness or fainting.

If this happens, stop taking Olmesartan Vir, contact your doctor immediately, and remain lying down in a horizontal position.

•Unknown frequency: If you experience yellowing of the white part of the eyes, dark urine, skin itching, even if you started taking Olmesartan Vir a long time ago,

contact your doctor immediately, who will evaluate your symptoms and decide how to continue treatment for high blood pressure.

To give you an idea of how many patients experience side effects, they are classified as frequent, infrequent, rare, and very rare.

These are other side effects known so far with Olmesartan Vir:

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

Dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastroenteritis, fatigue, sore throat, congestion or nasal discharge, bronchitis, flu-like symptoms, cough, chest pain, back pain, bone pain, joint pain, urinary tract infection, swelling of the calves, feet, hands, arms; blood in urine.

Some changes have also been observed in blood test results: increased levels of fat (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), increased urea in the blood, increased values in liver and muscle function tests:

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

Quick allergic reactions that can affect the whole body and may cause respiratory problems, and also a rapid drop in blood pressure, which can cause fainting (anaphylactic reactions), dizziness, vomiting, weakness, feeling unwell, muscle pain, allergic skin reactions, itching, skin rash, skin bumps (papules), angina (chest pain or discomfort).

In blood tests, a decrease in platelet cells (thrombocytopenia) has been observed.

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

Loss of energy, muscle cramps, impaired kidney function (your kidneys are not functioning well), kidney failure.

Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Some changes have been observed in blood tests, including increased levels of potassium (hyperkalemia) and increased levels of compounds related to kidney function.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usewww.notificaram.es. By reporting side effects, you can contribute to providing more information about 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 packaging and in the blister pack after«CAD». The expiration date refers to the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy or any other medication waste collection system. 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.

Composition of Olmesartan Vir

• The active ingredient is olmesartan medoxomil.

Olmesartan Vir 10 mg: Each film-coated tablet contains 10 mg of olmesartan medoxomil

• The other components are: lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, hydroxypropylcellulose, magnesium stearate. (See section 2 "Olmesartan Vir contains lactose")

The composition of the Yellow Opadry 03F82788: hypromellose (E464), titanium dioxide (E171), polyethylene glycol (E1521), yellow iron oxide (E172)

Appearance of the product and contents of the packaging

The Olmesartan Vir 10 mg tablets are film-coated, yellow, round, biconvex tablets, marked with the number "392" on one side and an "L" on the other.

Olmesartan Vir tablets are available in packaging of 14, 20, 28, 30, 56, 84, 90, and 98 tablets.

Only some packaging sizes may be commercially available

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Industria Química y Farnacéutica VIR, S.A.

C/ Laguna 66-70- Pol. Ind. URTINSA II

28923 Alcorcón (Madrid)

Spain

Responsible manufacturer

Pharmadox Healthcare Ltd

KW20A, Corradino Industrial Estate, Paola

PLA 3000, Malta

or

Industria Química y Farnacéutica VIR, S.A.

C/ Laguna 66-70- Pol. Ind. URTINSA II

28923 Alcorcón (Madrid)

Spain

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)http://www.aemps.gob.es/