OLMESARTAN VIR 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan Vir 40 mg Film-Coated Tablets EFG

olmesartan medoxomil

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of this Package Leaflet

1. What is Olmesartan Vir and what is it used for
2. What you need to know before taking Olmesartan Vir
3. How to take Olmesartan Vir
4. Possible side effects
5. Storage of Olmesartan Vir
6. Package Contents and Additional Information

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

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

Olmesartan Vir is used to treat 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. Usually, high blood pressure has no symptoms. It is very important to check your blood pressure to avoid damage.

High blood pressure can be controlled with medications like Olmesartan Vir. Your doctor has probably recommended that you make lifestyle changes to help lower your blood pressure (e.g., lose weight, stop smoking, reduce the amount of alcohol you consume, and reduce the amount of salt in your diet). Your doctor may also recommend that you exercise regularly, such as walking or swimming. It is very important to follow your doctor's recommendations.

2. What you need to know before taking Olmesartan Vir

Do not take Olmesartan Vir

• If you are allergic to olmesartan medoxomil or any of the other ingredients of this medication (listed in section 6);
• If you are pregnant for more than 3 months. (It is also best not to take Olmesartan Vir at the start of pregnancy – see section Pregnancy).
• If you have yellowing of the 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 if you are being treated to lower your blood pressure with medications that contain aliskiren.

If you suffer from 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 suffer or have suffered from 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 eliminate fluids (diuretics), or if you are on a low-sodium diet;
• high levels of potassium in your blood;
• problems with your adrenal glands;
• if you are taking any of the following medications for the treatment of high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may want to check 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 Vir"

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 your high blood pressure.

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

You must inform your doctor if you think you are (or might be) pregnant. Olmesartan Vir is not recommended at the start of pregnancy, and you should not take it if you are pregnant for more than 3 months, as it may cause serious harm to your baby (see section Pregnancy).

Children and Adolescents

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

Elderly Patients

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

Black Patients

As with other similar medications, the blood pressure-lowering effect of Olmesartan Vir is less in black patients.

Taking Olmesartan Vir with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

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

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

• Potassium supplements, a salt substitute that contains potassium, water pills (diuretics), or heparin (to thin the blood). Using these medications at the same time as Olmesartan Vir may increase the levels of potassium in your blood.

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

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

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

• Colesevelam hydrochloride, a medication that lowers the level of cholesterol in the blood, as it may reduce the effect of Olmesartan Vir. Your doctor may tell you to take Olmesartan Vir at least 4 hours after Colesevelam hydrochloride;

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

Taking Olmesartan Vir with Food and Drink

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 might 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 will recommend that you take another medication instead of Olmesartan Vir. This medication is not recommended at the start of pregnancy, and you should not take it if you are pregnant for more than 3 months, as it may cause serious harm to your baby.

Breastfeeding

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

Driving and Using Machines

While being treated for high blood pressure, you may experience drowsiness or dizziness. If this happens, do not drive or use machines until the symptoms go away. 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 some sugars, consult with them before taking this medication.

3. How to Take Olmesartan Vir

Follow the instructions for taking this medication exactly 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.

The 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 the doctor or the nearest emergency room, and take your medication with you.

In case of overdose or accidental ingestion, consult the Toxicology 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 forgotten doses.

If you stop taking Olmesartan Vir

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them. If they do occur, they are usually mild and do not require stopping treatment.

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

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

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.

• Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started treatment with Olmesartan Vir a long time ago, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treating your high blood pressure.

To give you an idea of how many patients have adverse reactions, they are classified as frequent, uncommon, rare, and very rare.

These are other known side effects of Olmesartan Vir:

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

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

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

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

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

In blood tests, a decrease in blood cells known as platelets (thrombocytopenia) has been observed.

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

Lack of energy, muscle cramps, affected kidney function (your kidneys do not work well), kidney failure.

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

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Olmesartan Vir

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 on the blister pack after "EXP". 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 wastewater or household waste. Dispose of the packaging and any unused medication in the SIGRE collection point at the pharmacy or in any other medication waste collection system. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Olmesartan Vir

• The active ingredient is olmesartan medoxomil.

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

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

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

Appearance of the Product and Package Contents

The Olmesartan Vir 40 mg tablets are film-coated, yellow, oval, biconvex, marked with the number "L324" on one side and smooth on the other.

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A, Corradino Industrial Estate, Paola

PLA 3000, Malta

or

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

Date of the Last Revision of this Package Leaflet:February 2025

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