OLMESARTAN VIR 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan Vir 20 mg Film-Coated Tablets EFG

olmesartan medoxomil

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Olmesartan Vir is and what it is used for
2. What you need to know before you take Olmesartan Vir
3. How to take Olmesartan Vir
4. Possible side effects
5. Storage of Olmesartan Vir
6. Contents of the pack and other information

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

Olmesartan Vir belongs to a group of medicines 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 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 medicines such as Olmesartan Vir. Your doctor has probably recommended that you make changes to your lifestyle to help lower your blood pressure (e.g., lose weight, stop smoking, reduce the amount of alcohol you drink, 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 you take Olmesartan Vir

Do not take Olmesartan Vir

• If you are allergic to olmesartan medoxomil or any of the other ingredients of this medicine (listed in section 6);
• If you are more than 3 months pregnant. (It is also better 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 (bile obstruction, e.g., gallstones).
• If you have diabetes or kidney problems (problems with your kidney function) and if you are being treated with medicines that contain aliskiren.

If you suffer from any of these conditions, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor before taking this medicine 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 diuretic medicines, 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 medicines for 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 assess your symptoms and decide how to continue treating your high blood pressure.

As with any other medicine to lower blood pressure, excessively low blood pressure in patients with blood flow disorders in the heart or brain may cause a stroke or heart attack. Therefore, your doctor will carefully check your blood pressure.

You should inform your doctor if you think you are (or might become) pregnant. Olmesartan Vir is not recommended at the start of pregnancy, and must not be taken if you are more than 3 months pregnant, 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 medicines, the blood pressure-lowering effect of Olmesartan Vir is smaller in black patients.

Taking Olmesartan Vir with other medicines

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

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

In particular, tell your doctor or pharmacist about any of the following medicines:

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

• Lithium (a medicine 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 medicines (NSAIDs) (medicines 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 medicines that lower blood pressure, as they may increase the effect of Olmesartan Vir;

• Colesevelam hydrochloride, a medicine 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 (indigestion remedies), 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 breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you think you are (or might become) pregnant. Your doctor will advise you to stop taking Olmesartan Vir before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Olmesartan Vir. This medicine is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.

Breast-feeding

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

Driving and using machines

While you are 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 medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Olmesartan Vir

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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 medicines.

For patients with mild or moderate kidney problems, the dose should not be higher than 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 to your doctor or the nearest emergency room immediately and take your medicine with you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Olmesartan Vir

If you forget a dose, take your 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 to take the Olmesartan Vir tablets until your doctor tells you to stop.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, they are usually mild and do not require treatment to be stopped.

The following side effects may be serious, although they are rare:

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 throat (larynx), 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 your 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 assess your symptoms and decide how to continue treatment for 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, tiredness, 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 the 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 may cause breathing problems, and a rapid drop in blood pressure, which can cause fainting (anaphylactic reactions), vertigo (feeling of dizziness), vomiting, weakness, feeling unwell, muscle pain, allergic skin reactions, itching, skin rash (exanthema), skin bumps (papules), angina (chest pain or discomfort).

In blood tests, a decrease in blood cells called 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan Vir

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

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan Vir

• The active substance is olmesartan medoxomil.

Olmesartan Vir 20 mg: Each film-coated tablet contains 20 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 packaging

The Olmesartan Vir 20 mg tablets are film-coated, yellow, round, biconvex, marked with the number "323" on one side and an "L" on the other.

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

Not all pack 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 last revision of this leaflet:February 2025

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