OLMESARTAN VISO FARMACÉUTICA 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Olmesartan Viso Farmacéutica 40 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

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

1. What Olmesartan Viso Farmacéutica is and what it is used for

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

The tablets are used to treat high blood pressure (also known as “hypertension”) in adults and in children and adolescents from 6 to 18 years of age. 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. Usually, high blood pressure does not present symptoms. It is important to control your blood pressure to avoid damage.

High blood pressure can be controlled with medicines such as olmesartan. Your doctor will probably also recommend that you make some changes in 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 important to follow this advice from your doctor.

2. What you need to know before you take Olmesartan Viso Farmacéutica

Do not takeOlmesartan Viso Farmacéutica

• 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 to avoid olmesartan 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., due to gallstones).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartan Viso Farmacéutica:

• if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also the information under the headings “Do not take Olmesartan Viso Farmacéutica” and “Warnings and precautions”.

Tell your doctor if you have any of the following health problems:

• Kidney problems.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medicines that increase urine production (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands.

Contact your doctor if you have severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

As with any other medicine that lowers blood pressure, excessive blood pressure reduction in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You should inform your doctor if you are pregnant or think you might be. Olmesartan is not recommended at the start 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 at this stage (see section Pregnancy).

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 on your own.

Children and adolescents

The use of olmesartan has been studied in children and adolescents. For more information, consult your doctor.

Olmesartan is not recommended for children from 1 year to less than 6 years and should not be used in children under 1 year, as there is no experience with it.

Other medicines and Olmesartan Viso Farmacéutica

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

• Other blood pressure-lowering medicines, as they may increase the effect of olmesartan.

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 take Olmesartan Viso Farmacéutica” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine production (diuretics), or heparin (to thin the blood). Using these medicines at the same time as olmesartan may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood changes and some types of depression), as it may increase lithium toxicity when used at the same time as olmesartan. If you need to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as they may increase the risk of kidney failure and reduce the effect of olmesartan.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartan. Your doctor may advise you to take olmesartan at least 4 hours before colesevelam hydrochloride.
• Certain antacids (indigestion remedies), as they may slightly reduce the effect of olmesartan.

Elderly patients

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

Black patients

As with other similar medicines, the blood pressure-lowering effect of Olmesartan Viso Farmacéutica is somewhat less in black patients.

Taking Olmesartán Viso Farmacéutica with food and drinks

Olmesartán Viso Farmacéuticacan be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

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. Your doctor will advise you to stop taking olmesartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of olmesartan. Olmesartan Viso Farmacéutica is not recommended during the first trimester of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breast-feeding

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel drowsy or dizzy during treatment for high blood pressure. If this happens, do not drive or use machines until the symptoms have gone away. Consult your doctor.

Olmesartán Viso Farmacéutica 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 Olmesartán Viso Farmacéutica

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Dose:

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

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

The tablets can be taken with or without food. Take the tablets with a sufficient amount of water (e.g., a glass). If possible, take your dose at the same time each day, e.g., at breakfast time.

Use in children and adolescents with high blood pressure

Children and adolescents from 6 to 18 years of age:

The recommended initial dose is 10 mg once a day. If blood pressure is not adequately controlled, your doctor may increase the dose to 20 mg or 40 mg per day. In children weighing less than 35 kg, the dose should not exceed 20 mg per day.

If you take moreOlmesartán Viso Farmacéuticathan you should

If you have taken more tablets than you should or if a child has accidentally taken some, contact your doctor or the nearest hospital emergency department immediately and take the medicine pack with you.

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

If you forget to takeOlmesartán Viso Farmacéutica

If you forget to take a dose, take your normal dose the next day. Do nottake a double dose to make up for forgotten doses.

If you stop takingOlmesartán Viso Farmacéutica

It is important to continue taking Olmesartán Viso Farmacéutica unless 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 side effects do occur, they are usually mild and do not require treatment to be stopped.

The following side effects can be serious, although they are rare (may affect up to 1 in 1,000 people):

Allergic reactions that can affect the whole body and may cause breathing problems, as well as a rapid decrease in blood pressure that can lead to fainting (anaphylactic reactions), swelling of the face, mouth, and/or throat, along with itching and skin rash. If this happens to you, stop takingOlmesartán Viso Farmacéuticaand consult your doctor immediately.

Rarely (but slightly more often in elderly patients), Olmesartán Viso Farmacéutica may cause a pronounced decrease in blood pressure in susceptible patients or as a result of an allergic reaction. This can cause fainting or severe dizziness.

If this happens to you, stop takingOlmesartán Viso Farmacéutica, consult your doctor immediately, and remain lying down.

These are other known side effects of Olmesartán Viso Farmacéutica:

Common side effects(may affect up to 1 in 10 people):

• dizziness
• headache
• nausea
• indigestion
• diarrhea
• stomach pain
• gastroenteritis
• fatigue
• sore throat
• nasal congestion and discharge
• bronchitis
• flu-like symptoms
• cough
• pain
• chest, back, bone, and joint pain
• urinary tract infection
• swelling of ankles, feet, legs, hands, arms
• blood in urine
• also, some changes in the results of certain blood tests have been observed:

• increased levels of fat (hypertriglyceridemia)
• increased levels of uric acid (hyperuricemia)
• increased urea levels in the blood
• increases in liver and muscle function test values.

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

• rapid allergic reactions that can affect the whole body and may cause breathing problems, as well as a rapid decrease in blood pressure that can lead to fainting (anaphylactic reactions), swelling of the face, dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, skin eruption (skin rash), skin swelling (hives), angina (chest pain or discomfort).
• in blood tests, a decrease in the number of a type of blood cell called platelets (thrombocytopenia) has been observed.

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

• lack of energy
• muscle cramps
• worsening of kidney function
• kidney failure
• some changes in the results of certain blood tests have been observed. These include increased levels of potassium in the blood (hyperkalemia) and increased levels of components related to kidney function.
• Intestinal angioedema: swelling in the intestine that causes symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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 Olmesartán Viso Farmacéutica a long time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

Additional side effects in children and adolescents:

In children, adverse reactions are similar to those reported in adults. However, dizziness and headaches are more frequently observed in children, and nasal bleeding is a common adverse reaction observed only in children.

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 through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartán Viso Farmacéutica

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. Package Contents and Additional Information

Composition of Olmesartán Viso Farmacéutica

The active ingredient is olmesartan medoxomil. Each tablet contains 40 mg of olmesartan medoxomil.

The other components are: microcrystalline cellulose, low-substituted hydroxypropylcellulose, lactose monohydrate, hydrogenated ricin oil, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide, and talc

Appearance of the Product and Package Contents

Olmesartán Viso Farmacéutica 40 mg are oval, white to off-white film-coated tablets, engraved with the number 438 on one side and smooth on the other, with a characteristic odor and approximately 15.3 mm in length, 7.2 mm in width, and an approximate diameter of 6.3 mm.

Olmesartán Viso Farmacéutica is available in packages of 28, 30, 56, 90, and 98 film-coated tablets and is packaged in PVC/Alu/OPA-Alu blisters.

Only some package sizes may be marketed

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoké Mýto

Czech Republic

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Netherlands Olmesartan medoxomil Glenmark 40mg film-coated tablets

Spain Olmesartan Viso Farmacéutica 40mg film-coated tablets EFG

Germany Olmesartan Glenmark 40mg film-coated tablets

Date of the last revision of this prospectus:February 2025.

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