Patient Information Leaflet

Olmesartan Viso Pharmaceutical 20 mg 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 Viso Pharmaceutical and what it is used for

2.What you need to know before starting Olmesartan Viso Pharmaceutical

3.How to take Olmesartan Viso Pharmaceutical

4.Possible side effects

1. Storage of Olmesartan Viso Pharmaceutical
2. Contents of the pack and additional information

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

The tabletsare used in the treatment of high blood pressure(also known as “hypertension”) in adults and in children and adolescents from 6 to 18 years old. 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 renal failure, stroke or blindness. Normally, high blood pressure does not present symptoms. It is essential to control blood pressure to prevent damage.

High blood pressure can be controlled with medicines like olmesartán. Your doctor probably also recommended that you make some lifestyle changes to help you reduce 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 takeOlmesartán Viso Farmacéutica

• if you are allergic to olmesartán medoxomilo or any of the other components of this medication (listed in section 6).

• if you are more than 3 months pregnant. (It is also recommended to avoid olmesartán 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, for example, due to gallstones).
• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskireno.

Warnings and precautions

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

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

• a converting enzyme inhibitor (ACEI) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskireno.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (such as potassium) at regular intervals. See also the information under the heading “Do not take Olmesartán Viso Farmacéutica”.

Inform your doctorif 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 medications that increase urine elimination (diuretics), or if you are on a low-sodium diet.
• Elevated potassium levels in the blood.
• Problems with the adrenal glands.

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

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

You should inform your doctor if you are pregnant or think you may be pregnant. Olmesartán is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby if taken during this period (see Pregnancy section).

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking olmesartán. Your doctor will decide whether to continue treatment. Do not stop taking olmesartán on your own.

Children and adolescents

Olmesartán has been studied in children and adolescents. For more information, consult your doctor.

Olmesartán 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.

Other medications and Olmesartán Viso Farmacéutica

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

• Other blood pressure-lowering medications, as they may increase the effect of olmesartán,

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

If you are taking a converting enzyme inhibitor (ACEI) or aliskireno (see also the information under the headings “Do not take Olmesartán Viso Farmacéutica” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medications that increase urine elimination (diuretics), or heparin (to thin the blood). The use of these medications at the same time as olmesartán may elevate potassium levels in the blood.
• Lithium (a medication used to treat mood changes and certain types of depression), as used at the same time as olmesartán may increase its toxicity. If you need to take lithium, your doctor will measure lithium levels in the blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) (medications to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as used at the same time as olmesartán may increase the risk of kidney insufficiency and reduce the effect of olmesartán.
• 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.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of olmesartán.

Older patients

If you are over 65 years old and your doctor decides to increase your olmesartán medoxomilo dose 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 medications, the blood pressure-lowering effect of Olmesartán Viso Farmacéutica is somewhat less in black patients.

Olmesartán Viso Farmacéutica with food and beverages

Olmesartán Viso Farmacéuticacan be taken with or without food.

Pregnancy and lactation

Pregnancy

If you are pregnant, or in the lactation period, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will advise you to stop taking olmesartán before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of olmesartán. Olmesartán is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby if used during this period (see Pregnancy section).

Lactation

Inform your doctor if you are in the lactation period or about to initiate lactation. Olmesartán Viso Farmacéutica 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.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Olmesartán Viso Farmacéutica contains lactose

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

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

Dose:

The recommended initial dose is 1 tablet of 10 mg per day. If blood pressure is not controlled adequately, 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). If possible, take your dose at the same time every day, for example, at breakfast time.

Use in children and adolescents with high blood pressure

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

The recommended initial dose is 10 mg per day.If blood pressure is not controlled adequately,your doctor may increase the dose up to20 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

In case you take a higher number of tablets than necessary or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency center immediately and bring the medication packaging with you.

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

If you forgot to takeOlmesartán Viso Farmacéutica

If you forgot to take a dose, take the usual dose the next day.Do nottake a double dose to compensate for the missed doses.

If you interrupt the treatment withOlmesartán Viso Farmacéutica

It is essential to continue takingOlmesartán Viso Farmacéutica, 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 side effects occur, they are usually mild and do not require stopping treatment.

The following side effects can be serious, although not many people may experience them: In rare cases (affecting up to 1 in 1,000 people), the following allergic reactions have been reported, which can affect the whole body:

During treatment with olmesartan, inflammation of the face, mouth, and/or larynx may occur, along with itching and skin rash.If this happens, stop takingOlmesartan Viso Farmacéuticaand consult your doctor immediately..

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

If this happens, stop takingOlmesartan Viso Farmacéutica, consult your doctor immediately, and remain lying down in a horizontal position.

These are other side effects known so far withOlmesartan Viso Farmacéutica:

Frequent 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, and arms
• blood in urine.
• Also, some changes in the results of certain blood tests have been observed:

• increase in triglyceride levels (hypertriglyceridemia)
• increase in uric acid levels (hyperuricemia)
• increase in urea levels in blood
• increases in liver and muscle function test values.

Infrequent 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 drop in blood pressure that can even lead to fainting (anaphylactic reactions), facial swelling, dizziness, vomiting, weakness, feeling unwell, muscle pain, allergic skin rash, itching, skin exanthema, 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
• kidney function deterioration
• renal failure
• some changes in the results of certain blood tests have been observed. These include increased potassium levels in blood (hyperkalemia) and increased levels of components related to kidney function.
• Intestinal angioedema: swelling in the intestine accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Unknown frequency:If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment withOlmesartan Viso Farmacéuticasome time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

Additional side effects in children and adolescents:

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

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance 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 use this medication after the expiration date that appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Olmesartán Viso Pharmaceutical

The active ingredient is olmesartan medoxomil. Each tablet contains 20 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 contents of the package

Olmesartán Viso Pharmaceutical 20 mg are round, film-coated tablets with a white to off-white color, engraved with the number 437 on one side and smooth on the other, with a characteristic odor and an approximate diameter of 8.6 mm.

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

Only some package sizes may be commercially available

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible for manufacturing

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

Ó

Glenmark Arzneimittel GmbH

Industriestr. 31, Gröbenzell, 82194,

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

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

NetherlandsOlmesartan medoxomil Glenmark 20mg filmomhulde tabletten

SpainOlmesartan Viso Farmacéutica 20mg comprimidos recubiertos con película EFG

GermanyOlmesartan Glenmark 20mg Filmtabletten

Last review date of this prospectus:February 2025.

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