OLMESARTAN VISO FARMACÉUTICA 10 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Olmesartan Viso Farmacéutica 10 mg film-coated tablets EFG

Olmesartan medoxomil

Read the entire summary of product characteristics carefully before starting to take this medication, as it contains important information for you.

• Keep this summary of product characteristics, 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 summary of product characteristics. See section 4.

Summary of Product Characteristics

1. What Olmesartan Viso Farmacéutica is and what it is used for
2. What you need to know before taking Olmesartan Viso Farmacéutica
3. How to take Olmesartan Viso Farmacéutica
4. Possible side effects
   1. Storage of Olmesartan Viso Farmacéutica
   2. Package contents and additional information

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

Olmesartan belongs to a group of medications known as 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 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 kidney failure, stroke, or blindness. Usually, high blood pressure does not present symptoms. It is essential to control your blood pressure to avoid damage.

High blood pressure can be controlled with medications like olmesartan. Your doctor will likely also recommend that you make some lifestyle changes to help lower your blood pressure (such as 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 crucial to follow your doctor's advice.

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

Do not takeOlmesartan Viso Farmacéutica

• 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 to avoid olmesartan at the start of pregnancy - see the Pregnancy section).
• if you have yellowing of the skin and eyes (jaundice) or problems with bile drainage from the gallbladder (bile duct obstruction, for example, due to gallstones).
• if you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.

Warnings and precautions

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

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

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

Your doctor may need to monitor your kidney function, blood pressure, and blood electrolyte levels (such as 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 medications 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 experience 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 medication that lowers blood pressure, excessive blood pressure reduction in patients with altered 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 may be pregnant. Olmesartan 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 if taken at this stage (see the Pregnancy section).

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 its use.

Other medications and Olmesartán Viso Farmacéutica

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

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

Your doctor may need to adjust 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 that contain potassium, medications that increase urine production (diuretics), or heparin (to thin the blood). Using these medications at the same time as olmesartan may increase potassium levels in the blood.
• Lithium (a medication used to treat mood changes and some types of depression), as it may increase lithium toxicity when used with olmesartan. If you need to take lithium, your doctor will monitor your lithium blood levels.
• Non-steroidal anti-inflammatory medications (NSAIDs) (medications 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 medication that lowers blood cholesterol levels, 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 (medications for indigestion), 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 medications, the blood pressure-lowering effect of Olmesartán Viso Farmacéutica is slightly less in black patients.

Taking Olmesartán Viso Farmacéutica with food and drinks

Olmesartán Viso Farmacéuticacan be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will advise you to stop taking olmesartan before becoming pregnant or as soon as you know you are pregnant and will recommend an alternative medication. Olmesartan Viso Farmacéutica is not recommended at the start of pregnancy and should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartán Viso Farmacéutica is not recommended in breastfeeding mothers, and your doctor may choose an alternative 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 using machines

You may feel drowsy or dizzy during blood pressure treatment. If this happens, do not drive or use machines 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 told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Olmesartán Viso Farmacéutica contains hydrogenated castor oil

This medication may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

3. How to take Olmesartán Viso Farmacéutica

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

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, for example, at breakfast time.

Use in children and adolescents with high blood pressure

Children and adolescents from 6 years to less than 18 years old:

The recommended initial dose is 10 mg once a day. If your 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 take more tablets than you should or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency department immediately and take the medication package 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 usual dose the next day. Do nottake a double dose to make up for missed doses.

If you stop takingOlmesartán Viso Farmacéutica

It is essential to continue taking Olmesartán Viso Farmacéutica unless your doctor tells you to stop.

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

4. Possible side effects

Like all medications, this medication 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 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 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 to you, stop takingOlmesartán Viso Farmacéuticaand consult your doctor immediately.

Rarely (but slightly more often in elderly patients), Olmesartán Viso Farmacéutica may cause a marked 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.
• some changes in blood test results have also been observed:

• increased fat levels (hypertriglyceridemia)
• increased uric acid levels (hyperuricemia)
• increased urea in 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 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 pectoris (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 blood test results have been observed, including increased potassium levels 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, the adverse reactions are similar to those reported in adults. However, dizziness and headaches are more frequent in children, and nasal bleeding is a common adverse reaction observed only in children.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this summary of product characteristics. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Olmesartán Viso Farmacéutica

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

Do not use this medication after the expiration date stated on the packaging and blister pack after the EXP date. The expiration date is 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. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Olmesartán Viso Farmaceutica

The active ingredient is olmesartán medoxomilo. Each tablet contains 10 mg of olmesartán medoxomilo.

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 Packaging Content

Olmesartán Viso Farmacéutica 10 mg are white to off-white, round, film-coated tablets, engraved with the number 476 on one side and smooth on the other, with a characteristic odor and an approximate diameter of 6.3 mm.

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

Only some pack 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

Further information about this medicinal product can be obtained from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

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

Netherlands Olmesartan medoxomil Glenmark 10 mg film-coated tablets

Spain Olmesartan Viso Farmacéutica 10 mg film-coated tablets EFG

Germany Olmesartan Glenmark 10 mg film-coated tablets

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

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