Olmesartan Viso Farmacéutica 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Olmesartán Viso Farmacéutica 10 mg film-coated tablets EFG

Olmesartan medoxomil

Read the entire 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Olmesartan belongs to a group of medicines 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 aged 6 to 18 years. High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this may lead to heart attack, heart or kidney failure, stroke, or blindness. Usually, high blood pressure does not cause symptoms. It is important to monitor your blood pressure to prevent organ damage.

High blood pressure can be controlled with medicines such as olmesartan. Your doctor has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and reducing salt in your diet). Your doctor may also recommend that you exercise regularly, such as walking or swimming. It is important to follow your doctor’s advice.

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

Do not take Olmesartán Viso Farmacéutica

• if you are allergic to olmesartan medoxomil or to any of the other ingredients of this medicine (listed in section 6).

• if you are more than 3 months pregnant. (It is also advisable to avoid olmesartan in early pregnancy – see Pregnancy section).

• if you have yellowing of the 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 failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before taking Olmesartán Viso Farmacéutica:

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

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

• aliskiren.

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

Inform your doctor if you have any of the following health conditions:

• 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 output (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 medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You must inform your doctor if you are pregnant or think you might be pregnant. The use of olmesartan is not recommended in early pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this stage (see 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 in children and adolescents has been studied. For more information, consult your doctor.

Olmesartan is not recommended for children from 1 year to less than 6 years of age and should not be used in children under 1 year of age, as there is no experience with its use in this age group.

Other medicines and Olmesartán Viso Farmacéutica

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

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

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Olmesartán Viso Farmacéutica” and “Warnings and precautions”).

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

Elderly patients

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

Black patients

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

Taking Olmesartán Viso Farmacéutica with food and drink

Olmesartán Viso Farmacéutica can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. 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 medicine instead of olmesartan. The use of Olmesartán Viso Farmacéutica is not recommended in early pregnancy, and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Olmesartán Viso Farmacéutica is not recommended for 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 medicine.

Driving and using machines

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

Olmesartán Viso Farmacéutica contains lactose

This medicine contains lactose (a type of sugar). If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Olmesartán Viso Farmacéutica

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage:

The recommended initial dose is 1 tablet of 10 mg once daily. If blood pressure is not adequately controlled, 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 impairment, the maximum dose is 20 mg once daily.

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

Use in children and adolescents with high blood pressure

Children and adolescents from 6 years up to but less than 18 years of age:

The recommended initial dose is 10 mg once daily. 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 more Olmesartán Viso Farmacéutica than you should

If you take more tablets than prescribed or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency department immediately and bring the medicine package with you.

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

If you forget to take Olmesartán Viso Farmacéutica

If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Olmesartán Viso Farmacéutica

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. If adverse effects occur, they are usually mild and it is not necessary to stop treatment.

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

During treatment with olmesartan, swelling of the face, mouth and/or larynx may occur, along with itching and skin rash. If this happens to you, stop taking Olmesartán Viso Farmacéutica and consult your doctor immediately.

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

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

The following are other known adverse effects reported so far with Olmesartán Viso Farmacéutica:

Frequent adverse 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:

• increase in fat levels (hypertriglyceridemia)

• increase in uric acid levels (hyperuricemia)

• increase in blood urea

• increases in liver and muscle function test values.

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

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

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

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

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with Olmesartán Viso Farmacéutica some time ago, contact your doctor immediately, who will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Additional adverse effects in children and adolescents:

In children, adverse reactions are similar to those reported in adults. However, dizziness and headaches occur more frequently in children, and nosebleeds are a frequent adverse reaction observed only in children.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan Viso Farmacéutica

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartán Viso Farmacéutica

The active substance is olmesartan medoxomil. Each tablet contains 10 mg of olmesartan medoxomil.

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

Appearance of the medicine and contents of the pack

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 odour 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, 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

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicine 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 most recent review of this leaflet: February 2025.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.