Leaflet: information for the user

Olmesartan medoxomil 10 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 pass it on to others even if they have similar symptoms to 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 medoxomil and what it is used for

2. What you need to know before you start taking olmesartan medoxomilolmesartan medoxomil

3. How to take olmesartan medoxomilolmesartan medoxomil

4. Possible side effects

5. Storage of olmesartan medoxomil

6. Contents of the pack and additional information

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

olmesartán cinfa is used to treat high blood pressure (also known as hypertension)in adults, and in children and adolescents from 6 years to less than 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 renal failure, stroke, or blindness.High blood pressure usually does not present symptoms. It is essential to control your blood pressure to prevent damage.

High blood pressure can be controlled with medicines like olmesartán cinfa. Your doctorprobably also recommended that you make some lifestyle changes to help you lower 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 take olmesartan cinfa

• If you are allergic to olmesartan medoxomilo or any of the othercomponents of this medication (listed in section 6).
• If you are more than 3 months pregnant. (It is also recommended to avoid olmesartan at the beginning ofpregnancy - see Pregnancy section).
• If you have a yellowish 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 aliskirén.

Warnings and precautions

Consult your doctor or pharmacist before starting to take olmesartan cinfa.

Tell your doctorif you are taking any of the following medications used to treat high blood pressure (hypertension):

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

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 olmesartan cinfa”.

Tell 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 production (diuretics), or if you are on a low-sodium diet.
• Elevated potassium levels in the blood.
• Problems with the adrenal glands.

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.

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.

Inform your doctor if you are pregnant or think you may be pregnant. Olmesartan is not recommended for use 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).

Black patients

Like other similar medications, the blood pressure-lowering effect of olmesartan is somewhat less in black patients.

Older patients

If you are 65 years or older and your doctor decides to increase your olmesartan medoxomilo dose to 40 mg per day, your doctor will regularly monitor your blood pressure to ensure it does not decrease too much.

Children and adolescents

Olmesartan has been studied in children and adolescents. For more information, consult your doctor. Olmesartan is not recommended for children aged 1 to less than 6 years, and it should not be used in children under 1 year, as there is no experience.

Taking olmesartan cinfa with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor or pharmacist about 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 aliskirén (see also the information under the headings “Do not take olmesartan cinfa” and “Warnings and precautions”).
• Potassium supplements, salt substitutes containing potassium, diuretics, or heparin (to thin the blood). The use of these medications at the same time as olmesartan 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 olmesartan may increase its toxicity. If you need to take lithium, your doctor will measure your 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 olmesartan may increase the risk of kidney failure and decrease the effect of olmesartan.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may decrease the effect of olmesartan. Your doctor may advise you to take olmesartan at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of olmesartan.

Taking olmesartan cinfa with food and drinks

Olmesartan can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Inform your doctor if you are pregnant or think you may be pregnant. Your doctor will advise you to stop taking olmesartan as soon as you know you are pregnant and to take another medication instead. Olmesartan is not recommended for use 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).

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Olmesartan is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

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

Olmesartan cinfa contains lactose.

This medication contains lactose. If your doctor has told you 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.

The recommended initial dose is 1 olmesartan 10 mg tablet per day. 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.

Inpatients with mild to moderate renal insufficiencythe 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 aged 6 to less than 18 years

The recommended initial dose is 10 mg per day. If the patient's blood pressure is not adequately controlled, the doctor may decide to change the dose up to 20 or 40 mg per day. In children weighing less than 35 kg, the dose will not exceed 20 mg per day.

If you take more olmesartan cinfa than you should

In case you take a higher number of tablets than necessary or if a child has accidentally ingested tablets.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take olmesartan cinfa

If you forget to take a dose, take the usual dose the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with olmesartan cinfa

It is essential to continue taking olmesartan, 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 may cause side effects, although not everyone will experience them. If they occur, they are often mild and do not require interrupting the 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 entire body: inflammation of the face, mouth, and/or larynx, along with itching and skin rash.If this happens, stop taking olmesartan and consult your doctor immediately.

Very rarely (but slightly more often in elderly patients) olmesartan 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 taking olmesartan, consult your doctor immediately, and remain lying down in a horizontal position.

Frequency unknown: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with olmesartan some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with the treatment for high blood pressure.

These are other side effects known so far with olmesartan:

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, chest pain,back pain, bone pain, joint pain, urinary tract infection, swelling ofankles, feet, legs, hands, arms, blood in urine.

Some changes have also been observed in the results of certain blood tests:increase in triglyceride levels (hypertriglyceridemia), increase in uric acid levels(hyperuricemia), increase in urea in the blood, increases in liver and muscle function test values.

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

Quick allergic reactions that can affect the entire body and may cause breathing problems, as well as a rapid decrease in blood pressure that can even lead to fainting (anaphylactic reactions), inflammation of the face, dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (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.

Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Some changes have been observed in the results of certain blood tests. These include an increase in potassium levels in the blood (hyperkalemia) and an increase in components related to kidney function.

Other side effects in children and adolescents:

Side effects similar to those reported in adults have been observed in children. However, dizziness and headache have been observed more frequently in children, and nosebleeds are a frequent side effect observed only in children.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it isa possible side effect that does not appear in this prospectus. You can also report themdirectly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute toproviding more information about 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/container/label after CAD. 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 drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medications that you no longer need. By doing so,you will help protect the environment.

Composition of olmesartan cinfa

• The active ingredient is olmesartan medoxomilo.

Each film-coated tablet contains 10 mg of olmesartan medoxomilo.

• The other components are:

Tablet core:microcrystalline cellulose, lactose monohydrate, povidone, hydroxypropyl cellulose, and magnesium stearate.

Tablet coating:Opadry Y-1-7000 (hypromellose, titanium dioxide, and macrogol).

Appearance of the product and contents of the packaging

Olmesartan cinfa 10 mg are film-coated tablets, cylindrical, white, biconvex, scored on one face, and marked with the code OL1 on the other face.

They are presented in blister packs containing 28 film-coated tablets.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet: February 2025

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

You can access detailed and updated information on this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/79899/P_79899.html

QR code to:https://cima.aemps.es/cima/dochtml/p/79899/P_79899.html