Prospect: Information for the User

Olmesartan Aurovitas 20 mg Film-Coated Tablets

Olmesartan medoxomil

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people who have the same symptoms as you, as it may harm them.

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

1.What is Olmesartan Aurovitas and what is it used for

2.What you need to know before starting to take Olmesartan Aurovitas

3.How to take Olmesartan Aurovitas

4.Possible adverse effects

5.Storage of Olmesartan Aurovitas

6.Contents of the package and additional information

OlmesartánAurovitasbelongs to a group of medicines called angiotensin II receptor antagonists. They lower blood pressure by relaxing blood vessels.

OlmesartánAurovitasis 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 kidney failure, stroke, or blindness. High blood pressure usually does not have symptoms. It is essential to control your blood pressure to prevent damage.

High blood pressure can be controlled with medicines like OlmesartánAurovitastablets. Your doctor may also have recommended that you make some lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing the amount of salt in your diet). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is essential to follow your doctor's advice.

Do not takeOlmesartán Aurovitas

-If you are allergic toolmesartán medoxomiloor to 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 (e.g. bile obstruction, such as gallstones).

-If you have diabetes or kidney insufficiency and are receiving treatment with a medication to reduce blood pressure that contains aliskireno.

Warnings and precautions

Consult your doctor before starting to takeOlmesartánAurovitas.

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

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

•Aliskireno.

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartán Aurovitas”.

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 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 that causes 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 reduces blood pressure, excessive blood pressure reduction in patients with altered blood flow to the heart or brain can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

Inform your doctor if you think you (or may be) pregnant. Olmesartán 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 taken at this stage (see Pregnancy section).

Black patients

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

Older patients

If you are over 65 years old and your doctor decides to increase your olmesartán medoxomilo dose to 40 mg daily, your doctor will need to regularly check your blood pressure to ensure that your blood pressure does not become too low.

Children and adolescents

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

TakingOlmesartánAurovitaswith 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 olmesartán.

It may be necessary for your doctor to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskireno (see also the information under the headings “Do not take Olmesartán Aurovitas” 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 olmesartán may elevate potassium levels in the blood.

-Lithium (a medication used to treat mood changes and some types of depression), as used at the same time as olmesartán may increase lithium 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 olmesartán may increase the risk of kidney failure 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 medoxomilo. Your doctor may advise you to take olmesartán medoxomilo at least 4 hours before colesevelam hydrochloride.

-Some antacids (remedies for indigestion), as they may slightly reduce the effect of olmesartán.

TakingOlmesartánAurovitaswith food and drinks

Olmesartán Aurovitascan be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually recommend that you stop taking olmesartán before becoming pregnant or as soon as you know you are pregnant, and recommend that you take another medication instead. Olmesartán is not recommended for use during pregnancy, and it should not be taken after the third month of pregnancy, as it can cause serious harm to your baby if taken at this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Olmesartán is not recommended for use during breastfeeding. Your doctor may choose another treatment if you wish to continue breastfeeding, especially if your baby is newborn or premature.

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

Driving and operating machinery

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

Olmesartán Aurovitas contains lactose

This medication contains lactose (a type of sugar). 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. In case of doubt, consult your doctor or pharmacist again.

The recommended initial dose is 1 tablet of 10 mg 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.

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 each day, for example, at breakfast time.

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

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 moreOlmesartánAurovitasthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to useOlmesartánAurovitas

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

If you interrupt treatment withOlmesartánAurovitas

It is essential to continue taking olmesartán, 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 treatment.

The following side effects may be serious, although they are not common:

In rare cases (affecting up to 1 in 1,000 people), the following allergic reactions have been reported, which can affect the entire body:

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

Rarely (but more frequently in older adults), olmesartan may cause a pronounced drop in blood pressure in susceptible individuals 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 (cannot be estimated from available data)

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 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, congestion, and nasal secretion, bronchitis, flu-like symptoms, cough, pain, chest, back, bone, or joint pain, urinary tract infection, swelling of the ankles, feet, legs, hands, or arms, blood in the urine.

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

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), chest pain (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, decreased kidney function, kidney insufficiency.

Some changes in the results of blood tests have also been observed. These include increased levels of potassium (hyperkalemia) and increased levels of compounds related to kidney function.

Other side effects in children and adolescents:

In children, side effects similar to those reported in adults have been observed. 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 is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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 after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofOlmesartán Aurovitas

-The active ingredient is olmesartan medoxomil. Each film-coated tablet contains 20 mg of olmesartan medoxomil.

-The other components are:

Tablet core:lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl cellulose of low substitution degree, magnesium stearate.

Tablet coating:hydroxypropyl cellulose, titanium dioxide (E171), talc.

Appearance of the product and contents of the packaging

Film-coated tablets, biconvex, round, white in color, with the mark “K” on one face and “18” on the other.

Olmesartán Aurovitas is available in blister packs of Polyamide/Aluminum/PVC-Aluminum.

Packaging sizes: 14, 28, and 56 film-coated tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: 07/2022

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