OLMESARTAN AUROVITAS 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartán Aurovitas 40 mg film-coated tablets EFG

Olmesartán medoxomil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Olmesartán Aurovitas and what is it used for
2. What you need to know before you take Olmesartán Aurovitas
3. How to take Olmesartán Aurovitas
4. Possible side effects
5. Storage of Olmesartán Aurovitas
6. Contents of the pack and other information

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

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

Olmesartán Aurovitas is used to treat high blood pressure (also known as hypertension) in adults and in children and adolescents from 6 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. Usually, high blood pressure does not present symptoms. It is important to control your blood pressure to avoid damage.

High blood pressure can be controlled with medicines like Olmesartán Aurovitas tablets. Your doctor has probably also advised you to make some changes to your lifestyle to help lower your blood pressure (e.g., lose weight, stop smoking, reduce alcohol consumption, and reduce salt intake in your diet). Your doctor may also have recommended 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 you take Olmesartán Aurovitas

Do not takeOlmesartán Aurovitas

• If you are allergic to olmesartán medoxomil or any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant (it is also better to avoid olmesartán at the start of pregnancy - see section Pregnancy).
• If you have yellowing of the skin and eyes (jaundice) or problems with bile drainage from the gallbladder (bile duct obstruction, e.g., 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

Tell your doctor before you start taking Olmesartán Aurovitas.

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

• An ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may check your kidney function, blood pressure, and blood 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 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 have 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 cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

You should inform your doctor if you think you are (or might become) pregnant. Olmesartán is not recommended during pregnancy, and it 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 period (see section Pregnancy).

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.

Black patients

As with other similar medicines, the blood pressure-lowering effect of olmesartán is somewhat smaller in black patients.

Elderly patients

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

Children and adolescents

Olmesartán medoxomil has been studied in children and adolescents. For more information, consult your doctor. The use of olmesartán medoxomil is not recommended in children under 6 years of age, and it should not be used in children under 1 year of age, as there is no experience available.

Taking Olmesartán Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor or pharmacist about any of the following medicines:

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

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (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 medicines at the same time as olmesartán may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood changes and some types of depression), as it may increase lithium toxicity when used at the same time as olmesartán. If you have to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines 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 olmesartán when used at the same time.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartán medoxomil. Your doctor may advise you to take olmesartán medoxomil at least 4 hours before colesevelam hydrochloride.
• Certain antacids (indigestion remedies), as they may slightly reduce the effect of olmesartán.

Taking Olmesartán Aurovitas with food and drink

Olmesartán Aurovitas can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking olmesartán before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead. Olmesartán is not recommended during pregnancy, and it should not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after this period.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. The use of olmesartán is not recommended during breastfeeding. Your doctor may choose another treatment if you want to continue breastfeeding, especially if your baby is newborn or premature.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may feel dizzy or sleepy while being treated for high blood pressure. If this happens, do not drive or use machines until the symptoms have gone away. Consult your doctor.

Olmesartán Aurovitas contains lactose

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Olmesartán Aurovitas

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, ask your doctor or pharmacist again.

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 daily.

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, e.g., at breakfast time.

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

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

If you take more Olmesartán Aurovitas than you should

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

If you forget to take Olmesartán Aurovitas

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

If you stop taking Olmesartán Aurovitas

It is important to continue taking olmesartán unless your doctor tells you to stop.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, they are often mild and do not require treatment to be stopped.

The following side effects may be serious, although they are rare:

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

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

Rarely (but more frequently in elderly people), olmesartán may cause a pronounced drop in blood pressure in susceptible individuals or as a result of an allergic reaction. This can cause fainting or severe dizziness. If this happens to you, stop taking olmesartán, consult your doctor immediately, and remain lying down.

Frequency not known (cannot be estimated from the available data)

If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started treatment with olmesartán a long time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

These are other known side effects of olmesartán:

Common side effects(may affect up to 1 in 10 people):

Dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastroenteritis, tiredness, sore throat, nasal congestion and discharge, bronchitis, flu-like symptoms, cough, pain, chest pain, 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 levels in the blood, increased 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 may cause breathing problems, as well as a rapid drop in blood pressure that can lead to fainting (anaphylactic reactions), facial inflammation, vertigo, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (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):

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

Lack of energy, muscle cramps, decreased kidney function, kidney failure.

Some changes in the results of blood tests have also been observed, including increased potassium levels (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 reported more frequently in children, and nosebleeds are a common side effect observed only in children.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartán Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartán Aurovitas

• The active substance is olmesartán medoxomil. Each film-coated tablet contains 40 mg of olmesartán medoxomil.
• The other ingredients are:

Core of the tablet:lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate.

Coating of the tablet:hydroxypropylcellulose, titanium dioxide (E171), talc.

Appearance of the product and contents of the pack

Film-coated tablets, biconvex, oval, white, with the mark “K” on one side and “19” on the other.

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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 under the following names:

Date of last revision of this leaflet: 01/2025

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