Olmesartan Aurovitas 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Olmesartán Aurovitas 20 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, ask 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Olmesartán Aurovitas belongs to a group of medicines called angiotensin II receptor antagonists. It lowers 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 aged 6 to less than 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 managed with medicines such as Olmesartán Aurovitas tablets. Your doctor may also have advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing salt intake). 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 taking Olmesartán Aurovitas

Do not take Olmesartán Aurovitas

• If you are allergic to olmesartán medoxomilo 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 olmesartán 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 renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before starting to take Olmesartán Aurovitas.

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

• An ACE inhibitor (ACEI) (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 blood levels of electrolytes (for example, potassium) at regular intervals.

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

Tell 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, diarrhoea, treatment with high doses of medicines that increase urine elimination (diuretics), or if you are on a low-salt diet.
• High blood potassium levels.
• Problems with the adrenal glands.

Contact your doctor if you experience severe, persistent diarrhoea causing 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, an excessive drop in 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 closely monitor your blood pressure.

You must inform your doctor if you think you are (or might be) pregnant. Use of olmesartán is not recommended in early pregnancy, and must not be taken after the third month of pregnancy, 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 diarrhoea after taking olmesartán. Your doctor will decide whether to continue treatment. Do not stop taking olmesartán on your own.

Patients of black origin

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

Elderly patients

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

Children and adolescents

Olmesartán medoxomilo has been studied in children and adolescents. For further information, consult your doctor. Use of olmesartán medoxomilo is not recommended in children aged 1 year to less than 6 years, and must not be used in children under 1 year of age, as there is no experience with its use in these age groups.

Taking Olmesartán Aurovitas with other medicines

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

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

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

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

If you are taking an angiotensin-converting enzyme (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, medicines that increase urine elimination (diuretics), or heparin (a blood thinner). Taking these medicines together with olmesartán may increase blood potassium levels.
• Lithium (a medicine used to treat mood disorders and certain types of depression), as taking it together with olmesartán may increase lithium toxicity. If you need to take lithium, your doctor will monitor your blood lithium levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as taking them together with olmesartán may increase the risk of kidney failure and reduce the effect of olmesartán.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, 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 (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 breast-feeding

Pregnancy

Inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking olmesartán before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartán is not recommended during pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby if used from that stage.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. Use of olmesartán is not recommended during breast-feeding. Your doctor may choose an alternative treatment if you wish to continue breast-feeding, especially if your baby is a newborn or premature.

If you are pregnant or breast-feeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Olmesartán Aurovitas contains lactose

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

3. How to take Olmesartán Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor. If in 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 impairment, 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 of water). If possible, take your dose at the same time each day, for example, with breakfast.

Children and adolescents aged 6 to less than 18 years:

The recommended initial dose is 10 mg once daily. If the patient's blood pressure is not adequately controlled, the doctor may decide to adjust the dose up 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine's packaging and leaflet 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 normal. Do not take a double dose to make up for forgotten doses.

If you stop taking Olmesartán Aurovitas

It is important to continue taking olmesartan, 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 will experience them. If they do occur, they are often mild and do not require discontinuation of treatment.

The following adverse effects may be serious, although they affect only a small number of people:

Rare cases (may affect up to 1 in 1,000 people) of the following allergic reactions, which may affect the entire body, have been reported:

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

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

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

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

The following are other known adverse effects associated with olmesartan so far:

Frequent adverse effects (may affect up to 1 in 10 people):

Dizziness, headache, nausea, indigestion, diarrhoea, stomach pain, gastroenteritis, fatigue, 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 (hypertriglyceridaemia), increased levels of uric acid (hyperuricaemia), increased 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 drop in blood pressure that may even lead to fainting (anaphylactic reactions), facial swelling, dizziness, vomiting, weakness, malaise, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives), angina pectoris (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):

Intestinal angioedema: swelling in the intestine associated with symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

Lack of energy, muscle cramps, reduced kidney function, renal failure.

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

Other adverse effects in children and adolescents:

In children, adverse 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 frequent adverse effect observed only in children.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan Aurovitas

Keep this medicine out of sight and reach of children.

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

Store below 30ºC.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartán Aurovitas

• The active substance is olmesartan medoxomil. Each film-coated tablet contains 20 mg of olmesartan medoxomil.
• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate.

Tablet coating: hydroxypropylcellulose, titanium dioxide (E171), talc.

Appearance of the product and contents of the pack

Film-coated tablets, biconvex, round, white, marked with "K" on one side and "18" on the other.

Olmesartán Aurovitas is available in blisters made of Polyamide/Aluminum/PVC-Aluminum.

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

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

Date of the most recent review of this leaflet: 01/2025

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