Olmesartan Aurovitas 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Olmesartán Aurovitas 10 mg film-coated tablets EFG

Olmesartan medoxomil

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet; 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 must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 side 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 can lead to heart attack, heart or kidney failure, stroke, or blindness. Usually, high blood pressure does not cause symptoms. It is important to control 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 olmesartan 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 best to avoid olmesartan at the beginning of 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 insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before starting 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 electrolyte levels (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, 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 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, 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 closely monitor your blood pressure.

You must inform your doctor if you think you are (or could be) pregnant. Olmesartan is not recommended during early pregnancy, and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if taken at 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.

Patients of black origin

As with other similar medicines, the blood pressure-lowering effect of olmesartan 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 olmesartan medoxomil to 40 mg daily, you will need regular blood pressure checks by your doctor to ensure your blood pressure does not become too low.

Children and adolescents

Olmesartan medoxomil has been studied in children and adolescents. For further information, consult your doctor. The use of olmesartan medoxomil is not recommended in children from 1 year to less than 6 years of age, and must not be used in children under 1 year of age, as there is no experience with its use in this age group.

Taking Olmesartán Aurovitas with other medicines

Inform 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 enhance the effect of olmesartan.

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

If you are taking an angiotensin-converting enzyme inhibitor (ACEI) 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 output (diuretics), or heparin (a blood thinner). 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 taken 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 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 olmesartan when taken together.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartan medoxomil. Your doctor may advise you to take olmesartan medoxomil at least 4 hours before colesevelam hydrochloride.
• Some antacids (remedies for indigestion), as they may slightly reduce the effect of olmesartan.

Taking Olmesartán Aurovitas with food and drink

Olmesartán Aurovitas can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will usually advise you to stop taking olmesartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartan 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 this point.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan is not recommended during breastfeeding. Your doctor may choose an alternative treatment if you wish to continue breastfeeding, especially if your baby is a 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 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 him before taking this medicine.

3. How to take Olmesartán Aurovitas

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended initial dose is 1 tablet of 10 mg daily. If blood pressure is not adequately controlled, your doctor may increase the dose to 20 mg or 40 mg daily 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 liquid (for example, 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 number: 91 562 04 20, stating the name of the medicine and the amount taken. It is recommended to bring the medicine package 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 missed 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 can 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 not many people 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, 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 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. Your doctor will evaluate 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 blood laboratory test results have also been observed: increase in fat levels (hypertriglyceridaemia), increase in uric acid levels (hyperuricaemia), increase in blood urea, elevations 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 entire 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, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives), angina pectoris (chest pain or discomfort).

In blood laboratory 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, presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

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

Some changes in blood laboratory test results have also been observed. These include increased potassium levels (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, 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 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 the sight and reach of children.

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

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and packaging 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 10 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, iron oxide red (E172), iron oxide yellow (E172).

Appearance of the product and pack contents

Film-coated tablets, biconvex, round, orange in colour, marked “K” on one side and “17” on the other.

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

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised 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 on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).