Openvas 20 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Openvas 20 mg film-coated tablets

Olmesartan medoxomil

Package leaflet contents

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

1. What is Openvas and what is it used for

Openvas belongs to a group of medicines known as angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

Openvas 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. High blood pressure usually does not cause symptoms. It is important to control your blood pressure to prevent organ damage.

High blood pressure can be managed with medications such as Openvas tablets. Your doctor has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and decreasing salt in your diet). Your doctor may also recommend regular physical exercise, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking Openvas

Do not take Openvas

• 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 advisable to avoid Openvas tablets 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 kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before starting to take Openvas.

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

• an angiotensin-converting enzyme (ACE) inhibitor (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 Openvas”.

Tell your doctor if you have any of the following health problems:

• 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 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 diarrhoea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Consult your doctor if you develop abdominal pain, nausea, vomiting, or diarrhoea after taking Openvas. Your doctor will decide whether to continue treatment. Do not stop taking Openvas on your own.

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 carefully monitor your blood pressure.

You must inform your doctor if you are pregnant or think you might be pregnant. The use of Openvas is not recommended at the beginning of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this stage (see Pregnancy section).

Patients of Black race

As with other similar medicines, the blood pressure-lowering effect of Openvas is somewhat less in patients of Black race.

Elderly patients

If you are 65 years of age or older and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, you will need regular monitoring of your blood pressure by your doctor to ensure it does not drop too low.

Children and adolescents

Openvas has been studied in children and adolescents. For further information, consult your doctor. Openvas 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 this age group.

Taking Openvas 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 Openvas.

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 information under the headings “Do not take Openvas” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine output (diuretics), or heparin (used to thin the blood). Taking these medicines together with Openvas may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood disorders and certain types of depression), as taking it together with Openvas may increase its toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), as taking them together with Openvas may increase the risk of kidney failure and reduce the effect of Openvas.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of Openvas. Your doctor may advise you to take Openvas at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion), as they may slightly reduce the effect of Openvas.

Taking Openvas with food and drink

Openvas can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking Openvas before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Openvas. The use of Openvas is not recommended at the beginning of pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Openvas is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, 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 during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Openvas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Openvas

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended initial dose is 1 tablet of Openvas 10 mg daily. If blood pressure is not adequately controlled, your doctor may increase the dose up 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 water (for example, a glass). 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 daily. If the patient's blood pressure is not adequately controlled, the doctor may decide to adjust the dose up to 20 mg or 40 mg once daily. In children weighing less than 35 kg, the dose must not exceed 20 mg once daily.

If you take more Openvas than you should

If you take more tablets than you should, or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency department immediately and bring the medicine package with you.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Openvas

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

If you stop taking Openvas

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

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 experiences them. If they do occur, they are often mild and do not require discontinuation of treatment.

The following adverse effects can be serious, although not many people may 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: swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking Openvas and consult your doctor immediately.

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

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching—even if you started treatment with Openvas 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 reported with Openvas so far:

Frequent adverse 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, pain, chest pain, back pain, bone pain, joint pain, urinary tract infection, swelling of ankles, feet, legs, hands, arms, blood in urine.

Some changes in certain blood test results have also been observed: increased levels of fat (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), 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 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 of malaise, 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 cells called platelets (thrombocytopenia) has been observed.

Rare adverse 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 accompanied by symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

Other adverse effects in children and adolescents:

Adverse effects observed in children are similar to those reported in adults. However, dizziness and headache have been observed 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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Openvas

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to 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 Openvas

The active substance is olmesartan medoxomilo.

Each film-coated tablet contains 20 mg of olmesartan medoxomilo.

The other components are: microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate, titanium dioxide (E171), talc and hypromellose (see section 2 “Openvas contains lactose”).

Appearance of the product and contents of the pack:

Openvas 20 mg film-coated tablets are white, round tablets with the imprint C14 on one side.

Openvas film-coated tablets are available in packs of 14, 28, 30, 56, 84, 90, 98 and 10 x 28 tablets, and in unit-dose perforated blister packs containing 10, 50 and 500 tablets.

Not all pack sizes are marketed.

Marketing Authorization Holder

Daiichi Sankyo España, S.A.

Paseo del Club Deportivo nº1,

Edificio 14, Planta baja izquierda

28223 Pozuelo de Alarcón - Madrid

Manufacturer

Daiichi Sankyo Europe GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

or

Qualiphar N.V.

Rijksweg, 9

2880 Bornem

Belgium

or

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

or

Menarini - Von Heyden GmbH (MvH)

Leipziger Strasse 7-13

01097 Dresden

Germany

or

LABORATORIOS MENARINI S.A.

Alfonso XII, 587

08918 Badalona (Barcelona)

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Olmes

Italy: Plaunac

Spain: Openvas

Date of the most recent revision of this leaflet: January 2025.

Other sources of information

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