OPENVAS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Openvas 10 mg Film-Coated Tablets

Olmesartan Medoxomil

Contents of the Package Leaflet

1. What is Openvas and what is it used for
2. What you need to know before you take Openvas
3. How to take Openvas
4. Possible side effects
5. Storing 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 called 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 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 cause symptoms. It is important to control your blood pressure to prevent damage.

High blood pressure can be controlled with medicines like Openvas tablets. Your doctor will probably also have recommended that you make some changes to your lifestyle to help lower your blood pressure (e.g., lose weight, stop smoking, reduce the amount of alcohol you drink, and reduce the amount of salt in your diet). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is important to follow this advice from your doctor.

2. What you need to know before you take 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 better to avoid Openvas tablets 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 obstruction, e.g., due to gallstones).
• If you have diabetes or kidney problems and are being treated with a medicine to lower blood pressure that contains aliskiren.

Warnings and precautions

Consult your doctor before starting to take Openvas.

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

• An angiotensin-converting enzyme inhibitor (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 Openvas”.

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 medicines that increase urine production (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 suffer from severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea 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, an excessive drop in blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

You should inform your doctor if you are pregnant or think you might be. Openvas is not recommended at the start 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 at this stage (see section Pregnancy).

Black patients

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

Elderly patients

If you are 65 years or older and your doctor decides to increase the dose of olmesartan medoxomil to 40 mg per day, you will need your doctor to check your blood pressure regularly to ensure it does not drop too much.

Children and adolescents

Openvas has been studied in children and adolescents. For more information, consult your doctor. Openvas is not recommended in children under 6 years of age, and it must not be used in children under 1 year of age, as there is no experience with its use.

Using Openvas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 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 Openvas” and “Warnings and precautions”).

• Potassium supplements, salt substitutes containing potassium, medicines that increase urine production (diuretics), or heparin (to thin the blood). Using these medicines at the same time as Openvas 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 Openvas. 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 Openvas.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, 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 (indigestion remedies), 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

You should inform your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking Openvas before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Openvas. Openvas is not recommended at the start of pregnancy, and it must not be taken when you are more than 3 months pregnant, as it may cause serious harm to your baby if taken from the third month of pregnancy onwards.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Openvas is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you want to breastfeed, especially if your baby is newborn or premature.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may feel drowsy or dizzy while taking blood pressure-lowering therapy. If this happens, do not drive or use machines until the symptoms have gone away. Consult your doctor.

Openvas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Openvas

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended initial dose is 1 Openvas 10 mg tablet per day. If your blood pressure is not controlled adequately, 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 problems, 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 per day. 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 who weigh less than 35 kg, the dose will not exceed 20 mg once daily.

If you take more Openvas than you should

If you have taken more tablets than you should, contact your doctor or the nearest hospital emergency department immediately and take the medicine pack with you.

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

If you forget to take Openvas

If you forget to take a dose, take your normal 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 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.

Rarely (may affect up to 1 in 1,000 people), the following allergic reactions that can affect the whole body have been reported: swelling of the face, mouth, and/or throat, along with itching and skin rash. If this happens to you, stop taking Openvas and consult your doctor immediately.

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

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

Common side 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 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), swelling of the face, dizziness, vomiting, weakness, feeling unwell, muscle pain, skin rash, allergic skin rash, itching, skin eruption (rash), skin swelling (hives), angina (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, worsening of kidney function, kidney failure, intestinal angioedema: swelling in the intestine that occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Some changes in the results of certain blood tests have been observed, including increased levels of potassium in the blood (hyperkalemia) and increased levels of components 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 via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Openvas

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 and blister after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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

What Openvas contains

The active substance is olmesartan medoxomil.

Each film-coated tablet contains 10 mg of olmesartan medoxomil.

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

Appearance and packaging

Openvas 10 mg film-coated tablets are white, round, and have the inscription C13 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 packs with single-dose blisters of 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Olmes

Italy: Plaunac

Spain: Openvas

Date of last revision of this leaflet:January 2025.

Other sources of information

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