IXIA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ixia 20 mg Film-Coated Tablets

Olmesartan 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 Package Leaflet

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

1. What is Ixia and what is it used for

Ixia belongs to a group of medicines called angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

Ixia 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 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 Ixia tablets. Your doctor will probably also recommend that you make some lifestyle changes to help lower your blood pressure (such as losing weight, quitting smoking, reducing the amount of alcohol you drink, and reducing the amount of salt in your diet). Your doctor may also recommend 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 Ixia

Do not take Ixia

• 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 Ixia 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 duct obstruction, for example, due to gallstones).
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and Precautions

Consult your doctor before starting to take Ixia.

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) (for example, 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 (such as potassium) at regular intervals.

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

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.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Ixia. Your doctor will decide whether to continue treatment. Do not stop taking Ixia 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 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. Ixia 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 Ixia is slightly less 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 need your doctor to regularly check your blood pressure to ensure it does not decrease too much.

Children and Adolescents

Ixia has been studied in children and adolescents. For more information, consult your doctor. Ixia 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 it.

Using Ixia 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 Ixia.

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

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Ixia” and “Warnings and Precautions”).

• Potassium supplements, salt substitutes that contain potassium, diuretics, or heparin (to thin the blood). Using these medicines at the same time as Ixia 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 Ixia. 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 decrease the effect of Ixia when used at the same time.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may decrease the effect of Ixia. Your doctor may advise you to take Ixia at least 4 hours before colesevelam hydrochloride.
• Certain antacids (indigestion remedies), as they may slightly reduce the effect of Ixia.

Taking Ixia with Food and Drink

Ixia 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 Ixia before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Ixia. Ixia 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 used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Ixia is not recommended in breastfeeding mothers, and your doctor may choose another treatment if you wish 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 during treatment for high blood pressure. If this happens, do not drive or use machines until the symptoms have gone away. Consult your doctor.

Ixia contains Lactose

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

3. How to Take Ixia

Follow exactly the instructions of administration of this medicine given to you by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended initial dose is 1 Ixia 10 mg tablet 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 problems, the maximum dose is 20 mg once a day.

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, for example, 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 a day. In children who weigh less than 35 kg, the dose will not exceed 20 mg once a day.

If you take more Ixia than you should

In case of taking a larger amount of tablets than necessary, or if a child has accidentally ingested tablets, contact your doctor or the nearest hospital emergency department immediately and take the medicine package with you.

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

If you forget to take Ixia

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

If you stop taking Ixia

It is important to continue taking Ixia 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 usually 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: swelling of the face, mouth, and/or larynx, along with itching and skin rash. If this happens to you, stop taking Ixia and consult your doctor immediately.

Rarely (but slightly more often in elderly patients), Ixia 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 Ixia, 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 Ixia 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 Ixia:

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:

increase in fat levels (hypertriglyceridemia), increase in uric acid levels (hyperuricemia), increase in urea in the blood, increases in 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 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 (skin rash), hives (skin swelling), 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 causes symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Some changes in the results of certain blood tests have been observed, including increased potassium levels 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 and Healthcare Products 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 Ixia

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 the month shown.

No special storage conditions are required.

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 Ixia

The active substance is olmesartan medoxomil.

Each film-coated tablet contains 20 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 “Ixia contains lactose”).

Appearance and Packaging of the Product

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

Ixia 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 Authorisation Holder

Menarini International Operations Luxembourg, S.A.

1, Avenue de la Gare L-1611 Luxembourg

Manufacturer

Berlin-Chemie AG

Glienicker Weg 125, D-12489 Berlin

Germany

or

DAIICHI SANKYO EUROPE GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

or

Laboratorios Menarini, S.A.

Alfons XII, 587 – E 08918 Badalona (Barcelona)

or

Qualiphar N.V.

Rijksweg 9, 2880 Bornem

Belgium

or

Menarini - Von Heyden GmbH (MvH)

Leipziger Strasse 7-13

01097 Dresden,

Germany

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder

Laboratorios Menarini, S.A.

Alfons XII, 587 - Badalona (Barcelona) Spain

“under license from Daiichi Sankyo Europe GmbH”

This medicine is authorised in the Member States of the European Economic Area under the following names:

Austria: Mencord

Belgium: Belsar

Cyprus: Olartan

Czech Republic: Sarten

Denmark: Benetor

Germany: Votum

Greece: Olartan

Finland: Benetor

France: Alteis

Iceland: Benetor

Ireland: Omesar

Italy: Olpress

Luxembourg: Belsar

Malta: Omesar

Norway: Benetor

Poland: Revival

Portugal: Olsar

Slovenia: Tensiol

Spain: Ixia

Date of last revision of this leaflet:01/2025

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 Healthcare Products (AEMPS) http://www.aemps.gob.es/