Ixía 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ixia 10 mg film-coated tablets

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 Ixia is and what it is used for
2. What you need to know before taking Ixia
3. How to take Ixia
4. Possible side effects
5. How to store Ixia
6. Contents of the pack and other information

1. What Ixia is and what it is used for

Ixia belongs to a group of medicines known as 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 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 monitor your blood pressure to prevent organ damage.

High blood pressure can be controlled with medicines such as Ixia 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 reducing salt in your diet). Your doctor may also recommend regular physical activity, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking Ixia

Do not take Ixia

• If you are allergic to olmesartan 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 Ixia 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 Ixia.

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 levels of electrolytes in your blood (for example, potassium) at regular intervals.

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

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, 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 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 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 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. Use of Ixia is not recommended at the beginning of pregnancy, and it should 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 Ixia is somewhat reduced 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

Ixia has been studied in children and adolescents. For further information, consult your doctor. Ixia is not recommended for children aged 1 year to less than 6 years, and should not be used in children under 1 year of age, as there is no experience with its use in this age group.

Taking Ixia 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 Ixia.

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 Ixia” 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 Ixia 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 Ixia. 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 Ixia may increase the risk of kidney failure and reduce the effect of Ixia.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of Ixia. Your doctor may advise you to take Ixia at least 4 hours before colesevelam hydrochloride.
• Certain antacids (remedies for indigestion), 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 pregnant. Your doctor will advise you to stop taking Ixia before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine instead of Ixia. The use of Ixia is not recommended during early 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. Ixia is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you intend 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 operating machinery

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

Ixia contains lactose

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

3. How to take Ixia

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

The recommended initial dose is 1 tablet of Ixia 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 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 Ixia than you should

If you take more tablets than necessary 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 Ixia

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 Ixia

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

Rarely (but slightly more frequently in elderly patients), Ixia may cause a marked drop in blood pressure in susceptible patients, or as a result of an allergic reaction. This may lead to fainting or severe dizziness. If this happens to you, stop taking Ixia, 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 Ixia some time ago—contact your doctor immediately. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

The following are other adverse effects known so far with Ixia:

Common 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 pain, bone pain, joint pain, urinary tract infection, swelling of ankles, feet, legs, hands or arms, blood in urine.

Some changes in certain blood test results have also been observed:

increase in fat levels (hypertriglyceridaemia), increase in uric acid levels (hyperuricaemia), increase in 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, vertigo, 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 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 causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Some changes in certain blood test results have been observed. These include increased levels of potassium in the blood (hyperkalaemia) 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 common 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 Ixia

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 containers and medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Ixia

The active substance is olmesartan medoxomil.

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

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

Appearance of the product and contents of the pack

Ixia 10 mg film-coated tablets are white, round tablets with the imprint C13 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 pre-cut blisters containing 10, 50 and 500 tablets.

Not all pack sizes are marketed.

Marketing Authorization 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)
Spain

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, contact the local representative of the Marketing Authorization Holder

Laboratorios Menarini, S.A.
Alfons XII, 587 - Badalona (Barcelona), Spain
“under license from Daiichi Sankyo Europe GmbH”

This medicine is authorized in the European Economic Area member states 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 the most recent review of this summary: 01/2025

Other sources of information

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