Ixía Plus 40/25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ixia Plus 40 mg/25 mg film-coated tablets

Olmesartan medoxomil / Hydrochlorothiazide

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, ask 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ixia Plus is and what it is used for

Ixia Plus contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used in the treatment of high blood pressure (hypertension):

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

• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the removal of excess fluid, increasing urine production by the kidneys.

Ixia Plus will only be prescribed if treatment with Ixia (olmesartan medoxomil) alone has not adequately controlled your blood pressure. The combined administration of both active substances in Ixia Plus contributes to a greater reduction in blood pressure than either substance administered alone.

You may already be taking medicines to treat high blood pressure, but your doctor may consider it necessary for you to take Ixia Plus to lower it further.

High blood pressure can be managed with medicines such as Ixia Plus 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 consumption, and reducing 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 your doctor's advice.

2. What you need to know before taking Ixia Plus

Do not take Ixia Plus

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other components of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant. (It is also advisable to avoid Ixia Plus in early pregnancy – see Pregnancy section).
• If you have kidney problems.
• If you have diabetes or renal failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have low levels of potassium or sodium in your blood, high levels of calcium or uric acid in your blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• If you have moderate or severe liver problems, yellowing of the skin or eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example due to gallstones).

If you think any of these apply to you, or are unsure, do not take the tablets. Speak to your doctor and follow their advice.

Warnings and precautions

Talk to your doctor before starting to use Ixia Plus.

Before taking the tablets, 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 electrolyte levels (e.g., potassium) at regular intervals.

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

Before taking the tablets, tell your doctor if you have any of the following health conditions:

• Kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Vomiting (with dizziness) or diarrhoea that is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine output (diuretics), or if you are on a low-salt diet.
• Problems with your adrenal glands (e.g., primary hyperaldosteronism).
• Diabetes.
• Systemic lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Ixia Plus.
• If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Ixia Plus, seek medical help immediately.

Contact your doctor if you experience any of the following symptoms:

• Severe, persistent diarrhoea causing significant weight loss. Your doctor will assess your symptoms and decide how to continue your blood pressure treatment.
• Vision disturbances or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which may occur from hours to weeks after taking Ixia Plus. This may lead to permanent vision loss if not treated.

Your doctor may want to see you more frequently and carry out some tests if you have any of these problems.

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

Ixia Plus may increase blood levels of lipids and uric acid (which causes gout – painful joint swelling). Your doctor will likely want to perform blood tests from time to time to monitor these possible changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely want to perform blood tests periodically to monitor this possible change. Some signs of electrolyte imbalances include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy, restless, vomiting, reduced need to urinate, or rapid heartbeat. Tell your doctor if you notice any of these symptoms.

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 heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for tests of parathyroid function, you should stop taking Ixia Plus before the tests are performed.

Athletes are advised that this medicine contains a component (hydrochlorothiazide) that may result in a positive analytical doping test.

You should inform your doctor if you are pregnant or think you might be pregnant. The use of Ixia Plus is not recommended in early 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).

Children and adolescents

Ixia Plus is not recommended for children and adolescents under 18 years of age.

Taking Ixia Plus 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 (antihypertensives), as they may increase the effect of Ixia Plus.

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 Ixia Plus” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood when used at the same time as Ixia Plus. These include:

• Potassium supplements (as well as salt substitutes containing potassium).

• Medicines that increase urine output (diuretics).

• Heparin (a blood thinner).

• Laxatives.

• Steroids.

• Adrenocorticotropic hormone (ACTH).

• Carbenoxolone (a medicine used to treat mouth and stomach ulcers).

• Sodium penicillin G (an antibiotic also known as sodium benzylpenicillin).

• Some painkillers such as aspirin or salicylates.

  • Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used with Ixia Plus. 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), when used together with Ixia Plus, may increase the risk of kidney failure and reduce the effect of Ixia Plus.
  • Sleeping pills, sedatives, and antidepressants, used with Ixia Plus, may cause a sudden drop in blood pressure upon standing.
  • Certain medicines such as baclofen and tubocurarine, used as muscle relaxants.
  • Amifostine and other cancer treatment medicines such as cyclophosphamide or methotrexate.
  • Cholestyramine and colestipol, medicines used to lower blood fat levels.
  • Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, which may reduce the effect of Ixia Plus. Your doctor may advise you to take Ixia Plus at least 4 hours before colesevelam hydrochloride.
  • Anticholinergic medicines such as atropine and biperiden.
  • Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
  • Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.
  • Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, which may alter heart rhythm.

• Oral antidiabetic medicines such as metformin, or insulin, used to lower blood sugar levels.

• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar levels, respectively, since Ixia Plus may enhance the blood sugar-raising effect of these medicines.

• Methyldopa, a medicine used to treat high blood pressure.

• Medicines such as noradrenaline, used to increase blood pressure and reduce heart rate.

• Difemanyl, used to treat slow heartbeat or reduce sweating.

• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.

• Calcium supplements.

• Amantadine, an antiviral medicine.

• Cyclosporine, a medicine used to prevent organ transplant rejection.

• Antibiotics from the tetracycline group or sparfloxacin.

• Amphotericin, a medicine used to treat fungal infections.

• Some antacids used to treat excess stomach acid, such as aluminium and magnesium hydroxide, which may slightly reduce the effect of Ixia Plus.

• Cisapride, used to increase movement of food through the stomach and intestine.

• Halofantrine, used to treat malaria.

Taking Ixia Plus with food and drinks

Ixia Plus can be taken with or without food.

Be cautious when drinking alcohol while taking Ixia Plus, as some people may feel weakness or dizziness. If this happens, avoid alcohol, including wine, beer, or alcoholic soft drinks.

Patients of Black ethnicity

As with other similar medicines, the blood pressure-lowering effect of Ixia Plus is somewhat reduced in patients of Black ethnicity.

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 Ixia Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Ixia Plus. The use of Ixia Plus is not recommended during pregnancy, and it must not be taken after the first 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 planning to breastfeed. Ixia Plus is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Use in athletes

Athletes are advised that this medicine contains a component (hydrochlorothiazide) that may result in a positive analytical doping test.

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.

Ixia Plus contains lactose

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

3. How to take Ixia Plus

Follow exactly the instructions for use of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is 1 tablet of Ixia Plus 40 mg/12.5 mg daily. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Ixia Plus 40 mg/25 mg daily.

Take the tablets with water. If possible, take your dose at the same time each day, for example, at breakfast time. It is important that you continue taking Ixia Plus until your doctor tells you to stop.

If you take more Ixia Plus than you should

If you take more tablets than prescribed or if a child accidentally swallows one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department, and take the medicine package with you.

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, indicating the medicine and the amount ingested.

If you forget to take Ixia Plus

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

If you stop taking Ixia Plus

It is important to continue taking Ixia Plus 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 experiences them.

However, the following adverse effects may be serious:

• Rarely, allergic reactions may occur that can affect the whole body, with swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking Ixia Plus and consult your doctor immediately.

• In sensitive individuals or as a result of an allergic reaction, Ixia Plus may cause blood pressure to drop too low. Fainting or dizziness may occur infrequently. If this happens, stop taking Ixia Plus, 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 Plus some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

Ixia Plus is a combination of two active substances. The following information first describes the adverse effects reported so far with the Ixia Plus combination (in addition to those already mentioned), and secondly, the known adverse effects of each of the two active substances when used separately.

These are other known adverse effects reported so far with Ixia Plus:

If these effects occur, they are often mild and you do not need to stop treatment.

Common adverse effects (may affect up to 1 in 10 people):

Dizziness, weakness, headache, fatigue, chest pain, swelling of ankles, feet, legs, hands or arms.

Uncommon adverse effects (may affect up to 1 in 100 people):

Rapid and strong heartbeat (palpitations), rash, eczema, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint, arm and leg pain, back pain, erectile problems in men, blood in urine.

Some changes in blood test results have also been observed uncommonly, including:

Increase in blood fat levels, increase in blood urea or uric acid, increase in creatinine, increase or decrease in blood potassium levels, increase in blood calcium levels, increase in blood sugar levels, increase in liver function test values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

Rare adverse effects (may affect up to 1 in 1,000 people):

Feeling unwell, disturbances in consciousness, skin swelling (hives), acute kidney failure.

In rare cases, some changes in blood test results have also been observed, including:

Increase in blood urea nitrogen, decrease in haemoglobin and haematocrit values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

Additional adverse effects reported with olmesartan medoxomil or hydrochlorothiazide when used alone, but not with Ixia Plus or at a higher frequency:

Olmesartan medoxomil:

Common adverse effects (may affect up to 1 in 10 people):

Bronchitis, cough, nasal congestion and discharge, sore throat, abdominal pain, indigestion, diarrhea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain.

Some changes in blood test results have also been frequently observed, including:

Increase in blood fat levels, increase in blood urea or uric acid, increase in liver or muscle function test levels.

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, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

Some changes in blood test results have also been observed uncommonly, including:

Reduction in the number of a type of blood cells called platelets (thrombocytopenia).

Rare adverse effects (may affect up to 1 in 1,000 people):

Worsening of kidney function, lack of energy; intestinal angioedema: swelling in the intestine associated with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Some changes in blood test results have also been observed rarely, including:

Increase in blood potassium levels.

Hydrochlorothiazide:

Very common adverse effects (may affect more than 1 in 10 people):

Changes in blood tests including: increase in blood fat levels and in uric acid levels.

Common adverse effects (may affect up to 1 in 10 people):

Feeling confused, abdominal pain, stomach discomfort, bloating sensation, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

Some changes in blood test results have also been observed, including:

Increase in creatinine, urea, calcium and blood sugar levels, decrease in blood chloride, potassium, magnesium and sodium levels. Increase in serum amylase (hyperamylasemia).

Uncommon adverse effects (may affect up to 1 in 100 people):

Decreased or loss of appetite, severe difficulty breathing, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light-sensitive skin reactions, itching, purple spots or dots on the skin due to minor bleeding (purpura), skin swelling (hives).

Rare adverse effects (may affect up to 1 in 1,000 people):

Inflammation and pain of the salivary glands, decrease in white blood cell count, decrease in platelet count, anaemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellow vision, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, symptoms of lupus erythematosus (such as skin rash, joint pain, coldness in hands and fingers), skin allergic reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing movement disorders).

Very rare adverse effects (may affect up to 1 in 10,000 people):

Electrolyte imbalance which may cause abnormally low levels of chloride in blood (hypochloraemic alkalosis), intestinal obstruction (paralytic ileus).

Acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

Adverse effects with unknown frequency (cannot be estimated from available data):

Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Skin and lip cancer (non-melanoma skin cancer).

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ixia Plus

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging and blister (after “EXP.”). The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ixia Plus

The active substances are:

Ixia Plus 40 mg/25 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

The other components are: microcrystalline cellulose, lactose monohydrate*, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, titanium dioxide (E171), talc, hypromellose and iron (III) oxides (E172).

• See previous section “Ixia Plus contains lactose”

Appearance of the product and contents of the pack

Ixia Plus 40 mg/25 mg film-coated tablets are pinkish, oval tablets, 15 x 7 mm, with the imprint “C25” on one side.

Ixia Plus film-coated tablets are available in packs of 14, 28, 30, 56, 84, 90, 98, 10 x 28 and 10 x 30 tablets, and in packs containing single-dose perforated blisters of 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

Local representative:

Laboratorios Menarini, S.A.

Alfonso XII, 587 - Badalona (Barcelona) Spain

Manufacturer

DAIICHI SANKYO EUROPE GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

or

Berlin-Chemie AG

Glienicker Weg 125

12489 Berlin

Germany

or

Menarini - Von Heyden GmbH

Leipziger Strasse 7-13, 01097 Dresden

Germany

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

Austria: Mencord Plus

Belgium: Belsar Plus

Cyprus: Olartan-plus

Czech Republic: Sarten Plus H

Denmark: Benetor Comp

Estonia: Mesar plus

Germany: Votum plus

Greece: Olartan-plus

France: Alteis Duo

Hungary: Laresin Plus

Ireland: Omesar Plus

Italy: Olprezide

Latvia: Mesar plus

Lithuania: Mesar plus

Luxembourg: Belsar Plus

Malta: Omesar plus

Portugal: Olsar Plus

Slovakia: Tenzar Plus

Slovenia: Co-Tensiol

Spain: Ixia Plus

Date of the most recent review of this summary: 01/2025

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/