Openvas Plus 40 mg/25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Openvas Plus 40 mg/25 mg film-coated tablets

Olmesartan medoxomil/Hydrochlorothiazide

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Openvas 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 body get rid of excess fluid, increasing urine production by the kidneys.

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

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

High blood pressure can be controlled with medicines such as Openvas Plus tablets. Your doctor may also have 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 Openvas Plus

Do not take Openvas 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 Openvas Plus in early pregnancy – see Pregnancy section).
• If you have kidney problems.
• If you have diabetes or renal insufficiency 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), which 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, gallstones).

If you think any of these apply to you, or you 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 take Openvas 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 inhibitor (ACE inhibitor) (e.g. 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 Openvas 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 elimination (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g. primary hyperaldosteronism).
• Diabetes.
• 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, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Openvas 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 Openvas Plus, contact your doctor 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 proceed with your blood pressure treatment.
• Decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from hours to weeks after taking Openvas Plus. This may lead to permanent vision impairment if not treated.

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

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

Openvas Plus may cause increased levels of fats and uric acid (which causes gout – painful joint swelling) in the blood. 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 imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, fatigued, drowsy or restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

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 lead to a 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 Openvas Plus before the tests are performed.

Athletes should be informed that this medicine contains a component that may result in a positive analytical finding in doping control tests.

Inform your doctor if you are pregnant or think you might be pregnant. The use of Openvas 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

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

Using Openvas 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 enhance the effect of Openvas Plus.

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Openvas Plus” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood when used together with Openvas Plus. These include:

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

• Medicines that increase urine elimination (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 Openvas 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 with Openvas Plus, may increase the risk of kidney failure and reduce the effectiveness of Openvas Plus.
  • Sleeping pills, sedatives, and antidepressants, when used with Openvas Plus, may cause a sudden drop in blood pressure upon standing.
  • Certain muscle relaxants such as baclofen and tubocurarine.
  • Amifostine and other cancer treatments 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 Openvas Plus. Your doctor may advise you to take Openvas 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 heart medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis.
  • 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 Openvas 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.

• Difemanil, used to treat slow heart rate or reduce sweating.

• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used in the treatment of 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, as they may slightly reduce the effect of Openvas Plus.

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

• Halofantrine, used for malaria.

Taking Openvas Plus with food and drinks

Openvas Plus can be taken with or without food.

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

Patients of Black race

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

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 Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of Openvas 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 about to start breastfeeding. Openvas Plus is not recommended for breastfeeding mothers, and your doctor may choose a different treatment if you wish to breastfeed.

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.

Use in athletes

Athletes are advised that this medicine contains an ingredient (hydrochlorothiazide) that may result in a positive analytical finding in doping controls.

Driving and operating machinery

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

Openvas Plus contains lactose

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

3. How to take Openvas Plus

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

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

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

If you take more Openvas Plus than you should

If you take more tablets than you should, or if a child accidentally ingests one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department and take the medicine packaging 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 Openvas 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 Openvas Plus

It is important to continue taking Openvas 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 may cause adverse effects, although not everyone will experience them.

However, the following adverse effects may be serious:

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

• Openvas Plus may cause a marked drop in blood pressure in susceptible patients or as a result of an allergic reaction. Fainting or dizziness may occur infrequently. If this happens, stop taking Openvas 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 Openvas Plus some time ago—contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Openvas Plus is a combination of two active substances. The following information first describes the adverse effects reported so far with the combination Openvas Plus (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 Openvas Plus:

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

Frequent 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 forceful heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle cramps and muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine.

Also, some changes in blood test results have 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 glucose 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).

Also, in rare cases, some changes in blood test results have 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 alone, but not with Openvas Plus or at a higher frequency:

Olmesartan medoxomil:

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

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

Also, frequent changes in blood test results have been 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 affecting the whole body, which may cause breathing difficulties and 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).

Also, uncommon changes in blood test results have been observed, 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 causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Also, rare changes in blood test results have been observed, including:

Increase in blood potassium levels.

Hydrochlorothiazide:

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

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

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

Confusion, abdominal pain, stomach discomfort, bloating sensation, diarrhoea, nausea, vomiting, constipation, glucose excretion in urine.

Also, some changes in blood test results have been observed, including:

Increase in creatinine, urea, calcium and blood glucose 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, photosensitivity skin reactions, itching, purple spots or patches on the skin due to small haemorrhages (purpura), skin swelling (hives).

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

Inflammation and pain of the salivary glands, decreased number of white blood cells, decreased number of platelets in blood, anaemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellowish perception of objects when looking at them, 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 systemic lupus erythematosus such as skin rash, joint pain and coldness in hands and fingers, skin allergic reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which may sometimes cause movement disturbances).

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

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

Acute breathing difficulty (symptoms include severe breathing difficulty, fever, weakness and confusion).

Adverse effects not known (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 kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 Plus

Keep this medicine out of 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 on the blister after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Openvas Plus

The active substances are:

Openvas 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 “Openvas Plus contains lactose”

Nature of the product and pack contents

Openvas Plus 40 mg/25 mg film-coated tablets are rose-coloured, oval-shaped tablets of 15 x 7 mm, with the imprint “C25” on one side.

Openvas 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 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

Berlin-Chemie AG

Glienicker Weg 125, D-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:

Germany: Olmes Plus
Italy: Plaunazide
Spain: Openvas Plus

Date of the most recent review 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/.