Leaflet: information for the user

Openvas Plus 40 mg/12.5 mg film-coated tablets

Olmesartan medoxomil/Hydrochlorothiazide

Read this 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 must not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

• Hydrochlorothiazide belongs to a group of medications called thiazide diuretics. It reduces blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

Openvas Plus will only be given if treatment with Openvas (olmesartan medoxomil) alone has not adequately controlled your blood pressure. The concurrent administration of both active ingredients in Openvas Plus contributes to reducing blood pressure more than if each active ingredient were administered alone.

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

High blood pressure can be controlled with medications like Openvas Plus tablets. Your doctor may also have recommended that you make some 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 engage in regular exercise, such as walking or swimming. It is essential to follow your doctor's advice.

Do not take Openvas Plus

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

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

Warnings and precautions

Consult your doctor before starting to take Openvas Plus.

Before taking the tablets, tell your doctor if you are taking any of the following medications used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme inhibitor (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 electrolyte levels in the blood (for example, potassium) at regular intervals.

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

Before taking the tablets,tell your doctorif you have any of the following health problems:

• Renal transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe or prolonged vomiting (while feeling dizzy) or diarrhea.
• Treatment with high doses of medications that increase urine elimination (diuretics), or if you are on a low-sodium diet.
• Problems with the adrenal glands (for example, primary aldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• If you have had skin cancer or if you 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 skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV rays while taking Openvas Plus.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Openvas Plus, seek medical attention immediately.

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

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.
• Decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased intraocular pressure, which can occur from a few hours to several weeks after taking Openvas Plus. This can lead to permanent vision loss if not treated.

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

Openvas Plus may cause an increase in blood levels of fats 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.

There may be a change in blood levels of certain chemical substances called electrolytes. Your doctor will likely want to perform blood tests from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

Like any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with blood flow problems in the heart or brain can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

If you are to undergo parathyroid function tests, stop taking Openvas Plus before the tests are performed.

It is reported to athletes that this medication contains a component that may establish a positive analytical result for doping control.

Inform your doctor if you are pregnant or think you may be pregnant. Openvas Plus is not recommended for use 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 period (see Pregnancy section).

Children and adolescents

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

Use of Openvas Plus with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Particularly, inform your doctor or pharmacist about any of the following medications:

• Other blood pressure-lowering medications (anti-hypertensives), as they may increase 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 the information under the headings “Do not take Openvas Plus” and “Warnings and precautions”).

• Medications that may alter potassium levels in the blood if used at the same time as Openvas Plus. These include:

-Potassium supplements (as well as salt substitutes that contain potassium).

-Medications that increase urine elimination (diuretics).

-Heparin (to thin the blood).

-Laxatives.

-Glucocorticoids.

-Adrenocorticotropic hormone (ACTH).

-Carbenoxolone (medication for the treatment of mouth and stomach ulcers).

-Penicillin G sodium (antibiotic also known as benzylpenicillin sodium).

-Some analgesics such as aspirin or salicylates.

• Lithium (medication used to treat mood changes and certain types of depression) if used at the same time as Openvas Plus may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as Openvas Plus may increase the risk of kidney failure and reduce the effect of Openvas Plus.
• Sedatives, hypnotics, and antidepressants, used with Openvas Plus may cause a sudden drop in blood pressure when standing up.
• Some medications such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medications used to treat cancer, such as cyclophosphamide or methotrexate.
• Colestiramine and colestipol, medications to reduce blood fat levels.
• Colesevelam hydrochloride, a medication that reduces blood cholesterol levels, as it may reduce the effect of Openvas Plus. Your doctor may advise you to take Openvas Plus at least 4 hours before colesevelam hydrochloride.
• Anticholinergic medications, such as atropine and biperiden.
• Medications such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Some medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digital, used to treat heart problems.
• Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injectables, which may change heart rhythm.

• Oral diabetes medications, such as metformin, or insulin, used to reduce blood sugar levels.
• Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar, respectively, as Openvas Plus may intensify the effect of increasing blood sugar that these medications produce.
• Metildopa, a medication used to treat high blood pressure.
• Medications such as noradrenaline, used to increase blood pressure and reduce heart rate.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Medications such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medication.
• Ciclosporin, a medication used to prevent organ transplant rejection.
• Antibiotics from the tetracycline group or ciprofloxacin.
• Amphotericin, a medication used to treat fungal infections.
• Some antacids, used to treat excess stomach acid, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of Openvas Plus.
• Cisapride, used to increase stomach and intestinal movement.
• Halofantrine, used to treat malaria.

Taking Openvas Plus with food and drinks

Openvas Plus can be taken with or without food.

Be careful when drinking alcohol while taking Openvas Plus, as some people may feel weak or dizzy. If this happens, do not drink any alcohol, including wine, beer, or alcoholic beverages.

Black patients

Like other similar medications, the blood pressure-lowering effect of Openvas Plus is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you may 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 advise you to take another medication instead of Openvas Plus. Openvas Plus is not recommended for use during 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 period.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Openvas Plus is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you want 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 medication.

Use in athletes

It is reported to athletes that this medication contains a component (hydrochlorothiazide) that may establish a positive analytical result for doping control.

Driving and operating machines

You may feel drowsy or dizzy while taking Openvas Plus for high blood pressure. If this happens, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

Openvas Plus contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended doseis 1 OpenvasPlus 40 mg/12.5 mg tablet per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 OpenvasPlus 40 mg/25 mg tablet per day.

Take the tablets with water. If possible, take your doseat the same time every day, for example, at breakfast time. It is essential to 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 take or if a child accidentally ingests one or more tablets, contact your doctor immediately or go to the nearest hospital emergency center and bring the medication packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Openvas Plus

If you forget to take a dose, take the usual dose the next day.Do nottake a double dose to compensate for the missed doses.

If you interrupt treatment with Openvas Plus

It is essential to continue taking Openvas Plus, unless your doctor tells you to stop treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

However, the following side effects may be serious:

• In rare cases, an allergic reaction may occur that can affect the entire body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash.If this happens, stop taking Openvas Plus and consult your doctor immediately..

• In sensitive individuals or as a result of an allergic reaction, Openvas Plus may cause blood pressure to drop too low. Infrequently, dizziness or fainting may occur.If this happens, stop taking Openvas Plus, consult your doctor immediately, and remain lying down in a horizontal position.

• Unknown frequency: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with Openvas Plus some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

Openvas Plus is a combination of two active principles. The following information, first, describes the side effects reported so far with the combination Openvas Plus (in addition to those already mentioned) and, second, the known side effects of the two active principles separately.

These are other side effects known so far with Openvas Plus:

If these effects occur, they are often mild anddo not need to interrupt treatment.

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

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

Rare side effects (may affect up to 1 in 100 people):

Fast and intense heartbeat (palpitations), hives, eczema, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain, arm and leg pain, back pain, erectile dysfunction in men, blood in urine.

Infrequently, some changes in blood tests have also been observed, including:

Increased levels of blood fat, increased urea or uric acid in blood, increased creatinine, increased or decreased levels of potassium in blood, increased levels of calcium in blood, increased blood sugar, increased values of liver function tests. Your doctor will monitor you through a blood test and tell you if you need to take any measures.

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

Feeling unwell, alterations in consciousness, skin swelling (hives), acute renal insufficiency.

Infrequently, some changes in blood test results have also been observed, including: increased urea nitrogen in blood, decreased values of hemoglobin and hematocrit. Your doctor will monitor you through a blood test and tell you if you need to take any measures.

Additional side effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not with Openvas Plus or at a higher frequency:

Olmesartan medoxomil:

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

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

Infrequently, some changes in blood test results have also been observed, including: increased levels of blood fat, increased urea or uric acid in blood, increased levels of liver or muscle function.

Rare side effects (may affect up to 1 in 100 people):

Quick allergic reactions that can affect the entire body and may cause breathing problems, as well as a rapid decrease in blood pressure that can even lead to fainting (anaphylactic reactions), inflammation of the face, angina (chest pain or discomfort known as angina pectoris), feeling unwell, skin allergic rash, itching, exanthema (skin rash), skin swelling (hives).

Infrequently, some changes in blood test results have also been observed, including: reduction in the number of a type of blood cell called platelets (thrombocytopenia).

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

Renal function deterioration, lack of energy.

Infrequently, some changes in blood test results have also been observed, including: increased potassium in blood.

Hidroclorotiazida:

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

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

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

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

Infrequently, some changes in blood test results have also been observed, including: increased creatinine, urea, calcium, and sugar levels in blood, decreased levels of chloride, potassium, magnesium, and sodium in blood. Increased serum amylase (hyperamylasemia).

Rare side effects (may affect up to 1 in 100 people):

Loss of appetite, severe difficulty breathing,allergic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light-sensitive skin reactions, itching, purple spots on the skin due to small hemorrhages (purpura), skin swelling (hives).

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

Salivary gland inflammation and pain, decreased white blood cell count, decreased platelet count in blood, anemia, 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 lungs, pancreatitis, jaundice, gallbladder infection, symptoms of lupus erythematosus (such as skin rash, joint pain, and cold hands and fingers), skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness(which sometimes causes movement alteration).

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

Electrolyte imbalance that can cause an abnormally low level of chloride in the blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus).

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

Unknown side effects (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 hemorrhage) or acute angle-closure glaucoma).

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging and blister (after “CAD.”).The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Openvas Plus

The active principles are:

Openvas Plus 40 mg/12.5 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

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

* See previous section“Openvas Plus contains lactose”

Appearance of the product and contents of the packaging

Openvas Plus 40 mg/12.5 mg film-coated tablets are yellow-brown, oval-shaped, 15 x 7 mm, with the inscription “C23” on one face.

Openvas Plus film-coated tablets are presented in packs of 14, 28, 30, 56, 84, 90, 98, 10 x 28 and 10 x 30 tablets, and in packs with pre-cut single-dose blisters of 10, 50 and 500 tablets.

Not all packs are marketed.

Marketing Authorization Holder:

Daiichi Sankyo España, S.A.

Paseo del Club Deportivo nº1,

Edificio 14, Ground floor left

28223 Pozuelo de Alarcón - Madrid

Responsible for manufacturing:

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 medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Olmes Plus

Italy: Plaunazide

Spain: Openvas Plus

Last review date of this leaflet: March 2022

Other sources of information

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/