Olmesartan/hydrochlorothiazide Aurovitas 40 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olmesartán/Hidroclorotiazida Aurovitas 40 mg/12.5 mg film-coated tablets EFG

olmesartán medoxomilo/hydrochlorothiazide

Read this entire leaflet carefully before you start using 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Olmesartán/Hidroclorotiazida Aurovitas is and what it is used for

Olmesartán/hidroclorotiazida contains two active substances, olmesartán medoxomilo and hidroclorotiazida, which are used in the treatment of high blood pressure (hypertension):

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

• Hidroclorotiazida belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body eliminate excess fluid, causing the kidneys to increase urine production.

You will only be prescribed olmesartán/hidroclorotiazida if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The combined administration of both active substances in this medicine contributes to a greater reduction in blood pressure than either substance given separately.

You may already be taking medicines to treat high blood pressure, but your doctor may wish to prescribe olmesartán/hidroclorotiazida to further lower your blood pressure.

High blood pressure can be controlled with medicines such as olmesartán/hidroclorotiazida 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 decreasing 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 Olmesartan/Hydrochlorothiazide Aurovitas

Do not take Olmesartan/Hydrochlorothiazide Aurovitas

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other ingredients 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 olmesartan/hydrochlorothiazide at the beginning of pregnancy – see Pregnancy section).
• If you have kidney problems.
• If you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have low levels of potassium or sodium, or 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, e.g., due to gallstones).

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

Warnings and precautions

Talk to your doctor before starting to take Olmesartan/Hydrochlorothiazide Aurovitas.

If you have previously experienced breathing 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 olmesartan medoxomil/hydrochlorothiazide, seek medical attention immediately.

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

• An ACE inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may periodically check your kidney function, blood pressure, and blood levels of electrolytes (e.g., potassium).

Also refer to the information in the section “Do not take Olmesartan/Hydrochlorothiazide Aurovitas”.

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.
• Severe or prolonged vomiting or diarrhoea lasting several days.
• Treatment with high doses of medicines that increase urine output (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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking olmesartan/hydrochlorothiazide.

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.
• If you experience vision changes or eye pain, which could be signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to weeks after taking olmesartan/hydrochlorothiazide. This may lead to permanent vision loss if untreated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.

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

Olmesartan/hydrochlorothiazide may increase blood levels of fats and uric acid (which causes gout – painful joint swelling). Your doctor will likely perform occasional blood tests to monitor these possible changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely perform occasional blood tests to monitor this possible change. Some signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, fatigue, low blood pressure (hypotension), weakness, sluggishness, tiredness, drowsiness or restlessness, nausea, vomiting, reduced need to urinate, rapid heartbeat. Inform your doctor if you notice any of these symptoms.

Like 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 closely monitor your blood pressure.

If you are scheduled to undergo tests for parathyroid function, you should stop taking olmesartan/hydrochlorothiazide before the tests.

Athletes should be aware that this medicine may result in a positive doping test.

Inform your doctor if you think you are (or may become) pregnant. Use of olmesartan/hydrochlorothiazide is not recommended at the beginning of pregnancy, and 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 period (see Pregnancy section).

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

Children and adolescents

Olmesartan/hydrochlorothiazide is not recommended for children and adolescents under 18 years of age.

Other medicines and Olmesartan/Hydrochlorothiazide Aurovitas

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 olmesartan/hydrochlorothiazide.

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 Olmesartan/Hydrochlorothiazide Aurovitas” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood when used together with olmesartan/hydrochlorothiazide. These include:
  • Potassium supplements (as well as salt substitutes containing potassium).
  • Medicines that increase urine production (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).
  • Certain painkillers such as aspirin or salicylates.
• The toxicity of lithium (a medicine used to treat mood disorders and certain types of depression) may increase when taken together with olmesartan/hydrochlorothiazide. 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 inflammatory symptoms, including arthritis, taken together with olmesartan/hydrochlorothiazide may increase the risk of kidney failure and reduce the effect of olmesartan/hydrochlorothiazide.
• Sleeping pills, sedatives, and antidepressants, as they may cause a sudden drop in blood pressure upon standing when used with olmesartan/hydrochlorothiazide.
• Certain muscle relaxants such as baclofen and tubocurarine.
• Amifostine and other cancer treatments such as cyclophosphamide or methotrexate.
• Colestyramine and colestipol, medicines used to lower blood fat levels.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, which may reduce the effect of olmesartan/hydrochlorothiazide. Your doctor may advise you to take olmesartan/hydrochlorothiazide 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, respectively, as olmesartan/hydrochlorothiazide may enhance their blood sugar-raising effect.
• 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 to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medicine.
• Cyclosporine, a medicine used to prevent organ transplant rejection.
• Certain antibiotics known as tetracyclines, or sparfloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Certain antacids used to treat excess stomach acid, such as aluminium and magnesium hydroxide, which may slightly reduce the effect of olmesartan/hydrochlorothiazide.
• Cisapride, used to increase gastrointestinal motility.
• Halofantrine, used to treat malaria.

Taking Olmesartan/Hydrochlorothiazide Aurovitas with food and drink

Olmesartan/hydrochlorothiazide can be taken with or without food.

Be cautious when drinking alcohol while taking olmesartan/hydrochlorothiazide, as some people may feel faint or dizzy. 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 olmesartan/hydrochlorothiazide is somewhat reduced in patients of Black ethnicity.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are (or may become) pregnant. Your doctor will usually advise you to stop taking olmesartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of olmesartan/hydrochlorothiazide is not recommended during pregnancy, and must not be used during the third month of pregnancy onward, as it may cause serious harm to your baby if taken from this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Use of olmesartan/hydrochlorothiazide is not recommended during breastfeeding. Your doctor may choose an alternative treatment if you wish to continue breastfeeding.

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 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.

Olmesartan/Hydrochlorothiazide Aurovitas contains lactose

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

3. How to take Olmesartán/Hidroclorotiazida Aurovitas

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

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

Take the tablet with water. If possible, you should take your dose at the same time each day, for example, with breakfast. It is important that you continue taking olmesartan/hydrochlorothiazide until your doctor tells you to stop.

If you take more Olmesartán/Hidroclorotiazida Aurovitas than you should

If you take more tablets than you should, or if a child accidentally swallows one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department, and bring 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: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Olmesartán/Hidroclorotiazida Aurovitas

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

If you stop taking Olmesartán/Hidroclorotiazida Aurovitas

It is important to keep taking olmesartan/hydrochlorothiazide 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.

However, the following adverse effects may be serious:

• Rarely, allergic reactions affecting the whole body may occur, including swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking olmesartan/hydrochlorothiazide and consult your doctor immediately.
• Olmesartan/hydrochlorothiazide 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 olmesartan/hydrochlorothiazide, consult your doctor immediately, and remain lying down in a horizontal position.
  • Frequency not known (cannot be estimated from available data): If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with olmesartan/hydrochlorothiazide some time ago, contact your doctor immediately. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

Olmesartan/hydrochlorothiazide is a combination of two active substances. The following information first describes adverse effects reported so far with the olmesartan/hydrochlorothiazide 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 olmesartan/hydrochlorothiazide:

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

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

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

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

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

Also observed uncommonly are some changes in blood test results, including:

Increased levels of fat in the blood, increased blood urea or uric acid, increased creatinine, increased or decreased levels of potassium in blood, increased calcium levels in blood, increased blood glucose, increased liver function test values. Your doctor will monitor you with a blood test and will advise you whether any action is needed.

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

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

Also observed rarely are some changes in blood test results, including:

Increased blood urea nitrogen, decreased hemoglobin and hematocrit values. Your doctor will monitor you with a blood test and will advise you whether any action is needed.

Additional adverse effects reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with olmesartan/hydrochlorothiazida, or reported more frequently with the individual components:

Olmesartan medoxomil:

Common (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.

Also frequently observed are some changes in blood test results, including:

Increased levels of fat in blood, increased blood urea or uric acid, increased liver or muscle enzyme levels.

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

Also observed uncommonly are some changes in blood test results, including:

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

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

Intestinal angioedema: swelling in the intestine associated with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Worsening of kidney function, lack of energy.

Also observed rarely are some changes in blood test results, including:

Increased potassium levels in blood.

Hydrochlorothiazide:

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

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

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

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

Also observed are some changes in blood test results, including:

Increased levels of creatinine, urea, calcium and blood glucose, decreased levels of chloride, potassium, magnesium and sodium in blood. Increased serum amylase (hyperamylasemia).

Uncommon (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 dots on the skin due to small hemorrhages (purpura), skin swelling (hives).

Rare (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, anemia, bone marrow suppression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellowish vision of objects, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), pancreatitis, jaundice, gallbladder infection, symptoms of lupus erythematosus such as skin rash, joint pain and coldness in hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious inflammation of the kidney (interstitial nephritis), fever, muscle weakness (which may sometimes cause movement disorders).

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

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

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

Frequency not known (cannot be estimated from available data):

• Sudden decrease in distance vision (acute myopia), decreased vision or eye pain due to increased intraocular pressure [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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan/Hydrochlorothiazide Aurovitas

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

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

6. Contents of the pack and other information

Composition of Olmesartan/Hydrochlorothiazide Aurovitas

• The active substances are olmesartan medoxomilo and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), talc, yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the pack

Film-coated tablets, biconvex, oval, reddish-yellow, marked with "K" on one side and "53" on the other.

Olmesartan/Hydrochlorothiazide Aurovitas is available in blister packs.

Pack sizes: 28 and 56 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain:	Olmesartan/Hydrochlorothiazide Aurovitas 40 mg/12.5 mg film-coated tablets EFG
Portugal:	Olmesartan medoxomil + Hydrochlorothiazide Aurovitas

Date of the most recent review of this leaflet: January 2025

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).