Package Leaflet: Information for the user

Olmesartán/Hidroclorotiazida Aurovitas 20 mg/25 mg film-coated tablets EFG

olmesartán medoxomilo/hidroclorotiazida

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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do 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.

1.What isOlmesartán/Hidroclorotiazida Aurovitasand for what it is used

2.What you need to know before starting totakeOlmesartán/Hidroclorotiazida Aurovitas

3.How to takeOlmesartán/Hidroclorotiazida Aurovitas

4.Possible side effects

5.Storage ofOlmesartán/Hidroclorotiazida Aurovitas

6.Contents of the pack and additional information

Olmesartán/hidroclorotiazidacontains two active ingredients, 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 reduces blood pressure by relaxing blood vessels.

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

They will only give you olmesartán/hidroclorotiazida if treatment with olmesartán medoxomilo alone has not adequately controlled blood pressure. The combined administration of both active ingredients in this medicine contributes to reducing blood pressure more than each substance administered separately.

You may already be taking medicines to treat high blood pressure, but your doctor may want to give you olmesartán/hidroclorotiazida to lower it further.

High blood pressure can be controlled with medicines like olmesartán/hidroclorotiazida tablets. Your doctor has probably also 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 exercise regularly, such as walking or swimming. It is essential to follow your doctor's advice.

Do not takeOlmesartán/Hidroclorotiazida Aurovitas

-If you are allergic toolmesartán medoxomilo or to hidroclorotiazidaor to any of the other components of this medication (including those listed in section 6) or to substances similar to hidroclorotiazida (sulfonamides).

-If you are more than 3 months pregnant (it is also better to avoid olmesartán/hidroclorotiazida at the beginning of pregnancy - see Pregnancy section).

-If you have severe kidney problems.

-If you have diabetes or kidney insufficiency and receive treatment with a medication to reduce blood pressure that contains aliskireno.

-If you have low levels of potassium, 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 severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, e.g., by gallstones).

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

Warnings and precautions

Consult your doctor before starting to take Olmesartán/Hidroclorotiazida Aurovitas.

If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience shortness of breath or severe difficulty breathing after taking olmesartán medoxomilo/hidroclorotiazida, go to your doctor immediately.

Before taking the tablets,tell your doctorifyou are taking any of the following medications 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.

-Aliskireno.

Your doctor may check your kidney function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

Also, see the information under the heading “Do not take Olmesartán/Hidroclorotiazida Aurovitas”.

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

-Mild to moderate kidney problems or if you have recently had a kidney transplant.

-Liver diseases.

-Heart failure or problems with heart valves or heart muscle.

-Vomiting or diarrhea, of intense or prolonged duration.

-Treatment with high doses of medications that increase urine production (diuretics), or if you are following a low-sodium diet.

-Problems with the adrenal glands (e.g., primary aldosteronism).

-Diabetes.

-Lupus erythematosus (an autoimmune disease).

-Allergy or asthma.

• If you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hidroclorotiazida, particularly its 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 exposure and UV rays while taking olmesartán/hidroclorotiazida.

Contact your doctor if you experienceany 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.

-If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within hours to weeks after takingolmesartán/hidroclorotiazida. This can lead to permanent vision loss if not treated. If you have had a previous allergy to penicillin or sulfonamide, you may be at higher risk of developing this.

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

Olmesartán/hidroclorotiazida may cause an increase in levels of fats and uric acid in the blood. Your doctor will probably want to perform blood tests from time to time to monitor these possible changes.

A change in blood levels of certain chemical substances called electrolytes may occur. Your doctor will probably 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.Inform your doctor if you notice any of these symptoms.

Like any other medication that reduces blood pressure, excessive blood pressure reduction in patients with alterations in blood flow to the heart or brain can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

If you are scheduled to undergo parathyroid function tests, stop taking olmesartán/hidroclorotiazida before performing them.

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

Inform your doctor if you think you are (or could be) pregnant. Olmesartán/hidroclorotiazida 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 at this stage (see Pregnancy section).

Children and adolescents

Olmesartán/hidroclorotiazidais not recommended for children and adolescents under 18 years old.

Other medications andOlmesartán/Hidroclorotiazida Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

-Other medications to reduce blood pressure (anti-hypertensives), as they may increase the effect ofolmesartán/hidroclorotiazida.

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskireno (also see the information under the headings “Do not takeOlmesartán/HidroclorotiazidaAurovitas” and “Warnings and precautions”).

-Medications that may alter potassium levels in the blood if used at the same time as olmesartán/hidroclorotiazida. These medications include:

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

•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 called benzylpenicillin sodium).

•Some analgesics such as aspirin or salicylates.

-The toxicity of lithium (medication used to treat mood changes and certain types of depression) may increase if taken at the same time as olmesartán/hidroclorotiazida. 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 olmesartán/hidroclorotiazida, may increase the risk of kidney failure and reduce the effect of olmesartán/hidroclorotiazida.

-Sedatives, hypnotics, and antidepressants, as used with olmesartán/hidroclorotiazida 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 olmesartán/hidroclorotiazida. Your doctor may advise you to take olmesartán/hidroclorotiazida at least 4 hours before colessevelam 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 injection, which may change heart rhythm.

-Oral antidiabetic 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 levels, respectively, as olmesartán/hidroclorotiazida may intensify the effect of increasing blood sugar levels produced by these medications.

-Metildopa, a medication used to treat high blood pressure.

-Medications such as norepinephrine, 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 rejection in organ transplants.

-Some antibiotics called tetracyclines, or enrofloxacin.

-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 olmesartán/hidroclorotiazida.

-Cisapride, used to increase stomach and intestinal movement.

-Halofantrine, used to treat malaria.

TakingOlmesartán/Hidroclorotiazida Aurovitaswith food and drinks

Olmesartán/hidroclorotiazidacan be taken with or without food.

Be careful when drinking alcohol while takingolmesartán/hidroclorotiazida, as some people may feel dizziness or fainting. 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 olmesartán/hidroclorotiazida is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are (or could be) pregnant. Your doctor will usually recommend that you stop taking olmesartán/hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and recommend that you take another medication instead. Olmesartán/hidroclorotiazida is not recommended for use during pregnancy, and in any case, it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby if taken at this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start. Olmesartán/hidroclorotiazida is not recommended for use during breastfeeding. Your doctor may choose another treatment if you want to continue breastfeeding.

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

Driving and operating machinery

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

Olmesartán/Hidroclorotiazida Aurovitascontains 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 dose is 1 tablet of olmesartán/hidroclorotiazida 20 mg/12.5 mg per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of olmesartán/hidroclorotiazida 20 mg/25 mg per day.

Take the tablet with water. If possible, take your dose at the same time every day, for example, at breakfast time. It is essential to continue taking olmesartán/hidroclorotiazida until your doctor tells you to stop.

If you take moreOlmesartán/HidroclorotiazidaAurovitasthan 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 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 taken.

If you forget to takeOlmesartán/HidroclorotiazidaAurovitas

If you forget to take a dose, take your usual dose the next day as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment withOlmesartán/HidroclorotiazidaAurovitas

It is essential to continue taking olmesartán/hidroclorotiazida, unless your doctor tells you to stop.

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:

-Allergic reactions that can affect the entire body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash, may occur in rare cases.If this happens, stop taking olmesartan/hydrochlorothiazide and consult your doctor immediately.

-Olmesartan/hydrochlorothiazidemay cause a significant drop in blood pressure in susceptible patients or as a result of an allergic reaction. In rare cases, dizziness or fainting may occur.If this happens, stop taking olmesartan/hydrochlorothiazide, consult your doctor immediately, and remain lying down in a horizontal position.

• Unknown frequency (cannot be estimated from available data)

If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started taking olmesartan/hydrochlorothiazide some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with the treatment for high blood pressure.

Olmesartan/hydrochlorothiazideis a combination of two active principles. The following information, first, describes the side effects reported so far with the combinationolmesartan/hydrochlorothiazide(in addition to those already mentioned) and, secondly, the side effects known of the two active principles separately.

These are other side effects known so far with olmesartan/hydrochlorothiazide:

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

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

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

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

Fast and intense heart rate (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.

Also, some changes in blood tests have been observed, including:

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased creatinine, increased or decreased levels of potassium in the blood, increased levels of calcium in the 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 action.

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

Unpleasant sensation, alterations in consciousness, skin swelling (hives), acute renal insufficiency.

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

Increased urea in the 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 action.

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

Olmesartan medoxomil:

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

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

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

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

Rare (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 drop in blood pressure that can even lead to fainting (anaphylactic reactions), inflammation of the face, angina (chest pain or discomfort), unpleasant sensation, skin allergic rash, itching, exanthema (skin rash), skin swelling (hives).

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

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

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

Renal function deterioration, lack of energy.

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

Increased potassium in the blood.

Hidroclorotiazida:

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

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

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

Confusion, abdominal pain, stomach discomfort, feeling of swelling, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

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

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

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

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

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

Salivary gland inflammation and pain, decreased number of white blood cells, decreased number of platelets in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, convulsions, yellowish perception of objects when looking at them, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), pancreatitis, jaundice, biliary tract infection, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, skin allergic reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement alteration).

Very rare (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 frequency (cannot be estimated from available data):

•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 hemorrhage) or acute angle-closure glaucoma].•Skin cancer and lip cancer (non-melanoma skin cancer).

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: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.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist if you are unsure how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Olmesartán/Hidroclorotiazida Aurovitas

- The active principles are olmesartán medoxomilo and hidroclorotiazida. Each film-coated tablet contains 20 mg of olmesartán medoxomilo and 25 mg of hidroclorotiazida.

- The other components are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, hydroxypropylcellulose of low degree of substitution, magnesium stearate.

Coating of the tablet: hypromellose, titanium dioxide (E171), talc, yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and contents of the packaging

Film-coated tablets, biconvex, round, pink, with the mark “K” on one face and “24” on the other.

Olmesartán/Hidroclorotiazida Aurovitas is available in blister packaging.

Packaging sizes : 14, 28, and 56 film-coated tablets.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Last review date of this leaflet: April 2022

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