OLMESARTAN/HYDROCHLOROTHIAZIDE AUROVITAS 20 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan/Hydrochlorothiazide Aurovitas 20 mg/12.5 mg film-coated tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Olmesartan/Hydrochlorothiazide Aurovitas is and what it is used for

Olmesartan/hydrochlorothiazide contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used to treat 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 to get rid of excess fluid, making the kidneys produce more urine.

Olmesartan/hydrochlorothiazide will only be given to you if treatment with olmesartan medoxomil alone has not controlled your blood pressure adequately. The combination of the two active substances in this medicine has been shown to be more effective in reducing blood pressure than either substance alone.

You may already be taking medicines for high blood pressure, but your doctor may now want to treat you with olmesartan/hydrochlorothiazide to further lower your blood pressure.

High blood pressure can be controlled with medicines such as olmesartan/hydrochlorothiazide tablets. Your doctor has probably also advised you to make some changes to your lifestyle to help lower your blood pressure (for example, losing weight, stopping smoking, reducing alcohol intake, and reducing the amount of salt in your diet). Your doctor may also have advised you to take regular exercise, such as walking or swimming. It is important to follow this advice.

2. What you need to know before you take Olmesartan/Hydrochlorothiazide Aurovitas

Do not takeOlmesartan/Hydrochlorothiazide Aurovitas

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6) or to medicines similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant (it is also better to avoid olmesartan/hydrochlorothiazide at the start of pregnancy - see section Pregnancy).
• If you have severe kidney problems.
• If you have diabetes or kidney problems and are treated with a blood pressure lowering medicine containing aliskiren.
• If you have low potassium, low sodium, high calcium or high uric acid levels in your blood which cannot be corrected by treatment.
• If you have severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with drainage of bile from the gallbladder (bile duct obstruction, e.g., due to gallstones).

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

Warnings and precautions

Talk to your doctor before you start taking Olmesartan/Hydrochlorothiazide Aurovitas.

If you have had problems with your lungs or breathing (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or difficulty breathing severely after taking olmesartan medoxomil/hydrochlorothiazide, see a doctor immediately.

Before taking the tablets, tell your doctorif you are taking any of the following medicines used to treat high blood pressure:

• a type of medicine called an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may want to check your kidney function, blood pressure, and the levels of certain chemicals in your blood (such as potassium) at regular intervals.

Also, read the information under the headings “Do not take Olmesartan/Hydrochlorothiazide Aurovitas” and “Warnings and precautions”.

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 disease.
• Heart failure or problems with your heart valves or heart muscle.
• Vomiting or diarrhea, which is severe or lasts for a long time.
• Treatment with high doses of medicines that increase urine production (diuretics), or if you are on a low salt diet.
• Problems with your adrenal glands (e.g., primary hyperaldosteronism).
• 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, especially 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 sun exposure and UV rays while taking olmesartan/hydrochlorothiazide.

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

• Severe diarrhea, which is persistent and causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.
• If you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which can occur within hours to weeks after taking olmesartan medoxomil/hydrochlorothiazide. This can lead to permanent loss of vision if not treated. If you have previously been allergic 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.

Olmesartan/hydrochlorothiazide may cause an increase in fat and uric acid levels in your blood. Your doctor will probably want to perform a blood test from time to time to check for these possible changes.

A change in the levels of certain chemicals in your blood (electrolytes) may occur. Your doctor will probably want to perform a blood test from time to time to check for this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, tiredness, sleepiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other medicine that lowers blood pressure, excessively low blood pressure in patients with heart or brain blood flow problems may cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

If you are going to have a parathyroid function test, you should stop taking olmesartan/hydrochlorothiazide before the test.

Athletes should be aware that this medicine may give a positive result in anti-doping tests.

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking olmesartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead. Olmesartan/hydrochlorothiazide is not recommended during 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 after the third month of pregnancy (see section Pregnancy).

Children and adolescents

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

Other medicines and Olmesartan/Hydrochlorothiazide Aurovitas

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Other medicines to lower blood pressure (antihypertensives), as they may increase the effect of olmesartan/hydrochlorothiazide.

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

If you are taking an ACE inhibitor or aliskiren (see also the 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 with olmesartan/hydrochlorothiazide. These medicines include:
• Potassium supplements (and salt substitutes containing potassium).
• Medicines that increase urine production (diuretics).
• Heparin (to thin the blood).
• Laxatives.
• Corticosteroids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (for the treatment of mouth and stomach ulcers).
• Sodium penicillin G (an antibiotic, also known as benzylpenicillin sodium).
• Certain painkillers such as aspirin or salicylates.
• The toxicity of lithium (a medicine used to treat mood changes and some types of depression) may increase if taken with olmesartan/hydrochlorothiazide. If you have to take lithium, your doctor will measure the levels of lithium in your blood.
• Non-steroidal anti-inflammatory medicines (NSAIDs, medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used with olmesartan/hydrochlorothiazide, may increase the risk of kidney problems and reduce the effect of olmesartan/hydrochlorothiazide.
• Sedatives, hypnotics, and antidepressants, as they may cause a sudden drop in blood pressure when standing up, when used with olmesartan/hydrochlorothiazide.
• Certain muscle relaxants such as baclofen and tubocurarine.
• Medicines such as amifostine and certain cancer medicines, such as cyclophosphamide or methotrexate.
• Cholestyramine and colestipol, medicines used to lower blood fat levels.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it 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, trifluperazine, ciamemazine, 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 erythromycin injection, which can change the 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, as olmesartan/hydrochlorothiazide may increase the effect of increasing blood sugar levels caused by these medicines.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines such as noradrenaline, used to increase blood pressure and decrease 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 rejection in transplanted patients.
• Certain antibiotics called tetracyclines, or sparfloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Certain antacids, used to treat stomach acid, such as aluminum and magnesium hydroxide, as they may slightly reduce the effect of olmesartan/hydrochlorothiazide.
• Cisapride, used to increase the movement of food in the stomach and intestines.
• Halofantrine, used to treat malaria.

Taking Olmesartan/Hydrochlorothiazide Aurovitas with food and drink

Olmesartan/hydrochlorothiazide can be taken with or without food.

Be careful when drinking alcohol while taking olmesartan/hydrochlorothiazide, as some people may feel faint or dizzy. If this happens, do not drink any alcohol, including wine, beer, or drinks containing alcohol.

Black patients

As with other similar medicines, the blood pressure-lowering effect of olmesartan/hydrochlorothiazide is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant or plan to become pregnant. Your doctor will normally advise you to stop taking olmesartan/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead. Olmesartan/hydrochlorothiazide is not recommended during 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 after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan/hydrochlorothiazide is not recommended during breastfeeding. Your doctor may choose another treatment if you want to continue breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may feel drowsy or dizzy while being treated for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared. Talk to your doctor.

Olmesartan/Hydrochlorothiazide Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Olmesartan/Hydrochlorothiazide Aurovitas

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended doseis one olmesartan/hydrochlorothiazide 20 mg/12.5 mg tablet per day. If your blood pressure is not controlled sufficiently, your doctor may change the dose to one olmesartan/hydrochlorothiazide 20 mg/25 mg tablet per day.

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

If you take more Olmesartan/Hydrochlorothiazide Aurovitas than you should

If you take more tablets than you should, or if a child accidentally takes some, contact your doctor or go to the nearest hospital casualty department immediately and take the medicine pack with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Olmesartan/Hydrochlorothiazide Aurovitas

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

If you stop taking Olmesartan/Hydrochlorothiazide Aurovitas

It is important to continue taking olmesartan/hydrochlorothiazide unless your doctor tells you to stop.

If you have any further questions on 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 all people suffer from them.

However, the following adverse effects can be serious:

• In rare cases, allergic reactions may occur that can affect the whole body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash. If this happens to you, stop taking olmesartan/hydrochlorothiazide and consult your doctor immediately.
• Olmesartan/hydrochlorothiazide may cause a pronounced drop in blood pressure, in susceptible patients or as a result of an allergic reaction. Dizziness or fainting may occur infrequently. If this happens to you, stop taking olmesartan/hydrochlorothiazide, consult your doctor immediately, and remain lying down in a horizontal position.
  • Frequency not known (cannot be estimated from the available data)

If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with olmesartan/hydrochlorothiazide a long time ago, contact your doctor immediately, who will assess your symptoms and decide how to continue with blood pressure treatment.

Olmesartan/hydrochlorothiazide is a combination of two active ingredients. The following information, first, describes the adverse effects reported so far with the olmesartan/hydrochlorothiazide combination (in addition to those already mentioned) and, second, the known adverse effects of the two active ingredients separately.

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

If these effects occur, they are often mild and it is not necessary 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.

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

Fast and intense heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, and muscle pain, joint pain, arm and leg pain, back pain, erection problems in men, blood in urine.

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

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

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

Feeling of discomfort, altered consciousness, skin swelling (hives), acute kidney failure.

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

Increased blood urea nitrogen, decreased hemoglobin and hematocrit values. Your doctor will monitor you with a blood test and tell you if you need to take any action.

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

Olmesartan medoxomil:

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

Bronchitis, cough, nasal congestion and 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.

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

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

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

Rapid allergic reactions that can affect the whole body and cause breathing problems, as well as a rapid drop in blood pressure that can lead to fainting (anaphylactic reactions), facial inflammation, angina (chest pain or discomfort known as angina pectoris), feeling of discomfort, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

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

Reduction in the number of a type of blood cells 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 rarely, including:

Increased potassium in the blood.

Hydrochlorothiazide:

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

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

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

Feeling of confusion, abdominal pain, stomach discomfort, feeling of bloating, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

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

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

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

Decreased or lost appetite, severe breathing difficulties, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions due to light sensitivity, itching, purple spots or patches 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 white blood cell count, decreased platelet count 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, infection in the gallbladder, lupus erythematosus symptoms such as skin rash, joint pain, and cold hands and fingers, allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which can sometimes cause movement disorders).

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 respiratory distress, fever, weakness, and confusion).

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

• Sudden decrease in distant vision (acute myopia), decreased vision or eye pain due to increased eye 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 it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Olmesartan/Hydrochlorothiazide Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the carton after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Olmesartan/Hydrochlorothiazide Aurovitas

• The active ingredients are olmesartan medoxomil and hydrochlorothiazide. Each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
• The other ingredients 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 package contents

Film-coated tablets, biconvex, round, yellow-red, with the mark "K" on one side and "23" on the other.

Olmesartan/Hydrochlorothiazide Aurovitas is available in blister packs.

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

Only some package 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

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

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 under the following names:

Date of the last revision of this prospectus: April 2022

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