OLMESARTAN/HYDROCHLOROTHIAZIDE MABO 20 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan/Hydrochlorothiazide MABO 20 mg/25 mg Film-Coated Tablets EFG

Olmesartan medoxomil/hydrochlorothiazide

Read the entire package leaflet carefully before starting to take this medication,

as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others,

even if they have the same symptoms as you, as it may harm them.

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

Contents of the Package Leaflet

1. What is Olmesartan/Hydrochlorothiazide MABO and what is it used for
2. What you need to know before taking Olmesartan/Hydrochlorothiazide MABO
3. How to take Olmesartan/Hydrochlorothiazide MABO
4. Possible side effects
5. Storage of Olmesartan/Hydrochlorothiazide MABO
6. Package Contents and Additional Information

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

Olmesartan/Hydrochlorothiazide MABO contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used to treat high blood pressure (hypertension):

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

Hydrochlorothiazide belongs to a group of medications called thiazide diuretics. It lowers blood pressure by helping to remove excess fluids, increasing urine production by the kidneys.

• Olmesartan medoxomil and hydrochlorothiazide will only be given if treatment with olmesartan medoxomil alone has not adequately controlled your blood pressure. The combination of both active substances in Olmesartan/Hydrochlorothiazide MABO helps to lower blood pressure more than either substance alone.

You may already be taking medications to treat high blood pressure, but your doctor may think it is necessary for you to take Olmesartan/Hydrochlorothiazide MABO to lower it further.

High blood pressure can be controlled with medications like Olmesartan/Hydrochlorothiazide MABO tablets. Your doctor has probably also recommended that you make some changes to your lifestyle to help lower your blood pressure (e.g., lose weight, stop smoking, reduce alcohol consumption, and reduce 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.

2. What you need to know before taking Olmesartan/Hydrochlorothiazide MABO

Do not take Olmesartan/Hydrochlorothiazide MABO

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or any of the other ingredients of this medication (listed in section 6) or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are pregnant for more than 3 months. (It is also best to avoid Olmesartan/Hydrochlorothiazide MABO at the start of pregnancy - see section Pregnancy).
• If you have severe kidney problems.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication containing aliskiren.
• If you have low potassium or sodium levels in your blood, high calcium or uric acid levels in your blood (with symptoms of gout or kidney stones), which 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 (bile duct obstruction, e.g., due to gallstones).

If you think any of these apply to you, 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 use Olmesartan/Hydrochlorothiazide MABO.

Before taking the tablets, tell your doctorif you 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), especially if you have kidney problems related to diabetes.
• Aliskiren.

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

See also the information under the heading “Do not take Olmesartan/Hydrochlorothiazide MABO”.

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 heart valves or heart muscle.
• Vomiting (while feeling nauseous) or diarrhea that is severe or lasts for several days.
• Treatment with high doses of medications that increase urine production (diuretics) or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g., primary hyperaldosteronism).
• Diabetes.
• Systemic lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• 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, and can occur within hours to a week after taking Olmesartan/Hydrochlorothiazide MABO. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamide, you may have a higher risk of developing it.
• 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 and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Olmesartan/Hydrochlorothiazide MABO.
• If you have had respiratory or lung 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 this medication, seek medical attention immediately.

Contact your doctor if you suffer from severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

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

Olmesartan/Hydrochlorothiazide MABO may cause an increase in blood fat and uric acid levels (which can cause gout - painful swelling of the joints). Your doctor will probably want to perform a blood test from time to time to monitor these possible changes.

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will probably want to perform a blood test 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 of weakness, slowness, tiredness, drowsiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other medication that lowers blood pressure, an excessive decrease in blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are going to have parathyroid function tests, you should stop taking Olmesartan/Hydrochlorothiazide MABO before these tests are performed.

Athletes are informed that this medication contains a component that may result in a positive doping test.

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking Olmesartan/Hydrochlorothiazide MABO before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take a different medication instead of Olmesartan/Hydrochlorothiazide MABO. It is not recommended to use Olmesartan/Hydrochlorothiazide MABO during pregnancy, and it should not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken at this stage.

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

Children and Adolescents

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

Using Olmesartan/Hydrochlorothiazide MABO with Other Medications

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

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

• Other blood pressure-lowering medications (antihypertensives), as they may increase the effect of Olmesartan/Hydrochlorothiazide MABO.

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 Olmesartan/Hydrochlorothiazide MABO” and “Warnings and Precautions”).

• Medications that may alter potassium levels in the blood when used at the same time as Olmesartan/Hydrochlorothiazide MABO. These include:
• Potassium supplements (as well as salt substitutes that contain potassium).
• Medications that increase urine production (diuretics).
• Heparin (to thin the blood).
• Laxatives.
• Steroids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (medication for treating mouth and stomach ulcers).
• Sodium penicillin G (antibiotic also known as benzylpenicillin sodium).
• Certain pain relievers like aspirin or salicylates.
• Lithium (medication used to treat mood changes and some types of depression) may increase lithium toxicity when used at the same time as Olmesartan/Hydrochlorothiazide MABO. If you need to take lithium, your doctor will measure lithium levels in your blood.

• Non-steroidal anti-inflammatory medications (NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as Olmesartan/Hydrochlorothiazide MABO, may increase the risk of kidney failure and reduce the effect of Olmesartan/Hydrochlorothiazide MABO.

• Sedatives, sleep-inducing medications, and antidepressants used with Olmesartan/Hydrochlorothiazide MABO may cause a sudden drop in blood pressure when standing up.
• Certain medications such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medications used for cancer treatment, such as cyclophosphamide or methotrexate.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of Olmesartan/Hydrochlorothiazide MABO. Your doctor may advise you to take Olmesartan/Hydrochlorothiazide MABO at least 4 hours before colesevelam hydrochloride.
• Colestyramine and colestipol, medications for lowering fat levels in the blood.
• Anticholinergic medications, such as atropine and biperiden.
• Medications such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiaprida, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Certain medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used in the treatment of heart problems.
• Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injection, which can change heart rhythm.
• Oral antidiabetic medications, such as metformin, or insulin, used to lower blood sugar levels.
• Beta-blockers and diazoxide, medications used in the treatment of high blood pressure or low blood sugar, respectively, as Olmesartan/Hydrochlorothiazide MABO may enhance the blood sugar-increasing effect of these medications.
• Methyldopa, a medication used to treat high blood pressure.
• Medications such as noradrenaline, used to increase blood pressure and decrease heart rate.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Medications such as probenecid, sulfinpyrazone, and allopurinol, used in the treatment of gout.
• Calcium supplements.
• Amantadine, an antiviral medication.
• Cyclosporine, a medication used to prevent organ transplant rejection.
• Antibiotics from the tetracycline group or esparfloxacin.
• Amphotericin, a medication used to treat fungal infections.
• Certain antacids, used to treat stomach acid excess, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of Olmesartan/Hydrochlorothiazide MABO.

• Cisapride, used to increase food movement in the stomach and intestine.
• Halofantrine, used for malaria.

Taking Olmesartan/Hydrochlorothiazide MABO with Food and Drinks

Olmesartan/Hydrochlorothiazide MABO can be taken with or without food.

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

Black Patients

As with other similar medications, the blood pressure-lowering effect of Olmesartan/Hydrochlorothiazide MABO is somewhat less in black patients.

Pregnancy and Breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking Olmesartan/Hydrochlorothiazide MABO before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take a different medication instead of Olmesartan/Hydrochlorothiazide MABO. It is not recommended to use Olmesartan/Hydrochlorothiazide MABO during pregnancy, and it should not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken at this stage.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. It is not recommended to use Olmesartan/Hydrochlorothiazide MABO during breastfeeding, and your doctor may choose a different treatment for you if you want to breastfeed.

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

Use in Athletes

Athletes are informed that this medication contains a component (hydrochlorothiazide) that may result in a positive doping test.

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. Consult your doctor.

Olmesartan/Hydrochlorothiazide MABO Contains Lactose

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

3. How to Take Olmesartan/Hydrochlorothiazide MABO

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

The recommended dose is 1 tablet of Olmesartan/Hydrochlorothiazide MABO 20 mg/12.5 mg per day. If your blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartan/Hydrochlorothiazide MABO 20 mg/25 mg per day.

Take the tablets with water. If possible, take your dose at the same time each day, for example, at breakfast time. It is essential to continue taking Olmesartan/Hydrochlorothiazide MABO until your doctor tells you to stop.

If You Take More Olmesartan/Hydrochlorothiazide MABO Than You Should

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

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

If You Forget to Take Olmesartan/Hydrochlorothiazide MABO

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

If You Stop Taking Olmesartan/Hydrochlorothiazide MABO

It is essential to continue taking Olmesartan/Hydrochlorothiazide MABO unless your doctor tells you to stop.

If you have any other questions about using this medication, 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 MABO and consult your doctor immediately.

Olmesartan/Hydrochlorothiazide MABO may cause a pronounced drop in blood pressure in susceptible patients or as a result of an allergic reaction. Dizziness or fainting can occur infrequently. If this happens to you, stop taking Olmesartan/Hydrochlorothiazide MABO, 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 Olmesartan/Hydrochlorothiazide MABO a long time ago, contact your doctor immediately, who will evaluate your symptoms and decide how to continue with blood pressure treatment.

Olmesartan/Hydrochlorothiazide MABO is a combination of two active ingredients. The following information describes the adverse effects reported so far with the Olmesartan/Hydrochlorothiazide combination (in addition to those already mentioned) and 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.

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

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

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

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

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 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 Adverse Effects (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, 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.

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

Additional Adverse Effects Reported with the Use of Olmesartan Medoxomil or Hydrochlorothiazide Alone, but Not with Olmesartan/Hydrochlorothiazide MABO or at a Higher Frequency:

Olmesartan Medoxomil:

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

Bronchitis, cough, nasal congestion or 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, including:

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

Uncommon Adverse Effects (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 decrease 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, including:

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

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

Renal function deterioration, lack of energy.

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

Increased potassium levels in the blood.

Hydrochlorothiazide:

Very Common Adverse Effects (may affect more than 1 in 10 people):

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

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

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

Uncommon Adverse Effects (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 Adverse Effects (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, seizures, yellowish perception of objects when looking at them, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, 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 (sometimes causing movement disorders).

Very Rare Adverse 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 (signs include severe respiratory distress, fever, weakness, and confusion).

Unknown Frequency:

Decreased vision or eye pain due to high 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 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: https://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 MABO

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging and blister (after "EXP.:"). The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Olmesartan/Hydrochlorothiazide MABO

The active ingredients are olmesartan medoxomil and hydrochlorothiazide. Each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

The other components (excipients) are: lactose monohydrate, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate, titanium dioxide (E 171), macrogol, triacetin, hypromellose, yellow iron oxide (E 172), and red iron oxide (E 172).

Product Appearance and Package Contents:

Olmesartan/Hydrochlorothiazide MABO 20 mg/25 mg is presented in the form of film-coated tablets, pink, round, 8.5 mm in size, with the inscription OH 22 on one side.

Olmesartan/Hydrochlorothiazide MABO film-coated tablets are presented in aluminum blisters, in packages of 28 tablets.

Marketing Authorization Holder:

MABO-FARMA, S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer:

Actavis Ltd.,

BLB 016 Bulebel Industrial Estate,

Zejtun ZTN 3000,

Malta.

Date of the Last Revision of this Prospectus: February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es/