Leaflet: information for the user

Olmesartan/Hydrochlorothiazide MABO 40 mg/12.5 mg film-coated tablets

Olmesartan medoxomil/hydrochlorothiazide

Read this leaflet carefully before you start taking this medicine,

because it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

- If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What is Olmesartan/Hydrochlorothiazide MABO and what it is 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. Contents of the pack and additional information

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

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

• Hidroclorotiazida belongs to a group of medications called thiazide diuretics.

It decreases blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

Olmesartán/Hidroclorotiazida MABO will only be given if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The concurrent administration of both active substances in Olmesartán/Hidroclorotiazida MABO contributes to reducing blood pressure more than if each substance were administered alone.

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

High blood pressure can be controlled with medications like Olmesartán/Hidroclorotiazida MABO 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 has also probably recommended that you engage in regular exercise, such as walking or swimming. It is essential to follow your doctor's advice.

Do not take Olmesartán/Hidroclorotiazida MABO

• If you are allergic to olmesartan medoxomil or to hydrochlorothiazide, or to any of the other

components 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 best to avoid Olmesartán/Hidroclorotiazida MABO at the beginning of pregnancy - see Pregnancy section).

• If you have kidney problems.

• If you have diabetes or kidney insufficiency and are being treated with a blood pressure lowering medicine that contains aliskiren

• If you have low levels of potassium or sodium in your blood, high levels of calcium or uric acid in your blood (with symptoms of gout or kidney stones), that do not improve with treatment.

• If you have moderate or severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, by gallstones).

If you think you have any of these cases, 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 Olmesartán/Hidroclorotiazida MABO

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

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in your blood (such as potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartán/Hidroclorotiazida MABO”.

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

• Kidney transplant.

• Liver diseases.

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

• Vomiting (feeling dizzy) or diarrhea, that is severe or lasts for several days.

• Treatment with high doses of medicines that increase urine production (diuretics), or if you are on a low-salt diet.

• Problems with the adrenal glands (for example, primary aldosteronism).

• Diabetes.

• Lupus erythematosus (an autoimmune disease).

• Allergy or asthma.

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 an increase in eye pressure, and may occur within a few hours to a week after taking Olmesartán/Hidroclorotiazida MABO. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it.

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV rays while taking Olmesartán/Hidroclorotiazida MABO.

• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking this medicine, seek medical attention immediately.

Contact your doctor if you experience severe, persistent diarrhea, and significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.

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

Olmesartán/Hidroclorotiazida MABO may cause an increase in levels of fats and uric acid in your blood. Your doctor will probably want to perform a blood test from time to time to monitor these possible changes.

You may experience a change in the levels of certain substances in your blood called electrolytes. 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 weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

Like any other medicine that lowers blood pressure, an excessive decrease in blood pressure in patients with heart or brain blood flow problems can cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are to have a parathyroid function test, you should stop taking Olmesartán/Hidroclorotiazida MABO before the test is performed.

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

You should inform your doctor if you are pregnant, think you may be pregnant, or intend to become pregnant. Olmesartán/Hidroclorotiazida MABO 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).

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after takingOlmesartán/Hidroclorotiazida MABO. Your doctor will decide whether to continue treatment. Do not stop takingCandesartán Maboon your own.

Children and adolescents

Olmesartán/Hidroclorotiazida MABO is not recommended for children and adolescents under 18 years old.

Use of Olmesartán/Hidroclorotiazida MABO with other medicines

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

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

• Other blood pressure lowering medicines (anti-hypertensives), as they may increase the effect of Olmesartán/Hidroclorotiazida MABO.

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 aliskiren (see also the information under the headings “Do not take Olmesartán/Hidroclorotiazida MABO” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood if taken at the same time as Olmesartán/Hidroclorotiazida MABO. These include:

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

- Medicines that increase urine production (diuretics).

- Heparin (to thin the blood).

- Laxatives.

- Steroids.

- Adrenocorticotropic hormone (ACTH).

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

- Penicillin G sodium (antibiotic also called benzylpenicillin sodium).

- Some analgesics such as aspirin or salicylates.

• Lithium (medicine used to treat mood changes and some types of depression) if taken at the same time as Olmesartán/Hidroclorotiazida MABO may increase lithium toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.

• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as Olmesartán/Hidroclorotiazida MABO may increase the risk of kidney failure and decrease the effect of Olmesartán/Hidroclorotiazida MABO

• Sedatives, sleep inducers, and antidepressants, used with Olmesartán/Hidroclorotiazida MABO may cause a sudden drop in blood pressure when standing up.

• Some medicines such as baclofen and tubocurarine, used as muscle relaxants.

• Amifostine and other medicines used to treat cancer, such as cyclophosphamide or methotrexate.

• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may decrease the effect of Olmesartán/Hidroclorotiazida MABO. Your doctor may advise you to take Olmesartán/Hidroclorotiazida MABO at least 4 hours before colesevelam hydrochloride.

• Cholestyramine and colestipol, medicines to lower cholesterol levels in the blood.

• Anticholinergic medicines, such as atropine and biperiden.

• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sulpiride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.

• Some medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digital, used to treat heart problems.

• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, that may change 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 Olmesartán/Hidroclorotiazida may intensify the effect of increasing blood sugar levels produced by these medicines.

• Metildopa, 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 transplant rejection.

• Antibiotics from the tetracycline group, or enoxacin.

• Amphotericin, a medicine 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 MABO.

• Cisapride, used to increase stomach and intestinal movement.

• Halofantrine, used to treat malaria.

Taking Olmesartán/Hidroclorotiazida MABO with food and drinks

Olmesartán/Hidroclorotiazida MABO can be taken with or without food.

Be careful when drinking alcohol while taking Olmesartán/Hidroclorotiazida MABO, as some people may feel dizzy or lightheaded. If this happens, do not drink any alcohol, including wine, beer, or drinks with alcohol.

Black patients

Like other similar medicines, the blood pressure lowering effect of Olmesartán/Hidroclorotiazida 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 intend to become pregnant. Your doctor will usually recommend that you stop taking Olmesartán/Hidroclorotiazida MABO before becoming pregnant or as soon as you know you are pregnant, and recommend that you take another medicine instead of Olmesartán/Hidroclorotiazida MABO. Olmesartán/Hidroclorotiazida MABO is not recommended for use during pregnancy, and in any case should not be administered from the third month of pregnancy, as it may cause serious harm to your baby if taken from that time.

Breastfeeding

You should inform your doctor if you are breastfeeding or plan to start breastfeeding. Olmesartán/Hidroclorotiazida MABO is not recommended for use during breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed.

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

Use in athletes

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

Driving and operating machines

You may feel drowsy or lightheaded while taking blood pressure medication. If this happens, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

Olmesartán/Hidroclorotiazida MABO contains lactose

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

Olmesartán/Hidroclorotiazida MABO contains Yellow No. 5

This medicine may cause allergic reactions because it contains Yellow No. 5 (E110). It may cause asthma, especially in patients allergic to aspirin.

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 Olmesartán/Hidroclorotiazida MABO 40 mg/12.5 mg tablet per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 Olmesartán/Hidroclorotiazida MABO 40 mg/25 mg tablet per day.

Take the tablets 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 MABO until your doctor tells you to stop.

If you take more Olmesartán/Hidroclorotiazida 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 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, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Olmesartán/Hidroclorotiazida MABO

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

If you interrupt treatment with Olmesartán/Hidroclorotiazida MABO

It is essential to continue taking Olmesartán/Hidroclorotiazida MABO, 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 medicines, this medicine can cause side effects, although not everyone will experience them.

However, the following side effects can be serious:

• In rare cases, an allergic reaction can 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, stop taking Olmesartán/Hidroclorotiazida MABO and consult your doctor immediately.

• Olmesartán/Hidroclorotiazida MABO can cause a too pronounced drop in blood pressure in susceptible patients or as a result of an allergic reaction. Infrequently, dizziness or fainting may occur.If this happens, stop taking Olmesartán/Hidroclorotiazida MABO, consult your doctor immediately, and remain lying down in a horizontal position.

•Unknown frequency: If you experience yellowing of the white of the eyes, dark urine, skin itching, even if you started treatment withOlmesartán/Hidroclorotiazida MABOsome time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

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

These are other known side effects reported so far with Olmesartán/Hidroclorotiazida:

If these effects occur, they are often mildand you do not need to interrupt treatment.

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

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

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

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

Also, infrequently, some changes in blood tests have been observed that include:

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 measures.

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

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

Also, in rare cases, some changes in blood test results have been observed that include:

Increased urea nitrogen 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 measures.

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

Additional side effects reported with the use of olmesartán medoxomilo or hidroclorotiazida alone, but not with Olmesartán/Hidroclorotiazida MABO or in a higher frequency:

Olmesartán medoxomilo:

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

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

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

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

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

Fast and intense allergic reactions that can affect the whole body and can 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 known as angina pectoris), unpleasant feeling, skin rash, itching, exanthema (skin rash), skin swelling (hives).

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

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

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

Renal function deterioration, lack of energy.

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

Increased potassium levels in the blood.

Hidroclorotiazida:

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

Changes in blood tests that include: increased fat in the blood and increased uric acid levels.

Frequent side effects (can 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 that include:

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

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

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

Rare side effects (can 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), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement alteration).

Very rare side effects (can 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:

Decreased vision or eye pain due to high 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 of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging and in

the blister (after “CAD.:”). The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and

the medication that you no longer need at the SIGRE point of the pharmacy. If in doubt

ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Olmesartán/Hidroclorotiazida MABO

The active principles are olmesartan medoxomil and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 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), red iron oxide (E172) and yellow-orange S (E110).

Appearance of the product and contents of the packaging:

Olmesartán/Hidroclorotiazida MABO 40 mg/12.5 mg is presented in the form of film-coated tablets, orange, oval, 15 mm by 7 mm, with the inscription OH 41 on one face.

Olmesartán/Hidroclorotiazida MABO film-coated tablets are presented in aluminum blisters, in packs of 28 tablets.

Holder of the marketing authorization:

MABO-FARMA, S.A

Calle Rejas 2, 1st floor

28821 Coslada (Madrid)

Spain

Responsible for manufacturing:

Actavis Ltd.,

BLB 016 Bulebel Industrial Estate,

Zejtun ZTN 3000,

Malta

Last review date of this leaflet: February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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