Olmesartan/hydrochlorothiazide Mabo 20 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartan/Hydrochlorothiazide MABO 20 mg/25 mg film-coated tablets EFG

Olmesartan medoxomil/hydrochlorothiazide

Read the entire 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, and must not be given to other

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

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are

effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Olmesartan/Hydrochlorothiazide MABO is 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. How to store Olmesartan/Hydrochlorothiazide MABO
6. Contents of the pack and other information

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

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

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

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

Olmesartán/Hidroclorotiazida MABO will only be prescribed if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The combined administration of both active substances in Olmesartán/Hidroclorotiazida MABO contributes to a greater reduction in blood pressure than when either substance is given alone.

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

High blood pressure can be controlled with medicines such as Olmesartán/Hidroclorotiazida MABO tablets. Your doctor has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing salt intake). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking Olmesartán/Hidroclorotiazida MABO

Do not take Olmesartán/Hidroclorotiazida MABO

• If you are allergic to olmesartán medoxomil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant. (It is also best to avoid Olmesartán/Hidroclorotiazida MABO in early pregnancy – see Pregnancy section).
• If you have severe kidney problems.
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing 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 severe liver problems, yellowing of the skin or eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).

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

Warnings and precautions

Talk to your doctor before starting to use Olmesartán/Hidroclorotiazida MABO.

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

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

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (for example, potassium) at regular intervals.

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

Before taking the tablets, tell your doctor if you have any of the following health conditions:

• 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 (feeling dizzy) or diarrhoea that is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine output (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (for example, primary hyperaldosteronism).
• Diabetes.
• 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 eye pressure, which may occur within a few hours to a week after taking Olmesartán/Hidroclorotiazida MABO. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this.
• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of some types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Olmesartán/Hidroclorotiazida MABO.
• If you have had breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop severe shortness of breath or difficulty breathing after taking this medicine, contact your doctor immediately.

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

Your doctor may want to see you more often and carry out some blood tests if you have any of these conditions.

Olmesartán/Hidroclorotiazida MABO may cause increased levels of fats and uric acid (which causes gout – painful joint swelling) in the blood. Your doctor will likely want to carry out blood tests from time to time to monitor these possible changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely want to carry out blood tests periodically to monitor this possible change. Some signs of electrolyte imbalances are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy or restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for parathyroid function tests, you should stop taking Olmesartán/Hidroclorotiazida MABO before the tests are performed.

Athletes are advised that this medicine contains a component that may result in a positive analytical finding in doping controls.

Inform your doctor if you are pregnant, think you might be pregnant, or plan to become pregnant. Use of Olmesartán/Hidroclorotiazida MABO is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this stage (see Pregnancy section).

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

Children and adolescents

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

Taking Olmesartán/Hidroclorotiazida MABO with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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

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

If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Olmesartán/Hidroclorotiazida MABO” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood when used together with Olmesartán/Hidroclorotiazida MABO. These include:

  • Potassium supplements (as well as salt substitutes containing potassium).
  • Medicines that increase urine output (diuretics).
  • Heparin (a blood thinner).
  • Laxatives.
  • Steroids.
  • Adrenocorticotropic hormone (ACTH).
  • Carbenoxolone (a medicine used to treat mouth and stomach ulcers).
  • Sodium penicillin G (an antibiotic also known as sodium benzylpenicillin).
  • Some painkillers such as aspirin or salicylates.

• Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used together with Olmesartán/Hidroclorotiazida MABO. If you need to take lithium, your doctor will monitor lithium levels in your blood.

• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with Olmesartán/Hidroclorotiazida MABO, may increase the risk of kidney failure and reduce the effect of Olmesartán/Hidroclorotiazida MABO.

• Sleeping pills, sedatives, and antidepressants, used together with Olmesartán/Hidroclorotiazida MABO, may cause a sudden drop in blood pressure upon standing.

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

• Amifostine and other cancer treatments such as cyclophosphamide or methotrexate.

• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may reduce 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 used to lower blood fat levels.

• Anticholinergic medicines such as atropine and biperiden.

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

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

• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, which may alter heart rhythm.

• Oral antidiabetic medicines such as metformin, or insulin, used to lower blood sugar levels.

• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, since Olmesartán/hydrochlorothiazide may enhance the blood sugar-raising effect of these medicines.

• Methyldopa, a medicine used to treat high blood pressure.

• Medicines such as noradrenaline, used to increase blood pressure and reduce heart rate.

• Difemanil, used to treat slow heart rate or reduce sweating.

• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used in the treatment of gout.

• Calcium supplements.

• Amantadine, an antiviral medicine.

• Cyclosporine, a medicine used to prevent organ transplant rejection.

• Antibiotics from the tetracycline group, or sparfloxacin.

• Amphotericin, a medicine used to treat fungal infections.

• Some antacids used to treat excess stomach acid, such as aluminium and magnesium hydroxide, which may slightly reduce the effect of Olmesartán/Hidroclorotiazida MABO.

• Cisapride, used to increase movement of food through the stomach and intestine.

• Halofantrine, used for malaria.

Taking Olmesartán/Hidroclorotiazida MABO with food and drinks

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

Be cautious when drinking alcohol while taking Olmesartán/Hidroclorotiazida MABO, as some people may feel faint or dizzy. If this happens, avoid alcohol, including wine, beer, or alcoholic soft drinks.

Patients of Black race

As with other similar medicines, the blood pressure-lowering effect of Olmesartán/Hidroclorotiazida MABO is somewhat reduced in patients of Black race.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Use of Olmesartán/Hidroclorotiazida MABO is not recommended during breastfeeding, and your doctor may choose another treatment if you wish to breastfeed.

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

Use in athletes

Athletes are advised that this medicine contains a component (hydrochlorothiazide) that may result in a positive analytical finding in doping controls.

Driving and using machines

You may feel drowsy or dizzy while being treated for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartán/Hidroclorotiazida MABO contains lactose

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

3. How to take Olmesartán/Hidroclorotiazida MABO

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

The recommended dose is 1 tablet of Olmesartán/Hidroclorotiazida MABO 20 mg/12.5 mg daily. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartán/Hidroclorotiazida MABO 20 mg/25 mg daily.

Take the tablets with water. If possible, take your dose at the same time each day, for example, with breakfast. It is important that you 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 swallows one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department, and bring the medicine packaging with you.

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

If you forget to take Olmesartán/Hidroclorotiazida MABO

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

If you stop taking Olmesartán/Hidroclorotiazida MABO

It is important to continue taking Olmesartán/Hidroclorotiazida MABO unless your doctor tells you to stop.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects,
although not everyone experiences them.

However, the following adverse effects may be serious:

• Rarely, allergic reactions may occur that can affect the entire body, with
  swelling of the face, mouth and/or larynx, together 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 too pronounced a drop in blood pressure in susceptible patients or as a result of an allergic reaction. Fainting or dizziness may occur infrequently. If this happens to you, stop taking Olmesartan/Hydrochlorothiazide MABO, consult your doctor immediately, and remain lying down in a horizontal position.

• Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with Olmesartan/Hydrochlorothiazide MABO some time ago, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Olmesartan/Hydrochlorothiazide MABO is a combination of two active substances. The following information first describes adverse effects reported so far with the combination Olmesartan/Hydrochlorothiazide (in addition to those already mentioned), and secondly, the known adverse effects of each of the two active substances when used separately.

The following 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 discontinue treatment.

Frequent 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):
Rapid and strong heartbeat (palpitations), rash, eczema, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint, arm and leg pain, back pain, erectile dysfunction in men, blood in urine.

Uncommonly, the following changes in blood test results have also been observed:
Increase in blood fat levels, increase in blood urea or uric acid, increase in creatinine, increase or decrease in blood potassium levels, increase in blood calcium levels, increase in blood sugar, increase in liver function test values. Your doctor will monitor you through a blood test and will advise you whether any action is needed.

Rare adverse effects (may affect up to 1 in 1,000 people):
Feeling unwell, disturbances in consciousness, skin swelling (hives), acute kidney failure.

Rarely, the following changes in blood test results have also been observed:
Increase in blood urea nitrogen, decrease in hemoglobin and hematocrit values. Your doctor will monitor you through a blood test and will advise you whether any action is needed.

Intestinal angioedema: swelling in the intestine presenting 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:

Frequent adverse effects (may affect up to 1 in 10 people):
Bronchitis, cough, nasal congestion or discharge, sore throat, abdominal pain, indigestion, diarrhea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain.

Frequently observed changes in blood test results include:
Increase in blood fat levels, increase in blood urea or uric acid, increase in liver or muscle function test levels.

Uncommon adverse effects (may affect up to 1 in 100 people):
Rapid allergic reactions affecting the whole body that may cause breathing difficulties and a rapid drop in blood pressure, which may even lead to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives).

Uncommonly observed changes in blood test results include:
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):
Worsening of kidney function, lack of energy.

Rarely observed changes in blood test results include:
Increase in blood potassium levels.

Hydrochlorothiazide:

Very frequent adverse effects (may affect more than 1 in 10 people):
Changes in blood tests including: increase in blood fat levels and blood uric acid levels.

Frequent adverse effects (may affect up to 1 in 10 people):
Confusion, abdominal pain, stomach discomfort, bloating sensation, diarrhea, nausea, vomiting, constipation, glucose in urine.

Changes observed in blood test results include:
Increase in creatinine, urea, calcium and blood sugar levels, decrease in blood chloride, potassium, magnesium and sodium levels. Increase in serum amylase (hyperamylasemia).

Uncommon adverse effects (may affect up to 1 in 100 people):
Decreased or loss of appetite, severe difficulty breathing, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light-sensitive skin reactions, itching, purple spots or patches on the skin due to minor bleeding (purpura), skin swelling (hives).

Rare adverse effects (may affect up to 1 in 1,000 people):
Inflammation and pain of the salivary glands, decrease in white blood cell count, decrease in platelet count, anaemia, 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, pancreas inflammation, jaundice, gallbladder infection, symptoms of lupus erythematosus such as skin rash, joint pain and coldness in hands and fingers, skin allergic reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement disorders).

Very rare adverse effects (may affect up to 1 in 10,000 people):
Electrolyte imbalance that may cause abnormally low chloride levels in blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus).

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

Frequency "not known":
Vision loss or eye pain due to increased 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging and on the blister (after "EXP.:"). The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of packaging and unused medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Olmesartan/Hydrochlorothiazide MABO

The active substances 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: monohydrate lactose, 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).

Appearance of the product and contents of the container:

Olmesartan/Hydrochlorothiazide MABO 20 mg/25 mg is presented as pinkish, round, film-coated tablets, 8.5 mm in diameter, with the imprint "OH 22" on one side.

Olmesartan/Hydrochlorothiazide MABO film-coated tablets are supplied in aluminum blisters, in packages containing 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 most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS):

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