OLMESARTAN/HYDROCHLOROTHIAZIDE MABO 40 MG/12.5 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan/Hydrochlorothiazide MABO 40 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.

• 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 experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Olmesartan/Hydrochlorothiazide MABO and what is it used for
2. What you need to know before you take Olmesartan/Hydrochlorothiazide MABO
3. How to take Olmesartan/Hydrochlorothiazide MABO
4. Possible side effects
5. Storing Olmesartan/Hydrochlorothiazide MABO
6. Pack contents and further 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 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 kidneys to remove excess fluid from the body, increasing urine production.

• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics.

Olmesartan/Hydrochlorothiazide MABO will only be given if treatment with olmesartan medoxomil alone has not controlled your blood pressure sufficiently. The combination of both active substances in Olmesartan/Hydrochlorothiazide MABO reduces blood pressure more than either substance alone.

You may already be taking medicines 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 medicines such as Olmesartan/Hydrochlorothiazide MABO tablets. Your doctor has probably also advised you to 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 have also advised you to take regular exercise, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before you take 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 medicine (listed in section 6) or to sulphonamides.

If you are more than 3 months pregnant. (It is also better to avoid Olmesartan/Hydrochlorothiazide MABO at the start of pregnancy - see section Pregnancy).

• If you have kidney problems.
• If you have diabetes or kidney problems and are being treated with a medicine that lowers blood pressure and contains aliskiren.
• If you have low potassium or sodium levels, high calcium or uric acid levels in your blood (with symptoms of gout or kidney stones), which do not improve with treatment.

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

Tell your doctor before you start taking Olmesartan/Hydrochlorothiazide MABO

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

• An angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems associated with 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:

• Kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Vomiting (feeling sick) or diarrhoea, which 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.

If you are taking a medicine that increases urine production (diuretic), your doctor may need to change your dose and/or take other precautions:

• 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 an increase in eye pressure, 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 had an allergy to penicillin or sulphonamide, 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 exposure and UV rays while taking Olmesartan/Hydrochlorothiazide MABO.
• If you have had respiratory or lung problems (e.g. inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking this medicine, seek medical attention immediately.

Tell your doctor if you have severe, persistent diarrhoea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your treatment for high blood pressure.

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 check for 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 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, an excessive drop in blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. That's why your doctor will carefully monitor your blood pressure.

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

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

You must tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Olmesartan/Hydrochlorothiazide MABO before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Olmesartan/Hydrochlorothiazide MABO. It is not recommended to take Olmesartan/Hydrochlorothiazide MABO during pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after that time.

Tell your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea 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 medicines

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

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

• Other medicines that lower blood pressure (antihypertensives), as they may increase the effect of Olmesartan/Hydrochlorothiazide MABO.

Your doctor may need to change 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”).

• Medicines that may change potassium levels in the blood if taken at the same time as Olmesartan/Hydrochlorothiazide MABO. These include:

Supplements that contain potassium (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 (a medicine used to treat mouth and stomach ulcers).
• Sodium penicillin G (an antibiotic also known as benzylpenicillin sodium).
• Certain painkillers such as aspirin or salicylates.
• Lithium (a medicine used to treat mood changes and some types of depression) may increase lithium toxicity if taken at the same time as Olmesartan/Hydrochlorothiazide MABO. If you have to take lithium, your doctor will measure lithium levels in your blood.

Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), taken 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 medicines, and antidepressants, used with Olmesartan/Hydrochlorothiazide MABO, may cause a sudden drop in blood pressure when standing up.
• Certain 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 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, medicines used to lower fat levels in the blood.
• Anticholinergic medicines, such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultoprida, tiaprida, 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 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 Olmesartan/Hydrochlorothiazide MABO may increase 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 to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medicine.
• Cyclosporin, a medicine used to prevent organ transplant rejection.
• Antibiotics of the tetracycline group or esparfloxacine.
• Amphotericin, a medicine used to treat fungal infections.
• Certain antacids, used to treat stomach acid, such as aluminium and magnesium hydroxide, as they may slightly reduce the effect of Olmesartan/Hydrochlorothiazide MABO.
• Cisapride, used to increase food movement in the stomach and intestines.
• Halofantrine, used to treat malaria.

Taking Olmesartan/Hydrochlorothiazide MABO with food and drink

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

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

Black patients

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

Pregnancy and breastfeeding

Pregnancy

You must tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Olmesartan/Hydrochlorothiazide MABO before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Olmesartan/Hydrochlorothiazide MABO. It is not recommended to take Olmesartan/Hydrochlorothiazide MABO during pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after that time.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Olmesartan/Hydrochlorothiazide MABO during breastfeeding, and your doctor may choose another 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 taking this medicine.

Use in athletes

Athletes are informed that this medicine 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 medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Olmesartan/Hydrochlorothiazide MABO contains orange yellow S

This medicine may cause allergic reactions because it contains orange yellow S (E110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Olmesartan/Hydrochlorothiazide MABO

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

The recommended dose is one Olmesartan/Hydrochlorothiazide MABO 40 mg/12.5 mg tablet per day. If your blood pressure is not controlled sufficiently, your doctor may change your dose to one Olmesartan/Hydrochlorothiazide MABO 40 mg/25 mg tablet per day.

Take the tablets with water. If possible, take your dose at the same time each day, e.g. at breakfast time. It is important that you continue to take 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 takes one or more tablets, contact your doctor or go to the nearest hospital emergency department immediately and take the medicine pack with you.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, 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 MABO

If you forget to take a daily dose, take your normal 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 important to continue taking Olmesartan/Hydrochlorothiazide MABO 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 MABOand 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 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, 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 principles. The following information first describes the adverse effects reported so far with the Olmesartan/Hydrochlorothiazide combination (in addition to those already mentioned) and, secondly, the known adverse effects of the two active principles 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 Adverse Effects (may affect up to 1 in 10 people):

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

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

Rapid 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 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 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.

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:

Frequent 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 frequently, including:

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

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

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

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

Frequent 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 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 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 reduced 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":

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 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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Olmesartán/Hidroclorotiazida MABO

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

No special storage conditions are required.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. 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 Olmesartán/Hidroclorotiazida MABO

The active ingredients 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 (E 172), and orange yellow S (E 110).

Product Appearance and Package Contents:

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 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/