Olmesartan/hydrochlorothiazide Mabo 40 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

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

Leaflet Contents

1. What Olmesartán/Hidroclorotiazida MABO is and what it is used for
2. What you need to know before taking Olmesartán/Hidroclorotiazida MABO
3. How to take Olmesartán/Hidroclorotiazida MABO
4. Possible side effects
5. How to store Olmesartán/Hidroclorotiazida 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 may also have advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and decreasing 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 starting to take Olmesartán/Hydrochlorothiazide MABO

Do not take Olmesartán/Hydrochlorothiazide MABO

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other
  components of this medicine (listed in section 6), or to substances similar to
  hydrochlorothiazide (sulphonamides).
• If you are more than 3 months pregnant. (It is also advisable to avoid Olmesartán/Hydrochlorothiazide MABO in early pregnancy – see Pregnancy section).
• If you have 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 the blood, high levels of calcium or uric acid in the blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• If you have moderate or 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
with your doctor and follow their advice.

Warnings and precautions

Talk to your doctor before starting to use Olmesartán/Hydrochlorothiazide 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 (e.g. 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 (e.g. potassium) at regular intervals.

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

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

• 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 elimination (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g. 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 hours to a week after taking Olmesartán/Hydrochlorothiazide MABO. This could lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulphonamides, 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 certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Olmesartán/Hydrochlorothiazide MABO.
• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. 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/Hydrochlorothiazide MABO may cause increased levels of fats and uric acid (which causes gout – painful joint swelling) in the blood. Your doctor will likely perform 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 perform blood tests periodically to monitor this possible change. Some signs of electrolyte imbalance include: 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 heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for parathyroid function tests, you must stop taking Olmesartán/Hydrochlorothiazide 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 may be pregnant, or plan to become pregnant. Use of Olmesartán/Hydrochlorothiazide MABO is not recommended in early pregnancy, and it must 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 diarrhoea after taking Olmesartán/Hydrochlorothiazide MABO. Your doctor will decide whether to continue treatment. Do not stop taking Candesartán MABO on your own.

Children and adolescents

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

Use of Olmesartán/Hydrochlorothiazide MABO with other medicines

Inform 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 enhance the effect of Olmesartán/Hydrochlorothiazide 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/Hydrochlorothiazide MABO” and “Warnings and precautions”).

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

  • Potassium supplements (as well as salt substitutes containing potassium).
  • Medicines that increase urine elimination (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/Hydrochlorothiazide MABO. If you need to take lithium, your doctor will monitor lithium blood levels.

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

• Sleeping pills, sedatives, and antidepressants, when used with Olmesartán/Hydrochlorothiazide 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 medicines used in cancer treatment, such as cyclophosphamide or methotrexate.

• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, which may reduce the effect of Olmesartán/Hydrochlorothiazide MABO. Your doctor may advise you to take Olmesartán/Hydrochlorothiazide 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 in the treatment of 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 in the treatment of high blood pressure or low blood sugar, respectively, as Olmesartán/hydrochlorothiazide may intensify their blood sugar-raising effect.

• 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 of the tetracycline group, or sparfloxacin.

• Amphotericin, a medicine used to treat fungal infections.

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

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

• Halofantrine, used to treat malaria.

Taking Olmesartán/Hydrochlorothiazide MABO with food and drinks

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

Be cautious when drinking alcohol while taking Olmesartán/Hydrochlorothiazide 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/Hydrochlorothiazide MABO is somewhat reduced in patients of Black race.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking Olmesartán/Hydrochlorothiazide MABO before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Olmesartán/Hydrochlorothiazide MABO. Olmesartán/Hydrochlorothiazide 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 that point.

Breastfeeding

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

If you are pregnant or breastfeeding, think you may 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 use of 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/Hydrochlorothiazide MABO contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

Olmesartán/Hydrochlorothiazide MABO contains sunset yellow FCF (E110)

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

3. How to take Olmesartan/Hydrochlorothiazide MABO

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet of Olmesartan/Hydrochlorothiazide MABO 40 mg/12.5 mg daily. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartan/Hydrochlorothiazide MABO 40 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 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 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 at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Olmesartan/Hydrochlorothiazide 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 Olmesartan/Hydrochlorothiazide MABO

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

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 cause adverse effects, although not everyone experiences them.

However, the following adverse effects may be serious:

• Rarely, allergic reactions affecting the entire body may occur, including swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking Olmesartán/Hidroclorotiazida MABO and consult your doctor immediately.

• Olmesartán/Hidroclorotiazida MABO may cause an excessive 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 Olmesartán/Hidroclorotiazida 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 Olmesartán/Hidroclorotiazida MABO some time ago, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Olmesartán/Hidroclorotiazida MABO is a combination of two active substances. The following information first describes the adverse effects reported so far with the combination Olmesartán/Hidroclorotiazida (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 Olmesartán/Hidroclorotiazida:

If these effects occur, they are often mild and you do not need to stop 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):

Rapid or strong heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, muscle pain, joint pain, arms and legs pain, back pain, erectile dysfunction in men, blood in urine.

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

Increased blood fat levels, increased blood urea or uric acid, increased creatinine, increased or decreased blood potassium levels, increased blood calcium levels, increased blood sugar levels, increased 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 renal failure.

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

Increased blood urea nitrogen, decreased 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 olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmesartán/Hidroclorotiazida MABO or at a higher frequency:

Olmesartan medoxomil:

Common 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:

Increased blood fat levels, increased blood urea or uric acid, increased liver or muscle enzyme levels.

Uncommon adverse effects (may affect up to 1 in 100 people):

Rapid allergic reactions affecting the whole body, which may cause breathing difficulties and a rapid drop in blood pressure that 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 rash), skin swelling (hives).

Uncommonly, some changes in blood test results have also 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):

Deterioration of kidney function, lack of energy.

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

Increased blood potassium levels.

Hydrochlorothiazide:

Very common adverse effects (may affect more than 1 in 10 people):

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

Common adverse effects (may affect up to 1 in 10 people):

Confusion, abdominal pain, stomach discomfort, bloating sensation, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

Some changes in blood test results have also been observed, including:

Increased creatinine, urea, calcium, and blood sugar levels; decreased blood chloride, potassium, magnesium, and sodium levels; increased 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, decreased number of white blood cells, decreased number of platelets in blood, anemia, bone marrow depression, restlessness, depression, sleep disturbances, 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, coldness in hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which may sometimes cause movement disturbances).

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 shortness of breath, fever, weakness, and confusion).

Frequency not known:

Reduced vision 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 they are possible adverse effects 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 the 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartán/Hydrochlorothiazide MABO

The active substances are olmesartan medoxomilo and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomilo 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 sunset yellow FCF (E 110).

Appearance of the product and pack contents:

Olmesartán/Hydrochlorothiazide MABO 40 mg/12.5 mg is presented as orange, oval, film-coated tablets, 15 mm by 7 mm, with the imprint "OH 41" on one side.

Olmesartán/Hydrochlorothiazide MABO film-coated tablets are available in aluminum blisters, in pack sizes of 28 tablets.

Marketing Authorization Holder:

MABO-FARMA, S.A
Calle Vía de los Poblados 3,
Building 6, 28033, Madrid,
Spain

Manufacturer:

Actavis Ltd.,
BLB 016 Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta

Date of the most recent review of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):
http://www.aemps.gob.es/