OLMESARTAN/HYDROCHLOROTHIAZIDE MABO 20 mg/12.5 mg FILM-COATED TABLETS

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 severe kidney problems.
• If you have diabetes or kidney problems and are being treated with a blood pressure lowering medicine containing aliskiren.
• If you have low potassium or sodium levels, high calcium or uric acid levels in your blood, which do not improve with treatment.
• If you have severe liver problems, yellowing of the skin and eyes (jaundice) or problems with drainage of bile from the gallbladder (biliary obstruction, e.g. due to gallstones).

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

Before taking Olmesartan/Hydrochlorothiazide MABO, talk to your doctor:

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 check your kidney function, blood pressure and levels of electrolytes (e.g. potassium) in your blood at regular intervals.

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

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

• Mild to moderate kidney problems, or if you have recently had a kidney transplant.
• Liver disease.
• Heart failure or problems with your heart valves or heart muscle.
• Vomiting (feeling sick) or diarrhoea, which is severe or lasts for a long time.
• Treatment with high doses of diuretics (medicines which increase urine production) or if you are on a low salt diet.

Children and adolescents

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

Using Olmesartan/Hydrochlorothiazide MABO with other medicines

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

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

• Other medicines to lower blood pressure, 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 ACE inhibitor or aliskiren (see also the information under the headings “Do not take Olmesartan/Hydrochlorothiazide MABO” and “Warnings and precautions”).

• Medicines that may affect potassium levels in the blood if taken with Olmesartan/Hydrochlorothiazide MABO. These include:

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 alcohol-containing refreshers.

Black patients

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

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. 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.

Breastfeeding

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

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Athletes

Athletes should be aware that this medicine contains a substance (hydrochlorothiazide) that may give a positive reaction in doping tests.

Driving and using machines

You may feel dizzy or drowsy while taking this medicine for high blood pressure. If this happens, do not drive or use machines until the symptoms have gone away. Ask your doctor for advice.

Olmesartan/Hydrochlorothiazide MABO contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Olmesartan/Hydrochlorothiazide MABO contains sunset yellow FCF (E110)

This medicine may cause allergic reactions as it contains sunset yellow FCF (E110), which may cause asthma, especially in patients allergic to aspirin.

3. How to take Olmesartan/Hydrochlorothiazide MABO

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

Swallow the tablets with water. If possible, take your dose at the same time each day, e.g. at breakfast time. It is important to continue taking Olmesartan/Hydrochlorothiazide MABO until your doctor tells you to stop.

If you take more Olmesartan/Hydrochlorothiazide MABO than you should

If you take more tablets than you should, or if a child accidentally swallows some, contact your doctor or go to the nearest hospital casualty department immediately and take the medicine pack with you.

In case of overdose or accidental ingestion, contact your doctor, pharmacist or the national poison control centre (telephone number: 91 562 04 20), providing as much information as possible about the medicine and the amount taken.

If you forget to take Olmesartan/Hydrochlorothiazide MABO

If you forget to take a dose, take your normal dose the next day. Do not take a double dose to make up for a forgotten dose.

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 Olmesartán/Hidroclorotiazida MABOand consult your doctor immediately.

Olmesartán/Hidroclorotiazida MABO may cause a pronounced drop in blood pressure in susceptible patients or as a result of an allergic reaction. Infrequently, fainting or dizziness may occur. If this happens to you, 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 whites of the eyes, dark urine, skin itching, even if you started treatment with Olmesartán/Hidroclorotiazida MABO a long time ago, contact your doctor immediately, who will evaluate your symptoms and decide how to continue with the treatment for blood pressure.

Olmesartán/Hidroclorotiazida MABO is a combination of two active principles. 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 the two active principles separately.

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

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):

Fast 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 in rare cases, 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 Olmesartán Medoxomil or Hidroclorotiazida Alone, but not with Olmesartán/Hidroclorotiazida MABOor at a Higher Frequency:

Olmesartán 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 fat levels 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):

Renal function deterioration, lack of energy.

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

Increased potassium levels in the blood.

Hidroclorotiazida:

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 excretion in urine.

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

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

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, 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, infection in the gallbladder, lupus erythematosus symptoms such as skin rash, joint pain, and cold hands and fingers, allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing movement disorders).

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

Electrolyte imbalance that can cause an abnormally low level of chloride in the blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus).

Acute respiratory distress (symptoms include severe respiratory distress, fever, weakness, and confusion).

Unknown Frequency:

Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), skin and lip cancer (non-melanoma skin cancer).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Olmesartán/Hidroclorotiazida MABO

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines should not be thrown down the drain or into the trash. 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 olmesartán medoxomil and hidroclorotiazida: Each film-coated tablet contains 20 mg of olmesartán medoxomil and 12.5 mg of hidroclorotiazida.

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 20 mg/12.5 mg is presented in the form of film-coated tablets, orange, round, 8.5 mm, with the inscription OH 21 on one face.

This medicine is 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/