OLMESARTAN/HYDROCHLOROTHIAZIDE PENSA PHARMA 40 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan / Hydrochlorothiazide Pensa Pharma 40 mg / 12.5 mg Film-Coated Tablets EFG

Olmesartan Medoxomil / Hydrochlorothiazide

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Olmesartan / Hydrochlorothiazide Pensa Pharma is and what it is used for
2. What you need to know before taking Olmesartan / Hydrochlorothiazide Pensa Pharma
3. How to take Olmesartan / Hydrochlorothiazide Pensa Pharma
4. Possible side effects
5. Storage of Olmesartan / Hydrochlorothiazide Pensa Pharma
6. Package Contents and Additional Information

1. What Olmesartan / Hydrochlorothiazide Pensa Pharma is and what it is used for

Olmesartan / Hydrochlorothiazide Pensa Pharma contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used to treat high blood pressure (hypertension):

? Olmesartan medoxomil belongs to a group of medications called angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

? Hydrochlorothiazide belongs to a group of medications called thiazide diuretics.

It lowers blood pressure by helping to remove excess fluids, increasing urine production by the kidneys.

Olmesartan / Hydrochlorothiazide will only be given if treatment with olmesartan alone has not adequately controlled your blood pressure. The combined administration of both active substances in Olmesartan / Hydrochlorothiazide Pensa Pharma helps to lower blood pressure more than if each substance were administered alone.

It may be that you are already taking medications to treat high blood pressure, but your doctor may believe it is necessary for you to take olmesartan / hydrochlorothiazide to lower it further.

High blood pressure can be controlled with medications like Olmesartan / Hydrochlorothiazide Pensa Pharma. Your doctor has probably also recommended that you make some lifestyle changes to help lower your blood pressure (such as losing weight, quitting smoking, reducing alcohol consumption, and reducing the amount of salt in your diet). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is essential to follow your doctor's advice.

2. What you need to know before taking Olmesartan / Hydrochlorothiazide Pensa Pharma

Do not take Olmesartan / Hydrochlorothiazide Pensa Pharma:

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other components of this medication (listed in section 6) or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are pregnant for more than 3 months. (It is also best to avoid olmesartan / hydrochlorothiazide at the start of pregnancy - see section Pregnancy).
• If you have severe kidney problems.
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains 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), which do not improve with treatment.
• If you have severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).

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

Warnings and Precautions:

Consult your doctor before starting to take Olmesartan / Hydrochlorothiazide Pensa Pharma.

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

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

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

See also the information under the heading "Do not take Olmesartan / Hydrochlorothiazide Pensa Pharma".

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 the heart valves or heart muscle.
• Vomiting (while feeling nauseous) or diarrhea, which is severe or prolonged for several days.
• Treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (such as primary hyperaldosteronism).
• Diabetes.
• Systemic lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• 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 cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Olmesartan / Hydrochlorothiazide Pensa Pharma.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking olmesartan / hydrochlorothiazide, seek medical attention immediately.

Contact your doctor if you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.
• If you experience a decrease in vision or eye pain, it could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or a sign of glaucoma development, increased pressure in your eyes, and can occur within a few hours to a week after taking olmesartan/hydrochlorothiazide. You should discontinue treatment and seek medical attention.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartan/Hydrochlorothiazide Pensa Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan/Hydrochlorothiazide Pensa Pharma on your own.

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

Olmesartan / Hydrochlorothiazide Pensa Pharma may cause an increase in blood fat and uric acid levels (which can cause gout - painful swelling of the joints). Your doctor will likely want to perform a blood test from time to time to monitor these possible changes.

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely want to perform a blood test from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, fatigue, drowsiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other medication that lowers blood pressure, excessive blood pressure reduction in patients with altered blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are going to have parathyroid function tests, you should stop taking Olmesartan / Hydrochlorothiazide Pensa Pharma before these tests are performed.

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

You should inform your doctor if you are pregnant or think you may be pregnant. Olmesartan / Hydrochlorothiazide Pensa Pharma is not recommended during pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage (see section Pregnancy).

Children and Adolescents:

Olmesartan / Hydrochlorothiazide Pensa Pharma is not recommended for children and adolescents under 18 years of age.

Use of Olmesartan / Hydrochlorothiazide Pensa Pharma with other medications:

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

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

• Other blood pressure-lowering medications (antihypertensives), as they may increase the effect of olmesartan/hydrochlorothiazide.

Your doctor may need to adjust 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 Pensa Pharma" and "Warnings and Precautions").

• Medications that may alter potassium levels in the blood if used at the same time as olmesartan/hydrochlorothiazide. These include:

• Potassium supplements (as well as salt substitutes that contain potassium).
• Medications that increase urine production (diuretics).
• Heparin (to thin the blood).
• Laxatives.
• Corticosteroids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (medication for the treatment of mouth and stomach ulcers).
• Sodium penicillin G (antibiotic also called benzylpenicillin sodium).
• Certain pain relievers such as aspirin or salicylates.

The lithium (medication used to treat mood changes and some types of depression) if used at the same time as olmesartan/hydrochlorothiazide may increase its toxicity. If you need to take lithium, your doctor will measure lithium levels in your blood.

• Non-steroidal anti-inflammatory medications (NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartan/hydrochlorothiazide, may increase the risk of kidney failure and reduce the effect of olmesartan/hydrochlorothiazide.
• Sedatives, sleep inducers, and antidepressants, used with olmesartan/hydrochlorothiazide, may cause a sudden drop in blood pressure when standing.
• Certain medications such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medications used for cancer treatment, such as cyclophosphamide or methotrexate.
• Colesevelam hydrochloride, a medication that lowers blood cholesterol levels, as it may reduce the effect of olmesartan/hydrochlorothiazide. Your doctor may advise you to take olmesartan/hydrochlorothiazide at least 4 hours before colesevelam hydrochloride.
• Colestyramine and colestipol, medications to lower blood fat levels.
• Anticholinergic medications, such as atropine and biperiden.
• Medications such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultoprida, tiaprida, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Certain medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used in the treatment of heart problems.
• Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injectables, which can change the heart rhythm.
• Oral antidiabetic medications, such as metformin, or insulin, used to lower blood sugar levels.
• Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar levels, respectively, as olmesartan/hydrochlorothiazide may enhance the effect of increasing blood sugar levels caused by these medications.
• Methyldopa, a medication used to treat high blood pressure.
• Medications such as noradrenaline, used to increase blood pressure and decrease heart rate.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Medications such as probenecid, sulfinpyrazone, and allopurinol, used in the treatment of gout.
• Calcium supplements.
• Amantadine, an antiviral medication.
• Cyclosporine, a medication used to prevent organ transplant rejection.
• Antibiotics of the tetracycline group or sparfloxacin.
• Amphotericin, a medication used to treat fungal infections.
• Certain antacids, used to treat stomach acid excess, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of olmesartan/hydrochlorothiazide.
• Cisapride, used to increase food movement in the stomach and intestine.
• Halofantrine, used for malaria.

Taking Olmesartan / Hydrochlorothiazide Pensa Pharma with food and drinks

Olmesartan / Hydrochlorothiazide can be taken with or without food.

Be careful when drinking alcohol while taking olmesartan / hydrochlorothiazide, as some people feel weak or dizzy. If this happens to you, do not drink any alcohol, including wine, beer, or drinks with alcohol.

Black Patients:

As with other similar medications, the blood pressure-lowering effect of Olmesartan / Hydrochlorothiazide Pensa Pharma is somewhat smaller in black patients.

Pregnancy and Breastfeeding:

Pregnancy

You should inform your doctor if you are pregnant (or think you may be pregnant). Your doctor will generally advise you to stop taking Olmesartan / Hydrochlorothiazide Pensa Pharma before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medication instead of Olmesartan / Hydrochlorothiazide Pensa Pharma. Olmesartan / Hydrochlorothiazide Pensa Pharma is not recommended during pregnancy, and it should not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken from that point on.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. Olmesartan / Hydrochlorothiazide Pensa Pharma is not recommended during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

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

Use in Athletes

Athletes are informed that this medication 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.

Information about Excipients:

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Olmesartan / Hydrochlorothiazide Pensa Pharma

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended doseis 1 tablet of Olmesartan / Hydrochlorothiazide Pensa Pharma 40 mg/12.5 mg per day. If your blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartan / Hydrochlorothiazide Pensa Pharma 40 mg/25 mg per day.

Take the tablets with water. If possible, take your dose at the same time every day, for example, at breakfast time. It is essential to continue taking Olmesartan / Hydrochlorothiazide Pensa Pharma until your doctor tells you to stop.

If you take more Olmesartan / Hydrochlorothiazide Pensa Pharma than you should:

If you take more tablets than you should or if a child accidentally ingests one or more tablets, contact your doctor immediately or go to the emergency department of the nearest hospital and take the medication package with you.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Olmesartan / Hydrochlorothiazide Pensa Pharma:

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

If you stop taking Olmesartan / Hydrochlorothiazide Pensa Pharma:

It is essential to continue taking olmesartan / hydrochlorothiazide unless your doctor tells you to stop.

If you have any other questions about using this medication, 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 may 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 takingOlmesartan/ HydrochlorothiazidePensa Pharmaand consult your doctor immediately.

• Olmesartan / Hydrochlorothiazide Pensa Pharma 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 takingOlmesartan/ HydrochlorothiazidePensa Pharma, 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 Pensa Pharma a long time ago, contact your doctor immediately, who will assess your symptoms and decide how to continue with blood pressure treatment.

Olmesartan / Hydrochlorothiazide Pensa Pharma is a combination of two active ingredients. 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 ingredients separately.

These are other known adverse effects withOlmesartan/ HydrochlorothiazidePensa Pharma:

If these effects occur, they are often mild and it is not necessary to interrupt 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):

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, 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 unwell, changes in consciousness, skin swelling (hives), acute kidney failure.

Also, some changes in blood test results have been observed, 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.

Additional adverse effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not withOlmesartan/ HydrochlorothiazidePensa Pharmaor at a higher frequency:

Olmesartan medoxomil:

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

Bronchitis, cough, nasal congestion and 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, including:

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

Uncommon 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 unwell, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

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

Decreased number of a type of blood cell called platelets (thrombocytopenia).

Rare adverse effects (may affect up to 1 in 1,000 people):

Kidney function impairment, lack of energy.

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

Increased potassium in the blood.

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

Hydrochlorothiazide:

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

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

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

Feeling of confusion, abdominal pain, stomach discomfort, feeling of bloating, diarrhea, nausea, vomiting, constipation, glucose 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).

Uncommon 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 number of white blood cells, decreased number of platelets in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures (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 (which sometimes causes 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 (signs include severe respiratory distress, fever, weakness, and confusion).

Adverse effects of unknown frequency (cannot be estimated from available data):Decreased vision and 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 / Hydrochlorothiazide Pensa Pharma

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 that appears on the packaging and 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. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition ofOlmesartán/ HydrochlorothiazidePensa Pharma

The active ingredient is olmesartan and hydrochlorothiazide. Each tablet contains 40 mg of olmesartán (in the form of olmesartán medoxomil) and 12.5 mg of hydrochlorothiazide.

The other components are:

• tablet core: Microcrystalline cellulose, Lactose monohydrate, Povidone, Hydroxypropylcellulose, and Magnesium stearate.
• tablet coating: Opadry Y-1-7000 (hypromellose, titanium dioxide, and macrogol), Yellow iron oxide, and Red iron oxide.

See section 2: information on excipients

Appearance of the product and package contents

Olmesartán / Hydrochlorothiazide Pensa Pharma 40 mg / 12.5 mg are film-coated tablets, yellow, oblong, biconvex with logo D3 on one side.

They are presented in aluminum-aluminum blister packs. Each pack contains 28 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 - Polígono Industrial Areta 31620

Huarte-Pamplona, Spain

Date of the last revision of this prospectus:February 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products. http://www.aemps.gob.es