OLMESARTAN/HYDROCHLOROTHIAZIDE PENSA PHARMA 20 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan / Hydrochlorothiazide Pensa Pharma 20 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 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Olmesartan / Hydrochlorothiazide Pensa Pharma and what is it used for
2. What you need to know before you take 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 further information

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

Olmesartan / Hydrochlorothiazide will only be given if treatment with olmesartan alone has not controlled your blood pressure adequately. The combination of the two active substances in Olmesartan / Hydrochlorothiazide Pensa Pharma helps to lower blood pressure more than either substance on its own.

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 to lower it further.

High blood pressure can be controlled with medicines such as Olmesartan / Hydrochlorothiazide Pensa Pharma. Your doctor may also have recommended that you 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 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 you take Olmesartan / Hydrochlorothiazide Pensa Pharma

Do not take Olmesartan / Hydrochlorothiazide Pensa Pharma:

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6) or to sulphonamide medicines.
• If you are more than 3 months pregnant. (It is also better to avoid olmesartan / hydrochlorothiazide 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 medicine containing aliskiren.
• If you have low levels of potassium or sodium in your blood, high levels of calcium or uric acid in your blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• If you have severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with the drainage of bile from the gallbladder (bile duct 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:

Tell your doctor before you start taking Olmesartan / Hydrochlorothiazide Pensa Pharma.

Before taking the tablets, tell your doctorif you are taking any of the following medicines for high blood pressure (hypertension):

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

Your doctor may 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 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 (feeling sick) or diarrhoea, which is severe or lasts for several days.
• Treatment with high doses of diuretic medicines, or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g. 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 some types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Olmesartan / Hydrochlorothiazide Pensa Pharma.
• 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 severe shortness of breath or difficulty breathing after taking olmesartan / hydrochlorothiazide, seek medical attention immediately.

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

• Severe, persistent diarrhoea 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, these 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 stop treatment and seek medical attention.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea 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 probably 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 probably 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, tiredness, drowsiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heart rate. 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. 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 medicine contains a component that may result in a positive doping test.

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

Children and adolescents:

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

Using Olmesartan / Hydrochlorothiazide Pensa Pharma 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 blood pressure-lowering medicines (antihypertensives), as they may increase the effect of olmesartan / hydrochlorothiazide.

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 Pensa Pharma” and “Warnings and precautions”).

• Medicines 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).
• Diuretic medicines.
• Heparin (to thin the blood).
• Laxatives.
• Corticosteroids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (a medicine for treating mouth and stomach ulcers).
• Sodium penicillin G (an antibiotic also known as benzylpenicillin sodium).
• Certain painkillers such as aspirin or salicylates.

The level of lithium (a medicine used to treat mood changes and some types of depression) in the blood may increase if taken with olmesartan / hydrochlorothiazide, potentially leading to an increase in lithium toxicity. If you have to take lithium, your doctor will monitor your lithium blood levels.

• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines 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 problems and reduce the effect of olmesartan / hydrochlorothiazide.
• Sedatives, hypnotics, and antidepressants, used with olmesartan / hydrochlorothiazide, may cause a sudden drop in blood pressure when standing up.
• Certain muscle relaxants such as baclofen and tubocurarine.
• 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. Your doctor may advise you to take olmesartan / hydrochlorothiazide at least 4 hours before colesevelam hydrochloride.
• Colestyramine and colestipol, medicines used to lower blood fat levels.
• Anticholinergic medicines, such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, cyanemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections, which can change the 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 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 sparfloxacin.
• 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.
• Cisapride, used to increase the movement of food in the stomach and intestines.
• Halofantrine, used to treat malaria.

Taking Olmesartan / Hydrochlorothiazide Pensa Pharma with food and drink

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, 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 Pensa Pharma is somewhat less in black patients.

Pregnancy and breastfeeding:

Pregnancy

You must tell your doctor if you are pregnant or think you might be pregnant. Your doctor will normally advise you to stop taking Olmesartan / Hydrochlorothiazide Pensa Pharma before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Olmesartan / Hydrochlorothiazide Pensa Pharma. Olmesartan / Hydrochlorothiazide Pensa Pharma is not recommended during pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after this time.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan / Hydrochlorothiazide Pensa Pharma is not recommended during breastfeeding, and your doctor will choose a different treatment for you if you want to breastfeed.

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

Use in athletes

Athletes are 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 gone away. Consult your doctor.

Information about excipients:

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.

3. How to take Olmesartan / Hydrochlorothiazide Pensa Pharma

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, consult your doctor or pharmacist again.

The recommended doseis one Olmesartan / Hydrochlorothiazide Pensa Pharma 20 mg/12.5 mg tablet per day. If your blood pressure is not controlled adequately, your doctor may change the dose to one Olmesartan / Hydrochlorothiazide Pensa Pharma 20 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 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 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 (tel. 91 562 04 20) stating the medicine and the amount taken.

If you forget to take Olmesartan / Hydrochlorothiazide Pensa Pharma:

If you forget to take a 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 Pensa Pharma:

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can 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 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 can occur infrequently. If this happens to you, stop takingOlmesartan/ HydrochlorothiazidePensa Pharma, 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 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 so far 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):

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 renal 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.

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 frequently, 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 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 impairment, lack of energy.

Also, some changes in blood test results have been observed rarely, 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 increased 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 excretion 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).

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 can cause 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 (signs include severe respiratory difficulty, fever, weakness, and confusion).

Adverse effects of unknown frequency (cannot be estimated from available data):Decreased vision and eye pain due to elevated 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 does not appear 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 shown on the packaging and blister pack (after "CAD.:"). The expiration date is the last day of the month indicated.

Medicines should not be disposed of 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 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 20 mg of olmesartan (as olmesartan 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 20 mg / 12.5 mg are yellow, cylindrical, biconvex film-coated tablets with the logo D1 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 2024

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