Olmesartan/hydrochlorothiazide Pensapharma 20 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olmesartan / hydrochlorothiazide pensa pharma 20 mg / 12.5 mg film-coated tablets EFG

Olmesartan medoxomil / hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

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

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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. How to store Olmesartan / hydrochlorothiazide Pensa Pharma
6. Contents of the pack and other information

1. What Olmesartán / hidroclorotiazida Pensa Pharma is and what it is used for

Olmesartán / hidroclorotiazida Pensa Pharma 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 will only be prescribed if treatment with olmesartán alone has not adequately controlled your blood pressure. The combined administration of both active substances in Olmesartán / hidroclorotiazida Pensa Pharma contributes to a greater reduction in blood pressure than when each 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 to lower it further.

High blood pressure can be controlled with medicines such as Olmesartán / hidroclorotiazida Pensa Pharma. Your doctor has likely also 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 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 ingredients of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant. (It is also advisable to avoid olmesartan / hydrochlorothiazide at the beginning of pregnancy – see Pregnancy section).
• If you have severe 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 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 situations apply to you, or you are unsure, do not take the tablets. Speak to your doctor and follow their advice.

Warnings and precautions:

Talk to your doctor before starting to take Olmesartan / hydrochlorothiazide Pensa Pharma.

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 (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may monitor 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 doctor if you have any of the following health conditions:

• Mild to moderate kidney problems, or if you have recently had a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Vomiting (with dizziness) 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 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 non-melanoma skin and lip cancer. Protect your skin from sun exposure and UV rays while taking Olmesartan / hydrochlorothiazide Pensa Pharma.
• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking olmesartan / hydrochlorothiazide, seek medical help immediately.

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

• Severe, persistent diarrhoea causing significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.
• If you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or signs of developing glaucoma (increased pressure in the eyes), which may occur within hours to a week after taking olmesartan/hydrochlorothiazide. You should stop treatment and seek medical attention.

Consult your doctor if you develop 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 frequently and perform some blood tests if you have any of these conditions.

Olmesartan / hydrochlorothiazide Pensa Pharma 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, 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 a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for parathyroid function tests, you should stop taking Olmesartan / hydrochlorothiazide Pensa Pharma 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 or think you might be pregnant. The use of Olmesartan / hydrochlorothiazide Pensa Pharma is not recommended at the beginning of 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 during this stage (see Pregnancy section).

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 medicines:

Tell 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 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 (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Olmesartan / hydrochlorothiazide Pensa Pharma” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood when used together with olmesartan / hydrochlorothiazide. 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 olmesartan / hydrochlorothiazide. If you need to take lithium, your doctor will monitor lithium levels in your blood.

• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with olmesartan / hydrochlorothiazide, may increase the risk of kidney failure and reduce the effect of olmesartan / hydrochlorothiazide.
• Sleeping pills, sedatives, and antidepressants, used together with olmesartan / hydrochlorothiazide, may cause a sudden drop in blood pressure when standing up.
• Certain medicines such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other cancer treatments such as cyclophosphamide or methotrexate.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, which may reduce the effect of olmesartan / hydrochlorothiazide. Your doctor may advise you to take olmesartan / hydrochlorothiazide 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 digoxin, 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 to treat high blood pressure or low blood sugar, respectively, since olmesartan / hydrochlorothiazide may enhance 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 in the treatment of gout.
• Calcium supplements.
• Amantadine, an antiviral medicine.
• Cyclosporine, a medicine used to prevent organ transplant rejection.
• Antibiotics from the tetracycline group, or sparfloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Some antacids used to treat excess stomach acid, such as aluminium and magnesium hydroxide, which may slightly reduce the effect of olmesartan / hydrochlorothiazide.
• Cisapride, used to increase stomach and intestinal movement.
• Halofantrine, used to treat malaria.

Taking Olmesartan / hydrochlorothiazide Pensa Pharma with food and drinks

Olmesartan / hydrochlorothiazide can be taken with or without food.

Be cautious when drinking alcohol while taking olmesartan / hydrochlorothiazide, as some people may feel weakness or dizziness. If this happens, avoid alcohol, including wine, beer, or alcoholic soft drinks.

Patients of Black African origin:

As with other similar medicines, the blood pressure-lowering effect of Olmesartan / hydrochlorothiazide Pensa Pharma is somewhat reduced in patients of Black African origin.

Pregnancy and breastfeeding:

Pregnancy

Inform your doctor if you are pregnant or suspect you might be pregnant. Your doctor will usually advise you to stop taking Olmesartan / hydrochlorothiazide Pensa Pharma before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of Olmesartan / hydrochlorothiazide Pensa Pharma 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 stage.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. The use of Olmesartan / hydrochlorothiazide Pensa Pharma is not recommended during breastfeeding, and your doctor will 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 using 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.

Information about excipients:

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

3. How to take Olmesartán / hidroclorotiazida Pensa Pharma

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

The recommended dose is 1 tablet of Olmesartán / hidroclorotiazida Pensa Pharma 20 mg/12.5 mg once daily. If blood pressure is not adequately controlled, your doctor may change your dose to 1 tablet of Olmesartán / hidroclorotiazida Pensa Pharma 20 mg/25 mg once 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 Olmesartán / hidroclorotiazida Pensa Pharma until your doctor tells you to stop.

If you take more Olmesartán / hidroclorotiazida Pensa Pharma than you should:

If you take more tablets than prescribed 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 package with you.

In case of overdose or accidental ingestion, contact your doctor, pharmacist immediately, 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 Olmesartán / hidroclorotiazida Pensa Pharma:

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

If you stop taking Olmesartán / hidroclorotiazida Pensa Pharma:

It is important to continue taking olmesartán / hidroclorotiazida 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 will experience them.

However, the following adverse effects may be serious:

• Rarely, allergic reactions affecting the whole 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/hydrochlorothiazide Pensa Pharma and contact your doctor immediately.

• Olmesartán/hydrochlorothiazide Pensa Pharma may cause a marked 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/hydrochlorothiazide Pensa Pharma, contact 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 have been taking Olmesartán/hydrochlorothiazide Pensa Pharma for some time, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Olmesartán/hydrochlorothiazide Pensa Pharma is a combination of two active substances. The following information first describes adverse effects reported so far with the olmesartan/hydrochlorothiazide combination (in addition to those already mentioned), and secondly, the known adverse effects of each of the two active substances taken separately.

These are other known adverse effects reported so far with Olmesartán/hydrochlorothiazide Pensa Pharma:

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

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

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

Uncommonly, the following changes in blood test results have also been observed:

Increase in blood fat levels, increase in blood urea or uric acid, increase in creatinine, increase or decrease in blood potassium levels, increase in blood calcium levels, increase in blood sugar levels, increase in liver function test values. Your doctor will monitor you with a blood test and 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, the following changes in blood test results have also been observed:

Increase in blood urea nitrogen, decrease in hemoglobin and hematocrit values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

Additional adverse effects reported with olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmesartán/hydrochlorothiazide Pensa Pharma or at a higher frequency:

Olmesartan medoxomil:

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

Bronchitis, cough, nasal congestion and 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:

Increase in blood fat levels, increase in blood urea or uric acid, increase in liver or muscle function test 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), swelling of the face, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives).

Uncommonly, the following changes in blood test results have also been observed:

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):

Worsening of kidney function, lack of energy.

Rarely, the following changes in blood test results have also been observed:

Increase in blood potassium levels.

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

Hydrochlorothiazide:

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

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

Frequent 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:

Increase in creatinine, urea, calcium, and blood sugar levels; decrease in blood chloride, potassium, magnesium, and sodium levels; increase in serum amylase (hyperamylasemia).

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

Decreased or loss of appetite, severe difficulty breathing, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity 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, decrease in white blood cell count, decrease in platelet count, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellowish vision, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, lupus-like symptoms such as skin rash, joint pain, and coldness in hands and fingers, allergic skin reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which may sometimes affect movement).

Very rare adverse effects (may affect up to 1 in 10,000 people):

Electrolyte imbalance which may cause abnormally low blood chloride levels (hypochloremic alkalosis), intestinal obstruction (paralytic ileus).

Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Adverse effects with unknown frequency (cannot be estimated from available data): Decreased vision and 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Pensa Pharma

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 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Hydrochlorothiazide Pensa Pharma

The active substances are 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, polyvinylpyrrolidone, 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 about excipients.

Appearance of the product and contents of the pack

Olmesartan / hydrochlorothiazide Pensa Pharma 20 mg / 12.5 mg are yellow, cylindrical, film-coated tablets, biconvex, with the logo D1 on one side.

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 - Areta Industrial Estate 31620

Huarte-Pamplona. Spain

Date of the most recent revision of this leaflet: February 2024

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