Leaflet: information for the user

Olmesartan / hydrochlorothiazide Pensa Pharma 20 mg / 12.5 mg film-coated tablets

Olmesartan medoxomil / hydrochlorothiazide

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

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

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

-This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What is Olmesartan / hydrochlorothiazide Pensa Pharma 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. Contents of the pack and additional information

Olmesartán / hidroclorotiazida Pensa Pharmacontains two active principles, olmesartán medoxomilo and hidroclorotiazida, which are used in the treatment of high blood pressure (hypertension):

?Olmesartán medoxomilo belongs to a group of medications called angiotensin II receptor antagonists. It reduces blood pressure by relaxing blood vessels.

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

It reduces blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

Olmesartán / hidroclorotiazidawill only be given if treatment with olmesartán alone has not adequately controlled your blood pressure. The concurrent administration of both active substances in Olmesartán / hidroclorotiazida Pensa Pharmacontributes to reducing blood pressure more than if each substance were administered alone.

You may already be taking medications to treat high blood pressure, but your doctor may believe it necessary for you to take Olmesartán / hidroclorotiazidato lower it further.

High blood pressure can be controlled with medications like Olmesartán / hidroclorotiazida Pensa Pharma. Your doctor has probably also recommended that you make some lifestyle changes to help lower your blood pressure (for example, 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.

Do not takeOlmesartan / 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 more than 3 months pregnant. (It is also best to avoidolmesartan / hydrochlorothiazideat the beginning of pregnancy - see Pregnancy section).
• If you have severe kidney problems.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains 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 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/ hydrochlorothiazidePensa 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) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

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

See also the information under the heading “Do not takeOlmesartan / 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 heart valves or heart muscle.
• Vomiting (feeling dizzy) or diarrhea, which is severe or lasts 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 (for example, primary aldosteronism).
• Diabetes.
• 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 the sun and UV rays while taking Olmesartan / hydrochlorothiazide Pensa Pharma.
• If you have had respiratory or pulmonary 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 experienceany of the following symptoms:

-severe, persistent diarrhea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.

-if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or a sign of developing glaucoma, increased pressure in your eyes, and may occur within a few hours to a week after taking olmesartan/hydrochlorothiazide. You should stop treatment and seek medical attention.

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

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

Olmesartan/ hydrochlorothiazidePensa Pharmamay cause an increase in levels of fats and uric acid in your blood. Your doctor will probably want to perform a blood test from time to time to monitor these possible changes.

You may experience a change in levels of certain substances in your blood called electrolytes. 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 weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

As with any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with alterations in 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 to undergo parathyroid function tests, you should stop takingOlmesartan/ hydrochlorothiazidePensa Pharmabefore the tests are performed.

It is reported to athletes that this medication contains a component that may establish a positive analytical result for doping control.

You should inform your doctor if you are pregnant or think you may be pregnant. Olmesartan/ hydrochlorothiazidePensa Pharmais not recommended for use at the beginning of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see Pregnancy section).

Children and adolescents:

Olmesartan/ hydrochlorothiazidePensa Pharmais not recommended for children and adolescents under 18 years old.

Use of Olmesartan/ hydrochlorothiazidePensa Pharma with other medications:

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

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

• Other blood pressure-lowering medications (anti-hypertensives), as they may increase the effect ofolmesartan / 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 asolmesartan / hydrochlorothiazide. These include:

- Potassium supplements (as well as salt substitutes that contain potassium).

- Diuretics.

- Heparin (to thin the blood).

- Laxatives.

- Steroids.

- Adrenocorticotropic hormone (ACTH).

- Carbenoxolone (medication for the treatment of mouth and stomach ulcers).

- Penicillin G sodium (antibiotic also known as benzylpenicillin sodium).

- Some analgesics such as aspirin or salicylates.

???Lithium (medication used to treat mood changes and some types of depression) if used at the same time asolmesartan / hydrochlorothiazidemay increase its toxicity. If you need to take lithium, your doctor will measureyour lithium levels in the blood.

• Non-steroidal anti-inflammatory drugs (NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time asolmesartan / hydrochlorothiazidemay increase the risk of kidney failure and reduce the effect ofolmesartan / hydrochlorothiazide.
• Sedatives, sleep inducers, and antidepressants, used witholmesartan / hydrochlorothiazidemay cause a sudden drop in blood pressure when standing.
• Some medications such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medications used to treat cancer, such as cyclophosphamide or methotrexate.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect ofolmesartan / hydrochlorothiazide. Your doctor may advise you to takeolmesartan / hydrochlorothiazideat least 4 hours before colesevelam hydrochloride.
• Colestiramine and colestipol, medications to lower cholesterol levels in the blood.
• Anticholinergic medications, such as atropine and biperiden.
• Medications such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sulpiride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Some medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digital, used to treat heart problems.
• Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injectables, which may change heart rhythm.
• Oral diabetes 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, asolmesartan / hydrochlorothiazidemay intensify the effect of increasing blood sugar levels produced by these medications.
• Metildopa, 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 to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medication.
• Ciclosporin, a medication used to prevent organ transplant rejection.
• Antibiotics from the tetracycline group, or enoxacin.
• Amphotericin, a medication used to treat fungal infections.
• Some antacids, used to treat excess stomach acid, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect ofolmesartan / hydrochlorothiazide.
• Cisapride, used to increase stomach and intestinal movement.
• Halofantrine, used to treat malaria.

Taking Olmesartan/ hydrochlorothiazidePensa Pharma with food and drinks:

Olmesartan / hydrochlorothiazidecan be taken with or without food.

Be careful when drinking alcohol while takingolmesartan / hydrochlorothiazide, as some people may feel weak or dizzy. If this happens, do not drink any alcohol, including wine, beer, or alcoholic beverages.

Black patients:

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

Pregnancy and breastfeeding:

Pregnancy

You should inform your doctor if you are pregnant, (or if you suspect you may be). Your doctor will usually recommend that you stop takingOlmesartan/ hydrochlorothiazidePensa Pharmabefore becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medication instead ofOlmesartan/ hydrochlorothiazidePensa Pharma. It is not recommended to useOlmesartan/ hydrochlorothiazidePensa Pharmaduring pregnancy, and in any case, it should not be administered from the third month of pregnancy, as it may cause serious harm to your baby if administered from that point on.

Breastfeeding

You should inform your doctor if you are breastfeeding or plan to start breastfeeding. It is not recommended to useOlmesartan/ hydrochlorothiazidePensa Pharmaduring breastfeeding, and your doctor will choose another treatment for you 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 medication.

Use in athletes:

It is reported to athletes that this medication contains a component (hydrochlorothiazide) that may establish a positive analytical result for doping control.

Driving and operating machinery:

You may feel drowsy or dizzy while taking this medication for high blood pressure. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

Information on excipients:

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended doseis 1 tablet ofOlmesartán/ hidroclorotiazidaPensa Pharma20 mg/12.5 mg per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet ofOlmesartán/ hidroclorotiazidaPensa Pharma20 mg/25 mg per day.

Take the tablets with water. If possible, take your doseat the same time every day, for example, at breakfast time. It is essential that you continue takingOlmesartán/ hidroclorotiazidaPensa Pharmauntil your doctor tells you to stop.

If you take moreOlmesartán/ hidroclorotiazidaPensa Pharmathan you should:

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

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

If you forget to take Olmesartán/ hidroclorotiazidaPensa Pharma:

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

If you interrupt treatment with Olmesartán/ hidroclorotiazidaPensa Pharma:

It is essential to continue taking olmesartán/ hidroclorotiazida, unless your doctor tells you to stop.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

However, the following side effects may be serious:

• In rare cases, an allergic reaction may occur, affecting the entire body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash.If this happens, stop takingOlmesartán/ hidroclorotiazidaPensa Pharmaand consult your doctor immediately..

• Olmesartán/ hidroclorotiazidaPensa Pharmamay cause a significant drop in blood pressure in susceptible patients or as a result of an allergic reaction. Less frequently, dizziness or fainting may occur.If this happens, stop takingOlmesartán/ hidroclorotiazidaPensa Pharma, consult your doctor immediately, and remain lying down in a horizontal position.

• Unknown frequency: If you experience yellowing of the white of the eyes, dark urine, skin itching, even if you started treatment withOlmesartán/Hidroclorotiazida Pensa Pharmasome time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

Olmesartán/ hidroclorotiazidaPensa Pharmais a combination of two active principles. The following information, first, describes the side effects reported so far with the combinationolmesartán/ hidroclorotiazida(in addition to those already mentioned) and, secondly, the side effects known of the two active principles separately.

These are other side effects known so far withOlmesartán/ hidroclorotiazidaPensa Pharma:

If these effects occur, they are often mild andyou do not need to interrupt treatment.

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

Dizziness, weakness, headache, fatigue, chest pain, swelling of ankles, feet, legs, hands, or arms.

Rare side effects (may affect up to 1 in 100 people):

Fast and intense heartbeat (palpitations), hives, eczema, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain, arm and leg pain, back pain, erectile dysfunction in men, blood in urine.

Also, less frequently, some changes in blood tests have been observed that include:

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased creatinine, increased or decreased levels of potassium in the blood, increased levels of calcium in the blood, increased blood sugar, increased values of liver function tests. Your doctor will monitor you through a blood test and tell you if you need to take any action.

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

Unpleasant sensation, alterations in consciousness, skin swelling (hives), acute renal insufficiency.

Also, less frequently, some changes in blood test results have been observed that include:

Increased urea nitrogen in the blood, decreased values of hemoglobin and hematocrit. Your doctor will monitor you through a blood test and tell you if you need to take any action.

Additional side effects reported with the use of olmesartán medoxomilo or hidroclorotiazida alone, but not withOlmesartán/ hidroclorotiazidaPensa Pharmaor at a higher frequency:

Olmesartán medoxomilo:

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

Bronchitis, cough, congestion and nasal 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, frequently, some changes in blood test results have been observed that include:

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

Rare side effects (may affect up to 1 in 100 people):

Fast and intense allergic reactions that can affect the entire body and cause breathing problems, as well as a rapid drop in blood pressure that can even lead to fainting (anaphylactic reactions), inflammation of the face, angina (chest pain or discomfort, known as angina pectoris), unpleasant sensation, skin rash, itching, hives, skin swelling (hives).

Also, less frequently, some changes in blood test results have been observed that include:

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

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

Renal function deterioration, lack of energy.

Also, less frequently, some changes in blood test results have been observed that include:

Increased potassium in the blood

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

Hidroclorotiazida:

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

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

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

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 that include:

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

Rare side effects (may affect up to 1 in 100 people):

Severe loss of appetite, severe difficulty breathing, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light-sensitive skin reactions, itching, purple spots on the skin due to small hemorrhages (purpura), skin swelling (hives).

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

Salivary gland inflammation and pain, 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), numbness and tingling, seizures, yellowish perception of objects when looking at them, blurred vision, dry eyes, irregular heartbeat, blood vessel inflammation, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, biliary tract infection, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement alteration).

Very rare side 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 difficulty breathing, fever, weakness, and confusion).

Side effects of unknown frequency (cannot be estimated from available data):Decreased vision and eye paindue to high pressure[possible signs offluid accumulation in the vascular layer of the eye (choroidal hemorrhage) oracute angle-closure glaucoma], skin cancer and lip cancer (non-melanoma skin cancer).

Reporting of side effects

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

Keepthis medicationout of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on thecontainer and on the blister (after “CAD.:”). The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Olmesartan / hydrochlorothiazide Pensa Pharma

The active ingredient is olmesartan and hydrochlorothiazide. Each tablet contains 20 mg of olmesartan (in the form of 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 on excipients

Appearance of the product and contents of the packaging

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

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

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible manufacturer:

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 - Industrial Estate Areta 31620

Huarte-Pamplona. Spain

Last review date of this leaflet: February 2024

The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices. http://www.aemps.gob.es