Leaflet: information for the user

Olmesartan/Amlodipine/Hydrochlorothiazide pensa 40 mg/5 mg/12.5 mg film-coated tablets

Olmesartan medoxomil / Amlodipine / 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, inform your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Olmesartan/Amlodipine/Hydrochlorothiazide Pensa is and what it is used for
2. What you need to know before you start taking Olmesartan/Amlodipine/Hydrochlorothiazide Pensa
3. How to take Olmesartan/Amlodipine/Hydrochlorothiazide Pensa
4. Possible side effects
5. Storage of Olmesartan/Amlodipine/Hydrochlorothiazide Pensa
6. Contents of the pack and additional information

Olmesartán/Amlodipino/Hidroclorotiazida contains three active substances called olmesartán medoxomilo, amlodipino (as amlodipino besilato) and hidroclorotiazida. The three substances help control high blood pressure.

• Olmesartán medoxomilo belongs to a group of medicines called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.

• Amlodipino belongs to a group of medicines called “calcium channel blockers”.

Amlodipino also decreases blood pressure by relaxing blood vessels.

• Hidroclorotiazida belongs to a group of medicines called thiazide diuretics. It decreases blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

The action of these substances contributes to decreasing blood pressure. Olmesartán/Amlodipino/Hidroclorotiazida is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled with the combination of olmesartán medoxomilo and amlodipino, taken as a fixed combination, or
• in patients who are already taking a fixed combination of olmesartán medoxomilo and hidroclorotiazida, along with tablets containing only amlodipino, or a fixed combination of olmesartán medoxomilo and amlodipino, along with tablets containing only hidroclorotiazida.

Olmesartán/Amlodipino/Hidroclorotiazida is used to treat high blood pressure:

Do not take Olmesartán/Amlodipino/Hidroclorotiazida Pensa:

• If you are allergic to olmesartan medoxomil, amlodipine, or a group of calcium channel blockers (dihydropyridines), to hydrochlorothiazide or to substances similar to hydrochlorothiazide (sulfonamides), or to any of the other components of this medication (listed in section 6).

Inform your doctor before taking Olmesartán/Amlodipino/Hidroclorotiazida if you think you may be allergic.

• If you have severe kidney problems.
• If you have diabetes or kidney insufficiency and are being treated with a blood pressure medication that contains aliskiren.
• If you have low levels of potassium or sodium in your blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in your blood, that do not improve with treatment.
• If you are more than 3 months pregnant. (It is also best to avoid Olmesartán/Amlodipino/Hidroclorotiazida at the beginning of pregnancy - see the section “Pregnancy and breastfeeding”).
• If you have severe liver problems, bile secretion problems, or obstruction of bile ducts from the gallbladder (e.g., due to gallstones), or have jaundice (yellow skin and eyes).
• If you have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate, or shock (including cardiogenic shock, which means shock due to severe heart problems).
• If you have very low blood pressure.
• If the blood flow to your heart is slow or blocked. This can happen if the blood vessels or heart valves that capture blood from the heart become narrowed (aortic stenosis).
• If you have low cardiac output after a heart attack (acute myocardial infarction). Low cardiac output can make you feel short of breath or have swelling in your feet and ankles.

Do not take Olmesartán/Amlodipino/Hidroclorotiazida if any of these cases occur.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartán/Amlodipino/Hidroclorotiazida.

Tell your doctorif you are taking any of the following blood pressure medications:

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

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in your blood (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartán/Amlodipino/Hidroclorotiazida Pensa”.

Tell your doctorif you have any of the following health problems:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-sodium diet.
• High levels of potassium in your blood.
• Problems with the adrenal glands (glands that produce hormones located above the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Reactions such as sunburn or rash after being in the sun or in a tanning bed.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The 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 exposure and UV rays while taking Olmesartán/Amlodipino/Hidroclorotiazida.
• 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 Olmesartán/Amlodipino/Hidroclorotiazida, 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 evaluate your symptoms and decide how to continue your blood pressure treatment.

Decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which can occur within a few hours to a week after taking Olmesartán/Amlodipino/Hidroclorotiazida. This can lead to permanent vision loss if not treated.

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

Like any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with heart or brain blood flow abnormalities can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

Olmesartán/Amlodipino/Hidroclorotiazida may cause an increase in lipid and uric acid levels in your blood. Your doctor may want to perform blood tests from time to time to monitor these possible changes.

You may experience changes in the levels of certain chemicals in your blood called electrolytes. Your doctor may want to perform blood tests 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.

If you are undergoing parathyroid function tests, stop taking Olmesartán/Amlodipino/Hidroclorotiazida before the tests are performed.

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

Inform your doctor if you are pregnant (or think you may be). Do not take Olmesartán/Amlodipino/Hidroclorotiazida at the beginning of pregnancy, and do not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see the section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years)

Olmesartán/Amlodipino/Hidroclorotiazida is not recommended for use in children and adolescents under 18 years.

Use of Olmesartán/Amlodipino/Hidroclorotiazida Pensa with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

• Other blood pressure medications, as they may increase the effect of Olmesartán/Amlodipino/Hidroclorotiazida.

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 Olmesartán/Amlodipino/Hidroclorotiazida Pensa” and “Warnings and precautions”).

• Lithium (a medication used to treat mood changes and some types of depression) when used with Olmesartán/Amlodipino/Hidroclorotiazida may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in your blood.
• Diltiazem,verapamil,used for heart rhythm and high blood pressure problems.
• Rifampicin,erythromycin, clarithromycin, tetracyclines, or ciprofloxacin,antibiotics used for tuberculosis and other infections.
• St. John's Wort(Hypericum perforatum), a herbal remedy for depression.
• Cisapride, used to increase stomach and intestinal movement.
• Difemanil, used to treat slow heart rate or to reduce sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve blood flow to the nervous system.
• Amantadine, used for Parkinson's disease.
• Potassium supplements, salt substitutes containing potassium, medications that increase urine production(diuretics),heparin(to thin the blood and prevent blood clots), ACE inhibitors (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medication for mouth and stomach ulcers), penicillin G sodium (an antibiotic also called benzylpenicillin sodium), some pain relievers such as aspirin or salicylates. The use of these medications with Olmesartán/Amlodipino/Hidroclorotiazida may alter potassium levels in your 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 as Olmesartán/Amlodipino/Hidroclorotiazida may increase the risk of kidney problems. The effect of Olmesartán/Amlodipino/Hidroclorotiazida may be reduced by NSAIDs. High doses of salicylates may increase the toxic effect on the central nervous system.
• Sedatives, antidepressants, and sleep-inducing medications, used with Olmesartán/Amlodipino/Hidroclorotiazida may cause a sudden drop in blood pressure when standing up.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of Olmesartán/Amlodipino/Hidroclorotiazida. Your doctor may advise you to take Olmesartán/Amlodipino/Hidroclorotiazida at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of Olmesartán/Amlodipino/Hidroclorotiazida.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medications, such as atropine and biperiden.

?Calcium supplements.

• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, used to lower cholesterol and triglyceride levels in the blood.
• Medications used to control the body's immune response(e.g., tacrolimus, cyclosporine), which allows your body to accept the transplanted organ.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications for:

• Treating certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• Treating low blood sugar(e.g., diazoxide) orhigh blood pressure(e.g., beta-blockers, methyldopa), as Olmesartán/Amlodipino/Hidroclorotiazida may affect the mechanism of action of these medications.
• Treating heart rhythm problems, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections.
• Treating HIV/AIDS(e.g., ritonavir, indinavir, nelfinavir).
• Treating fungal infections(e.g., ketoconazole, itraconazole, amphotericin).
• Treating heart problems, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digital.
• Treating cancer, such as amifostine, cyclophosphamide, or methotrexate.
• Increasing blood pressureanddecreasing heart rate, such as norepinephrine.
• Treating gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Lowering cholesterol levels in the blood, such as cholestyramine and colestipol.
• Lowering blood sugar levels, such as metformin or insulin.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Taking Olmesartán/Amlodipino/Hidroclorotiazida Pensa with food, drinks, and alcohol:

Olmesartán/Amlodipino/Hidroclorotiazida can be taken with or without food.

People taking Olmesartán/Amlodipino/Hidroclorotiazida should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipine, which may cause an unpredictable increase in the effect of lowering blood pressure of Olmesartán/Amlodipino/Hidroclorotiazida.

Be careful when drinking alcohol while taking Olmesartán/Amlodipino/Hidroclorotiazida, as some people may feel dizzy, nauseous, or experience headaches. If this happens, do not drink any alcohol.

Older patients:

If you are over 65 years old, your doctor will regularly monitor your blood pressure every time you increase your dose, to ensure that your blood pressure does not drop too low.

Pregnancy and breastfeeding:

Pregnancy

Inform your doctor if you are pregnant, or if you think you may be. Your doctor will advise you to stop taking Olmesartán/Amlodipino/Hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of Olmesartán/Amlodipino/Hidroclorotiazida. Do not take Olmesartán/Amlodipino/Hidroclorotiazida during pregnancy, and do not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period.

If you become pregnant while taking Olmesartán/Amlodipino/Hidroclorotiazida, inform and visit your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. Olmesartán/Amlodipino/Hidroclorotiazida is not recommended for mothers who are breastfeeding, and your doctor may choose another 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 medication.

Driving and operating machinery:

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

This medication contains less than 23 mg of sodium (1mmol) per coated tablet; this is, essentially “sodium-free”.

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

• The recommended dose of Olmesartán/Amlodipino/Hidroclorotiazida is one tablet per day.
• The tablets can be taken with or without food. Take the tablets with a little liquid (such as a glass of water). Do not chew the tablet. Do not take the tablets with grapefruit juice.
• If possible, take your daily dose at the same time each day, for example at breakfast time.

If You Take More Olmesartán/Amlodipino/Hidroclorotiazida Pensa Than You Should:

If you take more tablets than you should, you may experience a drop in blood pressure, accompanied by symptoms such as dizziness, and a rapid or slow heart rate.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that may develop up to 24-48 hours after ingestion.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20.

If You Forget to Take Olmesartán/Amlodipino/Hidroclorotiazida Pensa:

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

If You Interrupt Treatment with Olmesartán/Amlodipino/Hidroclorotiazida Pensa:

It is important to continue taking Olmesartán/Amlodipino/Hidroclorotiazida, unless your doctor tells you to stop treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them. If they occur, they are often mild and do not require interrupting treatment.

The following side effects may be serious, although they affect only a small group of people:

During treatment with Olmesartán/Amlodipino/Hidroclorotiazida, allergic reactions with inflammation of the face, mouth, and/or larynx (vocal cords), along with itching and skin rash may occur.If this happens, stop takingOlmesartán/Amlodipino/Hidroclorotiazidaand consult your doctor immediately..

Olmesartán/Amlodipino/Hidroclorotiazida may cause a pronounced drop in blood pressure in susceptible patients. This can cause severe dizziness or fainting.If this happens, stop takingOlmesartán/Amlodipino/Hidroclorotiazida, 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, itching of the skin, even if you started treatment withOlmesartán/Amlodipino/Hidroclorotiazidasome time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with the treatment for high blood pressure.

Olmesartán/Amlodipino/Hidroclorotiazida is a combination of three active substances. The following information, first, describes the side effects reported so far with the combination Olmesartán/Amlodipino/Hidroclorotiazida (in addition to those already mentioned) and, second, the known side effects of each of the active substances separately, or when two of the substances are taken together.

To give you an idea of the number of patients who may experience side effects, they have been classified as frequent, infrequent, rare, and very rare.

These are other side effects known so far with Olmesartán/Amlodipino/Hidroclorotiazida:

If these side effects occur, they are often mild anddo not need to interrupt treatment.

Frequent

(may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat, and runny nose, urinary tract infection, dizziness, headache, perception of heartbeats, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, sensation of urgency to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test results.

Infrequent

(may affect up to 1 in 100 people)

Vertigo when standing up, dizziness, rapid heartbeat, sensation of fainting, flushing and sensation of heat in the face, cough, dry mouth, muscle weakness, inability to have or maintain an erection.

These are the side effects known for each of the active substances separately or when two of the substances are taken together:

They may be side effects due to Olmesartán/Amlodipino/Hidroclorotiazida, even if they have not been observed so far with Olmesartán/Amlodipino/Hidroclorotiazida.

Very frequent

(may affect more than 1 in 10 people)

Edema (fluid retention).

Frequent

(may affect up to 1 in 10 people)

Bronchitis, stomach and intestinal infection, vomiting, increased blood sugar, sugar in urine, confusion, drowsiness, visual disturbances (including double vision and blurred vision), nasal secretion or congestion, sore throat, difficulty breathing, cough, abdominal pain, stomach burning, stomach discomfort, flatulence, joint or bone pain, back pain, bone pain, blood in urine, flu-like symptoms, chest pain, pain.

Infrequent

(may affect up to 1 in 100 people)

Reduction in the number of a type of blood cell called platelets, which can cause easy bruising or prolonged bleeding, anaphylactic reactions, abnormal decrease in appetite (anorexia), difficulty sleeping, irritability, mood changes including anxiety, feeling of depression, chills, sleep disturbances, alteration of taste, loss of consciousness, decrease in sense of touch, sensation of numbness, worsening of myopia, ringing in the ears (tinnitus), angina (pain or uncomfortable sensation in the chest, known as angina pectoris), irregular heartbeat, rash, hair loss, allergic skin inflammation, skin redness, purple patches or spots on the skin due to small hemorrhages (purpura), skin discoloration, red itchy patches (urticaria), increased sweating, itching, skin rash, skin reactions to light, such as sunburn or skin eruption, muscle pain, difficulty urinating, sensation of needing to urinate at night, enlargement of breast tissue in men, decreased libido, swelling of the face, feeling of discomfort, weight gain or loss, fatigue.

Rare

(may affect up to 1 in 1,000 people)

Salivary gland inflammation and pain, decrease in the number of white blood cells in the blood, which could increase the risk of infections, decrease in the number of red blood cells (anemia), bone marrow damage, restlessness, feeling of loss of interest (apathy), seizures (convulsions), yellowish perception of objects when looking at them, dry eyes, blood clots (thrombosis, embolism), fluid accumulation in the lungs, pneumonia, inflammation of small blood vessels and small blood vessels in the skin, pancreatitis, yellowing of the skin and eyes, acute inflammation of the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, severe skin reactions including intense skin rash, urticaria, skin redness, severe itching, blisters, peeling, and skin inflammation, Stevens-Johnson syndrome, toxic epidermal necrolysis, sometimes very severe, movement impairment, acute kidney failure, non-infectious kidney inflammation, kidney function decrease, fever.

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

Very rare

(may affect up to 1 in 10,000 people)

High muscle tension, numbness of hands or feet, heart attack, stomach inflammation, gum thickening, intestinal obstruction, liver inflammation.

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

Unknown frequency(cannot be estimated from available data): Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma), tremors, rigid posture, mask-like face, slow movements, and unsteady gait dragging the feet, 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

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

Store below 30 °C.

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

Composition of Olmesartán/Amlodipino/Hidroclorotiazida Pensa

The active principles are olmesartan medoxomil, amlodipine (as amlodipine besylate) and hydrochlorothiazide.

Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate) and 12.5 mg of hydrochlorothiazide.

The other components are:

Tablet core: Pregelatinized cornstarch, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.Tablet coating: Polyvinyl alcohol, macrogol, talc, titanium dioxide (E-171), iron oxide yellow (E-172).

Appearance of the product and content of the packaging

Olmesartán/Amlodipino/Hidroclorotiazida Pensa 40 mg/5 mg/12.5 mg film-coated tablets are yellowish clear, cylindrical, biconvex tablets with the inscription “t4” on one face.

Olmesartán/Amlodipino/Hidroclorotiazida Pensa film-coated tablets are presented in packaging with blisters of 28 tablets.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios CINFA, S.A.

Olaz-Chipi, 10 - Industrial Park Areta

31620 Huarte (Navarra)

Spain

Revision date of this leaflet:January 2025

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