Leaflet: information for the user

Olmesartan/Amlodipine/Hydrochlorothiazide pensa 40 mg/5 mg/25 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.

Content 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 lower blood pressure by relaxing blood vessels.

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

Amlodipino also lowers blood pressure by relaxing blood vessels.

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

The action of these substances contributes to lowering 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-dose combination, or
• in patients who are already taking a fixed-dose combination of olmesartán medoxomilo and hidroclorotiazida, along with tablets containing only amlodipino, or a fixed-dose combination of olmesartán medoxomilo and amlodipino, along with tablets containing only hidroclorotiazida.

Olmesartán/Amlodipino/Hidroclorotiazida is used for the treatment of 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 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, which 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 medications used to treat high blood pressure (hypertension):

• 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 elimination (diuretics), or if you are on a low-sodium diet.
• Elevated potassium levels in your blood.
• Problems with 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 blood pressure reduction 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 control for doping as positive.

Inform your doctor if you are pregnant (or think you may be). Do not use 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-lowering 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 certain 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 treatment.
• Cisapride, used to increase stomach and intestinal movement.
• Difemanil, used for slow heart rate or to reduce sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve blood circulation in the nervous system.
• Amantadine, used for Parkinson's disease.
• Potassium supplements, salt substitutes containing potassium, medications that increase urine elimination (diuretics), heparin (to thin 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. Using these medications at the same time as Olmesartán/Amlodipino/Hidroclorotiazida may alter your 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 failure. 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, hypnotics, and antidepressants, used with Olmesartán/Amlodipino/Hidroclorotiazida may cause a sudden drop in blood pressure when standing.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in your 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.

?Sodium supplements.

• Dantrolene(in infusion for severe body temperature abnormalities).
• Simvastatin, used to lower cholesterol and triglyceride levels in your 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 intravenous erythromycin.
• 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 your 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 adults:

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 use 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 used from the third month of pregnancy.

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”.

3. How to Take Olmesartán/Amlodipino/Hidroclorotiazida Pensa

4. Possible Adverse Effects

5. Conservation of Olmesartan/Amlodipine/Hydrochlorothiazide Pensa

6. Content of the packaging and additional information