Package Leaflet: Information for the Patient

Olmesartán/Amlodipino/Hidroclorotiazida Kern Pharma 20 mg/5 mg/12,5 mg Film-Coated Tablets

Olmesartán/Amlodipino/Hidroclorotiazida Kern Pharma 40 mg/5 mg/12,5 mg Film-Coated Tablets

Olmesartán/Amlodipino/Hidroclorotiazida Kern Pharma 40 mg/10 mg/12,5 mg Film-Coated Tablets

Olmesartán/Amlodipino/Hidroclorotiazida Kern Pharma 40 mg/5 mg/25 mg Film-Coated Tablets

Olmesartán/Amlodipino/Hidroclorotiazida Kern Pharma 40 mg/10 mg/25 mg Film-Coated Tablets

Olmesartán medoxomilo / Amlodipino / Hidroclorotiazida

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 give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isOlmesartán/Amlodipino/Hidroclorotiazida Kern Pharmaand what it is used for

2. What you need to know before starting to takeOlmesartán/Amlodipino/Hidroclorotiazida Kern Pharma

3. How to takeOlmesartán/Amlodipino/Hidroclorotiazida Kern Pharma

4. Possible side effects

5. Storage ofOlmesartán/Amlodipino/Hidroclorotiazida Kern Pharma

6. Contents of the pack and additional information

This medicine contains three active substances called olmesartan medoxomilo, amlodipine (as amlodipine besylate) and hydrochlorothiazide. The three substances help control high blood pressure.

• Olmesartan medoxomilo belongs to a group of medicines called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called “calcium channel blockers”. Amlodipine also decreases blood pressure by relaxing blood vessels.
• Hydrochlorothiazide 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. Olmesartan/hydrochlorothiazide/amlodipine is used to treat high blood pressure:

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

Do not take Olmesartán/Amlodipino/Hidroclorotiazida Kern Pharma

• If you are allergic to olmesartán medoxomilo, amlodipino, or a group of calcium channel blockers (dihidropiridinas), hidroclorotiazida, or substances similar to hidroclorotiazida (sulfonamidas), or any of the other components of this medication (listed in section 6).

Inform your doctor before taking this medication 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 medication to lower blood pressure that contains aliskirén.
• 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 this medication at the beginning of pregnancy - see section “Pregnancy and breastfeeding”).
• If you have severe liver problems, bile secretion problems, or obstruction of bile drainage 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 Kern Pharma:

Tell your doctorif you are taking any of the following medications used to treat high blood pressure (hypertension):

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

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 Kern Pharma”.

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.
• Intense 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 the adrenal glands (glands that produce hormones located above the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Skin 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 hidroclorotiazida, 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 this medication.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida 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 treatment for high blood pressure.
• 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 and may occur from a few hours to several weeks after taking olmesartán/amlodipino/hidroclorotiazida. This can lead to permanent vision impairment if not treated.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after takingOlmesartán/Amlodipino/Hidroclorotiazida. Your doctor will decide whether to continue treatment. Do not stop takingOlmesartán/Amlodipino/Hidroclorotiazidain monotherapy.

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 carefully monitor your blood pressure.

Olmesartán/Amlodipino/Hidroclorotiazida Kern Pharma 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 substances 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 scheduled to have parathyroid function tests, stop taking this medication 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 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 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.

Olmesartán/Amlodipino/Hidroclorotiazida Kern Pharma 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 (ACEI) or aliskirén (see also the information under the headings “Do not take Olmesartán/Amlodipino/Hidroclorotiazida Kern Pharma” 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,verapamilo,used for heart rhythm and high blood pressure problems.
• Rifampicina,eritromicina, claritromicina, tetraciclinas o esparfloxacino,antibiotics used for tuberculosis and other infections.
• St. John's Wort(Hypericum perforatum), a herbal remedy for depression treatment.
• Cisaprida, used to increase stomach and intestinal movement.
• Difemanilo, used for slow heart rate or to reduce sweating.
• Halofantrina, used for malaria.
• Vincamina IV, used to improve blood flow to the nervous system.
• Amantadina, used for Parkinson's disease.
• Potassium supplements, salt substitutes containing potassium, medications that increase urine elimination(diuretics),heparina(to thin the blood and prevent blood clots), ACE inhibitors (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolona (medication for mouth and stomach ulcers), penicillin G sodium (antibiotic also called benzylpenicillin sodium), some analgesics such as acetylsalicylic acid (“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 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, 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 perfusion for severe body temperature abnormalities).
• Simvastatina, used to lower cholesterol and triglyceride levels in the blood.
• Medications used to control the body's immune response(e.g., tacrolimus, ciclosporina), 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, 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.

Olmesartán/Amlodipino/Hidroclorotiazida Kern Pharma with food and beverages

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 amlodipino, 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 the 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 see your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. It has been shown that amlodipino and hidroclorotiazida pass into breast milk in small amounts. Do not use olmesartán/amlodipino/hidroclorotiazida in mothers who are breastfeeding, and your doctor may choose another treatment if you want 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 medication for high blood pressure. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

This medication contains less than23 mg of sodium (1mmol)per coated tablet; this is, essentially “sodium-free”.

3. How to take/use Olmesartan / Amlodipino / Hidroclorotiazida Kern Pharma

4. Possible Adverse Effects

5. Conservation of Olmesartán/Amlodipino/Hidroclorotiazida Kern Pharma

6. Contents of the packaging and additional information