Leaflet: information for the user

Olmesartan/Amlodipine/Hydrochlorothiazide Normon 40 mg/10 mg/12.5 mg film-coated tablets

Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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.

This medication 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 medications called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medications called “calcium channel blockers”. Amlodipine also decreases blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medications 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/Amlodipino/Hidroclorotiazida 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 Normon

• 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).
• If you think you may be allergic, inform your doctor before taking olmesartan/amlodipine/hydrochlorothiazide.
• 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 taking olmesartan/amlodipine/hydrochlorothiazide at the beginning of pregnancy - see the section “Pregnancy and breastfeeding”).
• If you have severe liver problems, bile secretion problems, or obstruction of bile duct 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 occur 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 olmesartan/amlodipine/hydrochlorothiazide if any of these cases occur.

Warnings and precautions

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

• If you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the blood vessel layer of the eye (choroidal hemorrhage) or increased pressure in the eye, and can occur within a few hours to a week after takingOlmesartán/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 shortness of breath or severe difficulty breathing after taking Olmesartán/Amlodipino/Hidroclorotiazida, seek medical attention immediately.

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

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 monitor your renal function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

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

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

• Renal problems or kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or cardiac muscle.
• Severe vomiting, diarrhea, treatment with high doses of diuretics, or if you are on a low-sodium diet.
• High levels of potassium in your blood.
• Problems with 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 a skin lesion appears unexpectedly 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 sun exposure and UV rays while taking this medication.

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 could be symptoms of increased pressure in the eye and can occur within a few hours to a weeks after taking olmesartan/amlodipine/hydrochlorothiazide. This can lead to permanent vision loss if not treated.

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.

Olmesartan/amlodipine/hydrochlorothiazide may cause an increase in lipid and uric acid levels in your blood. Your doctor will likely want to perform blood tests from time to time to monitor these possible changes.

You may experience changes in the levels of certain substances called electrolytes in your blood. Your doctor will likely 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, you should stop taking olmesartan/amlodipine/hydrochlorothiazide before the tests are performed.

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

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

Children and adolescents (under 18 years)

Olmesartan/amlodipine/hydrochlorothiazide is not recommended for use in children and adolescents under 18 years.

Taking Olmesartán/Amlodipino/Hidroclorotiazida Normon 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 olmesartan/amlodipine/hydrochlorothiazide.

Your doctor may need to modify 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 Normon” and “Warnings and precautions”).
• Lithium(a medication used to treat mood changes and certain types of depression) if used at the same time as olmesartan/amlodipine/hydrochlorothiazide 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, diuretics (medications that increase urine production), 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. Taking these medications at the same time as olmesartan/amlodipine/hydrochlorothiazide may alter potassium levels in your blood.
• Nonsteroidal anti-inflammatory drugs (NSAIDs)(medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartan/amlodipine/hydrochlorothiazide may increase the risk of kidney failure. The effect of olmesartan/amlodipine/hydrochlorothiazide 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 olmesartan/amlodipine/hydrochlorothiazide may cause a sudden drop in blood pressure when standing.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartan/amlodipine/hydrochlorothiazide. Your doctor may advise you to take olmesartan/amlodipine/hydrochlorothiazide at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of olmesartan/amlodipine/hydrochlorothiazide.
• 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 olmesartan/amlodipine/hydrochlorothiazide 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 pressure and decreasing heart rate, such as noradrenaline.
• 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 Normon with food and drinks

Olmesartan/amlodipine/hydrochlorothiazide can be taken with or without food.

People taking olmesartan/amlodipine/hydrochlorothiazide 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 olmesartan/amlodipine/hydrochlorothiazide.

Be careful when drinking alcohol while taking olmesartan/amlodipine/hydrochlorothiazide, 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 each 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 olmesartan/amlodipine/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of olmesartan/amlodipine/hydrochlorothiazide. Olmesartan/amlodipine/hydrochlorothiazide is not recommended for use during pregnancy, and should not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby if used from the third month of pregnancy.

If you become pregnant while taking olmesartan/amlodipine/hydrochlorothiazide, inform and see your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to start breastfeeding. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. Olmesartan/amlodipine/hydrochlorothiazide is not recommended for use in 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 machines

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

Olmesartán/Amlodipino/Hidroclorotiazida Normon contains sodium

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

3. How to Take Olmesartan / Amlodipino / Hidroclorotiazida Normon

4. Possible Adverse Effects

5. Conservation of Olmesartán/Amlodipino/Hidroclorotiazida Normon

6. Content of the packaging and additional information