Leaflet: information for the user

Olmesartan/Amlodipine/Hydrochlorothiazide Normon 20 mg/5 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 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/amlodipine/hydrochlorothiazide 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 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).
• If you think you may be allergic, inform your doctor before taking olmesartán/amlodipino/hidroclorotiazida.
• 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 olmesartán/amlodipino/hidroclorotiazida at the beginning of pregnancy - see 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 happen if the blood vessels or 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 Normon:

• If you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the blood vessel layer of the eye (choroidal hemorrhage) or increased eye pressure, which can occur within a few hours to a week after taking Olmesartán/Amlodipino/Hidroclorotiazida.
• 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 shortness of breath or severe difficulty breathing after taking Olmesartán/Amlodipino/Hidroclorotiazida, go to your doctor 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.
• Aliskirén.

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:

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or cardiac 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 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 a skin lesion appears unexpectedly during treatment. 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.

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 increased eye pressure and can occur within a few hours to a week after taking olmesartán/amlodipino/hidroclorotiazida. This can lead to permanent vision loss if not treated.

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 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 in your blood called electrolytes. 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 olmesartán/amlodipino/hidroclorotiazida 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). Olmesartán/amlodipino/hidroclorotiazida is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it can cause severe damage to your baby if taken during this stage (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.

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 olmesartán/amlodipino/hidroclorotiazida.

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 aliskirén (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 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 to treat slow heart rate or to reduce sweating.
• Halofantrina, used for malaria.
• Vincamina IV, used to improve blood circulation in the nervous system.
• Amantadina, used for Parkinson's disease.
• Supplements of potassium, salt substitutes containing potassium, medications that increase urine elimination(diuretics),heparina(to thin the blood and prevent blood clots), angiotensin-converting enzyme inhibitors (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 at the same time as olmesartán/amlodipino/hidroclorotiazida 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 olmesartán/amlodipino/hidroclorotiazida may increase the risk of kidney failure. The effect of olmesartán/amlodipino/hidroclorotiazida may decrease by NSAIDs. If high doses of salicylates are used, it 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 up.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may decrease 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 decrease 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).
• 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 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

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 levels of the active ingredient amlodipino in your blood, 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 whenever your dose is increased, 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. Olmesartán/amlodipino/hidroclorotiazida is not recommended for use during pregnancy, and it should not be taken if you are more than 3 months pregnant, as it can cause severe damage 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.

Lactation

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. Olmesartán/amlodipino/hidroclorotiazida 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 Olmesartan/Amlodipine/Hydrochlorothiazide Normon

6. Content of the packaging and additional information