Olmesartan/amlodipine/hydrochlorothiazide Normon 40 mg/10 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartan/Amlodipine/Hydrochlorothiazide Normon 40 mg/10 mg/25 mg film-coated tablets EFG

Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further 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, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Olmesartan/Amlodipine/Hydrochlorothiazide Normon is and what it is used for

This medicine contains three active substances: olmesartan medoxomil, amlodipine (as amlodipine besilate), and hydrochlorothiazide. These three substances help control high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called "angiotensin II receptor antagonists", which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called "calcium channel blockers". Amlodipine also lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

The combined action of these substances helps reduce your 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 medoxomil and amlodipine taken as a fixed-dose combination, or
• in adult patients who are already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide together with tablets containing amlodipine alone, or a fixed-dose combination of olmesartan medoxomil and amlodipine together with tablets containing hydrochlorothiazide alone.

2. What you need to know before starting to take Olmesartan/Amlodipine/Hydrochlorothiazide Normon

Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Normon

• If you are allergic to olmesartan medoxomil, amlodipine, or a specific group of calcium channel blockers (dihydropyridines), hydrochlorothiazide, or substances similar to hydrochlorothiazide (sulfonamides), or to any of the other components of this medicine (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 renal insufficiency and are being treated with a blood pressure-lowering medicine containing 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 advisable to avoid olmesartan/amlodipine/hydrochlorothiazide in early pregnancy – see section “Pregnancy and breastfeeding”).
• If you have severe liver problems, biliary secretion disorders, or obstruction of bile drainage from the gallbladder (e.g., due to gallstones), or have jaundice (yellowing of the skin and eyes).
• If you have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, meaning shock due to serious heart problems).
• If you have very low blood pressure.
• If blood flow from your heart is slow or blocked. This may occur if blood vessels or heart valves bringing blood out of the heart are narrowed (aortic stenosis).
• If you have low cardiac output following a heart attack (acute myocardial infarction). Low cardiac output may cause shortness of breath or swelling in your feet and ankles.

Do not take olmesartan/amlodipine/hydrochlorothiazide if any of these situations apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartan/Amlodipine/Hydrochlorothiazide Normon:

• If you experience vision loss or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within hours to a week after taking Olmesartan/Amlodipine/Hydrochlorothiazide.
• If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Olmesartan/Amlodipine/Hydrochlorothiazide, seek medical attention immediately.

Consult your doctor if you develop abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartan/Amlodipine/Hydrochlorothiazide Normon. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan/Amlodipine/Hydrochlorothiazide Normon without medical advice.

Tell your doctor if you are taking any of the following medicines used to treat high blood pressure (hypertension):

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

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

See also the information under the heading “Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Normon”.

Tell your doctor if you have any of the following health conditions:

• 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 medicines that increase urine output (diuretics), or if you are on a low-salt diet.
• High levels of potassium in the blood.
• Problems with the adrenal glands (hormone-producing glands located above the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• Skin reactions such as sunburn or rash after sun exposure or tanning beds.
• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun and UV exposure while taking this medicine.

Contact your doctor if you experience any of the following symptoms:

• Severe, persistent diarrhea causing significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.
• Vision loss or eye pain. These could be symptoms of increased eye pressure and may occur from hours to weeks after taking olmesartan/amlodipine/hydrochlorothiazide. This may lead to permanent vision deterioration if untreated.

As with any other medicine that lowers blood pressure, excessive reduction of blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

Olmesartan/amlodipine/hydrochlorothiazide may increase blood levels of lipids and uric acid (which causes gout – painful joint swelling). Your doctor may periodically perform blood tests to monitor these potential changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor may periodically perform blood tests to monitor this possible change. Some signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, drowsy, restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

If you are scheduled for parathyroid function tests, you must stop taking olmesartan/amlodipine/hydrochlorothiazide before the tests are performed.

Athletes are advised that this medicine contains a component that may result in a positive doping test.

Inform your doctor if you are pregnant (or think you might be). Use of olmesartan/amlodipine/hydrochlorothiazide is not recommended in early pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if taken during this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years of age)

The use of olmesartan/amlodipine/hydrochlorothiazide is not recommended in children and adolescents under 18 years of age.

Taking Olmesartan/Amlodipine/Hydrochlorothiazide Normon with other medicines

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

• Other blood pressure-lowering medicines, as they may enhance the effect of olmesartan/amlodipine/hydrochlorothiazide.

Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Normon” and “Warnings and precautions”).
• Lithium, a medicine used to treat mood disorders and certain types of depression, may have increased toxicity when taken with olmesartan/amlodipine/hydrochlorothiazide. If you need to take lithium, your doctor will monitor lithium levels in your blood.
• Diltiazem, verapamil, used for heart rhythm disorders and high blood pressure.
• Rifampicin, erythromycin, clarithromycin, tetracyclines, or sparfloxacin, 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 motility.
• Difemanoil, used to treat slow heart rate or 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, potassium-containing salt substitutes, diuretics (medicines that increase urine output), heparin (to thin blood and prevent clots), angiotensin-converting enzyme (ACE) inhibitors (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine for mouth and stomach ulcers), sodium penicillin G (an antibiotic also known as sodium benzylpenicillin), certain painkillers such as acetylsalicylic acid (“aspirin”) or salicylates. Using these medicines with olmesartan/amlodipine/hydrochlorothiazide may alter blood potassium levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other inflammation symptoms, including arthritis), when used with 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 central nervous system toxicity.
• Sleep-inducing medicines, sedatives, and antidepressants, when used with olmesartan/amlodipine/hydrochlorothiazide, may cause a sudden drop in blood pressure upon standing.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, 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), which may slightly reduce the effect of olmesartan/amlodipine/hydrochlorothiazide.
• Certain muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene (administered by infusion for severe body temperature abnormalities).
• Simvastatin, used to lower cholesterol and fat (triglyceride) levels in the blood.
• Medicines used to control the body’s immune response (e.g., tacrolimus, cyclosporine), which help the body accept a transplanted organ.

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

• Treat certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• Treat low blood sugar (e.g., diazoxide) or high blood pressure (e.g., beta-blockers, methyldopa), since olmesartan/amlodipine/hydrochlorothiazide may affect the mechanism of action of these medicines.
• Treat heart rhythm disorders, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections.
• Treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir).
• Treat fungal infections (e.g., ketoconazole, itraconazole, amphotericin).
• Treat heart problems, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis.
• Treat cancer, such as amifostine, cyclophosphamide, or methotrexate.
• Increase blood pressure and decrease heart rate, such as noradrenaline.
• Treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Lower blood fat levels, such as cholestyramine and colestipol.
• Lower blood sugar levels, such as metformin or insulin.

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

Taking Olmesartan/Amlodipine/Hydrochlorothiazide 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 increase blood levels of the active ingredient amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of olmesartan/amlodipine/hydrochlorothiazide.

Be cautious when drinking alcohol while taking olmesartan/amlodipine/hydrochlorothiazide, as some people may feel faint or dizzy. If this occurs, avoid alcohol.

Elderly patients

If you are over 65 years of age, your doctor will regularly monitor your blood pressure each time your dose is increased, to ensure that your blood pressure does not drop too much.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you might 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 recommend an alternative medicine. Use of olmesartan/amlodipine/hydrochlorothiazide is not recommended during pregnancy, and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

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

Breastfeeding

Inform your doctor if you are breastfeeding or about 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 breastfeeding mothers, and your doctor may choose an alternative 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 medicine.

Driving and use of machines

You may feel drowsy, unwell, dizzy, or have a headache while being treated for high blood pressure. If this happens, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartan/Amlodipine/Hydrochlorothiazide Normon contains sodium

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

3. How to take Olmesartan / Amlodipine / Hydrochlorothiazide Normon

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day.

The tablets can be taken with or without food. Take the tablets with some liquid (such as a glass of water). The tablet must not be chewed. 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 Normon 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 rapid or slow heartbeat.

If you take more tablets than prescribed or if a child accidentally ingests any tablets, contact your doctor immediately or go to the nearest emergency department, and bring the medicine package or this leaflet with you.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Olmesartán/Amlodipino/Hidroclorotiazida Normon

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

If you stop taking Olmesartán/Amlodipino/Hidroclorotiazida Normon

It is important to continue taking this medicine unless your doctor tells you to stop.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If they do occur, they are often mild and do not require stopping treatment.

The following two adverse effects may be serious:

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with Olmesartán Normon some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

During treatment with olmesartan/amlodipine/hydrochlorothiazide, allergic reactions may occur with swelling of the face, mouth, and/or larynx (vocal cords), along with skin itching and rash. If this happens, stop taking this medicine and consult your doctor immediately.

Olmesartan/amlodipine/hydrochlorothiazide may cause a marked drop in blood pressure in susceptible patients. This may lead to fainting or severe dizziness. If this happens, stop taking this medicine, consult your doctor immediately, and remain lying down in a horizontal position.

Decreased vision or eye pain may occur due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Olmesartan/amlodipine/hydrochlorothiazide is a combination of three active substances. The following information first describes adverse effects reported so far with the combination olmesartan/amlodipine/hydrochlorothiazide (in addition to those already mentioned), and secondly, the known adverse effects of each active substance individually or when two of the substances are taken together.

To give an idea of how many patients may experience adverse effects, they have been classified as frequent, uncommon, rare, and very rare.

These are other known adverse effects with olmesartan/amlodipine/hydrochlorothiazide so far:

If these effects occur, they are often mild and it is not necessary to stop treatment.

Frequent (may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat and nasal symptoms, urinary tract infection, dizziness, headache, awareness of heartbeat, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, feeling of urgency to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test results.

Uncommon (may affect up to 1 in 100 people)

Dizziness upon standing, vertigo, rapid heartbeat, feeling faint, facial flushing and sensation of warmth, cough, dry mouth, muscle weakness, inability to achieve or maintain an erection.

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

These may be adverse effects due to olmesartan/amlodipine/hydrochlorothiazide, even if they have not yet been observed with olmesartan/amlodipine/hydrochlorothiazide.

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 discharge or congestion, sore throat, difficulty breathing, cough, abdominal pain, heartburn, stomach discomfort, flatulence, joint or bone pain, back pain, bone pain, blood in urine, flu-like symptoms, chest pain, pain.

Uncommon (may affect up to 1 in 100 people)

Reduction in the number of a type of blood cells called platelets, which may lead to easy bruising or prolonged bleeding time, anaphylactic reactions, abnormally decreased appetite (anorexia), sleep problems, irritability, mood changes including anxiety, feeling of depression, chills, sleep disorders, altered sense of taste, loss of consciousness, reduced sense of touch, tingling sensation, worsening of myopia, ringing in the ears (tinnitus), angina (chest pain or discomfort, known as angina pectoris), irregular heartbeat, rash, hair loss, allergic skin inflammation, skin redness, purple spots or patches on the skin due to small hemorrhages (purpura), skin discoloration, itchy red welts (urticaria), increased sweating, pruritus, skin rash, skin reactions to light such as sunburn or skin rash, muscle pain, problems urinating, feeling of needing to urinate at night, breast enlargement in men, decreased sex drive, facial swelling, feeling of malaise, weight gain or loss, exhaustion.

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

Inflammation and pain of the salivary glands, decreased number of white blood cells in the blood, which could increase the risk of infections, decreased number of red blood cells (anemia), bone marrow damage, restlessness, feeling of loss of interest (apathy), attacks (seizures), yellowish perception of objects when looking at them, dry eyes, blood clots (thrombosis, embolism), fluid accumulation in the lungs, pneumonia, inflammation of blood vessels and small blood vessels in the skin, inflammation of the pancreas, yellowing of the skin and eyes, acute inflammation of the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pains, and coldness in hands and fingers, severe skin reactions including intense skin rash, urticaria, redness of the skin of the body, severe itching, blisters, peeling and inflammation of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe, impaired movement, acute kidney failure, non-infectious inflammation of the kidney, reduced kidney function, fever. Intestinal angioedema: swelling in the intestine presenting 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, inflammation of the stomach, gum overgrowth, intestinal obstruction, liver inflammation, acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Adverse effects of unknown frequency (cannot be estimated from available data)

Decreased vision or eye pain (possible signs of acute angle-closure glaucoma). Tremors, rigid posture, mask-like face, slow movements, and unbalanced gait with shuffling steps.

Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan/Amlodipine/Hydrochlorothiazide Normon

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

Do not use this medicine after the expiry date stated on the packaging and blister after "EXP.". The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Olmesartan/Amlodipine/Hydrochlorothiazide Normon

The active substances are olmesartan medoxomil, amlodipine (as amlodipine besilate) and hydrochlorothiazide.

Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besilate) and 25 mg of hydrochlorothiazide.

The other components are:

Tablet core: pregelatinized corn starch, silicified microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica and magnesium stearate.

Tablet coating: polyvinyl alcohol, titanium dioxide (E-171), macrogol 4000, talc, iron oxide red (E-172) and iron oxide yellow (E-172).

Appearance of the product and contents of the pack

Olmesartán/Amlodipino/Hidroclorotiazida Normon 40 mg/10 mg/25 mg film-coated tablets are pink, elliptical, biconvex tablets, with the imprint “OA10” on one side and “H25” on the other.

Olmesartán/Amlodipino/Hidroclorotiazida Normon film-coated tablets are available in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturing Responsible

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: February 2025

Other sources of information

Up-to-date detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/