OLMESARTAN/AMLODIPINE/HYDROCHLOROTHIAZIDE AUROVITAS 40 mg/10 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas 20 mg/5 mg/12.5 mg

film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas 40 mg/5 mg/12.5 mg

film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas 40 mg/10 mg/12.5 mg

film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas 40 mg/5 mg/25 mg

film-coated tablets EFG

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas 40 mg/10 mg/25 mg

film-coated tablets EFG

olmesartan medoxomil/amlodipine/hydrochlorothiazide

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas and what is it used for
2. What you need to know before taking Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas
3. How to take Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas
4. Possible side effects
5. Storage of Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas
6. Package contents and additional information

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

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

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

The action of these substances contributes to lowering your blood pressure. Olmesartan medoxomil/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 patients who are already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide, along with tablets containing only amlodipine, or a fixed-dose combination of olmesartan medoxomil and amlodipine, along with tablets containing only hydrochlorothiazide.

2. What you need to know before taking Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas

Do not take Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas

• If you are allergic to olmesartan medoxomil, amlodipine, or a special 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 medoxomil/amlodipine/hydrochlorothiazide.
• If you have severe kidney problems.
• If you have diabetes or kidney failure 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 pregnant for more than 3 months. (It is also best to avoid olmesartan medoxomil/amlodipine/hydrochlorothiazide at the start 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 if you have jaundice (yellowing of the skin and eyes).
• If you have insufficient blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, 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 narrow (aortic stenosis).
• If you have poor heart performance after suffering a heart attack (acute myocardial infarction). Poor heart performance can make you feel short of breath or have swelling in your feet and ankles.

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas.

If you have had respiratory or lung 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 olmesartan medoxomil/amlodipine/hydrochlorothiazide, see your doctor immediately.

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

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

Your doctor may check 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 Aurovitas".

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

• Kidney problems or a kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Severe vomiting, diarrhea, treatment with high doses of medicines that increase urine production (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 being in the sun or in a solarium.
• If you have had skin cancer or if you 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 skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking this medicine.

Contact your doctorif you experience any of the following symptoms:

• Severe diarrhea, persistent and causing significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your treatment for high blood pressure.
• Decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur from a few hours to a few weeks after taking olmesartan medoxomil/amlodipine/hydrochlorothiazide. This can lead to permanent vision impairment if left untreated.

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

Olmesartan medoxomil/amlodipine/hydrochlorothiazide may cause an increase in lipid and uric acid levels in the blood. Your doctor will likely want to perform a blood test from time to time to monitor these potential changes.

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely want to perform a blood test from time to time to monitor this potential change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, fatigue, drowsiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

If you are going to have parathyroid function tests, you should stop taking olmesartan medoxomil/amlodipine/hydrochlorothiazide before these tests are performed.

Athletes are informed that this medicine contains hydrochlorothiazide, which may produce a positive result in doping tests.

You should inform your doctor if you are pregnant (or think you might be). It is not recommended to use olmesartan medoxomil/amlodipine/hydrochlorothiazide during pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage (see section "Pregnancy and breastfeeding").

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas on your own.

Children and adolescents (under 18 years)

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

Elderly patients

If you are over 65 years old, your doctor will regularly check your blood pressure each time your dose is increased to ensure that your blood pressure does not decrease too much.

Other medicines and Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas

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

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

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 Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas" and "Warnings and precautions").

• Lithium(a medicine used to treat mood changes and some types of depression) may have its toxicity increased if used at the same time as olmesartan medoxomil/amlodipine/hydrochlorothiazide. If you need to take lithium, your doctor will measure lithium levels in your blood.
• Diltiazemand verapamil, used for heart rhythm problems 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 food movement in the stomach and intestine.
• Difemanil, used to treat slow heart rate or to decrease 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, medicines that increase urine production(diuretics), heparin(to thin blood and prevent blood clots), angiotensin-converting enzyme inhibitors (ACE inhibitors) (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine for treating mouth and stomach ulcers), penicillin G sodium (an antibiotic also called sodium benzylpenicillin), and some pain relievers like acetylsalicylic acid ("aspirin") or salicylates. The use of these medicines at the same time as olmesartan medoxomil/amlodipine/hydrochlorothiazide may alter potassium levels in the blood.
• Non-steroidal anti-inflammatory medicines(NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartan medoxomil/amlodipine/hydrochlorothiazide, may increase the risk of kidney failure. The effect of olmesartan medoxomil/amlodipine/hydrochlorothiazide may be decreased by NSAIDs. If high doses of salicylates are used, the toxic effect on the central nervous system may increase.
• Sleep-inducing medicines, sedatives, and antidepressants, used with olmesartan medoxomil/amlodipine/hydrochlorothiazide, may cause a sudden drop in blood pressure when standing.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may decrease the effect of olmesartan medoxomil/amlodipine/hydrochlorothiazide. Your doctor may advise you to take olmesartan medoxomil/amlodipine/hydrochlorothiazide at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and acidity), as they may slightly decrease the effect of olmesartan medoxomil/amlodipine/hydrochlorothiazide.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene(in infusion for severe body temperature anomalies).
• Simvastatin, used to lower cholesterol and fat (triglyceride) levels in the blood.
• Medicines used to control the body's immune response(e.g., tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), which makes it possible for your body to accept a transplanted organ.

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

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

• Treating certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultoprida, tiaprida, droperidol, or haloperidol.
• Treating low blood sugar(e.g., diazoxide) or high blood pressure(e.g., beta-blockers, methyldopa), as olmesartan medoxomil/amlodipine/hydrochlorothiazide may affect the mechanism of action of these medicines.
• 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 digitalis.
• Treating cancer, such as amifostine, cyclophosphamide, or methotrexate.
• Increasing blood pressureand decreasing heart rate, such as noradrenaline.
• Treating gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Lowering blood fat levels, such as colestyramine and colestipol.
• Lowering blood sugar levels, such as metformin or insulin.

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

Taking Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas with food and drinks

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

People taking olmesartan medoxomil/amlodipine/hydrochlorothiazide should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active ingredient amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effect of olmesartan medoxomil/amlodipine/hydrochlorothiazide.

Be careful when drinking alcohol while taking olmesartan medoxomil/amlodipine/hydrochlorothiazide, as some people feel faint or dizzy. If this happens to you, do not drink any alcohol.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, or if you think you might be. Your doctor will advise you to stop taking olmesartan medoxomil/amlodipine/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of olmesartan medoxomil/amlodipine/hydrochlorothiazide. The use of olmesartan medoxomil/amlodipine/hydrochlorothiazide is not recommended during pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage.

If you become pregnant while taking olmesartan medoxomil/amlodipine/hydrochlorothiazide, inform and see 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 medoxomil/amlodipine/hydrochlorothiazide is not recommended in breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may feel drowsy, sick, or dizzy, or have a headache while being treated for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially "sodium-free".

3. How to take Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one tablet per day.
• Tablets can be taken with or without food. Take the tablets with a little liquid (such as a glass of water). Do not chew the tablet. 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 Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas than you should

If you take more tablets than you should, you will probably experience a drop in blood pressure, accompanied by symptoms such as dizziness, and rapid or slow heartbeat.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion.

If you forget to take Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas

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

If you stop taking Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas

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

If you have any other 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 all people suffer from them. If they occur, they are often mild and do not require interrupting treatment.

The following adverse effects may be serious, although they affect only a small group of people:

• Allergic reactions with inflammation of the face, mouth and/or larynx (vocal cords), along with itching and skin rash. If this happens to you, stop taking this medicine and consult your doctor immediately.

• Sharp drop in blood pressure, in susceptible patients. This can cause fainting or severe dizziness. If this happens to you, stop taking this medicine, consult your doctor immediately, and remain lying down in a horizontal position.

• Frequency not known (cannot be estimated from available data)

If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with olmesartan medoxomil/amlodipine/hydrochlorothiazide a long time ago, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with blood pressure treatment

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

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

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

Frequent(may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat and nose, urinary tract infection, dizziness, headache, perception of heartbeats, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, urge to urinate, weakness, ankle swelling, fatigue, abnormal laboratory test values.

Infrequent(may affect up to 1 in 100 people)

Dizziness when standing up, vertigo, rapid heartbeat, feeling of fainting, flushing and feeling of heat in the face, cough, dry mouth, muscle weakness, inability to have or maintain an erection.

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

They may be adverse effects due to olmesartan medoxomil/amlodipine/hydrochlorothiazide, even if they have not been observed so far with olmesartan medoxomil/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 intestine infection, vomiting, increased blood sugar, sugar in urine, confusion, somnolence, visual disturbances (including double vision and blurred vision), nasal secretion 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.

Infrequent(may affect up to 1 in 100 people)

Reduction in the number of a type of blood cells called platelets, which can cause easy bruising or prolonged bleeding, anaphylactic reactions, abnormal decrease in appetite (anorexia), sleep problems, irritability, mood changes including anxiety, feeling of depression, chills, sleep disorders, alteration of taste, loss of consciousness, decreased sense of touch, tingling sensation, worsening of myopia, ringing in the ears (tinnitus), angina (pain or unpleasant sensation in the chest, known as angina pectoris), irregular heartbeats, rash, hair loss, allergic skin inflammation, skin redness, purple-colored spots or patches on the skin due to small hemorrhages (purpura), skin discoloration, red itchy patches (urticaria), increased sweating, itching, skin rash, skin reactions to light, such as sunburn or skin rash, muscle pain, urination problems, feeling of needing to urinate at night, increased breast size in men, decreased sexual desire, facial swelling, feeling of discomfort, weight gain or loss, exhaustion.

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

Inflammation and pain of the salivary glands, decrease in the number of white blood cells in the blood, which could increase the risk of infections, decrease in the number of red blood cells (anemia), bone marrow damage, restlessness, feeling of loss of interest (apathy), seizures (convulsions), yellowish perception of objects when looking at them, dry eyes, blood clots (thrombosis, embolism), inflammation of blood vessels and small blood vessels in the skin, pancreatitis, yellowing of the skin and eyes, acute inflammation of the gallbladder, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, severe skin reactions including intense skin rash, urticaria, skin redness of the body, severe itching, blisters, peeling, and skin inflammation, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes very severe, movement impairment, acute kidney failure, non-infectious kidney inflammation, decreased kidney function, fever.

Intestinal angioedema: swelling in the intestine that presents 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, stomach inflammation, gum thickening, intestinal obstruction, liver inflammation.

Acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

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

Sudden decrease in distant vision (acute myopia), decrease in vision or eye pain due to high eye pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma). Tremors, rigid posture, mask-like face, slow movements, and unsteady gait.

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

Reporting of adverse effects

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

5. Conservation of Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and blister pack after "EXP". The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that are no longer needed in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas

The active ingredients are olmesartan medoxomil, amlodipine, and hydrochlorothiazide.

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas 20 mg/5 mg/12.5 mg film-coated tablets

Each film-coated tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas 40 mg/5 mg/12.5 mg film-coated tablets

Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

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

Each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas 40 mg/5 mg/25 mg film-coated tablets

Each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 25 mg of hydrochlorothiazide.

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

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

The other ingredients are:

Core of the tablet:Microcrystalline cellulose (Grade-101 and Grade-102), pregelatinized corn starch, anhydrous colloidal silica, sodium croscarmellose, lactose, magnesium stearate.

Coating:Partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172), red iron oxide (E172) (only for 20mg/5mg/12.5mg, 40mg/10mg/25mg, and 40mg/10mg/12.5mg); black iron oxide (E172) (only for 20mg/5mg/12.5mg).

Appearance of the product and package contents

Film-coated tablet.

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas 20 mg/5 mg/12.5 mg film-coated tablets: [Size: approximately 8 mm]

Film-coated tablets of light orange color, round, biconvex, with the inscription "S1" on one face and smooth on the other face.

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas 40 mg/5 mg/12.5 mg film-coated tablets: [Size: approximately 10.5 mm]

Film-coated tablets of light yellow color, round, biconvex, with the inscription "S2" on one face and smooth on the other face.

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas 40 mg/10 mg/12.5 mg film-coated tablets: [Size: approximately 10.5 mm]

Film-coated tablets of grayish-red color, round, biconvex, with the inscription "S3" on one face and smooth on the other face.

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas 40 mg/5 mg/25 mg film-coated tablets: [Size: approximately 15x7 mm]

Film-coated tablets of light yellow color, oval, biconvex, with the inscription "S4" on one face and smooth on the other face.

Olmesartan/Amlodipine/Hydrochlorothiazide Aurovitas 40 mg/10 mg/25 mg film-coated tablets: [Size: approximately 15x7 mm]

Film-coated tablets of grayish-red color, oval, biconvex, with the inscription "S5" on one face and smooth on the other face.

Package sizes:

Blister pack: 14, 28, 30, 56, 60, 98, and 100 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the Member States of the European Economic Area with the following names:

Germany: OlmeAmlodipinHCT PUREN 20 mg/5 mg/12.5 mg - 40 mg/5 mg/12.5 mg - 40 mg/10 mg/12.5 mg - 40 mg/5 mg/25 mg - 40 mg/10mg/25 mg Filmtabletten

Poland: Amolisa HCT

Portugal: Amlodipine + Olmesartan medoxomil + Hydrochlorothiazide Generis

Spain: Olmesartán/Amlodipino/Hidroclorotiazida Aurovitas 20 mg/5 mg/12.5 mg; 40 mg/5 mg/12.5 mg; 40 mg/10 mg/12.5 mg; 40 mg/5 mg/25 mg; 40 mg/10 mg/25 mg; film-coated tablets

Date of the last revision of this leaflet:May 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).