Label: information for the user

Gaduar 20mg/5mg/12,5mg film-coated tablets

Gaduar 40mg/5mg/12,5mg film-coated tablets

Gaduar 40mg/5mg/25mg film-coated tablets

Gaduar 40mg/10mg/12,5mg film-coated tablets

Gaduar40mg/10mg/25mg film-coated tablets

olmesartán medoxomilo/amlodipino/hidroclorotiazida

Read this label carefully before starting to take this medication, as it contains important information for you.

-Keep this label, as you may need to refer to it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

1.What is Gaduar and for what it is used

2.What you need to know before starting to take Gaduar

3.How to take Gaduar

4.Possible adverse effects

5.Storage of Gaduar

6.Contents of the package and additional information

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 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/hydrochlorothiazide/amlodipine 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 combination, or
• in patients who are already taking a fixed combination of olmesartan medoxomil and hydrochlorothiazide, along with tablets containing only amlodipine, or a fixed combination of olmesartan medoxomil and amlodipine, along with tablets containing only hydrochlorothiazide.

Do not takeGaduar:

• 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 any of the other components of this medication (listed in section6). If you think you may be allergic, inform your doctor before taking Gaduar.
• 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 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, that do not improve with treatment.
• If you are more than 3months 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 your heart's blood flow 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 this medication if any of these cases occur.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gaduar.

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 in your blood (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Gaduar”.

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.
• Severe vomiting, diarrhea, treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-sodium diet.
• High levels of potassium in your blood.
• Problems with the adrenal glands (glands that produce hormones located above the kidneys).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergies 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 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.
• If you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within hours to weeks after taking this medication. This can lead to permanent vision loss if not treated. You are at higher risk of developing it if you have had an allergic reaction to penicillin or sulfonamide in the past.
• 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 severe shortness of breath or difficulty breathing after taking Gaduar, seek medical attention immediately.

Contact your doctorif 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 blood pressure treatment.
• Abdominal pain, nausea, vomiting, or diarrhea after taking this medication. Your doctor will decide whether to continue treatment. Do not stop taking Gaduar on your own.

Like any other medication that lowers blood pressure, excessive blood pressure reduction in patients with heart or brain blood flow alterations can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

This medication may cause an increase in lipid and uric acid levels in the 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 chemicals 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 undergoing parathyroid function tests, stop taking this medication before the tests are performed.

Use in athletes

Inform athletes that this medication contains a component (hydrochlorothiazide) that may result in a positive analytical result for doping control.

Inform your doctor if you are pregnant (or think you may be). This medication is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3months pregnant, as it may cause serious harm to your baby if taken during this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents

This medication is not recommended for use in children and adolescents under 18years.

Other medications andGaduar

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

• Other blood pressure-lowering medications, as they may increase the effect of Gaduar. 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 Gaduar” and “Warnings and precautions”).
• Lithium (a medication used to treat mood changes and certain types of depression) if used at the same time as Gaduar may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in the 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.
• Cisapride, used to increase stomach and intestinal movement.
• Difemanil, used to treat slow heart rhythm or to reduce sweating.
• Halofantrine, used for malaria.
• Vincamine IV, used to improve blood flow to the nervous system.
• Amantadine, used for Parkinson's disease.
• Potassium supplements, salt substitutes containing potassium, medications that increase urine production(diuretics),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. Using these medications at the same time as Gaduar may alter potassium levels in the blood.

• Nonsteroidal anti-inflammatory drugs (NSAIDs) (medications used to relieve pain, swelling, and inflammation, including arthritis), used at the same time as Gaduar may increase the risk of kidney problems. The effect of Gaduar may decrease with NSAIDs. If high doses of salicylates are used, it may increase the toxic effect on the central nervous system.
• Sedatives, sleep-inducing medications, and antidepressants, used with Gaduar may cause a sudden drop in blood pressure when standing.
• Colesevelam hydrochloride, a medication that lowers cholesterol levels in the blood, as it may decrease the effect of Gaduar. Your doctor may advise you to take Gaduar at least 4hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly decrease the effect of Gaduar.
• 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, sirolimus, temsirolimus, everolimus, and ciclosporin), 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 Gaduar 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 lipid 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.

TakingGaduarwith food, drinks, and alcohol

This medication can be taken with or without food.

People taking this medication 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 Gaduar to lower blood pressure.

Be careful when drinking alcohol while taking this medication, as some people may feel dizzy, nauseous, or experience headaches. If this happens, do not drink any alcohol.

Older patients

If you are over 65years 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 Gaduar before becoming pregnant or as soon as you know you are pregnant, and will recommend another medication in place of Gaduar. This medication is not recommended for use during pregnancy, and it should not be taken if you are more than 3months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy.

If you become pregnant while taking Gaduar, inform and visit 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. Gaduar is not recommended for use in breastfeeding mothers, 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 machinery

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

Gaduar contains lactose

If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as 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 small amount of 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 Gaduar 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 a rapid or slow heart rate.

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Gaduar

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

If you interrupt treatment with Gaduar

It is essential to continue taking this medication, unless your doctor tells you to stop treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If they occur, they are often mild and do not require interrupting treatment.

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

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

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

-If you experience yellowing of the white of the eyes, dark urine, itching of the skin, even if you started treatment with Olmesartan/amlodipine/hydrochlorothiazide some time ago, contact your doctor immediately, who will evaluate your symptoms and decide how to continue your treatment. Blood pressure medications (unknown frequency).

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

To give you an idea of the number of patients who may experience side effects, they have been classified as frequent, infrequent, rare, and very rare.

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

If these side 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 runny nose, urinary tract infection, dizziness, headache, perception of heartbeats, low blood pressure, nausea, diarrhea, constipation, muscle cramps, joint swelling, sensation of urgency to urinate, weakness, swelling of ankles, fatigue, abnormal laboratory test results.

Infrequent(may affect up to 1 in 100 people)

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

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

They may be side effects due to olmesartan/amlodipine/hydrochlorothiazide, even if they have not been observed so far with olmesartan/amlodipine/hydrochlorothiazide.

Frequent(may affect up to 1 in 10 people)

Edema (fluid retention).

Infrequent(may affect up to 1 in 10 people)

Edema (fluid retention).

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

Edema (fluid retention).

Very rare(may affect up to 1 in 10,000 people)

Edema (fluid retention).

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

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

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

Reporting side effects

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

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

Do not use this medication after the expiration date that appears on the box and the blister pack after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofGaduar

The active principles are olmesartan medoxomil, amlodipine (as amlodipine besylate) and hydrochlorothiazide.

• Gaduar20mg/5mg/12,5mg: each film-coated tablet contains 20mg of olmesartan medoxomil, 5mg of amlodipine (as amlodipine besylate) and 12,5mg of hydrochlorothiazide.
• Gaduar40mg/5mg/12,5mg: each film-coated tablet contains 40mg of olmesartan medoxomil, 5mg of amlodipine (as amlodipine besylate) and 12,5mg of hydrochlorothiazide.
• Gaduar40mg/5mg/25mg: each film-coated tablet contains 40mg of olmesartan medoxomil, 5mg of amlodipine (as amlodipine besylate) and 25mg of hydrochlorothiazide.
• Gaduar40mg/10mg/12,5mg: each film-coated tablet contains 40mg of olmesartan medoxomil, 10mg of amlodipine (as amlodipine besylate) and 12,5mg of hydrochlorothiazide.
• Gaduar40mg/10mg/25mg: each film-coated tablet contains 40mg of olmesartan medoxomil, 10mg of amlodipine (as amlodipine besylate) and 25mg of hydrochlorothiazide

The other components of the tablets are:

• Core of the tablet: povidone, pregelatinized cornstarch, microcrystalline cellulose, anhydrous colloidal silica, lactose monohydrate and magnesium stearate.
• Coating of the tablet:polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172), black iron oxide (E172) (only the film-coated tablets of 20mg/5mg/12,5mg) and red iron oxide (E172) (only the film-coated tablets of 20mg/5mg/12,5mg, 40mg/10mg/12,5mg and 40mg/10mg/25mg).

Appearance of the product and contents of the package

Gaduar20mg/5mg/12,5mg film-coated tablets are white to peach-colored, round, approximately 8mm in diameter, with a beveled edge and the inscription “OC1” on one side and smooth on the other.

Gaduar40mg/5mg/12,5mg film-coated tablets are light yellow, round, approximately 9,5mm in diameter, with a beveled edge and the inscription “OC2” on one side and smooth on the other.

Gaduar40mg/5mg/25mg film-coated tablets are light yellow, oval, approximately 15mm in length and 7mm in width, with a beveled edge and the inscription “OC3” on one side and smooth on the other.

Gaduar40mg/10mg/12,5mg film-coated tablets are terracotta red, round, approximately 9,5mm in diameter, with a beveled edge and the inscription “OC4” on one side and smooth on the other.

Gaduar40mg/10mg/25mg film-coated tablets are terracotta red, oval, approximately 15mm in length and 7mm in width, with a beveled edge and the inscription “OC5” on one side and smooth on the other.

The blisters of aluminum-aluminum contain 28 film-coated tablets, 56 film-coated tablets and 98film-coated tablets in the box.

Only some package sizes may be marketed.

Marketing Authorization Holder

Zentiva k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Responsible for manufacturing

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona,

08040 Barcelona, Spain

For more information about this medication, please contact the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Spain: Gaduar 20 mg/5 mg/ 12,5 mg film-coated tablets EFG

Gaduar40mg/5mg/12,5mg film-coated tablets EFG

Gaduar40mg/5mg/25mg film-coated tablets EFG

Gaduar40mg/10mg/12,5mg film-coated tablets EFG

Gaduar40mg/10mg/25mg film-coated tablets EFG

Latvia, Lithuania, Estonia:Gaduar

Germany: Olmesartan Amlodipin HCT Zentiva 20 mg/5 mg/12,5 mg Filmtabletten

Olmesartan Amlodipin HCT Zentiva 40 mg/5 mg/12,5 mg Filmtabletten

Olmesartan Amlodipin HCT Zentiva 40 mg/5 mg/25 mg Filmtabletten

Olmesartan Amlodipin HCT Zentiva 40 mg/10 mg/12,5 mg Filmtabletten

Olmesartan Amlodipin HCT Zentiva 40 mg/10 mg/25 mg Filmtabletten

Bulgaria: ???????

Last review date of this leaflet: January 2025

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/