GADUAR 40 MG/5 MG/12.5 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Gaduar 20mg/5mg/12.5mg film-coated tablets EFG

Gaduar 40mg/5mg/12.5mg film-coated tablets EFG

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

Gaduar 40mg/10mg/12.5mg film-coated tablets EFG

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

olmesartan medoxomil/amlodipine/hydrochlorothiazide

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is Gaduar and what is it used for
2. What you need to know before you take Gaduar
3. How to take Gaduar
4. Possible side effects
5. Storage of Gaduar
6. Contents of the pack and other information

1. What is Gaduar and what is it used for

This medicine 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 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 kidneys to remove excess fluid from the body, increasing urine production.

The action of these substances contributes to lowering your 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-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 you take Gaduar

Do not takeGaduar:

• 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 ingredients of this medicine (listed in section 6). 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 impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood, which do not improve with treatment.
• If you are more than 3 months pregnant. (It is also recommended to avoid this medicine at the start of pregnancy - see section “Pregnancy and breast-feeding”).
• If you have severe liver problems, biliary obstruction, or problems with 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 become narrowed (aortic stenosis).
• If you have poor heart function after suffering a heart attack (acute myocardial infarction). Poor heart function can make you feel short of breath or have swelling in your feet and ankles.

Do not take this medicine if any of these apply to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gaduar.

Tell your doctorif you are taking any of the following medicines 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 kidney function, blood pressure, and blood electrolyte levels (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 the heart valves or heart muscle.
• severe vomiting, diarrhea, treatment with high doses of 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 sunbed.
• 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 and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV radiation while taking this medicine.
• if you experience a decrease in vision or eye pain could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within hours to weeks after taking this medicine. This can lead to permanent vision impairment if not treated. You are at greater risk of developing it if you have previously had an allergic reaction to penicillin or sulfonamide.
• 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 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 assess your symptoms and decide how to proceed with your blood pressure treatment.
• If you experience abdominal pain, nausea, vomiting, or diarrhea after taking this medicine. Your doctor will decide whether to continue treatment. Do not stop taking Gaduar on your own.

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

This medicine 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 possible 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 possible 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 this medicine before these tests are performed.

Use in athletes

Athletes are informed that this medicine contains a component (hydrochlorothiazide) that may result in a positive doping control test.

You must inform your doctor if you are pregnant (or think you may be). This medicine is not recommended during pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see section “Pregnancy and breast-feeding”).

Children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Gaduar

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

• other blood pressure-lowering medicines, 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 medicine used to treat mood changes and some types of depression) if taken with Gaduar may increase its toxicity. If you have to take lithium, your doctor will measure lithium levels in your blood.
• diltiazem, 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 intestines.
• 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 that contain potassium, diuretics(water pills), 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), sodium penicillin G (an antibiotic also called sodium benzylpenicillin), and some pain relievers like acetylsalicylic acid (“aspirin”) or salicylates. Taking these medicines with Gaduar 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 Gaduar may increase the risk of kidney failure. The effect of Gaduar may be reduced by NSAIDs. If high doses of salicylates are used, it may increase the toxic effect on the central nervous system.
• sleep-inducing medicines, sedatives, and antidepressants, used with Gaduar may cause a sudden drop in blood pressure when standing up.
• colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of Gaduar. Your doctor may advise you to take Gaduar at least 4 hours before colesevelam hydrochloride.
• certain antacids(remedies for indigestion and heartburn), as they may slightly reduce the effect of Gaduar.
• some muscle relaxants, such as baclofen and tubocurarine.
• anticholinergic medicines, such as atropine and biperiden.
• calcium supplements.
• dantrolene(in 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, sirolimus, temsirolimus, everolimus, and cyclosporin), which allow your body to accept a transplanted organ.

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

Taking Gaduar with food, drinks, and alcohol

This medicine can be taken with or without food.

People taking this medicine 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 Gaduar.

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

Elderly 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 much.

Pregnancy and breast-feeding

Pregnancy

You must inform your doctor if you are pregnant or think you may be. Your doctor will advise you to stop taking Gaduar before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Gaduar. Gaduar is not recommended during pregnancy, and it must not be taken when you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage.

If you become pregnant while taking Gaduar, inform and consult your doctor immediately.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. Gaduar is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment if you wish to breast-feed.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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.

Gaduar contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Gaduar

Follow exactly the administration instructions of this medicine given 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 every 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 suffer from a drop in blood pressure, accompanied by symptoms such as dizziness, and rapid or slow heartbeat.

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

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

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 make up for forgotten doses.

If you stop taking Gaduar

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, they are usually mild and do not require treatment to be stopped.

The following side effects may be serious, although they only affect a small number 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 to you, stop taking this medicine and consult your doctor immediately.

- olmesartan/amlodipine/hydrochlorothiazide may cause a pronounced 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.

-if you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started treatment with Olmesartan/amlodipine/hydrochlorothiazide a long time ago, contact your doctor immediately, who will assess your symptoms and decide how to continue with your treatment. Medicines for blood pressure (frequency not known).

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 side effects known for 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 have side effects, they have been classified as frequent, uncommon, rare, and very rare.

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

If these effects occur, they are usually mild and do not require treatment to be stopped.

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, swelling of the joints, feeling of urgent need to urinate, weakness, swelling of the ankles, fatigue, abnormal laboratory test values.

Uncommon(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 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.

Very common(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, drowsiness, visual disturbances (including double vision and blurred vision), nasal 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)

Decrease in the number of a type of blood cells called platelets, which can cause easy bruising or prolonged bleeding, anaphylactic reactions, abnormally decreased appetite (anorexia), sleep problems, irritability, mood changes including anxiety, feeling of depression, chills, sleep disorders, alteration of the sense 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 inflammation of the skin, redness of the skin, 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 need 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), fluid accumulation in the lungs, pneumonia, 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, redness of the body skin, 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 inflammation of the kidney, 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, acute breathing difficulty (signs include severe breathing difficulty, fever, weakness, and confusion), stomach inflammation, gum thickening, intestinal obstruction, liver inflammation.

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

Decreased vision or eye pain due to high 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gaduar

Keep this medicine out of the 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.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition ofGaduar

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

• Gaduar 20 mg/5 mg/12.5 mg: each film-coated tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.
• Gaduar 40 mg/5 mg/12.5 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.
• Gaduar 40 mg/5 mg/25 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besylate), and 25 mg of hydrochlorothiazide.
• Gaduar 40 mg/10 mg/12.5 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besylate), and 12.5 mg of hydrochlorothiazide.
• Gaduar 40 mg/10 mg/25 mg: 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 of the tablets are:

• Core of the tablet: povidone, pregelatinized corn starch, 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 for 20 mg/5 mg/12.5 mg film-coated tablets), and red iron oxide (E172) (only for 20 mg/5 mg/12.5 mg, 40 mg/10 mg/12.5 mg, and 40 mg/10 mg/25 mg film-coated tablets).

Appearance of the product and package contents

Gaduar 20 mg/5 mg/12.5 mg film-coated tablets are white to peach-colored, round, approximately 8 mm in diameter, with a beveled edge and the inscription "OC1" on one side and smooth on the other.

Gaduar 40 mg/5 mg/12.5 mg film-coated tablets are light yellow, round, approximately 9.5 mm in diameter, with a beveled edge and the inscription "OC2" on one side and smooth on the other.

Gaduar 40 mg/5 mg/25 mg film-coated tablets are light yellow, oval, approximately 15 mm in length and 7 mm in width, with a beveled edge and the inscription "OC3" on one side and smooth on the other.

Gaduar 40 mg/10 mg/12.5 mg film-coated tablets are reddish-brown, round, approximately 9.5 mm in diameter, with a beveled edge and the inscription "OC4" on one side and smooth on the other.

Gaduar 40 mg/10 mg/25 mg film-coated tablets are reddish-brown, oval, approximately 15 mm in length and 7 mm in width, with a beveled edge and the inscription "OC5" on one side and smooth on the other.

The aluminum-aluminum blister packs contain 28, 56, or 98 film-coated tablets in the box.

Only some pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer

LABORATORI FUNDACIÓ DAU

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

08040 Barcelona, Spain

You can request more information about this medicine by contacting 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Gaduar 20 mg/5 mg/12.5 mg film-coated tablets EFG

Gaduar 40 mg/5 mg/12.5 mg film-coated tablets EFG

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

Gaduar 40 mg/10 mg/12.5 mg film-coated tablets EFG

Gaduar 40 mg/10 mg/25 mg film-coated tablets EFG

Latvia, Lithuania, Estonia: Gaduar

Germany: Olmesartan Amlodipin HCT Zentiva 20 mg/5 mg/12.5 mg film-coated tablets

Olmesartan Amlodipin HCT Zentiva 40 mg/5 mg/12.5 mg film-coated tablets

Olmesartan Amlodipin HCT Zentiva 40 mg/5 mg/25 mg film-coated tablets

Olmesartan Amlodipin HCT Zentiva 40 mg/10 mg/12.5 mg film-coated tablets

Olmesartan Amlodipin HCT Zentiva 40 mg/10 mg/25 mg film-coated tablets

Bulgaria: ???????

Date of last revision of this leaflet: January 2025

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