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 read 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 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.
The action of these substances contributes to decreasing blood pressure. Olmesartan/hydrochlorothiazide/amlodipine is used to treat high blood pressure:
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):
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:
Contact your doctorif you experience any of the following symptoms:
Like any other medication that lowers blood pressure, excessive blood pressure reduction in patients with alterations in blood flow to the heart or brain 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 period (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:
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications for:
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 levels of the active ingredient amlodipine in the blood, which may lead to 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 you increase your dose, 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 taken during this period.
If you become pregnant while taking Gaduar, inform and visit your doctor immediately.
Breastfeeding
Inform your doctor if you are breastfeeding or plan 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, breastfeeding, 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 certain sugar intolerance, consult with them before taking this medication.
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 make up 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 may cause side effects, although not everyone will experience them. If they do occur, they are often mild and do not require interrupting treatment.
The following side effects may be serious, although they 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 may 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 whites of the eyes, dark urine, skin itching, 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 nose, urinary tract infection, dizziness, headache, perception of heartbeats, low blood pressure, nausea, diarrhea, constipation, cramps, joint swelling, sensation of urgency to urinate, weakness, ankle swelling, 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.
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, drowsiness, visual disturbances (including double vision and blurred vision), nasal secretion or congestion, sore throat, difficulty breathing, cough, abdominal pain, stomach burning, 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 cell called platelets, which can cause easy bruising or prolong bleeding time, anaphylactic reactions, abnormal decrease in appetite (anorexia), sleep problems, irritability, mood changes including anxiety, sensation of depression, chills, sleep disorders, alteration of taste, loss of consciousness, decrease in sense of touch, sensation of numbness, worsening of nearsightedness, ringing in the ears (tinnitus), angina (pain or uncomfortable sensation in the chest, known as angina pectoris), irregular heartbeat, rash, hair loss, allergic skin inflammation, skin redness, purple patches or spots on the skin due to small hemorrhages (purpura), skin discoloration, red itchy patches (urticaria), increased sweating, pruritus, skin rash, skin reactions to light, such as sunburn or skin eruption, muscle pain, urination problems, sensation of needing to urinate at night, breast enlargement in men, decreased libido, swelling of the face, sensation of discomfort, weight gain or loss, fatigue.
Rare(may affect up to 1 in 1,000 people)
Salivary gland inflammation and pain, 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, sensation 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 small 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 eruption, urticaria, skin redness, severe itching, blisters, skin peeling, and inflammation, Stevens-Johnson syndrome, toxic epidermal necrolysis, sometimes very severe, movement impairment, acute kidney failure, non-infectious kidney inflammation, kidney function decrease, 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 respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion), stomach inflammation, gum thickening, intestinal obstruction, liver inflammation.
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 of 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.
The active principles are olmesartan medoxomil, amlodipine (as amlodipine besylate) and hydrochlorothiazide.
The other components of the tablets are:
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 with the inscription “OC1” on one face 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 with the inscription “OC2” on one face 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 with the inscription “OC3” on one face 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 with the inscription “OC4” on one face 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 with the inscription “OC5” on one face 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 of Medicines and Medical Products (AEMPS)http://www.aemps.gob.es/
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