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

Package leaflet: Information for the user

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

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

olmesartan medoxomil/amlodipine/hydrochlorothiazide

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Gaduar is and what it is used for

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

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

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 together with tablets containing amlodipine only, or a fixed-dose combination of olmesartan medoxomil and amlodipine together with tablets containing hydrochlorothiazide only.

2. What you need to know before taking Gaduar

Do not take Gaduar:

• If you are allergic to olmesartan medoxomil, amlodipine, or a specific group of calcium channel blockers (dihydropyridines), hydrochlorothiazide, or substances similar to hydrochlorothiazide (sulfonamides), or to any of the other components of this medicine (listed in section 6). If you think you may be allergic, inform your doctor before taking Gaduar.
• 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 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 advisable to avoid this medicine in early pregnancy – see section “Pregnancy and breastfeeding”).
• If you have severe liver problems, biliary secretion disorders, or obstruction of bile drainage from the gallbladder (e.g., due to gallstones), or have jaundice (yellowing of the skin and eyes).
• If you have inadequate blood supply to your tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, meaning shock due to serious heart problems).
• If you have very low blood pressure.
• If blood flow to your heart is slow or blocked. This may occur if blood vessels or heart valves that collect blood from the heart are narrowed (aortic stenosis).
• If you have low cardiac output following a heart attack (acute myocardial infarction). Low cardiac output may cause shortness of breath or swelling in your feet and ankles.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gaduar.

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

• kidney problems or a kidney transplant.
• liver disease.
• heart failure or problems with heart valves or heart muscle.
• severe vomiting, diarrhea, treatment with high doses of medicines that increase urine elimination (diuretics), or if you are on a low-salt diet.
• high levels of potassium in the blood.
• problems with the adrenal glands (hormone-producing glands located above the kidneys).
• diabetes.
• lupus erythematosus (an autoimmune disease).
• allergy or asthma.
• skin reactions such as sunburn or rash after sun exposure or use of tanning beds.
• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking this medicine.
• if you experience vision loss or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within hours to weeks after taking this medicine. This could lead to permanent vision loss if untreated. Your risk is higher if you have previously had an allergic reaction to penicillin or sulfonamides.
• if you have had breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking Gaduar, contact your doctor immediately.

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

• Severe, persistent diarrhea causing significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.
• If you develop 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 reduction in blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

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

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

If you are scheduled for parathyroid function tests, you must stop taking this medicine before the tests are performed.

Use in athletes

Athletes should be aware that this medicine contains a component (hydrochlorothiazide) that may result in a positive analytical finding in doping control tests.

Inform your doctor if you are pregnant (or think you might be). Use of this medicine is not recommended in early 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 “Pregnacy and breastfeeding”).

Children and adolescents

Use of this medicine is not recommended in children and adolescents under 18 years of age.

Other medicines and Gaduar

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

• other blood pressure-lowering medicines, as they may enhance 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 information under the headings “Do not take Gaduar” and “Warnings and precautions”).

• lithium, a medicine used to treat mood disorders and certain types of depression, may have increased toxicity when used with Gaduar. If you must take lithium, your doctor will monitor blood lithium levels.

• 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 movement of food through the stomach and intestines.

• difemethiazene, used to treat slow heart rate or to reduce sweating.

• halofantrine, used for malaria.

• vincamine IV, used to improve blood circulation in the nervous system.

• amantadine, used for Parkinson’s disease.

• potassium supplements, potassium-containing salt substitutes, medicines that increase urine elimination (diuretics), heparin (for blood thinning and prevention of blood clots), angiotensin-converting enzyme (ACE) inhibitors (for lowering blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine for mouth and stomach ulcers), sodium penicillin G (an antibiotic also known as sodium benzylpenicillin), some painkillers such as acetylsalicylic acid (“aspirin”) or salicylates. Using these medicines together with Gaduar may alter blood potassium levels.

• non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used with Gaduar may increase the risk of kidney failure. The effect of Gaduar may be reduced by NSAIDs. High doses of salicylates may increase central nervous system toxicity.

• sleep-inducing medicines, sedatives, and antidepressants, when used with Gaduar, may cause a sudden drop in blood pressure upon standing.

• colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, 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 (administered intravenously for serious 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 cyclosporine), which help the body accept a transplanted organ.

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

• treating certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
• treating low blood sugar (e.g., diazoxide) or high blood pressure (e.g., beta-blockers, methyldopa), as Gaduar may affect the mechanism of action of these medicines.
• treating heart rhythm problems, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injections.
• 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 pressure and decreasing heart rate, such as noradrenaline.
• treating gout, such as probenecid, sulfinpyrazone, and allopurinol.
• lowering blood fat levels, such as cholestyramine 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 need to take any other medicine.

Taking Gaduar with food, drinks, and alcohol

This medicine may be taken with or without food.

People taking this medicine should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could cause an unpredictable increase in Gaduar’s blood pressure-lowering effect.

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

Elderly patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure each time 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 think you might 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 an alternative medicine instead of Gaduar. Use of Gaduar is not recommended during pregnancy, and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

If you become pregnant while taking Gaduar, 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. Gaduar is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

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

Driving and use of machines

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

Gaduar contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Gaduar

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

• The recommended dose is one tablet per day.
• The tablets can be taken with or without food. Swallow the tablets with some 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 may experience a drop in blood pressure, accompanied by symptoms such as dizziness, and fast or slow heartbeat.

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

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

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

If you forget to take Gaduar

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

If you stop taking Gaduar

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

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

4. Possible adverse effects

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

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

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

• Olmesartan/amlodipine/hydrochlorothiazide may cause a marked drop in blood pressure in susceptible patients. This may lead to fainting or severe dizziness. If this happens 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 your eyes, dark urine, or skin itching—even if you started treatment with olmesartan/amlodipine/hydrochlorothiazide some time ago—contact your doctor immediately. Your doctor will assess your symptoms and decide how to proceed with your treatment. Medicines for blood pressure (frequency not known).

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

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

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

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

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

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

Very common (may affect more than 1 in 10 people)

Edema (fluid retention).

Common (may affect up to 1 in 10 people)

Bronchitis, stomach and intestinal infection, vomiting, increased blood sugar, sugar in urine, confusion, drowsiness, visual disturbances (including double vision and blurred vision), nasal discharge or congestion, sore throat, difficulty breathing, cough, abdominal pain, heartburn, stomach discomfort, flatulence, joint or bone pain, back pain, bone pain, blood in urine, flu-like symptoms, chest pain, pain.

Uncommon (may affect up to 1 in 100 people)

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

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

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

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

Decreased vision or eye pain due to increased 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 shuffling 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gaduar

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

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

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Gaduar

The active substances are olmesartan medoxomil, amlodipine (as amlodipine besilate) 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 besilate) 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 besilate) 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 besilate) and 25 mg of hydrochlorothiazide.
• Gaduar 40 mg/5 mg/12.5 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besilate) 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 besilate) and 25 mg of hydrochlorothiazide.

The other components of the tablets are:

• Tablet core: povidone, pregelatinized starch (from maize), microcrystalline cellulose, colloidal anhydrous silica, lactose monohydrate and magnesium stearate.
• Tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172) (only in the 20 mg/5 mg/12.5 mg film-coated tablets), and black iron oxide (E172) (only in the 20 mg/5 mg/12.5 mg film-coated tablets) and red iron oxide (E172) (only in the 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 contents of the pack

Gaduar 20 mg/5 mg/12.5 mg film-coated tablets are white to peach-coloured, round tablets, approximately 8 mm in diameter, with bevelled edges, marked with "OC1" on one side and smooth on the other.

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

Gaduar 40 mg/5 mg/25 mg film-coated tablets are light yellow, oval tablets, approximately 15 mm long and 7 mm wide, with bevelled edges, marked with "OC3" on one side and smooth on the other.

Gaduar 40 mg/10 mg/12.5 mg film-coated tablets are red brick-coloured, round tablets, approximately 9.5 mm in diameter, with bevelled edges, marked with "OC4" on one side and smooth on the other.

Gaduar 40 mg/10 mg/25 mg film-coated tablets are red brick-coloured, oval tablets, approximately 15 mm long and 7 mm wide, with bevelled edges, marked with "OC5" on one side and smooth on the other.

Aluminium-aluminium blister packs contain 28, 56 or 98 film-coated tablets in a carton.

Only certain pack sizes may be marketed.

Marketing Authorisation 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

or

Zentiva SA,

Bulevardul Pallady Theodor Nr. 50, Sector 3

032266, Bucharest, Romania

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Zentiva Spain S.L.U.

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

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorised in the European Economic Area member states 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, Italy, Greece: 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: ???????

Date of the most recent review of this summary: January 2025

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