Olmesartan/amlodipino/hidroclorotiazida alter 40 mg/10 mg/25 mg comprimidos recubiertos con pelicula efg

Patient Information Leaflet

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 20 mg/5 mg/12.5 mg Film-Coated Tablets

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg/5 mg/12.5 mg Film-Coated Tablets

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg/5 mg/25 mg Film-Coated Tablets

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg/10 mg/12.5 mg Film-Coated Tablets

Olmesartan/Amlodipine/Hydrochlorothiazide Alter 40 mg/10 mg/25 mg Film-Coated Tablets

Olmesartan medoxomil / Amlodipine / Hydrochlorothiazide

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Olmesartán/Amlodipino/Hidroclorotiazida Alter contains three active substances called olmesartán medoxomilo, amlodipino (as amlodipino besilato) and hidroclorotiazida. The three substances help to control high blood pressure.

• Olmesartán medoxomilo belongs to a group of medicines called “angiotensin II receptor antagonists”, which decrease blood pressure by relaxing blood vessels.
• Amlodipino belongs to a group of medicines called “calcium channel blockers”. Amlodipino also decreases blood pressure by relaxing blood vessels.
• Hidroclorotiazida belongs to a group of medicines 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. Olmesartán/Amlodipino/Hidroclorotiazida Alter is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled with the combination of olmesartán medoxomilo and amlodipino, taken as a fixed-dose combination, or
• in patients who are already taking a fixed-dose combination of olmesartán medoxomilo and hidroclorotiazida, along with tablets containing only amlodipino, or a fixed-dose combination of olmesartán medoxomilo and amlodipino, along with tablets containing only hidroclorotiazida.

Do not take Olmesartán/Amlodipino/Hidroclorotiazida Alter

• If you are allergic to olmesartán medoxomilo, amlodipino, or a group of calcium channel blockers (dihidropiridinas), hidroclorotiazida, or substances similar to hidroclorotiazida (sulfonamidas), or any of the other components of this medication (listed in section 6).
• If you think you may be allergic, inform your doctor before taking olmesartán/amlodipino/hidroclorotiazida.
• 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 aliskirén.
• 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, that do not improve with treatment.
• If you are more than 3 months pregnant. (It is also best to avoid olmesartán/amlodipino/hidroclorotiazida at the beginning of pregnancy - see section “Pregnancy and breastfeeding”).
• If you have severe liver problems, bile secretion problems, or obstruction of bile duct 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 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 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 olmesartán/amlodipino/hidroclorotiazida if any of these cases occur.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartán/Amlodipino/Hidroclorotiazida Alter:

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, 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 rays while taking this medication.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking Olmesartán/Amlodipino/Hidroclorotiazida Alter, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartán/Amlodipino/Hidroclorotiazida Alter. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartán/Amlodipino/Hidroclorotiazida Alter in monotherapy.

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

• An angiotensin-converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskirén.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartán/Amlodipino/Hidroclorotiazida Alter”.

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 cardiac muscle.
• Intense vomiting, diarrhea, treatment with high doses of medications that increase urine elimination (diuretics), or if you are on a low-sodium diet.
• Elevated potassium levels in the blood.
• Problems with the adrenal glands (glands that produce hormones 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 tanning bed.

Contact your doctor if 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 treatment for high blood pressure.
• Decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased pressure in the eye and may occur from a few hours to several weeks after taking olmesartán/amlodipino/hidroclorotiazida. This can lead to permanent vision loss if not treated.

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

Olmesartán/amlodipino/hidroclorotiazida may cause an increase in lipid and uric acid levels in the blood. Your doctor will likely want to perform blood tests from time to time to monitor these possible changes.

You may experience changes in the levels of certain substances in the blood called electrolytes. Your doctor will likely 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, you should stop taking olmesartán/amlodipino/hidroclorotiazida before the tests are performed.

It is reported to athletes that this medication contains a component that can result in a positive analytical control for doping as positive.

Inform your doctor if you are pregnant (or think you may be). Do not use olmesartán/amlodipino/hidroclorotiazida at the beginning of pregnancy, and do not take it if you are more than 3 months pregnant, as it can cause serious harm to your baby if taken at this stage (see section “Pregnancy and breastfeeding”).

Children and adolescents (under 18 years)

Olmesartán/amlodipino/hidroclorotiazida is not recommended for use in children and adolescents under 18 years.

Olmesartán/Amlodipino/Hidroclorotiazida Alter with other medications

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

• Other blood pressure-lowering medications, as they may increase the effect of olmesartán/amlodipino/hidroclorotiazida.

Your doctor may need to modify your dose and/or take other precautions:

• If you are taking an angiotensin-converting enzyme inhibitor (ACEI) or aliskirén (see also the information under the headings “Do not take Olmesartán/Amlodipino/Hidroclorotiazida Alter” and “Warnings and precautions”).
• Lithium(medication used to treat mood changes and certain types of depression) if used at the same time as olmesartán/amlodipino/hidroclorotiazida may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Diltiazem,verapamilo,used for heart rhythm and high blood pressure problems.
• Rifampicina,eritromicina, claritromicina, tetraciclinas o esparfloxacino,antibiotics used for tuberculosis and other infections.
• St. John's Wort(Hypericum perforatum), herbal remedy for depression treatment.
• Cisaprida, used to increase stomach and intestinal movement.
• Difemanilo, used for slow heart rhythm or to reduce sweating.
• Halofantrina, used for malaria.
• Vincamina IV, used to improve blood circulation in the nervous system.
• Amantadina, used for Parkinson's disease.
• Potassium supplements, salt substitutes containing potassium, medications that increase urine elimination(diuretics),heparina(to thin the blood and prevent blood clots), angiotensin-converting enzyme inhibitors (ACEIs) (to lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolona (medication for mouth and stomach ulcers), penicillin G sodium (antibiotic also called benzylpenicillin sodium), some pain relievers such as aspirin or salicylates. The use of these medications at the same time as olmesartán/amlodipino/hidroclorotiazida may alter potassium levels in the blood.
• Somenonsteroidal anti-inflammatory drugs(NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartán/amlodipino/hidroclorotiazida may increase the risk of kidney failure. The effect of olmesartán/amlodipino/hidroclorotiazida may decrease with NSAIDs. High doses of salicylates may increase the toxic effect on the central nervous system.
• Sedatives, hypnotics, and antidepressants, used with olmesartán/amlodipino/hidroclorotiazida 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 olmesartán/amlodipino/hidroclorotiazida. Your doctor may advise you to take olmesartán/amlodipino/hidroclorotiazida at least 4 hours before colesevelam hydrochloride.
• Certain antacids(remedies for indigestion and heartburn), as they may slightly decrease the effect of olmesartán/amlodipino/hidroclorotiazida.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medications, such as atropine and biperiden.
• Calcium supplements.
• Dantrolene(in perfusion for severe body temperature abnormalities).
• Simvastatina, used to lower cholesterol and triglyceride levels in the blood.
• Medications used to control the body's immune response(e.g., tacrolimus, ciclosporina), 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 olmesartán/amlodipino/hidroclorotiazida 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 cholesterol 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.

Olmesartán/Amlodipino/Hidroclorotiazida Alter with food and drinks

Olmesartán/amlodipino/hidroclorotiazida can be taken with or without food.

People taking olmesartán/amlodipino/hidroclorotiazida 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 amlodipino, which may cause an unpredictable increase in the effect of lowering blood pressure of olmesartán/amlodipino/hidroclorotiazida.

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

Older patients

If you are over 65 years old, your doctor will regularly monitor your blood pressure every time you increase the 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 olmesartán/amlodipino/hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of olmesartán/amlodipino/hidroclorotiazida. Do not use olmesartán/amlodipino/hidroclorotiazida during pregnancy, and do not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy.

If you become pregnant while taking olmesartán/amlodipino/hidroclorotiazida, inform and visit your doctor immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to start breastfeeding. It has been shown that amlodipino and hidroclorotiazida pass into breast milk in small amounts. Do not recommend olmesartán/amlodipino/hidroclorotiazida for mothers who are breastfeeding, and your doctor may choose another treatment if you want 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 medication for high blood pressure. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor.

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially “sodium-free”.

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.
• Try to take your daily dose at the same time each day, for example, at breakfast time.

If you take more Olmesartán/Amlodipino/Hidroclorotiazida Alter than you should

If you take more tablets than you should, you are likely to experience a drop in blood pressure, accompanied by symptoms such as dizziness, and a rapid or slow heart rate.

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

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

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 Olmesartán/Amlodipino/Hidroclorotiazida Alter

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 Olmesartán/Amlodipino/Hidroclorotiazida Alter

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 medications, this medication may 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 may be serious:

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 medication 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 medication, consult your doctor immediately, and remain lying down in a horizontal position.

Olmesartan/amlodipine/hydrochlorothiazide is a combination of three active substances. The following information, first, describes the side effects reported so far with the combination of 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.

Unknown frequency: If you experience yellowing of the white of the eyes, dark urine, skin itching, even if you started treatment with Olmesartan/Amlodipine/Hydrochlorothiazide Alter some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

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 do not require interrupting treatment.

Frequent(may affect up to 1 in 10 people)

Upper respiratory tract infection, sore throat, and/or nasal congestion, urinary tract infection, dizziness, headache, perception of heartbeats, low blood pressure, nausea, diarrhea, constipation, muscle 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.

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 (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 medication.

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

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

No special storage conditions are required for Olmesartán/Amlodipino/Hidroclorotiazida Alter 20 mg/5 mg/12,5 mg, Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg/10 mg/12,5 mg and Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg/10 mg/25 mg.

Do not store at a temperature above 30°C for Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg/5 mg/12,5 mg and Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg/5 mg/25 mg.

Medicines should not be disposed of through the drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Olmesartán/Amlodipino/Hidroclorotiazida Alter

• The active principles are olmesartán medoxomilo, amlodipino (as amlodipino besilato) and hidroclorotiazida.

Olmesartán/Amlodipino/Hidroclorotiazida Alter 20 mg /5 mg/12,5 mg: Each film-coated tablet contains 20 mg of olmesartán medoxomilo, 5 mg of amlodipino (as amlodipino besilato) and 12,5 mg of hidroclorotiazida.

Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg /5 mg/12,5 mg: Each film-coated tablet contains 40 mg of olmesartán medoxomilo, 5 mg of amlodipino (as amlodipino besilato) and 12,5 mg of hidroclorotiazida.

Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg /10 mg/12,5 mg: Each film-coated tablet contains 40 mg of olmesartán medoxomilo, 10 mg of amlodipino (as amlodipino besilato) and 12,5 mg of hidroclorotiazida.

Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg /5 mg/25 mg: Each film-coated tablet contains 40 mg of olmesartán medoxomilo, 5 mg of amlodipino (as amlodipino besilato) and 25 mg of hidroclorotiazida.

Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg /10 mg/25 mg: Each film-coated tablet contains 40 mg of olmesartán medoxomilo, 10 mg of amlodipino (as amlodipino besilato) and 25 mg of hidroclorotiazida.

• The other components are:

Tablet core: Maize pregelatinized starch, microcrystalline cellulose, sodium croscarmellose and magnesium stearate.

Tablet coating: Polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), yellow iron oxide (E172) (40 mg/5 mg/12,5 mg tablets) and red iron oxide (E172) (40 mg/10 mg/12,5 mg and 40 mg/10 mg/25 mg tablets).

Appearance of the product and contents of the package

Olmesartán/Amlodipino/Hidroclorotiazida Alter 20 mg /5 mg/12,5 mg: Film-coated tablets, white, round, biconvex, with the inscription “t5” on one face.

Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg /5 mg/12,5 mg: Film-coated tablets, light yellow, round, biconvex, with the inscription “t4” on one face.

Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg /10 mg/12,5 mg: Film-coated tablets, pink, round, biconvex, with the inscription “t3” on one face.

Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg /5 mg/25 mg: Film-coated tablets, light yellow, oblong, biconvex, with the inscription “t2” on one face and scored on the other face. The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Olmesartán/Amlodipino/Hidroclorotiazida Alter 40 mg /10 mg/25 mg: Film-coated tablets, pink, oblong, biconvex, with the inscription “t1” on one face and scored on the other. The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Olmesartán/Amlodipino/Hidroclorotiazida Alter is presented in blisters in packages containing 28 film-coated tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Olaz-Chipi 10, Industrial Estate Areta

31620 Huarte, Navarra

Spain

Last review date of this leaflet:February 2025

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/