Label: information for the user

Olmesartan/Hydrochlorothiazide Alter 40 mg/12.5 mg film-coated tablets

Olmesartan/Hydrochlorothiazide Alter 40 mg/25 mg film-coated tablets

Olmesartan medoxomil/Hydrochlorothiazide

Read this label carefully before starting to take this medicine, 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 medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as 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 label. See section 4.

Contents of the package and additional information

Olmesartán/Hidroclorotiazida Alter contains two active principles, olmesartán medoxomilo and hidroclorotiazida, which are used in the treatment of high blood pressure (hypertension):

• Olmesartán medoxomilo belongs to a group of medications called angiotensin II receptor antagonists. It reduces blood pressure by relaxing blood vessels.
• Hidroclorotiazida belongs to a group of medications called thiazide diuretics. It reduces blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

Olmesartán/Hidroclorotiazida Alter will only be given if treatment with Olmesartán (olmesartán medoxomilo) alone has not adequately controlled your blood pressure. The concurrent administration of both active substances in Olmesartán/Hidroclorotiazida Alter contributes to reducing blood pressure more than if each substance were administered alone.

You may already be taking medications to treat high blood pressure, but your doctor may believe it necessary for you to take Olmesartán/Hidroclorotiazida Alter to lower it further.

High blood pressure can be controlled with medications like Olmesartán/Hidroclorotiazida Alter tablets. Your doctor has probably also recommended that you make some lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing the amount of salt in your diet). Your doctor may also have recommended that you engage in regular exercise, such as walking or swimming. It is essential to follow your doctor's advice.

Do not take Olmesartán/Hidroclorotiazida Alter

• If you are allergic to olmesartán medoxomilo or to hidroclorotiazida, or to any of the other components of this medication (listed in section 6) or to substances similar to hidroclorotiazida (sulfonamides).
• If you are more than 3 months pregnant. (It is also better to avoid Olmesartán/Hidroclorotiazida Alter at the beginning of pregnancy - see Pregnancy section).
• If you have 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 in the blood (with symptoms of gout or kidney stones), that do not improve with treatment.
• If you have moderate or severe liver problems, or yellow skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, by gallstones).
• Olmesartán/Hidroclorotiazida Alter contains soy lecithin. Do not use it in case of allergy to peanuts or soy.

If you think you have any of these cases, or are not sure, do not take the tablets. Talk to your doctor and follow their advice.

Warnings and precautions

Consult your doctor before starting to take Olmesartán/Hidroclorotiazida Alter.

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Olmesartán/Hidroclorotiazida Alter.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you present shortness of breath or severe difficulty breathing after taking Olmesartán/Hidroclorotiazida Alter, go to your doctor immediately.

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

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

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

Your doctor may want to check your kidney function, blood pressure, and electrolyte levels in the blood (such as potassium) at regular intervals.

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

Before taking the tablets,tell your doctorif you have any of the following health problems:

• Renal transplant.
• Liver diseases.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting (while feeling dizzy) or diarrhea that is severe or lasts for several days.
• Treatment with high doses of medications that increase urine elimination (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (for example, primary hyperaldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.

Contact your doctorif you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.
• 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/Hidroclorotiazida Alter. This may lead to permanent vision impairment if not treated.

Your doctor may want to see you more often and perform some tests if you have any of these problems.

Olmesartán/Hidroclorotiazida Alter may cause an increase in lipid and uric acid levels in the blood. Your doctor will probably want to perform a blood test from time to time to control these possible changes. There may be a change in the levels in the blood of certain chemical substances called electrolytes. Your doctor will probably want to perform a blood test from time to time to control 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, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms. As with any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with heart or brain blood flow abnormalities may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are to undergo parathyroid function tests, you should stop taking Olmesartán/Hidroclorotiazida Alter before these tests are performed.

It is reported to athletes that this medication contains a component that may establish a positive analytical result for doping control.

You should inform your doctor if you are pregnant or think you may be pregnant. Olmesartán/Hidroclorotiazida Alter is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken from the third month of pregnancy (see Pregnancy section).

Children and adolescents

Olmesartán/Hidroclorotiazida Alter is not recommended for children and adolescents under 18 years old.

Taking Olmesartán/Hidroclorotiazida Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor or pharmacist about any of the following medications:

• Other blood pressure-lowering medications (anti-hypertensives), as they may increase the effect of Olmesartán/Hidroclorotiazida Alter.

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/Hidroclorotiazida Alter” and “Warnings and precautions”).

• Medications that may alter potassium levels in the blood if used at the same time as Olmesartán/Hidroclorotiazida Alter. These include:

• Potassium supplements (as well as salt substitutes that contain potassium).
• Medications that increase urine elimination (diuretics).
• Heparin (to thin the blood).
• Laxatives.
• Glucocorticoids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (medication for the treatment of mouth and stomach ulcers).
• Penicillin G sodium (antibiotic also called benzylpenicillin sodium).
• Some analgesics such as aspirin or salicylates.

• Lithium (medication used to treat mood changes and some types of depression) if used at the same time as Olmesartán/Hidroclorotiazida Alter may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as Olmesartán/Hidroclorotiazida Alter may increase the risk of kidney failure and decrease the effect of Olmesartán/Hidroclorotiazida Alter.
• Sedatives and antidepressants, used with Olmesartán/Hidroclorotiazida Alter may cause a sudden drop in blood pressure when standing up.
• Some medications such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medications used to treat cancer, such as cyclophosphamide or methotrexate.
• Colestiramine and colestipol, medications to lower blood cholesterol levels.
• Colesevelam hydrochloride, a medication that lowers blood cholesterol levels, as it may decrease the effect of Olmesartán/Hidroclorotiazida Alter. Your doctor may advise you to take Olmesartán/Hidroclorotiazida Alter at least 4 hours before colesevelam hydrochloride.
• Anticholinergic medications, such as atropine and biperiden.
• Medications such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Some medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digital, used to treat heart problems.
• Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injectables, that may change heart rhythm.
• Oral antidiabetic medications, such as metformin, or insulin, used to lower blood sugar levels.
• Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar levels, respectively, as Olmesartán/Hidroclorotiazida Alter may intensify the effect of increasing blood sugar levels produced by these medications.
• Metildopa, a medication used to treat high blood pressure.
• Medications such as noradrenaline, used to increase blood pressure and decrease heart rate.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Medications such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medication.
• Ciclosporin, a medication used to prevent organ transplant rejection.
• Antibiotics of the tetracycline group or esparfloxacino.
• Amphotericin, a medication used to treat fungal infections.
• Some antacids, used to treat excess stomach acid, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of Olmesartán/Hidroclorotiazida Alter.
• Cisapride, used to increase the movement of food in the stomach and intestines.
• Halofantrine, used to treat malaria.

Taking Olmesartán/Hidroclorotiazida Alter with food and drinks

Olmesartán/Hidroclorotiazida Alter can be taken with or without food.

Be careful when drinking alcohol while taking Olmesartán/Hidroclorotiazida Alter, as some people feel weak or dizzy. If this happens, do not drink any alcohol, including wine, beer, or soda with alcohol.

Black patients

As with other similar medications, the blood pressure-lowering effect of Olmesartán/Hidroclorotiazida Alter is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, or if you think you may be pregnant. Your doctor will advise you to stop taking Olmesartán/Hidroclorotiazida Alter before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of Olmesartán/Hidroclorotiazida Alter. Olmesartán/Hidroclorotiazida Alter is not recommended for use during pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Olmesartán/Hidroclorotiazida Alter is not recommended for use in breastfeeding mothers, 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 machines

You may feel drowsy or dizzy while taking blood pressure medication. If this happens, do not drive or operate machines until the symptoms have disappeared. Consult your doctor.

Olmesartán/Hidroclorotiazida Alter contains lactose

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

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

The recommended dose is 1 tablet of Olmesartán/Hidroclorotiazida Alter 40 mg/12.5 mg per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartán/Hidroclorotiazida Alter 40 mg/25 mg per day.

Take the tablets with water. If possible, take your dose at the same time every day , for example, at breakfast time. It is essential to continue taking Olmesartán/Hidroclorotiazida Alter until your doctor tells you to stop.

If you take more Olmesartán/Hidroclorotiazida Alter than you should

If you take more tablets than you should or if a child accidentally ingests one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department and bring the medication packaging 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, indicating the medication and the amount ingested.

If you forget to take Olmesartán/Hidroclorotiazida Alter

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

If you interrupt treatment with Olmesartán/Hidroclorotiazida Alter

It is essential to continue taking Olmesartán/Hidroclorotiazida Alter, unless your doctor tells you to stop.

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.

However, the following side effects may be serious:

• In rare cases, an allergic reaction may occur that can affect the entire body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash.If this happens, stop taking Olmesartán/Hidroclorotiazida Alter and consult your doctor immediately.
• Olmesartán/Hidroclorotiazida Alter may cause a significant drop in blood pressure in susceptible patients or as a result of an allergic reaction. Infrequently, dizziness or fainting may occur.If this happens, stop taking Olmesartán/Hidroclorotiazida Alter, consult your doctor immediately, and remain lying down in a horizontal position.
• Unknown frequency: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you started treatment with Olmesartán/Hidroclorotiazida Alter some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with the treatment for high blood pressure.

Olmesartán/Hidroclorotiazida Alter is a combination of two active principles. The following information, first, describes the side effects reported so far with the combination Olmesartán/Hidroclorotiazida Alter (in addition to those already mentioned) and, secondly, the known side effects of the two active principles separately.

These are other side effects known so far with Olmesartán/Hidroclorotiazida Alter:

If these effects occur, they are often mild andyou do not need to interrupt treatment.

Frequent side effects (may affect up to 1 in 10 people):

Dizziness, weakness, headache, fatigue, chest pain, swelling of ankles, feet, legs, hands, or arms.

Rare side effects (may affect up to 1 in 100 people):

Fast and intense heartbeat (palpitations), hives, eczema, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain, arm and leg pain, back pain, erectile dysfunction in men, blood in urine.

Also, some changes in blood tests have been observed infrequently, including:

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased creatinine, increased or decreased levels of potassium in the blood, increased levels of calcium in the blood, increased blood sugar, increased values of liver function tests. Your doctor will monitor you through a blood test and tell you if you need to take any measures.

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

Unpleasant sensation, alterations in consciousness, skin swelling (hives), acute renal insufficiency.

Also, some changes in blood test results have been observed in rare cases, including:

Increased urea in the blood, decreased values of hemoglobin and hematocrit. Your doctor will monitor you through a blood test and tell you if you need to take any measures.

Additional side effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmesartán/Hidroclorotiazida Alter or in a higher frequency:

Olmesartan medoxomil:

Frequent side effects (may affect up to 1 in 10 people):

Bronchitis, cough, congestion and nasal secretion, sore throat, abdominal pain, indigestion, diarrhea, nausea, gastroenteritis, joint pain or bone pain, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain.

Also, some changes in blood test results have been observed frequently, including:

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased levels of liver or muscle function.

Rare side effects (may affect up to 1 in 100 people):

Fast and intense allergic reactions that can affect the entire body and may cause breathing problems, as well as a rapid drop in blood pressure that can even cause fainting (anaphylactic reactions), inflammation of the face, angina (chest pain or discomfort known as angina pectoris), unpleasant sensation, skin rash, itching, exanthema (skin rash), skin swelling (hives).

Also, some changes in blood test results have been observed infrequently, including:

Reduction in the number of a type of blood cell, called platelets (thrombocytopenia).

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

Renal function deterioration, lack of energy.

Also, some changes in blood test results have been observed rarely, including: Increased potassium in the blood.

Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Hydrochlorothiazide:

Very frequent side effects (may affect more than 1 in 10 people):

Changes in blood tests, including: Increased fat in the blood and increased levels of uric acid.

Frequent side effects (may affect up to 1 in 10 people):

Confusion, abdominal pain, stomach discomfort, feeling of swelling, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

Also, some changes in blood test results have been observed, including:

Increased levels of creatinine, urea, calcium, and sugar in the blood, decreased levels of chloride, potassium, magnesium, and sodium in the blood. Increased serum amylase (hyperamylasemia).

Rare side effects (may affect up to 1 in 100 people):

Loss of appetite, severe difficulty breathing, skin allergic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light-sensitive skin reactions, itching, purple spots on the skin due to small hemorrhages (purpura), skin swelling (hives).

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

Salivary gland inflammation and pain, decreased white blood cell count, decreased platelet count in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellowish perception of objects when looking at them, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, biliary tract infection, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement alteration).

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

Electrolyte imbalance that can cause an abnormally low level of chloride in the blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus), acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

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

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

Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

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 Vigilance of Medicines for Human Usehttps://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.

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Olmesartán/Hidroclorotiazida Alter

• The active ingredients are:

Olmesartán/Hidroclorotiazida Alter 40 mg/12,5 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and 12,5 mg of hydrochlorothiazide.

Olmesartán/Hidroclorotiazida Alter 40 mg/25 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

• The other components are: lactose monohydrate*, microcrystalline cellulose, low-substitution hydroxypropyl cellulose, calcium stearate, hypromellose, triacetin, and titanium dioxide (E171).

Olmesartán/Hidroclorotiazida Alter 40 mg/12,5 mg also contains yellow iron oxide (E172).

Olmesartán/Hidroclorotiazida Alter 40 mg/25 mg also contains red iron oxide (E172).

*See previous section “Olmesartán/Hidroclorotiazida Alter contains lactose”.

Appearance of the product and contents of the packaging

Olmesartán/Hidroclorotiazida Alter 40 mg/12,5 mg: film-coated tablets, yellow, oblong, biconvex.

Olmesartán/Hidroclorotiazida Alter 40 mg /25 mg: film-coated tablets, dark pink, oblong, biconvex.

The tablets are presented in packs of 14, 28, 30, 56 and 90 tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

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

SpainOlmesartán/Hidroclorotiazida Alter 40 mg/25 mg film-coated tablets EFG

ItalyOlmesartan medoxomil and hydrochlorothiazide Alter

PortugalOlmesartan medoxomil + hydrochlorothiazide Alter 40 mg + 12,5 mg / 40 mg + 25 mg film-coated tablets MG

Last review date of this leaflet: February 2025.

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