Olmesartan/hydrochlorothiazide Alter 40 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

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

Olmesartan medoxomil/Hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Olmesartan/Hydrochlorothiazide Alter is and what it is used for
2. What you need to know before taking Olmesartan/Hydrochlorothiazide Alter
3. How to take Olmesartan/Hydrochlorothiazide Alter
4. Possible side effects
5. How to store Olmesartan/Hydrochlorothiazide Alter

Contents of the pack and other information

1. What Olmesartán/Hidroclorotiazida Alter is and what it is used for

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

• Olmesartán medoxomilo belongs to a group of medicines called angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

Olmesartán/Hidroclorotiazida Alter will only be prescribed if treatment with olmesartán (olmesartán medoxomilo) alone has not adequately controlled your blood pressure. The combined administration of both active substances in Olmesartán/Hidroclorotiazida Alter contributes to a greater reduction in blood pressure than either substance alone.

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

High blood pressure can be controlled with medicines such as Olmesartán/Hidroclorotiazida Alter tablets. Your doctor may also have advised you to make certain 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 exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking Olmesartan/Hydrochlorothiazide Alter

Do not take Olmesartan/Hydrochlorothiazide Alter

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other components of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant. (It is also advisable to avoid Olmesartan/Hydrochlorothiazide Alter in early pregnancy – see Pregnancy section).
• If you have kidney problems.
• If you have diabetes or renal insufficiency 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 in the blood (with symptoms of gout or kidney stones), which do not improve with treatment.
• If you have moderate or severe liver problems, yellowing of the skin or eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, e.g., due to gallstones).
• Olmesartan/Hydrochlorothiazide Alter contains soybean lecithin. It should not be used if you are allergic to peanuts or soy.

If you think any of these situations apply to you, or you are unsure, do not take the tablets. Speak to your doctor and follow their advice.

Warnings and precautions

Talk to your doctor before starting Olmesartan/Hydrochlorothiazide Alter.

• 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 cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Olmesartan/Hydrochlorothiazide Alter.
• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Olmesartan/Hydrochlorothiazide Alter, seek medical attention immediately.

Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Olmesartan/Hydrochlorothiazide Alter. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartan/Hydrochlorothiazide Alter used as monotherapy.

Before taking the tablets, 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), especially 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 Olmesartan/Hydrochlorothiazide Alter”.

Before taking the tablets, tell your doctor if you have any of the following health conditions:

• Kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Vomiting (with dizziness) or diarrhea that is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine elimination (diuretics), or if you are on a low-salt diet.
• Problems with adrenal glands (e.g., primary hyperaldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.

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

• Severe, persistent diarrhea causing significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.
• Vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from hours to weeks after taking Olmesartan/Hydrochlorothiazide Alter. This may lead to permanent vision impairment if not treated.

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

Olmesartan/Hydrochlorothiazide Alter may cause increased levels of lipids and uric acid (which causes gout – painful joint swelling) in the blood. Your doctor may periodically perform blood tests to monitor these potential changes. Changes in blood levels of certain chemicals called electrolytes may also occur. Your doctor may periodically perform blood tests to monitor this potential change. Some signs of electrolyte imbalance are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, fatigued, drowsy or restless, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms. As with any other medicine that lowers blood pressure, an excessive drop in blood pressure in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for parathyroid function tests, you should stop taking Olmesartan/Hydrochlorothiazide Alter before the tests are performed.

Athletes should be aware that this medicine contains a component that may result in a positive doping test.

Inform your doctor if you are pregnant or think you might be pregnant. Use of Olmesartan/Hydrochlorothiazide Alter is not recommended in early pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if taken during this period (see Pregnancy section).

Children and adolescents

Olmesartan/Hydrochlorothiazide Alter is not recommended for children and adolescents under 18 years of age.

Taking Olmesartan/Hydrochlorothiazide Alter with other medicines

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

In particular, inform your doctor or pharmacist about any of the following medicines:

• Other blood pressure-lowering medicines (antihypertensives), as they may enhance the effect of Olmesartan/Hydrochlorothiazide Alter.

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 Olmesartan/Hydrochlorothiazide Alter” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood when used together with Olmesartan/Hydrochlorothiazide Alter. These include:

• Potassium supplements (as well as salt substitutes containing potassium).

• Medicines that increase urine elimination (diuretics).

• Heparin (a blood thinner).

• Laxatives.

• Steroids.

• Adrenocorticotropic hormone (ACTH).

• Carbenoxolone (a medicine used to treat mouth and stomach ulcers).

• Sodium penicillin G (an antibiotic also known as sodium benzylpenicillin).

• Some painkillers such as aspirin or salicylates.

• Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used together with Olmesartan/Hydrochlorothiazide Alter. If you need to take lithium, your doctor will monitor lithium levels in your blood.

• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other inflammatory symptoms, including arthritis), when used together with Olmesartan/Hydrochlorothiazide Alter, may increase the risk of kidney failure and reduce the effect of Olmesartan/Hydrochlorothiazide Alter.

• Sleeping pills, sedatives, and antidepressants, when used with Olmesartan/Hydrochlorothiazide Alter, may cause a sudden drop in blood pressure upon standing.

• Certain muscle relaxants such as baclofen and tubocurarine.

• Amifostine and other cancer treatment medicines such as cyclophosphamide or methotrexate.

• Colestyramine and colestipol, medicines used to lower blood fat levels.

• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, which may reduce the effect of Olmesartan/Hydrochlorothiazide Alter. Your doctor may advise you to take Olmesartan/Hydrochlorothiazide Alter at least 4 hours before colesevelam hydrochloride.

• Anticholinergic medicines such as atropine and biperiden.

• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.

• Certain heart medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis.

• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, which may alter heart rhythm.

• Oral antidiabetic medicines such as metformin, or insulin, used to lower blood sugar levels.

• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, since Olmesartan/Hydrochlorothiazide Alter may enhance their blood sugar-raising effect.

• Methyldopa, a medicine used to treat high blood pressure.

• Medicines such as noradrenaline, used to increase blood pressure and reduce heart rate.

• Difemanil, used to treat slow heartbeat or reduce sweating.

• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.

• Calcium supplements.

• Amantadine, an antiviral medicine.

• Cyclosporine, a medicine used to prevent organ transplant rejection.

• Antibiotics from the tetracycline group or sparfloxacin.

• Amphotericin, a medicine used to treat fungal infections.

• Some antacids used to treat excess stomach acid, such as aluminum and magnesium hydroxide, which may slightly reduce the effect of Olmesartan/Hydrochlorothiazide Alter.

• Cisapride, used to increase stomach and intestinal motility.

• Halofantrine, used to treat malaria.

Taking Olmesartan/Hydrochlorothiazide Alter with food and drinks

Olmesartan/Hydrochlorothiazide Alter can be taken with or without food.

Be cautious when drinking alcohol while taking Olmesartan/Hydrochlorothiazide Alter, as some people may feel weakness or dizziness. If this occurs, avoid alcohol, including wine, beer, or alcoholic beverages.

Patients of Black ethnicity

As with other similar medicines, the blood pressure-lowering effect of Olmesartan/Hydrochlorothiazide Alter is somewhat reduced in patients of Black ethnicity.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking Olmesartan/Hydrochlorothiazide Alter before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Olmesartan/Hydrochlorothiazide Alter is not recommended during pregnancy, and it 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.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Olmesartan/Hydrochlorothiazide Alter 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Olmesartan/Hydrochlorothiazide Alter contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Olmesartán/Hidroclorotiazida Alter

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Take the tablets with water. If possible, take your dose at the same time each day, for example, with breakfast. It is important that you 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 swallows one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department and bring the medicine package 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, stating the name of the medicine and the amount ingested.

If you forget to take Olmesartán/Hidroclorotiazida Alter

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

If you stop taking Olmesartán/Hidroclorotiazida Alter

It is important to continue taking Olmesartán/Hidroclorotiazida Alter 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 may cause adverse effects, although not everyone experiences them.

However, the following adverse effects may be serious:

• Rarely, allergic reactions affecting the entire body may occur, including swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking Olmesartán/Hidroclorotiazida Alter and consult your doctor immediately.
• Olmesartán/Hidroclorotiazida Alter may cause a marked drop in blood pressure in susceptible patients or as a result of an allergic reaction. Fainting or dizziness may occur infrequently. If this happens, stop taking Olmesartán/Hidroclorotiazida Alter, consult your doctor immediately, and remain lying down in a horizontal position.
• Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with Olmesartán/Hidroclorotiazida Alter some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

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

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

If these effects occur, they are often mild and you do not need to stop treatment.

Common adverse effects (may affect up to 1 in 10 people):

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

Uncommon adverse effects (may affect up to 1 in 100 people):

Fast or pounding heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine.

Uncommonly, the following changes in blood test results have also been observed:

Increased levels of blood fats, increased blood urea or uric acid, increased creatinine, increased or decreased blood potassium levels, increased blood calcium levels, increased blood glucose, increased liver function test values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

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

Feeling unwell, disturbances in consciousness, skin swelling (hives), acute renal failure.

Rarely, the following changes in blood test results have also been observed:

Increased blood urea nitrogen, decreased hemoglobin and hematocrit values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

Additional adverse effects reported with olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmesartán/Hidroclorotiazida Alter or at a higher frequency:

Olmesartan medoxomil:

Common adverse effects (may affect up to 1 in 10 people):

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

Frequently observed changes in blood test results include:

Increased blood fat levels, increased blood urea or uric acid, increased liver or muscle function test levels.

Uncommon adverse effects (may affect up to 1 in 100 people):

Rapid allergic reactions affecting the whole body, which may cause breathing difficulties and a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin rash), skin swelling (hives).

Uncommonly, the following changes in blood test results have also been observed:

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

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

Worsening of kidney function, lack of energy.

Rarely, the following changes in blood test results have also been observed: Increased blood potassium levels.

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

Hydrochlorothiazide:

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

Changes in blood tests including: increased blood fat levels and increased uric acid levels.

Common adverse effects (may affect up to 1 in 10 people):

Confusion, abdominal pain, stomach discomfort, bloating sensation, diarrhea, nausea, vomiting, constipation, glucose in urine.

Changes in blood test results include:

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

Uncommon adverse effects (may affect up to 1 in 100 people):

Decreased or loss of appetite, severe breathing difficulty, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purple spots or patches on the skin due to minor bleeding (purpura), skin swelling (hives).

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

Inflammation and pain of the salivary glands, decreased number of white blood cells, decreased number of platelets in blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellowish vision, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, symptoms of systemic lupus erythematosus such as skin rash, joint pain, and coldness in hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing movement disturbances).

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

Electrolyte imbalance that may cause abnormally low chloride levels in blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus), acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion).

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

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

Reduced 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 adverse effects:

If you experience any adverse effect, talk to 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan/Hydrochlorothiazide Alter

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging and on the blister after "CAD". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, 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 Olmesartán/Hidroclorotiazida Alter

• The active substances 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-substituted 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 pack

Olmesartán/Hidroclorotiazida Alter 40 mg/12.5 mg: yellow, oblong, biconvex, film-coated tablets.

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain Olmesartán/Hidroclorotiazida Alter 40 mg/25 mg film-coated tablets EFG

Italy Olmesartan medoxomil e idroclorotiazide Alter

Portugal Olmesartan medoxomilo + hidroclorotiazida Alter 40 mg + 12.5 mg / 40 mg + 25 mg comprimidos revestidos por pelicula MG

Date of the most recent review of this leaflet: February 2025.

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