Olmesartan/hydrochlorothiazide Alter 20 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartán/Hydrochlorothiazide Alter 20 mg/12.5 mg film-coated tablets EFG

Olmesartán/Hydrochlorothiazide Alter 20 mg/25 mg film-coated tablets EFG

Olmesartan medoxomil/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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

Pack contents 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 hidroclorotiazida, 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.
• Hidroclorotiazida 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 helps reduce blood pressure more 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 decreasing salt intake). 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 Olmesartán/Hidroclorotiazida Alter

Do not take Olmesartán/Hidroclorotiazida Alter

• If you are allergic to olmesartán medoxomil or hydrochlorothiazide, or to any of the other ingredients 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 Olmesartán/Hidroclorotiazida Alter in early pregnancy – see Pregnancy section).
• If you have severe kidney problems.
• If you have diabetes or renal impairment 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) that do not improve with treatment.
• If you have severe liver problems, yellowing of the skin or eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example due to gallstones).
• Olmesartán/Hidroclorotiazida Alter contains soya lecithin. It should not be used if you are allergic to peanuts or soya.

If you think any of these 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 taking Olmesartán/Hidroclorotiazida 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 and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Olmesartán/Hidroclorotiazida 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 Olmesartán/Hidroclorotiazida Alter, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Olmesartán/Hidroclorotiazida Alter. Your doctor will decide whether to continue treatment. Do not stop taking Olmesartán/Hidroclorotiazida Alter as monotherapy without medical advice.

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 (ACE) inhibitor (for example 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 Olmesartán/Hidroclorotiazida Alter”.

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

• Mild to moderate kidney problems or if you have recently had a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe or prolonged vomiting (with dizziness) or diarrhoea lasting several days.
• Treatment with high doses of medicines that increase urine output (diuretics), or if you are on a low-salt diet.
• Problems with the 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 diarrhoea causing significant weight loss. Your doctor will assess your symptoms and decide on further treatment for your high blood pressure.
• Vision disturbances or eye pain. These may be signs 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 Olmesartán/Hidroclorotiazida Alter. This may lead to permanent vision loss if not treated.

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

Olmesartán/Hidroclorotiazida Alter may increase blood levels of fats and uric acid (which causes gout – painful joint swelling). Your doctor will likely perform periodic blood tests to monitor these potential changes. Changes in blood levels of certain chemicals called electrolytes may also occur. Your doctor will likely perform periodic blood tests to monitor this possible effect. Some signs of electrolyte imbalances include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy, restless, nauseous, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you experience any of these symptoms.

As with any other medicine that lowers blood pressure, excessive lowering of 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 Olmesartán/Hidroclorotiazida 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 Olmesartán/Hidroclorotiazida 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

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

Taking Olmesartán/Hidroclorotiazida Alter with other medicines

Tell 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 Olmesartán/Hidroclorotiazida Alter.

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

If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Olmesartán/Hidroclorotiazida Alter” and “Warnings and precautions”).

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

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

• Medicines that increase urine output (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).

• Certain 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 Olmesartán/Hidroclorotiazida 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 symptoms of inflammation, including arthritis), when used together with Olmesartán/Hidroclorotiazida Alter, may increase the risk of kidney failure and reduce the effectiveness of Olmesartán/Hidroclorotiazida Alter.

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

• Certain medicines such as baclofen and tubocurarine, used as muscle relaxants.

• Amifostine and other cancer treatments such as cyclophosphamide or methotrexate.

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

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

• Anticholinergic medicines such as atropine and biperiden.

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

• Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.

• 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 Olmesartán/Hidroclorotiazida 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 heart rate 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 of the tetracycline group, or sparfloxacin.

• Amphotericin, a medicine used to treat fungal infections.

• Certain antacids used to treat excess stomach acid, such as aluminium and magnesium hydroxide, as they may slightly reduce the effect of Olmesartán/Hidroclorotiazida Alter.

• Cisapride, used to increase movement of food through the stomach and intestine.

• Halofantrine, used to treat malaria.

Taking Olmesartán/Hidroclorotiazida Alter with food and drinks

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

Be cautious when drinking alcohol while taking Olmesartán/Hidroclorotiazida Alter, as some people may feel weakness or dizziness. If this happens, avoid alcohol, including wine, beer, or alcoholic soft drinks.

Black patients

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant or think you might be pregnant. Your doctor will usually advise you to stop taking Olmesartán/Hidroclorotiazida Alter before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartán/Hidroclorotiazida Alter is not recommended during pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby if taken from this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Use of Olmesartán/Hidroclorotiazida Alter is not recommended during breastfeeding, and your doctor will 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 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.

Olmesartán/Hidroclorotiazida Alter contains lactose

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

3. How to take Olmesartán/Hidroclorotiazida Alter

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

The recommended dose is 1 tablet of Olmesartán/Hidroclorotiazida Alter 20 mg/12.5 mg once daily. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartán/Hidroclorotiazida Alter 20 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 prescribed, 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 pack with you.

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

If you forget to take Olmesartán/Hidroclorotiazida Alter

If you forget to take a daily 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 treatment.

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 will experience them.

However, the following adverse effects may be serious:

• Rarely, allergic reactions may occur that can affect the entire body, with 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 evaluate 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):

Rapid or strong 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.

Some changes in blood test results have also been observed uncommonly, including:

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 via 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 kidney failure.

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

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

Additional adverse effects reported with olmesartan medoxomil or hydrochlorothiazide used 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.

Frequent changes in blood test results have also been observed, including:

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).

Uncommon changes in blood test results have also been observed, including:

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

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

Worsening of kidney function, lack of energy.

Rare changes in blood test results have also been observed, including: 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, bloated feeling, diarrhea, nausea, vomiting, constipation, glucose in urine.

Some changes in blood test results have also been observed, including:

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 difficulty breathing, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light-sensitive 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 perception of objects, 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 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 disorders).

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 (signs 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 blister pack following “EXP”. 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 unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. 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 20 mg/12.5 mg: each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

Olmesartán/Hidroclorotiazida Alter 20 mg/25 mg: each film-coated tablet contains 20 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, titanium dioxide (E171) and yellow iron oxide (E172).

Olmesartán/Hidroclorotiazida Alter 20 mg/25 mg also contains red iron oxide (E172).

• See previous section "Olmesartán/Hidroclorotiazida Alter contains lactose".

Appearance of the medicinal product and contents of the pack

Olmesartán/Hidroclorotiazida Alter 20 mg/12.5 mg: yellow, round, biconvex, film-coated tablets.

Olmesartán/Hidroclorotiazida Alter 20 mg/25 mg: light pink, oblong, biconvex, film-coated tablets.

The tablets are available 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 20 mg/12.5 mg /20 mg/25 mg film-coated tablets EFG

Italy: Olmesartan medoxomil e idroclorotiazide Alter

Portugal: Olmesartan medoxomilo + hidroclorotiazida Alter 20 mg + 12.5 mg / 20 mg + 25 mg film-coated tablets MG

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

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