Olmesartan/hydrochlorothiazide Combix 20 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Olmesartán/Hydrochlorothiazide Combix 20 mg/12.5 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; 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

Pack contents and other information

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

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

• Olmesartan medoxomil 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 will only be prescribed if treatment with olmesartan medoxomil alone has not adequately controlled your blood pressure. The combined administration of both active substances in Olmesartán/Hidroclorotiazida 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 to lower it further.

High blood pressure can be controlled with medicines such as Olmesartán/Hidroclorotiazida tablets. Your doctor has likely also 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 Combix

Do not take Olmesartán/Hidroclorotiazida Combix

• if you are allergic to olmesartán medoxomilo, hydrochlorothiazide, 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 Olmesartán/Hidroclorotiazida Combix early in pregnancy – see Pregnancy section).
• if you have kidney problems.
• 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, yellowing of the skin or eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, e.g., due to gallstones).
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Olmesartán/Hidroclorotiazida Combix:

• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.
• If you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to a week after taking Olmesartán/Hidroclorotiazida Combix.
• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 Olmesartán/Hidroclorotiazida Combix.
• 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, seek medical attention immediately.

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking olmesartán/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking olmesartán/hydrochlorothiazide monotherapy without medical advice.

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

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 several days.
• Treatment with high doses of medicines that increase urine output (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 develop severe, persistent diarrhea causing significant weight loss. Your doctor will assess your symptoms and determine how to proceed with your blood pressure treatment.

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

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

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor may periodically perform blood tests to monitor this potential change. Some signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy, restless, vomiting, reduced need to urinate, or 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 a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for parathyroid function tests, you must stop taking Olmesartán/Hidroclorotiazida before the tests are performed.

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

Inform your doctor if you are pregnant or think you may be pregnant. Use of Olmesartán/Hidroclorotiazida is not recommended early in pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this stage (see Pregnancy section).

Children and adolescents

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

Taking Olmesartán/Hidroclorotiazida Combix with other medicines

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

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 Olmesartán/Hidroclorotiazida Combix” and “Warnings and precautions”).

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

• Medicines that may alter potassium levels in the blood when used together with Olmesartán/Hidroclorotiazida. 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) – its toxicity may be increased when used with Olmesartán/Hidroclorotiazida. If you need to take lithium, your doctor will monitor lithium blood levels.
  • Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) – when used with Olmesartán/Hidroclorotiazida, they may increase the risk of kidney failure and reduce the effect of Olmesartán/Hidroclorotiazida.
  • Other blood pressure-lowering (antihypertensive) medicines, as they may enhance the effect of Olmesartán/Hidroclorotiazida.
  • Sleeping pills, sedatives, and antidepressants – when used with Olmesartán/Hidroclorotiazida, they may cause a sudden drop in blood pressure upon standing.
  • Certain muscle relaxants such as baclofen and tubocurarine.
  • Amifostine and other cancer treatments such as cyclophosphamide or methotrexate.
  • Cholestyramine and colestipol – medicines used to lower blood fat levels.
  • 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 – Olmesartán/Hidroclorotiazida 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.
  • Tetracycline antibiotics or sparofloxacin.
  • 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 Olmesartán/Hidroclorotiazida.
  • Cisapride – used to increase stomach and intestinal motility.
  • Halofantrine – used to treat malaria.

Taking Olmesartán/Hidroclorotiazida Combix with food, drinks, and alcohol

Olmesartán/Hidroclorotiazida can be taken with or without food.

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

Patients of Black race

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

Pregnancy and breastfeeding

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.

Pregnancy

Inform your doctor if you are pregnant or think you may be pregnant. Your doctor will advise you to stop taking Olmesartán/Hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Olmesartán/Hidroclorotiazida is not recommended during pregnancy, and must not be taken after the first 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 about to start breastfeeding. Olmesartán/Hidroclorotiazida is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

Use in athletes

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

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 resolve. Consult your doctor.

Olmesartán/Hidroclorotiazida Combix contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Olmesartán/Hidroclorotiazida Combix

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

Recommended dose: The recommended dose is 1 tablet of Olmesartán/Hidroclorotiazida 40 mg/12.5 mg once daily. If blood pressure is not adequately controlled, your doctor may adjust the dose to 1 tablet of Olmesartán/Hidroclorotiazida 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 as long as your doctor has not instructed you to stop.

If you take more Olmesartán/Hidroclorotiazida Combix than you should

If you take more tablets than prescribed, 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 medicine packaging 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, indicating the name of the medicine and the amount ingested.

If you forget to take Olmesartán/Hidroclorotiazida Combix

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

If you stop taking Olmesartán/Hidroclorotiazida Combix

It is important to continue taking Olmesartán/Hidroclorotiazida 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 can cause adverse effects, although not everyone will experience them.

However, the following adverse effects may be serious:

• In rare cases, 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 Olmesartan/Hydrochlorothiazide and consult your doctor immediately.
• Olmesartan/Hydrochlorothiazide may cause a marked drop in blood pressure in susceptible patients or as a result of an allergic reaction. Infrequently, fainting or dizziness may occur. If this happens to you, stop taking Olmesartan/Hydrochlorothiazide, 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 have just started treatment with Olmesartan/Hydrochlorothiazide, contact your doctor immediately, who will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Olmesartan/Hydrochlorothiazide is a combination of two active substances. The following information first describes the adverse effects reported so far with the combination Olmesartan/Hydrochlorothiazide (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 Olmesartan/Hydrochlorothiazide:

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

Frequent 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 and muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine.

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

Increase in blood fat levels, increase in blood urea or uric acid, increase in creatinine, increase or decrease in blood potassium levels, increase in blood calcium levels, increase in blood sugar levels, increase in liver function test values. Your doctor will monitor you through 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:

Increase in blood urea nitrogen, decrease in hemoglobin and hematocrit values. Your doctor will monitor you through a blood test and advise you whether any action is needed.

Additional adverse effects reported with use of olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmesartan/Hydrochlorothiazide or at a higher frequency:

Olmesartan medoxomil:

Frequent 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:

Increase in blood fat levels, increase in blood urea or uric acid, increase in 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 observed changes in blood test results include:

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.

Rarely observed changes in blood test results include:

Increase in blood potassium levels.

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

Hydrochlorothiazide:

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

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

Frequent 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 observed in blood test results include:

Increase in creatinine, urea, calcium, and blood sugar levels; decrease in blood chloride, potassium, magnesium, and sodium levels. Increase in 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, 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 disturbances, 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 lupus erythematosus such as skin rash, joint pain, coldness in hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which may sometimes affect movement).

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

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

Frequency not known:

Skin and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

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 Combix

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 “EXP.”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE 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 container and additional information

Composition of Olmesartan/Hydrochlorothiazide Combix

• The active substances are olmesartan medoxomil and hydrochlorothiazide.

Each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

• The other components are lactose monohydrate, microcrystalline cellulose (E460i), low-substituted hydroxypropylcellulose (E463), hydroxypropylcellulose (E463), stearic acid (E570), magnesium stearate (E470b), and Instacoat Universal Yellow A05R01290 composed of: hypromellose (E464), polyethylene glycol (E1521), talc (E553b), titanium dioxide (E171), iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the product and contents of the pack

Olmesartan/Hydrochlorothiazide Combix 20 mg/12.5 mg is presented as orange, round, biconvex, film-coated tablets with bevelled edges, engraved with "2" on one side and smooth on the other.

The tablets are packaged in Alu/Alu blister packs with desiccant.

The following pack sizes are available: 28 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

Zac Les Hautes Pâtures

Parc d'Activités des Pleupliers

25 rue des Pleupliers

92000 Nanterre

France

or

Netpharmalab Consulting Services

Crta. de Fuencarral, 22

28108 Alcobendas (Madrid)

Spain

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

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