OLMESARTAN/HYDROCHLOROTHIAZIDE COMBIX 20 mg/12.5 mg FILM-COATED TABLETS

Introduction

Leaflet:informationforthepatient

Olmesartan/HydrochlorothiazideCombix20mg/12.5mgfilm-coatedtablets

Olmesartan medoxomil/hydrochlorothiazide

Readtheleafletcarefullybeforeyoustarttakingthismedicinebecauseitcontainsimportantinformationforyou.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

Contents of the pack and further information

1. What is Olmesartan/Hydrochlorothiazide Combix and what is it used for

Olmesartan/Hydrochlorothiazide Combix contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used to treat 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 kidneys to remove excess fluid from the body, increasing urine production.

Olmesartan/Hydrochlorothiazide Combix will only be given to you if treatment with olmesartan medoxomil alone has not controlled your blood pressure sufficiently. The combination of the two active substances in Olmesartan/Hydrochlorothiazide Combix has been shown to reduce blood pressure more than either substance alone.

You may already be taking medicines to treat high blood pressure, but your doctor may think it is necessary for you to take Olmesartan/Hydrochlorothiazide Combix to lower it further.

High blood pressure can be treated with medicines such as Olmesartan/Hydrochlorothiazide Combix tablets. Your doctor may also have recommended that you make some changes to your lifestyle, such as losing weight, stopping smoking, reducing the amount of alcohol you drink, and reducing the amount of salt in your diet. Your doctor may also have suggested that you take some regular exercise, such as walking or swimming. It is important to follow this advice.

2. What you need to know before you take Olmesartan/Hydrochlorothiazide Combix

Do not take Olmesartan/Hydrochlorothiazide Combix

• if you are allergic to olmesartan medoxomil, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6), or to sulphonamide-derived medicines.
• if you are more than 3 months pregnant. (It is also better to avoid Olmesartan/Hydrochlorothiazide Combix in early pregnancy - see section Pregnancy).
• if you have kidney problems.
• if you have low potassium or sodium levels, high calcium or uric acid levels in your blood, which do not improve with treatment.
• if you have moderate or severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with drainage of the bile from the liver and gallbladder (bile duct obstruction, for example, due to gallstones).
• if you have diabetes or kidney impairment and you are treated with a blood pressure lowering medicine containing aliskiren.

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

Warnings and precautions

Tell your doctor or pharmacist before you start taking Olmesartan/Hydrochlorothiazide 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), especially if you have kidney problems related to diabetes.
• aliskiren
• if you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye, and can occur within hours to a week after taking Olmesartan/Hydrochlorothiazide Combix.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Olmesartan/Hydrochlorothiazide Combix.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or difficulty breathing severely after taking Olmesartan/Hydrochlorothiazide Combix, see your doctor immediately.

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

Tell your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking olmesartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking olmesartan/hydrochlorothiazide on your own.

See also the information under the heading “Do not take Olmesartan/Hydrochlorothiazide Combix”.

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

• Kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Vomiting (while feeling nauseous) or diarrhea, which is severe or lasts for several days.
• Treatment with high doses of diuretics, or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g. primary hyperaldosteronism).
• Diabetes.
• Systemic lupus erythematosus (an autoimmune disease).
• Allergy or asthma.

Contact your doctor if you experience severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

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

Olmesartan/Hydrochlorothiazide Combix 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 monitor these possible changes.

A change in blood electrolyte levels may occur. Your doctor will probably want to perform a blood test from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, tiredness, drowsiness or restlessness, vomiting, decreased 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 cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are going to have parathyroid function tests, you should stop taking Olmesartan/Hydrochlorothiazide Combix before these tests are performed.

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

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking Olmesartan/Hydrochlorothiazide Combix before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Olmesartan/Hydrochlorothiazide Combix. Olmesartan/Hydrochlorothiazide Combix is not recommended during pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Children and adolescents

Olmesartan/Hydrochlorothiazide Combix is not recommended for children and adolescents under 18 years.

Taking Olmesartan/Hydrochlorothiazide Combix with other medicines

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

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

• if you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Olmesartan/Hydrochlorothiazide Combix” and “Warnings and precautions”.

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

• Medicines that may change potassium levels in the blood if taken at the same time as Olmesartan/Hydrochlorothiazide Combix. These include:
• • Potassium supplements (as well as salt substitutes containing potassium).
  • Diuretics.
  • Heparin (to thin the blood).
  • Laxatives.
  • Corticosteroids.
  • Adrenocorticotropic hormone (ACTH).
  • Carbenoxolone (a medicine for treating mouth and stomach ulcers).
  • Sodium penicillin G (an antibiotic also known as benzylpenicillin sodium).
  • Certain painkillers such as aspirin or salicylates.
  • Lithium (a medicine used to treat mood changes and some types of depression) - if taken at the same time as Olmesartan/Hydrochlorothiazide Combix, its toxicity may increase. If you have to take lithium, your doctor will measure lithium levels in your blood.
  • Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), taken at the same time as Olmesartan/Hydrochlorothiazide Combix, may increase the risk of kidney failure and reduce the effect of Olmesartan/Hydrochlorothiazide Combix.
  • Other blood pressure lowering medicines (antihypertensives), as they may increase the effect of Olmesartan/Hydrochlorothiazide Combix.
  • Sedatives, hypnotics, and antidepressants, used with Olmesartan/Hydrochlorothiazide Combix, may cause a sudden drop in blood pressure when standing up.
  • Certain medicines such as baclofen and tubocurarine, used as muscle relaxants.
  • Amifostine and other medicines used to treat cancer, such as cyclophosphamide or methotrexate.
  • Colestyramine and colestipol, medicines used to lower blood fat levels.
  • Anticholinergic medicines, such as atropine and biperiden.
  • Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, cyanemazine, 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 erythromycin injections, which may change 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 levels, respectively, as Olmesartan/Hydrochlorothiazide Combix may increase the blood sugar increasing effect of these medicines.
  • Methyldopa, a medicine used to treat high blood pressure.
  • Medicines such as noradrenaline, used to increase blood pressure and decrease 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.
  • Cyclosporin, 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 Olmesartan/Hydrochlorothiazide Combix.
  • Cisapride, used to increase food movement in the stomach and intestines.
  • Halofantrine, used to treat malaria.

Taking Olmesartan/Hydrochlorothiazide Combix with food, drinks, and alcohol

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

Be careful when drinking alcohol while taking Olmesartan/Hydrochlorothiazide Combix, as some people may feel weak or dizzy. If this happens, do not drink any alcohol, including wine, beer, or alcoholic drinks.

Black patients

As with other similar medicines, the blood pressure lowering effect of Olmesartan/Hydrochlorothiazide Combix is somewhat less in black patients.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Tell your doctor if you are pregnant or think you might be. Your doctor will advise you to stop taking Olmesartan/Hydrochlorothiazide Combix before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Olmesartan/Hydrochlorothiazide Combix. Olmesartan/Hydrochlorothiazide Combix is not recommended during pregnancy, and must not be taken when you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan/Hydrochlorothiazide Combix is not recommended for women who are breastfeeding, and your doctor may choose a different treatment if you want to breastfeed.

Athletes

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

Driving and using machines

You may feel drowsy or dizzy while being treated for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

Olmesartan/Hydrochlorothiazide Combix contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to Take Olmesartan/Hydrochlorothiazide Combix

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

The recommended doseis 1 tablet of Olmesartan/Hydrochlorothiazide 40 mg/12.5 mg per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartan/Hydrochlorothiazide 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 important that you continue taking Olmesartan/Hydrochlorothiazide until your doctor tells you to stop.

If you take more Olmesartan/Hydrochlorothiazide Combix 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 emergency department of the nearest hospital and take the medication packaging with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Olmesartan/Hydrochlorothiazide Combix

If you forget to take a dose, take the usual dose the next day. Do nottake a double dose to make up for forgotten doses.

If you interrupt treatment with Olmesartan/Hydrochlorothiazide Combix

It is important to continue taking Olmesartán/Hidroclorotiazida, unless your doctor tells you to interrupt treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

However, the following side effects can be serious:

• In rare cases, allergic reactions can occur that can affect the whole body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash. If this happens to you, stop taking Olmesartan/Hydrochlorothiazide and consult your doctor immediately.
• Olmesartan/Hydrochlorothiazide can cause a significant drop in blood pressure in susceptible patients or as a result of an allergic reaction. Infrequently, fainting or dizziness can occur. If this happens to you, stop taking Olmesartan/Hydrochlorothiazide, 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 Olmesartan/Hydrochlorothiazide, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with blood pressure treatment.

Olmesartan/Hydrochlorothiazide is a combination of two active ingredients. The following information describes the side effects reported so far with the combination Olmesartan/Hydrochlorothiazide (in addition to those already mentioned) and the side effects known for the two active ingredients separately.

These are other known side effects of Olmesartan/Hydrochlorothiazide:

If these effects occur, they are usually mild and it is not necessary to interrupt treatment.

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

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

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

Rapid and intense heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, and muscle pain, joint pain, back pain, erection problems in men, blood in urine.

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

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

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

Feeling unwell, changes in consciousness, skin swelling (hives), acute kidney failure.

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

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

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

Olmesartan medoxomil:

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

Bronchitis, cough, nasal congestion and secretion, sore throat, abdominal pain, indigestion, diarrhea, nausea, gastroenteritis, joint 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 levels of urea or uric acid in the blood, increased liver or muscle function test values.

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

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

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

Decreased number of a type of blood cells called platelets (thrombocytopenia).

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

Renal function impairment, lack of energy.

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

Increased potassium levels in the blood.

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

Hydrochlorothiazide:

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

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

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

Feeling of confusion, abdominal pain, stomach discomfort, feeling of bloating, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

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

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

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

Decreased or loss of appetite, severe breathing difficulties, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions due to light sensitivity, itching, purple spots or patches on the skin due to small hemorrhages (purpura), skin swelling (hives).

Rare side 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 the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures (convulsions), 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, gallbladder infection, symptoms of lupus erythematosus such as skin rash, joint pain, and cold hands and fingers, allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which can sometimes cause movement disorders).

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 (signs include severe respiratory distress, fever, weakness, and confusion).

Unknown frequency:

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

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Olmesartan/Hydrochlorothiazide Combix

Keep this medication out of 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 pack after "EXP.". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Olmesartan/Hydrochlorothiazide Combix

• The active ingredients are olmesartan medoxomil and hydrochlorothiazide.

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

• The other ingredients 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), red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the Product and Package Contents

Olmesartan/Hydrochlorothiazide Combix 20 mg/12.5 mg is presented in the form of film-coated tablets, orange in color, round, biconvex with beveled edges, with the engraving "2" on one face and smooth on the other.

The tablets are presented in Alu/Alu blister packs with a desiccant.

The following package 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 Pâturages

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 Last Revision of this Leaflet:February 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/