OLMESARTAN/HYDROCHLOROTHIAZIDE COMBIX 40 MG/12.5 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Olmesartan/HydrochlorothiazideCombix 40 mg/12.5 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 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. Storing 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 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 has been shown to be more effective in reducing blood pressure 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 to lower it further.

High blood pressure can be controlled with medicines such as Olmesartan/Hydrochlorothiazide tablets. Your doctor has probably also advised you to make some changes to your lifestyle to help lower your blood pressure (e.g. lose weight, stop smoking, reduce alcohol consumption and reduce the amount of salt in your diet). Your doctor may also have advised you to take regular exercise, such as walking or swimming. It is important to follow your doctor's 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 at the start of 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 (with symptoms of gout or kidney stones), 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 the drainage of bile from the gallbladder (biliary obstruction, e.g. due to gallstones).
• if you have diabetes or kidney impairment and are treated with a blood pressure lowering medicine containing aliskiren.

If you think any of these apply to you, or if you are not sure, 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 eye pressure 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, in particular 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 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 severe difficulty breathing after taking Olmesartan/Hydrochlorothiazide, go to 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 prolonged for several days.
• Treatment with high doses of medicines that increase urine production (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 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 levels of certain chemicals called electrolytes 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, excessively low blood pressure in patients with heart or brain blood flow problems may lead to 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 before these tests are performed.

Athletes are informed that this medicine contains a component (hydrochlorothiazide) that may produce a positive result in doping tests.

You must tell your doctor if you are pregnant or think you might be pregnant. It is not recommended to take Olmesartan/Hydrochlorothiazide during pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Children and adolescents

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

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 alter potassium levels in the blood when used at the same time as Olmesartan/Hydrochlorothiazide. These include:
• Potassium supplements (as well as salt substitutes that contain potassium).
• Medicines that increase urine production (diuretics).
• Heparin (to thin the blood).
• Laxatives.
• Corticosteroids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (a medicine used to treat mouth and stomach ulcers).
• Sodium penicillin G (an antibiotic also known as benzylpenicillin sodium).
• Certain pain relievers such as aspirin or salicylates.
• Lithium (a medicine used to treat mood changes and some types of depression) may increase its toxicity when used at the same time as Olmesartan/Hydrochlorothiazide. If you have to take lithium, your doctor will monitor lithium levels in your blood.
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as Olmesartan/Hydrochlorothiazide, may increase the risk of kidney failure and reduce the effect of Olmesartan/Hydrochlorothiazide.
• Other blood pressure-lowering medicines (antihypertensives), as they may increase the effect of Olmesartan/Hydrochlorothiazide.
• Sedatives, hypnotics, and antidepressants, used with Olmesartan/Hydrochlorothiazide, 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 can 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 may increase the blood sugar-raising 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 stomach acid excess, such as aluminium and magnesium hydroxide, as they may slightly reduce the effect of Olmesartan/Hydrochlorothiazide.
• 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 can be taken with or without food.

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

Black patients

As with other similar medicines, the blood pressure-lowering effect of Olmesartan/Hydrochlorothiazide is somewhat smaller 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

You must tell your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking Olmesartan/Hydrochlorothiazide 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. It is not recommended to take Olmesartan/Hydrochlorothiazide during pregnancy, and you must not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Breastfeeding

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

Use in athletes

Athletes are informed 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, consult them before taking this medicine.

3. How to take Olmesartan/Hydrochlorothiazide Combix

Follow exactly the instructions of your doctor for taking this medicine. If you are not sure, ask your doctor or pharmacist again.

The recommended doseis one Olmesartan/Hydrochlorothiazide 40 mg/12.5 mg tablet per day. If your blood pressure is not adequately controlled, your doctor may change your dose to one Olmesartan/Hydrochlorothiazide 40 mg/25 mg tablet per day.

Take the tablets with water. If possible, take your dose at the same time each day, e.g. at breakfast time. It is important that you continue to take 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 takes one or more tablets, contact your doctor or go to the nearest hospital emergency department immediately and take the medicine pack with you.

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

If you forget to take Olmesartan/Hydrochlorothiazide Combix

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

If you stop taking Olmesartan/Hydrochlorothiazide Combix

It is important to continue taking Olmesartan/Hydrochlorothiazide unless your doctor tells you to stop.

If you have any further questions on 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 all people suffer from them.

However, the following adverse effects can be serious:

• In rare cases, allergic reactions may 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.
• In sensitive individuals or as a result of an allergic reaction, Olmesartan/Hydrochlorothiazide may cause blood pressure to drop too low. Dizziness or fainting can occur infrequently. 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 assess your symptoms and decide how to continue with blood pressure treatment.

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

These are other known adverse effects reported so far with Olmesartan/Hydrochlorothiazide.

If these effects occur, they are often mild and it is not necessary to interrupt 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 and intense heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, and muscle pain, joint pain, arm and leg 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 urea or uric acid in the blood, increased creatinine, increased or decreased potassium levels in the blood, increased calcium levels in the blood, increased blood sugar, 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 adverse effects (may affect up to 1 in 1,000 people):

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

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

Increased blood urea nitrogen, 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 adverse effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmesartan/Hydrochlorothiazide, or at a higher frequency:

Olmesartan medoxomil

Common adverse 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 urea or uric acid in the blood, increased liver or muscle function.

Uncommon adverse 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:

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):

Kidney function deterioration, lack of energy, pruritus.

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

Increased potassium in the blood.

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

Hydrochlorothiazide

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

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

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

Feeling confused, abdominal pain, stomach discomfort, feeling bloated, diarrhea, nausea, vomiting, constipation, glucose in urine.

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

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

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

Decreased or lost 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 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 the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures (convulsions), yellow 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, infection in the gallbladder, 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 adverse 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 of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date shown on the packaging and on the blister pack after "EXP.". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines 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 medicines 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 40 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 40 mg/12.5 mg is presented in the form of film-coated tablets of orange color, oval, biconvex, with the engraving "4" 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.