Patient Information Leaflet

Olmesartan/HydrochlorothiazideCombix 40 mg/12.5 mg Film-Coated Tablets

Olmesartan medoxomil/hydrochlorothiazide

Read this leaflet carefully before you start taking this medicine, as 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Olmesartán/HidroclorotiazidaCombix contains two active ingredients, 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 reduces blood pressure by relaxing blood vessels.

• Hidroclorotiazida belongs to a group of medicines called thiazide diuretics. It reduces blood pressure by contributing to the elimination of excess fluids, increasing urine production by the kidneys.

Olmesartán/Hidroclorotiazida will only be given if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The concurrent administration of both active ingredients in Olmesartán/Hidroclorotiazida contributes to reducing blood pressure more than if each active ingredient were administered alone.

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

High blood pressure can be controlled with medicines like Olmesartán/Hidroclorotiazida tablets. Your doctor has probably also recommended that you make some lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing the amount of salt in your diet). Your doctor has also probably recommended that you exercise regularly, such as walking or swimming. It is essential to follow your doctor's advice.

Do not take Olmesartán/Hidroclorotiazida Combix

-if you are allergic to olmesartán medoxomilo, hidroclorotiazida, any of the other components of this medication (listed in section 6), or similar substances to hidroclorotiazida (sulfonamides).

-if you are more than 3 months pregnant. (It is also better to avoid Olmesartán/Hidroclorotiazida at the beginning of pregnancy - see Pregnancy section).

-if you have kidney problems.

-if you have low levels of potassium or sodium in your blood, high levels of calcium or uric acid in your blood (with symptoms of gout or kidney stones), that do not improve with treatment.

-if you have moderate or severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, by gallstones).

-if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olmesartán/Hidroclorotiazida Combix:

-if you are taking any of the following medications used to treat high blood pressure (hypertension):

-an angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

-aliskiren

- If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and may occur within a few hours to a week after taking Olmesartán/Hidroclorotiazida Combix.

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Olmesartán/Hidroclorotiazida Combix.

• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience shortness of breath or severe difficulty breathing after taking Olmesartán/Hidroclorotiazida, go to your doctor immediately.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking olmesartán/hidroclorotiazida. Your doctor will decide whether to continue treatment. Do not stop taking olmesartán/hidroclorotiazida in monotherapy

See also the information under the heading “Do not take Olmesartán/Hidroclorotiazida 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 heart valves or heart muscle.

-vomiting (while feeling dizzy) or diarrhea, which is severe or lasts for several days.

-treatment with high doses of medications that increase urine elimination (diuretics), or if you are on a low-sodium diet.

-problems with the adrenal glands (for example, primary aldosteronism).

-diabetes.

-lupus erythematosus (an autoimmune disease).

-allergy or asthma.

Contact your doctor if you experience severe, persistent diarrhea, and significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.

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

Olmesartán/Hidroclorotiazida 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 chemical substances 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 weak, slow, tired, drowsy, or restless, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

Like any other medication that lowers blood pressure, excessive lowering of blood pressure in patients with heart or brain blood flow abnormalities, may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are to undergo parathyroid function tests, you should stop taking Olmesartán/Hidroclorotiazida before the tests are performed.

It is reported to athletes that this medication contains a component (hidroclorotiazida) that may produce a positive result in doping control tests.

You should inform your doctor if you are pregnant or think you may be pregnant.
Olmesartán/Hidroclorotiazida is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see Pregnancy section).

Children and adolescents

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

Taking Olmesartán/HidroclorotiazidaCombix with other medications

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

Your doctor may need to modify 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 Olmesartán/Hidroclorotiazida Combix” and “Warnings and precautions”.

Particularly, inform your doctor or pharmacist about any of the following medications:

-Medications that may alter potassium levels in the blood if used at the same time as Olmesartán/Hidroclorotiazida. These include:

-potassium supplements (as well as salt substitutes that contain potassium).

-diuretics.

-heparin (to thin the blood).

-laxatives.

-steroids.

-adrenocorticotropic hormone (ACTH).

-carbenoxolone (medication for the treatment of mouth and stomach ulcers).

-benzylpenicillin sodium (antibiotic also known as sodium penicillin).

-some analgesics such as aspirin or salicylates.

-lithium (medication used to treat mood changes and certain types of depression) if used at the same time as Olmesartán/Hidroclorotiazida may increase its toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.

-non-steroidal anti-inflammatory drugs (NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as Olmesartán/Hidroclorotiazida may increase the risk of kidney failure and reduce the effect of Olmesartán/Hidroclorotiazida.

-other blood pressure-lowering medications (anti-hypertensives), as they may increase the effect of Olmesartán/Hidroclorotiazida.

-sleep-inducing medications, sedatives, and antidepressants, used with Olmesartán/Hidroclorotiazida may cause a sudden drop in blood pressure when standing up.

-some medications such as baclofen and tubocurarine, used as muscle relaxants.

-amifostine and other medications used to treat cancer, such as cyclophosphamide or methotrexate.

-cholestyramine and colestipol, medications to reduce blood lipid levels.

-anticholinergic medications, such as atropine and biperiden.

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

-some medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digital, used in the treatment of heart problems.

-medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or erythromycin injectables, which may change heart rhythm.

-oral diabetes medications, such as metformin, or insulin, used to reduce blood sugar levels.

-beta-blockers and diazoxide, medications used in the treatment of high blood pressure or low blood sugar, respectively, as Olmesartán/Hidroclorotiazida may intensify the effect of increasing blood sugar that these medications produce.

-metildopa, a medication used to treat high blood pressure.

-medications such as noradrenaline, used to increase blood pressure and reduce heart rate.

-difemanil, used to treat slow heart rate or reduce sweating.

-medications such as probenecid, sulfinpyrazone, and allopurinol, used in the treatment of gout.

-calcium supplements.

-amantadine, an antiviral medication.

-ciclosporin, a medication used to prevent organ transplant rejection.

-antibiotics of the tetracycline group or ciprofloxacin.

-amphotericin, a medication used to treat fungal infections.

-some antacids, used in the treatment of excess stomach acid, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of Olmesartán/Hidroclorotiazida.

-cisapride, used to increase the movement of food in the stomach and intestines.

-halofantrine, used to treat malaria.

Taking Olmesartán/HidroclorotiazidaCombix with food, drinks, and alcohol

Olmesartán/Hidroclorotiazida can be taken with or without food.

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

Black patients

Like other similar medications, the blood pressure-lowering effect of Olmesartán/Hidroclorotiazida is somewhat less in black patients.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you are pregnant, or if you 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 advise you to take another medication instead of Olmesartán/Hidroclorotiazida.
Olmesartán/Hidroclorotiazida is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to start breastfeeding.
Olmesartán/Hidroclorotiazida is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed.

Use in athletes

It is reported to athletes that this medication contains a component (hidroclorotiazida) that may produce a positive result in doping control tests.

Driving and operating machines

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

Olmesartán/HidroclorotiazidaCombix contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

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

The recommended doseis 1 tablet of Olmesartán/Hidroclorotiazida 40 mg/12.5 mg per day.
If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartán/Hidroclorotiazida 40 mg/25 mg per day.

Take the tablets with water. If possible, take your doseat the same time every day, for example, with breakfast. It is essential that you continue taking Olmesartán/Hidroclorotiazida until your doctor tells you to stop.

If you take more Olmesartán/Hidroclorotiazida Combix than you should

If you take more tablets than you should take 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 medication packaging with you.

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

If you forget to take Olmesartán/Hidroclorotiazida Combix

If you forget to take a dose, take the usual dose the next day.Do nottake a double dose to compensate for the missed doses.

If you interrupt treatment with Olmesartán/Hidroclorotiazida Combix

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

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

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

However, the following side effects may be serious:

• In rare cases, an allergic reaction may occur, which can affect the entire body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash.If this happens, stop taking Olmesartán/Hidroclorotiazida and consult your doctor immediately.
• In sensitive individuals or as a result of an allergic reaction, Olmesartán/Hidroclorotiazida may cause blood pressure to drop too low. Infrequently, dizziness or fainting may occur.If this happens, stop taking Olmesartán/Hidroclorotiazida, 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 Olmesartán/Hidroclorotiazida,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue with the treatment for high blood pressure.

Olmesartán/Hidroclorotiazida is a combination of two active principles. The following information, first, describes the side effects reported so far with the combination Olmesartán/Hidroclorotiazida (in addition to those already mentioned) and, second, the side effects known of the two active principles separately.

These are other side effects known so far with Olmesartán/Hidroclorotiazida.

If these effects occur, they are often mild anddo not need to interrupt treatment.

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

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

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

Fast and intense heartbeat (palpitations), hives, eczema, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain, arm and leg pain, back pain, erectile dysfunction in men, blood in urine.

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

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

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

Unpleasant sensation, alterations in consciousness, skin swelling (hives), acute renal insufficiency.

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

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

Additional side effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmesartán/Hidroclorotiazida, or in a higher frequency:

Olmesartan medoxomil

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

Bronchitis, cough, congestion and nasal secretion, sore throat, abdominal pain, indigestion, diarrhea, nausea, gastroenteritis, joint pain 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, including:

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased levels of liver or muscle function.

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

Quick allergic reactions that can affect the entire body and cause breathing problems, as well as a rapid decrease in blood pressure that can even cause fainting (anaphylactic reactions), inflammation of the face, angina (chest pain or discomfort known as angina pectoris), unpleasant sensation, skin rash, itching, exanthema (skin eruption), skin swelling (hives).

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

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

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

Renal function deterioration, fatigue, pruritus.

Also, some changes in blood test results have been observed, 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 frequent side effects (may affect more than 1 in 10 people):

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

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

Confusion, abdominal pain, stomach discomfort, feeling of swelling, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

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

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

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

Loss of appetite, severe difficulty breathing, skin allergic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light sensitivity skin reactions, itching, purple spots on the skin due to small hemorrhages (purpura), skin swelling (hives).

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

Salivary gland inflammation and pain, decreased white blood cell count, decreased platelet count in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellow vision, blurry vision, dry eyes, irregular heartbeat, blood vessel inflammation, 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), skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever,muscle weakness (which sometimes causes movement alteration).

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 (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency:

Cancer of the skin and lips (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 hemorrhage) or acute angle-closure glaucoma].

Reporting of 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 prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special conditions for conservation are required.

Do not use this medication after the expiration date that appears on the packaging and on the blister after “CAD.:”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Olmesartán/Hidroclorotiazida Combix

· The active principles are olmesartan medoxomil and hydrochlorothiazide.

Cada comprimido recubierto con película contains 40 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), red iron oxide (E172) and yellow iron oxide (E172).

Appearance of the product and content of the packaging

Olmesartán/Hidroclorotiazida 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 desiccant.

The following packaging sizes are available: 28 tablets.

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet:February 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.