Leaflet: information for the user

Olmesartan / hydrochlorothiazide cinfa 20 mg/25 mg film-coated tablets

olmesartan medoxomil / hydrochlorothiazide

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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.

Olmesartan / hidrochlorothiazide cinfa contains two active principles, olmesartan medoxomil and hidrochlorothiazide,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 reduces blood pressure by relaxing blood vessels.
• Hidrochlorothiazide 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.

Olmesartan / hidrochlorothiazide will only be given if treatment with olmesartan medoxomil alone has not adequately controlled your blood pressure. The concurrent administration of both active substances in olmesartan / hidrochlorothiazide cinfa contributes to reducing blood pressure more than if each substance 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 olmesartan / hidrochlorothiazide to lower it further.

High blood pressure can be controlled with medicines like olmesartan / hidrochlorothiazide cinfa. 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 may also have recommended that you exercise regularly, such as walking or swimming. It is essential to follow your doctor's advice.

Do not take olmesartan / hidrochlorothiazide cinfa

• If you are allergic to olmesartan medoxomil or to hidrochlorothiazide, or to any of the other components of this medicine (listed in section 6) or to substances similar to hidrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant. (It is also better to avoid olmesartan / hidrochlorothiazide at the beginning of pregnancy - see the Pregnancy section).
• If you have severe kidney problems. If you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medication that contains aliskiren
• 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 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 think you have any of these cases, or are not sure, 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 olmesartan/hidrochlorothiazide.

Before taking the tablets, tell your doctor if you are taking any of the following blood pressure-lowering medicines:

• An ACE inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may check your kidney function, blood pressure, and electrolyte levels in your blood at regular intervals.

See also the information under the heading “Do not take olmesartan / hidrochlorothiazide cinfa”.

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

• Mild to moderate kidney problems or if you have recently had a kidney transplant.
• Liver diseases.
• Heart failure or problems with heart valves or heart muscle.
• Severe vomiting (feeling dizzy) or diarrhea, that is severe or lasts 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 (for example, primary aldosteronism).
• Diabetes.
• If you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few hours to a week after taking olmesartan/hidrochlorothiazide. This may lead to permanent vision loss if not treated.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• If you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hidrochlorothiazide, particularly 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 the sun and UV rays while taking olmesartan/hidrochlorothiazide.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking olmesartan / hidrochlorothiazide, see your doctor immediately.

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

Contact your doctor if you experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.
• Decreased vision or eye pain. These may be symptoms of increased eye pressure and may occur within a few hours to a week after taking olmesartan/hidrochlorothiazide. This may lead to permanent vision loss if not treated.

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

Olmesartan / hidrochlorothiazide may cause an increase in blood levels of fats and uric acid (which causes gout - painful swelling of the joints). Your doctor will probably want to perform blood tests from time to time to monitor these possible changes.

There may be a change in blood levels of certain chemicals called electrolytes. Your doctor will probably want to perform blood tests 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, nausea, vomiting, decreased need to urinate, rapid heart rate.

Tell your doctor if you notice any of these symptoms.

Like any other medicine that lowers blood pressure, an excessive decrease in blood pressure in patients with altered 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 to have parathyroid function tests, you should stop taking olmesartan / hidrochlorothiazide before the tests are performed.

It is reported to athletes that this medicine contains a component that may establish a positive analytical result for doping control.

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

Children and adolescents

Olmesartan / hidrochlorothiazide is not recommended for children and adolescents under 18 years old.

Taking olmesartan / hidrochlorothiazide cinfa with other medicines

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

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

• Other blood pressure-lowering medicines (anti-hypertensives), as they may increase the effect of olmesartan/hidrochlorothiazide.
• Your doctor may need to modify your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take olmesartan / hidrochlorothiazide cinfa” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood if used at the same time as olmesartan / hidrochlorothiazide. These include:
• Potassium supplements (as well as salt substitutes that contain potassium).
• Diuretics.
• Heparin (to thin the blood).
• Laxatives.
• Glucocorticoids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (medicine for the treatment of mouth and stomach ulcers).
• Penicillin G sodium (antibiotic also called benzylpenicillin sodium).
• Some analgesics such as aspirin or salicylates.
• Lithium (medicine used to treat mood changes and certain types of depression) if used at the same time as olmesartan / hidrochlorothiazide 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) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartan / hidrochlorothiazide may increase the risk of kidney failure and reduce the effect of olmesartan / hidrochlorothiazide.
• Sedatives and antidepressants, used with olmesartan / hidrochlorothiazide may cause a sudden drop in blood pressure when standing up.
• Some medicines such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medicines used to treat cancer, such as cyclophosphamide or methotrexate.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may reduce the effect of olmesartan/hidrochlorothiazide. Your doctor may advise you to take olmesartan/hidrochlorothiazide at least 4 hours before colesevelam hydrochloride.
• Cholestyramine and colestipol, medicines to lower blood fat levels.
• Anticholinergic medicines, such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol, used to treat certain psychiatric disorders.
• Some medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digital, used to treat heart problems.
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or erythromycin injectables, that may change heart rhythm.
• Oral anti-diabetic 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 / hidrochlorothiazide may intensify the effect of increasing blood sugar levels produced by these medicines.
• Metildopa, 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.
• Ciclosporin, a medicine used to prevent organ transplant rejection.
• Antibiotics in the tetracycline group, or ciprofloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Some antacids, used to treat excess stomach acid, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of olmesartan / hidrochlorothiazide.
• Cisapride, used to increase the movement of food in the stomach and intestines.
• Halofantrine, used to treat malaria.

Taking olmesartan / hidrochlorothiazide with food, drinks, and alcohol

Olmesartan / hidrochlorothiazide can be taken with or without food.

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

Black patients

Like other similar medicines, the blood pressure-lowering effect of olmesartan / hidrochlorothiazide is somewhat less in black patients.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you might be, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should inform your doctor if you are pregnant, (or if you suspect you might be). Your doctor will usually recommend that you stop taking olmesartan / hidrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine instead of olmesartan / hidrochlorothiazide. Olmesartan / hidrochlorothiazide is not recommended for use during pregnancy, and in no case should it be administered from the third month of pregnancy, as it may cause serious harm to your baby if taken at this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Olmesartan / hidrochlorothiazide is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Athletes

It is reported to athletes that this medicine contains a component (hidrochlorothiazide) that may establish a positive analytical result for doping control.

Driving and operating machines

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

Olmesartan / hidrochlorothiazide cinfa contains lactose.

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

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

The recommended dose is 1 tablet of olmesartan / hidrochlorothiazide 20 mg/12.5 mg per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of olmesartan / hidrochlorothiazide 20 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 essential that you continue taking olmesartan / hidrochlorothiazide until your doctor tells you to stop.

If you take more olmesartan / hidrochlorothiazide cinfa 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 center 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 olmesartan / hidrochlorothiazide cinfa

If you forget to take a daily dose, take the recommended dose the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with olmesartan / hidrochlorothiazide cinfa:

It is essential to continue taking olmesartan / hidrochlorothiazide, 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 that can affect the entire body, withinflammation of the face, mouth, and/or larynx, along with itching and skin rash.If this happens, stop taking olmesartan / hydrochlorothiazide and consult your doctor immediately.
• Olmesartan / hydrochlorothiazide may cause a significant drop in blood pressure in susceptible patients or as a result of an allergic reaction. Infrequently, dizziness or lightheadedness may occur.If this happens, stop taking olmesartan / hydrochlorothiazide, consult your doctor immediately, and remain lying down in a horizontal position.
• Unknown frequency: If you experience yellowing of the white of the eyes, dark urine, skin itching, even if you started treatment with olmesartan / hydrochlorothiazide some time ago,contact your doctor immediatelywho will evaluate your symptoms and decide how to continue treatment for high blood pressure.

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

These are other side effects known so far with olmesartan / hydrochlorothiazide:

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

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

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

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

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

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

Increased levels of fat in the blood, increased urea or uric acid in the blood, increasedcreatinine, 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 action.

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

Unpleasant sensation, alterations of consciousness, skin swelling (hives), acute renal failure.

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

Increased urea nitrogen 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 action.

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

Olmesartan medoxomil:

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

Bronchitis, cough, congestion and nasal 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, frequently, some changes in blood test results have been observed that include:

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

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

Fast and intense allergic reactions that can affect the entire body and may cause respiratory problems, as well as a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), inflammation of the face, angina (chest pain or discomfort known as angina pectoris), unpleasant sensation, skin allergic rash, itching, hives, skin swelling (hives).

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

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

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

Renal function deterioration, lack of energy.

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

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

Increased potassium in the blood.

Hidroclorotiazida:

Very frequent side effects (may affect more than 1 in 10 patients):

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 patients):

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 that include:

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 patients):

Severe loss of appetite, severe difficulty breathing, skin allergic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light sensitivity 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 patients):

Salivary gland inflammation and pain, 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, 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, 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 patients):

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).

Side effects of unknown frequency (cannot be estimated from available data):

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], skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is a possibleside effect that does not appear in this prospectus.Also, you can 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.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging 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 packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of olmesartan/hydrochlorothiazide cinfa

• The active principles are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
• The other components are:

• tablet core: microcrystalline cellulose, lactose monohydrate, povidone, hydroxypropylcellulose, and magnesium stearate.
• tablet coating: Opadry Y-1-7000 (hypromellose, titanium dioxide, and macrogol), yellow iron oxide, and red iron oxide.

Appearance of the product and contents of the packaging

Olmesartan/hydrochlorothiazide cinfa 20 mg /25 mg are film-coated tablets with a light pink color, cylindrical, biconvex, and marked with the logo D2 on one of its faces.

It is presented in aluminum blister packaging. Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - 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/

You can access detailed and updated information about this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/80956/P_80956.html

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