Leaflet: information for the user

Olmesartan / hydrochlorothiazide cinfa 40 mg/12.5 mg film-coated tablets

Olmesartan medoxomil / Hydrochlorothiazide

Read this leaflet carefully before you start to take 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.

Contents of the pack and additional information

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 medoxomilalonehas not adequately controlled your blood pressure. The concurrent administration of bothactive substances in olmesartan / hidrochlorothiazide cinfa contributes to reducing blood pressure more than if each of the substances were administered alone.

You may already be taking medicines to treat high blood pressure, but yourdoctor 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 somelifestyle 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 walkingor 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 Pregnancy section).
• If you have 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 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 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 before starting to use olmesartan/hidrochlorothiazide cinfa.

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

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

Your doctor may monitor 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:

• Renal transplant.
• Liver diseases.
• Heart failure or problems with heart valves or heart muscle.
• Severe or prolonged vomiting (while feeling dizzy) or diarrhea.
• Treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-salt diet.
• Problems with 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, which can occur within a few hours to a week after taking olmesartan/hidrochlorothiazide.
• 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 sun exposure 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, seek medical attention 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 can occur within a few hours to a week after taking olmesartan / hidrochlorothiazide. This can lead to permanent vision loss if not treated.

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

Olmesartan / hidrochlorothiazide may cause an increase in blood lipid and uric acid levels. Your doctor will likely want to perform blood tests from time to time to monitor these possible changes.

You may experience changes in blood levels of certain chemical substances called electrolytes. Your doctor will likely 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, 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 blood pressure reduction in patients with altered blood flow to the heart or brain can cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

If you are undergoing parathyroid function tests, stop taking olmesartan / hidrochlorothiazide before the tests are performed.

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

You must inform your doctor if you are pregnant, or think you may be pregnant. Do not take olmesartan / hidrochlorothiazide at the beginning of pregnancy, and do not take it if you are more than 3 months pregnant, as it can cause serious harm to your baby if taken from the third month of pregnancy (see Pregnancy section).

Children and adolescents

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

Taking olmesartan / hidrochlorothiazide cinfa with other medications

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

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

• Other blood pressure-lowering medications (anti-hypertensives), as they may increase the effect of olmesartan/hidrochlorothiazide cinfa.
• Your doctor may need to adjust your dose and/or take other precautions:
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take olmesartan / hidrochlorothiazide cinfa” and “Warnings and precautions”).
• Medications 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).
• Medications that increase urine production (diuretics).
• Heparin (to thin the blood).
• Laxatives.
• Glucocorticoids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (medication for treating mouth and stomach ulcers).
• Penicillin G sodium (antibiotic also known as benzylpenicillin sodium).
• 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 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) (medications 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 insufficiency and decrease the effect of olmesartan / hidrochlorothiazide.

• Medications that induce sleep, sedatives, and antidepressants, used with olmesartan / hidrochlorothiazide 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.
• Colestiramine and colestipol, medications to reduce blood lipid levels.
• Colesevelam hydrochloride, a medication that reduces blood cholesterol levels, as it may decrease the effect of olmesartan/hidrochlorothiazide. Your doctor may advise you to take olmesartan/hidrochlorothiazide at least 4 hours before colesevelam hydrochloride.
• 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 to treat heart problems.
• Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injectables, that may change heart rhythm.
• Oral diabetes medications, such as metformin, or insulin, used to reduce blood sugar levels.
• Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar, respectively, as olmesartan / hidrochlorothiazide 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 decrease heart rate.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Medications such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medication.
• Ciclosporin, a medication used to prevent organ transplant rejection.
• Antibiotics in the tetracycline group, or esparfloxacino.
• Amphotericin, a medication 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 stomach and intestinal motility.
• Halofantrine, used to treat malaria.

Taking olmesartan / hidrochlorothiazide cinfa 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 alcoholic beverages.

Black patients

Like other similar medications, the blood pressure-lowering effect of olmesartan / hidrochlorothiazide 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 must inform your doctor if you are pregnant, or think you may be pregnant. Your doctor will advise you to stop taking olmesartan / hidrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medication instead of olmesartan / hidrochlorothiazide. Do not take olmesartan / hidrochlorothiazide during pregnancy, and do not take it if you are more than 3 months pregnant, as it can cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Do not take olmesartan / hidrochlorothiazide while breastfeeding, and your doctor may choose another treatment if you want to breastfeed.

Use in athletes

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

Driving and operating machinery

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

Olmesartan / hidrochlorothiazide cinfa contains lactose.

This medication 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 or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet of olmesartan / hidrochlorothiazide cinfa 40 mg/12.5 mg per day. If blood pressure is not controlled adequately, your doctor may change the dose to 1 tablet of olmesartan / hidrochlorothiazide cinfa 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 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 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 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, althoughnot 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.
• In sensitive individuals or as a result of an allergic reaction, olmesartan / hydrochlorothiazide cinfa may cause blood pressure to drop too low. Infrequently, dizziness or fainting 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 whites 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 effectsknown 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 heart 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, 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):

Feeling unwell, alterations in consciousness, skin swelling (hives), acute renal insufficiency.

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 medoxomilo orhydrochlorothiazide alone, but not with olmesartan / hydrochlorothiazide or in a higher frequency:

Olmesartan medoxomilo:

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 breathing problems, as well as a rapid drop in blood pressure that can even lead to fainting (anaphylactic reactions), inflammation of the face, angina (chest pain or discomfort known as angina pectoris), feeling unwell, skin rash, itching, hives, skin swelling (hives).

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

Reduced 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, rarely, 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):

Feeling confused, abdominal pain, stomach discomfort, feeling bloated, 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):

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, insomnia, feeling of loss of interest (apathy), numbness and tingling, seizures, 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, biliary tract 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 (signs 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 apossibleside effect that does not appear in this prospectus.You can also report them directly through the Spanish System for the Pharmacovigilance 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 the 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 the 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 40 mg of olmesartan medoxomil and 12.5 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 40 mg /12.5 mg are yellow-coated, biconvex, oval tablets with the D3 logo on one of their faces.

They are 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

Date of the last review of this leaflet:February 2025

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

You can access detailed and updated information about this medication 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/80954/P_80954.html

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