Olmesartan/hydrochlorothiazide Cinfa 20 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olmesartan / hydrochlorothiazide cinfa 20 mg/12.5 mg film-coated tablets EFG

olmesartan medoxomil / hydrochlorothiazide

Please read all of 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What olmesartan / hydrochlorothiazide cinfa is and what it is used for
2. What you need to know before taking olmesartan / hydrochlorothiazide cinfa
3. How to take olmesartan / hydrochlorothiazide cinfa
4. Possible side effects
5. How to store olmesartan / hydrochlorothiazide cinfa
6. Contents of the pack and other information

1. What olmesartán / hidroclorotiazida cinfa is and what it is used for

Olmesartán / hidroclorotiazida cinfa contains two active substances, 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 lowers blood pressure by relaxing blood vessels.
• Hidroclorotiazida belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the removal of excess fluid through increased urine production by the kidneys.

Olmesartán / hidroclorotiazida will only be prescribed if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The combined administration of both active substances in olmesartán / hidroclorotiazida cinfa contributes to a greater reduction in blood pressure than either substance alone.

You may already be taking medicines to treat high blood pressure, but your doctor may consider it necessary for you to take olmesartán / hidroclorotiazida cinfa to lower it further.

High blood pressure can be controlled with medicines such as olmesartán / hidroclorotiazida cinfa. Your doctor has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and decreasing salt intake). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking olmesartan/hydrochlorothiazide cinfa

Do not take olmesartan/hydrochlorothiazide cinfa

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant. (It is also advisable to avoid olmesartan/hydrochlorothiazide at the beginning of pregnancy – see section Pregnancy.)
• If you have severe kidney problems. If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid in the blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• If you have severe liver problems, yellowing of the skin or eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example due to gallstones).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking olmesartan/hydrochlorothiazide.

Before taking the tablets, tell your doctor if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• An angiotensin-converting enzyme (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 blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take olmesartan/hydrochlorothiazide 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 disease.
• Heart failure or problems with heart valves or heart muscle.
• Vomiting (with dizziness) or diarrhoea that is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine elimination (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g. primary hyperaldosteronism).
• Diabetes.
• 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 increased pressure in the eye, which may occur within hours to a week after taking olmesartan/hydrochlorothiazide.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking olmesartan/hydrochlorothiazide.
• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking olmesartan/hydrochlorothiazide cinfa, contact your doctor immediately.

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

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

• Severe, persistent diarrhoea causing significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.
• Decreased vision or eye pain. These could be symptoms of increased eye pressure and may occur from hours to weeks after taking olmesartan/hydrochlorothiazide. This may lead to permanent vision loss if not treated.

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

Olmesartan/hydrochlorothiazide may increase blood levels of fats and uric acid (which causes gout – painful joint swelling). Your doctor will likely perform blood tests from time to time to monitor these possible changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely perform blood tests periodically to monitor this possible change. Some signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy, restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for parathyroid function tests, you should stop taking olmesartan/hydrochlorothiazide before these tests are performed.

Athletes are advised that this medicine contains a component that may result in a positive doping test.

Inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Use of olmesartan/hydrochlorothiazide is not recommended at the beginning of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this stage (see section Pregnancy and breastfeeding).

Children and adolescents

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

Taking olmesartan/hydrochlorothiazide cinfa with other medicines

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

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

• Other blood pressure-lowering medicines (antihypertensives), as they may increase the effect of olmesartan/hydrochlorothiazide.

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

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

• Medicines that may alter potassium levels in the blood when used together with olmesartan/hydrochlorothiazide. These include:

• Potassium supplements (as well as salt substitutes containing potassium).

• Medicines that increase urine elimination (diuretics).

• Heparin (a blood thinner).

• Laxatives.

• Steroids.

• Adrenocorticotropic hormone (ACTH).

• Carbenoxolone (a medicine used to treat mouth and stomach ulcers).

• Sodium penicillin G (an antibiotic also known as sodium benzylpenicillin).

• Some painkillers such as aspirin or salicylates.

• Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used together with olmesartan/hydrochlorothiazide. If you have to take lithium, your doctor will monitor lithium levels in your blood.

• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with olmesartan/hydrochlorothiazide, may increase the risk of kidney failure and reduce the effect of olmesartan/hydrochlorothiazide.

• Sleeping pills, sedatives, and antidepressants, used together with olmesartan/hydrochlorothiazide, may cause a sudden drop in blood pressure upon standing.

• Certain medicines such as baclofen and tubocurarine, used as muscle relaxants.

• Amifostine and other medicines used in cancer treatment, such as cyclophosphamide or methotrexate.

• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of olmesartan/hydrochlorothiazide. Your doctor may advise you to take olmesartan/hydrochlorothiazide at least 4 hours before colesevelam hydrochloride.

• Cholestyramine and colestipol, medicines used to lower blood fat levels.

• Anticholinergic medicines, such as atropine and biperiden.

• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, 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 in the treatment of heart problems.

• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, which may alter 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, respectively, since olmesartan/hydrochlorothiazide may enhance 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 reduce heart rate.

• Difemanil, used to treat slow heartbeat or reduce sweating.

• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used in the treatment of gout.

• Calcium supplements.

• Amantadine, an antiviral medicine.

• Cyclosporine, a medicine used to prevent organ transplant rejection.

• Antibiotics of the tetracycline group, or sparfloxacin.

• Amphotericin, a medicine used to treat fungal infections.

• Some antacids used to treat excess stomach acid, such as aluminium and magnesium hydroxide, as they may slightly reduce the effect of olmesartan/hydrochlorothiazide.

• Cisapride, used to increase movement of food through the stomach and intestine.

• Halofantrine, used for malaria.

Taking olmesartan/hydrochlorothiazide with food, drinks, and alcohol

Olmesartan/hydrochlorothiazide can be taken with or without food.

Be cautious when drinking alcohol while taking olmesartan/hydrochlorothiazide, as some people may feel weak or dizzy. If this happens, avoid alcohol, including wine, beer, or alcoholic soft drinks.

Patients of Black origin

As with other similar medicines, the blood pressure-lowering effect of olmesartan/hydrochlorothiazide is somewhat reduced in patients of Black origin.

Pregnancy and breastfeeding

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

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking olmesartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of olmesartan/hydrochlorothiazide is not recommended during pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby if taken from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Use of olmesartan/hydrochlorothiazide is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed.

Use in athletes

Athletes are advised that this medicine contains a component (hydrochlorothiazide) that may result in a positive doping test.

Driving and use of machines

You may feel drowsy or dizzy while being treated for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

olmesartan/hydrochlorothiazide cinfa contains lactose.

If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take olmesartan/hydrochlorothiazide cinfa

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

The recommended dose is 1 tablet of olmesartan/hydrochlorothiazide 20 mg/12.5 mg daily. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of olmesartan/hydrochlorothiazide 20 mg/25 mg daily.

Take the tablets with water. If possible, take your dose at the same time each day, for example, with breakfast. It is important that you continue taking olmesartan/hydrochlorothiazide until your doctor tells you to stop.

If you take more olmesartan/hydrochlorothiazide cinfa than you should

If you take more tablets than prescribed, 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 medicine packaging with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take olmesartan/hydrochlorothiazide cinfa

If you forget to take a daily dose, take the recommended dose the next day.

Do not take a double dose to make up for missed doses.

If you stop treatment with olmesartan/hydrochlorothiazide cinfa

It is important to continue taking olmesartan/hydrochlorothiazide unless your doctor tells you to stop treatment.

If you have any further questions about 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 everyone will experience them.

However, the following adverse effects may be serious:

• In rare cases, allergic reactions may occur that can affect the entire body, with swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens, stop taking olmesartan/hydrochlorothiazide and consult your doctor immediately.
• Olmesartan/hydrochlorothiazide may cause a marked drop in blood pressure in susceptible patients or as a result of an allergic reaction. Fainting or dizziness may occasionally occur. If this happens, stop taking olmesartan/hydrochlorothiazide, consult your doctor immediately, and remain lying down in a horizontal position.
• Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or itchy skin, even if you started treatment with olmesartan/hydrochlorothiazide some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

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

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

If these effects occur, they are often mild and you do not need to stop treatment.

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

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

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

Fast or strong heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle cramps and muscle pain, joint pain, pain in arms and legs, back pain, erectile problems in men, blood in urine.

Uncommonly, the following changes in blood tests have also been observed:

Increase in blood fat levels, increase in blood urea or uric acid, increase in creatinine, increase or decrease in blood potassium levels, increase in blood calcium levels, increase in blood glucose levels, increase in liver function test values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

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

Feeling unwell, disturbances in consciousness, skin swelling (hives), acute renal failure.

Rarely, the following changes in blood test results have also been observed:

Increase in blood urea nitrogen, decrease in haemoglobin and haematocrit values. Your doctor will monitor you with a blood test and advise you whether any action is needed.

Additional adverse effects reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with olmesartan/hydrochlorothiazide or at a higher frequency:

Olmesartan medoxomil:

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

Bronchitis, cough, nasal congestion and discharge, sore throat, abdominal pain, indigestion, diarrhoea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain.

Frequently observed changes in blood test results include:

Increase in blood fat levels, increase in blood urea or uric acid, increase in liver or muscle function test values.

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

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

Uncommonly, the following changes in blood test results have also been observed:

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

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

Worsening of kidney function, lack of energy.

Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Rarely, the following changes in blood test results have also been observed:

Increase in blood potassium levels.

Hydrochlorothiazide:

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

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

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

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

Changes in blood test results include:

Increase in creatinine, urea, calcium and blood glucose levels, decrease in blood chloride, potassium, magnesium and sodium levels. Increase in serum amylase (hyperamylasaemia).

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

Decreased or loss of appetite, severe difficulty breathing, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purple spots or patches on the skin due to minor bleeding (purpura), skin swelling (hives).

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

Inflammation and pain of the salivary glands, decreased number of white blood cells, decreased number of platelets in blood, anaemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellowish 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, gallbladder infection, symptoms of lupus erythematosus such as skin rash, joint pain, coldness in hands and fingers, skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing movement disorders).

Very rare adverse effects (may affect up to 1 in 10,000 patients):

Electrolyte imbalance which may cause abnormally low blood chloride levels (hypochloraemic alkalosis), intestinal obstruction (paralytic ileus), acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

Adverse effects with unknown frequency (cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of olmesartan/hydrochlorothiazide cinfa

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of olmesartan/hydrochlorothiazide cinfa

• The active substances are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 20 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 pack

Olmesartan/hydrochlorothiazide cinfa 20 mg/12.5 mg are yellow, film-coated, cylindrical, biconvex tablets, marked with the logo D1 on one side.

It is presented in aluminum blister packs. Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

5Date of the most recent review of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (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/80953/P_80953.html

QR code to: https://cima.aemps.es/cima/dochtml/p/80953/P_80953.html