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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Olmesartan/Hydrochlorothiazide Viatris 20 mg/12.5 mg film-coated tablets EFG

olmesartan medoxomil and hydrochlorothiazide

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could 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 the leaflet

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

1. What Olmesartán/Hidroclorotiazida Viatris is and what it is used for

Olmesartán/Hidroclorotiazida Viatris 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 body eliminate excess fluid, thereby increasing urine production by the kidneys.

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

You may already be taking medicines to treat high blood pressure, but your doctor may wish to switch you to olmesartán/hidroclorotiazida to achieve better blood pressure control.

High blood pressure can be managed with medicines such as olmesartán medoxomilo/hidroclorotiazida tablets. 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 reducing 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 you start taking Olmesartan/Hydrochlorothiazide Viatris

Do not take Olmesartán/Hidroclorotiazida Viatris:

• If you are allergic to olmesartan medoxomil, hydrochlorothiazide, 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 (olmesartan medoxomil/hydrochlorothiazide should also be avoided at the beginning of pregnancy – see Pregnancy section).
• If you have severe kidney problems.
• If you have low levels of potassium or sodium, or 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, yellowing of the skin or eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, due to gallstones).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor before starting to take Olmesartán/Hidroclorotiazida Viatris if you have any of the following health conditions:

• If you have previously experienced respiratory 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 medoxomil/hydrochlorothiazide, seek medical attention immediately.

• 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking olmesartan medoxomil/hydrochlorothiazide.

• Mild to moderate kidney problems or if you have recently undergone a kidney transplant.

• Liver disease.

• Heart failure or problems with heart valves or heart muscle.

• Severe vomiting or diarrhea lasting several days.

• Treatment with high doses of medicines that increase urine output (diuretics) or if you are on a low-salt diet.

• Problems with the adrenal glands (e.g., primary hyperaldosteronism).

• Diabetes.

• Lupus erythematosus (an autoimmune disease).

• Allergy or asthma.

• If you are taking any of the following medicines for high blood pressure:

• An ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems due to diabetes.

• Aliskiren.

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

Your doctor may periodically check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood.

Also refer to the information in the section "Do not take Olmesartán/Hidroclorotiazida Viatris."

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

Olmesartan medoxomil/hydrochlorothiazide may increase levels of fats and uric acid (which causes gout – painful swelling of joints) in the blood. Your doctor will likely perform periodic blood tests to monitor for these potential changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely perform periodic blood tests 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, fatigued, drowsy, or restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Inform your doctor if you experience 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 a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

If you are scheduled for tests of parathyroid function, you must stop taking olmesartan medoxomil/hydrochlorothiazide before the test.

Athletes should be aware that this medicine may result in a positive doping test.

Inform your doctor if you think you are (or may become) pregnant. Use of olmesartan medoxomil/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 period (see Pregnancy section).

During treatment:

Contact your doctor if you experience any of the following adverse effects:

• Severe, persistent diarrhea causing significant weight loss. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.
• Vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur within hours or weeks after taking olmesartan medoxomil/hydrochlorothiazide. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk.

Children and adolescents (under 18 years of age)

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

Black patients

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

Other medicines and Olmesartán/Hidroclorotiazida Viatris

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:

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

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

• Medicines that increase urine production (diuretics).

• Heparin (a blood thinner).

• Laxatives.

• Steroids.

• Adrenocorticotropic hormone (ACTH).

• Amphotericin (an antifungal medicine).

• 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 toxicity (a medicine used to treat mood disorders and certain types of depression) may increase if taken together with olmesartan medoxomil/hydrochlorothiazide. If you must take lithium, your doctor will monitor lithium levels in your blood.

• Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, aspirin, or diclofenac, used to relieve pain, swelling, and other inflammatory symptoms (including arthritis), may increase the risk of kidney failure and reduce the effect of olmesartan medoxomil/hydrochlorothiazide when used together.

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

• Medicines causing drowsiness, sedatives, and antidepressants, as they may cause a sudden drop in blood pressure upon standing when used with olmesartan medoxomil/hydrochlorothiazide.

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

• Amifostine and other cancer treatments such as cyclophosphamide or methotrexate.

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

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

• Anticholinergic medicines such as atropine and biperiden, used to treat irritable bowel syndrome, asthma, Parkinson’s disease, or other muscle problems.

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• 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 to treat heart problems.

• Medicines such as bepridil, mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, vincamine, 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 medoxomil/hydrochlorothiazide may enhance their blood sugar-raising effect.

• Medicines such as noradrenaline, used to increase blood pressure and reduce 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.

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

• Certain antibiotics known as tetracyclines or sparfloxacin.

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

• Cisapride, used to increase gastrointestinal motility.

• Halofantrine, used to treat malaria.

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

If you are taking an ACE inhibitor or aliskiren (see also information in sections "Do not take Olmesartán/Hidroclorotiazida Viatris" and "Warnings and precautions").

Taking Olmesartán/Hidroclorotiazida Viatris with alcohol

Be cautious when drinking alcohol while taking olmesartan medoxomil/hydrochlorothiazide, as some people may feel weak or dizzy. If this occurs, do not consume alcohol, including wine, beer, or alcoholic beverages.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are (or may become) pregnant. Your doctor will generally advise you to stop taking olmesartan medoxomil/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed and will recommend an alternative medicine. Olmesartan medoxomil/hydrochlorothiazide is not recommended during pregnancy and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby if taken from that point.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of olmesartan medoxomil/hydrochlorothiazide is not recommended during breastfeeding. Your doctor may choose an alternative treatment if you wish to continue breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using 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.

Olmesartán/Hidroclorotiazida Viatris contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".

3. How to take Olmesartán/Hidroclorotiazida Viatris

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Take the tablet with water. If possible, you should take your dose at the same time each day, for example, with breakfast.

If you take more Olmesartán/Hidroclorotiazida Viatris than you should

If you take more tablets than you should, or if a child accidentally ingests one or more tablets, contact a doctor immediately or go to the nearest hospital emergency department and bring the medicine packaging with you. Signs of overdose may include feeling unwell or drowsy, low blood pressure causing weakness or dizziness, changes in heart rate or excessive thirst.

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

If you forget to take Olmesartán/Hidroclorotiazida Viatris

If you forget to take a dose, take your usual dose the next day as normal. Do not take a double dose to make up for forgotten doses.

If you stop taking Olmesartán/Hidroclorotiazida Viatris

It is important to continue taking olmesartan medoxomil/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 experiences them.

If you experience any of the following effects, stop taking olmesartan medoxomil/hydrochlorothiazide and contact your doctor or go immediately to the nearest hospital emergency department:

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

• Allergic reactions that may affect the whole body. Signs include sudden appearance of rash or itching, swelling of the face, lips, mouth, tongue and/or larynx, and difficulty breathing.
• Sudden pain or sensation of tightness, heaviness or pressure in the chest. These may be signs of a heart problem called angina pectoris.
• Severe difficulty breathing, possibly with coughing up blood, increased sweating, anxiety, or pale skin. These may be signs of a lung problem, such as fluid accumulation or inflammation.

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

• Little or no urine output, or pain when urinating, accompanied by back pain, fever, nausea or vomiting, drowsiness, shortness of breath, or general malaise. These may be signs of kidney problems.
• Swelling and pain in the salivary glands.
• Signs of reduced numbers of different blood cells, which may cause pale skin, feeling tired and short of breath, dark urine (reduction in red blood cells), frequent infections with fever, chills, sore throat or mouth ulcers (reduction in white blood cells), bleeding or bruising longer than normal or occurring unexpectedly without injury (reduction in platelets).
• Seizures (convulsions).
• Loss and recovery of consciousness or fainting.
• Difficulty breathing, chest pain, weakness, rapid heartbeat, bluish skin coloration, or sudden pain in arms, legs, or feet (signs that a blood clot may have formed).
• Severe pain in the upper abdomen spreading to the back, possibly with a feeling of malaise. These may be signs of inflammation of the pancreas.
• Yellowing of the skin or the whites of the eyes (jaundice).
• Signs of lupus erythematosus such as skin rash, joint pain, and cold hands and feet. You may have experienced this previously or it may be new to you.
• Severe skin reactions causing painful red spots with peeling and blisters on the skin.

Very rare (may affect up to 1 in 10,000 people):

• Persistent constipation with abdominal pain and vomiting (feeling unwell), which may be signs of intestinal obstruction (paralytic ileus).

Frequency not known (cannot be estimated from available data):

• Vision loss or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• If you develop yellowing of the whites of the eyes, dark urine, or itchy skin, even if you started treatment with olmesartan medoxomil/hydrochlorothiazide some time ago, contact your doctor immediately, who will assess your symptoms and decide how to proceed with your blood pressure treatment.

Olmesartan medoxomil/hydrochlorothiazide may cause a marked drop in blood pressure in susceptible patients or as a result of an allergic reaction. Dizziness or weakness may occur uncommonly. If this happens, stop taking olmesartan medoxomil/hydrochlorothiazide, consult your doctor immediately, and remain lying down in a horizontal position.

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

These are other known adverse effects reported so far with olmesartan medoxomil and hydrochlorothiazide taken simultaneously:

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

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

• Dizziness, weakness, or fatigue.
• Headache.
• Chest pain.
• Swelling of ankles, feet, legs, hands, or arms.

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

• Rapid and strong heartbeat (palpitations).
• Skin rash, eczema.
• Sensation of spinning (vertigo).
• Drowsiness or lethargy.
• Cough.
• Indigestion, abdominal pain, nausea (feeling unwell), vomiting, or diarrhea.
• Muscle cramps or muscle pain.
• Joint pain, arm or leg pain, back pain.
• Problems achieving or maintaining an erection.
• Blood in the urine.

Also observed uncommonly are some changes in blood test results, including:

Increased blood fat levels, increased blood urea or uric acid, increased creatinine, increased or decreased blood potassium levels, increased blood calcium levels, increased blood sugar, increased liver function test values. Your doctor will monitor you with a blood test and will advise you if any action is needed.

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

• General feeling of malaise.
• Red, itchy or painful skin welts (hives or urticaria).

Also observed in rare cases are some changes in blood test results, including:

Increased blood urea nitrogen, decreased hemoglobin and hematocrit values. Your doctor will monitor you with a blood test and will advise you if any action is needed.

Additional adverse effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not with olmesartan medoxomil/hydrochlorothiazide:

Olmesartan medoxomil:

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

• Bronchitis, causing persistent cough, wheezing, and chest tightness.
• Nasal congestion or discharge, sore throat.
• Gastroenteritis, causing diarrhea with abdominal cramps and possibly fever.
• Joint or bone pain.
• Urinary tract infection causing pain or difficulty urinating.
• Flu-like symptoms.
• Pain.

Also observed frequently are some changes in blood test results, including:

Increased levels of substances used to measure muscle function.

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

• Swelling of the face.
• Itching.
• Sudden spreading of a skin rash with blisters or skin redness known as exanthema.

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

• Worsening of kidney function.
• Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea.
• Lack of energy or enthusiasm.

Very rare (may affect up to 1 in 10,000 people):

• Severe persistent diarrhea and significant weight loss.

Hydrochlorothiazide:

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

• Feeling confused.
• Stomach discomfort, bloating, gas, constipation.
• Glucose excretion in urine, which may cause urine to have a sweet smell and will be detected in a urine test.

Also observed are some changes in blood test results, including:

Decreased levels of chloride, magnesium, or sodium in blood, increased serum amylase (hyperamylasemia).

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

• Decreased or loss of appetite.
• Worsening of pre-existing myopia.
• Red spots on the skin (erythema) or skin reactions due to light sensitivity.
• Purple spots or patches under the skin due to small hemorrhages (purpura).

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

• Restlessness, depression, trouble sleeping, feeling of loss of interest (apathy).
• Tingling or numbness.
• Yellowish perception of objects when looking at them, blurred vision, dry eyes.
• Irregular heartbeat.
• Inflammation of blood vessels, causing a skin rash and sometimes blisters on the skin.
• Gallbladder infection, causing severe pain and tenderness in the upper abdomen, with fever.
• Muscle weakness (which sometimes causes difficulty moving).

Very rare (may affect up to 1 in 10,000 people):

• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (cannot be estimated from available data):

• Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 Viatris

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

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the carton and on the blister, after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Olmesartan/Hydrochlorothiazide Viatis

Active substances:

Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

Other components are:

(tablet core) sodium croscarmellose (E466), mannitol (E421), microcrystalline cellulose (E460i), low-substituted hydroxypropylcellulose (E463), anhydrous colloidal silica (E551), magnesium stearate (E572), sodium lauryl sulfate (E487), and

(tablet coating) hypromellose (E464), titanium dioxide (E171), macrogol, talc (E553b). See section 2 "Olmesartan/Hydrochlorothiazide Viatris contains sodium".

Appearance of the product and contents of the pack

Olmesartan/Hydrochlorothiazide Viatris are white, film-coated, round, biconvex tablets with bevelled edges, marked with "M" on one side and "H4" on the other.

Available in blister packs of 14, 28, 30, 56, 90 and 98 tablets, and calendar packs of 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Mylan Hungary Kft.
H-2900, Komárom
Mylan utca 1
Hungary

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: January 2025

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/)