Olmesartan/hydrochlorothiazide Viatris 40 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Olmesartán/Hidroclorotiazida Viatris 40 mg/12.5 mg film-coated tablets EFG

olmesartan medoxomil and hydrochlorothiazide

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 further 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. It could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents

1. What Olmesartán/Hidroclorotiazida Viatris is and what it is used for
2. What you need to know before taking Olmesartán/Hidroclorotiazida Viatris
3. How to take Olmesartán/Hidroclorotiazida Viatris
4. Possible side effects
5. How to store Olmesartán/Hidroclorotiazida 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 prescribed 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 each substance given separately.

You may already be taking medicines to treat high blood pressure, but your doctor may decide to prescribe olmesartán medoxomilo/hidroclorotiazida to achieve further blood pressure reduction.

High blood pressure can be controlled 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 decreasing dietary 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 Viatris

Do not take Olmesartan/Hydrochlorothiazide 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 (it is also best to avoid olmesartan medoxomil/hydrochlorothiazide early in pregnancy – see Pregnancy section).
• If you have 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 moderate or severe liver problems, yellowing of the skin or eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, e.g., 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 apply to you, or you are unsure, do not take the tablets. Speak to your doctor and follow their advice.

Warnings and precautions

Talk to your doctor before taking Olmesartan/Hydrochlorothiazide Viatris if you have any of the following health conditions:

• 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 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.

• Kidney transplant.

• Liver disease.

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

• Severe or prolonged vomiting or diarrhea.

• 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.

Talk to 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 Olmesartan/Hydrochlorothiazide Viatris".

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

Olmesartan medoxomil/hydrochlorothiazide may increase blood levels of fats and uric acid (which causes gout – painful joint swelling). Your doctor may periodically perform blood tests to monitor these potential changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely perform blood tests from time to time 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, or restless, nausea, vomiting, reduced need to urinate, or 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 heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

If you are scheduled for parathyroid function tests, you should 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 could become) pregnant. Use of olmesartan medoxomil/hydrochlorothiazide is not recommended early in pregnancy and must not be taken after the third month of pregnancy, 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 side effects:

• Severe, persistent diarrhea causing significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.
• Decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within hours or weeks of 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.

Patients of Black ethnicity

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

Other medicines and Olmesartan/Hydrochlorothiazide Viatris

Tell 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 the 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 (a medicine used to treat fungal infections).

• 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 some types of depression) may increase when taken with olmesartan medoxomil/hydrochlorothiazide. If you need to take lithium, your doctor will monitor lithium levels in your blood.
  • Non-steroidal anti-inflammatory drugs (NSAIDs, medicines such as ibuprofen, aspirin, or diclofenac, used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with olmesartan medoxomil/hydrochlorothiazide, may increase the risk of kidney failure and reduce the effect of olmesartan medoxomil/hydrochlorothiazide.
  • Other blood pressure-lowering medicines (antihypertensives such as methyldopa), as they may increase the effect of olmesartan medoxomil/hydrochlorothiazide.

• Sleeping pills, sedatives, and antidepressants, as they may cause a sudden drop in blood pressure when standing up 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, as it 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.

• 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, and 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, as 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, as they may slightly reduce the effect of olmesartan medoxomil/hydrochlorothiazide.

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

• 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 (also see information in the sections "Do not take Olmesartan/Hydrochlorothiazide Viatris" and "Warnings and precautions").

Taking Olmesartan/Hydrochlorothiazide Viatris with alcohol

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

Pregnancy and breastfeeding

Pregnancy

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

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.

Olmesartan/Hydrochlorothiazide 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 Olmesartan/Hydrochlorothiazide Viatris

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

The recommended dose is 1 tablet of Olmesartan/Hydrochlorothiazide Viatris 40 mg/12.5 mg once daily. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartan/Hydrochlorothiazide Viatris 40 mg/25 mg once 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 Olmesartan/Hydrochlorothiazide Viatris than you should

If you take more tablets than prescribed 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 an overdose may include feeling unwell or drowsy, low blood pressure causing weakness or dizziness, changes in heart rate or rhythm, or excessive thirst.

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, indicating the medicine and the amount ingested.

If you forget to take Olmesartan/Hydrochlorothiazide 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 missed doses.

If you stop taking Olmesartan/Hydrochlorothiazide Viatris

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

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 gets 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):

• Scant 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-coloured urine (reduced red blood cells), frequent infections with fever, chills, sore throat, or mouth ulcers (reduced white blood cells), bleeding or bruising for longer than normal or unexpectedly without injury (reduced platelets).
• Seizures (fits).
• Loss and recovery of consciousness or fainting.
• Difficulty breathing, chest pain, weakness, rapid heartbeat, bluish skin colour, or sudden pain in arms, legs, or feet (signs that a blood clot may have formed).
• Severe pain in the upper stomach spreading to the back, possibly with feeling unwell. These may be signs of inflammation of the pancreas.
• Yellowing of the skin or whites of the eyes (jaundice).
• Signs of systemic lupus erythematosus such as skin rash, joint pain, and cold hands and feet. You may have experienced this before or it may be new to you.
• Serious 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 experience yellowing of the whites of the eyes, dark urine, or itchy skin, even if you started treatment with olmesartan medoxomil/hydrochlorothiazide a long time ago, contact your doctor immediately, who will assess your symptoms and decide how to continue 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):

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

Some changes in blood test results have also been observed uncommonly, including:

Increased levels of blood fats, 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).

Some changes in blood tests have also been observed rarely, including:

Increased blood urea nitrogen, decreased haemoglobin and haematocrit 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 diarrhoea with abdominal cramps and possibly fever.
• Joint or bone pain.
• Urinary tract infection causing pain or difficulty urinating.
• Flu-like symptoms.
• Pain.

Some changes in blood test results have also been observed frequently, 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 diarrhoea.
• Lack of energy or enthusiasm.

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

• Severe persistent diarrhoea and significant weight loss.

Hydrochlorothiazide:

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

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

Some changes in blood test results have also been observed, including:

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

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 bleedings (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 may sometimes cause 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 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 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 stated on the carton and on the blister pack, 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 are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Hydrochlorothiazide Viatris

The active substances are:

Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

The other components are:

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

(tablet coating) hypromellose (E464), titanium dioxide (E171), macrogol, talc (E553b), yellow iron oxide (E172), red iron oxide (E172). See section 2, “Olmesartan/Hydrochlorothiazide Viatris contains sodium”.

Appearance of the product and contents of the pack

Olmesartan/Hydrochlorothiazide Viatris are light brown, film-coated, oblong, biconvex tablets with bevelled edges, marked with "M" on one side and "H6" on the other.

Available in blister packs containing 14, 28, 30, 56, 90 and 98 tablets, and calendar packs containing 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 medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

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

Date of the most recent review of this leaflet: January 2025

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