OLMESARTAN/HYDROCHLOROTHIAZIDE VIATRIS 20 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Olmesartan/Hydrochlorothiazide Viatris 20 mg/12.5 mg Film-Coated Tablets EFG

olmesartan medoxomil and hydrochlorothiazide

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

• Keep this leaflet, 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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Olmesartan/Hydrochlorothiazide Viatris is and what it is used for

Olmesartan/Hydrochlorothiazide Viatris contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used to treat high blood pressure (hypertension):

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body get rid of excess fluid, so the kidneys increase urine production.

You will only be given olmesartan medoxomil/hydrochlorothiazide if treatment with olmesartan medoxomil alone has not controlled your blood pressure adequately. The combination of both active substances in this medicine 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 want to give you olmesartan/hydrochlorothiazide to lower it further.

High blood pressure can be controlled with medicines such as olmesartan medoxomil/hydrochlorothiazide tablets. Your doctor will probably also have advised you to make some changes to your lifestyle to help lower your blood pressure (e.g. lose weight, stop smoking, reduce alcohol intake and reduce the amount of salt in your diet). Your doctor may also have advised you to take regular exercise, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before you take Olmesartan/Hydrochlorothiazide Viatris

Do not take Olmesartan/Hydrochlorothiazide Viatris:

• If you are allergic to olmesartan medoxomil, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6) or to medicines similar to hydrochlorothiazide (sulfonamides).
• If you are more than 3 months pregnant (it is also better to avoid olmesartan medoxomil/hydrochlorothiazide at the start of pregnancy - see section Pregnancy).
• If you have severe kidney problems.
• If you have low levels of potassium, sodium, or 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 or yellowing of the skin and eyes (jaundice) or problems with the drainage of bile from the gallbladder (bile duct obstruction, e.g. due to gallstones).
• If you have diabetes or kidney problems and are treated with a medicine that lowers blood pressure and contains aliskiren.

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

Warnings and precautions

Consult your doctorbefore starting to take Olmesartan/Hydrochlorothiazide Viatris if you have any of the following health problems:

• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking olmesartan medoxomil/hydrochlorothiazide, see your doctor immediately.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking olmesartan medoxomil/hydrochlorothiazide.
• Mild to moderate kidney problems or if you have recently had a kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Vomiting or diarrhea, intense or prolonged for several days.
• Treatment with high doses of diuretics (medicines that increase urine production) or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g. primary hyperaldosteronism).
• Diabetes.
• Systemic lupus erythematosus (an autoimmune disease).
• Allergy or asthma.
• If you are taking any of the following medicines to treat high blood pressure:

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

Your doctor may check your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals.

Also, see the information in the "Do not take Olmesartan/Hydrochlorothiazide Viatris" section.

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

Olmesartan medoxomil/hydrochlorothiazide may cause an increase in blood fat and uric acid levels (which can cause gout - painful swelling of the joints). Your doctor will probably want to perform a blood test from time to time to check for these possible changes.

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will probably want to perform a blood test from time to time to check for this possible change. Some signs of electrolyte changes are: thirst, dry mouth, pain or muscle cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, tiredness, drowsiness or restlessness, nausea, vomiting, decreased 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 cause a heart attack or stroke. Therefore, your doctor will closely monitor your blood pressure.

If you are scheduled to have parathyroid function tests, you should stop taking olmesartan medoxomil/hydrochlorothiazide before the tests are performed.

Athletes are informed that this medicine may give a positive result in doping control tests.

You must inform your doctor if you think you are (or might become) pregnant. Olmesartan medoxomil/hydrochlorothiazide is not recommended during 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 after this point (see section Pregnancy).

During treatment:

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

• Severe diarrhea, persistent and 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 a few hours or weeks after taking olmesartan medoxomil/hydrochlorothiazide. If left untreated, it can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing it.

Children and adolescents (under 18 years)

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

Black patients

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

Other medicines and Olmesartan/Hydrochlorothiazide Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 if used at the same time as olmesartan medoxomil/hydrochlorothiazide. These medicines are:

• Potassium supplements (including salt substitutes that contain potassium).
• Diuretics (medicines that increase urine production).
• Heparin (to thin the blood).
• Laxatives.
• Corticosteroids.
• 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 called benzylpenicillin sodium).
• Certain pain relievers such as aspirin or salicylates.
  • The toxicity of lithium (a medicine used to treat mood changes and some types of depression) may increase if taken at the same time as olmesartan medoxomil/hydrochlorothiazide. If you have to take lithium, your doctor will measure lithium levels in your blood.

• Non-steroidal anti-inflammatory medicines (NSAIDs, such as ibuprofen, aspirin, or diclofenac, used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as olmesartan medoxomil/hydrochlorothiazide, may increase the risk of kidney problems 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.
• Sedatives, sleeping pills, and antidepressants, as they may cause a sudden drop in blood pressure when standing up, used with olmesartan medoxomil/hydrochlorothiazide.
• Certain muscle relaxants such as baclofen and tubocurarine.
• Amifostine and other cancer medicines such as cyclophosphamide or methotrexate.
• Cholestyramine and colestipol, medicines used to lower blood fat levels.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, 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.
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• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, ciamemazine, 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 erythromycin injections, which can change the 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 levels, respectively, as olmesartan medoxomil/hydrochlorothiazide may enhance the blood sugar-increasing effect of these medicines.
• Medicines such as noradrenaline, used to increase blood pressure and decrease heart rate.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medicine.
• Cyclosporine, a medicine used to prevent organ rejection in transplants.
• Certain antibiotics called tetracyclines or sparfloxacin.
• Certain antacids, used to treat stomach acid excess, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of olmesartan medoxomil/hydrochlorothiazide.
• Cisapride, used to increase food movement in the stomach and intestines.
• Halofantrine, used to treat malaria.

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

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

Taking Olmesartan/Hydrochlorothiazide Viatris with alcohol

Be careful when drinking alcohol while taking olmesartan medoxomil/hydrochlorothiazide, as some people feel weak or dizzy. If this happens to you, do not drink any alcohol, including wine, beer, or alcoholic drinks.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are (or might become) pregnant or plan to become pregnant. Your doctor will generally advise you to stop taking olmesartan medoxomil/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will recommend that you take a different medicine instead of olmesartan medoxomil/hydrochlorothiazide. Olmesartan medoxomil/hydrochlorothiazide is not recommended during pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after this point.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan medoxomil/hydrochlorothiazide is not recommended during breastfeeding. Your doctor may choose a different treatment if you want 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 happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

Olmesartan/Hydrochlorothiazide Viatris contains sodium

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

3. How to take Olmesartan/Hydrochlorothiazide Viatris

Follow exactly the instructions for taking this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one Olmesartan/Hydrochlorothiazide Viatris 20 mg/12.5 mg tablet per day. If your blood pressure is not adequately controlled, your doctor may change your dose to one Olmesartan/Hydrochlorothiazide Viatris 20 mg/25 mg tablet per day.

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

If you take more Olmesartan/Hydrochlorothiazide Viatris than you should

If you take more tablets than you should or if a child accidentally swallows one or more tablets, contact a doctor or go to the nearest hospital emergency department immediately and take the medicine pack 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Olmesartan/Hydrochlorothiazide Viatris

If you forget to take a dose, take your usual dose the next day as usual. Do nottake a double dose to make up for forgotten 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 all people suffer from them.

If you experience any of the following effects, stop takingolmesartanmedoxomil/hydrochlorothiazideand contact your doctor or go to the emergency center of the nearest hospital immediately:

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

• Allergic reactions that can affect the whole body. The signs are sudden onset of skin rash or itching, swelling of the face, lips, mouth, tongue, and/or larynx, and difficulty breathing.
• Pain or feeling of oppression, heaviness, or pressure in the chest. These may be signs of a heart problem called angina pectoris.
• Severe breathing difficulties, possibly with coughing up blood, increased sweating, anxiety, or paleness of the 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 while urinating, with back pain, fever, nausea, or vomiting, drowsiness, shortness of breath, or general malaise. These may be signs of kidney problems.
• Inflammation and pain of the salivary glands.
• Signs of decreased number of different blood cells, which can cause paleness of the skin, feeling of tiredness, and shortness of breath, dark-colored urine (reduction of red blood cells), frequent infections with fever, chills, sore throat, or mouth ulcers (reduction of white blood cells), bleeding or bruising for longer than usual or unexpectedly, even without injury (reduction of platelets).
• Seizures (convulsions).
• Loss and recovery of consciousness or fainting.
• Difficulty breathing, chest pain, weakness, increased heart rate, bluish discoloration of the skin, or sudden pain in arms or legs or feet (signs that a blood clot may have formed).
• Severe pain in the upper abdomen that radiates to the back, possibly with a feeling of discomfort. These may be signs of pancreatitis.
• Yellowish discoloration of the skin or the white part of the eyes (jaundice).
• Signs of lupus erythematosus, such as skin rash, joint pain, and cold hands and fingers. You may have experienced this before or it may be new to you.
• Severe skin reactions that cause red, painful patches 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 of discomfort), which may be signs of intestinal obstruction (paralytic ileus).

Frequency Not Known(cannot be estimated from the available data):

• Decreased vision or eye pain due to high blood 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, itching of the 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 treatment for high blood pressure.

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

Olmesartan medoxomil/hydrochlorothiazide is a combination of two active ingredients, and the following information describes the adverse effects reported so far with the combination of olmesartan medoxomil and hydrochlorothiazide (in addition to those already mentioned) and the adverse effects known for each active ingredient 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 it is not necessary to interrupt 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 intense heartbeat (palpitations).
• Skin rash, eczema.
• Feeling of spinning (vertigo).
• Drowsiness or lethargy.
• Cough.
• Indigestion, abdominal pain, nausea (feeling of discomfort), vomiting, or diarrhea.
• Cramps or muscle pain.
• Pain in joints, arms, or legs, back pain.
• Difficulty achieving or maintaining an erection.
• Blood in the urine.

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

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased creatinine, increased or decreased potassium levels in the blood, increased calcium levels in the blood, increased blood sugar, increased liver function test values. Your doctor will monitor you with a blood test and tell you if you need to take any action.

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

• General feeling of discomfort.
• Red, itchy, or painful skin rashes (hives or urticaria).

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

Increased blood urea nitrogen, decreased hemoglobin, and hematocrit values. Your doctor will monitor you with a blood test and tell you if you need to take any action.

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, which causes persistent cough, wheezing, and chest tightness.
• Nasal congestion or secretion, sore throat.
• Gastroenteritis, which causes diarrhea with abdominal cramps and possibly fever.
• Pain in the joints or bones.
• Urinary tract infection, which causes pain or difficulty urinating.
• Flu-like symptoms.
• Pain.

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

Increased levels of substances that measure muscle function.

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

• Facial swelling.
• Itching.
• Sudden onset of a skin rash with blisters or redness of the skin, called exanthema.

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

• Renal function impairment.
• Lack of energy or enthusiasm.

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

• Persistent and severe diarrhea with significant weight loss.

Hydrochlorothiazide:

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

• Feeling of confusion.
• Stomach discomfort, feeling of bloating, gas, constipation.
• Glucose in the urine, which can make the urine smell sweet and will be detected in a urine test.

Also, some changes in blood test results have been observed, including:

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

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

• Decreased or lost 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, sleep problems, feeling of loss of interest (apathy).
• Numbness or tingling.
• Yellowish perception of objects when looking at them, blurred vision, dry eyes.
• Irregular heartbeat.
• Inflammation of blood vessels, which causes a skin rash and sometimes blisters on the skin.
• Infection in the gallbladder, which causes severe pain and tenderness to the touch in the upper abdomen, with fever.
• Muscle weakness (which can sometimes cause difficulty moving).

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

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

Frequency Not Known(cannot be estimated from the 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 that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date shown on the carton and blister, after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Olmesartan/Hydrochlorothiazide Viatris

The active ingredients are:

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

The other ingredients 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 Package Contents

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

They are available in blister packs of 14, 28, 30, 56, 90, and 98 tablets and calendar packs of 28 tablets.

Not all 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

You can request more information about this medicine by contacting 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 Last Revision of this Leaflet:September 2024

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