Patient Information Leaflet

Olmesartan/Hydrochlorothiazide Viatris 40 mg/12.5 mg Film-Coated Tablets

olmesartan medoxomil and hydrochlorothiazide

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking 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 additional information

Olmesartán/Hidroclorotiazida Viatris contains two active ingredients, 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 reduces blood pressure by relaxing blood vessels.

·Hidroclorotiazida belongs to a group of medicines called thiazide diuretics. It reduces blood pressure by helping the body to eliminate excess fluids, causing the kidneys to increase urine production.

Your doctor will only give youolmesartán medoxomilo/hidroclorotiazidaif treatment with olmesartán medoxomilo alone has not adequately controlled blood pressure. The combined administration of both active ingredients in this medicine contributes to reducing blood pressure more than each substance administered separately.

You may already be taking medicines to treat high blood pressure, but your doctor may want to give youolmesartán medoxomilo/hidroclorotiazidato lower it further.

High blood pressure can be controlled with medicines like olmesartán medoxomilo/hidroclorotiazida tablets. Your doctor may also have recommended that you make some lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing the amount of salt in your diet). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is essential to follow your doctor's advice.

Do not take Olmesartán/Hidroclorotiazida Viatris:

• If you are allergic to olmesartan medoxomil, to hydrochlorothiazide, to any of the other components of this medication (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 at the beginning of pregnancy - see Pregnancy section).
• If you have 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 moderate or severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, e.g., by gallstones).
• If you have diabetes or kidney insufficiency and receive treatment with a medication to reduce blood pressure that contains aliskiren.

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

Warnings and precautions

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

• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you present shortness of breath or severe difficulty breathing after taking olmesartan medoxomil/hydrochlorothiazide, go to the doctor immediately.
• If you have skin cancer or if an unexpected skin lesion appears during treatment. The treatment with hydrochlorothiazide, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking olmesartan medoxomil/hydrochlorothiazide.
• Renal transplant.
• Liver diseases.
• Heart failure or problems with heart valves or heart muscle.
• Vomiting or diarrhea, of intense or prolonged duration.
• Treatment with high doses of medications that increase urine elimination (diuretics) or if you are following a low-sodium 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 medications 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 the amount of electrolytes (e.g., potassium) in your blood at regular intervals.

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

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

Olmesartan medoxomil/hydrochlorothiazide may cause an increase in the levels of fats and uric acid in the blood.Your doctor will probably want to do a blood test from time to time to control these possible changes.

A change in the levels in the blood of certain chemical substances called electrolytes may occur. Your doctor will probably want to do a blood test from time to time to control this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Inform your doctor if you notice any of these symptoms.

Like any other medication that reduces blood pressure, an excessive decrease in blood pressure in patients with alterations in 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 undergo parathyroid function tests, you should stop taking olmesartan medoxomil/hydrochlorothiazide before doing them.

It is reported to athletes that this medication may establish a doping control analytical result as positive.

Inform your doctor if you think you are (or could be) pregnant.Olmesartan medoxomil/hydrochlorothiazide is not recommended for use at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see Pregnancy section).

During treatment:

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

• Severe, persistent diarrhea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.
• Decreased vision or eye pain. These may be symptoms offluid accumulation in the vascular layer of the eye (choroidal hemorrhage) oran increase in intraocular pressure and may occur a few hours or weeks after taking olmesartan medoxomil/hydrochlorothiazide. If not treated, it may cause permanent vision loss.If you have previously had an allergy to penicillin or sulfonamide, you may have a 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

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

Other medications and Olmesartan/Hidroclorotiazida Viatris

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

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

• Medications that may increase potassium levels in the blood if used at the same time as olmesartan medoxomil/hydrochlorothiazide.These medications are the following:

- Potassium supplements (as well as salt substitutes that contain potassium).

- Diuretics.

- Heparin (to thin the blood).

- Laxatives.

- Steroids.

- Adrenocorticotropic hormone (ACTH).

- Amphotericin, a medication to treat fungal infections.

- Carbenoxolone (medication to treat mouth and stomach ulcers).

- Penicillin G sodium (antibiotic, also called benzylpenicillin sodium).

- Some analgesics such as aspirin or salicylates.

• The toxicity of lithium (medication used to treat mood changes and some types of depression) may increase if taken at the same time as olmesartan medoxomil/hydrochlorothiazide.If you need to take lithium, your doctor will measure the lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medications 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 failure and reduce the effect of olmesartan medoxomil/hydrochlorothiazide.
• Other blood pressure-lowering medications (antihypertensives such as methyldopa), because they may increase the effect of olmesartan medoxomil/hydrochlorothiazide.
• Sedatives, sleep inducers, and antidepressants, because used together with olmesartan medoxomil/hydrochlorothiazide may cause a sudden drop in blood pressure when standing up.
• Baclofen and tubocurarine, muscle relaxants.
• Amifostine and other medications used to treat cancer such as cyclophosphamide or methotrexate.
• Colestiramine and colestipol, medications to reduce blood fat levels.
• Colesevelam hydrochloride, a medication that reduces 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 medications such as atropine and biperiden, used to treat irritable bowel syndrome, asthma, Parkinson's disease, or other muscle problems.
• Medications such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Some medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digital, used in the treatment of heart problems.
• Medications such as bepridil, mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, and vincamine or injectable erythromycin, which may change heart rhythm.
• Oral diabetes medications such as metformin or insulin, used to reduce blood sugar levels.
• Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar, respectively, as olmesartan medoxomil/hydrochlorothiazide may intensify the effect of increasing blood sugar that these medications produce.
• Medications such as noradrenaline, used to increase blood pressure and decrease heart rate.
• Difemanil, used to treat slow heart rate or reduce sweating.
• Medications such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medication.
• Ciclosporin, a medication used to prevent rejection in organ transplants.
• Certain antibiotics called tetracyclines or enoxacin.
• Some antacids, used to treat excess stomach acid such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of olmesartan medoxomil/hydrochlorothiazide.
• Cisapride, used to increase the movement of food in the stomach and intestine.
• 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 (see also the information in the "Do not take Olmesartán/Hidroclorotiazida Viatris" and "Warnings and precautions" sections).

Taking Olmesartán/Hidroclorotiazida Viatris with alcohol

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are (or could be) pregnant. Your doctor will usually recommend that you stop taking olmesartan medoxomil/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of olmesartan medoxomil/hydrochlorothiazide. Olmesartan medoxomil/hydrochlorothiazide is not recommended for use during pregnancy and should not be administered after the third month of pregnancy, as it may cause serious harm to your baby if administered at this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start. Olmesartan medoxomil/hydrochlorothiazide is not recommended for use during breastfeeding. Your doctor may choose another treatment if you want to continue breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

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

Olmesartán/Hidroclorotiazida Viatris contains sodium

This medication contains less than 1 mmolof sodium (23 mg) per tablet; this is, essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 tablet of Olmesartán/Hidroclorotiazida Viatris 40 mg/12.5 mg per day. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartán/Hidroclorotiazida Viatris 40 mg/25 mg per day.

Take the tablet with water. If possible, take your doseat the same time every day, for example, at breakfast time.

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 your doctor immediately or go to the nearest hospital emergency center and bring the medication 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Olmesartán/Hidroclorotiazida 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 the missed doses.

If you interrupt treatment with Olmesartán/Hidroclorotiazida Viatris

It is essential to continue taking olmesartánmedoxomilo/hydrochlorothiazide, unless your doctor tells you to stop treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following side effects, stop takingolmesartan medoxomilo/hidroclorotiazidaand contact your doctor or go to the nearest hospital emergency department immediately:

Rare(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, inflammation of the face, lips, mouth, tongue, and/or larynx, and difficulty breathing.
• Sudden chest pain or sensation of oppression, heaviness, or pressure. These may be signs of a heart problem called angina pectoris.
• Severe breathing difficulties, possibly with coughing up blood, increased sweating, anxiety, or pale skin. These may be signs of a lung problem, such as fluid or inflammation.

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

• Small or no urine output or painful urination, with back pain, fever, nausea, or vomiting, drowsiness, shortness of breath, or general discomfort. These may be signs of kidney problems.
• Inflammation and pain of the salivary glands.
• Signs of decreased numbers of different blood cells, which can cause pale skin, feeling tired, shortness of breath, dark-colored urine (reduced red blood cell count), frequent infections with fever, chills, sore throat, or mouth ulcers (reduced white blood cell count), bleeding or bruising for longer than usual or unexpectedly, even without injury (reduced platelet count).
• Seizures.
• Loss and recovery of consciousness or fainting.
• Difficulty breathing, chest pain, weakness, rapid heart rate, blue discoloration of the skin, or sudden pain in arms, legs, or feet (signs of blood clot formation).
• Intense pain in the upper stomach that extends to the back, possibly with discomfort. These may be signs of pancreatitis inflammation.
• Yellow discoloration of the skin or white part of the eyes (jaundice).
• Signs of lupus erythematosus, such as skin rash, joint pain, and cold hands and fingers. It may have occurred before or be new to you.
• Severe skin reactions, causing painful, red, and blistering skin.

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

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

Unknown frequency(cannot be estimated from available data):

• Decreased vision or eye pain due to high blood pressure (possible signs of fluid accumulation in the eye's vascular layer (choroidal hemorrhage) or acute angle-closure glaucoma).
• If you experience yellow discoloration of the white part of the eyes, dark urine, itching, even if you started treatment with olmesartan medoxomilo/hidroclorotiazida some time ago, contact your doctor immediately, who will evaluate your symptoms and decide how to continue treatment for high blood pressure.

Olmesartan medoxomilo/hidroclorotiazida may cause a significant drop in blood pressure in susceptible patients or as a result of an allergic reaction.Occasionally, dizziness or weakness may occur.If this happens, stop taking olmesartan medoxomilo/hidroclorotiazida, consult your doctor immediately, and remain lying down in a horizontal position.

Olmesartan medoxomilo/hidroclorotiazida is a combination of two active principles, and the following information first describes the side effects reported so far with the combination of olmesartan medoxomilo and hidroclorotiazide (in addition to those mentioned above) and, secondly, the known side effects of the two active principles separately.

These are other side effects known so far with olmesartan medoxomilo and hidroclorotiazide taken simultaneously:

If these effects occur, they are often mild anddo not need to interrupt treatment.

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

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

• Fast and intense heart rate (palpitations).
• Skin rash, eczema.
• Sensation of spinning (dizziness).
• Drowsiness or lethargy.
• Cough.
• Indigestion, abdominal pain, nausea (discomfort), vomiting, or diarrhea.
• Muscle cramps or pain.
• Joint pain, arm or leg pain, back pain.
• Difficulty achieving or maintaining an erection.
• Blood in the urine.

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

Increased levels of blood fat, 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, or increased liver function test values. Your doctor will monitor this through a blood test and tell you if you need to take any action.

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

• General discomfort.
• Red, itchy skin rash (hives or urticaria).

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

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

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

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

Additional side effects reported with the use of olmesartan medoxomilo or hidroclorotiazide alone, but not with olmesartan medoxomilo/hidroclorotiazide:

Olmesartan medoxomilo:

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

• Bronchitis, causing persistent cough, wheezing, and chest tightness.
• Congestion or nasal discharge, sore throat.
• Gastroenteritis, causing diarrhea with abdominal cramps and possibly fever.
• Joint or bone pain.
• Urinary tract infection causing painful or difficult urination.
• Symptoms similar to the flu.
• Pain.

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

Increased levels of substances that measure muscle function.

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

• Swelling of the face.
• Itching.
• Sudden onset of skin rash with blisters or redness of the skin called exanthema.

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

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

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

• Persistent and significant weight loss due to diarrhea.

Hidroclorotiazida:

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

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

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

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

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

• Loss of appetite or decreased appetite.
• Worsening of pre-existing myopia.
• Red skin rash (erythema) or skin reactions 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):

• Anxiety, depression, sleep problems, 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 skin rash and sometimes blisters on the skin.
• Biliary tract infection, causing severe pain and sensitivity to palpation 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 respiratory distress syndrome (signs include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency(cannot be estimated from available data):

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging and on the blister, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Olmesartan/Hydrochlorothiazide Viatris Composition

The active ingredients are:

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

The 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), yellow iron oxide (E172), red iron oxide (E172).See section 2 “Olmesartan/Hydrochlorothiazide Viatris contains sodium”.

Appearance of the product and contents of the package

Olmesartan/Hydrochlorothiazide Viatris are film-coated tablets with a light brown color, oblong, biconvex, with beveled edges, marked with “M” on one face and “H6” on the other.

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

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Or

Mylan Hungary Kft.

H-2900, Komárom

Mylan utca 1

Hungary

Further information on this medicinal product can be obtained by contacting 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 with the following names:

Last review date of this leaflet: April 2023

Further detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(https://www.aemps.gob.es/)