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

2. What you need to know before taking Olmesartan/Hydrochlorothiazide Teva

Do not take Olmesartan/Hydrochlorothiazide Teva:

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

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

Warnings and precautions

Consult your doctor before starting to take this medication.

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

• a converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may want to check your kidney function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartan/Hydrochlorothiazide Teva”.

Before taking the tablets, tell your doctorif you have any of the following health problems:

• Liver disease
• Heart failure or problems with heart valves or heart muscle
• Vomiting (nausea) or diarrhea, which is severe or prolonged for several days
• Treatment with high doses of medications that increase urine production (diuretics), or if you are on a low-salt diet
• Problems with the adrenal glands (such as primary hyperaldosteronism)
• Diabetes
• Lupus erythematosus (an autoimmune disease)
• Allergy or asthma
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 and UV exposure while taking this medication
• 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 this medication, seek medical attention immediately.
• Mild to moderate kidney problems or if you have recently had a kidney transplant.

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

• severe, persistent diarrhea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.
• blurred vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from a few hours to a few weeks after taking this medication. This can lead to permanent vision impairment if left untreated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it.

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking this medication. Your doctor will decide on the treatment to follow. Do not stop taking this medication on your own.

This medication may cause an increase in blood fat and uric acid levels (which can cause gout - painful swelling of the joints). Your doctor will likely want to perform a blood test from time to time to monitor these possible changes.

A change in blood electrolyte levels may occur. Your doctor will likely want to perform a blood test from time to time to monitor this possible change. Some signs of electrolyte changes are: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling of weakness, slowness, fatigue, 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 medication that lowers blood pressure, excessive blood pressure reduction in patients with altered blood flow to the heart or brain may cause a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are going to have parathyroid function tests, you should stop taking this medication before these tests are performed.

You must inform your doctor if you are pregnant or think you may be pregnant. This medication is not recommended during pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage (see section Pregnancy).

Children and adolescents

This medication is not recommended for children and adolescents under 18 years of age.

Other medications and Olmesartan/Hydrochlorothiazide Teva

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

In particular, tell your doctor or pharmacist about any of the following medications:

• Other blood pressure-lowering medications (antihypertensives), as they may increase the effect of this medication.
• Your doctor may need to adjust your dose and/or take other precautions:
• If you are taking a converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Olmesartan/Hydrochlorothiazide Teva” and “Warnings and precautions”).
• Medications that may alter potassium levels in the blood if used at the same time as this medication. These include:
• potassium supplements (as well as salt substitutes that contain potassium).
• medications that increase urine production (diuretics).
• heparin (to thin the blood).
• laxatives.
• corticosteroids.
• adrenocorticotropic hormone (ACTH).
• carbenoxolone (medication for the treatment of mouth and stomach ulcers).
• sodium penicillin G (antibiotic also called benzylpenicillin sodium).
• certain pain relievers such as aspirin or salicylates
• Lithium (medication used to treat mood changes and some types of depression) if used at the same time as this medication may increase its toxicity. If you need to take lithium, your doctor will measure lithium levels in your blood
• Non-steroidal anti-inflammatory medications (NSAIDs) (medications used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as this medication may increase the risk of kidney failure and reduce the effect of olmesartan/hydrochlorothiazide
• Sedatives, hypnotics, and antidepressants, used with this medication may cause a sudden drop in blood pressure when standing.
• Certain medications such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other medications used for cancer treatment, such as cyclophosphamide or methotrexate.
• Cholestyramine and colestipol, medications to lower blood fat levels
• Colesevelam hydrochloride, a medication that lowers blood cholesterol levels, as it may reduce the effect of this medication. Your doctor may advise you to take Olmesartan/Hydrochlorothiazide Teva at least 4 hours before colestipol hydrochloride.
• Anticholinergic medications, such as atropine and biperiden.
• Medications such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultoprida, tiaprida, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Certain medications such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used in the treatment of heart problems.
• Medications such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injectables, which may alter heart rhythm.
• Oral antidiabetic medications, such as metformin, or insulin, used to lower blood sugar levels.
• Beta-blockers and diazoxide, medications used to treat high blood pressure or low blood sugar levels, respectively, as this medication may enhance the blood sugar-increasing effect of these medications.
• Methyldopa, a medication used to treat high blood pressure.
• Medications such as noradrenaline, used to increase blood pressure and reduce 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.
• Cyclosporine, a medication used to prevent organ transplant rejection.
• Antibiotics of the tetracycline group or esparfloxacine.
• Amphotericin, a medication used to treat fungal infections.
• Certain antacids, used to treat stomach acid excess, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of this medication
• Cisapride, used to increase food movement in the stomach and intestine
• Halofantrine, used to treat malaria.

Taking Olmesartan/Hydrochlorothiazide Teva with food, drinks, and alcohol

Olmesartan/Hydrochlorothiazide Teva can be taken with or without food.

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

Black patients

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

Pregnancy and breastfeeding

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

Pregnancy

You must inform your doctor if you are pregnant (or think you may be pregnant). Your doctor will generally advise you to stop taking this medication before becoming pregnant or as soon as you know you are pregnant, and will recommend that you take another medication instead of Olmesartan/Hydrochlorothiazide Teva. This medication is not recommended during pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if taken at this stage.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. This medication is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

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.

Use in athletes

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

Olmesartan/Hydrochlorothiazide Teva contains lactose and orange yellow S

Lactose: If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

Orange yellow S: May cause allergic reactions.

3. How to take Olmesartan/Hydrochlorothiazide Teva

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist.

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

Swallow the tablet with water. Do not chew, crush, or break it. If possible, take your dose at the same time each day, for example, at breakfast time. It is essential to continue taking this medication until your doctor tells you to stop.

If you take more Olmesartan/Hydrochlorothiazide Teva than you should

If you take more tablets than you should or if a child accidentally ingests one or more tablets, contact your doctor or go to the emergency department of the nearest hospital immediately and bring the medication packaging with you.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Olmesartan/Hydrochlorothiazide Teva

If you forget to take a dose, take your usual dose the next day. Do nottake a double dose to make up for missed doses.

If you stop taking Olmesartan/Hydrochlorothiazide Teva

It is essential to continue taking this medication unless your doctor tells you to stop.

If you have any further questions about the use of this medication, 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.

However, the following adverse effects can be serious:

• In rare cases, allergic reactions can occur that can affect the whole body, with inflammation of the face, mouth, and/or larynx, along with itching and skin rash. If this happens to you, stop taking Olmesartan/Hydrochlorothiazide Teva and consult your doctor immediately.

• This medicine can cause a pronounced drop in blood pressure, in susceptible patients or as a result of an allergic reaction. Dizziness or fainting can occur infrequently. If this happens to you, stop taking Olmesartan/Hydrochlorothiazide Teva, consult your doctor immediately, and remain lying down in a horizontal position.

• Unknown frequency: if you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started treatment with this medicine a long time ago, contact your doctor immediatelyso that they can assess your symptoms and decide how to continue with blood pressure treatment.

This medicine is a combination of two active ingredients. The following information, first, describes the adverse effects reported so far with the combination of olmesartan medoxomil and hydrochlorothiazide (in addition to those already mentioned) and, second, the adverse effects known from the two active ingredients separately.

These are otheradverse effects known so far with olmesartan/hydrochlorothiazide:

If these adverse effects occur, they are often mild and it is not necessary to interrupt treatment.

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

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

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

Somnolence, rapid and intense heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, and muscle pain, joint pain, arm and leg pain, back pain, erection problems in men, blood in urine.

Some changes in blood tests have also 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 adverse effects (may affect up to 1 in 1,000 people):

Feeling of discomfort, alterations in consciousness, skin lumps (hives), acute kidney failure.

Some changes in blood test results have also been observed rarely, 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 the combination of olmesartan/hydrochlorothiazide or at a higher frequency:

Olmesartan medoxomil:

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

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

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

Increased levels of fat in the blood, increased urea or uric acid in the blood, increased liver or muscle function test values.

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

Rapid allergic reactions that can affect the whole body and can cause breathing problems, as well as a rapid drop in blood pressure that can lead to fainting (anaphylactic reactions), facial inflammation, angina (chest pain or discomfort known as angina pectoris), feeling of discomfort, allergic skin rash, itching, exanthema (skin rash), skin lumps (hives).

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

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

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

Worsening of kidney function, lack of energy.

Intestinal angioedema: intestinal inflammation that manifests with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

Increased potassium levels in the blood.

Hydrochlorothiazide:

Very common adverse effects (may affect more than 1 in 10 people):

Changes in blood tests, including: increased fat and uric acid levels in the blood.

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

Feeling of confusion, abdominal pain, stomach discomfort, feeling of bloating, diarrhea, nausea, vomiting, constipation, glucose in urine.

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

Increased creatinine, urea, calcium, and blood sugar levels, decreased chloride, potassium, magnesium, and sodium levels in the blood. Increased serum amylase (hyperamylasemia).

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

Decreased or lost appetite, severe breathing difficulties, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions due to light sensitivity, itching, purple spots or patches on the skin due to small hemorrhages (purpura), skin lumps (hives).

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

Inflammation and pain of the salivary glands, decreased number of white blood cells, decreased number of platelets in the blood, anemia, bone marrow damage, restlessness, feeling "depressed" or depressed, sleep problems, loss of interest (apathy), tingling and numbness, seizures (convulsions), yellowish perception of objects when looking at them, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, infection in the gallbladder, symptoms of lupus erythematosus (such as skin rash, joint pain, and cold hands and fingers), allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which can sometimes cause movement disorders).

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

Electrolyte imbalance that can cause an abnormally reduced level of chloride in the blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus).

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

Unknown adverse effects (frequency cannot be estimated from available data):

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

Decreased vision 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).

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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 Teva

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the box or blister after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the containers and medicines you no longer need in the SIGRE point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Olmesartan/Hydrochlorothiazide Teva

• The active ingredients are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
• The other ingredients are:

Core of the tablet:Lactose monohydrate, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, microcrystalline cellulose Type 102, magnesium stearate

Coating of the tablet:Opadry II Orange 33G23991 which contains: hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin (E1518), yellow iron oxide (E172), red iron oxide (E172), orange yellow S (E110)

Appearance of the Product and Package Contents

Olmesartan/Hydrochlorothiazide Teva 20 mg/12.5 mg are film-coated tablets of orange color, round, biconvex, 8.5 mm in diameter, and with OH 21 engraved on one side.

Package Sizes

Blister packs (Al-Al): 14, 28, 30, 56, 98 film-coated tablets.

Calendar blister packs (Al-Al): 28 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Manufacturer

Actavis Ltd.

BLB016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Teva Pharma S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid (Spain)

Date of the last revision of thisprospectus:December 2021

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86786/P_86786.html

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