Leaflet:information for the user

Olmesartan/Hydrochlorothiazide Teva 40 mg/12.5 mg film-coated tablets

Olmesartan medoxomil/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 yourdoctororpharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Olmesartan/Hydrochlorothiazide Teva

4.Possible side effects

5.Storage of Olmesartan/Hydrochlorothiazide Teva

6.Contents of the pack and additional information

This medicine 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 contributing to the elimination of excess fluids, increasing urine production by the kidneys.

This medicine will only be given to you if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The combined administration of both active ingredients in this medicine contributes to reducing blood pressure more than if each active ingredient were administered alone.

You may already be taking medicines to treat high blood pressure, but your doctor may believe it necessary for you to take this medicine to lower it further.

High blood pressure can be controlled with medicines like this. 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 Teva:

• if you are allergic to olmesartan medoxomil or to 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 more than 3 months pregnant (It is also best to avoid this medication at the beginning of pregnancy - see Pregnancy section).
• if you have low levels of potassium or sodium in your blood, 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 diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren
• if you have kidney problems
• if you have liver problems, moderate or severe, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example, by gallstones).

If you think you have any of these cases, 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 doctor if you are taking any of the following medications used to treat high blood pressure (hypertension):

• a converting enzyme inhibitor (ACE inhibitor) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

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

See also the information under the heading “Do not take Olmesartán/Hidroclorotiazida Teva”.

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

• liver disease
• heart failure or problems with heart valves or heart muscle
• severe or prolonged vomiting (nausea) or diarrhea
• 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 (for example, 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. The treatment with hydrochlorothiazide, particularly 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 rays while taking this medication
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking this medication, seek medical attention immediately.
• kidney transplant.

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

• severe, persistent diarrhea that causes significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your treatment for high blood pressure.
• decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased pressure in the eye and may occur from a few hours to several weeks after taking this medication. This can lead to permanent vision loss if not treated. 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 further treatment. Do not stop taking this medication on your own.

This medication may cause an increase in levels of fats and uric acid (which causes gout – painful swelling of the joints) in the blood. Your doctor will probably want to perform blood tests from time to time to monitor these possible changes.

You may experience a change in blood levels of certain chemical substances called electrolytes. Your doctor will probably want to perform blood tests 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 weak, slow, tired, drowsy, or restless, nausea, vomiting, decreased need to urinate, rapid heart rate.Tell your doctor if you notice any of these symptoms.

Like any other medication that lowers blood pressure, an excessive decrease in blood pressure in patients with impaired 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 to undergo parathyroid function tests, you should stop taking this medication before the tests are performed.

You should inform your doctor if you are pregnant or think you may be pregnant. This medication is not recommended for use at the beginning of pregnancy, and it 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).

Children and adolescents

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

Other medications and Olmesartán/Hidroclorotiazida Teva

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:

• other blood pressure-lowering medications (anti-hypertensives), 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 an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Olmesartán/Hidroclorotiazida 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 containing potassium).
• diuretics.
• heparin (to thin the blood).
• laxatives.
• steroids.
• adrenocorticotropic hormone (ACTH).
• carbenoxolone (medication for the treatment of mouth and stomach ulcers).
• penicillin G sodium (antibiotic also called benzylpenicillin sodium).
• some analgesics such as aspirin or salicylates
• lithium (medication used to treat mood changes and certain types of depression) if used at the same time as this medication may increase toxicity. If you need to take lithium, your doctor will measure lithium levels in the blood
• non-steroidal anti-inflammatory drugs (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
• sleep-inducing medications, sedatives, and antidepressants, used with this medication may cause a sudden drop in blood pressure when standing up.
• Some medications such as baclofen and tubocurarine, used as muscle relaxants.
• amifostine and other medications used for cancer treatment, such as cyclophosphamide or methotrexate.
• colestiramine and colestipol, medications to reduce fat levels in the blood
• colesevelam hydrochloride, a medication that reduces cholesterol levels in the blood, as it may reduce the effect of this medication. Your doctor may advise you to take Olmesartán/Hidroclorotiazida Teva at least 4 hours before colesevelam hydrochloride.
• anticholinergic medications, such as atropine and biperiden.
• 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 mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or erythromycin injectables, that may change heart rhythm.
• oral diabetes medications, such as metformin, or insulin, used to reduce blood sugar levels.
• beta-blockers and diazoxide, medications used in the treatment of high blood pressure or low blood sugar, respectively, as this medication may intensify the effect of increasing blood sugar that these medications produce.
• metildopa, a medication used to treat high blood pressure.
• Medications such as noradrenaline, used to increase blood pressure and reduce heart rate.
• difenamilo, used to treat slow heart rate or reduce sweating.
• Medications such as probenecid, sulfinpyrazone, and allopurinol, used in the treatment of gout.
• calcium supplements.
• amantadine, an antiviral medication.
• ciclosporin, a medication used to prevent organ transplant rejection.
• antibiotics of the tetracycline group, or ciprofloxacin.
• amphotericin, a medication used in the treatment of fungal infections.
• Some antacids, used in the treatment of excess stomach acid, such as aluminum hydroxide and magnesium, as they may slightly reduce the effect of this medication
• cisaprida, used to increase the movement of food in the stomach and intestine
• halofantrina, used for malaria.

Taking Olmesartán/Hidroclorotiazida Teva with food, drinks, and alcohol

Olmesartán/Hidroclorotiazida Teva can be taken with or without food.

Be careful when drinking alcohol while taking this medication, as some people may feel weak or dizzy. If this happens, do not drink any alcohol, including wine, beer, or alcoholic beverages.

Black patients

Like 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, consult your doctor before using this medication.

Pregnancy

You should inform your doctor if you are pregnant, (or if you suspect you may be). Your doctor will usually recommend that you 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 Olmesartán/Hidroclorotiazida Teva. This medication is not recommended for use during pregnancy, and in any case, it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby if taken at this stage (see Pregnancy section).

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. This medication is not recommended for use 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 taking this medication for high blood pressure. If this happens, do not drive or use machines until the symptoms have disappeared. Consult your doctor.

Use in athletes

Inform athletes that this medication contains a component (hydrochlorothiazide) that may result in a positive analytical result for doping control.

Olmesartán/Hidroclorotiazida Teva contains lactose and yellow iron oxide

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

Yellow iron oxide: May cause allergic reactions.

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

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

Swallow the tablet with water. Do not bite, chew, or break it. If possible, take your dose at the same time every 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 Olmesartán/Hidroclorotiazida 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 immediately or go to the nearest hospital emergency center and bring the medication packaging with you.

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

If you forget to take Olmesartán/Hidroclorotiazida Teva

If you forget to take a dose, take the usual dose the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Olmesartán/Hidroclorotiazida Teva

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

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

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

However, the following side effects can be serious:

• In rare cases, an allergic reaction 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, stop taking Olmesartán/Hidroclorotiazida Teva and consult your doctor immediately.

• This medicine can cause a significant drop in blood pressure in susceptible patients or as a result of an allergic reaction. Less frequently, dizziness or fainting can occur.If this happens, stop taking Olmesartán/Hidroclorotiazida Teva, consult your doctor immediately, and remain lying down in a horizontal position.

• Frequency unknown: if you experience yellowing of the whites of the eyes, dark urine, itching on the skin, even if you started treatment with this medicine some time ago,contact your doctor immediatelyso that they can evaluate your symptoms and decide how to continue with the treatment for high blood pressure.

This medicine is a combination of two active principles. The following information, first, describes the side effects reported so far with the combination of olmesartán medoxomilo and hidroclorotiazida (in addition to those already mentioned) and, second, the known side effects of the two active principles separately.

These are otherknown side effects so far with olmesartán/hidroclorotiazida:

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

Frequent side effects (can affect up to 1 in 10 people):

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

Rare side effects (can affect up to 1 in 100 people):

Drowsiness, rapid and intense heart palpitations, hives, eczema, dizziness, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, and muscle pain, joint pain, arm and leg pain, back pain, erectile dysfunction in men, blood in urine.

Also, some changes in blood tests have been observed, including:

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

Rare side effects (can affect up to 1 in 1,000 people):

Unpleasant sensation, alterations in consciousness, skin nodules (hives), acute renal insufficiency.

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

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

Additional side effects reported with the use of olmesartán medoxomilo or hidroclorotiazida alone, but not with the combination of olmesartán/hidroclorotiazida or in a higher frequency:

Olmesartán medoxomilo:

Frequent side effects (can affect up to 1 in 10 people):

Bronchitis, cough, congestion or nasal 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.

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

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

Rare side effects (can affect up to 1 in 100 people):

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

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

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

Rare side effects (can affect up to 1 in 1,000 people):

Renal function deterioration, lack of energy.

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

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

Increased potassium levels in the blood.

Hidroclorotiazida:

Very frequent side effects (can affect more than 1 in 10 people):

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

Frequent side effects (can affect up to 1 in 10 people):

Confusion, abdominal pain, stomach discomfort, feeling of swelling, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.

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

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

Rare side effects (can affect up to 1 in 100 people):

Loss of appetite, severe difficulty breathing, skin allergic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light sensitivity reactions, itching, purple spots on the skin due to small hemorrhages (purpura), skin nodules (hives).

Rare side effects (can affect up to 1 in 1,000 people):

Salivary gland inflammation and pain, decreased white blood cell count, decreased platelet count in the blood, anemia, bone marrow damage, restlessness, feeling "down" or depressed, difficulty sleeping, loss of interest (apathy), tingling and numbness, seizures, 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, biliary tract infection, symptoms of lupus erythematosus (such as skin rash, joint pain, and cold hands and feet), skin allergic reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement alteration).

Very rare side effects (can affect up to 1 in 10,000 people):

Electrolyte imbalance that can cause abnormally low chloride levels in the blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus).

Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

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

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

Decreased vision or eye pain due to high blood pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).

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 theSpanish 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.

Keepthis medicationout of the sight and reach of children.

This medication does not require special conditions for conservation.

Do not usethis medicationafter the expiration date that appears onthe box or blisterafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, please ask your pharmacisthow to dispose ofthepackaging and of themedications you no longerneed. By doing so, you will help protect the environment.

Composition of Olmesartán/Hidroclorotiazida Teva

• The active principles are olmesartán medoxomilo and hidroclorotiazida. Each tablet contains 40 mg of olmesartán medoxomilo and 12.5 mg of hidroclorotiazida.
• The other components are:

Tablet core:Lactose monohydrate,low-substituted hydroxypropylcellulose, hydroxypropylcellulose, microcrystalline cellulose Type 102, magnesium stearate

Tablet coating:Opadry II Orange 33G23991 containing: hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin (E1518), yellow iron oxide (E172), red iron oxide (E172), yellow-orange S (E110)

Product appearance and packaging content

Olmesartán/Hidroclorotiazida Teva 40 mg/12.5 mg are orange-coated, oval, biconvex tablets, 15 x 7 mm in size, with OH 41 engraved on one face.

Packaging sizes

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

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

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

Netherlands

Responsible manufacturer

Actavis Ltd.

BLB016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

For more information about this medication, please contact the local representative of the marketing authorization holder:

Teva Pharma S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Last review date of thisleaflet:December 2021

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and updated information about this medication by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/86788/P_86788.html

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