Olmesartan/hydrochlorothiazide Teva 20 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olmesartan/Hydrochlorothiazide Teva 20 mg/12.5 mg film-coated tablets EFG

Olmesartan medoxomil/hydrochlorothiazide

Read all of 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

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

Contents of the leaflet

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

1. What Olmesartán/Hidroclorotiazida Teva is and what it is used for

This medicine contains two active substances, olmesartán medoxomilo and hidroclorotiazida, which are used in the treatment of high blood pressure (hypertension):

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

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

This medicine will only be prescribed to you if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The combined administration of both active substances in this medicine contributes to a greater reduction in blood pressure than when either substance is given alone.

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

High blood pressure can be controlled with medicines such as this one. Your doctor may also have advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing salt intake). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before starting to take Olmesartán/Hidroclorotiazida Teva

Do not take Olmesartán/Hidroclorotiazida Teva:

• if you are allergic to olmesartán medoxomilo or hydrochlorothiazide, or to any of the other components of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
• if you are more than 3 months pregnant (It is also advisable to avoid this medicine in early pregnancy – see Pregnancy section).
• 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) that do not improve with treatment.
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.
• if you have severe kidney problems.
• if you have severe liver problems, yellowing of the skin or eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, for example due to gallstones).

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

Warnings and precautions

Talk to your doctor before starting to take this medicine.

Before taking the tablets**, tell your doctor** if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (e.g., 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 conditions:

• Liver disease
• Heart failure or problems with heart valves or heart muscle
• Vomiting (nausea) or diarrhoea that is severe or lasts for several days
• Treatment with high doses of medicines that increase urine elimination (diuretics), or if you are on a low-salt diet
• Problems with the adrenal glands (e.g., primary hyperaldosteronism)
• Diabetes
• Lupus erythematosus (an autoimmune disease)
• Allergy or asthma
• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV rays while taking this medicine.
• If you have previously experienced breathing or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking this medicine, seek medical help immediately.
• Mild to moderate kidney problems or if you have recently undergone a kidney transplant.

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

• Severe, persistent diarrhoea 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, which may occur from a few hours to several weeks after taking this medicine. This may lead to permanent vision impairment if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking this medicine. Your doctor will decide on the appropriate treatment. Do not stop taking this medicine on your own.

This medicine may cause increased levels of fats and uric acid (which causes gout – painful joint swelling) in the blood. Your doctor will likely want to perform blood tests from time to time to monitor these possible changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor will likely want to perform blood tests periodically to monitor this possible change. Some signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, slow, tired, drowsy, restless, nausea, vomiting, reduced 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 lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for tests assessing parathyroid function, you must stop taking this medicine before the tests are performed.

Inform your doctor if you are pregnant or think you might be pregnant. Use of this medicine is not recommended in early pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken during this stage (see Pregnancy section).

Children and adolescents

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

Other medicines and Olmesartán/Hidroclorotiazida Teva

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

In particular, inform your doctor or pharmacist about any of the following medicines:

• Other blood pressure-lowering medicines (antihypertensives), as they may enhance the effect of this medicine.
• Your doctor may need to adjust your dose and/or take other precautions:
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Olmesartán/Hidroclorotiazida Teva” and “Warnings and precautions”).
• Medicines that may alter blood potassium levels when used together with this medicine. These include:
• potassium supplements (as well as salt substitutes containing potassium).
• medicines that increase urine elimination (diuretics).
• heparin (a blood thinner).
• laxatives.
• steroids.
• adrenocorticotropic hormone (ACTH).
• carbenoxolone (a medicine used to treat mouth and stomach ulcers).
• sodium penicillin G (an antibiotic also known as sodium benzylpenicillin).
• some painkillers such as aspirin or salicylates.
• Lithium (a medicine used to treat mood disorders and certain types of depression) – its toxicity may be increased when used together with this medicine. If you need to take lithium, your doctor will monitor lithium blood levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other inflammatory symptoms, including arthritis) – when used together with this medicine, they may increase the risk of kidney failure and reduce the effect of olmesartán/hydrochlorothiazida.
• Sleeping pills, sedatives, and antidepressants – when used with this medicine, they may cause a sudden drop in blood pressure upon standing.
• Certain medicines such as baclofen and tubocurarine, used as muscle relaxants.
• Amifostine and other cancer-treatment 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, which may reduce the effect of this medicine. Your doctor may advise you to take Olmesartán/Hidroclorotiazida Teva at least 4 hours before colesevelam hydrochloride.
• Anticholinergic medicines such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, 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 mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, which may alter heart rhythm.
• Oral antidiabetic medicines such as metformin, or insulin, used to lower blood sugar levels.
• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, as this medicine may enhance their blood sugar-raising effect.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines such as noradrenaline, used to increase blood pressure and reduce heart rate.
• Difemanil, used to treat slow heartbeat or reduce sweating.
• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Calcium supplements.
• Amantadine, an antiviral medicine.
• Cyclosporine, a medicine used to prevent organ transplant rejection.
• Antibiotics from the tetracycline group, or sparfloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Some antacids used to treat excess stomach acid, such as aluminium and magnesium hydroxide, which may slightly reduce the effect of this medicine.
• Cisapride, used to increase stomach and intestinal motility.
• Halofantrine, used to treat malaria.

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

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

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

Patients of Black race

As with other similar medicines, the blood pressure-lowering effect of olmesartán/hydrochlorothiazida is somewhat lower in patients of Black race.

Pregnancy and breastfeeding

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

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will generally advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Olmesartán/Hidroclorotiazida Teva. Use of this medicine is not recommended during pregnancy, and it must not be administered from the third month of pregnancy onward, as it may cause serious harm to your baby if taken from that point.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to start. Use of this medicine is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed.

Driving and using machines

You may feel drowsy or dizzy while undergoing treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Use in athletes

Athletes should be aware that this medicine contains a component (hydrochlorothiazide) that may lead to a positive result in doping control tests.

Olmesartán/Hidroclorotiazida Teva contains lactose and sunset yellow S

Lactose: If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Sunset yellow S: May cause allergic-type reactions.

3. How to take Olmesartan/Hydrochlorothiazide Teva

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

The recommended dose is one tablet of Olmesartan/Hydrochlorothiazide Teva 20 mg/12.5 mg daily. If blood pressure is not adequately controlled, your doctor may increase the dose to one tablet of Olmesartan/Hydrochlorothiazide Teva 20 mg/25 mg daily.

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

If you take more Olmesartan/Hydrochlorothiazide Teva than you should

If you take more tablets than prescribed or if a child accidentally swallows one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department, and take the medicine pack with you.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine 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 not take a double dose to make up for forgotten doses.

If you stop taking Olmesartan/Hydrochlorothiazide Teva

It is important to continue taking this medicine unless your doctor tells you to stop.

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

4. Possible adverse effects

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

However, the following adverse effects may be serious:

• Rarely, allergic reactions may occur that can affect the entire body, with swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking Olmesartan/Hydrochlorothiazide Teva and consult your doctor immediately.

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

• Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or itching of the skin, even if you started treatment with this medicine some time ago, contact your doctor immediately so that your symptoms can be evaluated and a decision made on how to continue your blood pressure treatment.

This medicine is a combination of two active substances. 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 secondly, the known adverse effects of each of the two active substances when used separately.

These are other known adverse effects reported so far with olmesartan/hydrochlorothiazide:

If these adverse effects occur, they are often mild and you do not need to stop 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):

Drowsiness, rapid and strong heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle cramps and muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine.

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

Increase in blood fat levels, increase in blood urea or uric acid, increase in creatinine, increase or decrease in blood potassium levels, increase in blood calcium levels, increase in blood glucose levels, increase in liver function test values. Your doctor will monitor you with a blood test and will advise you whether any action is needed.

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

Feeling unwell, disturbances in consciousness, skin lumps (wheals), acute renal failure.

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

Increase in blood urea nitrogen, decrease in haemoglobin and haematocrit values. Your doctor will monitor you with a blood test and will advise you whether any action is needed.

Additional adverse effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not with the olmesartan/hydrochlorothiazide combination or at a higher frequency:

Olmesartan medoxomil:

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

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

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

Increase in blood fat levels, increase in blood urea or uric acid, increase in liver or muscle function test levels.

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

Rapid allergic reactions affecting the whole body, which may cause breathing difficulties and a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), facial swelling, angina (pain or discomfort in the chest, known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin eruption), skin lumps (wheals).

Uncommonly, some changes in blood test results have also been observed, 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 presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

Increase in blood potassium levels.

Hydrochlorothiazide:

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

Changes in blood tests including: increase in blood fat and blood uric acid levels.

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

Confusion, abdominal pain, stomach discomfort, bloating sensation, diarrhoea, nausea, vomiting, constipation, glucose in urine.

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

Increase in creatinine, urea, calcium and blood glucose levels, decrease in blood chloride, potassium, magnesium and sodium levels. Increase in serum amylase (hyperamylasaemia).

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

Decreased or loss of appetite, severe difficulty breathing, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purple spots or patches on the skin due to small haemorrhages (purpura), skin lumps (wheals).

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

Inflammation and pain of the salivary glands, decrease in white blood cell count, decrease in platelet count, anaemia, bone marrow damage, restlessness, feeling "low" or depressed, sleep disturbances, feeling of 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, gallbladder infection, symptoms of systemic lupus erythematosus (such as skin rash, joint pains, cold hands and fingers), allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which may sometimes cause movement disorders).

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

Electrolyte imbalance that may cause abnormally low blood chloride levels (hypochloraemic alkalosis), intestinal obstruction (paralytic ileus).

Acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

Adverse effects not known (frequency cannot be estimated from available data):

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

Reduced 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan/Hydrochlorothiazide Teva

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Hydrochlorothiazide Teva

• The active substances are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
• 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 6 cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin (E1518), yellow iron oxide (E172), red iron oxide (E172), sunset yellow FCF (E110)

Appearance of the product and contents of the pack

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

Pack sizes

Al-Al blister packs: 14, 28, 30, 56, 98 film-coated tablets.

Al-Al calendar blister packs: 28 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem

The Netherlands

Manufacturer

Actavis Ltd.

BLB016, Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

For further information about this medicinal product, 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)

Date of the most recent review of this product information: December 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) (http://www.aemps.gob.es/)

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. 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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