OLMESARTAN/HYDROCHLOROTHIAZIDE TARBIS 20 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olmesartan/HydrochlorothiazideTarbis20 mg/25 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

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

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

Olmesartan/Hydrochlorothiazide Tarbis will only be given if treatment with olmesartan medoxomil alone has not adequately controlled your blood pressure. The combination of the two active substances in Olmesartan/Hydrochlorothiazide Tarbis helps to lower blood pressure more than either substance alone.

You may already be taking medicines to treat high blood pressure, but your doctor may think it is necessary for you to take Olmesartan/Hydrochlorothiazide Tarbis to lower it further.

High blood pressure can be controlled with medicines such as Olmesartan/Hydrochlorothiazide Tarbis tablets. Your doctor may also have recommended that you make some changes to your lifestyle, such as losing weight, stopping smoking, reducing alcohol intake, 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 important to follow your doctor's advice.

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

Do not take Olmesartan/Hydrochlorothiazide Tarbis

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6) or to sulphonamide-related substances.
• If you are more than 3 months pregnant. (It is also better to avoid Olmesartan/Hydrochlorothiazide Tarbis at the start of pregnancy - see section Pregnancy).
• If you have severe kidney problems.
• If you have diabetes or kidney problems and are being treated with a medicine containing aliskiren.
• If you have low potassium or sodium levels, high calcium or uric acid levels in your blood (with symptoms of gout or kidney stones), that do not improve with treatment.
• If you have severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with the drainage of bile from the gallbladder (biliary obstruction, e.g. due to gallstones).

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

Warnings and precautions

Talk to your doctor before you start taking Olmesartan/Hydrochlorothiazide Tarbis.

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Olmesartan/Hydrochlorothiazide Tarbis.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Olmesartan/Hydrochlorothiazide Tarbis, seek medical attention immediately.

Before taking the tablets, tell your doctorif 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 need to check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Olmesartan/HydrochlorothiazideTarbis”

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

• Mild to moderate kidney problems or if you have recently had a kidney transplant.

• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Vomiting (being sick) or diarrhoea, which is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine production (diuretics), or if you are on a low-salt diet.
• Problems with the adrenal glands (e.g. primary hyperaldosteronism).
• Diabetes.
• Systemic lupus erythematosus (an autoimmune disease).
• Allergy or asthma.

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

Severe, persistent diarrhoea that causes significant weight loss. Your doctor will assess your symptoms and decide how to proceed with your blood pressure treatment.

If you experience changes in your vision or pain in one or both eyes. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or the development of glaucoma, increased pressure in your eyes, and can occur within hours to a week after taking Olmesartan/Hydrochlorothiazide Tarbis. You should stop treatment and seek medical attention.

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

A change in blood levels of certain chemicals called electrolytes may occur. Your doctor will probably want to do a blood test from time to time to check for 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, tiredness, drowsiness or restlessness, nausea, vomiting, decreased need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other medicine that lowers blood pressure, an excessive drop in blood pressure in patients with impaired blood flow to the heart or brain may cause a heart attack or stroke. That's why your doctor will carefully monitor your blood pressure.

If you are going to have parathyroid function tests, you should stop taking Olmesartan/Hydrochlorothiazide Tarbis before these tests are performed.

Athletes are informed that this medicine contains a component that may result in a positive doping test.

You should tell your doctor if you are pregnant or think you might be pregnant. Your doctor will normally advise you to stop taking Olmesartan/Hydrochlorothiazide Tarbis before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Olmesartan/Hydrochlorothiazide Tarbis. It is not recommended to use Olmesartan/Hydrochlorothiazide Tarbis during pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Children and adolescents

Olmesartan/Hydrochlorothiazide Tarbis is not recommended for children and adolescents under 18 years of age.

Using Olmesartan/Hydrochlorothiazide Tarbis with other medicines

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

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

• Other medicines to lower blood pressure (antihypertensives), as they may increase the effect of Olmesartan/Hydrochlorothiazide Tarbis.

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Olmesartan/Hydrochlorothiazide Tarbis” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood when used at the same time as Olmesartan/Hydrochlorothiazide Tarbis. These include:

• Potassium supplements (including salt substitutes that contain potassium).
• Medicines that increase urine production (diuretics).
• Heparin (to thin the blood).
• Laxatives.
• Corticosteroids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (a medicine used to treat mouth and stomach ulcers).
• Sodium penicillin G (an antibiotic also known as benzylpenicillin sodium).
• Certain painkillers such as aspirin or salicylates.

• Lithium (a medicine used to treat mood changes and some types of depression) may have its toxicity increased if taken at the same time as Olmesartan/Hydrochlorothiazide Tarbis. If you have to take lithium, your doctor will measure lithium levels in your blood.
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), used at the same time as Olmesartan/Hydrochlorothiazide Tarbis, may increase the risk of kidney problems and reduce the effect of Olmesartan/Hydrochlorothiazide Tarbis.
• Sedatives, hypnotics, and antidepressants, used with Olmesartan/Hydrochlorothiazide Tarbis, may cause a sudden drop in blood pressure when standing up.
• Certain muscle relaxants such as baclofen and tubocurarine.
• Amifostine and other medicines used to treat cancer, such as cyclophosphamide or methotrexate.
• Cholestyramine and colestipol, medicines used to lower blood fat levels.
• Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Olmesartan/Hydrochlorothiazide Tarbis. Your doctor may advise you to take Olmesartan/Hydrochlorothiazide Tarbis at least 4 hours before colesevelam hydrochloride.
• Anticholinergic medicines, such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluperazine, cyanemazine, 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 erythromycin injections, which can change heart rhythm.
• Oral antidiabetic medicines, such as metformin, or insulin, used to lower blood sugar levels.
• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar levels, respectively, as Olmesartan/Hydrochlorothiazide Tarbis may increase the effect of increasing blood sugar levels caused by these medicines.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines such as noradrenaline, used to increase blood pressure and decrease 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.
• Cyclosporin, a medicine used to prevent organ transplant rejection.
• Antibiotics of the tetracycline group or sparfloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Certain antacids, used to treat stomach acid, such as aluminium and magnesium hydroxide, as they may slightly reduce the effect of Olmesartan/Hydrochlorothiazide Tarbis.
• Cisapride, used to increase food movement in the stomach and intestines.
• Halofantrine, used to treat malaria.

Using Olmesartan/Hydrochlorothiazide Tarbis with food and drink

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

Be careful when drinking alcohol while taking Olmesartan/Hydrochlorothiazide Tarbis, as some people feel weak or dizzy. If this happens, do not drink any alcohol, including wine, beer, or drinks containing alcohol.

Black patients

As with other similar medicines, the blood pressure-lowering effect of Olmesartan/Hydrochlorothiazide Tarbis is somewhat less in black patients.

Pregnancy and breastfeeding

Pregnancy

You should tell your doctor if you are pregnant or think you might be pregnant. Your doctor will normally advise you to stop taking Olmesartan/Hydrochlorothiazide Tarbis before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Olmesartan/Hydrochlorothiazide Tarbis. It is not recommended to use Olmesartan/Hydrochlorothiazide Tarbis during pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use Olmesartan/Hydrochlorothiazide Tarbis during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Use in athletes

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

Driving and using machines

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

Olmesartan/Hydrochlorothiazide Tarbis contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Olmesartan/Hydrochlorothiazide Tarbis

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, consult your doctor or pharmacist again.

The recommended doseis one Olmesartan/Hydrochlorothiazide Tarbis 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 Tarbis 20 mg/25 mg tablet per day.

Take the tablets with water. If possible, take your dose at the same time each day, e.g. at breakfast time. It is important that you continue to take this medicine until your doctor tells you to stop.

If you take more Olmesartan/Hydrochlorothiazide Tarbis than you should

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

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

If you forget to take Olmesartan/Hydrochlorothiazide Tarbis

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

If you stop taking Olmesartan/Hydrochlorothiazide Tarbis

It is important to continue taking Olmesartan/Hydrochlorothiazide Tarbis unless your doctor tells you to stop.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

However, the following two adverse effects can be serious:

• In rare cases, allergic reactions may 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 Tarbisand consult your doctor immediately.

• Olmesartan/Hydrochlorothiazide Tarbis may 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 Tarbis, consult your doctor immediately, and remain lying down in a horizontal position.

Olmesartan/Hydrochlorothiazide Tarbis is a combination of two active principles. The following information first describes the adverse effects reported so far with the combination Olmesartan/Hydrochlorothiazide Tarbis (in addition to those already mentioned) and, secondly, the known adverse effects of the two active principles separately.

These are other known adverse effects of Olmesartan/Hydrochlorothiazide:

If these 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):

Fast 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.

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

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

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

Feeling of discomfort, altered consciousness, skin swelling (hives), acute kidney failure.

Also, some changes in blood test results have 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 Olmesartan/Hydrochlorothiazide or at a Higher Frequency:

Olmesartan Medoxomil:

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

Bronchitis, cough, nasal congestion and 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 frequently, including:

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

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

Rapid allergic reactions that can affect the whole body and 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 swelling (hives).

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

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

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

Renal function impairment, lack of energy.

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

Increased potassium in the blood.

Hydrochlorothiazide:

Very Common Adverse Effects (may affect more than 1 in 10 people):

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

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.

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).

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 swelling (hives).

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

Inflammation and pain of the salivary glands, decreased white blood cell count, decreased platelet count in the blood, anemia, bone marrow depression, restlessness, depression, sleep problems, feeling of 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, gallbladder infection, lupus erythematosus symptoms 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 (sometimes causing 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 respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

Adverse Effects of Unknown Frequency (cannot be estimated from available data):Decreased vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)

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

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 Tarbis

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the packaging and blister pack (after "EXP.:"). The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Olmesartan/Hydrochlorothiazide Tarbis

The active ingredients are olmesartan medoxomil and hydrochlorothiazide.

Olmesartan/Hydrochlorothiazide Tarbis 20 mg/25 mg: each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

The other components (excipients) are: lactose monohydrate, hydroxypropylcellulose, microcrystalline cellulose, low-substituted hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), polyethylene glycol, and talc.

Product Appearance and Package Contents

Olmesartan/Hydrochlorothiazide Tarbis 20 mg/25 mg is presented in the form of film-coated tablets, white or almost white, round, and biconvex, with the inscription 'J2' on one face.

Olmesartan/Hydrochlorothiazide Tarbis film-coated tablets are presented in packages of 28 tablets and in blister packs with 500 unit-dose tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028- Barcelona (Spain)

Manufacturer

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173-Sant Cugat del Vallès (Barcelona)

Spain

Laboratorios Lesvi, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona (Spain)

Date of the Last Revision of this Prospectus: December 2021

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