Olmesartan and hydrochlorothiazide Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Olmesartan and Hydrochlorothiazide Zentiva 20 mg / 12.5 mg film-coated tablets, 20 mg / 25 mg film-coated tablets, 40 mg / 12.5 mg film-coated tablets, 40 mg / 25 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Olmesartan and Hydrochlorothiazide Zentiva is and what it is used for

The name of this medicine is Olmesartan and Hydrochlorothiazide Zentiva 20 mg / 12.5 mg, 20 mg /
25 mg, 40 mg / 12.5 mg or 40 mg / 25 mg, and will be referred to as Olmesartan and Hydrochlorothiazide
Zentiva throughout this text.
Olmesartan and Hydrochlorothiazide Zentiva 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 (AIIRAs).
It lowers blood pressure by relaxing blood vessels.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (“water tablets”).
It lowers blood pressure by helping the body eliminate excess fluid by increasing urine production by the kidneys.
Olmesartan and Hydrochlorothiazide Zentiva will be prescribed to you only if olmesartan medoxomil alone
has not adequately controlled your blood pressure. When taken together, the two active substances in
Olmesartan and Hydrochlorothiazide Zentiva help lower blood pressure more than when each is used alone.
You may already be taking another medicine to treat high blood pressure, but your doctor may choose to prescribe
Olmesartan and Hydrochlorothiazide Zentiva to lower it further.
High blood pressure can be managed with medicines such as Olmesartan and Hydrochlorothiazide Zentiva tablets.
Your doctor has likely also advised you to make lifestyle changes, which help reduce your blood pressure
(for example, losing weight, quitting smoking, reducing alcohol intake, and reducing salt in your diet).
Your doctor may also have encouraged you to engage in regular physical activity such as walking or swimming.
It is important to follow your doctor’s advice.

2. What you should know before taking Olmesartan and Hydrochlorothiazide Zentiva

Do not take Olmesartan and Hydrochlorothiazide Zentiva

• If you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
• If you are more than three months pregnant. (It is best to avoid Olmesartan and Hydrochlorothiazide Zentiva even in early pregnancy – see pregnancy section).
• If you have kidney problems.
• If you have low levels of potassium, low levels of sodium, high levels of calcium, or high levels of uric acid in the blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• If you have moderate to severe liver problems, or yellowing of the skin and eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, e.g. gallstones).
• If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think any of these conditions apply to you, or you are unsure, do not take the medicine.
Contact your doctor and follow their advice.
Warnings and precautions
Talk to your doctor or pharmacist before taking Olmesartan and Hydrochlorothiazide Zentiva.
Before taking the tablets, tell your doctor if any of the following health conditions apply to you:

• Kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe or prolonged vomiting or diarrhoea lasting several days.
• Treatment with high doses of diuretic tablets ("water pills") or if you are on a low-salt diet.
• Problems with your adrenal glands (e.g. primary aldosteronism).
• Diabetes.
• If you have previously 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 exposure to sunlight and UV radiation while taking Olmesartan and Hydrochlorothiazide Zentiva.
• If you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to a week after taking Olmesartan and Hydrochlorothiazide Zentiva. If untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillins or sulfonamides, you may have an increased risk of developing this condition.
• Systemic lupus erythematosus (an autoimmune disease).
• Allergies or asthma.
• If you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), particularly if you have diabetes-related kidney problems.
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take Olmesartan and Hydrochlorothiazide Zentiva".

Contact your doctor if any of the following symptoms occur:

• Severe, prolonged diarrhoea causing significant weight loss. Your doctor will assess your symptoms and decide how to continue your antihypertensive treatment.

Your doctor may want to examine you more frequently and carry out blood tests if you have any of these conditions.
As with any medicine that lowers blood pressure, excessive reduction of blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Your doctor will therefore monitor your blood pressure carefully.
You must inform your doctor if you think you are pregnant (or could become pregnant). Olmesartan and Hydrochlorothiazide Zentiva is not recommended in early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section "Pregnancy").
Laboratory tests
Olmesartan and Hydrochlorothiazide Zentiva may cause increased levels of fats and uric acid (the cause of gout – painful joint swelling) in the blood. Your doctor may want to perform periodic blood tests to monitor these conditions.
It may alter the levels of certain substances called electrolytes in the blood. Your doctor may want to perform periodic blood tests to monitor these conditions. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), feeling weak, listless, tired, drowsy, restless, nausea, vomiting, reduced need to urinate, and rapid heartbeat. Inform your doctor if you experience any of these symptoms.
If you are scheduled for parathyroid function tests, you must stop taking Olmesartan and Hydrochlorothiazide Zentiva before the tests are performed.
Important information for athletes:
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
Olmesartan and Hydrochlorothiazide Zentiva is not recommended for children and adolescents under 18 years of age.
Other medicines and Olmesartan and Hydrochlorothiazide Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist about any of the following medicines. Your doctor may need to adjust the dose or take other precautions.

• Medicines that may alter potassium levels in the blood when used at the same time as Olmesartan and Hydrochlorothiazide Zentiva. These include:
• Potassium supplements (such as potassium-containing salt substitutes).
• Diuretic tablets ("water pills").
• Heparin (used to thin the blood).
• Laxatives.
• Steroids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (a medicine used to treat mouth and stomach ulcers).
• Sodium penicillin G (also known as sodium benzylpenicillin, an antibiotic).
• Some pain medicines such as aspirin or salicylates.
• Lithium (a medicine used to treat mood disorders and certain types of depression) used together with Olmesartan and Hydrochlorothiazide Zentiva may increase lithium toxicity. If you need to take lithium, your doctor will monitor your blood lithium levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used together with Olmesartan and Hydrochlorothiazide Zentiva may increase the risk of kidney failure, and the effect of Olmesartan and Hydrochlorothiazide Zentiva may be reduced by NSAIDs.
• Other blood pressure-lowering medicines (antihypertensives), as the effect of Olmesartan and Hydrochlorothiazide Zentiva may be increased.
• An ACE inhibitor or aliskiren (see also information in the sections "Do not take Olmesartan and Hydrochlorothiazide Zentiva" and "Warnings and precautions").
• Sleeping pills, sedatives, and antidepressants, used together with Olmesartan and Hydrochlorothiazide Zentiva, may cause a sudden drop in blood pressure when standing up.
• Certain medicines such as baclofen and tubocurarine, used to relax muscles.
• Amifostine and some 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 reduces cholesterol levels in the blood, which may reduce the effect of Olmesartan and Hydrochlorothiazide Zentiva. Your doctor may advise you to take Olmesartan and Hydrochlorothiazide Zentiva at least 4 hours before colesevelam hydrochloride.
• Anticholinergic agents, such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric conditions.
• Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or injectable digoxin, used to treat heart conditions.
• 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 reduce blood glucose levels.
• Beta-blockers and diazoxide, medicines used to treat high blood pressure and low blood sugar, respectively, as Olmesartan and Hydrochlorothiazide Zentiva may enhance their hyperglycaemic effect.
• Medicines such as noradrenaline, used to increase blood pressure and slow heart rate.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
• Difemanyl, used to treat slow heart rate or reduce sweating.
• Calcium supplements.
• Amantadine, an antiviral medicine.
• Cyclosporine, a medicine used to prevent rejection of transplanted organs.
• Certain antibiotics called tetracyclines or sparfloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Certain antacids used to treat excess stomach acid, such as aluminium and magnesium hydroxide, as the effect of Olmesartan and Hydrochlorothiazide Zentiva may be slightly reduced.
• Cisapride, used to increase movement of food through the stomach and intestine.
• Halofantrine, used to treat malaria.

Olmesartan and Hydrochlorothiazide Zentiva with food, drinks and alcohol
Olmesartan and Hydrochlorothiazide Zentiva can be taken with or without food.
Be cautious when consuming alcohol while taking Olmesartan and Hydrochlorothiazide Zentiva, as some people may experience fainting or dizziness. If this occurs, do not drink any alcoholic beverages, including wine, beer, or carbonated alcoholic drinks.
Patients of Black ethnicity
As with other similar medicines that lower blood pressure, the blood pressure-lowering effect of Olmesartan and Hydrochlorothiazide Zentiva is reduced in Black patients.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are pregnant (or could become pregnant). Your doctor will advise you to stop taking Olmesartan and Hydrochlorothiazide Zentiva before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartan and Hydrochlorothiazide Zentiva is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Olmesartan and Hydrochlorothiazide Zentiva is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
You may experience drowsiness or dizziness during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.
Olmesartan and Hydrochlorothiazide Zentiva contains lactose
This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Olmesartan and Hydrochlorothiazide Zentiva

Take this medicine exactly as your doctor has instructed. If you have any doubts,
consult your doctor or pharmacist.
Olmesartan and Hydrochlorothiazide Zentiva is a combination of two active substances, meaning
you should take only one tablet daily.
The recommended dose is one tablet of Olmesartan and Hydrochlorothiazide Zentiva 20 mg/12.5 mg
or one tablet of Olmesartan and Hydrochlorothiazide Zentiva 40 mg/12.5 mg daily. Your doctor
will decide which dosage is most suitable for you, based on your previous treatment.
However, if your blood pressure is not controlled, your doctor may decide to change your dose to one tablet of Olmesartan and Hydrochlorothiazide Zentiva 20 mg/25 mg or one tablet of Olmesartan and Hydrochlorothiazide Zentiva 40 mg/25 mg daily, respectively.
Olmesartan and Hydrochlorothiazide Zentiva can be taken with or without food. Swallow the
tablets with a glass of water. If possible, you should take your dose at the same time every day,
for example at breakfast time. It is important that you continue taking
Olmesartan and Hydrochlorothiazide Zentiva until your doctor tells you otherwise.
If you take more Olmesartan and Hydrochlorothiazide Zentiva than you should
If you take more tablets than prescribed, or if a child accidentally swallows one or more tablets,
go immediately to your doctor or the nearest emergency room, taking the medicine pack with you.
If you forget to take Olmesartan and Hydrochlorothiazide Zentiva
If you forget to take a dose, take your usual dose the next day. Do not take a double
dose to make up for the missed dose.
If you stop taking Olmesartan and Hydrochlorothiazide Zentiva
It is important to continue taking Olmesartan and Hydrochlorothiazide Zentiva unless your doctor
tells you to stop.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
However, the following side effects can be serious:

• Allergic reactions that may affect the whole body, with swelling of the face, mouth and/or throat (larynx), together with itching and redness, rarely.
• Rapid allergic reactions that may affect the whole body and may cause breathing problems, and a rapid drop in blood pressure which may also lead to fainting (anaphylactic reactions), which may occur uncommonly.
• Olmesartan and Hydrochlorothiazide Zentiva may cause an excessive reduction in blood pressure in predisposed individuals or as a result of an allergic reaction. Dizziness or fainting may occur uncommonly. If this happens, stop taking Olmesartan and Hydrochlorothiazide Zentiva, contact your doctor immediately and lie down.

Olmesartan and Hydrochlorothiazide Zentiva is a combination of two active substances, and the following information first lists other side effects reported so far with the combination of olmesartan medoxomil and hydrochlorothiazide (in addition to those already mentioned above), followed by those known for the individual active substances.
There are other known side effects related to the combination of olmesartan medoxomil and hydrochlorothiazide. If these side effects occur, they are often mild and treatment interruption is not necessary.

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

• Dizziness; headache.
• Weakness; chest pain; fatigue; swelling of the ankles, feet, legs, hands or arms.

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

• Feeling lightheaded or dizzy when standing up from a sitting or lying position; drowsiness.
• Vertigo.
• Awareness of heartbeat (palpitations).
• Cough.
• Abdominal pain; diarrhoea; indigestion; nausea; vomiting.
• Eczema; redness (erythema).
• Joint pain; back pain; muscle cramps; muscle pain; pain in arms and legs.
• Blood in the urine.
• Difficulty in erection.
• Some blood test abnormalities have been observed, including:
• Increase in blood levels of fats or cholesterol.
• 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 tests. Your doctor will detect these from blood tests and will inform you if any action is needed.

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

• Changes in consciousness.
• Skin blisters (wheals).
• Acute renal failure.
• Feeling unwell.
• Some blood test abnormalities have been observed, including:
• Increase in blood urea nitrogen.
• Decrease in haemoglobin and haematocrit values in blood. Your doctor will detect these from blood tests and will inform you if any action is needed.

Additional side effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but not with the combination of olmesartan medoxomil and hydrochlorothiazide or with higher frequency:

Olmesartan medoxomil

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

• Bronchitis; cough; sore throat; runny or blocked nose.
• Abdominal pain; diarrhoea; indigestion; gastroenteritis (inflammation of the stomach or intestine); nausea.
• Joint pain; back pain; bone pain.
• Blood in the urine.
• Urinary tract infections.
• Flu-like symptoms; pain.
• Some blood test abnormalities have commonly been observed, including:
• Increase in blood fat levels.
• Increase in blood urea or uric acid.
• Increase in liver and muscle function tests.

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

• Angina (chest pain or discomfort), known as angina pectoris.
• Allergic skin redness (erythema).
• Rash, itching, skin blisters (wheals).
• Swelling of the face.
• Feeling unwell.
• Some blood test abnormalities have been observed uncommonly, including:
• Reduction in the number of certain blood cells called platelets (thrombocytopenia).

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

• Impaired kidney function.
• Loss of energy.
• Some blood test abnormalities have been observed rarely, including:
• Increase in blood potassium levels.

Hydrochlorothiazide

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

• Changes in blood test results:
• Increase in levels of fats, cholesterol.
• Increase in uric acid levels.

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

• Excretion of glucose in the urine.
• Confusion.
• Abdominal pain; constipation; diarrhoea; stomach discomfort; bloating; nausea; vomiting.
• Some blood test abnormalities have been observed, including:
• Increase in creatinine, urea, calcium and blood glucose levels.
• Decrease in chloride, potassium, magnesium and sodium levels in blood.
• Increase in serum amylase (hyperamylasaemia).

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

• Decrease or loss of appetite.
• Worsening of pre-existing myopia (near blindness).
• Severe breathing difficulties.
• Erythema; skin reactions to light; itching; small purple spots or patches on the skin due to minor bleeding (purpura); skin blisters (wheals).

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

• Swollen and painful salivary glands.
• Reduction in red blood cells, which may make the skin appear pale and cause fatigue or shortness of breath.
• Bone marrow damage; reduction in white blood cells; reduction in the number of platelets in blood.
• Feeling indifferent (apathy) or depressed; restlessness, sleep disturbances.
• Seizures.
• Tingling and numbness.
• Dry eyes; blurred vision; seeing yellow objects (xanthopsia).
• Irregular heartbeat.
• Inflammation of blood vessels, blood clots (thrombosis or embolism).
• Shortness of breath; lung inflammation; fluid accumulation in the lungs; pulmonary oedema.
• Pancreatitis.
• Gallbladder infection; jaundice.
• Symptoms of systemic lupus erythematosus such as erythema, skin rash, joint pain, cold hands and fingers, skin peeling and blisters.
• Muscle weakness; impaired voluntary movements.
• Non-infectious inflammation of the kidneys (interstitial nephritis).
• Impaired kidney function.
• Fever.

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

• Electrolyte imbalances causing abnormally low chloride levels in blood (hypochloraemic alkalosis).
• Intestinal obstruction (paralytic ileus).

Frequency not known (frequency cannot be estimated from the available data):

• Skin and lip cancer (non-melanoma skin cancer).
• Vision loss or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion), acute myopia or acute angle-closure glaucoma).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olmesartan and Hydrochlorothiazide Zentiva

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions. Do not use
Olmesartan and Hydrochlorothiazide Zentiva after the expiry date stated on the carton and
blister after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Olmesartan and Hydrochlorothiazide Zentiva contains
The active substances are: olmesartan medoxomil and hydrochlorothiazide.
Olmesartan and Hydrochlorothiazide Zentiva 20 mg / 12.5 mg: Each film-coated tablet contains 20 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide.
Olmesartan and Hydrochlorothiazide Zentiva 20 mg / 25 mg: Each film-coated tablet contains 20 mg olmesartan medoxomil and 25 mg hydrochlorothiazide.
Olmesartan and Hydrochlorothiazide Zentiva 40 mg / 12.5 mg: Each film-coated tablet contains 40 mg olmesartan medoxomil and 12.5 mg hydrochlorothiazide.
Olmesartan and Hydrochlorothiazide Zentiva 40 mg / 25 mg: Each film-coated tablet contains 40 mg olmesartan medoxomil and 25 mg hydrochlorothiazide.
The other components are: microcrystalline cellulose, monohydrate lactose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose - 11, magnesium stearate, anhydrous colloidal silicon dioxide, talc, hypromellose, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172).

Description of the appearance of Olmesartan and Hydrochlorothiazide Zentiva and package contents
Olmesartan and Hydrochlorothiazide Zentiva 20 mg / 12.5 mg: round, light brown, film-coated tablets.
Olmesartan and Hydrochlorothiazide Zentiva 20 mg / 25 mg: round, pink or rose-coloured, film-coated tablets.
Olmesartan and Hydrochlorothiazide Zentiva 40 mg / 12.5 mg: oval, light brown, film-coated tablets.
Olmesartan and Hydrochlorothiazide Zentiva 40 mg / 25 mg: oval, pink or rose-coloured, film-coated tablets.
Olmesartan and Hydrochlorothiazide Zentiva film-coated tablets are available in Al/Al blisters (OPA/Al/PVC and aluminium foil) in pack sizes of 14, 28, 30, 50, 56, 84, 90, 98, 100 and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Zentiva Italia S.r.l.
Viale L. Bodio, 37/B
20158 Milan, Italy

Manufacturer
S.C. Zentiva, S.A., B-dul Theodor Pallady nr.50, sector 3, 032266 Bucharest, Romania.

This medicinal product is authorized in the European Economic Area Member States under the following names: