OLMESARTAN 20 mg /12.5 Mg Film-Coated Tablets

Зміст інструкції

1. Olmesartan medoxomil/hydrochlorothiazide
   1. What is Olmesartan medoxomil and Hydrochlorothiazide Teva Italia and what it is used for
   2. What you need to know before taking Olmesartan medoxomil and Hydrochlorothiazide Teva Italia
   3. How to take Olmesartan medoxomil and Idroclorotiazide Teva Italia
   4. Possible side effects
   5. How to store Olmesartan medoxomil and Idroclorotiazide Teva Italia
   6. Package Contents and Other Information

Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 20 mg/12.5 mg film-coated tablets
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 20 mg/25 mg film-coated tablets
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 40 mg/12.5 mg film-coated tablets
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 40 mg/25 mg film-coated tablets

Olmesartan medoxomil/hydrochlorothiazide

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Olmesartan medoxomil and Hydrochlorothiazide Teva Italia contains two active ingredients called olmesartan
medoxomil and hydrochlorothiazide, used for the treatment of high blood pressure (hypertension):

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists, and reduces blood pressure through a relaxing action on the blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It reduces blood pressure by helping the body to eliminate excess fluids, causing the kidneys to produce more urine.

You will be given Olmesartan medoxomil and Hydrochlorothiazide Teva Italia only if olmesartan
medoxomil alone has not been sufficient to adequately control blood pressure. When
taken together, the two active ingredients of Olmesartan medoxomil and Hydrochlorothiazide Teva
Italia help to reduce blood pressure more than they would if taken separately.
You may already be taking medicines to treat high blood pressure, but your doctor may
give you Olmesartan medoxomil and Hydrochlorothiazide Teva Italia to lower it further.
High blood pressure can be controlled with medicines such as Olmesartan medoxomil and Hydrochlorothiazide
Teva Italia tablets. Your doctor has probably also recommended that you make some
changes to your lifestyle to help reduce blood pressure (for example, losing
weight, quitting smoking, reducing alcohol intake and reducing the amount of salt in your diet). Your
doctor may also strongly advise you to take regular exercise, such as walking
or swimming. It is important that you follow your doctor's advice.

2. What you need to know before taking Olmesartan medoxomil and Hydrochlorothiazide Teva Italia

Do not take Olmesartan medoxomil and Hydrochlorothiazide Teva Italia:

• if you are allergic to olmesartan medoxomil, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6) or to substances similar to hydrochlorothiazide (sulphonamides)
• if you are pregnant for more than three months (it is advisable to avoid using Olmesartan medoxomil and Hydrochlorothiazide Teva Italia even during the first months of pregnancy - see section pregnancy)
• if you have low levels of potassium or sodium, or if you have high levels of calcium or uric acid in the blood (with symptoms of gout or kidney stones), which do not improve after treatment
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren. [This refers only to the 20 mg/12.5 mg and 20 mg/25 mg dosages]
• if you suffer from severe kidney problems
• if you suffer from severe liver problems or yellowing of the skin and eyes (jaundice) or problems related to the drainage of bile from the gallbladder (bile duct obstruction or gallstones) [This refers only to the 40 mg/12.5 mg and 40 mg/25 mg dosages]
• if you suffer from kidney problems
• if you suffer from severe liver problems or yellowing of the skin and eyes (jaundice) or problems related to the drainage of bile from the gallbladder (bile duct obstruction or gallstones). If you think that any of these conditions apply to you, or you are not sure, do not take the medicine. Contact your doctor and follow their advice.

Warnings and precautions
Talk to your doctor before taking Olmesartan medoxomil and Hydrochlorothiazide Teva Italia.
Before taking the medicine, consult your doctorif you are taking any of the following medicines used
to treat high blood pressure:

• an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren.

The doctor may check your kidney function, blood pressure and the amount of
electrolytes in the blood (e.g. potassium) at regular intervals.
See also what is stated under “Do not take Olmesartan medoxomil and Hydrochlorothiazide Teva
Italia”.
Before taking the medicine, consult your doctorif you also have any of the following health problems:

• liver disease
• heart failure or problems with the heart valves or heart muscle
• severe or prolonged vomiting or diarrhoea
• treatment with high doses of diuretics or if you are following a low-salt diet
• problems with the adrenal glands (for example primary aldosteronism)
• diabetes
• lupus erythematosus (an autoimmune disease)
• allergies or asthma
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Long-term use of hydrochlorothiazide, especially at high doses, can increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays during treatment with Olmesartan medoxomil and Hydrochlorothiazide Teva Italia
• if you have previously suffered from respiratory or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide. Seek immediate medical attention if

you experience shortness of breath or difficulty breathing of any kind after taking Olmesartan
medoxomil and Hydrochlorothiazide Teva Italia.
[This refers only to the 20 mg/12.5 mg and 20 mg/25 mg dosages]

• mild to moderate kidney problems, or if you have had a kidney transplant [This refers only to the 40 mg/12.5 mg and 40 mg/25 mg dosages]
• kidney transplant

Tell your doctor if you experience the following symptoms:

• severe and prolonged diarrhoea with significant weight loss. Your doctor will assess the symptoms and decide whether to continue this antihypertensive treatment.
• decreased visual acuity and eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and may occur from a few hours to several weeks after taking Olmesartan medoxomil and Hydrochlorothiazide Teva Italia. This condition, if left untreated, can lead to permanent vision loss. If you have recently had an allergy to penicillin or sulphonamides, you may be at high risk of developing this symptom.

Your doctor may want to see you more often and do some tests if you are in any
of the following conditions.
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia can cause an increase in levels of fats and
uric acid (cause of gout – painful swelling of the joints) in the blood. Your doctor
will probably want to have blood tests done periodically to assess these conditions.
This medicine can alter the levels of certain substances, called electrolytes, in the blood. Your doctor
will probably want to have blood tests done periodically to assess these conditions. Signs of
changes in electrolytes are thirst, dry mouth, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), feeling weak, apathy, tiredness, drowsiness or
restlessness, nausea, vomiting, reduced need to urinate, rapid heartbeat. Tell your
doctor if you experience these symptoms.
As with any medicine that lowers blood pressure, an excessive reduction in pressure in patients with disturbances of blood flow to the heart or brain could lead to a
heart attack or stroke. Therefore, your doctor will carefully monitor your blood
pressure.
If you need to have parathyroid function tests, you should stop taking Olmesartan
medoxomil and Hydrochlorothiazide Teva Italia before having these tests.
If you practice sports, this medicine may alter the results of a doping test, making it
positive.
You should tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Olmesartan medoxomil and Hydrochlorothiazide Teva Italia is not recommended at the beginning
of pregnancy and should not be taken if you are pregnant for more than 3 months, as it can
cause serious harm to the baby if taken during that period (see section “Pregnancy”).

Children and adolescents
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia is not recommended in children and adolescents under
18 years of age.

Other medicines and Olmesartan medoxomil and Hydrochlorothiazide Teva Italia
Tell 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 the following:

• Other medicines that lower blood pressure (antihypertensives) may increase the effect of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia.
• The doctor may need to adjust the dose and/or take other precautions:
• If you are taking an ACE inhibitor or aliskiren (see also what is stated under “Do not take Olmesartan medoxomil and Hydrochlorothiazide Teva Italia” and “Warnings and precautions”).
• Medicines that can alter potassium levels in the blood when used together with Olmesartan medoxomil and Hydrochlorothiazide Teva Italia. These include:
• potassium supplements (as well as potassium-based salt substitutes)
• diuretics
• heparin (to thin the blood)
• laxatives
• steroids
• adrenocorticotropic hormone (ACTH)
• carbenoxolone (a medicine used to treat mouth and stomach ulcers)
• sodium penicillin G (also called benzylpenicillin sodium, an antibiotic)
• some painkillers such as aspirin or salicylates
• Lithium (a medicine used to treat mood swings and some types of depression) used at the same time as Olmesartan medoxomil and Hydrochlorothiazide Teva Italia may increase lithium toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis) used at the same time as Olmesartan medoxomil and Hydrochlorothiazide Teva Italia may increase the risk of kidney impairment and the effect of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia may be reduced by NSAIDs
• Sleeping pills, sedatives and antidepressants, as the use of these medicines together with Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 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 for cancer treatment, such as cyclophosphamide or methotrexate
• Cholestyramine and colestipol, medicines used to reduce fats in the blood
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as the effect of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia may decrease. Your doctor may advise you to take Olmesartan medoxomil and Hydrochlorothiazide Teva Italia at least 4 hours before colesevelam hydrochloride
• Anticholinergic medicines, such as atropine and biperidene
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamezazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol, used to treat certain psychiatric illnesses
• Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digitalis, used to treat heart conditions
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or erythromycin by injection, which can alter the 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 or hypoglycemia, respectively, as Olmesartan medoxomil and Hydrochlorothiazide Teva Italia can amplify their hyperglycemic effect
• Methyldopa, a medicine used to treat high blood pressure
• Medicines such as norepinephrine, used to increase blood pressure and slow down the heart rate
• Difemanil, used to treat a slow heartbeat or reduce sweating
• Medicines such as probenecid, sulfinpyrazone and allopurinol, used for the treatment of gout
• 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
• Some antacids, such as aluminium hydroxide and magnesium hydroxide (used for stomach acidity) because they can reduce the effectiveness of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia
• Cisapride, used to increase the movement of food in the stomach and intestines
• Allofantrine, used for malaria.

Olmesartan medoxomil and Hydrochlorothiazide Teva Italia with food, drinks and alcohol
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia can be taken with or without food.
Be careful when drinking alcohol while being treated with Olmesartan medoxomil and
Hydrochlorothiazide Teva Italia, as some people may experience fainting or dizziness. If
this happens to you, do not drink any type of alcoholic beverage, including wine, beer or fizzy alcoholic drinks.

Patients of black ethnicity
As with other similar medicines, the blood pressure-lowering effect of Olmesartan
medoxomil and Hydrochlorothiazide Teva Italia may be somewhat reduced in patients of black ethnicity.

For those who practice sports:the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before using this medicine.
Pregnancy
You should tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking Olmesartan
medoxomil and Hydrochlorothiazide Teva Italia before starting a pregnancy or as soon as you know you are
pregnant, and will advise you to take another medicine instead of Olmesartan medoxomil and
Hydrochlorothiazide Teva Italia. Olmesartan medoxomil and Hydrochlorothiazide Teva Italia is not recommended
during pregnancy and should not be taken if you are pregnant for more than 3 months, as it can
cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Olmesartan medoxomil and
Hydrochlorothiazide Teva Italia is not recommended in mothers during breastfeeding, and your doctor may
choose another treatment if you wish to breastfeed.

Driving and using machines
You may feel drowsy or dizzy while being treated for high blood pressure. If this happens, do not
drive or use machines until the symptoms disappear. Consult your doctor.
[This refers only to the 20 mg/12.5 mg and 40 mg/12.5 mg tablets]

Olmesartan medoxomil and Hydrochlorothiazide Teva Italia contains lactose and sunset yellow
Lactose: if your doctor has diagnosed you with intolerance to some sugars, contact them before
taking this medicinal product.
Sunset yellow: may cause allergic reactions
[This refers only to the 20 mg/25 mg and 40 mg/25 mg dosages]

Olmesartan medoxomil and Hydrochlorothiazide Teva Italia contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact them before taking this
medicinal product.

3. How to take Olmesartan medoxomil and Idroclorotiazide Teva Italia

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
[This refers only to the 20 mg/12.5 mg and 20 mg/25 mg dosages]

The recommended doseof Olmesartan medoxomil and Idroclorotiazide Teva Italia 20 mg/12.5 mg is
one tablet a day. However, if your blood pressure is not controlled, your doctor may decide
to change your prescription to one tablet a day of Olmesartan medoxomil and Idroclorotiazide
Teva Italia 20 mg/25 mg.
[This refers only to the 40 mg/12.5 mg and 40 mg/25 mg dosages]

The recommended doseof Olmesartan medoxomil and Idroclorotiazide Teva Italia 40 mg/12.5 mg is
one tablet a day. However, if your blood pressure is not controlled, your doctor may decide
to change the prescription to one tablet a day of Olmesartan medoxomil and Idroclorotiazide
Teva Italia 40 mg/25 mg.
Swallow the tablets with a little water. Do not bite, chew or break the tablets. Take your
dose every day at the same time, for example with breakfast. It is important to continue to
take Olmesartan medoxomil and Idroclorotiazide Teva Italia as long as your doctor considers it
appropriate.

If you take more Olmesartan medoxomil and Idroclorotiazide Teva Italia than you should
If you take more tablets than you should, or if a child accidentally ingests one or more tablets,
contact your doctor or the nearest emergency room immediately. Bring the medicine packaging with you.

If you forget to take Olmesartan medoxomil and Idroclorotiazide Teva Italia
If you forget to take a dose, take your usual dose the next day. Do nottake a
double dose to make up for a missed dose.

If you stop taking Olmesartan medoxomil and Idroclorotiazide Teva Italia
It is important to continue to take Olmesartan medoxomil and Idroclorotiazide Teva Italia as long as
your doctor considers it appropriate.
If you have any doubts 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 can affect the whole body with swelling of the face, mouth and/or vocal cords (larynx) associated with itching and skin rash. If this happens, stop taking Olmesartan medoxomil and Idroclorotiazide Teva Italia and contact your doctor immediately.
• Olmesartan medoxomil and Idroclorotiazide Teva Italia can cause an excessive drop in blood pressure in predisposed individuals or as a result of an allergic reaction. Dizziness or fainting are not frequent. If this happens, stop taking Olmesartan medoxomil and Idroclorotiazide Teva Italia, contact your doctor immediately and lie down.
• Not known frequency: If you experience yellowing of the sclera (white of the eyes), dark urine, skin itching, even if you have been taking Olmesartan medoxomil and

Idroclorotiazide Teva Italia for a long time, contact your doctor immediatelywho will evaluate the
symptoms and decide how to proceed with therapy.
Olmesartan medoxomil and Idroclorotiazide Teva Italia is a combination of two active ingredients and the
following information first presents the other side effects reported so far with the combination of
Olmesartan medoxomil and Idroclorotiazide Teva Italia (in addition to those already mentioned above) and then
those known for each active ingredient.

These are the other side effects known so far with Olmesartan medoxomil and Idroclorotiazide
Teva Italia:
If these side effects occur, they are often mild and you should not stop treatment.
Common side effects (may affect up to 1 in 10 people):
Dizziness, weakness, headache, fatigue, chest pain, swelling of the ankles, feet, legs, hands
or arms.
Uncommon side effects (may affect up to 1 in 100 people):
Sleepiness, fast heartbeat (palpitations), skin rash, 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 the urine.
Among the uncommon effects, some changes in blood tests have been found, such as:
Increased levels of fats in the blood, increased levels of urea or uric acid in the blood, increased
creatinine, increased or decreased levels of potassium in the blood, increased levels of calcium
in the blood, increased blood sugar (glucose level), increased liver function levels. Your doctor will be aware of this from blood tests and will tell you if anything needs to be done.
Rare side effects (may affect up to 1 in 1,000 people):
Feeling unwell, disturbances in consciousness, skin blisters (urticaria), acute kidney
impairment.
Among the rare effects, some changes in blood tests have been found, such as:
Increased blood urea nitrogen, decreased hemoglobin and hematocrit values. Your doctor will be aware of this from blood tests and will tell you if anything needs to be done.

Further side effects reported with the use of olmesartan medoxomil or hydrochlorothiazide alone, but

not with Olmesartan medoxomil and Idroclorotiazide Teva Italia or at a higher frequency:

Olmesartan medoxomil:
Common side effects (may affect up to 1 in 10 people):
Bronchitis, cough, stuffy or runny nose, sore throat, abdominal pain, indigestion, diarrhea, nausea,
gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection,
flu-like symptoms, pain.
Among the common effects, some changes in blood tests have been found, such as:
Increased levels of fats in the blood, increased levels of urea or uric acid in the blood, increased
liver and muscle function indices.
Uncommon side effects (may affect up to 1 in 100 people):
Rapid allergic reactions that can affect the whole body and can cause breathing problems
as well as a rapid drop in blood pressure that can also lead to fainting (anaphylactic reactions), swelling of the face, angina (chest pain or discomfort; also known as angina
pectoris), feeling unwell, allergic skin rash, itching, rash (skin eruption),
skin blisters (urticaria).
Among the uncommon effects, some changes in blood tests have been found, such as:
Decrease in a type of blood cells, platelets (thrombocytopenia).
Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, lack of energy.
Among the rare effects, some changes in blood tests have been found, such as:
increased potassium in the blood

Hydrochlorothiazide:
Very common side effects (may affect more than 1 in 10 people):
Changes in blood tests, such as: Increased levels of fats and uric acid in the blood.
Common side effects (may affect up to 1 in 10 people):
Feeling of confusion, abdominal pain, stomach upset, feeling of fullness, diarrhea,
nausea, vomiting, constipation, excretion of glucose in the urine.
Among the common effects, some changes in blood tests have been found, such as:
increased levels of creatinine, urea, calcium and glucose in the blood, reduced levels of chloride,
potassium, magnesium and sodium in the blood. Increased serum amylase (hyperamylasemia).
Uncommon side effects (may affect up to 1 in 100 people):
Decreased or loss of appetite, severe breathing difficulties, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions to light, itching,
purple spots on the skin due to small hemorrhages (purpura), skin blisters (urticaria).
Rare side effects (may affect up to 1 in 1,000 people):
Swollen and painful salivary glands, decreased number of white blood cells, decreased number
of platelets, anemia, bone marrow damage, restlessness, feeling “down” or
depression, sleep problems, feeling of disinterest (apathy), tingling and numbness, seizures,
objects that are looked at appear yellow, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism)
inflammation of the lungs, fluid accumulation in the lungs, inflammation of the pancreas, jaundice,
infection of the gallbladder, symptoms of lupus erythematosus (such as rash, joint pain and cold hands
and fingers), allergic skin reactions, peeling and blistering of the skin,
non-infectious inflammation of the kidney (interstitial nephritis), fever, muscle weakness (which sometimes
causes difficulty moving).
Very rare side effects (may affect up to 1 in 10,000 people):
Electrolyte disturbances causing an abnormal reduction in chloride levels in the blood (hypochloremic alkalosis), paralytic intestinal obstruction (ileus).
Acute respiratory distress (signs include severe shortness of breath, fever, weakness and
confusion).
Not known (frequency cannot be estimated based on available data)
Skin and lip tumor (non-melanoma skin cancer).
Decreased visual acuity 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 side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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 medoxomil and Idroclorotiazide Teva Italia

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 which is stated on the blister and the box after
“Exp,”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 medoxomil and Hydrochlorothiazide Teva Italia contains

• The active ingredients are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
• The active ingredients are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
• The active ingredients are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
• The active ingredients are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
• The other excipients are: Tablet core:Lactose monohydrate, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, cellulose, microcrystalline type 102, magnesium stearate Tablet coating:[Refers only to 20 mg/12.5 mg and 40 mg/12.5 mg tablets] Opadry II Orange 33G23991 containing: Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin (E1518), yellow iron oxide (E172), red iron oxide (E172), Sunset Yellow FCF aluminum lake (E110)

[Refers only to 20 mg/25 mg and 40 mg/25 mg tablets] Opadry II Pink 33G34149
containing: Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350,
triacetin (E1518), yellow iron oxide (E172), red iron oxide (E172)

Description of the appearance of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia and package contents
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 20 mg/12.5 mg film-coated tablets are
orange, round, biconvex, with a diameter of 8.5 mm and with OH 21 engraved on one side.
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 20 mg/25 mg film-coated tablets are
pink, round, biconvex, with a diameter of 8.5 mm and with OH 22 engraved on one side.
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 40 mg/12.5 mg film-coated tablets are
orange, oval, biconvex, 15 x 7 mm and with OH 41 engraved on one side.
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 40 mg/25 mg film-coated tablets are
pink, oval, biconvex, 15 x 7 mm and with OH 42 engraved on one side.

Pack size
Blisters (Al-Al): 14, 28, 30, 56, 98 film-coated tablets
Calendar blisters (Al-Al): 28 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Marketing authorization holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
Manufacturer
Actavis Ltd.,
BLB 015-016 Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta