Olmesartan medoxomil and hydrochlorothiazide Teva Italia: detailed information

Package leaflet: Information for the patient

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
Equivalent 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Olmesartan medoxomil and Hydrochlorothiazide Teva Italia is and what it is used for
What you need to know before taking Olmesartan medoxomil and Hydrochlorothiazide Teva Italia
How to take Olmesartan medoxomil and Hydrochlorothiazide Teva Italia
Possible side effects
How to store Olmesartan medoxomil and Hydrochlorothiazide Teva Italia
Contents of the pack and other information

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

Olmesartan medoxomil and Hydrochlorothiazide Teva Italia contains two active substances 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 by relaxing blood vessels.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It reduces blood pressure by helping the body get rid of excess fluid, causing the kidneys to produce more urine.

Olmesartan medoxomil and Hydrochlorothiazide Teva Italia will be prescribed to you only if olmesartan medoxomil alone has not been sufficient to adequately control your blood pressure. When administered together, the two active substances in Olmesartan medoxomil and Hydrochlorothiazide Teva Italia help reduce blood pressure more than when administered separately. You may already be taking medicines to treat high blood pressure, but your doctor may prescribe Olmesartan medoxomil and Hydrochlorothiazide Teva Italia to further lower it. High blood pressure can be controlled with medicines such as Olmesartan medoxomil and Hydrochlorothiazide Teva Italia tablets. Your doctor has likely also recommended that you make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and reducing salt in your diet). Your doctor may also strongly advise regular physical activity, such as walking or swimming. It is important that you follow these recommendations from your doctor.

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 (sulfonamides)
if you are more than three months pregnant (use of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia is advised to be avoided even during the first months of pregnancy – see section on pregnancy)
if you have low levels of potassium or sodium, or 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 impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren. [Applies only to dosages 20 mg/12.5 mg and 20 mg/25 mg]
if you have severe kidney problems
if you have severe liver problems or yellowing of the skin and eyes (jaundice), or conditions related to bile drainage from the gallbladder (biliary obstruction or gallstones) [Applies only to dosages 40 mg/12.5 mg and 40 mg/25 mg]
if you have kidney problems
if you have severe liver problems or yellowing of the skin and eyes (jaundice), or conditions related to bile drainage from the gallbladder (biliary obstruction or gallstones). If you think any of these conditions apply to you, or are unsure, 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 this medicine, consult your doctor if you are taking any of the following medicines used
to treat high blood pressure:

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

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.
See also the section “Do not take Olmesartan medoxomil and Hydrochlorothiazide Teva Italia”.
Before taking this medicine, consult your doctor if you also have any of the following health conditions:

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 diuretics or if you are on a low-salt diet
adrenal gland problems (e.g., primary hyperaldosteronism)
diabetes
systemic lupus erythematosus (an autoimmune disease)
allergies or asthma
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 during treatment with Olmesartan medoxomil and Hydrochlorothiazide Teva Italia.
if you have previously experienced respiratory or lung problems (including lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. Consult a doctor immediately if you experience shortness of breath or any breathing difficulties after taking Olmesartan medoxomil and Hydrochlorothiazide Teva Italia.
[Applies only to dosages 20 mg/12.5 mg and 20 mg/25 mg]
mild to moderate kidney problems, or if you have had a kidney transplant [Applies only to dosages 40 mg/12.5 mg and 40 mg/25 mg]
kidney transplant

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

severe and prolonged diarrhoea with significant weight loss. Your doctor will assess your symptoms and decide whether to continue this antihypertensive treatment.
decreased visual acuity and 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 several weeks after taking Olmesartan medoxomil and Hydrochlorothiazide Teva Italia. If left untreated, this condition may lead to permanent vision loss. If you have recently had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this symptom.

Your doctor may want to examine you more frequently and perform blood tests if you are in any of the following conditions.
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia may increase blood lipid and uric acid levels (which can cause gout – painful joint swelling). Your doctor will likely perform periodic blood tests to monitor these conditions.
This medicine may alter blood levels of certain substances called electrolytes. Your doctor will likely 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), weakness, apathy, fatigue, drowsiness or restlessness, nausea, vomiting, reduced need to urinate, and rapid heartbeat. Inform your doctor if you experience these symptoms.
As with any medicine that lowers blood pressure, excessive reduction in blood pressure in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.
If you are undergoing parathyroid function tests, you must stop taking Olmesartan medoxomil and Hydrochlorothiazide Teva Italia before the test.
If you engage in sports, this medicine may affect doping test results, causing a positive outcome.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Olmesartan medoxomil and Hydrochlorothiazide Teva Italia is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if taken during this period (see section “Pregnancy”).
Children and adolescents
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia is not recommended for children and adolescents under 18 years of age.
Other medicines and Olmesartan medoxomil and Hydrochlorothiazide Teva Italia
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 the following:

Other medicines that lower blood pressure (antihypertensives) may increase the effect of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia.
Your doctor may need to adjust the dose and/or take additional precautions:
If you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take Olmesartan medoxomil and Hydrochlorothiazide Teva Italia” and “Warnings and precautions”).
Medicines that may 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 known as sodium benzylpenicillin, an antibiotic)
certain painkillers such as aspirin or salicylates
Lithium (a medicine used to treat mood swings and certain types of depression) taken together with Olmesartan medoxomil and Hydrochlorothiazide Teva Italia may increase lithium toxicity. If you are taking 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) taken together with 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 taking these medicines together with Olmesartan medoxomil and Hydrochlorothiazide Teva Italia may cause a sudden drop in blood pressure upon standing.
Certain medicines such as baclofen and tubocurarine, used to relax muscles.
Amifostine and certain other medicines used in cancer treatment, such as cyclophosphamide or methotrexate.
Cholestyramine and colestipol, medicines used to reduce blood fats.
Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may reduce the effect of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia. 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 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 digitalis, used to treat heart conditions.
Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or intravenous 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 hypertension or hypoglycemia, respectively, as Olmesartan medoxomil and Hydrochlorothiazide Teva Italia may enhance their hyperglycemic effect.
Methyldopa, a medicine used to treat high blood pressure.
Medicines such as noradrenaline, used to increase blood pressure and slow heart rate.
Difemanil, used to treat slow heart rate 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 rejection of transplanted organs.
Certain antibiotics called tetracyclines or sparfloxacin.
Amphotericin, a medicine used to treat fungal infections.
Certain antacids, such as aluminium and magnesium hydroxide (used for stomach acidity), as they may reduce the effectiveness of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia.
Cisapride, used to increase movement of food through the stomach and intestines.
Halofantrine, used to treat 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 cautious when consuming alcohol during treatment with Olmesartan medoxomil and Hydrochlorothiazide Teva Italia, as some people may experience fainting or dizziness. If this happens to you, do not drink any alcoholic beverages, including wine, beer, or carbonated 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 athletes: using the drug without therapeutic need constitutes doping and may result in a positive doping test.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
Pregnancy
Inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually 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 recommend an alternative medicine. Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 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 baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Olmesartan medoxomil and Hydrochlorothiazide Teva Italia is not recommended for nursing mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.
Driving and using machines
You may experience drowsiness or dizziness while being treated for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor.
[Applies only to tablets 20 mg/12.5 mg and 40 mg/12.5 mg]
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia contains lactose and sunset yellow
Lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicinal product.
Sunset yellow: may cause allergic reactions
[Applies only to dosages 20 mg/25 mg and 40 mg/25 mg]
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Olmesartan medoxomil and Hydrochlorothiazide Teva Italia

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
[Applies only to dosage strengths 20 mg/12.5 mg and 20 mg/25 mg]
The recommended dose of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 20 mg/12.5 mg is one tablet daily. However, if your blood pressure is not adequately controlled, your doctor may decide to change your prescription to one tablet daily of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 20 mg/25 mg.
[Applies only to dosage strengths 40 mg/12.5 mg and 40 mg/25 mg]
The recommended dose of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 40 mg/12.5 mg is one tablet daily. However, if your blood pressure is not adequately controlled, your doctor may decide to change your prescription to one tablet daily of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia 40 mg/25 mg.
Swallow the tablets with a little water. Do not chew, crush or break the tablets. Take your dose at the same time each day, for example with breakfast. It is important to continue taking Olmesartan medoxomil and Hydrochlorothiazide Teva Italia for as long as your doctor considers it necessary.

If you take more Olmesartan medoxomil and Hydrochlorothiazide Teva Italia than you should
If you take more tablets than prescribed, or if a child accidentally swallows one or more tablets, contact your doctor or the nearest emergency department immediately. Take the medicine pack with you.

If you forget to take Olmesartan medoxomil and Hydrochlorothiazide Teva Italia
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 treatment with Olmesartan medoxomil and Hydrochlorothiazide Teva Italia
It is important to continue taking Olmesartan medoxomil and Hydrochlorothiazide Teva Italia for as long as your doctor considers it necessary.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Allergic reactions affecting 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 Hydrochlorothiazide Teva Italia and contact your doctor immediately.
Olmesartan medoxomil and Hydrochlorothiazide Teva Italia may cause excessive lowering of blood pressure in predisposed individuals or as a result of an allergic reaction. Dizziness or fainting are not common. If this happens, stop taking Olmesartan medoxomil and Hydrochlorothiazide Teva Italia, contact your doctor immediately and lie down.
Frequency not known: If you develop yellowing of the sclera (white part of the eyes), dark urine, or skin itching, even if you have been taking Olmesartan medoxomil and Hydrochlorothiazide Teva Italia for a long time, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with treatment.

Olmesartan medoxomil and Hydrochlorothiazide Teva Italia is a combination of two active substances. The following information first lists other side effects reported so far with the combination of Olmesartan medoxomil and Hydrochlorothiazide Teva Italia (in addition to those already mentioned above), followed by those known for each individual active substance.

These are the other known side effects reported so far with Olmesartan medoxomil and Hydrochlorothiazide Teva Italia:
If these side effects occur, they are often mild and you do not need to 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):
Drowsiness, rapid heartbeat (palpitations), skin rash, eczema, dizziness, 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.

Among the uncommon side effects, some blood test abnormalities have been observed, 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 glucose (glucose level in the blood), increased 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):
Feeling unwell, disturbances in consciousness, skin blisters (wheals), acute kidney impairment.

Among the rare side effects, some blood test abnormalities have been observed, such as:
increased blood urea nitrogen, decreased haemoglobin and haematocrit values. Your doctor will detect these from blood tests and will inform you if any action is needed.

Additional side effects reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with Olmesartan medoxomil and Hydrochlorothiazide Teva Italia or at a different frequency:

Olmesartan medoxomil:
Common side effects (may affect up to 1 in 10 people):
Bronchitis, cough, nasal congestion or runny nose, sore throat, abdominal pain, indigestion, diarrhoea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain.

Among the common side effects, some blood test abnormalities have been observed, such as:
increased levels of fats in the blood, increased levels of urea or uric acid in the blood, increased liver and muscle function tests.

Uncommon side 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 lead to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort; known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin rash), skin blisters (wheals).

Among the uncommon side effects, some blood test abnormalities have been observed, such as:
decrease in platelets (thrombocytopenia), a type of blood cell.

Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, lack of energy.

Among the rare side effects, some blood test abnormalities have been observed, such as:
increased potassium in the blood.

Hydrochlorothiazide:
Very common side effects (may affect more than 1 in 10 people):
Blood test abnormalities, such as: increased levels of fats and uric acid in the blood.

Common side effects (may affect up to 1 in 10 people):
Confusion, abdominal pain, stomach discomfort, bloating, diarrhoea, nausea, vomiting, constipation, glucose in urine.

Among the common side effects, some blood test abnormalities have been observed, such as:
increased levels of creatinine, urea, calcium and glucose in the blood, decreased 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, photosensitivity skin reactions, itching, 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, decreased number of white blood cells, decreased number of platelets, anaemia, bone marrow damage, restlessness, feeling low or depressed, sleep disturbances, feeling of disinterest (apathy), tingling and numbness, seizures, objects appearing yellow when looked at, 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 pain, cold hands and fingers), skin allergic reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which may sometimes cause difficulty in movement).

Very rare side effects (may affect up to 1 in 10,000 people):
Electrolyte disturbances causing abnormally low chloride levels in the blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus).

Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Not known (frequency cannot be estimated from the available data):
Skin and lip cancer (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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Hydrochlorothiazide 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 stated on the blister pack and outer carton after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 medoxomil and Hydrochlorothiazide Teva Italia contains

The active substances are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
The active substances are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
The active substances are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
The active substances are olmesartan medoxomil and hydrochlorothiazide. Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
Other components (excipients) are: Tablet core: Lactose monohydrate, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, microcrystalline cellulose type 102, magnesium stearate. Tablet coating: [Applies 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 aluminium lake (E110).

[Applies 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 contents of the
pack

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 marked with "OH 21" 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 marked with "OH 22" 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 marked with "OH 41" 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 marked with "OH 42" on one side.

Pack sizes
Blister packs (AI-AI): 14, 28, 30, 56, 98 film-coated tablets
Calendar blister packs (AI-AI): 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
The Netherlands

Manufacturer
Actavis Ltd.,
BLB 015-016 Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta