Olmesartan and hydrochlorothiazide Doc Generici

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 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 their symptoms are the same as yours, as it may 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:

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

1. What OLMESARTAN and HYDROCHLOROTHIAZIDE DOC is and what it is used for

OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 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 reduces blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

You will be given OLMESARTAN and HYDROCHLOROTHIAZIDE DOC if olmesartan medoxomil alone has not
adequately controlled your blood pressure. When given together, the two active substances in
OLMESARTAN and HYDROCHLOROTHIAZIDE DOC help lower blood pressure more than when administered separately.
You may already be taking medicines to treat high blood pressure, but your doctor may prescribe
OLMESARTAN and HYDROCHLOROTHIAZIDE DOC to further reduce it.
High blood pressure can be controlled with medicines such as OLMESARTAN and HYDROCHLOROTHIAZIDE DOC
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 decreasing the amount of salt in your diet). Your doctor may also have encouraged you to exercise regularly, such as walking or swimming. It is important that you follow these recommendations from your doctor.

2. What you should know before taking OLMESARTAN and HYDROCHLOROTHIAZIDE DOC

Do not take OLMESARTAN and HYDROCHLOROTHIAZIDE DOC

• 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 (use of OLMESARTAN and HYDROCHLOROTHIAZIDE is also advised against during the first months of pregnancy – see section “Pregnancy”)
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren
• if you have low levels of potassium or sodium, or high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood that do not improve with treatment

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 bile flow problems from the gallbladder (biliary obstruction, for example due to gallstones)

40 mg/12.5 mg and 40 mg/25 mg

• if you have kidney problems
• if you have severe or moderate liver problems or yellowing of the skin and eyes (jaundice) or bile flow problems from the gallbladder (biliary obstruction, for example due to 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, pharmacist, or nurse before taking OLMESARTAN and
HYDROCHLOROTHIAZIDE DOC.
Before taking the medicine, consult your doctor if you are taking any of the following medicines used to
treat high blood pressure:

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

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (for
example potassium) in your blood at regular intervals.
See also the section “Do not take OLMESARTAN and HYDROCHLOROTHIAZIDE DOC”.
Before taking the medicine, consult your doctor if you have any of the following health problems:

• Liver problems
• Heart failure or heart valve or heart muscle problems
• Severe or prolonged vomiting or diarrhoea
• Treatment with high doses of diuretics or if you are on a low-salt diet
• Adrenal gland problems (for example primary aldosteronism)
• Diabetes
• Lupus erythematosus (an autoimmune disease)
• Allergies or asthma
• If you have previously had skin cancer or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking OLMESARTAN and HYDROCHLOROTHIAZIDE DOC.
• 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 pressure in the eye and may occur from a few hours to a week after taking OLMESARTAN and HYDROCHLOROTHIAZIDE DOC. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillins or sulfonamides, you may have a higher risk of developing this disorder.

(applies only to 20 mg/12.5 mg and 20 mg/25 mg)

• Mild or moderate kidney problems or if you have recently had a kidney transplant (applies only to 40 mg/12.5 mg and 40 mg/25 mg)
• Kidney transplant

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

• Severe, persistent diarrhoea causing significant weight loss. Your doctor may assess your symptoms and decide how to continue your blood pressure treatment.
• Vision loss or eye pain. These may be symptoms of increased pressure inside the eye and may appear within hours or weeks of starting treatment with OLMESARTAN and HYDROCHLOROTHIAZIDE DOC. If untreated, this may lead to permanent vision loss.

Your doctor may want to examine you more frequently and perform some tests if you are in any of these conditions.
OLMESARTAN and HYDROCHLOROTHIAZIDE DOC may increase levels of fats and uric acid (which causes gout – painful joint swelling) in the blood. Your doctor may want to carry out periodic blood tests to monitor these conditions.
It may alter levels of certain substances called electrolytes in the blood. Your doctor may want to carry out 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, rapid heartbeat. Inform your doctor if these symptoms occur.
As with any medicine that lowers blood pressure, excessive reduction in blood pressure in patients with blood flow disorders to the heart or brain may lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
If you need to undergo parathyroid function tests, you must stop taking OLMESARTAN and
HYDROCHLOROTHIAZIDE DOC before the tests.
If you engage in sports, this medicine may affect the results of anti-doping tests, causing a positive result.
Inform your doctor if you think you may be pregnant or plan to become pregnant.
OLMESARTAN and HYDROCHLOROTHIAZIDE DOC is not recommended during early pregnancy and must not
be taken if you are more than three months pregnant, as it may cause severe harm to the baby if taken during this period (see section “Pregnancy”).
Children and adolescents
OLMESARTAN and HYDROCHLOROTHIAZIDE DOC is not recommended for children and adolescents under
18 years of age.
Other medicines and OLMESARTAN and HYDROCHLOROTHIAZIDE DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
In particular, inform your doctor or pharmacist about the following medicines:

• Other medicines that lower blood pressure (antihypertensives) may enhance the effect of OLMESARTAN and HYDROCHLOROTHIAZIDE DOC. Your doctor may need to adjust the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also section “Do not take OLMESARTAN and HYDROCHLOROTHIAZIDE DOC” and “Warnings and precautions”).

• Medicines that may alter potassium levels in the blood when used together with OLMESARTAN and HYDROCHLOROTHIAZIDE DOC. These include: potassium supplements (such as potassium-containing 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 benzylpenicillin sodium, an antibiotic), or some painkillers such as aspirin or salicylates

• Lithium (a medicine used to treat mood swings and certain types of depression) used together with
  OLMESARTAN and HYDROCHLOROTHIAZIDE DOC may increase lithium toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood

• Non-steroidal anti-inflammatory drugs (NSAIDs), used to reduce pain, swelling, and other symptoms of inflammation, including arthritis, may increase the risk of kidney failure when used together with OLMESARTAN and HYDROCHLOROTHIAZIDE DOC, and the effectiveness of OLMESARTAN and HYDROCHLOROTHIAZIDE DOC may be reduced by NSAIDs

• Sleeping pills, sedatives, and antidepressants, as these medicines used together with OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 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 for cancer treatment, such as cyclophosphamide or methotrexate

• Cholestyramine and colestipol, medicines to reduce blood fats

• Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may reduce the effect of OLMESARTAN and HYDROCHLOROTHIAZIDE DOC. Your doctor may advise you to take OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 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 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 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 high blood pressure or low blood sugar, respectively, as OLMESARTAN and HYDROCHLOROTHIAZIDE DOC may enhance their hyperglycaemic 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 used for stomach acidity, such as aluminium and magnesium hydroxide, as they may slightly reduce the effect of OLMESARTAN and HYDROCHLOROTHIAZIDE DOC

• Cisapride, used to increase movement of food in the stomach and intestines

• Halofantrine, used for malaria

• If you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking OLMESARTAN and HYDROCHLOROTHIAZIDE DOC, consult a doctor immediately.

OLMESARTAN and HYDROCHLOROTHIAZIDE DOC with food, drinks, and alcohol
OLMESARTAN and HYDROCHLOROTHIAZIDE DOC may be taken with or without food.
Be cautious about consuming alcohol while taking OLMESARTAN and HYDROCHLOROTHIAZIDE DOC,
as some people may experience fainting or dizziness. If this happens to you, do not consume any more alcohol, including wine, beer, or carbonated alcoholic beverages.
Patients of African descent
As with other similar medicines, the blood pressure-lowering effect of OLMESARTAN and
HYDROCHLOROTHIAZIDE DOC is somewhat reduced in patients of African descent.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant or if you plan to become pregnant. Your doctor will usually advise you to stop taking OLMESARTAN and
HYDROCHLOROTHIAZIDE DOC before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of OLMESARTAN and HYDROCHLOROTHIAZIDE DOC.
OLMESARTAN and HYDROCHLOROTHIAZIDE DOC is not recommended during pregnancy and must not be
taken if you are more than three months pregnant, as it may cause severe harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to start breastfeeding. OLMESARTAN and
HYDROCHLOROTHIAZIDE DOC is not recommended for nursing mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice 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.
20 mg/12.5 mg and 40 mg/12.5 mg
OLMESARTAN and HYDROCHLOROTHIAZIDE DOC contains lactose (a type of sugar) and sunset
yellow
Lactose: if your doctor has told you that you have an intolerance to certain sugars, contact them before taking
this medicine.
Sunset yellow: may cause allergic reactions.
20 mg/25 mg and 40 mg/25 mg
OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 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 DOC

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

20 mg/12.5 mg and 20 mg/25 mg
The recommended dose is one tablet of OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 20 mg/12.5 mg daily. However, if blood pressure is not controlled, your doctor may decide to adjust the dose to one tablet of OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 20 mg/25 mg daily.

40 mg/12.5 mg and 40 mg/25 mg
The recommended dose is one tablet of OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 40 mg/12.5 mg daily. However, if blood pressure is not controlled, your doctor may decide to adjust the dose to one tablet of OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 40 mg/25 mg daily.

Swallow the tablets with a glass of water. If possible, take the dose at the same time each day, for example with breakfast. It is important to continue taking OLMESARTAN and HYDROCHLOROTHIAZIDE DOC unless your doctor tells you otherwise.

If you take more OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 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 nearest emergency department, and bring the medicine pack with you.

If you forget to take OLMESARTAN and HYDROCHLOROTHIAZIDE DOC
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 forgotten dose.

If you stop taking OLMESARTAN and HYDROCHLOROTHIAZIDE DOC
It is important to keep taking OLMESARTAN and HYDROCHLOROTHIAZIDE DOC unless your doctor tells you to stop.

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 everybody gets them.
However, the following two side effects can be serious:

• Allergic reactions affecting the whole body, with swelling of the face, mouth and/or larynx (the site of the vocal cords), associated with itching and skin rash, may occur rarely. If this happens, stop taking OLMESARTAN and IDROCLOROTIAZIDE DOC and contact your doctor immediately.
• OLMESARTAN and IDROCLOROTIAZIDE DOC may cause excessive lowering of blood pressure in susceptible individuals or as a result of an allergic reaction. Dizziness or fainting may occur uncommonly. If this happens, stop taking OLMESARTAN and IDROCLOROTIAZIDE DOC, contact your doctor immediately and lie down. OLMESARTAN and IDROCLOROTIAZIDE DOC is a combination of two active substances. The information below 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.

Other side effects reported so far with the olmesartan and hydrochlorothiazide combination:
If these effects occur, they are usually mild and treatment does not need to be stopped.
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)
Awareness of heartbeat (palpitations), skin rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle cramps and muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine.
Uncommonly, the following changes in blood test results have also been observed:
increase in blood fat levels, increase in blood urea or uric acid levels, increase in creatinine, increase or decrease in blood potassium levels, increase in blood calcium levels, increase in blood glucose, increase in liver function tests. Your doctor will detect these from blood tests and will advise 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 renal failure.
Rarely, the following changes in blood tests have also been observed:
Increase in blood urea nitrogen, decrease in haemoglobin and haematocrit values. Your doctor will detect these from blood tests and will advise you if any action is needed.

Additional side effects reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with OLMESARTAN and IDROCLOROTIAZIDE DOC or with different frequency:
Olmesartan medoxomil
Common side effects (may affect up to 1 in 10 people):
Bronchitis, cough, runny or stuffy 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.
Commonly observed laboratory test abnormalities include:
increase in blood fat levels, increase in blood urea or uric acid levels, increase in liver and muscle function tests.
Uncommon side effects (may affect up to 1 in 100 people):
Immediate allergic reactions affecting the whole body, which may cause breathing difficulties or 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 reaction, itching, rash (skin eruption), skin blisters (wheals).
Uncommonly, the following changes in blood tests have also been observed:
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, lack of energy.
Rarely, the following laboratory test abnormalities have also been observed:
increase in blood potassium levels.

Hydrochlorothiazide
Very common side effects (may affect more than 1 in 10 people):
Changes in blood tests including: increase in blood fat and uric acid levels.
Common side effects (may affect up to 1 in 10 people):
Feeling confused, abdominal pain, gastric disturbances, bloating sensation, diarrhoea, nausea, vomiting, constipation, glucose in urine.
Changes in blood tests have also been observed, including:
increase in blood creatinine, urea, calcium and glucose levels, decrease in blood chloride, potassium, magnesium and sodium levels. Increase in serum amylase (hyperamylasaemia).
Uncommon side effects (may affect up to 1 in 100 people):
Decreased or loss of appetite, severe breathing difficulties, cutaneous anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light-induced skin reactions, itching, purpuric spots or patches on the skin due to minor haemorrhages (purpura), skin blisters (wheals).
Rare side effects (may affect up to 1 in 1,000 people):
Swollen and painful salivary glands, decreased white blood cell count, decreased platelet count, anaemia, bone marrow damage, restlessness, feeling depressed, sleep disorders, lack of interest (apathy), tingling and numbness, seizures, seeing yellow objects, 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 lupus erythematosus such as skin rash, joint pain and cold hands and fingers, skin allergic reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing motor limitations).
Very rare side effects (may affect up to 1 in 10,000 people):
Electrolyte disturbances causing abnormally low blood chloride levels (hypochloraemic alkalosis). Intestinal blockage (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):
Sudden-onset reduction in distance vision (acute myopia), decreased vision or eye pain due to increased pressure (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 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: 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 DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What OLMESARTAN and HYDROCHLOROTHIAZIDE DOC contains
The active substances are olmesartan medoxomil and hydrochlorothiazide. One tablet contains 20 mg of olmesartan
medoxomil and 12.5 mg of hydrochlorothiazide.
The active substances are olmesartan medoxomil and hydrochlorothiazide. One tablet contains 20 mg of olmesartan
medoxomil and 25 mg of hydrochlorothiazide.
The active substances are olmesartan medoxomil and hydrochlorothiazide. One tablet contains 40 mg of olmesartan
medoxomil and 12.5 mg of hydrochlorothiazide.
The active substances are olmesartan medoxomil and hydrochlorothiazide. One tablet contains 40 mg of olmesartan
medoxomil and 25 mg of hydrochlorothiazide.

The other components are:
Tablet core: monohydrate lactose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose,
microcrystalline cellulose type 102, magnesium stearate.
Coating
20 mg/12.5 mg and 40 mg/12.5 mg
Opadry II Orange 33G23991 containing: hypromellose 6cP, titanium dioxide (E171), monohydrate lactose,
macrogol 3350, triacetin (E1518), yellow iron oxide (E172), red iron oxide (E172), sunset yellow FCF (E110).
20 mg/25 mg and 40 mg/25 mg
Opadry II Pink 33G34149 containing: hypromellose 6cP, titanium dioxide (E171), monohydrate lactose, macrogol
3350, triacetin (E1518), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of OLMESARTAN and HYDROCHLOROTHIAZIDE DOC and contents of the pack
OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 20 mg/12.5 mg tablets are film-coated,
orange, round, biconvex, 8.5 mm in diameter, with "OH21" engraved on one side.
OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 20 mg/25 mg tablets are film-coated, pink,
round, biconvex, 8.5 mm in diameter, with "OH22" engraved on one side.
OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 40 mg/12.5 mg tablets are film-coated,
orange, oval, biconvex, 15x7 mm, with "OH41" engraved on one side.
OLMESARTAN and HYDROCHLOROTHIAZIDE DOC 40 mg/25 mg tablets are film-coated, pink,
oval, biconvex, 15x7 mm, with "OH42" engraved on one side.

Packaging
Al-Al blisters containing 14, 28 or 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano, Italy

Manufacturer responsible for batch release
Actavis Ltd, BLB016, Bulebel Industrial Estate, ZTN 3000, Malta
Balkanpharma Dupnitsa AD, 3 Samokovsko Shosse Str, Dupnitsa 2600, Bulgaria

This medicinal product is authorized in the European Economic Area Member States under the following names:
Estonia: Olsert HCT Sigillata
Italy: OLMESARTAN and HYDROCHLOROTHIAZIDE DOC