OLMESARTAN 20 mg /12,5 Mg Фильм-Coated Таблетки

Содержание инструкции

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

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

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 may 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 and HYDROCHLOROTHIAZIDE DOC is and what it is used for
• 2. What you need to know before you take 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 is OLMESARTAN and IDROCLOROTIAZIDE DOC and what is it used for

OLMESARTAN and IDROCLOROTIAZIDE DOC contains two active ingredients, olmesartan medoxomil and
hydrochlorothiazide, which are used for the treatment of high blood pressure (hypertension):

• Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists”. It lowers blood pressure by relaxing the blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body to eliminate excess fluids by causing the kidneys to produce more urine.

You will be given OLMESARTAN and IDROCLOROTIAZIDE DOC if olmesartan medoxomil alone has not
adequately controlled your blood pressure. When given together, the two active ingredients of
OLMESARTAN and IDROCLOROTIAZIDE DOC help to lower blood pressure more than if they are administered
alone.
You may already be taking medicines to treat high blood pressure, but your doctor may prescribe
OLMESARTAN and IDROCLOROTIAZIDE DOC to lower it even further.
High blood pressure can be controlled with medicines such as OLMESARTAN and IDROCLOROTIAZIDE DOC
tablets. Your doctor has probably also recommended that you make some changes to your lifestyle to help
lower your blood pressure (for example, lose weight, stop smoking, reduce
alcohol intake and reduce the amount of salt in your diet). Your doctor may also have advised you to do
regular exercise, such as walking or swimming. It is important that you follow this advice from your doctor.

2. What you need to know before taking OLMESARTAN and IDROCLOROTIAZIDE DOC

Do not take OLMESARTAN and IDROCLOROTIAZIDE DOC

• if you are allergic to olmesartan medoxomil or to hydrochlorothiazide, or to 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 and IDROCLOROTIAZIDE even during the first months of pregnancy - see section “Pregnancy”)
• if you have diabetes or impaired kidney function and are being treated with a medicine that lowers blood pressure, containing aliskiren
• if you have low levels of potassium, sodium, or high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood that do not improve following 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 problems with bile flow from the gallbladder (bile obstruction, for example 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 problems with bile flow from the gallbladder (bile obstruction, for example 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, pharmacist or nurse before taking OLMESARTAN and
IDROCLOROTIAZIDE DOC.
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

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (such as
potassium) in your blood at regular intervals.
See also what is stated under “Do not take OLMESARTAN and IDROCLOROTIAZIDE DOC”.
Before taking the medicine, consult your doctorif you have any of the following health problems:

• Liver problems
• Heart failure or problems with heart valves or heart muscle
• Severe or prolonged vomiting or diarrhea
• Treatment with high doses of diuretics or if you are on 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. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking OLMESARTAN and IDROCLOROTIAZIDE DOC.
• If you have blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a period of a few hours to a week after taking OLMESARTAN and IDROCLOROTIAZIDE DOC. If left untreated, this can lead to permanent vision loss. If you have 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 doctorif you experience any of the following symptoms:

• severe, persistent diarrhea that causes significant weight loss. Your doctor may assess the symptoms and decide how to continue treatment for blood pressure.
• blurred vision or eye pain. These may be symptoms of increased pressure inside the eye and may occur within hours or weeks of starting treatment with OLMESARTAN AND IDROCLOROTIAZIDE DOC. If left untreated, this can lead to permanent vision loss.

Your doctor may want to see you more often and do some tests if you are in any of these conditions.
OLMESARTAN and IDROCLOROTIAZIDE DOC may 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 periodic blood tests
to assess these conditions.
It can alter the levels of certain substances, called electrolytes, in the blood. Your doctor will probably
perform periodic blood tests to assess these conditions. Signs of electrolyte disturbances 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 these symptoms appear.
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. Your doctor will therefore
carefully monitor your blood pressure.
If you need to have tests for parathyroid function, you must stop taking OLMESARTAN and
IDROCLOROTIAZIDE DOC before performing these tests.
If you are practicing sports, this medicine may alter the results of a doping test, making it positive.
You must inform your doctor if you think you are pregnant or planning to become pregnant.
OLMESARTAN and IDROCLOROTIAZIDE DOC is not recommended in early pregnancy and must not
be taken if you are pregnant for more than three months as it can cause serious harm to the baby if
taken during that period (see section “pregnancy”).

Children and adolescents
OLMESARTAN and IDROCLOROTIAZIDE DOC is not recommended in children and adolescents under
18 years of age.

Other medicines and OLMESARTAN and IDROCLOROTIAZIDE DOC
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 medicines:

• Other medicines that lower blood pressure (antihypertensives) may increase the effect of OLMESARTAN AND IDROCLOROTIAZIDE 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 what is stated under “Do not take OLMESARTAN AND IDROCLOROTIAZIDE DOC” and “Warnings and precautions”).
• Medicines that can alter the levels of potassium in the blood if used together with OLMESARTAN and IDROCLOROTIAZIDE DOC. These include: potassium supplements (such as salt substitutes containing potassium) or diuretics or heparin (to thin the blood) or laxatives or steroids or adrenocorticotropic hormone (ACTH) or carbenoxolone (a medicine used to treat mouth and stomach ulcers) or sodium penicillin G (also called benzylpenicillin sodium, an antibiotic) or some painkillers such as aspirin or salicylates
• Lithium (a medicine used to treat mood swings and some types of depression) used together with

OLMESARTAN and IDROCLOROTIAZIDE DOC may increase the toxicity of lithium. If you need to take
lithium, your doctor will measure the levels of lithium in your blood

• Non-steroidal anti-inflammatory drugs (NSAIDs), used to reduce pain, swelling and any other symptoms of inflammation, including arthritis) may increase the risk of kidney failure if used together with OLMESARTAN and IDROCLOROTIAZIDE DOC and the effectiveness of OLMESARTAN and IDROCLOROTIAZIDE DOC may be reduced by NSAIDs
• Sleeping pills, sedatives and antidepressants, because these medicines used together with OLMESARTAN and IDROCLOROTIAZIDE DOC may cause a sudden drop in blood pressure when getting up
• Some 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 to reduce fats in the blood
• Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may decrease the effect of OLMESARTAN and IDROCLOROTIAZIDE DOC. Your doctor may advise you to take OLMESARTAN and IDROCLOROTIAZIDE DOC 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 some psychiatric disorders
• Some medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digoxin, used to treat heart problems
• 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 glucose levels in the blood
• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar levels, respectively, as OLMESARTAN and IDROCLOROTIAZIDE DOC may increase their blood sugar-raising 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, used for stomach acidity, such as aluminum and magnesium hydroxide, because they may slightly reduce the effect of OLMESARTAN and IDROCLOROTIAZIDE DOC
• Cisapride, used to increase the movement of food in the stomach and intestines
• Allofantine, used for malaria
• If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking OLMESARTAN and IDROCLOROTIAZIDE DOC, consult a doctor immediately.

OLMESARTAN and IDROCLOROTIAZIDE DOC with food, drinks and alcohol
OLMESARTAN and IDROCLOROTIAZIDE DOC can be taken with or without food.
Be careful to drink alcohol while taking OLMESARTAN and IDROCLOROTIAZIDE DOC,
as some people may experience fainting or dizziness. If this happens to you, do not drink
any more alcohol, including wine, beer or alcoholic beverages.

Black patients
As with other similar medicines, the blood pressure-lowering effect of OLMESARTAN and
IDROCLOROTIAZIDE DOC is somewhat reduced in black patients.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you are pregnant or if there is a possibility of becoming
pregnant. As a rule, your doctor will advise you to stop taking OLMESARTAN and
IDROCLOROTIAZIDE DOC before you become pregnant or as soon as you find out you are pregnant and will
advise you to take another medicine instead of OLMESARTAN and IDROCLOROTIAZIDE DOC.
OLMESARTAN and IDROCLOROTIAZIDE DOC is not recommended during pregnancy and must not
be taken if you are pregnant for more than three 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 planning to start breastfeeding. OLMESARTAN and
IDROCLOROTIAZIDE DOC is not recommended in mothers during breastfeeding and your doctor may choose
another treatment for you if you wish to breastfeed.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or
pharmacist for advice before taking this medicine.

Driving and using machines
You may feel drowsy or dizzy while being treated for high blood pressure. If this happens, do not drive or
use machines until the symptoms have disappeared. Ask your doctor for advice.
20 mg/12,5 mg and 40 mg/12,5 mg

OLMESARTAN and IDROCLOROTIAZIDE DOC contains lactose (a type of sugar) and yellow
sunset
Lactose: if your doctor has told you that you have an intolerance to some sugars, contact them before taking
this medicine.
Yellow sunset: may cause allergic reactions.
20 mg/25 mg and 40 mg/25 mg

OLMESARTAN and IDROCLOROTIAZIDE DOC contains lactose (a type of sugar).
If your doctor has told you that you have an intolerance to some sugars, contact them before taking this
medicine.

3. How to take OLMESARTAN and IDROCLOROTIAZIDE DOC

Always take this medicine exactly as your doctor has instructed. If you have any doubts, ask your
doctor or pharmacist.
20 mg/12.5 mg and 20 mg/25 mg

The recommended doseis one tablet of OLMESARTAN and IDROCLOROTIAZIDE DOC 20 mg/12.5
mg per day. However, if blood pressure is not controlled, your doctor may decide to change the dose to one
tablet of OLMESARTAN and IDROCLOROTIAZIDE DOC 20 mg/25 mg per day.
40 mg/12.5 mg and 40 mg/25 mg

The recommended doseis one tablet of OLMESARTAN and IDROCLOROTIAZIDE DOC 40 mg/12.5
mg per day. However, if blood pressure is not controlled, your doctor may decide to change the dose to one
tablet of OLMESARTAN and IDROCLOROTIAZIDE DOC 40 mg/25 mg per day.
Swallow the tablets with a little water. If possible, take the dose every day at the same time, for
example at breakfast time. It is important to continue taking OLMESARTAN and
IDROCLOROTIAZIDE DOC until your doctor tells you to stop.

If you take more OLMESARTAN and IDROCLOROTIAZIDE DOC than you should
If you take more tablets than you should, or if a child accidentally swallows one or more tablets, go
immediately to your doctor or the nearest emergency room, bringing the medicine packaging with you.

If you forget to take OLMESARTAN and IDROCLOROTIAZIDE DOC
If you forget to take a dose, take the usual dose the next day. Do not take a double dose
to make up for a forgotten dose.

If you stop taking OLMESARTAN and IDROCLOROTIAZIDE DOC
It is important to continue taking OLMESARTAN and IDROCLOROTIAZIDE DOC unless your doctor
tells you to stop.
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 two side effects can be serious:

• Allergic reactions that can affect the whole body with swelling of the face, mouth and/or larynx (the site of the vocal cords) associated with itching and rash, can occur rarely. Ifthishappens,stoptreatmentwithOLMESARTANandIDROCLOROTIAZIDE DOC and contact your doctor immediately.
• OLMESARTAN and IDROCLOROTIAZIDE DOC can cause an excessive reduction in blood pressure in predisposed individuals or as a result of an allergic reaction. Dizziness or fainting can occur infrequently. If this happens, stop treatment withOLMESARTAN and IDROCLOROTIAZIDE DOC, contact your doctor immediately and lie down.OLMESARTAN and IDROCLOROTIAZIDE DOC is a combination of two active ingredients and the following information first mentions other side effects reported so far with the combination of olmesartan medoxomil and hydrochlorothiazide (in addition to those already reported above) and subsequently those known for the separate active ingredients.

Other side effects known so far with the combination of olmesartan and hydrochlorothiazide:
If these effects occur, they are generally 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)
Perception of heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal
pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain, arm and
leg pain, back pain, difficulty with erection in men, blood in the urine.
Alterations in blood test results have also been observed infrequently, including:
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 glucose in the blood, increased liver function indices. 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 1000):
Feeling unwell, disturbances of consciousness, skin blisters (urticaria), acute kidney failure.
Alterations in blood tests have also been observed rarely, including:
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 and IDROCLOROTIAZIDE DOC or with a higher 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, diarrhea, nausea,
gastroenteritis, joint or bone pain, back pain, blood in the urine, urinary tract infection, flu-like symptoms, pain.
Alterations in laboratory tests have also been observed commonly, including: increased
levels of fats in the blood, increased levels of urea or uric acid in the blood, increased liver
function and muscle indices.
Uncommon side effects (may affect up to 1 in 100):
Immediate allergic reactions that can affect the whole body and can cause breathing problems or rapid drop in blood pressure that can also lead to fainting (anaphylactic reactions), swelling of the face, angina (chest pain or discomfort, known as angina
pectoris), feeling unwell, allergic skin reaction, itching, rash (skin eruption), skin blisters (urticaria).
Alterations in blood tests have also been observed infrequently, including:
reduction in the number of certain blood cells called platelets (thrombocytopenia).
Rare side effects (may affect up to 1 in 1000):
Impaired kidney function, lack of energy.
Alterations in laboratory tests have also been observed rarely, including:
increased potassium in the blood.

Hydrochlorothiazide
Very common side effects (may affect more than 1 in 10 people):
Alterations in blood tests including: 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 discomfort, feeling of fullness, diarrhea, nausea, vomiting,
constipation, elimination of glucose with urine.
Alterations in blood tests have also been observed, including:
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):
Decreased or loss of appetite, severe breathing difficulties, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions to light, itching, purplish spots or
patches on the skin due to small hemorrhages (purpura), skin blisters (urticaria).
Rare side effects (may affect up to 1 in 1000):
Swollen and painful salivary glands, decreased number of white blood cells, decreased number
of platelets, anemia, bone marrow damage, restlessness, feeling of depression, sleep disturbances,
lack of interest (apathy), tingling and numbness, convulsions, 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, 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, skin peeling and blisters, non-infectious inflammation of the kidney (interstitial nephritis), fever, muscle weakness (sometimes causing limitations of movement).
Very rare side effects (may affect up to 1 in 10,000):
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):
Rapid onset of distant vision impairment (acute myopia), decreased vision 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, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package and on the blister 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 and IDROCLOROTIAZIDE DOC contains
The active ingredients are olmesartan medoxomil and hydrochlorothiazide. One tablet contains 20 mg of olmesartan
medoxomil and 12.5 mg of hydrochlorothiazide.
The active ingredients are olmesartan medoxomil and hydrochlorothiazide. One tablet contains 20 mg of olmesartan
medoxomil and 25 mg of hydrochlorothiazide
The active ingredients are olmesartan medoxomil and hydrochlorothiazide. One tablet contains 40 mg of olmesartan
medoxomil and 12.5 mg of hydrochlorothiazide
The active ingredients are olmesartan medoxomil and hydrochlorothiazide. One tablet contains 40 mg of olmesartan
medoxomil and 25 mg of hydrochlorothiazide
The other ingredients are:

Tablet core:lactose monohydrate, 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), lactose monohydrate,
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), lactose monohydrate, macrogol
3350, triacetin (E1518), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of OLMESARTAN and IDROCLOROTIAZIDE DOC and package contents
The tablets of OLMESARTAN and IDROCLOROTIAZIDE DOC 20 g/12.5 mg are film-coated,
orange, round, biconvex, with a diameter of 8.5 mm and with the inscription OH21 on one side
The tablets of OLMESARTAN and IDROCLOROTIAZIDE DOC 20 g/25 mg are film-coated, pink,
round, biconvex, with a diameter of 8.5 mm and with the inscription OH22 on one side
The tablets of OLMESARTAN and IDROCLOROTIAZIDE DOC 40 g/12.5 mg are film-coated,
orange, oval, biconvex, 15x7 mm and with the inscription OH41 on one side
The tablets of OLMESARTAN and IDROCLOROTIAZIDE DOC 40 mg/25 mg are film-coated, pink,
oval, biconvex, 15x7mm and with the inscription OH42 on one side

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

Marketing authorisation holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan

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 authorised in the Member States of the European Economic Area with the following
names:
Estonia Olsert HCT Sigillata
Italy OLMESARTAN and IDROCLOROTIAZIDE DOC