OLMESARTAN 20 mg /12.5 Mg Film-Coated Tablets

Зміст інструкції

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

Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/12.5 mg film-coated tablets
Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 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 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 medoxomil and Hydrochlorothiazide Mylan is and what it is used for
• 2. What you need to know before you take Olmesartan medoxomil and Hydrochlorothiazide Mylan
• 3. How to take Olmesartan medoxomil and Hydrochlorothiazide Mylan
• 4. Possible side effects
• 5. How to store Olmesartan medoxomil and Hydrochlorothiazide Mylan
• 6. Contents of the pack and other information

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

Olmesartan medoxomil and Hydrochlorothiazide Mylan 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 get rid of excess fluids, causing the kidneys to produce more urine.

Olmesartan medoxomil and Hydrochlorothiazide Mylan will only be prescribed to you if olmesartan medoxomil
alone has not adequately controlled your blood pressure. When administered together, the two active ingredients of this medicine help to reduce 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 medoxomil and
Hydrochlorothiazide Mylan to achieve a further reduction.
High blood pressure can be controlled with medicines such as Olmesartan medoxomil and
Hydrochlorothiazide Mylan tablets. Your doctor has probably also recommended that you
make some changes to your lifestyle to help reduce your blood pressure
(for example, lose weight, stop smoking, reduce alcohol intake and reduce salt intake in your diet). Your doctor may have also urged you to exercise regularly, 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 Mylan

Do not take Olmesartan medoxomil and Hydrochlorothiazide Mylan

• 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 (sulphonamides)
• if you are pregnant for more than three months (it is advisable to avoid using Olmesartan medoxomil and Hydrochlorothiazide Mylan even during the first months of pregnancy - see section “Pregnancy”)
• if you have severe kidney problems
• if you have low levels of potassium or sodium, or if you have high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood that do not improve after treatment
• if you suffer from severe liver problems or yellowing of the skin and eyes (jaundice) or problems with the flow of bile from the gallbladder (biliary obstruction, for example gallstones)
• 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. If you think that any of these conditions apply to you, or you are not sure, do not take the tablets. Contact your doctor and follow their advice.

Warnings and precautions
Consult your doctorbefore taking Olmesartan medoxomil and Hydrochlorothiazide Mylan if you have any of the following health problems:

• Mild or moderate kidney problems or if you have had a recent kidney transplant
• Liver disease
• Heart failure or problems with heart valves or heart muscle
• Vomiting (feeling unwell) or severe or prolonged diarrhea
• 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 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 (for example potassium) in your blood at regular intervals.
See also what is stated in the section “Do not take Olmesartan medoxomil and Hydrochlorothiazide Mylan”.
Your doctor may want to visit you more often and do some tests if you are in any of the above conditions.
Olmesartan medoxomil and Hydrochlorothiazide Mylan 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 perform periodic blood tests to assess these conditions.
It can alter the levels of certain substances, called electrolytes, in the blood. Your doctor will probably want to perform periodic blood tests to assess these conditions. The signs of electrolyte alterations are: thirst, dry mouth, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), feeling weak, apathy, fatigue, drowsiness or restlessness, nausea, vomiting, reduced need to urinate, rapid heart rate. Tell your doctor if these symptoms occur.
As with any medicine that lowers blood pressure, an excessive reduction in pressure in patients with disorders 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 parathyroid function tests, you must stop taking Olmesartan medoxomil and Hydrochlorothiazide Mylan before performing 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 are pregnant or if you might become pregnant. Olmesartan medoxomil and Hydrochlorothiazide Mylan 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”).
During treatment
Tell your doctor if you experience any of the following symptoms:

• severe and prolonged diarrhea with significant weight loss. Your doctor will assess the symptoms and decide whether to continue this treatment for blood pressure.
• decreased vision or eye pain. These may be symptoms of increased pressure in your eye and can occur within hours or weeks of taking Olmesartan medoxomil and Hydrochlorothiazide Mylan. This increase, if left untreated, can lead to permanent vision impairment.

Children and adolescents (under 18 years of age)
Olmesartan medoxomil and Hydrochlorothiazide Mylan is not recommended in children and adolescents under 18 years of age.

Black patients
As with other similar medicines, the blood pressure-lowering effect of this medicine is somewhat reduced in black patients.

Other medicines and Olmesartan medoxomil and Hydrochlorothiazide Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist about the following medicines:

• Medicines that can increase potassium levels in the blood if used in combination with Olmesartan medoxomil and Hydrochlorothiazide Mylan. These include:
• potassium supplements (such as salt substitutes containing potassium)
• diuretics
• heparin (to thin the blood)
• laxatives
• steroids
• adrenocorticotropic hormone (ACTH)
• amphotericin, a medicine used to treat fungal infections
• 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 together with Olmesartan medoxomil and Hydrochlorothiazide Mylan can 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 such as ibuprofen, aspirin and diclofenac,

used to reduce pain, swelling and other symptoms of inflammation) used together with Olmesartan medoxomil and Hydrochlorothiazide Mylan may increase the risk of kidney failure. The effectiveness of Olmesartan medoxomil and Hydrochlorothiazide Mylan may be reduced by NSAIDs.

• Other medicines that lower blood pressure (antihypertensives, such as methyldopa), as the effectiveness of Olmesartan medoxomil and Hydrochlorothiazide Mylan may be increased
• Sleeping pills, sedatives and antidepressants, used together with Olmesartan medoxomil and Hydrochlorothiazide Mylan 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 to treat cancer, 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 medoxomil and Hydrochlorothiazide Mylan. Your doctor may advise you to take Olmesartan medoxomil and Hydrochlorothiazide Mylan at least 4 hours before colesevelam hydrochloride.
• Anticholinergic medicines, such as atropine and biperidene, used for the treatment of irritable bowel syndrome, asthma, Parkinson's disease or other muscle problems
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamezazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol, used to treat some mental illnesses
• Some medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digitalis, used to treat heart diseases
• Medicines such as bepridil, mizolastine, pentamidine, terfenadine, dofetilide, ibutilide and vincamine or erythromycin by injection, which can alter the heart rhythm
• Oral antidiabetic medicines, such as metformin or insulin, used to reduce blood sugar levels
• Beta-blockers and diazoxide, medicines used to treat high blood pressure and low blood sugar, respectively, as Olmesartan medoxomil and Hydrochlorothiazide Mylan may increase their hyperglycemic effect
• 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 stop the rejection of transplanted organs
• Certain antibiotics called tetracyclines or sparfloxacin
• Some antacids, used for stomach acidity, such as aluminum and magnesium hydroxide, as they may slightly reduce the effectiveness of Olmesartan medoxomil and Hydrochlorothiazide Mylan
• Cisapride, used to increase the movement of food in the stomach and intestines
• Alofantrine, used for malaria.

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 in the section “Do not take Olmesartan medoxomil and Hydrochlorothiazide Mylan” and “Warnings and precautions”).

Olmesartan medoxomil and Hydrochlorothiazide Mylan with alcohol
Be careful to drink alcohol during treatment with Olmesartan medoxomil and Hydrochlorothiazide Mylan, as some people may experience fainting or dizziness. If this happens to you, do not drink alcohol, including wine, beer or alcoholic beverages.

Pregnancy and breastfeeding
Pregnancy
You should tell your doctor if you are pregnant, suspect you might be pregnant or are planning to become pregnant.
As a rule, your doctor will advise you to stop taking Olmesartan medoxomil and Hydrochlorothiazide Mylan 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 medoxomil and Hydrochlorothiazide Mylan. Olmesartan medoxomil and Hydrochlorothiazide Mylan 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 after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Olmesartan medoxomil and Hydrochlorothiazide Mylan is not recommended in breastfeeding mothers and your doctor may choose another treatment for you if you wish to breastfeed.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
You may feel drowsy or dizzy during treatment for high blood pressure. If this happens, do not drive or operate machinery until the symptoms have disappeared. Consult your doctor for advice.

3. How to take Olmesartan medoxomil and Hydrochlorothiazide Mylan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet of Olmesartan medoxomil and Hydrochlorothiazide Mylan 20
mg/12.5 mg daily. However, if your blood pressure is not controlled, your doctor may
decide to change your dose to one tablet of Olmesartan medoxomil and Hydrochlorothiazide Mylan
20 mg/25 mg daily.
Swallow the tablets with a little water. If possible, take your dose every day at the same
time, for example with breakfast.

If you take more Olmesartan medoxomil and Hydrochlorothiazide Mylan than you should
If you take more tablets than you should or if a child accidentally ingests one or more tablets
immediately go to your doctor or the nearest emergency room bringing with you the
package of the medicine. Signs of an overdose may include feeling unwell or drowsy, low blood pressure, which causes a feeling of weakness or
dizziness, changes in heart rate or rhythm, or excessive thirst.

If you forget to take Olmesartan medoxomil and Hydrochlorothiazide Mylan
If you forget to take a dose, take your normal dose the next day. Do nottake a
double dose to make up for the missed dose.

If you stop taking Olmesartan medoxomil and Hydrochlorothiazide Mylan
It is important to continue taking Olmesartan medoxomil and Hydrochlorothiazide Mylan unless your
doctor tells you to stop the treatment.
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.

If you notice any of the following side effects, stop taking Olmesartan medoxomil and
Idroclorotiazide Mylan and contact your doctor or the nearest hospital emergency room
immediately:
Uncommon(may affect up to 1 in 100 people):

• Allergic reactions that can affect the whole body. The signs include sudden skin rash or itching, swelling of the face, lips, mouth, tongue and/or the area of the vocal cords (larynx) and difficulty breathing.
• Sudden chest pain or a feeling of oppression, heaviness or pressure in the chest. These can be signs of a heart problem known as angina pectoris.
• Severe difficulty breathing, sometimes also cough with presence of blood, increased sweating, anxiety or pale skin. These can be signs of a lung problem such as fluid accumulation or inflammation.

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

• Scarcity or absence of urine or pain during urination, with back pain, fever, feeling sick or unwell, feeling sleepy, shortness of breath or general malaise. These can be signs of kidney problems.
• Swollen and painful salivary glands
• Signs of a decrease in the number of different blood cells, which can cause paleness of the skin, feeling tired and short of breath and dark urine (decrease in the number of red blood cells), frequent infections with fever, chills, sore throat or mouth ulcers (decrease in the number of white blood cells in the blood), unexpected bleeding or bruising or that lasts longer than usual, when you have not injured yourself (reduced number of platelets)
• Epileptic seizures (convulsions)
• Loss and recovery of consciousness, or fainting
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin color, sudden pain in arms, legs or feet (signs of possible blood clot formation)
• Severe pain in the upper abdomen, radiating to the back, sometimes with feeling sick or unwell. These can be signs of inflammation of the pancreas.
• Yellowing of the skin or the whites of the eyes (jaundice)
• Signs of lupus erythematosus, such as skin rash, joint pain and cold hands and fingers. You may have suffered from this in the past or they may appear for the first time.
• Severe skin reactions causing painful red spots with peeling and blisters on the skin.

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

• Persistent constipation with abdominal pain and vomiting (feeling sick), which can be signs of intestinal obstruction (paralytic ileus).

Not known(frequency cannot be estimated from available data):

• Decreased vision or eye pain (possible signs of acute angle-closure glaucoma).

Olmesartan medoxomil and Idroclorotiazide Mylan can cause an excessive reduction in blood
pressure in predisposed individuals or as a result of an allergic reaction. Dizziness or fainting
may occur uncommonly. If this should happen, stop taking
Olmesartan medoxomil and Idroclorotiazide Mylan, contact your doctor immediately and
lie down.
Olmesartan medoxomil and Idroclorotiazide Mylan is a combination of two active ingredients and the
following information first mentions other side effects reported so far with the combination
olmesartan medoxomil and hydrochlorothiazide (in addition to those already mentioned above) and subsequently those
known for the separate active ingredients.

Other side effects so far known of olmesartan medoxomil and hydrochlorothiazide taken together:
If these side effects occur, they are often mild and you should not stop the
treatment.
Common(may affect up to 1 in 10 people):

• Dizziness, weakness or fatigue
• Headache
• Chest pain
• Swelling of ankles, feet, legs, hands or arms.

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

• Perception of heartbeat (palpitations)
• Skin rash, eczema
• Feeling of dizziness (vertigo)
• Feeling of numbness or sleepiness
• Cough
• Indigestion, abdominal pain, nausea (feeling sick), vomiting (feeling sick) or diarrhea
• Muscle cramps or muscle pain
• Joint pain, arm and leg pain, back pain
• Difficulty having and maintaining an erection
• Blood in the urine. Some changes in laboratory tests have also been observed uncommonly, 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 levels of sugar in the blood, increased substances that measure liver function. Your doctor will be aware of this from blood tests and will tell you if you need to do anything.

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

• General feeling of unwellness
• Raised, reddish, itchy or painful areas of the skin (hives, or urticaria). Some changes in laboratory tests have also been observed rarely, including the following: increased blood urea nitrogen, decreased values of hemoglobin and hematocrit. Your doctor will be aware of this from blood tests and will tell you if you need to do anything.

Further side effects reported with the use of olmesartan medoxomil or hydrochlorothiazide
alone, but not with Olmesartan medoxomil and Idroclorotiazide Mylan:
Olmesartan medoxomil:
Common(may affect up to 1 in 10 people):

• Bronchitis, which causes a persistent cough, wheezing and chest tightness
• Runny or blocked nose, sore throat
• Gastroenteritis, which causes loose and watery stools with stomach cramps and sometimes fever
• Joint or bone pain
• Urinary tract infections, which cause pain or difficulty urinating
• Flu-like symptoms
• Pain.

Some changes in laboratory tests have also been observed commonly
including: increased substances that measure muscle function.

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

• Swelling of the face
• Itching
• Sudden widespread skin rash with red skin or the presence of blisters, known as an exanthem.

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

• Impaired kidney function
• Lack of energy or enthusiasm.

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

• Severe, persistent diarrhea and significant weight loss.

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

• Feeling of confusion
• Stomach upset, feeling of fullness, flatulence, constipation
• Elimination of glucose with the urine, which can cause a sweet smell of the urine and detectable in urine tests.

Some changes in laboratory tests have also been observed including: reduction of
levels of chloride, magnesium or sodium in the blood, increased serum amylase (hyperamylasemia).

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

• Decreased or loss of appetite
• Worsening of pre-existing myopia
• Red spots on the skin (erythema) or skin reactions to light
• Purplish spots under the skin due to small hemorrhages (purpura) Rare(may affect up to 1 in 1,000):
• Feeling restless, feeling “down” or depressed, sleep disturbances, lack of interest (apathy)
• Tingling and numbness (“pins and needles”)
• Seeing yellow objects, blurred vision, dry eyes
• Irregular heartbeat
• Inflammation of blood vessels, which causes skin rash and, sometimes, blisters on the skin
• Infection of the gallbladder, which causes severe pain and tension in the upper abdomen, with fever
• Muscle weakness (sometimes causing limitations of movement).

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 http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa . By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Olmesartan medoxomil and Idroclorotiazide Mylan

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25° C.
Do not use this medicine after the expiry date which is stated on the box and 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 medoxomil and Hydrochlorothiazide Mylan contains
The active ingredients are:
Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/12.5 mg: each film-coated tablet
contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/25 mg: each film-coated tablet
contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
The other ingredients are:
(tablet core) sodium croscarmellose, mannitol, microcrystalline cellulose,
low substitution hydroxypropylcellulose, anhydrous colloidal silica, magnesium
stearate, sodium lauryl sulfate and (tablet coating) hypromellose, titanium dioxide (E171), macrogol, talc.
Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/25 mg: (tablet coating)
also contains yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Olmesartan medoxomil and Hydrochlorothiazide Mylan and package
contents
Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/12.5 mg, film-coated tablets are
white, film-coated, round, biconvex tablets with beveled edges imprinted on one
side with “ M” and “ H4” on the opposite side.
Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/25 mg, film-coated tablets are
yellow, film-coated, oblong, biconvex tablets with beveled edges imprinted on
one side with “ M” and “ H5” on the opposite side.
Olmesartan medoxomil and Hydrochlorothiazide Mylan film-coated tablets are available in
blister packs of 14, 28, 30, 56, 90, 98 and calendar packs of 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan

Manufacturer
McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Mylan Hungary Kft., H-2900, Komárom, Mylan utca 1, Hungary

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Greece Olmesartan/HCTZ Mylan 20 mg/12.5 mg, 20 mg/25 mg film-coated tablets
Ireland
Olmesartan medoxomil/Hydrochlorothiazide 20 mg/12.5 mg, 20 mg/25 mg
film-coated tablets
Portugal Olmesartan medoxomilo + Hidroclorotiazida Mylan
Spain
Olmesartan/Hidroclorotiazida Mylan 20 mg/12.5 mg, 20 mg/25mg
comprimidos recubiertos con película EFG