OLMITZE 20 mg /12.5 Mg Film-Coated Tablets

Зміст інструкції

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

Olmitze 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

Olmesartan medoxomil and hydrochlorothiazide
Generic medicine

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Olmitze is and what it is used for

Olmitze contains two active ingredients, olmesartan medoxomil and hydrochlorothiazide, which are used for the
treatment of high blood pressure (hypertension) in adults:

• 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 diuretics (water tablets). It lowers blood pressure by helping the body to eliminate excess fluids by causing the kidneys to produce more urine.

You will be prescribed Olmitze if olmesartan medoxomil alone has not adequately controlled your
blood pressure. When administered together, the two active ingredients of Olmitze help to
reduce blood pressure more than they would if administered alone.
You may already be taking medicines to treat high blood pressure, but your doctor may prescribe Olmitze to
achieve a further reduction.
High blood pressure can be controlled with medicines such as Olmitze tablets. Your doctor has
probably also recommended that you make some changes to your lifestyle to help reduce your blood
pressure (for example, losing weight, quitting smoking, reducing alcohol intake and reducing the amount
of salt in your diet). Your doctor may also have advised 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 Olmitze

Do not take Olmitze

• 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 the use of Olmitze even during the first months of pregnancy - see section “Pregnancy”)
• if you have low levels of potassium or sodium, or if you have high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood that do not improve following treatment
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren [This only applies to 20 mg/12.5 mg and 20 mg/25 mg]
• if you have severe kidney problems
• 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) [This only applies to 40 mg/12.5 mg and 40 mg/25 mg]
• if you have kidney problems
• if you suffer from moderate or 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 think that any of these conditions apply to you, or you are not sure, do not take the tablets. Contact
your doctor first and follow their advice.

Warnings and precautions
Talk to your doctor before taking Olmitze.
Before taking the tablets, tell 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
(for example potassium) in your blood at regular intervals.
See also what is stated under “Do not take Olmitze”.
Before taking the tablets, tell your doctorif you have any of the following health problems:

• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Vomiting (feeling sick) or severe or prolonged diarrhoea.
• Treatment with high doses of water tablets (diuretics) or if you are following a low-salt diet.
• Problems with the adrenal glands (for example primary aldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergies or asthma.
• If you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Olmitze.
• If you have experienced breathing problems or lung problems (including inflammation or fluid in the lungs) in the past following the intake of hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Olmitze, seek immediate medical attention. [This only applies 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. [This only applies to 40 mg/12.5 mg and 40 mg/25 mg]
• Kidney transplant.

Tell your doctor if any of the following symptoms occur:

• severe and prolonged diarrhoea with significant weight loss. Your doctor needs to assess the symptoms and decide how to proceed with this antihypertensive treatment.
• decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in your eye and can occur within hours or weeks of taking Olmitze. This increase, if left untreated, can lead to permanent vision impairment. If you have had an allergy to penicillin or sulphonamide in the past, you may be at greater risk of developing these symptoms.

Your doctor may want to visit you more often and do some tests if you have any of the
previous conditions.
Olmitze 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 need 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. 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 you notice the
appearance of these symptoms.
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 can lead to a heart attack or stroke. Your doctor must therefore carefully monitor your blood pressure.
If you need to have parathyroid function tests, you must stop taking Olmitze before
performing these tests.
You must tell your doctor if you think you are pregnant (or could become pregnant).
Olmitze 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 (see section
“Pregnancy”).
Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking
Olmitze. The doctor will decide whether to continue the treatment. Do not stop taking Olmitze on
your own.

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

Children and adolescents
Olmitze is not recommended in children and adolescents under 18 years of age.

Other medicines and Olmitze
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:

• Other medicines that lower blood pressure (antihypertensives), as they may increase the effect of Olmitze.
• The doctor may need to adjust the dose and/or take other precautions:
• if you are taking an ACE inhibitor or aliskiren (see also what is stated under “Do not take Olmitze” and “Warnings and precautions”).
• Medicines that can cause changes in potassium levels in the blood when used in conjunction with Olmitze. These include:
• potassium supplements (such as salt substitutes containing potassium)
• water tablets (diuretics)
• heparin (to thin the blood)
• laxatives
• steroids
• adrenocorticotropic hormone (ACTH)
• carbenoxolone (a medicine used to treat mouth and stomach ulcers)
• sodium penicillin G (also called benzylpenicillin sodium, an antibiotic)
• some painkillers such as acetylsalicylic acid or salicylates
• Lithium (a medicine used to treat mood swings and some types of depression) used together with Olmitze may increase the toxicity of lithium. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs - medicines used to reduce pain, swelling and other symptoms of inflammation, including arthritis) used together with Olmitze may increase the risk of kidney failure and the effectiveness of Olmitze may be reduced by NSAIDs.
• Sleeping pills, sedatives and antidepressants, as they may cause a sudden drop in blood pressure when getting up when used together with Olmitze.
• 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, as it may decrease the effect of Olmitze. Your doctor may advise you to take Olmitze at least 4 hours before colesevelam hydrochloride.
• Anticholinergic medicines, such as atropine and biperidene
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol, used to treat some psychiatric illnesses
• Some medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digitalis, used to treat heart conditions
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or erythromycin by injection, which can alter the heart rhythm
• Oral antidiabetic medicines such as metformin, or insulin, used to reduce glucose levels in the blood
• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, as Olmitze may increase their hyperglycemic effect
• Methyldopa, a medicine used to treat high blood pressure
• Medicines such as norepinephrine, used to increase blood pressure and slow down the heart rate
• Difemanil, used to treat a slow heartbeat or reduce sweating
• Medicines such as probenecid, sulfinpyrazone and allopurinol, used for the treatment of gout
• Calcium supplements
• Amantadine, an antiviral medicine
• Cyclosporine, a medicine used to prevent organ rejection in transplant patients
• Certain antibiotics called tetracyclines or sparfloxacin
• Amphotericin, a medicine used to treat fungal infections
• Some antacids, used for heartburn, such as aluminum and magnesium hydroxide, as they may slightly reduce the effectiveness of Olmitze
• Cisapride, used to increase the movement of food in the stomach and intestines
• Alofantrine, used for malaria.

Olmitze with food, drinks and alcohol
Olmitze can be taken with or without food.
Be careful to drink alcohol during treatment with Olmitze, as some people may
experience fainting or dizziness. If this happens, do not drink any more alcohol, including wine, beer or alcoholic beverages
carbonated.

Black race patients
As with other similar medicines, the blood pressure lowering effect of Olmitze is, to some
extent, reduced in patients of black race.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for advice before taking this medicine.
Pregnancy
You must tell your doctor if you think you are pregnant (or could become pregnant). Usually, your doctor will advise you to stop taking Olmitze before becoming pregnant
or as soon as you know you are pregnant and advise you to take another medicine instead of Olmitze.
Olmitze 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 are planning to start breastfeeding. Olmitze is not
recommended in breastfeeding mothers and your doctor may choose another
treatment if you wish to breastfeed.

Driving and using machines
You may feel drowsy or dizzy when 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.
[This only applies to 20 mg/12.5 mg and 40 mg/12.5 mg]

Olmitze contains lactose and yellow sunset
Lactose: If you have been diagnosed with intolerance to some sugars, contact your
doctor before taking this medicine.
Yellow sunset: may cause allergic reactions.
[This only applies to 20 mg/25 mg and 40 mg/25 mg]

Olmitze contains lactose
If you have been diagnosed with intolerance to some sugars, contact your
doctor before taking this medicine.

3. How to take Olmitze

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

The recommended doseis one Olmitze 20 mg/12.5 mg tablet a day. However, if your
blood pressure is not controlled, your doctor may decide to change your dose to one Olmitze
20 mg/25 mg tablet a day.
[Applies only to 40 mg/12.5 mg and 40 mg/25 mg]

The recommended doseis one Olmitze 40 mg/12.5 mg tablet a day. However, if your
blood pressure is not controlled, your doctor may decide to change your dose to one Olmitze
40 mg/25 mg tablet a day.
Swallow the tablet with a little water. Do not bite, chew or break the tablet. If possible,
take your dose every day at the same time, for example at breakfast. It is important to continue to
take Olmitze until your doctor tells you to stop.

If you take more Olmitze 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 with you the packaging of the
medicine.

If you forget to take Olmitze
If you forget to take a dose, take your usual dose the next day. Do nottake a
double dose to make up for a missed dose.

If you stop taking Olmitze
It is important to continue to take Olmitze unless your doctor tells you to stop.
If you have any further questions on 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 everyone will experience 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 skin rash, may occur rarely. If this occurs, stop taking Olmitze and contact yourdoctorimmediately.
• Olmitze may 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 occurs, stop taking Olmitze, contact yourdoctorimmediately and lie down.
• Frequency not known: if you experience yellowing of the white part of your eyes, dark urine, skin itching, even if you started therapy with Olmitze a long time ago, contact yourdoctorimmediately who will evaluate your symptoms and decide how to continue therapy for blood pressure.

Olmitze is a combination of two active ingredients and the following information first mentions the other
side effects reported so far with the olmesartan and hydrochlorothiazide association (in addition to those already
mentioned above) and subsequently those known for the individual active ingredients.

These are the side effects known so far with Olmitze:
If these side effects occur, they are often mild and it is not necessary to interrupt the
treatment.
Common side effects (may affect up to 1 in 10 people):
Dizziness, weakness, headache, fatigue, chest pain, swelling of the ankles, feet, legs, hands or arms.
Uncommon side effects (may affect up to 1 in 100 people):
Sleepiness, perception of heartbeat (palpitations), skin rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain, arm and leg pain, back pain, difficulty of erection in men, blood in the urine.
Laboratory test alterations have also been observed uncommonly:
Increased levels of fats in the blood, increased levels of urea or uric acid in the blood, increased creatinine, increase or decrease of potassium levels 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 1,000 people):
Feeling unwell, disturbances of consciousness, skin blisters (urticaria), acute renal failure, intestinal angioedema: a swelling of the intestine that presents with symptoms such as abdominal pain, nausea, vomiting and diarrhea.
Laboratory test alterations have also been observed rarely:
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 Olmitze 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.
Laboratory test alterations have also been observed commonly:
Increased levels of fats in the blood, increased levels of urea or uric acid in the blood, increased liver and muscle function indices.
Uncommon side effects (may affect up to 1 in 100 people):
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), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin reaction, itching, rash (skin eruption), skin blisters (urticaria).
Laboratory test alterations have also been observed uncommonly:
Reduction in the number of some blood cells called platelets (thrombocytopenia).
Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, lack of energy.
Laboratory test alterations have also been observed rarely:
Increased potassium in the blood.

Hydrochlorothiazide:
Very common side effects (may affect more than 1 in 10 people):
Laboratory test alterations 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.
Some laboratory test alterations 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).
Effects indesiderati non comuni (possono interessare fino a 1 persona su 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 on the skin due to small hemorrhages (purpura), skin blisters (urticaria).
Rare side effects (may affect up to 1 in 1,000 people):
Swollen and painful salivary glands, decreased number of white blood cells, decreased number of platelets, anemia, bone marrow damage, restlessness, feeling of depression, sleep disturbances, lack of interest (apathy), tingling and numbness, convulsions, vision of yellow objects, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, accumulation of fluid 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 kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing limitations in movement).
Very rare side effects (may affect up to 1 in 10,000 people):
Electrolyte disturbances causing an abnormal reduction in chloride levels in the blood (hypochloremic alkalosis), intestinal blockage (paralytic ileus).
Not known (frequency cannot be estimated on the basis of available data):
Skin and lip cancer (non-melanoma skin cancer).
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 experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Olmitze

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the package or 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 eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What Olmitze contains

• The active ingredients are olmesartan medoxomil and hydrochlorothiazide. Each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
• The active ingredients are olmesartan medoxomil and hydrochlorothiazide. Each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
• The active ingredients are olmesartan medoxomil and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
• The active ingredients are olmesartan medoxomil and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
• The other ingredients are: Tablet core:Lactose monohydrate, low substitution hydroxypropylcellulose, hydroxypropylcellulose, microcrystalline cellulose Type 102, magnesium stearate. Tablet coating:[Applies only to 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), aluminium lake yellow sunset FCF (E110). [Applies only to 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 Olmitze and package contents
Olmitze 20 mg/12.5 mg film-coated tablets are orange, round, biconvex, 8.5 mm in
diameter and with OH 21 imprinted on one side.
Olmitze 20 mg/25 mg film-coated tablets are pink, round, biconvex, 8.5 mm in diameter
and with OH 22 imprinted on one side.
Olmitze 40 mg/12.5 mg film-coated tablets are orange, oval, biconvex, 15x7mm and with
OH 41 imprinted on one side.
Olmitze 40 mg/25 mg film-coated tablets are pink, oval, biconvex, 15x7 mm and with OH 42
imprinted on one side.

Packs
Blister packs (Al-Al): 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Marketing authorization holder
Day Zero ehf.
Reykjavíkurvegur 62
Hafnarfjörður 220
Iceland

Manufacturer
Actavis Limited,
Blb 015-016 Bulebel Industrial Estate,
Zejtun, ZTN 3000,
Malta

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
EE: Lodamaz
IT: Olmitze
[Complete with national data]