PACKAGE LEAFLET: INFORMATION FOR THE USER

OLPREZIDE 20 mg/12.5 mg film-coated tablets, 20 mg/25 mg film-coated tablets

olmesartan medoxomil/hydrochlorothiazide
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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. WHAT OLPREZIDE IS AND WHAT IT IS USED FOR

OLPREZIDE contains two substances called olmesartan medoxomil and hydrochlorothiazide. Both
help control high blood pressure (hypertension).

Olmesartan medoxomil belongs to a group of medicines known as “angiotensin II receptor antagonists”. It lowers blood pressure by relaxing blood vessels.
Hydrochlorothiazide belongs to a group of substances known as “thiazide diuretics”. It lowers blood pressure by helping the body get rid of excess fluid, by making the kidneys produce more urine.

You will be given OLPREZIDE if OLPRESS (olmesartan medoxomil) alone has not adequately controlled
your blood pressure. When administered together, the two active substances in OLPREZIDE help reduce
blood pressure more than when given separately.
If you are already taking medicines to treat high blood pressure, your doctor may prescribe OLPREZIDE
to achieve further blood pressure reduction.
High blood pressure can be controlled with medicines such as OLPREZIDE tablets. Your doctor has
likely also recommended that you make certain lifestyle changes to help lower your blood pressure (for
example, losing weight, quitting smoking, reducing alcohol intake, and reducing dietary salt). 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 OLPREZIDE

Do not take OLPREZIDE

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 OLPREZIDE is advised against even during the first months of pregnancy - see section “Pregnancy and breastfeeding”).
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
if you have severe kidney problems.
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 your blood that do not improve with treatment.
if you have severe liver problems, yellowing of the skin and eyes (jaundice), or problems with bile flow from the gallbladder (biliary obstruction, for example gallstones).

If you think you are in any of the conditions described above, or are unsure, do not take the
medicine. Contact your doctor and follow their advice.
Warnings and precautions
Talk to your doctor before using OLPREZIDE.
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 monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the information under the heading "Do not take OLPREZIDE"
Before taking the medicine, consult your doctor if you have any of the following health problems:

Mild or moderate kidney problems, or if you have recently undergone a kidney transplant.
Liver disease.
Heart failure or problems with heart valves or heart muscle.
Severe or prolonged vomiting or diarrhoea lasting several days.
Treatment with high doses of diuretics or if you are on a low-salt diet.
Adrenal gland disorders (e.g. primary aldosteronism).
Diabetes.
Systemic lupus erythematosus (an autoimmune disease).
Allergies or asthma.
If you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays during treatment with OLPREZIDE.

Inform your doctor if any of the following symptoms occur:
severe and prolonged diarrhoea with significant weight loss. Your doctor will evaluate your symptoms and decide whether to continue this antihypertensive treatment;
vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye, which may occur within hours or weeks of taking Olprezide. If untreated, this increase in pressure may lead to permanent vision impairment.
Your doctor may want to examine you more frequently and order blood tests if you are in any of the above conditions.
OLPREZIDE may increase blood lipid and uric acid levels (a cause of gout – painful joint swelling). Your doctor may wish to perform periodic blood tests to monitor these conditions.
Levels of certain substances called electrolytes in your blood may change. Your doctor may wish to perform periodic blood tests to monitor these conditions. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), general weakness, lethargy, fatigue, drowsiness or lack of rest, nausea, vomiting, reduced need to urinate, and rapid heartbeat. Inform your doctor
if these symptoms occur.
As with any medicine that lowers blood pressure, excessive reduction of blood pressure in patients with circulatory disorders of the heart or brain may lead to heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
If you need to undergo tests for parathyroid function, you must stop taking OLPREZIDE before the tests.
If you engage in sports, this medicine may affect the results of anti-doping tests, causing a positive outcome.
You must inform your doctor if you think you are pregnant or planning to become pregnant.
OLPREZIDE is not recommended during early pregnancy and must not be taken after the third month
of pregnancy as it may cause serious harm to the unborn baby if taken during this period (see section “Pregnancy and breastfeeding”).
Children and adolescents
OLPREZIDE is not recommended for children and adolescents under 18 years of age.
Other medicines and OLPREZIDE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist about the following medicines:

Other medicines that lower blood pressure (antihypertensives) may enhance the effect of OLPREZIDE. Your doctor may need to adjust the dose and/or take other precautions. If you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take OLPREZIDE" and "Warnings and precautions")
Medicines that may alter potassium levels in the blood when used concomitantly with OLPREZIDE. These include: potassium supplements (such as potassium-containing salt substitutes), diuretics, heparin (a blood thinner), 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 certain painkillers such as aspirin or salicylates
Lithium (a medicine used to treat mood swings and certain types of depression) used together with OLPREZIDE may increase lithium toxicity. If you are to take lithium, your doctor will monitor lithium levels in your blood.
Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other inflammatory symptoms, including arthritis) used together with OLPREZIDE may increase the risk of kidney failure. The effectiveness of OLPREZIDE may be reduced by NSAIDs.
Sleeping pills, sedatives, and antidepressants, used together with OLPREZIDE, 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 cancer treatments such as cyclophosphamide or methotrexate
Cholestyramine and colestipol, medicines used to reduce blood lipid levels
Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may reduce the effect of OLPREZIDE. Your doctor may advise you to take OLPREZIDE at least 4 hours before colesevelam hydrochloride
Anticholinergic medicines such as atropine and biperiden
Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric conditions
Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart conditions
Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, which may affect 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 glucose levels, respectively, as OLPREZIDE 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
Dihexyverine, 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 effectiveness of OLPREZIDE
Cisapride, used to increase movement of food through the stomach and intestines
Halofantrine, used for malaria

OLPREZIDE with food and drinks
OLPREZIDE can be taken with or without food. Be cautious about consuming alcohol during treatment with OLPREZIDE, as some people may feel weak or dizzy. If this happens to you, do not drink any more alcohol, including wine, beer, or flavoured alcoholic beverages.
Patients of Black ethnicity
As with other similar medicines, the blood pressure-lowering effect of OLPREZIDE may be somewhat reduced in patients of Black ethnicity.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant or if you are planning to become pregnant. Your doctor will usually advise you to stop taking OLPREZIDE before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine to OLPREZIDE. OLPREZIDE is not recommended during pregnancy and must not be taken after the third month of pregnancy as it may cause serious harm to the unborn baby if taken after this time.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. OLPREZIDE is not recommended during breastfeeding and your doctor may choose another treatment if you wish to breastfeed.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist 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.
OLPREZIDE contains lactose
This medicine contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE OLPREZIDE

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one tablet of OLPREZIDE 20 mg/12.5 mg daily. However, if your
blood pressure is not controlled, your doctor may decide to change your prescription to one tablet of
OLPREZIDE 20 mg/25 mg daily.
Swallow the tablets with a little water. If possible, take your daily dose at the same time each day, for
example with breakfast. It is important to continue taking OLPREZIDE unless your doctor tells you
otherwise.
If you take more OLPREZIDE than you should
If you take more tablets than prescribed or if a child accidentally swallows any, go immediately to your
doctor or the nearest emergency room, taking the medicine pack with you.
If you forget to take OLPREZIDE
If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up
for a forgotten dose.
If you stop taking OLPREZIDE
It is important to continue taking OLPREZIDE unless your doctor tells you to stop.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
However, the following two adverse reactions can be serious:

Allergic reactions affecting the whole body, with swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash, may occur rarely. If this happens, stop taking OLPREZIDE and contact your doctor immediately.
OLPREZIDE may cause excessive lowering of blood pressure in susceptible individuals or as a result of an allergic reaction. Dizziness or fainting are not very common. If this happens, stop taking OLPREZIDE, contact your doctor immediately and remain lying down.

OLPREZIDE is a combination of two active substances, and the information below first lists other adverse reactions reported so far with the OLPREZIDE combination (in addition to those already mentioned above), followed by those known for the individual active substances.

Other possible adverse reactions reported so far with OLPREZIDE:
If these adverse reactions occur, they are often mild and you should not stop treatment with OLPREZIDE.

Common adverse reactions (may affect up to 1 in 10 people):
Dizziness, weakness, headache, fatigue, chest pain, swelling of ankles, feet, legs, hands or arms.

Uncommon adverse reactions (may affect up to 1 in 100 people):
Awareness of heartbeat (palpitations), skin rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle pain and muscle cramps, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine.
Uncommonly, some laboratory test abnormalities have also been observed, including: increased blood lipid levels, increased blood urea or uric acid levels, increased creatinine, increased or decreased blood potassium levels, increased blood calcium levels, increased blood glucose, increased liver function tests. Your doctor will detect these from blood tests and will advise you if any action is needed.

Rare adverse reactions (may affect up to 1 in 1,000 people):
Feeling unwell, disturbances of consciousness, skin blisters (wheals), acute renal failure.
Rarely, some laboratory test abnormalities have also been observed, including:
increased blood urea nitrogen, decreased hemoglobin and hematocrit values. Your doctor will detect these from blood tests and will advise you if any action is needed.

Additional adverse reactions reported with olmesartan medoxomil or hydrochlorothiazide used alone,
but not with OLPREZIDE or with higher frequency:

Olmesartan medoxomil:
Common adverse reactions (may affect up to 1 in 10 people):
Bronchitis, cough, nasal hypersecretion, dry throat, abdominal pain, indigestion, diarrhea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, influenza-like symptoms, pain.
Commonly observed laboratory test abnormalities include: increased blood lipid levels, increased blood urea or uric acid levels, increased liver and muscle function tests.

Uncommon adverse reactions (may affect up to 1 in 100 people):
Rapid allergic reactions affecting the whole body, which may cause breathing difficulties or a rapid drop in blood pressure leading to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin reaction, itching, exanthema (skin rash), skin blisters (wheals).
Uncommonly observed laboratory test abnormalities include:
reduction in the number of certain blood cells called platelets (thrombocytopenia).

Rare adverse reactions (may affect up to 1 in 1,000 people):
Renal function impairment, weakness.
Rarely, some laboratory test abnormalities have also been observed, including:
increased blood potassium levels.

Hydrochlorothiazide:
Very common adverse reactions (may affect more than 1 in 10 people):
Laboratory test abnormalities including: increased levels of fats and uric acid in the blood.

Common adverse reactions (may affect up to 1 in 10 people):
Confusion, abdominal pain, gastric disturbances, bloating sensation, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.
Some laboratory test abnormalities have also been observed, including: increased blood levels of creatinine, urea, calcium and glucose, decreased blood levels of chloride, potassium, magnesium and sodium. Increased serum amylase (hyperamylasemia).

Uncommon adverse reactions (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, photosensitivity skin reactions, itching, small red or purple spots on the skin due to minor bleeding (purpura), skin blisters (wheals).

Rare adverse reactions (may affect up to 1 in 1,000 people):
Swollen and painful salivary glands, decreased white blood cell count, decreased platelet count, anemia, bone marrow damage, restlessness, feeling of depression, sleep disturbances, 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 systemic lupus erythematosus such as skin 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 movement limitations).

Very rare adverse reactions (may affect up to 1 in 10,000 people):
Electrolyte imbalances causing abnormally low chloride levels in the blood (hypochloremic alkalosis).
Intestinal obstruction (paralytic ileus).

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):
Decreased vision or eye pain (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 adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE OLPREZIDE

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

6. PACK CONTENTS AND OTHER INFORMATION

What OLPREZIDE contains
The active substances are:
OLPREZIDE 20 mg/12.5 mg: each film-coated tablet contains 20 mg of olmesartan medoxomil
and 12.5 mg of hydrochlorothiazide.
OLPREZIDE 20 mg/25 mg: each film-coated tablet contains 20 mg of olmesartan medoxomil and
25 mg of hydrochlorothiazide.
The excipients are:
Microcrystalline cellulose, monohydrate lactose*, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate,
titanium dioxide (E171), talc, hypromellose, iron (III) oxide (E172).
*See the section “OLPREZIDE contains lactose” above.

Description of the appearance of OLPREZIDE and pack contents
OLPREZIDE 20 mg/12.5 mg film-coated tablets are reddish-yellow, round-shaped, 8.5 mm in diameter, with the code C22 engraved on one side.
OLPREZIDE 20 mg/25 mg film-coated tablets are pink, round-shaped, 8.5 mm in diameter, with the code C24 engraved on one side.
OLPREZIDE is available in packs containing 14, 28, 30, 56, 84, 90, 98, and 10x28 film-coated tablets, as well as in packs containing 10, 50 and 500 film-coated tablets with unit-dose divisible blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 – Luxembourg
under license from Daiichi Sankyo Europe GmbH
Marketing Authorisation Holder for distribution:
Malesci Istituto Farmacobiologico S.p.A. – Bagno a Ripoli
Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse, 1
85276 Pfaffenhofen (Germany)
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin (Germany)
Menarini Von Heyden GmbH
Leipziger Strasse 7-13,
01097 Dresden (Germany)

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria: Mencord Plus
Belgium: Belsar Plus
Cyprus: Olartan-plus
Czech Republic: Sarten Plus H
Estonia: Mesar plus
Germany: Votum plus
Greece: Olartan-plus
France: Alteis Duo
Hungary: Laresin Plus
Ireland: Omesar Plus
Italy: Olprezide
Latvia: Mesar plus
Lithuania: Mesar plus
Luxembourg: Belsar Plus
Malta: Omesar plus
Poland: Revival Plus
Portugal: Olsar Plus
Slovakia: Tenzar Plus
Slovenia: Co-Tensiol
Spain: Ixia Plus

PATIENT LEAFLET: INFORMATION FOR THE USER

OLPREZIDE 40 mg/12.5 mg film-coated tablets, 40 mg/25 mg film-coated tablets

olmesartan medoxomil/hydrochlorothiazide
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 others, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. WHAT OLPREZIDE IS AND WHAT IT IS USED FOR

Olprezide contains two active substances called 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 blood vessels.
Hydrochlorothiazide belongs to a group of medicines called “diuretics”. It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

You will be given Olprezide if Olpress (olmesartan medoxomil) alone has not adequately controlled your blood pressure. When administered together, the two active substances in Olprezide help reduce blood pressure more than when either is given alone. You may already be taking medicines to treat high blood pressure, but your doctor may prescribe Olprezide to achieve further blood pressure reduction.
High blood pressure can be managed with medicines such as Olprezide tablets. Your doctor has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and decreasing dietary salt). Your doctor may also have encouraged you to exercise regularly, such as walking or swimming. It is important that you follow your doctor’s advice.

2. WHAT YOU SHOULD KNOW BEFORE TAKING OLPREZIDE

Do not take OLPREZIDE:

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 Olprezide is advised against even during the first months of pregnancy – see the section “Pregnancy”).
if you have kidney problems.
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 your blood that do not improve with treatment.
if you have moderate or severe liver problems, yellowing of the skin and eyes (jaundice), or bile flow problems from the gallbladder (biliary obstruction, e.g. gallstones).

If you think you are in any of the above conditions, or are unsure, do not take this
medicine. Contact your doctor and follow their advice.
Warnings and precautions
Talk to your doctor before using Olprezide.
Before taking this medicine, consult your doctor if you are taking any of the following medicines used
to treat high blood pressure:

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

Your doctor may check your kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium) at regular intervals.
See also the section "Do not take Olprezide".
Before taking this medicine, consult your doctor if you also have any of the following health conditions:

Kidney transplant.
Liver disease.
Heart failure or heart valve or heart muscle problems.
Severe or prolonged vomiting or diarrhoea lasting several days.
Treatment with high doses of diuretics or if you are on a low-salt diet.
Adrenal gland problems (e.g. primary hyperaldosteronism).
Diabetes.
Systemic lupus erythematosus (an autoimmune disease).
Allergies or asthma.
If you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun and UV exposure while taking Olprezide.

Inform your doctor if any of the following symptoms occur:

severe and prolonged diarrhoea with significant weight loss. Your doctor will assess your symptoms and decide whether to continue this antihypertensive treatment;
changes in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye, which may occur within hours or weeks of taking Olprezide. If untreated, this pressure increase may lead to permanent vision impairment.

Your doctor may want to examine you more frequently and perform blood tests if you have any of the
above conditions.
Olprezide may increase blood levels of fats and uric acid (which causes gout – painful joint swelling). Your doctor will likely perform periodic blood tests to monitor these conditions.
It may alter blood levels of certain substances called electrolytes. Your doctor will likely perform periodic blood tests to monitor these conditions. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), feeling weak, apathetic, tired, drowsy, restless, nauseous, or vomiting, reduced need to urinate, and rapid heartbeat. Inform your doctor if these symptoms occur.
As with any medicine that lowers blood pressure, excessive lowering of blood pressure in patients with heart or brain blood flow disorders could lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
If you are undergoing tests for parathyroid function, you must stop taking Olprezide before the tests.
If you engage in sports, this medicine may affect anti-doping test results, causing a positive outcome.
Inform your doctor if you think you are pregnant or plan to become pregnant.
Olprezide is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section “Pregnancy”).
Children and adolescents
Olprezide is not recommended for children and adolescents under 18 years of age.
Other medicines and Olprezide
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the
following medicines.
In particular, inform your doctor or pharmacist about the following medicines:

Other medicines that lower blood pressure (antihypertensives) may increase the effect of Olprezide. Your doctor may need to adjust the dose and/or take other precautions. If you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Olprezide" and "Warnings and precautions").
Medicines that may alter potassium levels in the blood when used together with Olprezide. These include: potassium supplements (such as potassium-containing salt substitutes), diuretics, heparin (a blood thinner), 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 certain painkillers such as aspirin or salicylates.
Lithium (a medicine used to treat mood swings and certain types of depression) used together with Olprezide may increase lithium toxicity. If you need to take lithium, your doctor will monitor your blood lithium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis) used together with Olprezide may increase the risk of kidney failure. The effectiveness of Olprezide may be reduced by NSAIDs.
Sleeping pills, sedatives, and antidepressants, when used with Olprezide, 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 cancer treatments such as cyclophosphamide or methotrexate.
Cholestyramine and colestipol, medicines used to lower blood fats.
Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may reduce the effect of Olprezide. Your doctor may advise you to take Olprezide at least 4 hours before colesevelam hydrochloride.
Anticholinergic medicines such as atropine and biperiden.
Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, zuclopenthixol, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric conditions.
Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart conditions.
Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or intravenous erythromycin, which may affect 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 Olprezide may enhance their hypotensive and hyperglycaemic effects.
Methyldopa, a medicine used to treat high blood pressure.
Medicines such as noradrenaline, used to increase blood pressure and slow heart rate.
Difemanyl, 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 drug.
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 effectiveness of Olprezide.
Cisapride, used to increase movement of food through the stomach and intestines.
Halofantrine, used for malaria.

Olprezide with food and drink
Olprezide can be taken with or without food.
Be cautious about consuming alcohol during treatment with Olprezide, as some people may experience fainting or dizziness. If this happens, do not drink any more alcohol, including wine, beer, or carbonated alcoholic beverages.
Patients of Black ethnicity
As with other similar medicines, the blood pressure-lowering effect of Olprezide may be somewhat reduced in patients of Black ethnicity.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant or plan to become pregnant. Your doctor will usually advise you to stop taking Olprezide before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Olprezide is not recommended during pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Olprezide is not recommended during breastfeeding, and your doctor may choose another treatment if you wish to breastfeed.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
You may experience drowsiness or dizziness during antihypertensive treatment. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.
Olprezide contains lactose
This medicine contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE OLPREZIDE

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one tablet of Olprezide 40 mg/12.5 mg daily. However, if your
blood pressure is not controlled, your doctor may decide to change your prescription to one tablet
of Olprezide 40 mg/25 mg daily.
Swallow the tablets with a little water. If possible, take your dose at the same time each day,
for example with breakfast. It is important to keep taking Olprezide until your doctor tells you
to stop.
If you take more Olprezide 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 nearest emergency room, taking the medicine pack with you.
If you forget to take Olprezide
If you forget to take a dose, take your usual dose the next day. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Olprezide
It is important to continue taking Olprezide 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 ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
However, the following two adverse reactions can be serious:

Allergic reactions affecting the whole body, with swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash, may occur rarely. If this happens, stop taking Olprezide and contact your doctor immediately.
Olprezide 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 Olprezide, contact your doctor immediately and remain lying down. Olprezide is a combination of two active substances, and the following information first lists other adverse reactions reported so far with Olprezide (in addition to those already mentioned above), followed by those known for the individual active substances.

Other adverse reactions so far known with Olprezide:
If these adverse reactions occur, they are often mild and you should not stop treatment with Olprezide.
Common adverse reactions (may affect up to 1 in 10 people):
Dizziness, weakness, headache, fatigue, chest pain, swelling of the ankles, feet, legs, hands, or arms.
Uncommon adverse reactions (may affect up to 1 in 100 people):
Awareness of heartbeat (palpitations), skin rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle cramps, muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine. Uncommonly, some laboratory test abnormalities have also been observed, including: increased levels of lipids 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 calcium levels in the blood, increased blood glucose, increased liver function tests. Your doctor will detect these from blood tests and will inform you if any action is needed.
Rare adverse reactions (may affect up to 1 in 1,000 people):
Feeling unwell, disturbances of consciousness, skin blisters (wheals), acute kidney failure. Rarely, some laboratory test abnormalities have also been observed, including: increased blood urea nitrogen, decreased hemoglobin and hematocrit values. Your doctor will detect these from blood tests and will inform you if any action is needed.

Additional adverse reactions reported with olmesartan medoxomil or hydrochlorothiazide used alone,
but not with Olprezide or with higher frequency:

Olmesartan medoxomil:
Common adverse reactions (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 urine, urinary tract infection, influenza-like symptoms, pain.
Commonly observed laboratory test abnormalities include: increased levels of lipids in the blood, increased levels of urea or uric acid in the blood, increased liver and muscle function tests.
Uncommon adverse reactions (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, possibly leading to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), skin allergic reactions, itching, rash, skin blisters (wheals).
Uncommonly, some laboratory test abnormalities have also been observed, including: reduced number of platelets (thrombocytopenia).
Rare adverse reactions (may affect up to 1 in 1,000 people):
Impaired kidney function, weakness.
Rarely, some laboratory test abnormalities have also been observed, including: increased potassium levels in the blood.

Hydrochlorothiazide:
Very common adverse reactions (may affect more than 1 in 10 people):
Laboratory test abnormalities including: increased levels of lipids and uric acid in the blood.
Common adverse reactions (may affect up to 1 in 10 people):
Confusion, abdominal pain, gastric disturbances, bloating, diarrhea, nausea, vomiting, constipation, glucose excretion in urine.
Some laboratory test abnormalities 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 adverse reactions (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, photosensitivity skin reactions, itching, purpuric spots or patches on the skin due to small hemorrhages (purpura), skin blisters (wheals).
Rare adverse reactions (may affect up to 1 in 1,000 people):
Swollen and painful salivary glands, decreased white blood cell count, decreased platelet count, anemia, bone marrow damage, restlessness, feeling depressed, sleep disturbances, 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, lupus-like symptoms (such as skin rash, joint pain, cold hands and fingers), allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing motor limitations).
Very rare adverse reactions (may affect up to 1 in 10,000 people):
Electrolyte disturbances causing abnormally low chloride levels in the blood (hypochloremic alkalosis). Intestinal obstruction (paralytic ileus).
Adverse reactions with frequency not known (frequency cannot be estimated from the available data):
Decreased vision or eye pain (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).

5. HOW TO STORE OLPREZIDE

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

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Olprezide contains
The active substances are:
Olprezide 40 mg/12.5 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and
12.5 mg of hydrochlorothiazide.
Olprezide 40 mg/25 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and 25
mg of hydrochlorothiazide.
The other components are:
Microcrystalline cellulose, monohydrate lactose*, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate,
titanium dioxide (E171), talc, hypromellose, iron (III) oxide (E172).
*See the section “Olprezide contains lactose” above.

Description of the appearance of Olprezide and contents of the pack
Olprezide 40 mg/12.5 mg: film-coated tablets of 15x7 mm, yellowish-red in colour, oval-shaped, with the code C23 engraved on one side;
Olprezide 40 mg/25 mg: film-coated tablets of 15x7 mm, pink in colour, oval-shaped, with the code C25 engraved on one side.
Olprezide is available in packs containing 14, 28, 30, 56, 84, 90, 98, 10x28 and 10x30 film-coated tablets, and in packs containing 10, 50 and 500 film-coated tablets with pre-scored blisters for single doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 – Luxembourg
Sales Licence Holder:
Istituto Farmacobiologico Malesci S.p.A. – via Lungo L’Ema, 7 – Loc. Ponte a Ema, 50015 Bagno a
Ripoli – Florence - Italy

Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse, 1
85276 Pfaffenhofen (Germany)
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin (Germany)
Menarini Von Heyden GmbH
Leipziger Strasse 7-13,
01097 Dresden (Germany)

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Mencord Plus
Belgium: Belsar Plus
Cyprus: Olartan-plus
Czech Republic: Sarten Plus H
Estonia: Mesar plus
Germany: Votum plus
Greece: Olartan-plus
France: Alteisduo
Hungary: Laresin Plus
Ireland: Omesar Plus
Italy: Olprezide
Latvia: Mesar plus
Lithuania: Mesar plus
Luxembourg: Belsar Plus
Malta: Omesar plus
Portugal: Olsar Plus
Slovakia: Tenzar Plus
Slovenia: Co-Tensiol
Spain: Ixia Plus