PACKAGE LEAFLET: INFORMATION FOR THE USER

OLMEGAN 20 mg/12.5 mg, 20 mg/25 mg

film-coated tablets
(olmesartan medoxomil/hydrochlorothiazide)
Read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. WHAT OLMEGAN IS AND WHAT IT IS USED FOR

OLMEGAN 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, increasing urine production by the kidneys.

You will be prescribed OLMEGAN if OLMETEC (olmesartan medoxomil) alone has not adequately controlled your blood pressure. When administered together, the two active substances in OLMEGAN reduce blood pressure more than when given separately.
If you are already taking medicines to treat high blood pressure, your doctor may prescribe OLMEGAN to achieve further blood pressure reduction.
High blood pressure can be managed with medicines such as OLMEGAN 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 your doctor’s advice.

2. WHAT YOU SHOULD KNOW BEFORE TAKING OLMEGAN

Do not take OLMEGAN:

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 (it is advisable to avoid using OLMEGAN even during the first months of pregnancy – see the 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 the blood that do not improve with treatment;
if you have severe liver problems, yellowing of the skin or eyes (jaundice), or problems with bile flow from the gallbladder (biliary obstruction, for example due to gallstones).

If you think any of these conditions apply to you, or are unsure, do not take the medicine.
Contact your doctor and follow their advice.

Warnings and precautions
Talk to your doctor before using OLMEGAN.
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), especially if you have kidney problems related to diabetes;
aliskiren.

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

mild or moderate kidney problems, or if you have recently undergone a kidney transplant;
liver diseases;
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 OLMEGAN;
if you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Olmegan, consult a doctor immediately.

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 OLMEGAN. If untreated, this increase in pressure may lead to permanent vision impairment.

Your doctor may wish to monitor you more frequently and order blood tests if you have any of the conditions listed above.
Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Olmegan. Your doctor will decide whether to continue treatment. Do not stop taking Olmegan on your own.

OLMEGAN may increase levels of fats and uric acid in the blood (which can cause gout – painful joint swelling). Your doctor may want to perform periodic blood tests to monitor these conditions.

Levels of certain substances called electrolytes in the blood may change. Your doctor may want to perform periodic blood tests to monitor these conditions. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle weakness, fatigue, low blood pressure (hypotension), weakness, lethargy, tiredness, 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 in 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 OLMEGAN before the tests.

For athletes:
Using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.

You must inform your doctor if you think you may be pregnant or plan to become pregnant.
OLMEGAN 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 child if taken during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents
OLMEGAN is not recommended for children and adolescents under 18 years of age.

Other medicines and OLMEGAN
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 OLMEGAN. Your doctor may need to adjust the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also “Do not take OLMEGAN” and “Warnings and precautions”);
Medicines that may alter potassium levels in the blood when used concomitantly with OLMEGAN. These include: potassium supplements (such as potassium-containing salt substitutes), diuretics, heparin (to thin the blood), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), sodium penicillin G (also known as sodium benzylpenicillin, 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 OLMEGAN 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 OLMEGAN may increase the risk of kidney failure. The effectiveness of OLMEGAN may be reduced by NSAIDs;
Sleeping pills, sedatives, and antidepressants, used together with OLMEGAN, 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 fat levels;
Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may reduce the effect of OLMEGAN. Your doctor may advise you to take OLMEGAN at least 4 hours before colesevelam hydrochloride;
Anticholinergic medicines such as atropine and biperiden;
Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, 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 alter heart rhythm;
Oral antidiabetic medicines such as metformin, or insulin, used to reduce blood glucose levels;
Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood glucose levels, respectively, as OLMEGAN 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;
Dihexyline, 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;
Some antacids used for stomach acidity, such as aluminium and magnesium hydroxide, as they may slightly reduce the effectiveness of OLMEGAN;
Cisapride, used to increase movement of food through the stomach and intestines;
Halofantrine, used for malaria.

OLMEGAN with food and drinks
OLMEGAN can be taken with or without food. Be cautious when consuming alcohol during treatment with OLMEGAN, as some people may feel weak or dizzy. If this happens, 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 OLMEGAN may be somewhat reduced in patients of Black ethnicity.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant or plan to become pregnant. Usually, your doctor will advise you to stop taking OLMEGAN before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of OLMEGAN. OLMEGAN 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 child if taken after this time.

Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. OLMEGAN is not recommended for nursing mothers, and your doctor may choose another treatment if you wish to breastfeed.

If you are pregnant, breastfeeding, think you may be pregnant, suspect you are pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking any 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.

OLMEGAN 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 OLMEGAN

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 OLMEGAN 20 mg/12.5 mg tablet daily. However, if your
blood pressure is not controlled, your doctor may decide to change your prescription to one
OLMEGAN 20 mg/25 mg tablet 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 keep taking OLMEGAN unless your doctor tells you
to stop.
If you take more OLMEGAN than you should
If you take more tablets than you should, or if a child accidentally swallows any tablets,
go immediately to your doctor or the nearest emergency department, taking the medicine
packaging with you.
If you forget to take OLMEGAN
If you forget to take a dose, take your usual dose the next day. Do not take a double
dose to make up for the missed dose.
If you stop taking OLMEGAN
It is important to continue taking OLMEGAN unless your doctor tells you to stop.
If you have any doubts about how to use 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 adverse reactions can be serious:

Allergic reactions affecting the whole body, with swelling of the face, mouth and/or larynx (the site of the vocal cords), associated with itching and skin rash, may occur rarely. If this happens, stop taking OLMEGAN and contact your doctor immediately.
OLMEGAN 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 OLMEGAN, contact your doctor immediately and lie down.
Frequency not known: if you develop yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been on OLMEGAN therapy for a long time, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with treatment for high blood pressure.

OLMEGAN is a combination of two active substances. The information below first lists other adverse reactions reported so far with the OLMEGAN 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 OLMEGAN:
If these adverse reactions occur, they are often mild and you should not stop treatment with OLMEGAN.

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, diarrhoea, 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 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 become aware of these through 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 haemoglobin and haematocrit values. Your doctor will become aware of these through 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 OLMEGAN 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, diarrhoea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, influenza-like symptoms, pain.

Commonly, 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 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 reactions, itching, rash, skin blisters (wheals).

Uncommonly, some laboratory test abnormalities have also been observed, including: reduced number of certain blood cells called platelets (thrombocytopenia).

Rare adverse reactions (may affect up to 1 in 1,000 people):
Impaired kidney function, weakness.
Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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 fats and uric acid in the blood.

Common adverse reactions (may affect up to 1 in 10 people):
Feeling confused, abdominal pain, gastric disturbances, bloating sensation, diarrhoea, 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 (hyperamylasaemia).

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 purple spots or patches on the skin due to minor haemorrhages (purpura), skin blisters (wheals).

Rare adverse reactions (may affect up to 1 in 1,000 people):
Swollen and painful salivary glands, decreased number of white blood cells, decreased number of platelets, anaemia, 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, symptoms of systemic lupus erythematosus such as skin rash, joint pain, cold hands and fingers, allergic skin reactions, skin peeling and blisters, non-infectious inflammation of the kidney (interstitial nephritis), fever, muscle weakness (sometimes causing motor limitations).

Very rare adverse reactions (may affect up to 1 in 10,000 people):
Electrolyte imbalances causing abnormally low chloride levels in the blood (hypochloraemic alkalosis). Intestinal obstruction (paralytic ileus).
Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

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).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 OLMEGAN

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 the 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 OLMEGAN contains
The active substances are:
OLMEGAN 20 mg/12.5 mg: each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
OLMEGAN 20 mg/25 mg: each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
The excipients are:
Microcrystalline cellulose, lactose monohydrate*, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, titanium dioxide (E171), talc, hypromellose, iron (III) oxide (E172).
*See the section above “OLMEGAN contains lactose”
Description of the appearance of OLMEGAN and pack contents
OLMEGAN 20 mg/12.5 mg film-coated tablets are reddish-yellow, round, 8.5 mm in diameter, with the code C22 engraved on one side.
OLMEGAN 20 mg/25 mg film-coated tablets are pink, round, 8.5 mm in diameter, with the code C24 engraved on one side.
OLMEGAN is available in packs of 14, 28, 30, 56, 84, 90, 98, and 10x28 film-coated tablets, and in packs of 10, 50 and 500 film-coated tablets with unit-dose divisible blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Daiichi Sankyo Italia SpA
Via Paolo di Dono, 73
00142 Rome
Italy
Manufacturer responsible for batch release
Daiichi Sankyo Europe GmbH
Luitpoldstrasse, 1
85276 Pfaffenhofen (Germany)
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin (Germany)
This medicinal product is authorized in the European Economic Area countries under the following names:
Austria: Olmetec Plus
Belgium: Olmetec Plus
Denmark: Olmetec Plus
Germany: Olmetec Plus
Greece: Olmetec Plus
Finland: Olmetec Plus
France: CoOlmetec
Iceland: Olmetec Plus
Ireland: Benetor Plus
Italy: OLMEGAN
Luxembourg: Olmetec Plus
Netherlands: Olmetec HCTZ
Norway: Olmetec Comp
Portugal: Olmetec Plus
Spain: Olmetec Plus
United Kingdom: Olmetec Plus

PACKAGE LEAFLET: INFORMATION FOR THE USER

OLMEGAN 40 mg/12.5 mg, 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 their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. WHAT OLMEGAN IS AND WHAT IT IS USED FOR

OLMEGAN 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 reduces blood pressure by relaxing blood vessels.
Hydrochlorothiazide belongs to a group of medicines called "diuretics". It reduces blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

You will be given OLMEGAN if Olmetec (olmesartan medoxomil) alone has not adequately controlled your blood pressure. When administered together, the two active substances in OLMEGAN help reduce blood pressure more than when used individually.
You may already be taking medicines to treat high blood pressure, but your doctor may prescribe OLMEGAN to achieve further reduction.
High blood pressure can be controlled with medicines such as OLMEGAN 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 OLMEGAN

Do not take OLMEGAN:

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 OLMEGAN is also not recommended 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 the blood that do not improve with treatment;
if you have moderate or 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 any of these conditions apply to you, or are unsure, do not take the medicine.
Contact your doctor and follow their advice.

Warnings and precautions

Talk to your doctor before taking OLMEGAN.
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 (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
aliskiren.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the section “Do not take OLMEGAN”.

Before taking the 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 (for example 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 sun exposure and UV rays during treatment with OLMEGAN;
if you have previously experienced breathing or lung problems (including lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Olmegan, consult a doctor immediately.

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;
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 the eye, which may occur within hours or weeks of starting OLMEGAN. If untreated, this increase in pressure may lead to permanent vision impairment.

Your doctor may wish to monitor you more frequently and perform blood tests if you have any of the above conditions.
Contact your doctor if, after taking Olmegan, you experience abdominal pain, nausea, vomiting, or diarrhoea. The doctor will decide whether to continue treatment. Do not stop taking Olmegan on your own.

OLMEGAN may increase levels of fats and uric acid (a cause of gout – painful joint swelling) in the blood. Your doctor may want to perform periodic blood tests to monitor these conditions.

It may alter levels of certain substances called electrolytes in the blood. Your doctor may want 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, apathy, fatigue, drowsiness or restlessness, nausea, vomiting, reduced need to urinate, and rapid heartbeat. Inform your doctor if you experience these symptoms.

As with any medicine that lowers blood pressure, excessive reduction in blood pressure in patients with impaired blood flow to 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 OLMEGAN before the tests.

For athletes:

using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.

Inform your doctor if you think you may be pregnant or are planning a pregnancy.

OLMEGAN 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 child if taken during this period (see section “Pregnancy”).

Children and adolescents

OLMEGAN is not recommended for children and adolescents under 18 years of age.

Other medicines and OLMEGAN

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 OLMEGAN. Your doctor may need to adjust the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also “Do not take OLMEGAN” and “Warnings and precautions”).
Medicines that may alter potassium levels in the blood when used together with OLMEGAN. These include: potassium supplements (such as potassium-containing salt substitutes), diuretics, heparin (to thin the blood), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), sodium penicillin G (also known as benzylpenicillin sodium, an antibiotic), or certain painkillers such as aspirin or salicylates.
Lithium (a medicine used to treat mood swings and certain types of depression) used together with OLMEGAN may increase lithium toxicity. If you are taking lithium, your doctor will monitor lithium levels in your blood.
Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis) used together with OLMEGAN may increase the risk of kidney failure. The effectiveness of OLMEGAN may be reduced by NSAIDs.
Sleeping pills, sedatives, and antidepressants, when used together with OLMEGAN, 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 treatment medicines 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 OLMEGAN. Your doctor may advise you to take OLMEGAN 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 lower blood glucose levels.
Beta-blockers and diazoxide, medicines used to treat high blood pressure and low blood sugar, respectively, as OLMEGAN 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.
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.
Some antacids used for stomach acidity, such as aluminium and magnesium hydroxide, as they may slightly reduce the effectiveness of OLMEGAN.
Cisapride, used to increase movement of food through the stomach and intestines.
Halofantrine, used for malaria.

OLMEGAN with food and drink

OLMEGAN can be taken with or without food.

Be cautious about consuming alcohol during treatment with OLMEGAN, as some people may experience fainting or dizziness. If this happens, do not drink any more alcohol, including wine, beer, or carbonated alcoholic drinks.

Patients of Black ethnicity

As with other similar medicines, the blood pressure-lowering effect of OLMEGAN may be somewhat reduced in patients of Black ethnicity.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you may be pregnant or are planning a pregnancy. Your doctor will usually advise you to stop taking OLMEGAN before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. OLMEGAN 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 child if taken after the third month of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding or planning to breast-feed. OLMEGAN is not recommended for nursing mothers, and your doctor may choose an alternative treatment if you wish to breast-feed.

If you are pregnant or breast-feeding, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may experience drowsiness or dizziness during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.

OLMEGAN contains lactose:

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

3. HOW TO TAKE OLMEGAN

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 OLMEGAN 40 mg/12.5 mg daily. However, if your
blood pressure is not adequately controlled, your doctor may decide to change your prescription to
one tablet of OLMEGAN 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 continue taking OLMEGAN until your doctor tells you
to stop.
If you take more OLMEGAN than you should
If you take more tablets than prescribed or if a child accidentally swallows one or more tablets,
go immediately to your doctor or the nearest emergency room, taking the medicine pack with you.
If you forget to take OLMEGAN
If you forget to take a dose, take your usual dose the next day. Do not take a double
dose to make up for the missed dose.
If you stop treatment with OLMEGAN
It is important to continue taking OLMEGAN 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 everybody experiences them.
However, the following 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 OLMEGAN and contact your doctor immediately.
OLMEGAN may cause excessive lowering of blood pressure in predisposed individuals or as a result of an allergic reaction. Dizziness or fainting may occur not uncommonly. If this happens, stop taking OLMEGAN, contact your doctor immediately and lie down.
Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been on OLMEGAN therapy for a long time, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with treatment for arterial hypertension.

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

Other adverse reactions reported so far with OLMEGAN:
If these adverse reactions occur, they are often mild and you do not need to stop treatment with OLMEGAN.

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, the following laboratory test abnormalities have also been observed: increased levels of blood lipids, increased blood urea or uric acid levels, increased creatinine, increased or decreased blood potassium levels, increased blood calcium levels, increased blood glucose levels, 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, the following laboratory test abnormalities have also been observed:
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 OLMEGAN 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 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):
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), feeling unwell, allergic skin reaction, itching, rash, skin blisters (wheals).

Uncommonly, the following laboratory test abnormalities have been observed: reduced number of certain blood cells called platelets (thrombocytopenia).

Rare adverse reactions (may affect up to 1 in 1,000 people):
Impaired renal function, weakness.

Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

Rarely, the following laboratory test abnormalities have been observed: increased blood potassium levels.

Hydrochlorothiazide

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

Common adverse reactions (may affect up to 1 in 10 people):
Confusion, abdominal pain, gastric disturbances, bloating sensation, diarrhea, nausea, vomiting, constipation, glucose in urine.

Laboratory test abnormalities observed include: increased levels of creatinine, urea, calcium and glucose in blood, decreased levels of chloride, potassium, magnesium and sodium in 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, purpura (small hemorrhages causing spots or patches on the skin), 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, yellow vision, 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, 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 disturbances causing abnormally low chloride levels in blood (hypochloremic alkalosis). Intestinal obstruction (paralytic ileus).

Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the website
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 OLMEGAN

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 the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What OLMEGAN contains
The active substances are:
OLMEGAN 40 mg/12.5 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
OLMEGAN 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, lactose monohydrate*, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, titanium dioxide (E171), talc, hypromellose, iron (III) oxide (E172).
*See the section above “OLMEGAN contains lactose”
Description of the appearance of OLMEGAN and the contents of the pack
OLMEGAN 40 mg/12.5 mg, film-coated tablets, oval, 15x7 mm, yellowish-red in colour, with the code C23 engraved on one side;
OLMEGAN 40 mg/25 mg, film-coated tablets, oval, 15x7 mm, pink in colour, with the code C25 engraved on one side.
OLMEGAN is available in packs containing 14, 28, 30, 56, 84, 90, 98, 10x28 and 10x30 film-coated tablets, and in packs of 10, 50 and 500 film-coated tablets with pre-perforated blister for single dose.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Daiichi Sankyo Italia SpA
Via Paolo di Dono, 73
00142 Rome
Italy
Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse, 1
85276 Pfaffenhofen (Germany)
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin (Germany)
This medicinal product is authorised in the European Economic Area Member States under the
following names:
Austria: Olmetec Plus
Belgium: Olmetec Plus
Denmark: Olmetec Plus
Germany: Olmetec Plus
Greece: Olmetec Plus
Finland: Olmetec Plus
France: CoOlmetec
Iceland: Olmetec Plus
Ireland: Benetor Plus
Italy: OLMEGAN
Luxembourg: Olmetec Plus
Netherlands: Olmetec HCTZ
Norway: Olmetec Comp
Portugal: Olmetec Plus
Spain: Olmetec Plus
United Kingdom: Olmetec Plus