Package leaflet: Information for the patient

Irbediur 300 mg/25 mg film-coated tablets

irbesartan/hydrochlorothiazide
Please read this leaflet carefully before starting to take 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. This medicine may be harmful even if their symptoms are the same as yours.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Irbediur is and what it is used for

Irbediur is a combination of two active substances: irbesartan and hydrochlorothiazide.
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to its receptors located in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, resulting in relaxation of the blood vessels and a reduction in blood pressure.
Hydrochlorothiazide belongs to a group of medicines (so-called thiazide diuretics) that increase urine production, thereby lowering blood pressure.
The two active ingredients in Irbediur work together to reduce blood pressure to a greater extent than either medicine alone.
Irbediur is used to treat high blood pressure when treatment with either irbesartan or hydrochlorothiazide alone has not adequately controlled your blood pressure.

2. What you should know before taking Irbediur

Do not take Irbediur

if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to hydrochlorothiazide or to any sulfonamide-derived medicines.
if you are more than 3 months pregnant (it is best to avoid taking Irbediur even in early pregnancy – see Pregnancy section).
if you have severe liver or kidney problems.
if you have difficulty urinating.
if your doctor finds you have persistently high calcium levels or low potassium levels in the blood.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Irbediur if you are in any of the following situations:

excessive vomiting or diarrhoea.
if you have kidney disorders or have had a kidney transplant.
if you have heart problems.
if you have liver problems.
if you have diabetes.
if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid or pounding heartbeat), especially if you are being treated for diabetes.
if you have systemic lupus erythematosus (also known as lupus or SLE).
if you have primary aldosteronism (a condition involving excessive production of the hormone aldosterone, leading to sodium retention and subsequent increase in blood pressure).
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.
if you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 while taking Irbediur.
if you have previously experienced breathing 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 Irbediur, consult a doctor immediately.

Contact your doctor if, after taking Irbediur, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Irbediur on your own.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the section "Do not take Irbediur".

You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Irbediur is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section "Pregnancy").

Also, inform your doctor:

if you are on a low-salt diet.
if you have symptoms such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an excessively rapid heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in Irbediur).
if you have noticed an increased, faster-than-normal sensitivity of the skin to sunlight, with symptoms of sunburn (such as redness, itching, swelling, rash).
if you are scheduled for surgery or need to take anaesthetics.
if you experience a decrease in vision or pain in one or both eyes while taking Irbediur. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (glaucoma), and may occur from a few hours to one week after taking Irbediur. If untreated, these may lead to permanent loss of vision. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition. You must stop taking Irbediur and consult a doctor promptly.

Hydrochlorothiazide, contained in this medicine, may lead to positive results in anti-doping tests.

Children and adolescents
Irbediur must not be given to children and adolescents (under 18 years of age).

Other medicines and Irbediur
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Diuretics such as hydrochlorothiazide contained in Irbediur may interact with other medicines. Preparations containing lithium must not be taken together with Irbediur unless under strict medical supervision.

Your doctor may consider it necessary to adjust the dose and/or take additional precautions:

If you are taking an ACE inhibitor or aliskiren (see also sections "Do not take Irbediur" and "Warnings and precautions").

You may need blood tests if you are using:

potassium supplements.
potassium-containing salt substitutes.
potassium-sparing agents or other diuretics.
certain laxatives.
medicines for the treatment of gout.
vitamin D supplements.
medicines to control heart rhythm.
medicines for diabetes (oral medications such as repaglinide or insulin).
carbamazepine (a medicine used to treat epilepsy).

It is also important to inform your doctor if you are taking other medicines to lower blood pressure, steroids, cancer treatments, pain medicines, arthritis medicines, or colestyramine and colestipol to lower blood cholesterol levels.

Irbediur with food and drink
Irbediur can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbediur, if you drink alcohol while being treated with this medicine, you may feel more dizzy when standing up, especially when moving from a sitting to a standing position.

Pregnancy, breastfeeding and fertility

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Irbediur before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Irbediur is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Irbediur is not recommended for women who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
It is unlikely that Irbediur will affect your ability to drive or use machines. However, dizziness or fatigue may occasionally occur during treatment for high blood pressure. If this happens to you, talk to your doctor before driving or using machines.

Irbediur contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Irbediur

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose of Irbediur is one tablet daily. Your doctor will prescribe Irbediur if your previous therapy has not sufficiently lowered your blood pressure. Your doctor will advise you on how to switch from your previous treatment to Irbediur.
Method of administration
Irbediur is for oral use. Swallow the tablets with a sufficient amount of liquid (for example, a glass of water). You may take Irbediur with or without food. Try to take the medicine at the same time every day. It is important to continue therapy unless otherwise instructed by your doctor.
The maximum blood pressure-lowering effect is achieved after 6–8 weeks of starting treatment.
If you take more Irbediur than you should
If you accidentally take too many tablets, contact your doctor immediately.
Children must not take Irbediur
Irbediur must not be given to children under 18 years of age. If a child ingests any tablets, contact your doctor immediately.
If you forget to take Irbediur
If you forget to take a dose, continue with your next dose as normal. Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some of these effects may be serious and may require medical attention.
In patients treated with irbesartan, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported. If you experience any of these symptoms or have difficulty breathing, stop taking Irbediur and contact your doctor immediately.

The side effects are listed below according to their frequency of occurrence.
The side effects reported in clinical studies in patients treated with Irbediur were:

Common side effects (may affect up to 1 in 10 people)

nausea/vomiting
urinary disorders
fatigue
dizziness (also when moving from a sitting or lying position to standing)
blood tests may show increased levels of an enzyme measuring muscle and heart function (creatine kinase), or increased levels of substances measuring kidney function (blood urea nitrogen, creatinine).
Inform your doctor if any of these side effects cause you problems.

Uncommon side effects (may affect up to 1 in 100 people)

diarrhoea
hypotension
weakness
rapid heartbeat
hot flushes
swelling
sexual dysfunction (problems during sexual activity)
blood tests may show decreased levels of potassium and sodium in the blood. Inform your doctor if any of these side effects cause you problems.

Side effects reported after marketing of Irbediur
Since the launch of Irbediur on the market, some side effects have been reported.
Side effects with unknown frequency include: headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and renal dysfunction, elevated blood potassium levels, and allergic reactions (rash, urticaria, localized swelling of the face, lips, mouth, tongue or throat). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

As with any combination of two active substances, side effects associated with each individual component cannot be excluded.

Side effects associated with irbesartan alone
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock), reduced number of red blood cells (anaemia – symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and pale appearance), and reduced number of platelets (blood cells essential for blood clotting) have also been reported.

Rare (may affect up to 1 in 1,000 people): intestinal angioedema (swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea)

Side effects associated with hydrochlorothiazide alone
Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterised by severe pain in the upper stomach, often with nausea and vomiting; sleep disturbances; depression; blurred vision; lack of white blood cells, which may lead to frequent infections and fever; reduced number of platelets (essential component for blood clotting), reduced number of red blood cells (anaemia) characterised by fatigue, headache, shortness of breath during exercise, dizziness and pale appearance; kidney problems; lung problems including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to sunlight; inflammation of blood vessels; a skin disorder characterised by skin peeling over the entire body; lupus erythematosus, identified by a rash that may appear on the face, neck and scalp; allergic reactions; muscle weakness and muscle cramps; irregular heartbeat; drop in blood pressure upon changing body position; swelling of the salivary glands; elevated blood sugar levels; sugar in the urine; increases in certain types of fats in the blood; elevated levels of uric acid in the blood which may cause gout.

Very rare (may affect up to 1 in 10,000 people): acute respiratory distress (symptoms include severe shortness of breath, fever, weakness and confusion).

Not known (frequency cannot be estimated from the available data): skin and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Irbediur

Keep this medicine out of the sight and reach of children.
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 store above 25°C.
Store in the original packaging to protect from moisture.
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. Package contents and other information

What Irbediur contains

The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbediur 300 mg/25 mg contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, povidone, magnesium stearate.
Coating: Opadry II 31F86925 brown [monohydrate lactose, hypromellose, titanium dioxide (E 171), polyethylene glycol, red iron oxide (E172), black iron oxide (E172)].

Description of the appearance of Irbediur and contents of the pack
Irbediur 300 mg/25 mg film-coated tablets are dark pink, biconvex, oval tablets, with "452" printed on one side.
Box containing 28 film-coated tablets in blisters.

Marketing Authorization Holder
Lanova Farmaceutici S.r.l. – Via Conca D’Oro n. 212 – 00141 Rome, Italy

Manufacturer
PSI Supply nv - Axxes Business Park, Guldensporenpark 22, Block C - 9820 Merelbeke, Belgium

Patient information leaflet

Irbediur 300 mg/12.5 mg film-coated tablets

irbesartan/hydrochlorothiazide
Please read this leaflet carefully before you start 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. This medicine could be harmful to others, even if their symptoms are the same as yours.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Irbediur is and what it is used for

Irbediur is a combination of two active substances: irbesartan and hydrochlorothiazide.
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to its receptors located in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, resulting in relaxation of the blood vessels and a lowering of blood pressure.
Hydrochlorothiazide belongs to a group of medicines (so-called thiazide diuretics) that increase urine production, thereby lowering blood pressure.
The two active ingredients in Irbediur work together to lower blood pressure to a greater extent than either medicine given alone.
Irbediur is used to treat high blood pressure when treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled your blood pressure.

What you need to know before taking Irbediur

Do not take Irbediur

if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to hydrochlorothiazide or to any of the medicines derived from sulfonamides.
if you are more than 3 months pregnant (it is better to avoid taking Irbediur even in the early stages of pregnancy – see section on Pregnancy).
if you have severe liver or kidney problems.
if you have difficulty passing urine.
if your doctor finds that you have persistently high calcium levels or low potassium levels in your blood.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Irbediur if you are in any of the following situations:

excessive vomiting or diarrhoea
if you have kidney disorders or have had a kidney transplant
if you have heart problems
if you have liver disorders
if you have diabetes
if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid or pounding heartbeat), especially if you are being treated for diabetes
if you have systemic lupus erythematosus (also known as lupus or SLE)
if you have primary hyperaldosteronism (a condition associated with excessive production of the hormone aldosterone, leading to sodium retention and, consequently, increased blood pressure)
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
if you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and of the lips. Protect your skin from exposure to sunlight and UV rays while taking Irbediur.
if you have previously experienced breathing 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 Irbediur, consult a doctor immediately.

Talk to your doctor if, after taking Irbediur, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Irbediur on your own.
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 section "Do not take Irbediur".
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Irbediur is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if taken during this period (see section "Pregnancy").
Also inform your doctor:

if you are on a low-salt diet
if you have symptoms such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an excessively rapid heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in Irbediur)
if you have noticed an increased, faster-than-normal sensitivity of the skin to sunlight, with symptoms of sunburn (such as redness, itching, swelling, rash)
if you are scheduled for surgery or need to take anaesthetics
if you experience changes in vision or pain in one or both eyes while taking Irbediur. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (glaucoma), which may occur from a few hours to a week after taking Irbediur. If left untreated, these may lead to permanent loss of vision. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition. You must stop taking Irbediur and consult your doctor promptly.

Hydrochlorothiazide, contained in this medicine, may cause a positive result in anti-doping tests.
Children and adolescents
Irbediur must not be given to children and adolescents (under 18 years of age).

Other medicines and Irbediur
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diuretics such as hydrochlorothiazide contained in Irbediur may affect other medicines. Medicines containing lithium must not be taken together with Irbediur unless under strict medical supervision.
Your doctor may consider it necessary to adjust your dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also sections "Do not take Irbediur" and "Warnings and precautions").
You may need blood tests if you are using:

potassium supplements
salt substitutes containing potassium
potassium-sparing agents or other diuretics
certain laxatives
medicines for the treatment of gout
vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral antidiabetic medicines such as repaglinide or insulin)
carbamazepine (a medicine used to treat epilepsy)

It is also important to inform your doctor if you are taking other medicines to lower blood pressure, steroids, cancer treatments, pain medicines, medicines for arthritis, or colestyramine and colestipol to lower blood cholesterol levels.

Irbediur with food and drink
Irbediur can be taken with or without food.
Due to the hydrochlorothiazide contained in Irbediur, if you drink alcohol while being treated with this medicine, you may feel more dizzy when standing up, especially when moving from a sitting to an upright position.

Pregnancy, breast-feeding and fertility
Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Irbediur before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Irbediur is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if taken after the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Irbediur is not recommended for women who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
It is unlikely that Irbediur will affect your ability to drive or use machines.
However, dizziness or fatigue may occasionally occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or operating machinery.

Irbediur contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Irbediur

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dosage
The recommended dose of Irbediur is one tablet daily. Your doctor will prescribe Irbediur if your previous treatment has not sufficiently lowered your blood pressure. Your doctor will advise you on how to switch from your previous treatment to Irbediur.
Administration method
Irbediur is for oral use. Swallow the tablets with a sufficient amount of liquid (for example, a glass of water). You may take Irbediur with or without food. Try to take the medicine at the same time every day. It is important to continue therapy unless otherwise instructed by your doctor.
Maximum blood pressure-lowering effect is achieved after 6–8 weeks of starting treatment.
If you take more Irbediur than you should
If you accidentally take too many tablets, contact your doctor immediately.
Children must not take Irbediur
Irbediur must not be given to children under 18 years of age. If a child swallows any tablets, contact your doctor immediately.
If you forget to take Irbediur
If you forget to take a dose, simply take the next dose at your regular time. Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Some of these effects may be serious and may require medical attention.
Rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you experience any of these symptoms or if you have difficulty breathing, stop taking Irbediur and contact your doctor immediately.
The side effects listed below are categorized according to their frequency of occurrence:
Side effects reported in clinical studies in patients treated with Irbediur include:

Common side effects (may affect up to 1 in 10 people)

nausea/vomiting
urinary disorders
fatigue
dizziness (also when moving from a sitting or lying position to standing)
blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase), or increased levels of substances that measure kidney function (blood urea nitrogen, creatinine).

Inform your doctor if any of these side effects cause you problems.

Uncommon side effects (may affect up to 1 in 100 people)

diarrhoea
hypotension
weakness
rapid heartbeat
hot flushes
swelling
sexual dysfunction (problems with sexual activity)
blood tests may show decreased levels of potassium and sodium in the blood. Inform your doctor if any of these side effects cause you problems.

Side effects reported after marketing of Irbediur
Since the marketing of Irbediur, some side effects have been reported. Side effects with unknown frequency include: headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and renal dysfunction, elevated blood potassium levels and allergic reactions (rash, urticaria, localized swelling of the face, lips, mouth, tongue or throat). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.
As with any combination of two active substances, side effects associated with each component cannot be excluded.

Side effects associated with irbesartan alone
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock), reduced number of red blood cells (anaemia – symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance) and reduced platelet count (blood cells essential for blood clotting) have also been reported.
Rare (may affect up to 1 in 1,000 people): intestinal angioedema (swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea).

Side effects associated with hydrochlorothiazide alone
Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterized by severe pain in the upper abdomen, often with nausea and vomiting; sleep disturbances; depression; blurred vision; lack of white blood cells, which may lead to frequent infections and fever; reduced platelet count (a component essential for blood clotting), reduced red blood cell count (anaemia) characterized by fatigue, headache, shortness of breath during exercise, dizziness and pale appearance; kidney problems; lung problems including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to sunlight; inflammation of blood vessels; a skin disorder characterized by peeling of the skin all over the body; lupus erythematosus, identified by a rash that may appear on the face, neck and scalp; allergic reactions; muscle weakness and muscle spasms; irregular heartbeat; drop in blood pressure upon changing body position; swelling of the salivary glands; elevated blood sugar levels; sugar in the urine; increases in certain types of fat in the blood; elevated levels of uric acid in the blood which may cause gout.
Very rare (may affect up to 1 in 10,000 people): acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).
Not known ( frequency cannot be estimated from the available data): skin and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

Reporting of side effects
If you experience any side effect, including those not listed in this patient information leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Irbediur

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after Exp.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging to protect from moisture.
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. Package contents and other information

What Irbediur contains

The active substances are irbesartan and hydrochlorothiazide. Each Irbediur 300 mg/12.5 mg film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, povidone, magnesium stearate, yellow iron oxide (E 172), red iron oxide (E 172).
Coating: Opadry II 32F84835 pink [Irbediur monohydrate lactose, hypromellose, titanium dioxide (E 171), macrogol, yellow iron oxide (E 172), red iron oxide (E 172)].

Description of the appearance of Irbediur and contents of the pack
Irbediur 300 mg/12.5 mg film-coated tablets are peach-coloured, biconvex, oval tablets with "451" imprinted on one side.
Box containing 28 film-coated tablets in blisters.

Marketing Authorization Holder
Lanova Farmaceutici S.r.l. – Via Conca D’Oro n. 212 – 00141 Rome, Italy

Manufacturer
PSI Supply nv - Axxes Business Park, Guldensporenpark 22, Block C - 9820 Merelbeke, Belgium

Patient Information Leaflet

Irbediur 150 mg/12.5 mg film-coated tablets

irbesartan/hydrochlorothiazide
Please read this entire leaflet carefully before you start 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. This medicine may be harmful to them, even if their symptoms are the same as yours.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Irbediur is and what it is used for

Irbediur is a combination of two active substances: irbesartan and hydrochlorothiazide.
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Angiotensin-II is a substance produced in the body that binds to its receptors located in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, resulting in relaxation of the blood vessels and lowering of blood pressure.
Hydrochlorothiazide belongs to a group of medicines (so-called thiazide diuretics) that increase urine production, thereby lowering blood pressure.
The two active ingredients in Irbediur work together to lower blood pressure to a greater extent than either drug alone.
Irbediur is used to treat high blood pressure when treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled your blood pressure.

What you need to know before taking Irbediur

Do not take Irbediur

if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to hydrochlorothiazide or to any medicines derived from sulfonamides.
if you are more than 3 months pregnant (it is better to avoid taking Irbediur even in the early stages of pregnancy – see section Pregnancy).
if you have severe liver or kidney problems.
if you have difficulty urinating.
if your doctor finds you have persistently high calcium levels or low potassium levels in the blood.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Irbediur and if you are in any of the following conditions:

excessive vomiting or diarrhoea
if you have kidney disorders or have had a kidney transplant
if you have heart problems
if you have liver problems
if you have diabetes
if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or pallor, numbness, rapid and pounding heartbeat), especially if you are being treated for diabetes
if you have systemic lupus erythematosus (also known as lupus or SLE)
if you have primary hyperaldosteronism (a condition associated with excessive production of the hormone aldosterone, leading to sodium retention and subsequently increased blood pressure)
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
if you have previously had skin cancer or are developing 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 while taking Irbediur.
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 Irbediur, consult a doctor immediately.
Talk to your doctor if, after taking Irbediur, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Irbediur on your own.

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 section "Do not take Irbediur".
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Irbediur is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if taken during this period (see section "Pregnancy").
Also, inform your doctor:

if you are on a low-salt diet
if you have symptoms such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an excessively rapid heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in Irbediur)
if you have noticed an increase, faster than normal, in skin sensitivity to sunlight with symptoms of sunburn (such as redness, itching, swelling, rash)
if you are scheduled for surgery or need to take anaesthetics
if you experience reduced vision or eye pain in one or both eyes while taking Irbediur. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure (glaucoma) and may occur from a few hours to a week after taking Irbediur. If untreated, they may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition. You must stop taking Irbediur and consult your doctor promptly.

Hydrochlorothiazide, contained in this medicine, may cause positive results in anti-doping tests.
Children and adolescents
Irbediur must not be given to children and adolescents (under 18 years of age).
Other medicines and Irbediur
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diuretic medicines such as hydrochlorothiazide contained in Irbediur may affect other medicines. Preparations containing lithium must not be taken together with Irbediur unless under strict medical supervision.
Your doctor may consider it necessary to adjust the dose and/or take additional precautions:
If you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Irbediur" and "Warnings and precautions").
You may need blood tests if you are using:

potassium supplements
salt substitutes containing potassium
potassium-sparing agents or other diuretics
certain laxatives
medicines for the treatment of gout
vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral medications such as repaglinide or insulin)
carbamazepine (a medicine used to treat epilepsy)

It is also important to inform your doctor if you are taking other medicines to lower blood pressure, steroids, cancer-treatment medicines, painkillers, medicines for arthritis, or colestyramine and colestipol to lower cholesterol levels in the blood.
Irbediur with food and drink
Irbediur can be taken with or without food.
Due to the hydrochlorothiazide contained in Irbediur, if you drink alcohol during treatment with this medicine, you may feel more dizzy when standing up, especially when moving from a sitting to an upright position.
Pregnancy, breastfeeding and fertility
Pregnancy
Inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Irbediur before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Irbediur. Irbediur is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Irbediur is not recommended for women who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
It is unlikely that Irbediur will affect your ability to drive or use machines.
However, dizziness or fatigue may occasionally occur during treatment for high blood pressure. If this happens to you, talk to your doctor before driving or using machines.
Irbediur contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Irbediur

Take this medicine exactly as your doctor has told you. If you are unsure, check with your doctor or pharmacist.
Dosage
The recommended dose of Irbediur is one or two tablets daily. Irbediur will be prescribed by your doctor if your previous treatment has not sufficiently reduced your blood pressure. Your doctor will advise you on how to switch from your previous treatment to Irbediur.
Method of administration
Irbediur is for oral use. Swallow the tablets with a sufficient amount of liquid (for example, a glass of water). You may take Irbediur with or without food. Try to take the medicine at the same time each day. It is important to continue therapy unless otherwise instructed by your doctor.
The maximum blood pressure-lowering effect will be achieved after 6–8 weeks of starting treatment.
If you take more Irbediur than you should
If you accidentally take too many tablets, contact your doctor immediately.
Children must not take Irbediur
Irbediur must not be given to children under 18 years of age. If a child swallows any tablets, contact your doctor immediately.
If you forget to take Irbediur
If you forget to take a dose, simply take the next dose at your regular time. Do not take a double dose to make up for the forgotten dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some of these effects may be serious and may require medical attention.
In patients treated with irbesartan, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported. If you experience any of these symptoms or have difficulty breathing, stop taking Irbediur and contact your doctor immediately.

The side effects listed below are categorized according to their frequency of occurrence.
Side effects reported in clinical studies in patients treated with Irbediur include:

Common side effects (may affect up to 1 in 10 people)

nausea/vomiting
urinary disorders
fatigue
dizziness (also when moving from a sitting or lying position to a standing position)
blood tests may show increased levels of an enzyme measuring muscle and heart function (creatine kinase), or increased levels of substances measuring kidney function (blood urea nitrogen, creatinine).

Inform your doctor if any of these side effects cause you problems.

Uncommon side effects (may affect up to 1 in 100 people)

diarrhoea
hypotension
weakness
rapid heartbeat
hot flushes
swelling
sexual dysfunction (problems with sexual activity)
blood tests may show decreased levels of potassium and sodium in the blood. Inform your doctor if any of these side effects cause you problems.

Side effects reported after the marketing of Irbediur
Since Irbediur has been marketed, some side effects have been reported. Side effects with unknown frequency include: headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and renal dysfunction, elevated blood potassium levels, and allergic reactions (rash, urticaria, localized swelling of the face, lips, mouth, tongue or throat). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

As with any combination of two active substances, side effects associated with each component cannot be ruled out.

Side effects associated with irbesartan alone
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock), reduced number of red blood cells (anaemia – symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), and reduced platelet count (blood cells essential for blood clotting) have also been reported.

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

Side effects associated with hydrochlorothiazide alone
Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterized by severe pain in the upper abdomen, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which may lead to frequent infections and fever; reduced platelet count (a component essential for blood clotting), reduced number of red blood cells (anaemia) characterized by fatigue, headache, shortness of breath during exercise, dizziness and pale appearance; kidney problems; lung problems including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to sunlight; inflammation of blood vessels; a skin disorder characterized by peeling of the skin over the entire body; lupus erythematosus, identified by a rash that may appear on the face, neck and scalp; allergic reactions; muscle weakness and cramps; altered heartbeat; drop in blood pressure upon changing body position; swelling of the salivary glands; elevated blood sugar levels; sugar in the urine; increases in certain types of blood fats; elevated levels of uric acid in the blood which may cause gout.

Very rare (may affect up to 1 in 10,000 people): acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: “https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Irbediur

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister pack after "Exp".
The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Irbediur contains

The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbediur 150 mg/12.5 mg contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, povidone, magnesium stearate.
Coating: Opadry II 32F38977 white [monohydrate lactose, hypromellose, titanium dioxide (E 171), macrogol].

Description of the appearance of Irbediur and contents of the pack
The IRBEDIUR 150 mg/12.5 mg tablets are white or almost white, biconvex, oval-shaped, with "450" printed on one side.
Carton pack containing 28 film-coated tablets in blister packs.

Marketing Authorization Holder
Lanova Farmaceutici S.r.l. – Via Conca D’Oro n. 212 – 00141 Roma, Italy

Manufacturer
PSI Supply nv - Axxes Business Park, Guldensporenpark 22, Block C - 9820 Merelbeke, Belgium