PACKAGE LEAFLET: INFORMATION FOR THE USER

Lubersan 150 mg/12.5 mg tablets

Irbesartan and Hydrochlorothiazide
Equivalent medicine
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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Never give it to others. Even if their symptoms are the same as yours, it could be dangerous.
If any of the side effects worsen or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What Irbesartan and Hydrochlorothiazide tablets are and what they are used for
What you need to know before taking Irbesartan and Hydrochlorothiazide tablets
How to take Irbesartan and Hydrochlorothiazide tablets
Possible side effects
How to store Irbesartan and Hydrochlorothiazide tablets
Contents of the pack and other information

1. WHAT IS IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS AND WHAT IS IT USED FOR?

Irbesartan and Hydrochlorothiazide Tablets 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 receptors located on blood vessels, causing them to narrow. This results in an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, leading to relaxation of the blood vessels and a reduction in blood pressure.
Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that increase urine production, thereby lowering blood pressure.
The two active substances in Irbesartan and Hydrochlorothiazide Tablets work together to reduce blood pressure more effectively than either medicine used alone.
Irbesartan and Hydrochlorothiazide Tablets is used for the treatment of hypertension when treatment with either irbesartan or hydrochlorothiazide alone has not adequately controlled blood pressure.

2. WHAT YOU SHOULD KNOW BEFORE TAKING IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS

Do not take Irbesartan and Hydrochlorothiazide Tablets

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 other sulfonamide-derived medicines
If you are more than 3 months pregnant. It is also recommended to avoid Irbesartan and Hydrochlorothiazide Tablets in early pregnancy (see section Pregnancy)
If you have severe liver or kidney problems
If you have difficulty urinating
If your doctor has determined that you have consistently high levels of calcium or low levels of potassium 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 Irbesartan and Hydrochlorothiazide Tablets if you are in any of the following situations:

You have excessive vomiting or diarrhoea
You have kidney disorders or have had a kidney transplant
You have heart problems
You have liver problems
You have diabetes
You develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, numbness, pounding heartbeat), especially if you are being treated for diabetes
You have systemic lupus erythematosus (also known as lupus or SLE)
You have primary hyperaldosteronism (a condition associated with excessive production of the hormone aldosterone, leading to sodium retention and, in turn, 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 with high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Irbesartan and Hydrochlorothiazide Tablets
If you have previously experienced breathing or lung problems (including inflammation or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Lubersan, consult a doctor immediately.

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 Irbesartan and Hydrochlorothiazide Tablets"
You must inform your doctor if you are pregnant (or plan to become pregnant). Irbesartan and Hydrochlorothiazide Tablets are not recommended during early pregnancy and must not be taken after the third month of pregnancy as it may cause serious harm to the unborn baby (see section Pregnancy).
Also inform your doctor if:

You are on a low-salt diet
You experience signs 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 Irbesartan and Hydrochlorothiazide Tablets)
You notice an increased sensitivity of the skin to sunlight, manifesting as faster-than-normal onset of sunburn symptoms (such as redness, itching, swelling, blistering)
You need to undergo surgery or receive anaesthetics
You experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) and may occur from a few hours to several weeks after taking Lubersan. If left untreated, this may lead to permanent loss of vision. If you have previously had an allergy to penicillin or sulfonamides, you may be at greater risk of developing these symptoms. You must stop taking Irbesartan and Hydrochlorothiazide Tablets and consult a doctor immediately.

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

Potassium supplements
Potassium-containing salt substitutes
Potassium-sparing agents or other diuretics (fluid-eliminating tablets)
Certain laxatives
Medicines for the treatment of gout
Therapeutic vitamin D supplements
Medicines to control heart rhythm
Medicines for diabetes (oral agents 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, anticancer medicines, painkillers, medicines for arthritis, or bile acid sequestrants such as cholestyramine or colestipol to reduce cholesterol in the blood.
Taking Irbesartan and Hydrochlorothiazide Tablets with food, drinks and alcohol
Irbesartan and Hydrochlorothiazide Tablets can be taken with or without food.
Due to the hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide Tablets, drinking alcohol during treatment with this medicine may increase the likelihood of dizziness, especially when moving from a sitting to an upright position.
Pregnancy, breastfeeding and fertility
Pregnancy
Inform your doctor if you are pregnant (or planning to become pregnant). Your doctor will normally advise you to stop taking Irbesartan and Hydrochlorothiazide Tablets before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Irbesartan and Hydrochlorothiazide Tablets are not recommended during early pregnancy and must not be taken after the third month of pregnancy because they may cause serious harm to the unborn baby.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Irbesartan and Hydrochlorothiazide Tablets are not recommended during breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
It is unlikely that Irbesartan and Hydrochlorothiazide Tablets will affect your ability to drive or use machines. However, occasionally during treatment for hypertension, you may experience dizziness or fatigue. If this occurs, discuss it with your doctor before driving or operating machinery.
Irbesartan and Hydrochlorothiazide Tablets contain lactose. If your doctor has told you that you have an intolerance to certain sugars (e.g. lactose), contact him or her before taking this medicine.
Irbesartan and Hydrochlorothiazide Tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS

Take this medicine exactly as your doctor has told you. If you are unsure,
consult your doctor or pharmacist.
Dosage
The recommended dose of Irbesartan and Hydrochlorothiazide Tablets is one tablet per day.
Irbesartan and Hydrochlorothiazide Tablets will be prescribed by your doctor if your previous
antihypertensive treatment has not provided adequate blood pressure reduction. Your doctor
will advise you on how to switch from your previous treatment to Irbesartan and Hydrochlorothiazide Tablets.
Method of administration
Irbesartan and Hydrochlorothiazide Tablets are for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. a glass of water). You may take Irbesartan and Hydrochlorothiazide Tablets with or without food. Try to take the medicine at the same time each day. It is important to continue taking Irbesartan and Hydrochlorothiazide Tablets unless otherwise instructed by your doctor.
Maximum antihypertensive effect should be achieved within 6–8 weeks after starting treatment.
Children must not take Irbesartan and Hydrochlorothiazide Tablets
Irbesartan and Hydrochlorothiazide Tablets must not be administered to children under 18 years of age. If a child accidentally ingests any tablets, contact your doctor immediately.
If you take more Irbesartan and Hydrochlorothiazide Tablets than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan and Hydrochlorothiazide Tablets
If you accidentally forget to take your daily dose, simply take the next dose at the usual 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 ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some of these adverse reactions may be serious and may require medical attention.
Rare cases of allergic reactions (skin rash, urticaria) as well as localized swelling of the face, lips, and/or tongue have been reported in patients taking irbesartan.
If you experience any of the adverse reactions listed above or develop shortness of breath, stop treatment with Irbesartan and Hydrochlorothiazide tablets and contact your doctor immediately.

The frequency of the adverse reactions listed below is defined using the following convention:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Adverse reactions reported in clinical studies in patients treated with Irbesartan and Hydrochlorothiazide tablets were:

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

Nausea/vomiting
Urinary disorders
Fatigue
Dizziness (also when moving from sitting or lying down to standing)
Blood tests may show increased levels of an enzyme measuring muscle and heart function (creatine kinase) or substances measuring kidney function (azotemia, creatinine). If any of these adverse reactions cause you problems, discuss them with your doctor.

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

Diarrhea
Low blood pressure
Fainting
Increased heart rate
Hot flushes
Swelling
Sexual dysfunction (problems with sexual performance)
Blood tests may show decreased levels of potassium and sodium.

If any of these adverse reactions cause you problems, discuss them with your doctor.

Adverse reactions reported after marketing authorization of Irbesartan and Hydrochlorothiazide tablets
Since the marketing of Irbesartan and Hydrochlorothiazide tablets, some adverse reactions have been reported. Adverse reactions with unknown frequency include: headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and impaired kidney function, elevated blood potassium levels, and allergic reactions such as skin 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, adverse reactions associated with each individual component cannot be excluded.

Adverse reactions associated with the use of irbesartan alone
In patients taking irbesartan alone, in addition to the adverse reactions listed above, chest pain, severe allergic reactions (anaphylactic shock), reduced number of red blood cells (anemia – symptoms may include fatigue, headache, shortness of breath during physical exertion, dizziness, and pallor), a decrease in platelet count (blood cells essential for blood clotting), and low blood sugar levels have also been reported.

Adverse reactions associated with the use of hydrochlorothiazide alone
In patients treated with hydrochlorothiazide alone, the following additional adverse reactions have been observed: loss of appetite, gastric 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 accompanied by nausea and vomiting, sleep disturbances, depression, blurred vision, reduced white blood cell count (which may lead to frequent infections and fever), reduced platelet count (essential components for blood clotting), reduced number of red blood cells (anemia) characterized by fatigue, headache, shortness of breath during exercise, dizziness, and pale appearance, kidney disease, 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 skin peeling over the entire body, cutaneous lupus erythematosus, identified by a rash that may appear on the face, neck, and scalp, allergic reactions, muscle weakness and cramps, altered heartbeat, low 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: 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 adverse reactions associated with hydrochlorothiazide may increase with higher doses of this substance.

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: http://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 IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS

Keep this medicine out of the sight and reach of children.
Do not use Irbesartan and Hydrochlorothiazide Tablets after the expiry date stated on the
carton and blister pack after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the
environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Irbesartan and Hydrochlorothiazide tablets contain
The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet contains
150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
The excipients are
Core: calcium carboxymethylcellulose (ECG-505), colloidal silicon dioxide (Aerosil 200),
povidone (PVP K29/32), sodium starch glycolate Type A (Glycolys), talc and magnesium stearate.
Coating: hypromellose 15 cP (E464), lactose monohydrate, titanium dioxide (E171) and
polyethylene glycol 3000, iron oxide red (E172) and iron oxide yellow (E172).
What Irbesartan and Hydrochlorothiazide tablets look like and contents of the pack
Irbesartan and Hydrochlorothiazide 150 mg/12.5 mg tablets are film-coated, oval-shaped, peach-coloured tablets, embossed with "ML 34" on one side and smooth on the other.
Irbesartan and Hydrochlorothiazide 150 mg/12.5 mg tablets are supplied in blisters containing 28, 56 or 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Luxpharma S.r.l.
Via Mazzini 20
20123 Milano - Italy
Manufacturer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz, Poland
This medicinal product is authorised in Member States under the following trade names:
United Kingdom: Irbesartan/Hydrochlorothiazide 150 mg/12.5 mg tablets
Germany: Irbesartan/Hydrochlorothiazid Heumann 150 mg/12.5 mg filmtabletten
Italy: Lubersan 150 mg/12.5 mg film-coated tablets
Spain: Irbesartán/Hidroclorotiazida Viso Farmacéutica 150 mg/12.5 mg coated tablets EFG
This leaflet was last approved on

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lubersan 300 mg/12.5 mg tablets

Irbesartan and Hydrochlorothiazide
Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Never give it to others. Even if their symptoms are the same as yours, it could be harmful.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What Irbesartan and Hydrochlorothiazide tablets are and what they are used for
What you need to know before taking Irbesartan and Hydrochlorothiazide tablets
How to take Irbesartan and Hydrochlorothiazide tablets
Possible side effects
How to store Irbesartan and Hydrochlorothiazide tablets
Contents of the pack and other information

1. WHAT IS IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS AND WHAT IS IT USED FOR?

Irbesartan and Hydrochlorothiazide Tablets 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 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 blood vessels and a reduction in blood pressure.

Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that increase urine production, thereby lowering blood pressure.

The two active ingredients in Irbesartan and Hydrochlorothiazide Tablets work together to lower blood pressure more effectively than either medicine used alone.

Irbesartan and Hydrochlorothiazide Tablets is used for the treatment of hypertension when treatment with either irbesartan or hydrochlorothiazide alone has not adequately controlled blood pressure.

2. WHAT YOU SHOULD KNOW BEFORE TAKING IRBESARTAN AND

HYDROCHLOROTHIAZIDE TABLETS
Do not take Irbesartan and Hydrochlorothiazide Tablets

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 other sulfonamide-derived medicines
If you are more than 3 months pregnant. (It is also recommended to avoid Irbesartan and Hydrochlorothiazide Tablets in early pregnancy; see section Pregnancy)
If you have severe liver or kidney problems
If you have difficulty urinating
If your doctor has determined that you have consistently high blood calcium levels or low blood potassium levels
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 Irbesartan and Hydrochlorothiazide Tablets if you are in
one of the following situations:

You have excessive vomiting or diarrhea
You have kidney disorders or have had a kidney transplant
You have heart problems
You have liver problems
You have diabetes
You develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, numbness, pounding heartbeat), especially if you are being treated for diabetes.
You have lupus erythematosus (also known as lupus or SLE)
You have primary hyperaldosteronism (a condition associated with excessive production of the hormone aldosterone, causing sodium retention and, in turn, increased blood pressure).
if you are taking one 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, particularly long-term use with 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 Irbesartan and Hydrochlorothiazide Tablets.
If you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If, after taking Lubersan, you develop shortness of breath or severe breathing difficulties, consult a doctor immediately.

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 Irbesartan and Hydrochlorothiazide
Tablets”
You must inform your doctor if you are pregnant (or planning to become pregnant). Irbesartan
and Hydrochlorothiazide Tablets is not recommended in early pregnancy and must not be
taken after the third month of pregnancy as it may cause serious harm to the unborn baby (see
section Pregnancy).
Also inform your doctor if:

You are on a low-salt diet
You experience signs such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an excessively fast heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan and Hydrochlorothiazide Tablets)
You notice increased sensitivity of the skin to sunlight, manifesting as more rapid onset than normal of sunburn symptoms (such as redness, itching, swelling, blistering)
You need to undergo surgery or receive anesthetics.
You experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) and may occur within hours to weeks after taking Lubersan. If left untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing these symptoms. You must stop taking Irbesartan and Hydrochlorothiazide Tablets and consult your doctor immediately.

The hydrochlorothiazide contained in this medicine may lead to positive results in doping tests.
Children and adolescents
Irbesartan and Hydrochlorothiazide Tablets must not be administered to children and
adolescents (under 18 years of age).
Other medicines and Irbesartan and Hydrochlorothiazide Tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those obtained without a prescription.
Diuretics such as hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide Tablets
may interact with other medicines. Preparations containing lithium should not be taken together with Irbesartan and Hydrochlorothiazide Tablets 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 Irbesartan and Hydrochlorothiazide Tablets” and "Warnings and precautions”).
You may need blood tests if you are taking:

potassium supplements
potassium-containing salt substitutes
potassium-sparing agents or other diuretics (water-eliminating tablets)
certain laxatives
medicines for the treatment of gout
therapeutic vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral agents 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, anticancer medicines, painkillers, medicines for arthritis, or cholestyramine or colestipol to reduce cholesterol in the blood.
Irbesartan and Hydrochlorothiazide Tablets with food, drinks and alcohol
Irbesartan and Hydrochlorothiazide Tablets can be taken with or without food.
Due to the hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide Tablets, if you
consume alcohol during treatment with this medicine, you may experience increased dizziness, especially when moving from a sitting to a standing position.
Pregnancy, breastfeeding and fertility
Pregnancy
Inform your doctor if you are pregnant (or planning to become pregnant). Your doctor will
usually advise you to stop taking Irbesartan and Hydrochlorothiazide Tablets before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Irbesartan and Hydrochlorothiazide Tablets is not recommended in early pregnancy and must not be taken after the third month of pregnancy because it may cause serious harm to the unborn baby.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Irbesartan and
Hydrochlorothiazide Tablets is not recommended during breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
It is unlikely that Irbesartan and Hydrochlorothiazide Tablets will affect your ability to drive or
operate machinery. However, occasionally, during treatment for hypertension, you may experience dizziness or fatigue. If this occurs, discuss it with your doctor before driving or operating machinery.
Irbesartan and Hydrochlorothiazide Tablets contains lactose. If your doctor has told you that you have an intolerance to certain sugars (e.g., lactose), contact him before taking this
medicine.
Irbesartan and Hydrochlorothiazide Tablets contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.,
essentially 'sodium-free'.

3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS

Take this medicine exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Dosage
The recommended dose of Irbesartan and Hydrochlorothiazide Tablets is one tablet per day.
Irbesartan and Hydrochlorothiazide Tablets will be prescribed by your doctor when previous
antihypertensive therapy has not provided adequate blood pressure reduction. Your doctor
will advise you on how to switch from your previous treatment to Irbesartan and
Hydrochlorothiazide Tablets.
Method of administration
Irbesartan and Hydrochlorothiazide Tablets are for oral use. Swallow the tablets with a
sufficient amount of liquid (e.g. a glass of water). You may take Irbesartan and
Hydrochlorothiazide Tablets with or without food. Try to take the daily dose at the same time
every day. It is important to continue taking Irbesartan and Hydrochlorothiazide Tablets
unless otherwise instructed by your doctor.
Maximum antihypertensive effect should be achieved within 6–8 weeks after starting treatment.
Children must not take Irbesartan and Hydrochlorothiazide Tablets
Irbesartan and Hydrochlorothiazide Tablets must not be given to children under 18 years of
age. If a child ingests any tablets, contact your doctor immediately.
If you take more Irbesartan and Hydrochlorothiazide Tablets than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan and Hydrochlorothiazide Tablets
If you accidentally miss a daily dose, simply take the next dose at the scheduled time. 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 ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Some of these adverse effects may be serious and may require medical attention.
Rare cases of allergic reactions (skin rash, urticaria) as well as localized swelling of the face, lips, and/or tongue have been reported in patients taking irbesartan.
If you experience any of the adverse effects listed above or develop shortness of breath,
discontinue treatment with Irbesartan and Hydrochlorothiazide tablets and contact your doctor immediately:
The frequency of the adverse effects listed below is defined using the following convention:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

The adverse effects reported in clinical studies in patients treated with Irbesartan and Hydrochlorothiazide tablets were:

Common adverse 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 substances measuring kidney function (azotemia, creatinine). If any of these adverse effects cause you problems, discuss them with your doctor.

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

Diarrhea
Low blood pressure
Fainting
Increased heart rate
Flushing
Swelling
Sexual dysfunction (problems with sexual performance)
Blood tests may show decreased levels of potassium and sodium.

If any of these adverse effects cause you problems, discuss them with your doctor.

Adverse effects reported after marketing of Irbesartan and Hydrochlorothiazide tablets
Since the marketing of Irbesartan and Hydrochlorothiazide tablets, some adverse effects have been reported. The adverse effects with unknown frequency include headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, abnormalities in liver function and impaired kidney function, elevated blood potassium levels, and allergic reactions such as skin rash, urticaria, and 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, adverse effects associated with each individual component cannot be excluded.

Adverse effects associated with the use of irbesartan alone
In patients taking irbesartan alone, in addition to the adverse effects listed above, chest pain, severe allergic reactions (anaphylactic shock), reduced number of red blood cells (anemia – symptoms may include fatigue, headache, shortness of breath during exercise, dizziness, and paleness), decreased platelet count (blood cells essential for blood clotting), and low blood sugar levels have also been reported.

Adverse effects associated with the use of hydrochlorothiazide alone
In patients treated with hydrochlorothiazide alone, the following additional adverse effects have been observed: loss of appetite, gastric 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 accompanied by nausea and vomiting, sleep disturbances, depression, blurred vision, reduction in white blood cells, which may lead to frequent infections and fever, decreased platelet count (essential components for blood clotting), reduced number of red blood cells (anemia) characterized by fatigue, headache, shortness of breath during exercise, dizziness, and pale appearance, kidney disease, lung problems including pneumonia or fluid accumulation in the lungs, increased skin sensitivity to sunlight, inflammation of blood vessels, a skin disorder characterized by peeling of the skin over the entire body, cutaneous lupus erythematosus, identified by a rash that may appear on the face, neck, and scalp, allergic reactions, muscle weakness and spasms, irregular heartbeat, low 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: Acute respiratory distress (symptoms include severe shortness of breath, fever, weakness, and confusion).

Frequency not known (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 adverse effects associated with hydrochlorothiazide may increase with higher doses of this molecule.

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

5. HOW TO STORE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS

Keep this medicine out of the sight and reach of children.
Do not use Irbesartan and Hydrochlorothiazide Tablets after the expiry date stated on the
carton and blister after EXP. The expiry date refers to the last day of the month.
This medicine requires no special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Irbesartan and Hydrochlorothiazide tablets contain
The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
The excipients are
Core: calcium carboxymethylcellulose (ECG-505), colloidal silicon dioxide (Aerosil 200),
povidone (PVP K29/32), sodium starch glycolate Type A (Glycolys), talc and magnesium stearate.
Coating: hypromellose 15 cP (E464), monohydrate lactose, titanium dioxide (E171) and
polyethylene glycol 3000, red iron oxide (E172) and yellow iron oxide (E172).
What Irbesartan and Hydrochlorothiazide tablets look like and contents of the pack
Irbesartan and Hydrochlorothiazide tablets 300 mg/12.5 mg are film-coated, oval, peach-coloured tablets, marked with "ML 33" on one side and smooth on the other.
Irbesartan and Hydrochlorothiazide 300 mg/12.5 mg tablets are supplied in blisters of 28 tablets, 56 tablets and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Luxpharma S.r.l.
Via Mazzini 20
20123 Milano - Italy
Manufacturer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz, Poland
This medicinal product is authorized in Member States under the following trade names:
United Kingdom: Irbesartan/Hydrochlorothiazide 300 mg/12.5 mg tablets
Germany: Irbesartan/Hydrochlorothiazid Heumann 300 mg/12.5 mg filmtabletten
Italy: Lubersan 300 mg/12.5 mg film-coated tablets
Spain: Irbesartán/Hidroclorotiazida Viso Farmacéutica 300 mg/12.5 mg comprimidos recubiertos con película EFG
This summary of product characteristics was last approved on

PACKAGE LEAFLET: INFORMATION FOR THE USER

Lubersan 300 mg/25 mg tablets

Irbesartan and Hydrochlorothiazide
Equivalent medicine
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. Never give it to others. Even if their symptoms are the same as yours, it could be dangerous.
If any of the side effects worsens or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What Irbesartan and Hydrochlorothiazide tablets are and what they are used for
What you need to know before taking Irbesartan and Hydrochlorothiazide tablets
How to take Irbesartan and Hydrochlorothiazide tablets
Possible side effects
How to store Irbesartan and Hydrochlorothiazide tablets
Contents of the pack and other information

1. WHAT IS IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS AND WHAT IS IT USED FOR?

Irbesartan and Hydrochlorothiazide Tablets 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 by the body that binds to its receptors located on 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 (called thiazide diuretics) that increase urine production, thereby lowering blood pressure.

The two active substances in Irbesartan and Hydrochlorothiazide Tablets work together to lower blood pressure more effectively than either medicine alone.

Irbesartan and Hydrochlorothiazide Tablets are used to treat high blood pressure (hypertension) when treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled blood pressure.

2. WHAT YOU SHOULD KNOW BEFORE TAKING IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS

Do not take Irbesartan and Hydrochlorothiazide Tablets

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 other sulfonamide-derived medicines
If you are more than 3 months pregnant. It is also recommended to avoid Irbesartan and Hydrochlorothiazide Tablets in early pregnancy (see section Pregnancy)
If you have severe liver or kidney problems
If you have difficulty urinating
If your doctor has determined that you have consistently high blood calcium levels or low potassium levels
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 Irbesartan and Hydrochlorothiazide Tablets if you are in any of the following conditions:

You have excessive vomiting or diarrhoea
You have kidney disorders or have had a kidney transplant
You have heart problems
You have liver problems
You have diabetes
You develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, numbness, pounding heartbeat), especially if you are being treated for diabetes.
You have lupus erythematosus (also known as lupus or SLE)
You have primary aldosteronism (a condition associated with excessive production of the hormone aldosterone, causing sodium retention and, in turn, increased blood pressure).
if you are taking one of the following medicines used to treat high blood pressure:
- an "ACE inhibitor” (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
- aliskiren
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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Irbesartan and Hydrochlorothiazide Tablets.
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 difficulty breathing after taking Lubersan, consult a doctor immediately.

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 Irbesartan and Hydrochlorothiazide Tablets".
You must inform your doctor if you are pregnant (or planning to become pregnant). Irbesartan and Hydrochlorothiazide Tablets are not recommended during early pregnancy and must not be taken after the third month of pregnancy as it may cause serious harm to the unborn baby (see section Pregnancy).
Also inform your doctor if:

You are on a low-salt diet
You experience signs such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan and Hydrochlorothiazide Tablets)
You notice increased sensitivity of the skin to sunlight, manifesting as faster-than-normal onset of sunburn symptoms (such as redness, itching, swelling, blistering)
You are due to undergo surgery or receive anaesthetics
You experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion), which may occur from a few hours to several weeks after taking Lubersan. If left untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing these symptoms. You must stop taking Irbesartan and Hydrochlorothiazide Tablets and consult your doctor immediately.

The hydrochlorothiazide contained in this medicine may result in a positive anti-doping test.
Children and adolescents
Irbesartan and Hydrochlorothiazide Tablets must not be given to children and adolescents (under 18 years of age).
Other medicines and Irbesartan and Hydrochlorothiazide Tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Diuretics such as hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide Tablets may interact with other medicines. Preparations containing lithium must not be taken together with Irbesartan and Hydrochlorothiazide Tablets unless under strict medical supervision.
Your doctor may consider it necessary to adjust your dose and/or take additional precautions:
If you are taking an ACE inhibitor or aliskiren (see also sections: "Do not take Irbesartan and Hydrochlorothiazide Tablets" and "Warnings and precautions").
You may need blood tests if you are taking:

potassium supplements
potassium-containing salt substitutes
potassium-sparing agents or other diuretics (tablets for fluid elimination)
certain laxatives
medicines for the treatment of gout
therapeutic vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral agents 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, anticancer medicines, painkillers, medicines for arthritis, or the cholesterol-lowering resins cholestyramine or colestipol.
Taking Irbesartan and Hydrochlorothiazide Tablets with food, drinks and alcohol
Irbesartan and Hydrochlorothiazide Tablets can be taken with or without food.
Due to the hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide Tablets, if you drink alcohol during treatment with this medicine, you may experience increased dizziness, especially when moving from a sitting to a standing position.
Pregnancy, breastfeeding and fertility
Pregnancy
You must inform your doctor if you are pregnant (or planning to become pregnant). Your doctor will usually advise stopping Irbesartan and Hydrochlorothiazide Tablets before you become pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Irbesartan and Hydrochlorothiazide Tablets are not recommended during early pregnancy and must not be taken after the third month of pregnancy because they may cause serious harm to the unborn baby.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Irbesartan and Hydrochlorothiazide Tablets are not recommended during breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
No studies on the ability to drive or use machines have been performed. It is unlikely that Irbesartan and Hydrochlorothiazide Tablets will affect your ability to drive or use machines. However, occasionally, during treatment for high blood pressure, you may experience dizziness or fatigue. If this occurs, discuss it with your doctor before driving or operating machinery.
Irbesartan and Hydrochlorothiazide Tablets contain lactose. If your doctor has told you that you have an intolerance to certain sugars (such as lactose), contact them before taking this medicine.
Irbesartan and Hydrochlorothiazide Tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS

Take this medicine exactly as your doctor has told you. If you are unsure,
consult your doctor or pharmacist.
Dosage
The recommended dose of Irbesartan and Hydrochlorothiazide Tablets is one tablet daily.
Irbesartan and Hydrochlorothiazide Tablets will be prescribed by your doctor if your previous
antihypertensive treatment has not provided adequate blood pressure reduction. Your doctor
will advise you on how to switch from your previous treatment to Irbesartan and
Hydrochlorothiazide Tablets.
Method of administration
Irbesartan and Hydrochlorothiazide Tablets are for oral use. Swallow the tablets with a
sufficient amount of fluid (e.g. a glass of water). You may take Irbesartan and
Hydrochlorothiazide Tablets with or without food. Try to take the medicine at the same time
every day. It is important to continue taking Irbesartan and Hydrochlorothiazide Tablets unless
otherwise instructed by your doctor.
Maximum antihypertensive effect should be achieved within 6–8 weeks after starting treatment.
Children must not take Irbesartan and Hydrochlorothiazide Tablets
Irbesartan and Hydrochlorothiazide Tablets must not be given to children under 18 years of age.
If a child accidentally ingests any tablets, contact a doctor immediately.
If you take more Irbesartan and Hydrochlorothiazide Tablets than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan and Hydrochlorothiazide Tablets
If you accidentally miss a daily dose, simply take the next dose at the usual 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 ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Some of these adverse effects may be serious and may require medical attention.
Rare cases of allergic reactions (rash, urticaria) as well as localized swelling of the face, lips, and/or tongue have been reported in patients taking irbesartan.
If you experience any of the adverse effects listed above or develop shortness of breath, stop treatment with Irbesartan and Hydrochlorothiazide tablets and contact your doctor immediately.

The frequency of the adverse effects listed below is defined using the following convention:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people

Adverse effects reported in clinical studies in patients treated with Irbesartan and Hydrochlorothiazide tablets were:

Common adverse 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 an increase in levels of an enzyme measuring muscle and heart function (creatine kinase) or substances measuring kidney function (blood urea nitrogen, creatinine).
If any of these adverse effects cause you problems, discuss them with your doctor.

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

Diarrhea
Low blood pressure
Fainting
Increased heart rate
Flushing
Swelling (oedema)
Sexual dysfunction (problems with sexual performance)
Blood tests may show decreased levels of potassium and sodium.

If any of these adverse effects cause you problems, discuss them with your doctor.

Adverse effects reported after marketing authorization of Irbesartan and Hydrochlorothiazide tablets
Since the marketing of Irbesartan and Hydrochlorothiazide tablets, the following adverse effects have been reported. Adverse effects with unknown frequency include: headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and impaired kidney function, elevated blood potassium levels, and allergic reactions such as rash, urticaria, and 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, adverse effects associated with each individual component cannot be excluded.

Adverse effects associated with the use of irbesartan alone
In patients taking irbesartan alone, in addition to the adverse effects listed above, the following have also been reported: chest pain, severe allergic reactions (anaphylactic shock), reduced number of red blood cells (anaemia – symptoms may include fatigue, headache, shortness of breath during exercise, dizziness, and pallor), a decrease in platelet count (blood cells essential for blood clotting), and low blood sugar levels.

Adverse effects associated with the use of hydrochlorothiazide alone
In patients treated with hydrochlorothiazide alone, the following additional adverse effects have been observed: loss of appetite, gastric irritation, stomach cramps, constipation, jaundice (yellowing of the skin and/or whites of the eyes), inflammation of the pancreas characterized by severe upper abdominal pain, often accompanied by nausea and vomiting, sleep disturbances, depression, blurred vision, reduced white blood cell count (which may lead to frequent infections and fever), reduced platelet count (essential components for blood clotting), reduced number of red blood cells (anaemia) characterized by fatigue, headache, shortness of breath during exercise, dizziness, and pale appearance, kidney disease, lung problems including pneumonia or fluid accumulation in the lungs, increased skin sensitivity to sunlight, inflammation of blood vessels, a skin disorder characterized by peeling of the skin over the entire body, cutaneous lupus erythematosus, identified by a rash that may appear on the face, neck, and scalp, allergic reactions, muscle weakness and spasms, irregular heartbeat, low 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 blood uric acid levels which may cause gout.

Very rare: 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 adverse effects associated with hydrochlorothiazide may increase with higher doses of this substance.

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

5. HOW TO STORE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS

Keep this medicine out of the sight and reach of children.
Do not use Irbesartan and Hydrochlorothiazide Tablets after the expiry date stated on the
carton and blister pack after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of 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 Irbesartan and Hydrochlorothiazide tablets contain
The active substances are irbesartan and hydrochlorothiazide. Each film-coated tablet contains
300 mg of irbesartan and 25 mg of hydrochlorothiazide.
The excipients are
Core: calcium carboxymethylcellulose (ECG-505), colloidal silicon dioxide (Aerosil 200),
povidone (PVP K29/32), sodium starch glycolate Type A (Glycolys), talc and magnesium stearate.
Coating: hypromellose 15 cP (E464), lactose monohydrate, titanium dioxide (E171),
polyethylene glycol 3000, red iron oxide (E172), yellow iron oxide (E172) and black iron oxide (E172).
What Irbesartan and Hydrochlorothiazide tablets look like and contents of the pack
Irbesartan and Hydrochlorothiazide tablets 300 mg/25 mg are film-coated, oval, peach-coloured tablets,
with “ML 32” printed on one side and smooth on the other side.
Irbesartan and Hydrochlorothiazide 300 mg/25 mg tablets are supplied in blisters of 28 tablets, 56
tablets and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Luxpharma S.r.l.
Via Mazzini 20
20123 Milano - Italy
Manufacturer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz, Poland
This medicinal product is authorised in Member States under the following trade names:
United Kingdom: Irbesartan/Hydrochlorothiazide 300 mg/25 mg tablets
Germany: Irbesartan/Hydrochlorothiazid Heumann 300 mg/25 mg filmtabletten
Italy: Lubersan 300 mg/25 mg film-coated tablets
Spain: Irbesartán/Hidroclorotiazida Viso Farmacéutica 300 mg/25 mg comprimidos
recubiertos con película EFG
This leaflet was last approved on