LUBERSAN 150 mg /12.5 Mg Film-Coated Tablets

Зміст інструкції

1. Lubersan 150 mg/12,5 mg tablets
   1. WHAT IS IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS AND WHAT IT IS FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN AND
   3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS
   6. PACKAGE CONTENTS AND OTHER INFORMATION
2. Lubersan 300 mg/12,5 mg tablets
   1. WHAT IS IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS AND WHAT IT IS FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN AND
   3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS
   6. CONTENTS OF THE PACK AND OTHER INFORMATION
3. Lubersan 300 mg/25 mg tablets
   1. WHAT IS IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS AND WHAT IT IS FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN AND
   3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Lubersan 150 mg/12,5 mg tablets

Irbesartan and Hydrochlorothiazide
Generic medicine

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 gets worse or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Irbesartan and Hydrochlorothiazide tablets are and what they are used for
• 2. What you need to know before you take Irbesartan and Hydrochlorothiazide tablets
• 3. How to take Irbesartan and Hydrochlorothiazide tablets
• 4. Possible side effects
• 5. How to store Irbesartan and Hydrochlorothiazide tablets
• 6. Contents of the pack and other information

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

PURPOSE
Irbesartan and Hydrochlorothiazide tablets is a combination of two active ingredients, 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 a narrowing of these vessels. This results in an
increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these
receptors, causing a relaxation of blood vessels and a lowering of blood
pressure.
Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that
determine an increased production of urine with a consequent lowering of blood
pressure.
The two active ingredients of Irbesartan and Hydrochlorothiazide tablets work together determining
a lowering of blood pressure values greater than that caused by the individual drugs
administered separately.
Irbesartan and Hydrochlorothiazide tablets is used for the treatment of hypertension,
when treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled
blood pressure.

2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN AND

HYDROCHLOROTHIAZIDE TABLETS
Do not take Irbesartan and Hydrochlorothiazide tablets

• If you are allergicto irbesartan or any of the other ingredients of this medicine (listed in section 6)
• If you are allergicto hydrochlorothiazide or other medicines derived from sulfonamides
• If you are pregnant for more than 3 monthsIt is also advisable to avoid Irbesartan and Hydrochlorothiazide tablets at the beginning of pregnancy (see section Pregnancy)
• If you have severe liver or kidney problems
• If you have difficulty urinating
• If the doctor establishes that you have consistently high blood levels of calcium or low levels ofpotassium
• if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren

Warnings and precautions
Consult your doctorbefore taking Irbesartan and Hydrochlorothiazide tablets and if you are in
one of the following conditions:

• You experience excessive vomiting or diarrhea
• You suffer from kidney disordersor have a kidney transplant
• You suffer from heart disorders
• You suffer from liver disorders
• You suffer from diabetes
• If you develop low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or pallor, numbness, racing heartbeat), especially if you are being treated for diabetes.
• You suffer from lupus erythematosus(also known as lupus or SLE)
• You suffer from primary aldosteronism(a condition related to high production of the hormone aldosterone, which causes 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" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Irbesartan and Hydrochlorothiazide tablets
• If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the intake of hydrochlorothiazide in the past. If, after taking Lubersan, you experience shortness of breath or severe difficulty breathing, consult a doctor immediately.

The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated under "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 at the beginning of pregnancy and should not be
taken after the third month of pregnancy as it may cause serious harm to the baby (see
section Pregnancy).

Also inform your doctor if:

• You are following a low-salt diet
• You have signs such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomitingor a excessively fast heartbeatwhich may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan and Hydrochlorothiazide tablets)
• You have experienced an increased sensitivity of the skin to the sun, which manifests with the faster than normal onset of sunburn symptoms (such as redness, itching, swelling, blistering)
• You need to undergo surgery(surgical) or receive anesthetics.
• If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) and can occur within a few hours to a few weeks of taking Lubersan. If left untreated, this can lead to permanent vision loss. If you have had an allergy to penicillin or sulfonamides in the past, you may be at greater risk of developing these symptoms. You should stop taking Irbesartan and Hydrochlorothiazide tablets and consult a doctor immediately.

Hydrochlorothiazide contained in this medicine can give positive results in the doping
test.

Children and adolescents
Irbesartan and Hydrochlorothiazide tablets should not be given to children and
adolescents (under 18 years of age).

Other medicines and Irbesartan and Hydrochlorothiazide tabletsTell your doctor or
pharmacist if you are taking or have recently taken any other medicines, including those
obtained without a prescription.
Diuretic drugs such as hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide tablets
can have an effect on other medicines. Preparations containing lithium should not
be taken with Irbesartan and Hydrochlorothiazide tablets unless under strict medical
control.
The doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is stated under: "Do not
take 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 diuretics or other diuretics (pills for eliminating fluids)
• some 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 insulins)
• carbamazepine (a medicine for the treatment of epilepsy).

It is also important to tell your doctor if you are taking other medicines to lower
blood pressure, steroids, anticancer drugs, painkillers, medicines for arthritis or cholestyramine or colestipol resins to lower blood cholesterol.

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 therapy with this medicine, you may experience a greater
sensation of dizziness, especially when going from a sitting to an upright position.

Pregnancy, breastfeeding and fertility
Pregnancy
You must inform your doctor if you are pregnant (or planning to become pregnant). As a rule,
your doctor will advise you to stop taking Irbesartan and Hydrochlorothiazide tablets
before you become pregnant or as soon as you know you are pregnant and will advise
you to take another medicine. Irbesartan and Hydrochlorothiazide tablets is not recommended
at the beginning of pregnancy and should not be taken after the third month of pregnancy because
it can cause serious harm to the baby.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Irbesartan and
Hydrochlorothiazide tablets is not recommended during breastfeeding and your doctor may
choose another treatment if you wish to breastfeed, especially if the baby is
newborn or premature.

Driving and operating machinery
It is unlikely that Irbesartan and Hydrochlorothiazide tablets will affect your ability to
drive vehicles and operate machinery. However, occasionally, during treatment
for hypertension you may experience dizziness or fatigue. If this happens, talk to
your doctor before driving vehicles or using machinery.

Irbesartan and Hydrochlorothiazide tablets contains lactose.If your doctor has told you that you have
an intolerance to some 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, which is
essentially ‘sodium-free’.

3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS

Take this medicine following exactly the instructions of your doctor. If you have any doubts,
consult your doctor or pharmacist.

Dosage
The recommended dose of Irbesartan and Hydrochlorothiazide tablets is one tablet a day.
Irbesartan and Hydrochlorothiazide tablets will be prescribed by your doctor if previous
antihypertensive therapy has not provided adequate lowering of blood
pressure. The doctor will advise you on how to switch from previous treatment to that with
Irbesartan and Hydrochlorothiazide tablets.

Method of administration
Irbesartan and Hydrochlorothiazide tablets is for oral use. Swallow the tablets with a
sufficient amount of fluids (e.g. a glass of water). You can take Irbesartan and
Hydrochlorothiazide tablets with or without food. Try to take the medicine every day at the
same time. It is important to continue taking Irbesartan and Hydrochlorothiazide tablets unless
otherwise indicated by your doctor.
The maximum antihypertensive effect should be achieved 6-8 weeks after the start of
therapy.

Children should not take Irbesartan and Hydrochlorothiazide tablets
Irbesartan and Hydrochlorothiazide tablets should not be administered to children under
18 years of age. If a child swallows 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 the daily dose, simply take the normal
dose at the scheduled time. Do not take a double dose to compensate for the
forgotten dose.
If you have any doubts 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 will experience them.
Some of these side effects may be serious and may require medical attention.
Rare cases of allergic reactions (skin rash, hives) 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 side effects listed above or experience shortness of breath,
stop treatment with Irbesartan and Hydrochlorothiazide tablets and contact
your doctor immediately:
The frequency of the side effects reported 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 side effects reported in clinical studies in patients treated with Irbesartan and
Hydrochlorothiazide tablets were:

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

• nausea/vomiting
• urination disorders
• fatigue
• dizziness (even when moving from a sitting or lying position to standing)
• blood tests may show an increase in levels of an enzyme that measures muscle and cardiac function (creatine kinase) or substances that measure kidney function (azotemia, creatinine). If any of these side effects cause you problems,talk to your doctor

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

• diarrhea
• low blood pressure
• fainting
• increased heart rate
• hot flashes
• swelling
• sexual dysfunction (problems with sexual performance)
• blood tests may show a decrease in levels of potassium and sodium.

If any of these side effects cause you problems,talk to your doctor

Side effects reported after marketing authorization of Irbesartan and
Hydrochlorothiazide tablets
Since the marketing of Irbesartan and Hydrochlorothiazide tablets, some side effects have been reported. The side effects with unknown frequency are: headache,
tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and impaired kidney function, high levels of potassium in the blood
and allergic reactions such as skin rash, hives, 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 ingredients, side effects associated with each
individual component cannot be excluded.

Side effects associated with the use of irbesartan alone
In patients taking irbesartan alone, in addition to the side effects listed above, have
also been reported 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 pallor), a decrease in the number of platelets
(blood cells essential for blood clotting) and low blood sugar levels.

Side effects associated with the use of hydrochlorothiazide alone
The following additional side effects have been found in patients treated with hydrochlorothiazide alone: 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 with nausea and vomiting,
sleep disturbances, depression, blurred vision, decreased white blood cells, which may lead to
frequent inflammation, fever, decreased number of platelets (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 the sun, inflammation of blood vessels, a
skin disorder characterized by scaling of the skin all over the body, cutaneous lupus
erythematosus, identified by a rash that may appear on the face, neck and scalp, allergic reactions, muscle weakness and spasm, altered heartbeat,
lowering of blood pressure following a change in body position,
swelling of the salivary glands, high blood sugar levels, sugar in the
urine, increases in some types of fat in the blood, high levels of uric acid in the blood
which can cause gout.
Very rare: Acute respiratory distress (signs include severe shortness of breath, fever,
weakness and confusion).
Not known (frequency cannot be estimated on the basis of available data): skin and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
It is known that the side effects associated with hydrochlorothiazide may increase with higher doses of this molecule.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
tell your doctor or pharmacist .You can also report side effects
directly through the national reporting system at
http://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 IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS

Keep this medicine out of the sight and reach of children.
Do not use Irbesartan and Idroclorotiazide tablets after the expiry date stated on the
cardboard box and on the blister after EXP. The expiry date refers to the last day
of the month.
This medicine does not require any particular 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. PACKAGE CONTENTS AND OTHER INFORMATION

What Irbesartan and Hydrochlorothiazide tablets contain
The active ingredients 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, red iron oxide (E172) and yellow iron oxide (E172)

What Irbesartan and Hydrochlorothiazide tablets look like and what the pack contains?
Irbesartan and Hydrochlorothiazide tablets 150 mg/12.5 mg are film-coated
tablets, oval, peach-colored, with “ML 34” imprinted on one side and smooth on the other side.
Irbesartan and Hydrochlorothiazide 150 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 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 the Member States with 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 comprimidos
recubiertos con película EFG

Lubersan 300 mg/12,5 mg tablets

Irbesartan and Hydrochlorothiazide
Generic medicine

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 pass it on to others. Even if their symptoms are the same as yours, it may be harmful.
• If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Irbesartan and Hydrochlorothiazide tablets are and what they are used for
• 2. What you need to know before you take Irbesartan and Hydrochlorothiazide tablets
• 3. How to take Irbesartan and Hydrochlorothiazide tablets
• 4. Possible side effects
• 5. How to store Irbesartan and Hydrochlorothiazide tablets
• 6. Contents of the pack and other information

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

PURPOSE
Irbesartan and Hydrochlorothiazide tablets is a combination of two active ingredients, 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 a narrowing of these vessels. This results in an
increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these
receptors, causing a relaxation of the blood vessels and a lowering of blood
pressure.
Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that
determine an increased production of urine with a consequent lowering of blood
pressure.
The two active ingredients of Irbesartan and Hydrochlorothiazide tablets act together determining
a lowering of blood pressure values greater than that caused by the single drugs
administered individually.
Irbesartan and Hydrochlorothiazide tablets is used for the treatment of hypertension,
when treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled
blood pressure.

2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN AND

HYDROCHLOROTHIAZIDE TABLETS
Do not take Irbesartan and Hydrochlorothiazide tablets

• If you are allergicto irbesartan or to any of the other ingredients of this medicine (listed in section 6)
• If you are allergicto hydrochlorothiazide or to other medicines derived from sulfonamides
• If you are pregnant for more than 3 months.(It is also advisable to avoid Irbesartan and Hydrochlorothiazide tablets at the beginning of pregnancy - see section Pregnancy)
• If you have severe liver or kidney problems
• If you have difficulty urinating
• If your doctor establishes that you have consistently high blood calcium levels or low levels ofpotassium
• if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren

Warnings and precautions
Consult your doctorbefore taking Irbesartan and Hydrochlorothiazide tablets and if you are in
one of the following conditions:

• You experience excessive vomiting or diarrhea
• You suffer from kidney disordersor have a kidney transplant
• You suffer from heart disorders
• You suffer from liver disorders
• You suffer from diabetes
• If you develop low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or pallor, numbness, fast heartbeat), especially if you are being treated for diabetes.
• You suffer from lupus erythematosus(also known as lupus or SLE)
• You suffer from primary aldosteronism(a condition related to high production of the hormone aldosterone, which causes 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" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV radiation while taking Irbesartan and Hydrochlorothiazide tablets
• If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the intake of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Lubersan, consult a doctor immediately.

The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated under "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 at the beginning of pregnancy and should not be
taken after the third month of pregnancy as it may cause serious harm to the baby (see
section Pregnancy).

Also inform your doctor if:

• You are following a low-salt diet
• You have signs such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomitingor a excessively fast heartbeatwhich may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan and Hydrochlorothiazide tablets)
• You have noticed an increased sensitivity of the skin to the sun, which manifests with the faster onset than normal of the symptoms of sunburn (such as redness, itching, swelling, blistering)
• You have to undergo surgeryor receive anesthetics.
• If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) and can occur within a few hours to a few weeks of taking Lubersan. If left untreated, this can lead to permanent vision loss. If you have had an allergy to penicillin or sulfonamides in the past, you may be at greater risk of developing these symptoms. You should stop taking Irbesartan and Hydrochlorothiazide tablets and consult a doctor immediately.

The hydrochlorothiazide contained in this medicine may give positive results in doping tests.

Children and adolescents
Irbesartan and Hydrochlorothiazide tablets should not be given to children and
adolescents (under 18 years of age).

Other medicines and Irbesartan and Hydrochlorothiazide tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those obtained without a prescription.
Diuretic medicines such as hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide tablets
can have an effect on other medicines. Lithium-containing preparations should not
be taken with Irbesartan and Hydrochlorothiazide tablets unless under strict medical
control.
The doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is stated under: "Do not
take 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 diuretics or other diuretics (water pills)
• some laxatives
• medicines for the treatment of gout
• therapeutic vitamin D supplements
• medicines to control the heartbeat
• medicines for diabetes (oral agents such as repaglinide or insulins)
• carbamazepine (a medicine for the treatment of epilepsy).

It is also important to tell your doctor if you are taking other medicines to lower
blood pressure, steroids, anticancer drugs, painkillers, medicines for arthritis or cholesterol-lowering resins
cholestyramine or colestipol.

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 therapy with this medicine, you may experience a greater
sensation of dizziness, especially when moving from a sitting to an upright position.

Pregnancy, breastfeeding and fertility
Pregnancy
You must inform your doctor if you are pregnant (or planning to become pregnant). As a rule,
your doctor will advise you to stop taking Irbesartan and Hydrochlorothiazide tablets
before you start a pregnancy or as soon as you find out you are pregnant and will advise
you to take another medicine. Irbesartan and Hydrochlorothiazide tablets are not recommended
at the beginning of pregnancy and should not be taken after the third month of pregnancy because
it may cause serious harm to the baby.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Irbesartan and
Hydrochlorothiazide tablets are not recommended during breastfeeding and your doctor may
choose another treatment if you wish to breastfeed, especially if the baby is
newborn or premature.

Driving and operating machinery
It is unlikely that Irbesartan and Hydrochlorothiazide tablets will affect your ability to
drive vehicles and operate machinery. However, occasionally, during treatment
for hypertension you may experience dizziness or fatigue. If this happens, talk to your
doctor before driving vehicles or using machinery.

Irbesartan and Hydrochlorothiazide tablets contains lactose.If your doctor has told you that you have
an intolerance to some 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, which is
essentially ‘sodium-free’.

3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS

Take this medicine following exactly the instructions of your doctor. If you have any doubts,
consult your doctor or pharmacist.

Dosage
The recommended dose of Irbesartan and Hydrochlorothiazide tablets is one tablet a day.
Irbesartan and Hydrochlorothiazide tablets will be prescribed by your doctor if previous
antihypertensive therapy has not provided adequate lowering of blood
pressure. Your doctor will advise you on how to switch from previous treatment to treatment with
Irbesartan and Hydrochlorothiazide tablets.

Method of administration
Irbesartan and Hydrochlorothiazide tablets is for oral use. Swallow the tablets with a
sufficient amount of liquid (e.g. a glass of water). You can take Irbesartan and
Hydrochlorothiazide tablets with or without food. Try to take the daily dose every
day at the same time. It is important to continue taking Irbesartan and Hydrochlorothiazide
tablets unless otherwise indicated by your doctor.
The maximum antihypertensive effect should be achieved 6-8 weeks after the start of
therapy.

Children should not take Irbesartan and Hydrochlorothiazide tablets
Irbesartan and Hydrochlorothiazide tablets should not be administered to children under
18 years of age. If a child swallows 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 the daily dose, simply take the next
normal dose at the scheduled time. Do not take a double dose to make up for the
missed dose.
If you have any doubts 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 will experience them.
Some of these side effects may be serious and may require medical attention.
Rare cases of allergic reactions (skin rash, hives) 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 side effectslisted above or experience shortness of breath,
stop treatment with Irbesartan and Idroclorotiazide tablets and contact
your doctor immediately:
The frequency of the side effects reported below is defined using the following
convention:
Common: may occur in up to 1 in 10 people
Uncommon: may occur in up to 1 in 100 people
The side effects reported in clinical studies in patients treated with Irbesartan and
Idroclorotiazide tablets were:

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

• nausea/vomiting
• urination disorders
• fatigue
• dizziness (even when moving from a sitting or lying position to standing)
• blood tests may show an increase in the levels of an enzyme that measures muscle and cardiac function (creatine kinase) or substances that measure kidney function (azotemia, creatinine). If any of these side effects cause you problems,talk to your doctor

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

• diarrhea
• low blood pressure
• fainting
• increased heart rate
• hot flashes
• swelling
• sexual dysfunction (problems with sexual performance)
• blood tests may show a decrease in potassium and sodium levels.

If any of these side effects cause you problems,talk to your doctor

Side effects reported after marketing of Irbesartan and
Idroclorotiazide tablets
Since the marketing of Irbesartan and Idroclorotiazide tablets, some side effects have been reported.
Side effects with unknown frequency are: headache,
tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and impaired kidney function, high potassium levels in the blood
and allergic reactions such as skin rash, hives, 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 ingredients, side effects associated with each
individual component cannot be ruled out.

Side effects associated with the use of irbesartan alone
In patients taking irbesartan alone, in addition to the side effects listed above, have
also been reported 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 number of platelets
(blood cells essential for blood clotting) and low blood sugar levels.

Side effects associated with the use of hydrochlorothiazide alone
In patients treated with hydrochlorothiazide alone, the following additional side 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 with nausea and vomiting,
sleep disturbances, depression, blurred vision, reduced white blood cells, which may lead to
frequent inflammation, fever, decreased number of platelets (essential components
for blood clotting), reduced number of red blood cells (anemia)
characterized by fatigue, headache, shortness of breath during exercise, dizziness and
paleness, kidney disease, lung problems including pneumonia or fluid accumulation
in the lungs, increased skin sensitivity to the sun, inflammation of blood vessels, a
skin disorder characterized by scaling of the skin all over the body, lupus
erythematosus cutaneous, identified by a rash that may appear on the face, neck and scalp, allergic reactions, weakness and muscle spasm, altered heartbeat,
lowering of blood pressure following a change in body position,
swelling of the salivary glands, high blood sugar levels, sugar in the
urine, increases in certain types of fat in the blood, high uric acid levels in the blood
which can cause gout.
Very rare: Acute respiratory distress (signs include severe shortness of breath, fever,
weakness and confusion).
Not known (frequency cannot be estimated on the basis of available data): skin and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
It is known that the side effects associated with hydrochlorothiazide may increase with higher doses
of this molecule.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
tell your doctor or pharmacist .You can also report side effects
directly through the national reporting system at
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects
you can contribute to providing 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 Idroclorotiazide tablets after the expiry date stated on the
cardboard box and on the blister after EXP. The expiry date refers to the last day
of the month.
This medicine does not require any particular 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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Irbesartan and Hydrochlorothiazide tablets contain
The active ingredients 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), lactose monohydrate, titanium dioxide (E171) and
polyethylene glycol 3000, red iron oxide (E172) and yellow iron oxide (E172)

What Irbesartan and Hydrochlorothiazide tablets look likeand what the
pack contains ?
Irbesartan and Hydrochlorothiazide tablets 300 mg/12.5 mg are film-coated
tablets, oval, peach-colored, with “ML 33” imprinted on one side and smooth on the other side.
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 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 the Member States with 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

Lubersan 300 mg/25 mg tablets

Irbesartan and Hydrochlorothiazide
Generic medicine

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

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

Contents of this leaflet:

• 1. What Irbesartan and Hydrochlorothiazide tablets are and what they are used for
• 2. What you need to know before you take Irbesartan and Hydrochlorothiazide tablets
• 3. How to take Irbesartan and Hydrochlorothiazide tablets
• 4. Possible side effects
• 5. How to store Irbesartan and Hydrochlorothiazide tablets
• 6. Contents of the pack and other information

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

PURPOSE
Irbesartan and Hydrochlorothiazide tablets is a combination of two active ingredients, 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 a narrowing of these vessels. This results in an
increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these
receptors, causing a relaxation of the blood vessels and a lowering of blood
pressure.
Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that
determine an increased production of urine with a consequent lowering of blood
pressure.
The two active ingredients of Irbesartan and Hydrochlorothiazide tablets work together determining
a lowering of blood pressure values greater than that caused by the individual drugs
administered separately.
Irbesartan and Hydrochlorothiazide tablets is used for the treatment of hypertension,
when treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled
blood pressure.

2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN AND

HYDROCHLOROTHIAZIDE TABLETS
Do not take Irbesartan and Hydrochlorothiazide tablets

• If you are allergicto irbesartan or to any of the other ingredients of this medicine (listed in section 6)
• If you are allergicto hydrochlorothiazide or to other medicines derived from sulfonamides
• If you are pregnant for more than 3 monthsIt is also advisable to avoid Irbesartan and Hydrochlorothiazide tablets at the beginning of pregnancy (see section Pregnancy)
• If you have severe liver or kidney problems
• If you have difficulty urinating
• If the doctor establishes that you have consistently high blood calcium levels or low levels ofpotassium
• if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren

Warnings and precautions
Consult your doctorbefore taking Irbesartan and Hydrochlorothiazide tablets and if you are in
one of the following conditions:

• You experience excessive vomiting or diarrhea
• You suffer from kidney disordersor have a kidney transplant
• You suffer from heart disorders
• You suffer from liver disorders
• You suffer from diabetes
• If you develop low blood sugar levels(symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or pallor, numbness, fast heartbeat), especially if you are being treated for diabetes.
• You suffer from lupus erythematosus(also known as lupus or SLE)
• You suffer from primary aldosteronism(a condition related to high production of the hormone aldosterone, which causes 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” (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV radiation while taking Irbesartan and Hydrochlorothiazide tablets
• If you have had breathing or lung problems (including inflammation or fluid in the lungs) following taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Lubersan, consult a doctor immediately.

The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated under "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 at the beginning of pregnancy and should not be
taken after the third month of pregnancy as it can cause serious harm to the baby (see
section Pregnancy).

Also inform your doctor if:

• You are following a low-salt diet
• You have signs such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomitingor a very fast heartbeatwhich may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan and Hydrochlorothiazide tablets)
• You have experienced an increased sensitivity to the sun, which manifests with the faster than normal onset of sunburn symptoms (such as redness, itching, swelling, blistering)
• You need to undergo surgery(surgical) or receive anesthetics.
• You experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) and can occur within a few hours to a few weeks of taking Lubersan. If left untreated, this can lead to permanent vision loss. If you have had an allergy to penicillin or sulfonamides in the past, you may be at greater risk of developing these symptoms. You should stop Irbesartan and Hydrochlorothiazide tablets and consult a doctor immediately.

The hydrochlorothiazide contained in this medicine may give positive results in
doping tests.

Children and adolescents
Irbesartan and Hydrochlorothiazide tablets should not be given to children and
adolescents (under 18 years of age).

Other medicines and Irbesartan and Hydrochlorothiazide tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those obtained without a prescription.
Diuretic drugs such as hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide tablets
can have an effect on other medicines. Preparations containing lithium should not
be taken with Irbesartan and Hydrochlorothiazide tablets unless under strict medical
control.
The doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is stated under: "Do not
take 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 diuretics or other diuretics (water pills)
• some 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 insulins)
• carbamazepine (a medicine for the treatment of epilepsy).

It is also important to tell your doctor if you are taking other medicines to reduce
blood pressure, steroids, anticancer drugs, painkillers, medicines for arthritis or cholestyramine or colestipol resins to lower blood cholesterol.

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 therapy with this medicine, you may experience a greater
sensation of dizziness, especially when going 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). As a rule,
your doctor will advise you to stop taking Irbesartan and Hydrochlorothiazide tablets
before you become pregnant or as soon as you find out you are pregnant and will advise
you to take another medicine. Irbesartan and Hydrochlorothiazide tablets is not recommended
at the beginning of pregnancy and should not be taken after the third month of pregnancy because
it can cause serious harm to the baby.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Irbesartan and
Hydrochlorothiazide tablets is not recommended during breastfeeding and your doctor may
choose another treatment if you wish to breastfeed, especially if the baby is
newborn or premature.

Driving and using machines
No studies have been conducted on the ability to drive vehicles and operate machinery. It is
unlikely that Irbesartan and Hydrochlorothiazide tablets will affect the ability to drive
vehicles and operate machinery. However, occasionally, during treatment
for hypertension, you may experience dizziness or fatigue. If this happens, talk to
your doctor before driving vehicles or using machinery.

Irbesartan and Hydrochlorothiazide tablets contains lactose.If your doctor has told you that you have
an intolerance to some 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, which
is essentially ‘sodium-free’.

3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS

Take this medicine following exactly the instructions of your doctor. If you have any doubts,
consult your doctor or pharmacist.

Dosage
The recommended dose of Irbesartan and Hydrochlorothiazide tablets is one tablet a day.
Irbesartan and Hydrochlorothiazide tablets will be prescribed by your doctor if previous
antihypertensive therapy has not provided adequate lowering of blood
pressure. The doctor will advise you on how to switch from previous treatment to that with
Irbesartan and Hydrochlorothiazide tablets.

Method of administration
Irbesartan and Hydrochlorothiazide tablets is for oral use. Swallow the tablets with a
sufficient amount of fluids (e.g. a glass of water). You can take Irbesartan and
Hydrochlorothiazide tablets with or without food. Try to take the medicine every day at the
same time. It is important to continue taking Irbesartan and Hydrochlorothiazide tablets unless
otherwise indicated by your doctor.
The maximum antihypertensive effect should be achieved 6-8 weeks after the start of
therapy.

Children should not take Irbesartan and Hydrochlorothiazide tablets
Irbesartan and Hydrochlorothiazide tablets should not be administered to children under
18 years of age. If a child swallows 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 the daily dose, simply take the normal
dose at the scheduled time. Do not take a double dose to compensate for the
forgotten dose.
If you have any doubts 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 side effects may be serious and may require medical attention.
Rare cases of allergic reactions (skin rash, hives) 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 side effects listed above or experience shortness of breath,
stop treatment with Irbesartan and Idroclorotiazide tablets and contact
your doctor immediately:
The frequency of the side effects reported 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 side effects reported in clinical studies in patients treated with Irbesartan and
Idroclorotiazide tablets were:

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

• nausea/vomiting
• urination disorders
• fatigue
• dizziness (even when moving from a sitting or lying position to standing)
• blood tests may show an increase in the levels of an enzyme that measures muscle and cardiac function (creatine kinase) or substances that measure kidney function (azotemia, creatinine). If any of these side effects cause you problems,talk to your doctor

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

• diarrhea
• low blood pressure
• fainting
• increased heart rate
• hot flashes
• swelling
• sexual dysfunction (problems with sexual performance)
• blood tests may show a decrease in potassium and sodium levels.

If any of these side effects cause you problems,talk to your doctor

Side effects reported after marketing authorization of Irbesartan and
Idroclorotiazide tablets
Since the marketing of Irbesartan and Idroclorotiazide tablets, some side effects have been reported. The side effects with unknown frequency are: headache,
tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and impaired kidney function, high levels of potassium in the blood
and allergic reactions such as skin rash, hives, 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 ingredients, side effects associated with each
individual component cannot be ruled out.

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

Side effects associated with the use of hydrochlorothiazide alone
In patients treated with hydrochlorothiazide alone, the following additional side effects have been found: 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 with nausea and vomiting,
sleep disturbances, depression, blurred vision, reduced white blood cells, which can lead to
frequent inflammation, fever, decreased number of platelets (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 the sun, inflammation of the blood vessels, a
skin disorder characterized by scaling of the skin all over the body, cutaneous lupus
erythematosus, identified by a rash that may appear on the face, neck and scalp, allergic reactions, muscle weakness and spasm, altered heartbeat,
lowering of blood pressure following a change in body position,
swelling of the salivary glands, high blood sugar levels, sugar in the
urine, increases in some types of fat in the blood, high levels of uric acid in the blood
which can cause gout.
Very rare: Acute respiratory distress (signs include severe shortness of breath, fever,
weakness and confusion).
Not known (frequency cannot be estimated based on available data): skin and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
It is known that the side effects associated with hydrochlorothiazide may increase with higher doses
of this molecule.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
tell your doctor or pharmacist .You can also report side effects
directly through the national reporting system at
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects
you can contribute to providing 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 Idroclorotiazide tablets after the expiry date stated on the
cardboard box and on the blister after EXP. The expiry date refers to the last day
of the month.
This medicine does not require any particular 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. PACKAGE CONTENTS AND OTHER INFORMATION

What Irbesartan and Hydrochlorothiazide tablets contain
The active ingredients 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) and
polyethylene glycol 3000, red iron oxide (E172) and yellow iron oxide (E172) and black iron
oxide (E172)

What Irbesartan and Hydrochlorothiazide tablets look like and what the
pack contains?
Irbesartan and Hydrochlorothiazide tablets 300 mg/25 mg are film-coated,
oval, peach-colored tablets, imprinted with “ML 32” 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 Milan - Italy

Manufacturer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz , Poland

This medicinal product is authorised in the Member States with 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 film-coated
tablets EFG