Irbesartan and hydrochlorothiazide Sandoz: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Irbesartan and hydrochlorothiazide Sandoz 150 mg/12.5 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

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

Contents of this leaflet

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

1. WHAT IRBESARTAN AND HYDROCHLOROTHIAZIDE SANDOZ IS AND WHAT IT IS USED FOR

Irbesartan and hydrochlorothiazide Sandoz is a combination of two active substances, irbesartan and hydrochlorothiazide.
Irbesartan belongs to a group of medicines called angiotensin-II receptor antagonists, which work by dilating blood vessels, thereby reducing blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics (medicines that help increase urine production).
The two active substances in Irbesartan and hydrochlorothiazide Sandoz work together to lower blood pressure more effectively than when either substance is used alone.
Irbesartan and hydrochlorothiazide Sandoz is used to treat high blood pressure (hypertension) when treatment with irbesartan or hydrochlorothiazide alone does not provide adequate control of blood pressure.

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

DO NOT take Irbesartan and Hydrochlorothiazide Sandoz if:

you are allergic to irbesartan, hydrochlorothiazide, or any of the excipients of this medicine (listed in section 6)
you are allergic to sulfonamide derivatives (e.g. other thiazides, certain antibacterial medicines such as co-trimoxazole; ask your doctor if you are unsure)
you are more than 3 months pregnant (it is better to avoid taking Irbesartan and Hydrochlorothiazide Sandoz even in early pregnancy – see section “Pregnancy”)
you have severe liver function impairment
you have severe kidney function impairment or your kidneys are not producing urine
you have a condition associated with persistently high calcium levels or low potassium levels in the blood
you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

Children and adolescents
Irbesartan and Hydrochlorothiazide Sandoz must not be given to children and
adolescents under 18 years of age.
Warnings and precautions
These tablets are generally not recommended in the following cases:

if you have primary aldosteronism (Conn’s syndrome), a tumour of the adrenal gland associated with muscle weakness, excessive thirst, and frequent urination
if you have liver or kidney problems
if you are taking lithium for mental health conditions (also see “Other medicines and Irbesartan and Hydrochlorothiazide Sandoz” below)
if you are taking aliskiren, a medicine used to treat high blood pressure.

You must inform your doctor if you think you are pregnant (or if there is a possibility of
becoming pregnant).
Irbesartan and Hydrochlorothiazide Sandoz 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 if taken during this period (see section “Pregnancy”).
Talk to your doctor or pharmacist 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
you are taking diuretics ( medicines that help you urinate )
you are on a low-salt diet
you have had or are experiencing severe vomiting and/or diarrhoea
you have heart failure
you have narrowing of the arteries to the kidneys (renal artery stenosis)
you have recently had a kidney transplant
you have “aortic or mitral valve stenosis” ( narrowing of the heart valves ) or “hypertrophic cardiomyopathy” (a disorder causing thickening of the heart muscle )
you are diabetic
you have a condition causing joint pain, skin rashes, and fever (systemic lupus erythematosus, also known as lupus or SLE )
you develop photosensitivity reactions (skin sensitivity to sunlight) during treatment
you have high calcium levels or potassium levels, or are on a low-potassium diet
you need to take an anaesthetic (even from the dentist) or before undergoing surgery
you experience symptoms such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or excessively rapid heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan and Hydrochlorothiazide Sandoz)
you experience vision changes or eye pain in one or both eyes while taking Irbesartan and Hydrochlorothiazide Sandoz. This could be a sign of glaucoma, increased pressure in the eye(s). You must stop taking Irbesartan and Hydrochlorothiazide Sandoz and contact your doctor immediately.
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 radiation while taking Irbesartan and Hydrochlorothiazide Sandoz.

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 Sandoz”.
Talk to your doctor if you are an athlete about to undergo anti-doping testing, as
Irbesartan and Hydrochlorothiazide Sandoz contains an active substance that may lead to a
positive anti-doping test.
For those engaged in sports: using the medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test regardless.

Other medicines and Irbesartan and Hydrochlorothiazide Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust your dose and/or take other precautions if you are taking:

lithium (a medicine for the treatment of mania or depression)
an ACE inhibitor or aliskiren (see also sections “Do not take Irbesartan and Hydrochlorothiazide Sandoz” and “Warnings and precautions”)
potassium supplements
potassium-containing salt substitutes
potassium-sparing medicines
other diuretics ( medicines that help you urinate )
certain laxatives
medicines for the treatment of gout
therapeutic vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral antidiabetics or insulin)
steroids
medicines for cancer treatment
painkillers or medicines for treating arthritis
cholestyramine and colestipol resins used to lower cholesterol levels in the blood
carbamazepine (a medicine for treating epilepsy)

Irbesartan and Hydrochlorothiazide Sandoz with food and drinks
Do not drink alcohol while taking this medicine, as alcohol and Irbesartan and Hydrochlorothiazide Sandoz may increase each other's effects. If you drink alcohol during treatment with this medicine, you may experience increased dizziness when standing up, especially when rising from a sitting position.
Excessive dietary salt intake may reduce the effectiveness of these tablets.
Irbesartan and Hydrochlorothiazide Sandoz can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, talk to your doctor or pharmacist before taking any medicine.
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of
becoming pregnant). Your doctor will usually advise you to stop taking Irbesartan and
Hydrochlorothiazide Sandoz before pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine. Irbesartan and Hydrochlorothiazide Sandoz is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Irbesartan and Hydrochlorothiazide Sandoz is not recommended for women who are breastfeeding, and your doctor may prescribe 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 Sandoz will affect your ability to drive or use machines. However, dizziness or fatigue may occasionally occur during treatment for high blood pressure. If this happens to you, discuss it with your doctor before driving or operating machinery.

Irbesartan and Hydrochlorothiazide Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Irbesartan and Hydrochlorothiazide Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE SANDOZ

Take Irbesartan and Hydrochlorothiazide Sandoz exactly as directed by your
doctor. If you have any doubts, you must consult your doctor or pharmacist.
Irbesartan and Hydrochlorothiazide Sandoz will be prescribed by your doctor when your previous
treatment for hypertension has not sufficiently lowered your blood pressure.
Your doctor will advise you on how to switch from your previous treatment to these tablets.
Use in adults and elderly
The usual dose is one tablet once daily.
Use in children and adolescents (under 18 years of age)
The use of Irbesartan and Hydrochlorothiazide Sandoz is not recommended in children and
adolescents under 18 years of age.
Take the tablet with a glass of water, preferably at the same time each day, with or without food.
If you take more Irbesartan and Hydrochlorothiazide Sandoz than you should
If you take too many tablets, contact immediately the nearest hospital emergency department or your doctor.
If this happens, you may experience symptoms of low blood pressure such as dizziness or fainting, and lying down with your legs raised may help.
If you forget to take Irbesartan and Hydrochlorothiazide Sandoz
It is important that you take this medicine every day. However, if you forget to take one or more doses, take it as soon as you remember, then continue with your regular dosing schedule.
Do not take a double
dose to make up for the forgotten dose.
If you stop taking Irbesartan and Hydrochlorothiazide Sandoz
Always consult your doctor if you wish to stop treatment. Even if you feel well, you may still need to continue taking this medicine.
If you have any doubts about how to use Irbesartan and Hydrochlorothiazide Sandoz, consult your doctor or
pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Irbesartan and hydrochlorothiazide Sandoz may cause adverse reactions,
although not everyone experiences them.
If you notice any of the following adverse reactions, contact your doctor immediately:

swelling of the face, lips, mouth, eyes, tongue or throat (angioedema)
difficulty breathing, dizziness (severe hypersensitivity)
These are symptoms of severe allergic reactions that must be treated immediately, usually in a hospital.

Contact your doctor immediately also if you experience:

jaundice (yellowing of the skin and/or eyes)

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

Dizziness
Nausea / vomiting
Urinary disorders
Fatigue
Increased blood urea, creatinine and creatine kinase levels in the blood

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

Diarrhea
Dizziness upon standing
Fainting due to low blood pressure
Increased heart rate
Swelling
Hot flushes
Sexual problems, changes in libido
Low levels of potassium and sodium in the blood

Not known (frequency cannot be estimated from the available data):

Skin rash, urticaria, itching
High levels of potassium in the blood
Headache
Hearing ringing, buzzing, roaring or clicking sounds in the ears
Cough
Indigestion (dyspepsia)
Loss of appetite
Changes in liver function or hepatitis (liver inflammation)
Joint and muscle pain
Impaired kidney function

As with any combination of two active substances, adverse reactions associated with each individual component cannot be ruled out.
Adverse reactions associated with irbesartan alone
In addition to the adverse reactions listed above, chest pain, severe allergic reactions (anaphylactic shock) and reduced platelet count (blood cells essential for blood clotting) have also been reported.
Adverse reactions associated with hydrochlorothiazide alone
Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterized by severe pain in the upper abdomen, often with nausea and vomiting; sleep disturbances; depression; blurred vision; reduction in white blood cells, which may lead to frequent infections and fever; reduced platelet count (a component essential for blood clotting); reduced red blood cell count (anaemia) characterized by tiredness, headache, shortness of breath during exercise, dizziness and pale appearance; kidney problems; lung problems including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to sunlight; inflammation of blood vessels; a skin disorder characterized by peeling of the skin all over the body; cutaneous lupus erythematosus, identified by a skin rash that may appear on the face, neck and scalp; allergic reactions; weakness and muscle cramps; irregular heartbeat; drop in blood pressure upon changing body position; swelling of the salivary glands; elevated blood sugar levels; sugar in the urine; increases in certain types of blood fats; elevated levels of uric acid in the blood which may cause gout; myopia; increased pressure in the eyes (glaucoma); skin and lip cancer (non-melanoma skin cancer).
It is also known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following 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 SANDOZ

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, the carton, and
the bottle after the wording “Exp”. The expiry date refers to the last day of that
month.
PVC/PVDC/ALU blisters
Do not store above 30°C.
Keep the medicine in the original packaging to protect it from moisture.
HDPE bottles and ALU/ALU blisters:
Keep the medicine in the original packaging to protect it from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer used. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Irbesartan and hydrochlorothiazide Sandoz contains
The active substances are irbesartan and hydrochlorothiazide.
Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
The other components are
Tablet core
Microcrystalline cellulose,
lactose monohydrate (see the end of section 2 for further information),
sodium croscarmellose,
anhydrous colloidal silica,
hypromellose 3 mPas,
silicified microcrystalline cellulose, and
magnesium stearate.
Film coating
Hypromellose 6 mPas,
hydroxypropylcellulose,
macrogol 6000,
lactose monohydrate (see the end of section 2 for further information),
titanium dioxide (E171),
iron oxide (black and red) (E172), and
talc.
Description of the appearance of Irbesartan and hydrochlorothiazide Sandoz and contents of the pack
Irbesartan and hydrochlorothiazide Sandoz is an apricot-coloured, oval, biconvex, film-coated tablet, with "150H" imprinted on one side.
The film-coated tablets are packed in PVC/PVDC/ALU blisters or ALU/ALU blisters and placed in a carton box or packed in an HDPE bottle with a PP screw cap and a silica gel desiccant.
PVC/PVDC/ALU blisters:
7, 14, 28, 30, 56, 84, 90, 98, 100 film-coated tablets.
ALU/ALU blisters:
7, 14, 28, 30, 56, 84, 90, 98, 100 film-coated tablets.
HDPE bottles:
100, 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)
Manufacturers
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
LEK S.A., ul. Podlipie 16, 95-010 Stryków, Poland
LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE PATIENT

Irbesartan and hydrochlorothiazide Sandoz 300 mg/12.5 mg film-coated tablets

Generic 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. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. WHAT IRBESARTAN AND HYDROCHLOROTHIAZIDE SANDOZ IS AND WHAT IT IS USED FOR

Irbesartan and hydrochlorothiazide Sandoz is a combination of two active substances, irbesartan and hydrochlorothiazide.
Irbesartan belongs to a group of medicines called angiotensin-II receptor antagonists, which work by dilating blood vessels, thereby reducing blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics (medicines that help increase urine production).
The two active substances in Irbesartan and hydrochlorothiazide Sandoz work together to lower blood pressure more effectively than when either is used alone.
Irbesartan and hydrochlorothiazide Sandoz is used to treat high blood pressure (hypertension), when treatment with irbesartan or hydrochlorothiazide alone does not provide adequate control of your blood pressure.

2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN AND HYDROCHLOROTHIAZIDE SANDOZ

DO NOT take Irbesartan and Hydrochlorothiazide Sandoz if:

you are allergic to irbesartan, hydrochlorothiazide, or any of the excipients of this medicine (listed in section 6)
you are allergic to sulfonamide derivatives (e.g. other thiazides, certain antibacterial medicines such as co-trimoxazole; ask your doctor if you are unsure)
you are more than 3 months pregnant (it is better to avoid taking Irbesartan and Hydrochlorothiazide Sandoz even in the early stages of pregnancy – see section “Pregnancy”)
you have severe impairment of liver function
you have severe impairment of kidney function or your kidneys are not producing urine
you have a condition associated with persistently high calcium levels or low potassium levels in the blood
you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

if you have primary aldosteronism (Conn’s syndrome), a tumour of the adrenal gland associated with muscle weakness, excessive thirst, and frequent urination
if you have liver or kidney problems
if you are also taking lithium for mental health conditions (see also “Other medicines and Irbesartan and Hydrochlorothiazide Sandoz” below)
if you are taking aliskiren, a medicine used to treat high blood pressure.

You must inform your doctor if you think you are pregnant (or if there is a possibility of
becoming pregnant).
Irbesartan and Hydrochlorothiazide Sandoz is not recommended during early pregnancy and
must not be taken after the third month of pregnancy, as it may cause serious harm to the
unborn baby if taken during this period (see section “Pregnancy”).
Talk to your doctor or pharmacist 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
you are taking diuretics ( medicines that help you to urinate )
you are on a low-salt diet
you have had or currently have severe vomiting and/or diarrhoea
you have heart failure
you have narrowing of the arteries to the kidneys (renal artery stenosis)
you have recently had a kidney transplant
you have “aortic or mitral valve stenosis” ( a narrowing of the heart valves ) or “hypertrophic cardiomyopathy” (a disorder causing thickening of the heart muscle )
you are diabetic
you suffer from a condition causing joint pain, skin rashes, and fever (systemic lupus erythematosus, also known as lupus or SLE )
you develop photosensitivity reactions (skin sensitivity to sunlight) during treatment
you have high levels of calcium or potassium in your blood, or are on a low-potassium diet
you need to take an anaesthetic (including from a dentist) or before undergoing surgery
you experience symptoms such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or a very rapid heartbeat, which could indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan and Hydrochlorothiazide Sandoz)
you experience vision changes or pain in one or both eyes while taking Irbesartan and Hydrochlorothiazide Sandoz. This could be a sign of glaucoma, increased pressure in the eye(s). You must stop treatment with Irbesartan and Hydrochlorothiazide Sandoz and contact your doctor immediately.
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 radiation while taking Irbesartan and Hydrochlorothiazide Sandoz.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information under the heading “Do not take Irbesartan and Hydrochlorothiazide Sandoz”.
Talk to your doctor if you are an athlete about to undergo doping control, as Irbesartan and Hydrochlorothiazide Sandoz contains an active ingredient that may lead to a positive doping test.
For those engaged in sports: using this medicine without a medical need constitutes doping and may result in a positive anti-doping test.

Other medicines and Irbesartan and Hydrochlorothiazide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust your dose and/or take other precautions if you are taking:

lithium (a medicine used to treat mania or depression )
an ACE inhibitor or aliskiren (see also the sections “Do not take Irbesartan and Hydrochlorothiazide Sandoz” and “Warnings and precautions”)
potassium supplements
potassium-containing salt substitutes
potassium-sparing medicines
other diuretics ( medicines that help you to urinate )
certain laxatives
medicines used to treat gout
therapeutic vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral antidiabetics or insulin)
steroids
medicines used to treat cancer
painkillers or medicines used to treat arthritis
cholestyramine and colestipol resin used to lower cholesterol levels in the blood
carbamazepine (a medicine used to treat epilepsy )

Irbesartan and Hydrochlorothiazide Sandoz with food and drink
Do not drink alcohol while taking this medicine, as alcohol and Irbesartan and Hydrochlorothiazide Sandoz may increase each other's effects. If you drink alcohol during treatment with this medicine, you may feel more dizzy when standing up, especially when rising from a sitting position.
Excessive dietary salt intake may reduce the effectiveness of these tablets.
Irbesartan and Hydrochlorothiazide Sandoz can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, talk to your doctor or pharmacist before taking any medicine.

Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Irbesartan and Hydrochlorothiazide Sandoz before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine. Irbesartan and Hydrochlorothiazide Sandoz is not recommended during pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken during this period.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Irbesartan and Hydrochlorothiazide Sandoz is not recommended for women who are breastfeeding, and your doctor may prescribe an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
Irbesartan and Hydrochlorothiazide Sandoz is unlikely to affect your ability to drive or use machines. However, dizziness or tiredness may occasionally occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or operating machinery.

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

Irbesartan and Hydrochlorothiazide Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE SANDOZ

Take Irbesartan and Hydrochlorothiazide Sandoz exactly as prescribed by your
doctor. If you have any doubts, consult your doctor or pharmacist.
Irbesartan and Hydrochlorothiazide Sandoz will be prescribed by your doctor when your previous
treatment for hypertension has not sufficiently lowered your blood pressure.
Your doctor will advise you on how to switch from your previous treatment to these tablets.
Use in adults and elderly
The usual dose is one tablet once daily.
Use in children and adolescents (under 18 years of age)
The use of Irbesartan and Hydrochlorothiazide Sandoz is not recommended in children and
adolescents under 18 years of age.
Take the tablet with a glass of water, preferably at the same time each day, with or without food.
If you take more Irbesartan and Hydrochlorothiazide Sandoz than you should
If you take too many tablets, contact the nearest hospital emergency department or your doctor immediately. If this happens, you may experience symptoms of low blood pressure such as dizziness or fainting; lying down with your legs raised may help.
If you forget to take Irbesartan and Hydrochlorothiazide Sandoz
It is important that you take this medicine every day. However, if you forget to take one or more doses, take it as soon as you remember, then continue with your normal dosing schedule. Do not take a double dose to make up for the missed dose.
If you stop taking Irbesartan and Hydrochlorothiazide Sandoz
Always consult your doctor before stopping treatment. Even if you feel well, you may still need to continue taking this medicine.
If you have any doubts about how to use Irbesartan and Hydrochlorothiazide Sandoz, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

swelling of the face, lips, mouth, eyes, tongue or throat (angioedema)
difficulty breathing, dizziness (severe hypersensitivity)

These are symptoms of serious allergic reactions that must be treated immediately,
usually in a hospital.
Contact your doctor immediately also if you experience:

jaundice (yellowing of the skin and/or eyes)

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

Dizziness
Nausea / vomiting
Urinary disorders
Fatigue
Increased blood urea nitrogen, creatinine and creatine kinase levels in blood

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

Diarrhea
Dizziness upon standing
Fainting due to low blood pressure
Rapid heartbeat
Swelling
Hot flushes
Sexual dysfunction, changes in libido
Low levels of potassium and sodium in the blood

Not known (frequency cannot be estimated from the available data):

Rash, hives, itching
High levels of potassium in the blood
Headache
Ringing, buzzing, roaring or clicking sounds in the ears (tinnitus)
Cough
Indigestion (dyspepsia)
Loss of appetite
Liver function abnormalities or hepatitis (liver inflammation)
Joint and muscle pain
Impaired kidney function

As with any combination of two active substances, adverse reactions associated with each
individual component cannot be excluded.
Adverse reactions associated with irbesartan alone
In addition to the adverse reactions listed above, chest pain, severe allergic reactions
(anaphylactic reactions) and reduced platelet count (blood cells essential for blood
coagulation) have been reported.
Adverse reactions associated with hydrochlorothiazide alone
Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the
skin and/or whites of the eyes); inflammation of the pancreas characterized by severe pain in
the upper abdomen, often with nausea and vomiting; sleep disorders; depression; blurred
vision; reduction in white blood cells, which may lead to frequent infections, fever; reduced
platelet count (a component essential for blood coagulation), reduced red blood cell count
(anemia) characterized by fatigue, headache, shortness of breath during exercise, dizziness and
pale appearance; kidney problems; lung problems including pneumonia or fluid accumulation
in the lungs; increased skin sensitivity to sunlight; inflammation of blood vessels; a skin
disorder characterized by skin peeling over the entire body; cutaneous lupus erythematosus,
identified by a skin rash that may appear on the face, neck and scalp; allergic reactions;
weakness and muscle cramps; irregular heartbeat; drop in blood pressure upon changing
body position; swelling of the salivary glands; elevated blood sugar levels; sugar in urine;
increases in certain types of blood lipids; elevated levels of uric acid in the blood which may
cause gout, myopia, increased pressure in the eyes (glaucoma), skin and lip cancer (melanoma
skin cancer).
It is also known that adverse effects associated with hydrochlorothiazide may increase with
higher doses of hydrochlorothiazide.
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 following 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 SANDOZ

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, carton, and bottle after the wording “Exp”. The expiry date refers to the last day of that month.
PVC/PVDC/ALU blisters:
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
HDPE bottles and ALU/ALU blisters:
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Irbesartan and hydrochlorothiazide Sandoz contains
The active substances are irbesartan and hydrochlorothiazide.
Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
The other components are:
Tablet core:
Microcrystalline cellulose,
lactose monohydrate (see the end of section 2 for further information),
sodium croscarmellose,
anhydrous colloidal silica,
hypromellose 3 mPas,
silicified microcrystalline cellulose, and
magnesium stearate.
Film coating:
Hypromellose 6 mPas,
hydroxypropylcellulose,
macrogol 6000,
lactose monohydrate (see the end of section 2 for further information),
titanium dioxide (E171),
iron oxide (yellow and red) (E172), and
talc.

Description of the appearance of Irbesartan and hydrochlorothiazide Sandoz and pack contents
Irbesartan and hydrochlorothiazide Sandoz is a film-coated, oval, biconvex tablet with an apricot colour, marked with "300H" on one side.
The film-coated tablets are packed in PVC/PVDC/ALU blisters or ALU/ALU blisters and placed in a carton box, or packed in HDPE bottles with a polypropylene screw cap and a silica gel desiccant.

PVC/PVDC/ALU blisters:
7, 10, 14, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100 film-coated tablets.

ALU/ALU blisters:
7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100 film-coated tablets.

HDPE bottles:
100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturers
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
LEK S.A., ul. Podlipie 16, 95-010 Stryków, Poland
LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE PATIENT

Irbesartan and hydrochlorothiazide Sandoz 300 mg/25 mg film-coated tablets

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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. WHAT IRBESARTAN AND HYDROCHLOROTHIAZIDE SANDOZ IS AND WHAT IT IS USED FOR

Irbesartan and hydrochlorothiazide Sandoz is a combination of two active substances, irbesartan and hydrochlorothiazide.
Irbesartan belongs to a group of medicines called angiotensin-II receptor antagonists, which work by dilating blood vessels, thereby reducing blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics (medicines that help increase urine production).
The two active substances in Irbesartan and hydrochlorothiazide Sandoz work together to lower blood pressure with a greater effect than when either is used alone.
Irbesartan and hydrochlorothiazide Sandoz is used to treat high blood pressure (hypertension), when treatment with irbesartan or hydrochlorothiazide alone does not provide adequate control of your blood pressure.

2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN AND HYDROCHLOROTHIAZIDE SANDOZ

DO NOT take Irbesartan and Hydrochlorothiazide Sandoz if:

you are allergic to irbesartan, hydrochlorothiazide, or any of the excipients of this medicine (listed in section 6)
you are allergic to sulfonamide derivatives (e.g. other thiazides, certain antibacterial medicines such as co-trimoxazole; ask your doctor if you are unsure)
you are more than 3 months pregnant (it is better to avoid taking Irbesartan and Hydrochlorothiazide Sandoz even in the early stages of pregnancy – see section “Pregnancy”)
you suffer from severe impairment of liver function
you suffer from severe impairment of kidney function or your kidneys are not producing urine
you have a condition associated with persistently high calcium levels or low potassium levels in the blood
you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

if you have primary aldosteronism (Conn’s syndrome), a tumour of the adrenal gland associated with muscle weakness, excessive thirst, and frequent urination
if you have liver or kidney problems
if you are also taking lithium for mental health conditions (see also “Other medicines and Irbesartan and Hydrochlorothiazide Sandoz” below)
if you are taking aliskiren, a medicine used to treat high blood pressure.

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant).
Irbesartan and Hydrochlorothiazide Sandoz is not recommended during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken during this period (see section “Pregnancy”).
Talk to your doctor or pharmacist 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
you are taking diuretics ( medicines that help you pass urine )
you are on a low-salt diet
you have had or are experiencing severe vomiting and/or diarrhoea
you have heart failure
you have narrowing of the arteries to the kidneys (renal artery stenosis)
you have recently had a kidney transplant
you have “aortic or mitral valve stenosis” ( a narrowing of the heart valves ) or “hypertrophic cardiomyopathy” (a disorder causing thickening of the heart muscle )
you are diabetic
you suffer from a condition causing joint pain, skin rashes, and fever (systemic lupus erythematosus, also known as lupus or SLE )
you develop photosensitivity reactions (skin sensitivity to sunlight) during treatment
you have high calcium or potassium levels or are on a low-potassium diet
you need to take an anaesthetic (even from your dentist) or before undergoing surgery
you experience symptoms such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or a very rapid heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan and Hydrochlorothiazide Sandoz)
you experience changes in vision or eye pain in one or both eyes while taking Irbesartan and Hydrochlorothiazide Sandoz. This could be a sign of glaucoma, increased pressure in the eye(s). You must stop taking Irbesartan and Hydrochlorothiazide Sandoz and contact your doctor immediately.
you have previously had skin cancer or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV radiation while taking Irbesartan and Hydrochlorothiazide Sandoz.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information under the heading “Do not take Irbesartan and Hydrochlorothiazide Sandoz”.
Talk to your doctor if you are an athlete about to undergo doping control, as Irbesartan and Hydrochlorothiazide Sandoz contains an active substance that may lead to positive doping test results.
For those engaged in sports: using this medicine without a medical need constitutes doping and may result in a positive anti-doping test regardless.

Other medicines and Irbesartan and Hydrochlorothiazide Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may consider it necessary to adjust your dose and/or take additional precautions if you are taking:

lithium (a medicine used to treat mania or depression )
an ACE inhibitor or aliskiren (see also the sections “Do not take Irbesartan and Hydrochlorothiazide Sandoz” and “Warnings and precautions”)
potassium supplements
potassium-containing salt substitutes
potassium-sparing medicines
other diuretics ( medicines that help you pass urine )
certain laxatives
medicines used to treat gout
therapeutic vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral antidiabetics or insulin)
steroids
medicines used to treat cancer
painkillers or medicines for treating arthritis
cholestyramine and colestipol resins used to lower blood cholesterol levels
carbamazepine (a medicine used to treat epilepsy )

Irbesartan and Hydrochlorothiazide Sandoz with food and drink
Do not drink alcohol while taking this medicine, as alcohol and Irbesartan and Hydrochlorothiazide Sandoz may increase each other's effects. If you drink alcohol during treatment with this medicine, you may experience increased dizziness when standing up, especially when rising from a sitting position.
Excessive dietary salt intake may reduce the effectiveness of these tablets.
Irbesartan and Hydrochlorothiazide Sandoz may be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking any medicine.
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Irbesartan and Hydrochlorothiazide Sandoz before pregnancy or as soon as you find out you are pregnant, and will recommend an alternative medicine. Irbesartan and Hydrochlorothiazide Sandoz is not recommended during pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Irbesartan and Hydrochlorothiazide Sandoz is not recommended for women who are breastfeeding, and your doctor may prescribe 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 Sandoz will affect your ability to drive or operate machinery. However, dizziness or fatigue may occasionally occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or using machinery.

Irbesartan and Hydrochlorothiazide Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Irbesartan and Hydrochlorothiazide Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE SANDOZ

Take Irbesartan and Hydrochlorothiazide Sandoz exactly as directed by your
doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will prescribe Irbesartan and Hydrochlorothiazide Sandoz when your previous
treatment for hypertension has not sufficiently lowered your blood pressure.
Your doctor will advise you on how to switch from your previous treatment to these tablets.
Use in adults and elderly
The usual dose is one tablet once daily.
Use in children and adolescents (under 18 years of age)
The use of Irbesartan and Hydrochlorothiazide Sandoz is not recommended in children and
adolescents under 18 years of age.
Take the tablet with a glass of water, preferably at the same time each day, with or without food.
If you take more Irbesartan and Hydrochlorothiazide Sandoz than you should
If you take too many tablets, contact immediately the nearest hospital emergency department or your doctor. If this happens, you may experience symptoms of low blood pressure such as dizziness or fainting, and lying down with your legs raised may help.
If you forget to take Irbesartan and Hydrochlorothiazide Sandoz
It is important that you take the medicine every day. However, if you forget to take one or more doses, take it as soon as you remember, then continue with your regular dosing schedule.
Do not take a double
dose to make up for the missed dose.
If you stop taking Irbesartan and Hydrochlorothiazide Sandoz
Always consult your doctor if you wish to stop treatment. Even if you feel well, you may still need to continue taking this medicine.
If you have any questions about the use of Irbesartan and Hydrochlorothiazide Sandoz, consult your doctor or
pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Irbesartan and hydrochlorothiazide Sandoz may cause adverse effects,
although not everybody experiences them.
If you notice any of the following adverse effects, contact your doctor immediately:

swelling of the face, lips, mouth, eyes, tongue or throat (angioedema)
breathing difficulties, dizziness (severe hypersensitivity)
These are symptoms of severe allergic reactions which must be treated immediately, usually in a hospital.

Contact your doctor immediately also if you experience:

jaundice (yellowing of the skin and/or eyes)

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

Dizziness
Nausea / vomiting
Urinary disorders
Fatigue
Increased blood urea nitrogen, creatinine and creatine kinase levels in blood

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

Diarrhea
Dizziness upon standing
Fainting due to low blood pressure
Rapid heartbeat
Swelling
Hot flushes
Sexual problems, changes in libido
Low levels of potassium and sodium in the blood

Not known (frequency cannot be determined from available data):

Rash, urticaria, itching
High levels of potassium in the blood
Headache
Ringing, buzzing, roaring or clicking sounds in the ears
Cough
Indigestion (dyspepsia)
Loss of appetite
Impaired liver function or hepatitis (liver inflammation)
Joint and muscle pain
Impaired kidney function

As with any combination of two active substances, adverse effects associated with each individual component cannot be ruled out.
Adverse effects associated with irbesartan alone
In addition to the adverse effects listed above, chest pain, severe allergic reactions (anaphylactic shock) and reduced platelet count (blood cells essential for blood clotting) have also been reported.
Adverse effects associated with hydrochlorothiazide alone
Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterized by severe pain in the upper abdomen, often with nausea and vomiting; sleep disturbances; depression; blurred vision; lack of white blood cells, which may lead to frequent infections and fever; reduced platelet count (a component essential for blood clotting), decreased red blood cell count (anemia) characterized by tiredness, headache, shortness of breath during exercise, dizziness and pale appearance; kidney problems; lung problems including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to sunlight; inflammation of blood vessels; a skin disorder characterized by peeling of the skin all over the body; cutaneous lupus erythematosus, identified by a skin rash that may appear on the face, neck and scalp; allergic reactions; weakness and muscle cramps; irregular heartbeat; drop in blood pressure upon changing body position; swelling of the salivary glands; elevated blood sugar levels; sugar in urine; increases in certain types of blood fats; elevated levels of uric acid in the blood which may cause gout, myopia, increased eye pressure (glaucoma); cancer of the skin and lips (non-melanoma skin cancer).
It is also known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, carton, and bottle after the wording “Exp”. The expiry date refers to the last day of that month.
PVC/PVDC/ALU blisters
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
HDPE bottles and ALU/ALU blisters
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Irbesartan and hydrochlorothiazide Sandoz contains
The active substances are irbesartan and hydrochlorothiazide.
Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
The other components are:
Tablet core:
Microcrystalline cellulose,
lactose monohydrate (see the end of section 2 for further information),
sodium croscarmellose,
anhydrous colloidal silica,
hypromellose 3 mPas,
silicified microcrystalline cellulose, and
magnesium stearate.
Film coating:
hypromellose 6 mPas,
hydroxypropylcellulose,
macrogol 6000,
lactose monohydrate (see the end of section 2 for further information),
titanium dioxide (E171),
iron oxide (black and red) (E172), and
talc.

Description of the appearance of Irbesartan and hydrochlorothiazide Sandoz and pack contents
Irbesartan and hydrochlorothiazide Sandoz is a dark pink, oval-shaped, biconvex, film-coated tablet, marked with "300" on one side and "25H" on the other.
The film-coated tablets are packaged in PVC/PVDC/ALU blisters or ALU/ALU blisters and placed in a carton box or packaged in an HDPE bottle with a polypropylene screw cap and silica gel desiccant.

PVC/PVDC/ALU blisters:
7, 14, 28, 30, 56, 84, 90, 98, 100 film-coated tablets.

ALU/ALU blisters:
7, 14, 28, 30, 56, 84, 90, 98, 100 film-coated tablets.

HDPE bottles:
100, 250 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)