Irbesartan Tecnigen: detailed information

Patient Information Leaflet

Irbesartan TecniGen 75 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:
1 What Irbesartan TecniGen is and what it is used for
2 What you need to know before taking Irbesartan TecniGen
3 How to take Irbesartan TecniGen
4 Possible side effects
5 How to store Irbesartan TecniGen
6 Contents of the pack and other information

1. What Irbesartan TecniGen is and what it is used for

Irbesartan TecniGen belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced by the body that binds to receptors in the blood vessels, causing them to constrict. This results in an increase in blood pressure.
Irbesartan TecniGen prevents angiotensin-II from binding to these receptors, allowing the blood vessels to dilate and blood pressure to decrease. Irbesartan TecniGen slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan TecniGen is used

to treat high blood pressure ( essential arterial hypertension )
to protect the kidney in hypertensive patients with high blood pressure, type 2 diabetes, and evidence of kidney dysfunction shown by laboratory tests.

2. What you should know before taking Irbesartan TecniGen

Do not take Irbesartan TecniGen:

if you are allergic (hypersensitive) to irbesartan or to any of the other ingredients of this medicine (listed in section 6)
if you are more than 3 months pregnant (it is also advisable to avoid taking Irbesartan TecniGen during early pregnancy – see section Pregnancy)
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Irbesartan TecniGen
if you are in any of the following conditions:

excessive vomiting or diarrhoea
if you have kidney disorders
if you have heart problems
if you are taking Irbesartan TecniGen for diabetic kidney disease. In this case, your doctor may prescribe regular blood tests, especially to monitor serum potassium levels in case of reduced kidney function
if you are due to undergo surgery or receive anaesthetics
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

Your doctor may monitor 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 TecniGen"
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Irbesartan TecniGen 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 used during this period (see section Pregnancy).

Children and adolescents
This medicine should not be used in children and adolescents, as its safety and efficacy have not yet been fully established.

Other medicines and Irbesartan TecniGen:
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 an ACE inhibitor or aliskiren (see also sections "Do not take Irbesartan TecniGen" and "Warnings and precautions").

You may need blood tests if you are taking:

potassium supplements
potassium-containing salt substitutes
potassium-sparing medicines (such as certain diuretics)
medicines containing lithium

The effectiveness of irbesartan may be reduced if you take certain painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).

Irbesartan TecniGen with food and drink
Irbesartan TecniGen can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Irbesartan TecniGen before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Irbesartan TecniGen 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 beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or about to start breastfeeding. Irbesartan TecniGen is not recommended for women who are breastfeeding. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
No studies on the ability to drive or use machines have been conducted. It is unlikely that Irbesartan TecniGen affects the ability to drive or operate machinery. However, occasionally, dizziness or fatigue may occur during treatment for high blood pressure. If this occurs, talk to your doctor before driving or operating machinery.

Irbesartan TecniGen contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), contact him/her before taking this medicine.

3. How to take Irbesartan TecniGen

Always take Irbesartan TecniGen exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Method of administration
Irbesartan TecniGen is for oral use. Swallow the tablets with a sufficient amount of liquid (for example: a glass of water). You may take Irbesartan TecniGen with or without food.
Try to take the medicine at the same time each day. Treatment should be continued for as long as your doctor considers it necessary.

Patients with high blood pressure: The usual dose is 150 mg once daily (two tablets per day). The dose may subsequently be increased to 300 mg (four tablets per day) once daily, depending on the reduction in blood pressure levels.
Patients with high blood pressure and type 2 diabetes with kidney disease: In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose is 300 mg (four tablets per day) once daily for the treatment of associated kidney disease.

Your doctor may decide to use lower doses, especially at the beginning of treatment, in particular patients such as those on haemodialysis, or in patients over 75 years of age.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting therapy.
Use in children and adolescents
Irbesartan TecniGen must not be given to children under 18 years of age. If a child ingests any tablets, contact your doctor immediately.
If you take more Irbesartan TecniGen than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan TecniGen
If you accidentally miss a dose, continue with your next dose as scheduled. Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Not known: frequency cannot be estimated from the available data

Side effects reported in clinical studies in patients treated with irbesartan include:

Very common (may affect more than 1 in 10 people): if you have high blood pressure and type 2 diabetes with kidney disease, blood tests may show high potassium levels.
Common (may affect up to 1 in 10 people): dizziness, feeling unwell/nausea, fatigue, and blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness upon standing from lying or sitting position, low blood pressure upon standing from lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (haemoglobin) have also been reported.
Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Additional side effects have been reported since the marketing of Irbesartan.
Side effects with unknown frequency include: sensation of dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, abnormal liver function, increased potassium levels in the blood, kidney function disturbances, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Irbesartan TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister after Exp. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What Irbesartan TecniGen contains
The active substance is irbesartan.
Each tablet contains 75 mg of irbesartan.
The excipients are: monohydrate lactose, microcrystalline cellulose, croscarmellose sodium,
hypromellose, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171) and macrogol 3350.

Description of the appearance of Irbesartan TecniGen and contents of the pack
Irbesartan TecniGen 75 mg film-coated tablets are white, oblong and convex.
Irbesartan TecniGen 75 mg film-coated tablets are available in packs containing 14, 28, 30, 56 and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)

Manufacturer
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal

This medicinal product is authorised in the European Economic Area Member States under the following names:
Germany: Irbesartan Tecnimede 75 mg Filmtabletten
France: Irbesartan Tecnimede 75 mg comprimé pelliculé
Greece: Irbesartan Tecnimede 75 mg Επικαλυμμένα με λεπτό υμένιο δισκία
Italy: Irbesartan TecniGen 75 mg compresse rivestite con film
Portugal: Irbesartan Tecnimede
United Kingdom: Irbesartan

Patient Information Leaflet: Information for the User

Irbesartan TecniGen 150 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Irbesartan TecniGen is and what it is used for

Irbesartan TecniGen belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced by the body that binds to receptors in the blood vessels, causing them to constrict. This results in an increase in blood pressure.
Irbesartan TecniGen prevents angiotensin-II from binding to these receptors, allowing the blood vessels to dilate and thereby reducing blood pressure. Irbesartan TecniGen slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan TecniGen is used

to treat high levels of arterial pressure ( essential arterial hypertension )
to protect the kidneys in hypertensive patients with high arterial pressure, type 2 diabetes, and evidence of kidney dysfunction in laboratory tests.

2. What you need to know before taking Irbesartan TecniGen

Do not take Irbesartan TecniGen:

if you are allergic (hypersensitive) to irbesartan or to any of the other ingredients of this medicine (listed in section 6)
if you are more than 3 months pregnant (it is better to avoid taking Irbesartan TecniGen even in the early stages of pregnancy – see section Pregnancy)
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Irbesartan TecniGen
if you are in any of the following conditions:

excessive vomiting or diarrhoea
if you have kidney disorders
if you have heart problems
if you are taking Irbesartan TecniGen for diabetic kidney disease. In this case, your doctor may prescribe regular blood tests, especially to monitor serum potassium levels in case of poor kidney function
if you are due to undergo surgery or receive anaesthetics
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

Your doctor may monitor 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 TecniGen"
You must inform your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). Irbesartan TecniGen is not recommended during early
pregnancy and must not be taken if you are more than 3 months pregnant, as it
may cause serious harm to the unborn baby if taken during this period (see section
Pregnancy).
Children and adolescents
This medicine should not be used in children and adolescents, as its safety and
efficacy have not yet been fully established.
Other medicines and Irbesartan TecniGen:
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 other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the sections:
"Do not take Irbesartan TecniGen" and "Warnings and precautions")
You may need blood tests if you are taking:

potassium supplements
potassium-containing salt substitutes
potassium-sparing medicines (such as certain diuretics)
medicines containing lithium

If you take certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), the effectiveness of irbesartan may be reduced.
Irbesartan TecniGen with food and drink
Irbesartan TecniGen can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant); your doctor will usually advise you to stop taking Irbesartan TecniGen before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Irbesartan TecniGen. Irbesartan TecniGen is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Irbesartan TecniGen
is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
No studies on the ability to drive vehicles or use machinery have been conducted. It is unlikely that Irbesartan TecniGen affects the ability to drive or operate machinery. However, occasionally, during treatment for high blood pressure, dizziness or fatigue may occur. If this happens, discuss it with your doctor before driving or operating machinery.
Irbesartan TecniGen contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars (e.g., lactose), contact him/her before taking this medicine.

3. How to take Irbesartan TecniGen

Always take Irbesartan TecniGen exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Method of administration
Irbesartan TecniGen is for oral use. Swallow the tablets with a sufficient amount of liquid (for example: a glass of water). You may take Irbesartan TecniGen with or without food.
Try to take the medicine at the same time each day. Treatment should be continued for as long as your doctor considers it necessary.

Patients with high blood pressure: The usual dose is 150 mg once daily. The dosage may subsequently be increased to 300 mg (two tablets daily) once daily, depending on the reduction in blood pressure levels.
Patients with high blood pressure and type 2 diabetes with kidney disease: In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose is 300 mg (two tablets daily) once daily for the treatment of associated kidney disease.

Your doctor may decide to use lower doses, especially at the beginning of treatment, in particular patients such as those on haemodialysis, or in patients over 75 years of age.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting therapy.
Use in children and adolescents
Irbesartan TecniGen must not be given to children under 18 years of age. If a child ingests any tablets, contact your doctor immediately.
If you take more Irbesartan TecniGen than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan TecniGen
If you accidentally miss a dose, continue your treatment as normal. Do not take a double dose to make up for the forgotten dose.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.
As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you experience any of these symptoms or have difficulty breathing, stop taking Irbesartan TecniGen and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Not known: frequency cannot be estimated from the available data

Side effects reported in clinical studies in patients treated with irbesartan include:

Very common (may affect more than 1 in 10 people): if you have high blood pressure, type 2 diabetes and kidney disease, blood tests may show high levels of potassium.
Common (may affect up to 1 in 10 people): dizziness, feeling unwell/nausea, fatigue, and blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase). In patients with high blood pressure, type 2 diabetes and kidney disease, dizziness upon standing from lying or sitting position, low blood pressure upon standing from lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (haemoglobin) have also been reported.
Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Additional side effects have been reported since the marketing of irbesartan. Side effects with unknown frequency include: dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, abnormal liver function, increased blood potassium levels, kidney function disorders, and inflammation of the small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Irbesartan TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after Exp. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What Irbesartan TecniGen contains
The active substance is irbesartan.
Each tablet contains 150 mg of irbesartan.
The excipients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
hypromellose, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E171) and macrogol
3350.
Description of the appearance of Irbesartan TecniGen and contents of the pack
Irbesartan TecniGen 150 mg film-coated tablets are white, oblong, convex and marked on one side.
The tablet may be divided into two equal halves.
Irbesartan TecniGen 150 mg film-coated tablets are available in packs containing 14,
28, 30, 56 and 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Manufacturer
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal
This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
Germany: Irbesartan Tecnimede 150 mg Filmtabletten
France: Irbesartan Tecnimede 150 mg comprimé pelliculé
Greece: Irbesartan Tecnimede 150 mg Επικαλυμμένα με λεπτό υμένιο δισκία
Italy: Irbesartan TecniGen 150 mg compresse rivestite con film
Portugal: Irbesartan Tecnimede
United Kingdom: Irbesartan

Package leaflet: Information for the user

Irbesartan TecniGen 300 mg film-coated tablets

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
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, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Irbesartan TecniGen is and what it is used for
What you need to know before taking Irbesartan TecniGen
How to take Irbesartan TecniGen
Possible side effects
How to store Irbesartan TecniGen
Package contents and other information

1. What Irbesartan TecniGen is and what it is used for

Irbesartan TecniGen belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced by the body that binds to receptors in blood vessels, causing them to constrict. This results in an increase in blood pressure.
Irbesartan TecniGen prevents angiotensin-II from binding to these receptors, allowing blood vessels to dilate and blood pressure to decrease. Irbesartan TecniGen slows down the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Irbesartan TecniGen is used

to treat high levels of arterial pressure ( essential arterial hypertension )
to protect the kidney in hypertensive patients with high arterial pressure, type 2 diabetes, and evidence of kidney dysfunction shown by laboratory tests.

2. What you should know before taking Irbesartan TecniGen

Do not take Irbesartan TecniGen:

if you are allergic (hypersensitive) to irbesartan or to any of the other ingredients of this medicine (listed in section 6)
if you are more than 3 months pregnant (it is better to avoid taking Irbesartan TecniGen even in the early stages of pregnancy – see section Pregnancy)
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Irbesartan TecniGen
if you are in any of the following conditions:

excessive vomiting or diarrhoea
if you have kidney problems
if you have heart problems
if you are taking Irbesartan TecniGen for diabetic kidney disease. In this case, your doctor may prescribe regular blood tests, especially to monitor serum potassium levels in case of poor kidney function
if you are due to undergo surgery or receive anaesthetics
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

Your doctor may monitor 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 TecniGen"
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Irbesartan TecniGen 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).

Children and adolescents
This medicine should not be used in children and adolescents, as its safety and efficacy have not yet been fully established.

Other medicines and Irbesartan TecniGen:
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 an ACE inhibitor or aliskiren (see also the sections "Do not take Irbesartan TecniGen" and "Warnings and precautions").

You may need blood tests if you are taking:

potassium supplements
salt substitutes containing potassium
potassium-sparing medicines (such as certain diuretics)
medicines containing lithium

The effectiveness of irbesartan may be reduced when taking certain painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs).

Irbesartan TecniGen with food and drink
Irbesartan TecniGen can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Irbesartan TecniGen before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine. Irbesartan TecniGen 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 beyond the third month of pregnancy.

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

Driving and using machines
No studies on the ability to drive or use machines have been conducted. It is unlikely that Irbesartan TecniGen affects the 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 operating machinery.

Irbesartan TecniGen contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), contact your doctor before taking this medicine.

3. How to take Irbesartan TecniGen

Always take Irbesartan TecniGen exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Method of administration
Irbesartan TecniGen is for oral use. Swallow the tablets with a sufficient amount of liquid (for example: a glass of water). You may take Irbesartan TecniGen with or without food.
Try to take the medicine at the same time each day. Treatment should be continued for as long as your doctor considers it necessary.

Patients with high blood pressure: The usual dose is 150 mg once daily. The dose may later be increased to 300 mg once daily, depending on the reduction in blood pressure levels.
Patients with high blood pressure and type 2 diabetes with kidney disease: In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose is 300 mg once daily for the treatment of associated kidney disease.

Use in children and adolescents
Irbesartan TecniGen must not be given to children under 18 years of age. If a child accidentally ingests any tablets, contact a doctor immediately.

If you take more Irbesartan TecniGen than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan TecniGen
If you accidentally miss a dose, continue with your next dose as scheduled. Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Some of these side effects can be serious and may require medical attention.
As with similar medicines, rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you experience any of these symptoms or have difficulty breathing, stop taking Irbesartan TecniGen and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Not known: frequency cannot be estimated from the available data

Side effects reported in clinical studies in patients treated with irbesartan include:

Very common (may affect more than 1 in 10 people): if you have high blood pressure, type 2 diabetes and kidney disease, blood tests may show high levels of potassium.
Common (may affect up to 1 in 10 people): dizziness, feeling unwell/nausea, fatigue, and blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness upon standing from a lying or sitting position, low blood pressure upon standing from a lying or sitting position, joint or muscle pain, and decreased levels of a protein in red blood cells (haemoglobin) have also been reported.
Uncommon (may affect up to 1 in 100 people): increased heart rate, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems related to sexual performance), chest pain.

Additional side effects have been reported since the marketing of Irbesartan.
Side effects with frequency not known are: sensation of dizziness, headache, taste disturbances, ringing in the ears, muscle cramps, joint and muscle pain, abnormal liver function, increased potassium levels in the blood, kidney function disturbances, and inflammation of the small blood vessels, particularly affecting the skin (a condition known as leukocytoclastic vasculitis). Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Irbesartan TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What Irbesartan TecniGen contains
The active substance is irbesartan.
Each tablet contains 300 mg of irbesartan.
The excipients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose,
hypromellose, anhydrous colloidal silicon dioxide, magnesium stearate, titanium dioxide (E171) and polyethylene glycol 3350.
Description of the appearance of Irbesartan TecniGen and the contents of the pack
Irbesartan TecniGen 300 mg film-coated tablets are white, oblong and biconvex.
Irbesartan TecniGen 300 mg film-coated tablets are available in packs of 14, 28, 30, 56 and 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
TECNIGEN S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Manufacturer
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora, Portugal
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2; Abrunheira, 2710-089 Sintra, Portugal
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: Irbesartan Tecnimede 300 mg Filmtabletten
France: Irbesartan Tecnimede 300 mg comprimé pellicullé
Greece: Irbesartan Tecnimede 300 mg Επικαλυμμένα με λεπτό υμένιο δισκία
Italy: Irbesartan TecniGen 300 mg compresse rivestite con film
Portugal: Irbesartan Tecnimede
United Kingdom: Irbesartan