IRBESARTAN AUROBINDO

Package leaflet: Information for the user

Irbesartan Aurobindo 150 mg tablets, 300 mg 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:

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

1. What is Irbesartan Aurobindo and what is it used for?

Irbesartan Aurobindo 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 narrow. This leads to an increase in blood pressure.
Irbesartan prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels and a reduction in blood pressure. Irbesartan Aurobindo slows the decline in renal function in patients with hypertension and type 2 diabetes.
Irbesartan Aurobindo is used in adult patients:

• for the treatment of high blood pressure (essential hypertension)
• to protect the kidneys in patients with high blood pressure, type 2 diabetes, and evidence of kidney impairment confirmed by laboratory tests.

2. What you need to know before taking Irbesartan Aurobindo

Do not take Irbesartan Aurobindo:

• if you are allergic 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 Irbesartan Aurobindo during early pregnancy – see the section on 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 Aurobindo and if any one
of the following applies to you:

• if you have excessive vomiting or diarrhoea
• if you have kidney problems
• if you have heart problems
• if you are being treated with Irbesartan Aurobindo for kidney disease due to diabetes. In this case, your doctor may carry out regular blood tests, particularly to monitor potassium levels in the blood in case of reduced kidney function
• if you are about to undergo surgery (a surgical procedure) or will be given an anaesthetic
• if you are taking any of the following medicines used to treat high blood pressure:
  – an ACE inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  – aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (for example potassium) at regular intervals.
See also the information under the heading "Do not take Irbesartan Aurobindo".
You must inform your doctor if you think you are (or might be) pregnant. Irbesartan Aurobindo is not recommended during early pregnancy and must not be taken after the third month of pregnancy because it may cause serious harm to the unborn baby if used during this period (see the section on Pregnancy).

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

Other medicines and Irbesartan Aurobindo
Tell 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 Aurobindo” and “Warnings and precautions”),
you may need to have blood tests if you are taking:

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

If you are taking certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), the effect of irbesartan may be reduced.

Irbesartan Aurobindo with food, drinks and alcohol
Irbesartan Aurobindo can be taken with or without food.

Pregnancy, breast-feeding and fertility
Pregnancy
Inform your doctor if you think you are (or might be) pregnant. Your doctor will normally advise you to stop taking Irbesartan Aurobindo before pregnancy or as soon as you know you are pregnant and will recommend an alternative treatment. Irbesartan Aurobindo 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 from the third month onwards.

Breast-feeding
Inform your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan Aurobindo is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been conducted. It is unlikely that Irbesartan Aurobindo affects your ability to drive and use machines. However, dizziness and fatigue may occasionally occur during treatment for high blood pressure. If you experience these symptoms, you should consult your doctor before attempting to drive or use machinery.

3. How to take Irbesartan Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your
doctor or pharmacist.
Method of administration
Irbesartan Aurobindo is for oral use. Swallow the tablets with a sufficient amount of liquid (e.g.
a glass of water). You may take Irbesartan Aurobindo with or without food. Try to take your daily dose at the same time each day. It is important that you continue to take Irbesartan Aurobindo unless your doctor tells you otherwise.
Patients with high blood pressure
The usual dose is 150 mg once daily. The dose may be increased to 300 mg once daily depending on your blood pressure response.
Patients with high blood pressure and type 2 diabetes with kidney disease
In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease.
Your doctor may recommend a lower dose, particularly when starting treatment in certain patients such as those undergoing haemodialysis or those over 75 years of age.
Maximum antihypertensive effect should be achieved within 4–6 weeks after starting treatment.
If you take more Irbesartan Aurobindo than you should
If you have accidentally taken too many tablets, contact your doctor immediately.
Use in children and adolescents
Irbesartan Aurobindo must not be given to children under 18 years of age. If a child swallows any tablets, contact your doctor immediately.
If you forget to take Irbesartan Aurobindo
If you accidentally miss a daily dose, take your next dose as usual.
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. Some of these side effects may be serious and require immediate medical attention.
As with other similar medicines, rare cases of skin allergic reactions (rashes, urticaria) and localized swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you develop any of these symptoms or shortness of breath, stop taking Irbesartan Aurobindo 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

Side effects reported in clinical studies for 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 increased 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 enzyme). 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 reduced levels of a protein in red blood cells (haemoglobin) have been reported.
Uncommon (may affect up to 1 in 100 people): increased heart rate, hot flushes, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some side effects have been reported after marketing of Irbesartan. The side effects for which frequency is not known are: sensation of spinning (vertigo), headache, taste disturbances, tinnitus, muscle cramps, joint and muscle pain, abnormal liver function, increased potassium levels in blood, impaired kidney function, inflammation of blood capillaries, mainly those in 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 Aurobindo

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 pack, after "EXP".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Irbesartan Aurobindo contains

• The active substance is irbesartan. Each tablet contains 150 mg of irbesartan. Each tablet contains 300 mg of irbesartan.

The other components are: microcrystalline cellulose (E460), calcium hydrogen phosphate dihydrate, sodium
starch glycolate (Type A), hypromellose (E464), polysorbate 80 (E433), talc (E553b), colloidal anhydrous
silica (E551), sodium stearyl fumarate.

Description of the appearance of Irbesartan Aurobindo and package contents
Tablet
Irbesartan Aurobindo 150 mg tablets
White to almost white, biconvex, oval-shaped, uncoated tablets, marked with "H 29" on one side and smooth on the other side.

Irbesartan Aurobindo 300 mg tablets
White to almost white, biconvex, oval-shaped, uncoated tablets, marked with "H 30" on one side and smooth on the other side.

Irbesartan Aurobindo tablets are available in transparent PVC/PVdC/aluminium blisters and in white opaque HDPE bottles.
Pack sizes:
Blister packs: 28 tablets.
Bottle packs: 30 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturers:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares, Odyssey Business Park, West End Road,
South Ruislip HA4 6QD
United Kingdom

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Irbesartan Aurobindo
Netherlands: Irbesartan Aurobindo 150 mg/300 mg, tabletten