IRBESARTAN 150 mg Coated Tablets

Зміст інструкції

1. Irbesartan Aurobindo 150 mg tablets, 300 mg tablets
   1. What is Irbesartan Aurobindo 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. Package Contents and Other Information

Irbesartan Aurobindo 150 mg tablets, 300 mg tablets

Generic medicine

Read this leaflet carefully before you start 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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same
symptoms as you, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What is Irbesartan Aurobindo and what it is used for
• 2. What you need to know before you take 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 it is used for

Irbesartan Aurobindo belongs to a group of medicines known as Angiotensin II Receptor Blockers. Angiotensin II is a substance produced by the body that binds to receptors in blood vessels causing them to narrow. This causes an increase in blood pressure.
Irbesartan prevents the binding of angiotensin II to these receptors, causing relaxation of the blood vessels and lowering blood pressure. Irbesartan Aurobindo slows the decline in kidney 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)
• for the protection of the kidneys in patients with high blood pressure, type 2 diabetes and evidence of kidney impairment documented with laboratory data.

2. What you need to know before taking Irbesartan Aurobindo

Do not take Irbesartan Aurobindo:

• if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant for more than 3 months (it is also best to avoid Irbesartan Aurobindo even at the beginning of pregnancy - see the section on Pregnancy).
• If you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure containing aliskiren.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Irbesartan Aurobindo and if any of the following applies to you:

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

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (for example potassium) in your blood at regular intervals.
See also what is stated under “Do not take Irbesartan Aurobindo”.
You must inform your doctor if you think you are (or might be) pregnant. Irbesartan Aurobindo is not
recommended in the early stages of pregnancy and must not be taken if you are pregnant for more than 3 months because
it can cause serious harm to the baby if used during this phase (see the section on pregnancy).

Children and adolescents
This medicine should not be used in children and adolescents as 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 need to adjust your dose and/or take other precautions.
If you are taking an ACE inhibitor or aliskiren (see also what is stated under “Do not take
Irbesartan Aurobindo” and “Warnings and precautions”).

You may need to have blood tests if you take:

• potassium supplements
• blood substitutes containing potassium
• potassium-sparing medicines (such as some diuretics)
• medicines containing lithium

If you take some painkillers called non-steroidal anti-inflammatory drugs, the effect of irbesartan may
be reduced.

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

Pregnancy, breastfeeding and fertility
Pregnancy
You must tell your doctor if you think you are (or might be) pregnant. Your doctor will normally advise you to stop taking Irbesartan Aurobindo before becoming pregnant or as soon as you know you are
pregnant and will advise you to take another medicine instead of Irbesartan Aurobindo. Irbesartan Aurobindo
is not recommended in the early stages of pregnancy and must not be taken if you are pregnant for more than 3
months because it can cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Irbesartan Aurobindo is not recommended
to mothers who are breastfeeding and your doctor may choose another treatment if you wish to breastfeed,
especially if the baby is a newborn or was born prematurely.

Driving and using machines
Studies have not been performed on the effects on the ability to drive and use machines. It is unlikely that
Irbesartan Aurobindo will affect your ability to drive and use machines. However, dizziness and fatigue may
occasionally occur during treatment for high blood pressure. If these symptoms occur, you should consult your doctor before trying to drive or use machines.

3. How to take Irbesartan Aurobindo

Take this medicine following exactly the instructions of your doctor. If you have any doubts, 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 can 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 until your
doctor tells you to do otherwise.

Patients with high blood pressure
The usual dose is 150 mg once a day. The dose may be increased to 300 mg once a day
depending on the 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 a day is the preferred
maintenance dose for the treatment of associated kidney disease.
The doctor may recommend a lower dose, particularly when starting treatment in some patients
such as those on hemodialysisor those over 75 years of age.
The maximum antihypertensive effect should be reached within 4-6 weeks of 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 should 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 have accidentally forgotten to take a daily dose, take the next one as normal.
Do not take a double dose to make up for a missed dose.
If you have any doubts 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 require medical attention.
As with other similar medicines, rare cases of skin allergic reactions (rashes, hives) and also localised 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 has been 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
The side effects reported in clinical studies for patients treated with irbesartan were:
Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2
diabetes with kidney disease, blood tests may show an increase in potassium levels.
Common (may affect up to 1 in 10 people): dizziness, feeling unwell/vomiting, fatigue and blood tests may show increased levels of an enzyme that measures the function of the muscles
and heart (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with
kidney disease, dizziness has been reported when getting up from a lying or sitting position, low blood
pressure when getting up from a lying or sitting position, joint or muscle pain and
reduced levels of a protein in red blood cells (haemoglobin).
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 the marketing of Irbesartan. The side effects
for which the frequency is not known are: feeling of spinning, headache, altered taste, ringing
in the ears, muscle cramps, joint and muscle pain, abnormal liver function,
increased potassium levels in the blood, impaired kidney function, inflammation of the capillaries
mainly those of the skin (a condition known as leucocytoclastic 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 get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
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 which is stated on the carton and blister, after “EXP”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 ingredient is irbesartan. Each tablet contains 150 mg of irbesartan. Each tablet contains 300 mg of irbesartan.

The other ingredients are: microcrystalline cellulose (E460), dihydrate calcium hydrogen phosphate, 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, imprinted 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, imprinted with “H 30” on one
side and smooth on the other side.
Irbesartan Aurobindo tablets are available in transparent PVC/PVdC/aluminum blisters and in
opaque white HDPE bottles.
Pack sizes:
Blister packs: 28 tablets.
Bottle packs: 30 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following
names:
Italy Irbesartan Aurobindo
Netherlands Irbesartan Aurobindo 150 mg/ 300 mg, tablets