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IRBESARTAN 75 MG FILM-COATED TABLETS

Active substance(s): IRBESARTAN / IRBESARTAN / IRBESARTAN

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Package leaflet: Information for the user
Irbesartan 75 mg film-coated tablets
irbesartan
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
If you get any side effects , talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Irbesartan is and what it is used for
2.
What you need to know before you take Irbesartan
3.
How to take Irbesartan
4.
Possible side effects
5.
How to store Irbesartan
6.
Contents of the pack and other information

1. What Irbesartan is and what it is used for
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists.
Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels
causing them to tighten. This results in an increase in blood pressure. Irbesartan prevents the
binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood
pressure to lower. Irbesartan slows the decrease of kidney function in patients with high blood
pressure and type 2 diabetes.
Irbesartan is used in adult patients
 to treat high blood pressure (essential hypertension)
 to protect the kidney in patients with high blood pressure, type 2 diabetes and
laboratory evidence of impaired kidney function.

2. What you need to know before you take Irbesartan
Do not take Irbesartan
 if you are allergic to irbesartan or any of the other ingredients of this medicine (listed
in section 6)
 if you are more than 3 months pregnant. (It is also better to avoid Irbesartan in
early pregnancy – see pregnancy section)
 if you have diabetes or impaired kidney function and you are treated with a blood
pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist before taking Irbesartan and if any of the following apply
to you:
 if you get excessive vomiting or diarrhoea
 if you suffer from kidney problems
 if you suffer from heart problems

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if you receive Irbesartan for diabetic kidney disease. In this case your doctor may
perform regular blood tests, especially for measuring blood potassium levels in case
of poor kidney function
if you are going to have an operation (surgery) or be given anaesthetics
if you are taking any of the following medicines used to treat high blood pressure:
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you
have diabetes-related kidney problems
- aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Irbesartan”.
You must tell your doctor if you think you are (or might become) pregnant. Irbesartan is not
recommended in early pregnancy, and must not be taken if you are more than 3 months
pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy
section).
Children and adolescents
This medicinal product should not be used in children and adolescents because the safety and
efficacy have not yet been fully established.
Other medicines and Irbesartan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Your doctor may need to change your dose and/or to take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do
not take Irbesartan” and “Warnings and precautions”).
You may need to have blood checks if you take:
 potassium supplements
 salt substitutes containing potassium
 potassium-sparing medicines (such as certain diuretics)
 medicines containing lithium
If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of
irbesartan may be reduced.
Irbesartan with food and drink
Irbesartan can be taken with or without food.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will
normally advise you to stop taking Irbesartan before you become pregnant or as soon as you
know you are pregnant and will advise you to take another medicine instead of Irbesartan.
Irbesartan is not recommended in early pregnancy, and must not be taken when more than 3
months pregnant, as it may cause serious harm to your baby if used after the third month of
pregnancy.
Breast-feeding

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Tell your doctor if you are breast-feeding or about to start breast-feeding. Irbesartan is not
recommended for mothers who are breast-feeding, and your doctor may choose another
treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born
prematurely.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Irbesartan is unlikely to affect your ability to drive or use machines. However, occasionally
dizziness or weariness may occur during treatment of high blood pressure. If you experience
these, talk to your doctor before attempting to drive or use machines.
Irbesartan contains lactose. If you have been told by your doctor that you have an
intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

3.

How to take Irbesartan

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Method of administration
Irbesartan is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass
of water). You can take Irbesartan with or without food. Try to take your daily dose at about
the same time each day. It is important that you continue to take Irbesartan until your doctor
tells you otherwise.




Patients with high blood pressure
The usual dose is 150 mg once a day (two tablets a day). The dose may later be
increased to 300 mg (four tablets a day) once daily depending on 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 (four tablets a day)
once daily is the preferred maintenance dose for the treatment of associated kidney
disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients
such as those on haemodialysis, or those over the age of 75 years.
The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning
treatment.
Use in children and adolescents
Irbesartan should not be given to children under 18 years of age. If a child swallows some
tablets, contact your doctor immediately.
If you take more Irbesartan than you should
If you accidentally take too many tablets, contact your doctor immediately.
If you forget to take Irbesartan
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double
dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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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 allergic skin reactions (rash, urticaria), as well as
localized swelling of the face, lips and/or tongue have been reported in patients taking
irbesartan. If you get any of these symptoms or get short of breath, stop taking Irbesartan
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 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 increased
level of potassium.


Common (may affect up to 1 in 10 people): dizziness, feeling sick/vomiting, fatigue
and blood tests may show raised levels of an enzyme that measures the muscle and
heart function (creatine kinase enzyme). In patients with high blood pressure and type
2 diabetes with kidney disease, dizziness when getting up from a lying or sitting
position, low blood pressure when getting up from a lying or sitting position, pain in
joints or muscles and decreased levels of a protein in the red blood cells
(haemoglobin) were also reported.



Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough,
diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual
performance), chest pain.

Some undesirable effects have been reported since marketing of irbesartan. Undesirable
effects where the frequency is not known are: feeling of spinning, headache, taste disturbance,
ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of platelets,
abnormal liver function, increased blood potassium levels, impaired kidney function, 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.

5.

How to store Irbesartan

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 on the blister
after EXP. The expiry date refers to the last day of that month.

4

This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6.

Contents of the pack and other information

What Irbesartan contains
 The active substance is irbesartan. Each tablet of Irbesartan 75 mg contains 75 mg
irbesartan.
 The other ingredients are lactose monohydrate, croscarmellose sodium, Povidone K30, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide (E171).
What Irbesartan looks like and contents of the pack
Irbesartan 75 mg film-coated tablets are white to off white, oval shaped, biconvex, film
coated tablets, debossed with “L172” on one side and “75” on other side.
Irbesartan 75 mg film-coated tablets are supplied in cartons with blister of Aluminium foil
and white Opaque PVC/PVdC film of 10 and 14 tablets.
Pack sizes:
14, 28, 30, 56, 84, 90 and 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fair-Med Healthcare GmbH
Planckstrasse 13
22765 Hamburg
Germany
Manufacturer
Fair-Med Healthcare GmbH
Industriestr. 32
23843 Bad Oldesloe
Germany
This medicinal product is authorised in the Member States of the EEA under the
following names:
Germany
Malta
United Kingdom

Irbesartan Fair-Med 75mg, 150mg, 300mg Filmtabletten
Irbesartan Fair-Med 75mg, 150mg, 300mg film-coated tablets
Irbesartan 75mg, 150mg, 300mg film-coated tablets

This leaflet was last revised in January 2017.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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