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IRBESARTAN 75 MG FILM-COATED TABLETS

Active substance(s): IRBESARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.
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.

Irbesartan 75 mg Film-coated Tablets
Irbesartan 150 mg Film-coated Tablets
Irbesartan 300 mg Film-coated Tablets

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.

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 or pharmacist.
- 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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.

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 localised 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.

1. WHAT IRBESARTAN IS AND WHAT IT IS USED FOR

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.

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)
- protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.

Side effects reported in clinical studies for patients treated with Irbesartan were:
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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.

Do not take Irbesartan if you
- are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)
- are more than 3 months pregnant. (It is also better to avoid Irbesartan in early pregnancy – see pregnancy section)
- if you have diabetes mellitus or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

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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.

Warnings and precautions
Talk to your doctor before taking Irbesartan and if any of the following apply to you:
- if you get excessive vomiting or diarrhea
- if you suffer from kidney problems
- if you suffer from heart problems
- 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:
o
an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
o
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”.

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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.

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).

This medicinal product does not require any special storage conditions.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRBESARTAN

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, 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 Irbesartan 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.

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.

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.

Other medicines and Irbesartan

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

What Irbesartan contains
- The active substance is irbesartan. Each film-coated tablet contains 75/150/300 mg of irbesartan.
- The other ingredients are lactose monohydrate, croscarmellose sodium, povidone K-30, magnesium stearate, hypromellose 5 cP, macrogol 4000 and titanium
dioxide (E171).

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.

What Irbesartan looks like and contents of the pack
Irbesartan 75 mg Film-coated Tablets:
White to off-white, oval-shaped, biconvex film-coated tablets debossed with “L172” on one side and “75” on the other side.
Irbesartan 150 mg Film-coated Tablets:
White to off-white, oval-shaped, biconvex film-coated tablets debossed with “L173” on one side and “150” on the other side.

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.

Irbesartan 300 mg Film-coated Tablets:
White to off-white, oval-shaped, biconvex film-coated tablets debossed with “L174” on one side and “300” on the other side.
Pack sizes: 28 film-coated tablets

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.

Marketing Authorisation Holder and Manufacturer
Torrent Pharma GmbH
Südwestpark 50, 90449 Nürnberg
Germany

Breast-feeding
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.

This medicinal product is authorised in the Member States of the EEA under the following names:
The Netherlands: Irbesartan Torrent 75/150/300 mg filmomhulde tabletten
Germany: Irbesartan Heumann 75/150/300 mg Filmtabletten
United Kingdom: Irbesartan 75/150/300 mg Film-coated Tablets

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.

This leaflet was last approved in 12/2015.

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 medicinal product.
3. HOW TO TAKE IRBESARTAN
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Patients with high blood pressure
The recommended dose is 150 mg once a day. The dose may later be increased to 300 mg 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 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.
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PRODUCT NAME

:

Irbesartan

COUNTRY : UK

LOCATION : Indrad

ITEM / PACK

:

Leaflet

NO. OF COLORS: 1

REMARK : Folding Length 35 mm

DESIGN STYLE

:

Front/Back

PANTONE SHADE NOS.:

SUBSTRATE :

CODE

:

xxxxxxx-xxxx

Activities

DIMENSIONS (MM)

:

180 x 340

Prepared By Pkg.Dev

THERAPEUTIC RANGE :

-

ART WORK SIZE

:

S/S

DATE

:

04-12-2015

Black

Reviewed By

Department

Supersedes A/W No. :

Name

Signature

Pkg.Dev
RA

Approved By CQA

This colour proof is not colour binding. Follow Pantone shade reference for actual colour matching.

Date

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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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