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IRBESARTAN SANDOZ 300MG FILM-COATED TABLETS

Active substance(s): IRBESARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Irbesartan Sandoz 75 mg film-coated tablets
Irbesartan Sandoz 150 mg film-coated tablets
Irbesartan Sandoz 300 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 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.
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

been fully established.

What Irbesartan is and what it is used for

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

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.

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 tablets are 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

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

What you need to know before you take
Irbesartan

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.

Do NOT take Irbesartan if you:
• are allergic to irbesartan or any of the 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 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
• 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 aliskiren.
• 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.
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).

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 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

Children and adolescents
This medicinal product should not be used in children and
adolescents because the safety and efficacy have not yet

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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.

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at about the same time each day. It is important that you
continue to take Irbesartan until your doctor tells you otherwise.

5

Patients with high blood pressure:
The usual dose is 150 mg once a day. The dose may later be
increased to 300 mg once daily depending on blood pressure
response.

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 outer carton, the blister and bottle after EXP.
The expiry date refers to the last day of that month.

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.

Do not store above 30°C.

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.

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.

After first opening the bottles: 3 months.

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

6

Use in children and adolescents
Irbesartan should not be given to children and
adolescents under 18 years of age. If a child swallows
some tablets, contact your doctor immediately.

What Irbesartan contains
- The active substance is Irbesartan. Each tablet contains
75, 150 or 300 mg irbesartan.

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

- The other ingredients are:
Tablet core:
Microcrystalline cellulose
Lactose monohydrate
Croscarmellose sodium
Silica, colloidal anhydrous
Hypromellose
Magnesium stearate.

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.

4

Contents of the pack and other
information

Tablet coating:
Hypromellose
Hydroxypropylcellulose
Macrogol 6000
Lactose monohydrate
Titanium dioxide (E 171)
Talc.

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.

What Irbesartan looks like and contents of the pack

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.

Irbesartan 75 mg film- coated tablets are white, oval
biconvex film- coated tablets, debossed with ‘75’ on one
side and scored on the other side.
The scoreline is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.
Irbesartan 150 mg film- coated tablets are white, oval
biconvex film- coated tablets, debossed with ‘150’ on one
side and scored on the other side.
The scoreline is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.

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.

Irbesartan 300 mg film- coated tablets are white, oval
biconvex film- coated tablets, debossed with ‘300’ on one
side and scored on the other side.
The scoreline is only to facilitate breaking for ease of
swallowing and not to divide into equal doses.

• 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.

Irbesartan is available in blister (oPA/Al/PVC//Al or
PVC/PVDC//Al) or in bottle (high density polyethylene
(HDPE) container).
oPA/Al/PVC//Al or PVC/PVDC//Al blisters: 7, 10, 14, 20, 28,
30, 56, 60, 84, 90, 98, 100 film- coated tablets.
oPA/Al/PVC//Al or PVC/PVDC//Al unit dose blisters: 56x1,
100x1 film- coated tablets.

• 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.

HDPE bottle: 100, 250 film- coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

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.

Sandoz Limited, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR.
United Kingdom
Manufacturer:
Lek Pharmaceuticals d.d., Verovškova 57
1526 Ljubljana, Slovenia. or Lek S.A., ul. Domaniewska 50C
02-672 Warsaw, Poland. or Salutas Pharma GmbH, Otto
von Guericke Allee 1, 39179 Barleben, Germany. or
Salutas Pharma GmbH, Dieselstrasse 5, D-70839
Gerlingen, Germany. or Lek Pharmaceuticals d.d.,
Trimlini 2D, 9220 Lendava, Slovenia

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: www.mhra.gov.uk/yellowcard By reporting side
affects you can help provide more information on the safety
of this medicine.

This leaflet was last revised in 09/2015

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Artwork Proof Box
Ref: R001: Renewal + V012
Proof no.
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Date prepared:
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Colours:
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Black 20%
Dimensions: 165 x 310 mm

Font size:
7.5pt
Fonts:
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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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