Skip to Content

UK Edition. Click here for US version.

IRBESARTAN MILPHARM 75 MG TABLETS

Active substance(s): IRBESARTAN

View full screen / Print PDF » Download PDF ⇩
Transcript
Irbesartan 75 mg tablets
Irbesartan 150 mg tablets
Irbesartan 300 mg 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. 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 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

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 Irebesartan”.
You must tell your doctor if you think you are (or might become)
pregnant. Irbesartan is not recommended in early pregnancy, and

Black

P150

P150

Irbesartan

Package leaflet: Information for the user

Irbesartan

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

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
Tell your doctor if you are breast-feeding or about to start breastfeeding. 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
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 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 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.

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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

By reporting side effects you can help provide more information on
the safety of this medicine.

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

5. How to store Irbesartan
Keep this medicine out of the sight and reach of children.

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.

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.

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.

This medicinal product does not require any special storage
conditions

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.
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, 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 or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

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 contains 75 mg of irbesartan.
Each tablet contains 150 mg of irbesartan.
Each tablet contains 300 mg of irbesartan.



The other ingredients are: Microcrystalline cellulose 101,
calcium hydrogen phosphate dihydrate, sodium starch
glycolate (Type A), hypromellose (5cp), polysorbate 80, talc,
silica colloidal anhydrous, sodium stearyl fumarate.

What Irbesartan looks like and contents of the pack
Tablet.
Irbesartan 75 mg tablets:
White to off-white, biconvex oval shaped uncoated tablets
debossed with ‘H 28’ on one side and plain on other side.
Irbesartan 150 mg tablets:
White to off-white, biconvex oval shaped uncoated tablets
debossed with ‘H 29’ on one side and plain on other side.
Irbesartan 300 mg tablets:
White to off-white, biconvex oval shaped uncoated tablets
debossed with ‘H 30’ on one side and plain on other side.
Irbesartan is available in PVC / PVdC-Aluminium and bottles of
high density polyethylene (HDPE):
Presentations:
Blisters: 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets
Bottles of high density polyethylene (HDPE): 30 and 500 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
UK - Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
MT - Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana FRN 1913
Malta
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This leaflet was last revised in 03/2015.

Expand view ⇕

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.

Hide