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IRBESARTAN/HYDROCHLOROTHIAZIDE MYLAN 300 MG/25 MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / IRBESARTAN

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Package leaflet: Information for the patient

Irbesartan/Hydrochlorothiazide
150 mg/12.5 mg tablets
Irbesartan/Hydrochlorothiazide
300 mg/12.5 mg tablets
Irbesartan/Hydrochlorothiazide
300 mg/25 mg tablets
(irbesartan/hydrochlorothiazide)
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/Hydrochlorothiazide is and what
it is used for
2. What you need to know before you take
Irbesartan/Hydrochlorothiazide
3. How to take Irbesartan/Hydrochlorothiazide
4. Possible side effects
5. How to store Irbesartan/Hydrochlorothiazide
6. Contents of the pack and other information

1. What Irbesartan/Hydrochlorothiazide
is and what it is used for
Irbesartan/Hydrochlorothiazide is a combination
of two active substances, irbesartan and
hydrochlorothiazide.
Irbesartan belongs to a group of medicines known as
angiotensin-II receptor antagonists.
Angiotensin-II is a substance produced in the body
that 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.
Hydrochlorothiazide is one of a group of medicines
(called thiazide diuretics) that causes increased urine
output and so causes a lowering of blood pressure.
The two active ingredients in Irbesartan/
Hydrochlorothiazide work together to lower blood
pressure further than if either was given alone.
Irbesartan/Hydrochlorothiazide is used to treat
high blood pressure, when treatment with irbesartan
or hydrochlorothiazide alone did not provide
adequate control of your blood pressure.

2. What you need to know before you
take Irbesartan/Hydrochlorothiazide
Do not take Irbesartan/Hydrochlorothiazide:
• if you are allergic to irbesartan or any of the other
ingredients of this medicine (listed in section 6)
• if you are allergic to hydrochlorothiazide or any
other sulfonamide-derived medicines
• if you are more than 3 months pregnant (it is also
better to avoid Irbesartan/Hydrochlorothiazide in
early pregnancy – see pregnancy section)
• if you have severe liver or kidney problems
• if your doctor determines that you have
persistently high calcium or low potassium levels
in your blood
• if you have diabetes mellitus or impaired kidney
function and you are treated with a blood lowering
medicine called aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Irbesartan/Hydrochlorothiazide and if any of the
following apply to you:
• if you get excessive vomiting or diarrhoea
• if you suffer from kidney problems, including
narrowing of the kidney artery or have had a
kidney transplant
• if you suffer from heart problems, including a
narrowing of the valves in the heart, an enlarged
heart muscle or a weakness of the heart muscle
(heart failure)
• if you have a narrowing of the heart blood vessels,
which may cause chest pain e.g. angina
• if you suffer from other liver problems
• if you suffer from diabetes
• if you suffer from lupus erythematosus (also known
as lupus or SLE)
• if you have a history of allergies or asthma
• if you suffer from primary aldosteronism (a
condition related to high production of the
hormone aldosterone, which causes sodium
retention and, in turn, an increase in blood pressure)
• if you are on a low-salt diet
• you are taking diuretics (water tablets)
• 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/Hydrochlorothiazide”
You must tell your doctor if you think you
are (or might become) pregnant. Irbesartan/
Hydrochlorothiazide 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).

During treatment
You should also tell your doctor:
• if you have signs such as abnormal thirst,
dry mouth, general weakness, drowsiness,
muscle pain or cramps, nausea, vomiting, or an
abnormally fast heart beat which may indicate an
excessive effect of hydrochlorothiazide (contained
in Irbesartan/Hydrochlorothiazide)
• if you experience an increased sensitivity of the
skin to the sun with symptoms of sunburn (such as
redness, itching, swelling, blistering) occurring more
quickly than normal
• if you are going to have an operation (surgery) or
be given anaesthetics
• if you have changes in your vision or pain in one
or both of your eyes while taking Irbesartan/
Hydrochlorothiazide. This could be a sign that you
are developing glaucoma, increased pressure in
your eye(s). You should discontinue Irbesartan/
Hydrochlorothiazide treatment and seek
medical attention.
• If you need to have a blood test to check how the
parathyroid (a gland which helps maintain calcium
levels) is working, tell the doctor or hospital staff
you are taking this medicine.
The hydrochlorothiazide contained in this medicine
could produce a positive result in an anti-doping test.

Children and adolescents
Irbesartan/Hydrochlorothiazide should not be given
to children and adolescents (under 18 years).

Other medicines and Irbesartan/
Hydrochlorothiazide
Tell your doctor or pharmacist if you are taking, have
recently taken, or might take any other medicines.
Diuretic agents such as the hydrochlorothiazide
contained in Irbesartan/Hydrochlorothiazide may
have an effect on other medicines.
Preparations containing lithium (used to treat
mental health problems) should not be taken with
Irbesartan/Hydrochlorothiazide without close
supervision by your doctor.
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/Hydrochlorothizide” and “Warnings
and precautions”).
You may need to have blood checks if you take:
• potassium supplements
• salt substitutes containing potassium
• potassium sparing medicines or other diuretics
(water tablets)
• some laxatives
• medicines for the treatment of gout e.g.probenecid,
sulfinpyrazone
• therapeutic vitamin D or calcium supplements
• medicines to control heart rhythm e.g. digoxin
• medicines for diabetes (oral agents or insulins)
• carbamazepine (a medicine for the treatment
of epilepsy)
• amphotericin (a medicine used to treat
fungal infections)
• penicillin G-sodium (an antibiotic used to treat
bacterial infections).
• carbenoxolone (used for stomach and mouth ulcers)
• medicines that may increase levels of potassium in
your blood e.g. heparin (used to prevent blood clots)
It is also important to tell your doctor if you are
taking other medicines to reduce your blood
pressure, steroids, medicines to treat cancer e.g.
cyclophosphamide, methotrexate, pain killers known
as NSAIDs or ‘COX-2’ inhibitors e.g. celecoxib or
acetylsalicylic acid, amantadine (a medicine used to
treat Parkinsons disease or influenza), allopurinol for
gout, medicines that effect stomach emptying e.g.
atropine, biperiden or colestyramine and colestipol
resins for lowering blood cholesterol.

Irbesartan/Hydrochlorothiazide with alcohol
Due to the hydrochlorothiazide contained in
Irbesartan/Hydrochlorothiazide, if you drink alcohol
while on treatment with this medicine, you may have
an increased feeling of dizziness on standing up,
especially when getting up from a sitting position.

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/
Hydrochlorothiazide before you become pregnant or
as soon as you know you are pregnant and will advise
you to take another medicine instead of Irbesartan/
Hydrochlorothiazide. Irbesartan/Hydrochlorothiazide
is not recommended during 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 breast-feeding. Irbesartan/Hydrochlorothiazide
is not recommended for mothers who are
breast-feeding, and your doctor may choose
another treatment for you if you wish to breastfeed, 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/
Hydrochlorothiazide 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/Hydrochlorothiazide 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.

50060021

Irbesartan Hydrochlorothiazide 300 mg / 12.5 mg,
Description 150 mg / 12.5 mg,300 mg / 25 mg 28
Component Type Leaflet
Affiliate Item Code 686380
Superceded Affiliate Item Code 442867
TrackWise PR No. 686380
MA No.

04569/1292,
04569/1293,
04569/1294

Packing Site/Printer NA
Supplier Code 50060021

Pharma Code 4148
SAP No. NA
Vendor Job No. 260142
Trackwise Proof No. 4
Glams Proof No. 1
Client Market UK
Keyline/Drawing No. NA
Barcode Info NA

Date: 30 Nov 2015
No. of colours
Colours

1

Time: 11:47
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

3. How to take Irbesartan/
Hydrochlorothiazide
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Dosage
The recommended dose of Irbesartan/
Hydrochlorothiazide is one tablet a day. Irbesartan/
Hydrochlorothiazide will usually be prescribed by
your doctor when your previous treatment did not
reduce your blood pressure enough. Your doctor
will instruct you how to switch from the previous
treatment to Irbesartan/Hydrochlorothiazide.

Not known (frequency cannot be estimated from
the available data):
• headache
• ringing in the ears
• cough
• taste disturbance, indigestion
• pain in joints and muscles
• blood tests may show that the liver is not
working properly
• blood tests may show increased level of potassium
in your blood.
As for any combination of two active substances, side
effects associated with each individual component
cannot be excluded.

Side effects associated with irbesartan alone

Method of administration
Irbesartan/Hydrochlorothiazide is for oral use.
Swallow the tablets with a sufficient amount of fluid
(e.g. one glass of water). You can take Irbesartan/
Hydrochlorothiazide 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/Hydrochlorothiazide until your doctor tells
you otherwise.
The maximal blood pressure lowering effect should
be reached 6-8 weeks after beginning treatment.

If you take more Irbesartan/Hydrochlorothiazide
than you should
If you accidentally take too many tablets, contact
your doctor immediately. You may feel dizzy, weak,
feel your heart beating faster or slower, sick and
sleepy or drowsy.

Children should not take Irbesartan/
Hydrochlorothiazide
Irbesartan/Hydrochlorothiazide should not be given
to children under 18 years of age. If a child swallows
some tablets, contact your doctor immediately.

If you forget to take Irbesartan/
Hydrochlorothiazide
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. 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. If you notice any of the
following side effects, stop taking Irbesartan/
Hydrochlorothiazide and contact your doctor or
go to the nearest hospital casualty department
straight away:
Uncommon (may affect up to 1 in 100 people):
• yellowing of the skin and whites of the eyes
Not known (frequency cannot be estimated from
the available data):
• rare cases of allergic skin reactions (rash, urticaria),
as well as localised swelling of the face, lips and/or
tongue and difficulty breathing.
• heart beat is faster and uneven or feeling of skipped
heart beat (palpitations), pounding in chest, feeling
faint and dizzy, which may be caused by problems
with the heart rhythm. This can be detected by ECG
(a test used to show how the heart is beating).
• an increase in number of infections that you get e.g.
sore throat, mouth ulcers, or looking pale, feeling
tired, breathless, especially after exercise, bruising
or bleeding more easily, which may be due to a
reduction in the number or type of blood cells in
the blood. This may be caused by a problem with
the bone marrow (where blood cells are produced).
• paleness, feeling tired or breathless, which may be
caused by the breakdown of red blood cells.
• sudden pain in one eye with decreased or cloudy
vision, rainbow-like halos around lights.
• pain and difficulty when breathing, fever, chest
pain and cough, caused by fluid on the lungs
(pulmonary oedema).
• passing water more often, in greater amounts which
is pale in colour, or straining or being unable to pass
water or less often, which may be darker in colour or
may be bloody. This may be due to problems with
the kidneys.
• severe upper stomach pain and feeling and being
sick, which may be due to liver problems.
• rash with raised purple spots and flat red areas caused
by inflammation of the blood vessels (vasculitis).
• a serious allergic skin reaction, which includes rash
with flat red areas, blistering and large areas of
peeling skin all over the body.
• cutaneous lupus erythematosus - you may notice a
rash that may appear on the face, neck and scalp.
• increased sensitivity of the skin to the sun.
• inflammation of the pancreas - you may have severe
stomach pain that radiates round to the back and
feeling or being sick.

Other possible side effects

In addition to the side effects listed above, chest pain
has also been reported.

Side effects associated with hydrochlorothiazide
alone
Not known (frequency cannot be estimated from
the available data):
• Loss of appetite
• stomach irritation, stomach cramps, constipation
• sleep disorders
• depression
• blurred vision, colour vision affected with objects
appearing more yellow than they are (xanthopsia),
short-sightedness (acute myopia)
• fever
• weakness and muscle spasm
• tingling, pricking or burning feelings of skin “pins
and needles” (paresthesia)
• restlessness, light-headedness
• reduced blood pressure after a change in
body position
• swelling of the salivary glands
• high sugar levels in the blood
• sugar in the urine
• increases in some kinds of blood fat; high uric acid
levels in the blood, which may cause gout.
It is known that side effects associated with
hydrochlorothiazide may increase with higher doses
of hydrochlorothiazide.

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/
Hydrochlorothiazide
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, label or blister after EXP. The
expiry date refers to the last day of that month.
The in-use shelf-life of the product when stored in
bottles is 90 days once opened.
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/Hydrochlorothiazide contains
• The active substances are irbesartan and
hydrochlorothiazide.
Each 150 mg/12.5 mg tablet contains 150 mg of
irbesartan and 12.5 mg of hydrochlorothiazide.
Each 300 mg/12.5 mg tablet contains 300 mg of
irbesartan and 12.5 mg of hydrochlorothiazide.
Each 300 mg/25 mg tablet contains 300 mg of
irbesartan and 25 mg of hydrochlorothiazide.
• The other ingredients are: cellulose microcrystalline
(E460), silica, colloidal anhydrous, sodium
laurilsulfate, pregelatinised starch (maize),
magnesium stearate (E470b), povidone (K-90),
lactose monohydrate, croscarmellose sodium,
quinoline yellow (E104) and iron oxide red (E172).

What Irbesartan/Hydrochlorothiazide looks like
and contents of the pack
Irbesartan/Hydrochlorothiazide 150 mg/12.5 mg
tablets are peach, oval, biconvex tablets debossed
with “M” on one side of the tablet and “I33” on the
other side
Irbesartan/Hydrochlorothiazide 300 mg/12.5 mg
tablets are peach, oval, biconvex tablets debossed
with “M” on one side of the tablet and “I34” on the
other side.

Side effects reported in clinical studies for patients
treated with irbesartan/hydrochlorothiazide
combination tablets were:

Irbesartan/Hydrochlorothiazide 300 mg/25 mg tablets
are pink, oval, biconvex tablets debossed with “M” on
one side of the tablet and “I35” on the other side.

Common (may affect up to in 10 people):
• feeling sick/being sick (nausea/vomiting)
• feeling tired (fatigue)
• dizziness
• blood tests may show raised levels of an enzyme
that measures how the muscles and heart are
working (creatine kinase) or raised levels of
substances that measure how the kidney is working
(blood urea nitrogen, creatinine).

Irbesartan/Hydrochlorothiazide is available in blisters
of 14, 28, 30, 56, 90, 98, 100 tablets, blister unit-dose
of 56 x 1 tablets, calendar pack of 28 tablets and in
bottles of 500 tablets.

Uncommon (may affect up to 1 in 100 people):
• diarrhoea
• low blood pressure
• fainting
• heart rate increased
• flushing
• swelling
• sexual dysfunction (problems with sexual performance)
• blood tests may show lowered levels of potassium
and sodium in your blood
• feeling dizzy after getting up from a lying or
sitting position

Irbesartan Hydrochlorothiazide 300 mg / 12.5 mg,
Description 150 mg / 12.5 mg,300 mg / 25 mg 28
Component Type Leaflet
Affiliate Item Code 686380
Superceded Affiliate Item Code 442867
TrackWise PR No. 686380
MA No.

04569/1292,
04569/1293,
04569/1294

Packing Site/Printer NA
Supplier Code 50060021

Pharma Code 4148
SAP No. NA
Vendor Job No. 260142
Trackwise Proof No. 4
Glams Proof No. 1
Client Market UK
Keyline/Drawing No. NA
Barcode Info NA

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer:
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1,
Hungary.
Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
This leaflet was last revised in 11/2015.

Date: 30 Nov 2015
No. of colours
Colours

1

686380
50060021

Time: 11:47
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 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.

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