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IRBESARTAN/HYDROCHLOROTHIAZIDE MYLAN 150 MG/12.5 MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / IRBESARTAN / 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
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 diabetesrelated 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 breastfeeding, 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/
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.

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.
50061965

Irbesartan Hydrochlorothiazide 300 mg / 12.5 mg,

Description 150 mg / 12.5 mg,300 mg / 25 mg 28
Component Type Leaflet
Affiliate Item Code 968565
Superceded Affiliate Item Code 686380
TrackWise PR No. 968565
MA No.

04569/1292, 04569/1293,
04569/1294

Packing Site/Printer N/A
Supplier Code 50061965

Pharma Code 4945
SAP No. N/A
Vendor Job No. 288657
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 12 AUG 2016
No. of colours
Colours

1

Time: 10:02
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

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.

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.






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
Uncommon (may affect up to 1 in 100 people):
• chest pain

Not known (frequency cannot be estimated
from the available data):

• bruising and bleeding more easily which may be
caused by a reduced number of platelets (blood
clotting cells)

Side effects associated with
hydrochlorothiazide alone
Not known (frequency cannot be estimated
from the available data):

Children should not take
Irbesartan/Hydrochlorothiazide







If you forget to take
Irbesartan/Hydrochlorothiazide





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








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 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.

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

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

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

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.

Common (may affect up to in 10 people):

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.






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).

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

Not known (frequency cannot be estimated
from the available data):
• headache
• ringing in the ears

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.
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 09/2016.
968565

50061965

Irbesartan Hydrochlorothiazide 300 mg / 12.5 mg,

Description 150 mg / 12.5 mg,300 mg / 25 mg 28
Component Type Leaflet
Affiliate Item Code 968565
Superceded Affiliate Item Code 686380
TrackWise PR No. 968565
MA No.

04569/1292, 04569/1293,
04569/1294

Packing Site/Printer N/A
Supplier Code 50061965

Pharma Code 4945
SAP No. N/A
Vendor Job No. 288657
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 12 AUG 2016
No. of colours
Colours

1

Time: 10:02
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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