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IRBESARTAN/HYDROCHLOROTHIAZIDE BROWN & BURK 300 MG/25 MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / IRBESARTAN

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2) Strength

: Irbesartan/Hydrochlorothiazide Brown & Burk
Film-coated Tablets - BBUK
: 150 mg/12.5 mg, 300 mg/25 mg & 300 mg/12.5 mg

3) Component

: Leaflet

4) No. of Colours

: 1

5) Dimension

: 150 x 420 mm

6) Artwork Code

: NA

7) Pharma Code

: NA

8) Font Type and Size

: Arial Narrow, 9pt

1) Product

Colours used

Black

Colours not for printing
Keylines

9) Technical Specification : NA

Code No. :

WOA
WA

Reason for Change
Approved
by

Contract Giver/
PL holder

Regulatory
Affairs

NA

Revision: 00

NA

Date : 21-03-2017
Head Production/
Packing (Site)

Packaging
Development

Head QC
(Site)

Head QA
(Site)

Sign/
Date

150 mm

150 mm

Package leaflet: Information for the user

3. How to take Irbesartan/Hydrochlorothiazide
tablets

Irbesartan/Hydrochlorothiazide Brown & Burk
150mg/12.5mg, 300mg/25mg and 300mg/12.5mg
Film-coated tablets
Read all of these 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.
The full name of this product is Irbesartan
/Hydrochlorothiazide 150mg/12.5mg, 300mg/12.5mg and
300mg/25mg Film- coated Tablets but within the leaflet it
w ill referred to as Irbesartan /Hydrochlorothiazide tablets.
What is in this leaflet
1. What Irbesartan/Hydrochlorothiazide tablets are and
what they are used for
2. What you need to know before you take
Irbesartan/Hydrochlorothiazide tablets
3. How to take Irbesartan/Hydrochlorothiazide tablets
4. Possible side effects
5. How to store Irbesartan/Hydrochlorothiazide tablets
6. Contents of the pack and other information
1. What Irbesartan/Hydrochlorothiazide tablets are
and what they are used for

Folding
here

Do not take Irbesartan/Hydrochlorothiazide tablets
• if you are allergic to irbesartan or any of the other
ingredients of this medecine (listed in section 6).
• if you are allergic to hydrochlorothiazide or any other
sulfonamidederived medicines
• if you are more than 3 months pregnant. (It is also
better to avoid Irbesartan /Hydrochlorothiazide tablets
in early pregnancy - see pregnancy section)
• if you have severe liver or kidney problems
• if you have difficulty in producing urine
• if your doctor determines that you have persistently
high calcium or low potassium levels in your blood
• if you have diabetes or impaired kidney function and
you are treated with aliskiren (another medicine to
treat high blood pressure)
Warnings and precautions
Ta l k t o y o u r d o c t o r b e f o r e t a k i n g
Irbesartan/Hydrochlorothiazide tablets
- if you get excessive vomiting or diarrhoea
- if you suffer from kidney problems or have a kidney
transplant
- if you suffer from heart problems
- if you suffer from liver problems
- if you suffer from diabetes
- if you suffer from lupus erythematosus (also known as
lupus or SLE)
- 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 taking any of the following medicines used to
treat high blood pressure:
- an ACE-inhibitor (for example enalapril, lisinopril,
ramipiril) 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 tablets ".
You must tell your doctor if you think you are (or might
become) pregnant. Irbesartan/ Hydrochlorothiazide
tablets 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).

Size: 150 x 420 mm
Front Side

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.

Folding
here

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/Hydrochlorothiazide tablets contact your
doctor immediately.
Side effects reported in clinical studies for patients treated
with Irbesartan/Hydrochlorothiazide tablets were:
Common (may affect up to 1 in 10 people):
• nausea/vomiting
• abnormal urination
• fatigue
• dizziness (including when getting up from a lying or
sitting position)
• blood tests may show raised levels of an enzyme that
measures the muscle and heart function (creatine
kinase) or raised levels of substances that measure
kidney function (blood urea nitrogen, creatinine).
Uncommon (may affect up to 1 in 100 people):
• diarrhea
• 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.
Not known (frequency cannot be estimated from the
available data):
headache, ringing in the ears, cough, taste disturbance,
indigestion, pain in joints and muscles, liver function
abnormal, inflammation of the liver causing yellowing of
the skin or eyes, impaired kidney function, kidney failure,
increased level of potassium in your blood and allergic
reactions such as rash, hives, swelling of the face, lips,
mouth, tongue or throat. Uncommon cases of jaundice
(yellowing of the skin and/or whites of the eyes) have also
been reported.
As for any combination of two active substances, side
effects associated with each individual component cannot
be excluded.
Side effects associated with irbesartan alone
In addition to the side effects listed above, chest pain has
also been reported.
Side effects associated with hydrochlorothiazide
alone
Loss of appetite; stomach irritation; stomach cramps;
constipation; jaundice (yellowing of the skin and/or whites
of the eyes); inflammation of the pancreas characterised
by severe upper stomach pain, often with nausea and
vomiting; sleep disorders; depression; blurred vision; lack
of white blood cells, which can result in frequent infections,
fever; decrease in the number of platelets (a blood cell
essential for the clotting of the blood), decreased number
of red blood cells (anaemia) characterised by tiredness,
headaches, being short of breath
when exercising, dizziness and
looking pale; kidney disease; lung

Pharmacode
Pharmacode

5. How to store Irbesartan/Hydrochlorothiazide
tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on carton or blister after EXP. The expiry date
refers to the last day of that month.
PVC/ACLAR-Aluminium blister packaging:
Do not store above 30° C.
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 and Hydrochlorothiazide tablets
contain
• The active substances are irbesartan and
hydrochlorothiazide.
- Each Irbesartan/Hydrochlorothiazide
150mg/12.5mg film-coated tablet contains 150mg
of irbesartan and 12.5mg hydrochlorothiazide.
- Each Irbesartan/Hydrochlorothiazide
300mg/12.5mg film-coated tablet contains 300mg
of irbesartan and 12.5mg of hydrochlorothiazide.
- Each Irbesartan and Hydrochlorothiazide
300mg/25mg film-coated tablet contains 300mg of
irbesartan and 25mg of hydrochlorothiazide.
The other ingredients are:
Tablet core:
150mg/ 12.5 mg and 300mg/ 25 mg film-coated tablets
mannitol, sodium starch glycolate Type B, povidone K 30,
polysorbate 80, Hypromellose 2910 5cps, silica colloidal
anhydrous, magnesium stearate
300mg/ 12.5 mg film-coated tablets
mannitol, sodium starch glycolate Type B, povidone K 30,
polysorbate 80, Hypromellose 2910 5cps, silica colloidal
anhydrous, magnesium stearate, iron oxide red, iron oxide
yellow
Film-coat:
150mg/ 12.5 mg and 300mg/ 12.5 mg film-coated tablets
Hypromellose 2910, titanium dioxide, macrogol 3350,
carnauba wax, iron oxide yellow and iron oxide red
300mg/ 25 mg film-coated tablets
Hypromellose 2910, titanium dioxide, macrogol 3350, iron
oxide red; carnauba wax and black iron oxide.
What Irbesartan/Hydrochlorothiazide tablets looks
like and contents of the pack
Irbesartan/Hydrochlorothiazide 150 mg/12.5 mg
film-coated Tablets are Peach coloured, capsule shaped,
biconvex, film-coated tablets, approximately 14 mm long
and 7 mm wide, debossed with 'IH' on one face and plain
on other face.
Irbesartan/Hydrochlorothiazide 300 mg/25 mg film-coated
Tablets are Brick red coloured, capsule shaped, biconvex,
film-coated tablets, approximately 18 mm long and 9 mm
wide, debossed with 'IH1' on one face and plain on other
face.
Irbesartan/Hydrochlorothiazide 300 mg/12.5 mg filmcoated Tablets are Peach coloured, capsule shaped,
biconvex, film-coated tablets, approximately 18 mm long
and 9 mm wide debossed with 'IH2' on one face and plain
on other face.
Pack contents are 10, 14, 28, 30, 56, 84, 90 and 98 tablets
in PVC/ACLAR/Aluminium blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Ltd.
5 Marryat Close
Hounslow West
Middlesex
TW4 5DQ
United Kingdom
This leaflet was last revised in 01/2017

BBUK Code

Artwork Code

Size: 150 x 420 mm
Back Side

420 mm

2. What you need to know before you take
Irbesartan/Hydrochlorothiazide tablets

4. Possible side effects

420 mm

Irbesartan/Hydrochlorothiazide tablets contains 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 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.
Hydrochlorothiazide is one of a
group of medicines (called
thiazide diuretics) that causes
Pharmacode
increased urine output and so
causes a lowering of blood
pressure.
The two active ingredients in
Irbesartan/Hydrochlorothiazid
e tablets work together to lower blood pressure further
than if either was given alone.
Irbesartan/Hydrochlorothiazide tablets is used to treat
high blood pressure, when treatment with irbesartan or
hydrochlorothiazide alone did not provide adequate
control of your blood pressure.

You should also tell your doctor if you:
- are on a low-salt diet
- 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 tablets)
- 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
- are going to have an operation (surgery) or be given
anaesthetics
- have changes in your vision or pain in one or both of
your eyes while taking Irbesartan/Hydrochlorothiazide
tablets. This could be a sign that you are developing
glaucoma, increased pressure in your eye(s). You
should discontinue Irbesartan/Hydrochlorothiazide
tablets treatment and seek medical attention.
Hydrochlorothiazide contained in this medicine could
produce a positive result in an anti-doping test.
Children and adolescents
Irbesartan and Hydrochlorothiazide should not be given to
children and adolescents (under 18 years).
Other medicines and Irbesartan/Hydrochlorothiazide
tablets
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 tablets may have an
effect on other medicines. Preparations containing lithium
should not be taken with Irbesartan/Hydrochlorothiazide
tablets 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/Hydrochlorothiazide tablets” 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
• therapeutic vitamin D supplements
• medicines to control heart rhythm
• medicines for diabetes (oral agents or insulins)
• carbamazepine (a medicine for the treatment of
epilepsy)
It is also important to tell your doctor if you are taking other
medicines to reduce your blood pressure, steroids,
medicines to treat cancer, pain killers, arthritis medicines,
or colestyramine and colestipol resins to reduce
cholesterol in your blood.
Irbesartan/Hydrochlorothiazide tablets with food,
drink and alcohol
Irbesartan/Hydrochlorothiazide tablets can be taken with
or without food.
Due to the hydrochlorothiazide contained in
Irbesartan/Hydrochlorothiazide tablets, 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, breast-feeding and fertility
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 tablets 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 tablets.
Irbesartan/Hydrochlorothiazide tablets 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
breast-feeding. Irbesartan/Hydrochlorothiazide tablets
are not recommended for mothers who are breastfeeding, and your doctor may choose another treatment
for you if you wish to breastfeed, especially if your baby is
newborn, or was born prematurely.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
No studies on the effects on the ability to drive and use
machines have been performed.
Irbesartan/Hydrochlorothiazide tablets are 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.

195 mm

195 mm

Irbesartan/Hydrochlorothiazide

Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Dosage
The recommended dose is one 150mg/12.5mg,
300mg/12.5mg or 300mg/25mg tablet a day or two
150mg/12.5mg tablets a day.
Irbesartan/Hydrochlorothiazide tablets will usually be
prescribed by your doctor when your previous treatment
for high blood pressure did not provide appropriate blood
pressure reduction. Your doctor will instruct you how to
switch from the previous treatment to
Irbesartan/Hydrochlorothiazide tablets.
Method of administration
Irbesartan/Hydrochlorothiazide tablets are for oral
use. Swallow the tablets with a sufficient amount of
fluid (e.g. one glass of water). You can take
Irbesartan/Hydrochlorothiazide tablets 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 tablets 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
tablets than you should
If you accidentally take too many tablets, contact your
doctor immediately.
Use in children and adolescents
Irbesartan/Hydrochlorothiazide tablets 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
tablets
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.

problems including pneumonia or build-up of fluid in the
lungs; increased sensitivity of the skin to the sun;
inflammation of blood vessels; a skin disease
characterized by the peeling of the skin all over the body;
cutaneous lupus erythematosus, which is identified by a
rash that may appear on the face, neck, and scalp; allergic
reactions; weakness and muscle spasm; altered heart
rate; 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 Yellow Card Scheme at
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

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Further information

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