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IRBESARTAN HYDROCHLOROTHIAZIDE ACTAVIS 150MG/12.5MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / IRBESARTAN

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Irbesartan Hydrochlorothiazide
150mg/12.5mg, 300mg/12.5mg and
300mg/25mg Film-coated 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.
•  The full name of this product is Irbesartan Hydrochlorothiazide
150mg/12.5mg, 300mg/12.5mg and 300mg/25mg Filmcoated Tablets but within the leaflet it will be 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
3 How to take
4 Possible side effects
5 How to store
6 Contents of the pack and other information
1 What Irbesartan Hydrochlorothiazide tablets are and

what they are used for

Irbesartan Hydrochlorothiazide tablets 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 tablets
work together to lower blood pressure further than if either was given
alone.
Irbesartan Hydrochlorothiazide tablets is used in the treatment of
high blood pressure (essential hypertension), 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
Do not take Irbesartan Hydrochlorothiazide tablets if you

• are allergic to irbesartan or hydrochlorothiazide, or any of the other
ingredients of this medicine (listed in section 6), or to medicines
chemically related to sulfonamide (ask your doctor or pharmacist for
further clarification).
• are more than 3 months pregnant. (It is also better to avoid
Irbesartan Hydrochlorothiazide tablets in early pregnancy – see
Warnings and precaution sand Pregnancy section).
• have severe liver or kidney problems.
• have difficulty in producing urine.
•h
 ave a condition which is associated with persistently high calcium
or low potassium levels in your blood.
•h
 ave diabetes or impaired kidney function and you are treated with a
blood pressure lowering medicine containing aliskiren

Warnings and precautions

You must tell your doctor if you think that 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).

You should also tell your doctor if you:

• are on a low-salt diet
•h
 ave 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)
•e
 xperience 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
•h
 ave 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 hydrochlorothiazide shoud 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.

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, colestyramine and colestipol resins
to reduce cholesterol in your blood, nondepolarizing skeletal muscle
relaxants (e.g. tubocurarine), anticholinergic agents (e.g. atropine,
beperiden) or amantadine.
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”)

Irbesartan Hydrochlorothiazide tablets with food, drink
and alcohol

Irbesartan Hydrochlorothiazide tablets can be taken with or without
food.

Talk to your doctor before using 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, ramipril), in
particular if you have diabetes-related kidney problems.
• aliskiren.

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.

Your doctor may check your kidney function, blood pressure, and
the amount of electrolytes (e.g. potassium) in your blood at regular
intervals.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Irbesartan Hydrochlorothiazide tablets 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.


See also information under the heading “Do not take Irbesartan
Hydrochlorothiazide tablets”
continued top of next column
AAAH1542

Pregnancy and breast-feeding

Pregnancy
You must tell your doctor if you think that 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
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.

continued over page

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 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

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 is 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.

Use in children and adolescents

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

If you take more Irbesartan Hydrochlorothiazide tablets
than you should
If you accidentally take too many 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.

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 Hydrochlorothiazide tablets and contact your
doctor immediately.
Side effects reported in clinical studies for patients treated with
Irbesartan Hydrochlorothiazide tablets were:
•C
 ommon (may affect up to 1 in 10 people): nausea/vomiting,
abnormal urination, fatigue and dizziness (including when getting
up from a lying or sitting position) and 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).

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; dizziness at hight; numbness, tingling or pins and needles;
light-headedness; restlessness; electrolyte imbalance (including
hypokalaemia and hyponatraemia); changes in vision or pain in one or
both eyes.
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. Also you
can help to make sure that medicines remain as safe as possible by
reporting any unwanted side effects via the internet at www.mhra.gov.
uk/yellowcard. Alternatively you can call Freephone 0808 100 3352
(available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper
form available from your local pharmacy.

5 How to store

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
tablet container, carton and on the blister after EXP. The expiry date
refers to the last day of that month.
Al/PVDC/PVC blister packaging: Do not store above 25°C
HDPE tablet containers with desiccant: This medicinal product 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 tablets contain

• T he 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 filmcoated tablet contains 300mg of irbesartan and 12.5mg of
hydrochlorothiazide.
Each Irbesartan Hydrochlorothiazide 300mg/25mg film-coated tablet
contains 300mg of irbesartan and 25mg of hydrochlorothiazide.
The other ingredients are:
• T ablet core: mannitol (E421), povidone (K29-32 or equivalent),
microcrystalline cellulose, croscarmellose sodium, silica colloidal
anhydrous, magnesium stearate.
• F ilm-coat: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350,
talc, iron oxide yellow (E172), iron oxide red (E172).
Irbesartan Hydrochlorothiazide 300mg/12.5mg and 300mg/25mg
film-coated tablets also contain iron oxide black (E172).

What Irbesartan Hydrochlorothiazide tablets looks like
and contents of the pack

Irbesartan Hydrochlorothiazide 150mg/12.5mg film-coated tablets are
pink, biconvex, oval-shaped, 6.5 x 12.7mm film-coated tablet with a
H engraved on one side and I on the other side.
Irbesartan Hydrochlorothiazide 300mg/12.5mg film-coated tablets are
pink, biconvex, oval-shaped, 8.2 x 16.0mm film-coated tablet with a
H engraved on one side and I on the other side.
Irbesartan Hydrochlorothiazide 300mg/25mg film-coated tablets are
dark pink, biconvex, oval-shaped, 8.2 x 16.0mm film-coated tablet with
a H engraved on one side and I on the other side.
Pack sizes: 28 film-coated tablets
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjordur
Iceland

•U
 ncommon (may affect up to 1 in 100 people): diarrhoea, low
blood pressure, fainting, heart rate increased, flushing, swelling and
sexual dysfunction (problems with sexual performance). Blood tests
may show lowered levels of potassium and sodium in your blood,
yellowing of the skin and/or whites of the eyes (jaundice).

Manufacturer
Actavis Group PTC ehf
Reykjavíkurvegi 78
220 Hafnarfjordur
Iceland

•N
 ot 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.

Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600,
Bulgaria
This leaflet was last revised in August 2014

As for any combination of two active substances, side effects
associated with each individual component cannot be excluded. In
patients taking irbesartan alone, in addition to the side effects listed
above, chest pain has also been reported.
Additional side effects associated with the other component of
Irbesartan Hydrochlorothiazide tablets (hydrochlorothiazide) alone
are: loss of appetite; stomach irritation; stomach cramps; constipation;
jaundice seen as 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 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 characterised 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;
continued top of next column
AAAH1542

Actavis, Barnstaple, EX32 8NS, UK

Irbesartan Hydrochlorothiazide
150mg/12.5mg, 300mg/12.5mg and
300mg/25mg Film-coated 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.
•  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 will be 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
3 How to take
4 Possible side effects
5 How to store
6 Contents of the pack and other information

1 What Irbesartan Hydrochlorothiazide tablets are and
what they are used for

Irbesartan Hydrochlorothiazide tablets 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 tablets work
together to lower blood pressure further than if either was given alone.
Irbesartan Hydrochlorothiazide tablets is used in the treatment of high
blood pressure (essential hypertension), 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

Do not take Irbesartan Hydrochlorothiazide tablets if you

• are allergic to irbesartan or hydrochlorothiazide, or any of the other
ingredients of this medicine (listed in section 6), or to medicines chemically
related to sulfonamide (ask your doctor or pharmacist for further clarification).
• are more than 3 months pregnant. (It is also better to avoid Irbesartan
Hydrochlorothiazide tablets in early pregnancy – see Warnings and
precautions and Pregnancy section).
• have severe liver or kidney problems.
• have difficulty in producing urine.
• h ave a condition which is associated with persistently high calcium or low
potassium levels in your blood.
• h ave 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 using 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, 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.

continued top of next column
AAAH1543

See also information under the heading “Do not take Irbesartan
Hydrochlorothiazide tablets”
You must tell your doctor if you think that 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).

You should also tell your doctor if you:

• are on a low-salt diet
• h ave 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)
• e xperience an increased sensitivity of the skin to the sun with symptoms of
sunburn (such as redness, itching, swelling, blistering) occurring more quickly
than normal
• a re going to have an operation (surgery) or be given anaesthetics
• h ave 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 hydrochlorothiazide shoud 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.

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, colestyramine and colestipol resins to reduce cholesterol
in your blood, nondepolarizing skeletal muscle relaxants (e.g. tubocurarine),
anticholinergic agents (e.g. atropine, beperiden) or amantadine.
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”)

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 and breast-feeding

Pregnancy
You must tell your doctor if you think that 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 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 tablets 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.

continued over page

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 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

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 is 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.

Use in children and adolescents

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

If you take more Irbesartan Hydrochlorothiazide tablets than
you should
If you accidentally take too many 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.

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 Hydrochlorothiazide tablets and contact your doctor
immediately.
Side effects reported in clinical studies for patients treated with Irbesartan
Hydrochlorothiazide tablets were:
•C
 ommon (may affect up to 1 in 10 people): nausea/vomiting, abnormal
urination, fatigue and dizziness (including when getting up from a lying or
sitting position) and 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).

increased sensitivity of the skin to the sun; inflammation of blood vessels;
a skin disease characterised 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; dizziness at height; numbness; tingling or pins and
needles; light-headedness; restlessness; electrolyte imbalance (including
hypokalaemia and hyponatraemia); changes in vision or pain in one or both
eyes.
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. Also you can help to make sure
that medicines remain as safe as possible by reporting any unwanted side
effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can
call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to
Fridays) or fill in a paper form available from your local pharmacy.

5 How to store

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 tablet
container, carton and on the blister after EXP. The expiry date refers to the last
day of that month.
Al/PVDC/PVC blister packaging: Do not store above 25°C
HDPE tablet containers with desiccant: This medicinal product 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 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 Hydrochlorothiazide 300mg/25mg film-coated tablet
contains 300mg of irbesartan and 25mg of hydrochlorothiazide.
The other ingredients are:
• Tablet core: mannitol (E421), povidone (K29-32 or equivalent), microcrystalline
cellulose, croscarmellose sodium, silica colloidal anhydrous, magnesium
stearate.
• F ilm-coat: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron
oxide yellow (E172), iron oxide red (E172).
Irbesartan Hydrochlorothiazide 300mg/12.5mg and 300mg/25mg filmcoated tablets also contain iron oxide black (E172).

What Irbesartan Hydrochlorothiazide tablets looks like and
contents of the pack

Irbesartan Hydrochlorothiazide 150mg/12.5mg film-coated tablets are pink,
biconvex, oval-shaped, 6.5 x 12.7mm film-coated tablet with a H engraved on
one side and I on the other side.
Irbesartan Hydrochlorothiazide 300mg/12.5mg film-coated tablets are pink,
biconvex, oval-shaped, 8.2 x 16.0mm film-coated tablet with a H engraved on
one side and I on the other side.
Irbesartan Hydrochlorothiazide 300mg/25mg film-coated tablets are dark pink,
biconvex, oval-shaped, 8.2 x 16.0mm film-coated tablet with a H engraved on
one side and I on the other side.
Pack sizes: 28 film-coated tablets

•U
 ncommon (may affect up to 1 in 100 people): diarrhoea, low blood
pressure, fainting, heart rate increased, flushing, swelling and sexual
dysfunction (problems with sexual performance). Blood tests may show
lowered levels of potassium and sodium in your blood, yellowing of the skin
and/or whites of the eyes (jaundice).

Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjordur
Iceland

•N
 ot 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.

Manufacturer
Actavis Group PTC ehf
Reykjavíkurvegi 78
220 Hafnarfjordur
Iceland
This leaflet was last revised in August 2014

As for any combination of two active substances, side effects associated with
each individual component cannot be excluded. In patients taking irbesartan
alone, in addition to the side effects listed above, the following has also been
reported
• Uncommon (may affect up to 1 in 100 people): chest pain .
Additional side effects associated with the other component of Irbesartan
Hydrochlorothiazide tablets (hydrochlorothiazide) alone are:
•N
 ot known (frequency cannot be estimated from the available data):
loss of appetite; stomach irritation; diarrhoea; constipation; jaundice seen as
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; yellow 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 problems including pneumonia or build-up of fluid in the lungs;

continued top of next column
AAAH1543

Actavis, Barnstaple, EX32 8NS, UK

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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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