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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 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

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 Irbesartan

Hydrochlorothiazide tablets

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.
• have a condition which is associated with persistently high calcium
or low potassium levels in your blood.
• have diabetes or impaired kidney function and you are treated with a
blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor 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.

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.
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 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”
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Technical
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S.Anson
20.10.17
21.11.17
S.Anson

Date sent:
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Date received: 20.10.17

Dimensions:
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Supplier:
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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 Irbesartan Hydrochlorothiazide tablets
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.

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; 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.

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).

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 or search for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects you can help provide more information on the
safety of this medicine.

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 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 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:
• 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
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

•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

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.
-N
 ot known (frequency cannot be estimated from the available data):
decrease in the number of platelets (a blood cell essential for the
clotting of the blood).
Additional side effects associated with the other component of
Irbesartan Hydrochlorothiazide tablets (hydrochlorothiazide) alone
are:
• Not 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; yellow vision;
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

Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600,
Bulgaria
This leaflet was last revised in October 2017

If you would like a
leaflet with larger
text, please contact
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Irbesrtan HCT 150mg/12.5mg, 300mg/12.5mg & 300mg/25mg Tablets PIL - UK
approved for print/date

Proof Round

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UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA1375

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
20.10.17
21.11.17
S.Anson

Date sent:
20.10.17
Date received: 20.10.17

Dimensions:
190 x 380
Min Body Text Size: 8pt
Supplier:
Actavis Bulgaria
Dupnitsa

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

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Further information

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