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IRBESARTAN/HYDROCHLOROTHIAZIDE 300 MG/25 MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / IRBESARTAN / HYDROCHLOROTHIAZIDE / IRBESARTAN / HYDROCHLOROTHIAZIDE / IRBESARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Irbesartan/ Hydrochlorothiazide 150 mg/12.5 mg Film-coated Tablets
Irbesartan/ Hydrochlorothiazide 300 mg/ 12.5 mg Film-coated Tablets
Irbesartan/ Hydrochlorothiazide 300 mg/ 25 mg Film-coated Tablets
Irbesartan/Hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
What is in this leaflet:
1. What Irbesartan/Hydrochlorothiazide Tablets is and what it is 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
IS AND WHAT IT IS USED FOR
Irbesartan/Hydrochlorothiazide Tablet 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 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 TABLETS
Do not take Irbesartan/Hydrochlorothiazide Tablets
If you are allergic (hypersensitive) to irbesartan or any of the other
ingredients of Irbesartan/Hydrochlorothiazide Tablets
 If you are allergic (hypersensitive) to hydrochlorothiazide or any other
sulfonamide-derived medicines
 If you are more than 3 months pregnant. (It is also better to avoid
Iresartan/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 mellitus or impaired kidney function and you
are treated with aliskiren (another medicine to treat high blood
pressure).


Warnings and Precautions
Talk to your doctor before taking Irbesartan/Hydrochlorothiazide
Tablets and if any of the following apply to you:





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 aliskiren.

You must tell your doctor if you think you are (or might become)
pregnant. Irbesartan/Hydrochlorothiazide Tablet 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
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 Tablets)
 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 Tablets. This could
be sign that you are developing glaucoma, increased pressure in your
eye(s). You should discontinue irbesartan/hydrochlorothiazide
treatment and seek medical attention.



The hydrochlorothiazide contained in this medicine could produce a
positive result in an anti-doping test.
Children and adolescents
Irbesartan/Hydrochlorothiazide Tablets 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 aliskiren.
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 treatment for 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 for
lowering blood cholesterol.
Irbesartan/Hydrochlorothiazide Tablets with food and drink
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, specially 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 Tablet 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 Tablet 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.
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.
Irbesartan/Hydrochlorothiazide Tablets 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
TABLETS
Always take Irbesartan/Hydrochlorothiazide Tablets exactly as your
doctor has told you. You should check with your doctor or pharmacist if
you are not sure.
Dosage
The usual dose of Irbesartan/Hydrochlorothiazide Tablets is one or two
tablets a day. Irbesartan/Hydrochlorothiazide Tablets 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 Tablets.
Method of administration
Irbesartan/Hydrochlorothiazide Tablet 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.
If you take more Irbesartan/Hydrochlorothiazide Tablets than you
should
If you accidentally take too many tablets, contact your doctor
immediately.
Children should not take Irbesartan/Hydrochlorothiazide Tablets
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 product, ask your
doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Irbesartan/Hydrochlorothiazide Tablets can cause
side effects, although not everybody gets them.
Some side effects could be very serious. If you have any of the side
effects below, see a doctor straight away:





Inflammation of the pancreas characterised by severe upper
stomach pain, often with nausea and vomiting.
Toxic epidermal necrolysis characterised by allergic skin
reactions like rash, hives, swelling of the face, lips, mouth, tongue
or throat, headache, cough, pain in muscles or peeling of the skin
all over the body.
Necrotizing angitis (vasculitis, cutaneous vasculitis) characterised
by pain in joints and muscles, skin redness, inflammation of
blood vessels.

Side effects reported in clinical studies for patients treated with
Irbesartan/Hydrochlorothiazide Tablets were:
Common side effects (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 side effects (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.


Rare (may affect up to 1 in 1,000 people)
allergic skin reactions (rash, urticaria)
 localised swelling of the face, lips and/or tongue
 short of breath


If any of these side effects causes you problems, talk to your doctor.
Side effects reported since the launch of Irbesartan/
Hydrochlorothiazide Tablets
Some undesirable effects have been reported since the marketing of the
combination of Irbesartan and Hydrochlorothiazide. Undesirable effects
where the frequency is not known are: headache, ringing in the ears,
cough, taste disturbance, indigestion, pain in joints and muscles, liver
function abnormal and impaired kidney function, 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 white of the eye) 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 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 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
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
carton and on the blister after EXP. The expiry date refers to the last day
of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Irbesartan/Hydrochlorothiazide Tablets contains
The active substances are Irbesartan and Hydrochlorothiazide.
Each film-coated tablet contains 150 mg of Irbesartan and 12.5 mg of
Hydrochlorothiazide.
Each film-coated tablet contains 300 mg of Irbesartan and 12.5 mg of
Hydrochlorothiazide.
Each film-coated tablet contains 300 mg of Irbesartan and 25 mg of
Hydrochlorothiazide.
The other ingredients are
Core: carboxymethylcellulose calcium, colloidal silicon dioxide,
povidone (PVP K29/32), sodium starch glycolate type A, talc and
magnesium stearate.
Coating:
150mg/12.5mg & 300mg/12.5mg film-coated tablets: hypromellose 15 cp
(E464), lactose monohydrate, titanium dioxide (E171) & polyethylene
glycol 3000, iron oxide red (E172) & iron oxide yellow (E172).
300mg/25mg film-coated tablets: hypromellose 15 cp (E464), lactose
monohydrate, titanium dioxide (E171) & polyethylene glycol 3000, iron
oxide red (E172), iron oxide yellow (E172) & iron oxide black (E172).
What do Irbesartan/Hydrochlorothiazide Tablets look like and
contents of the pack
Irbesartan/Hydrochlorothiazide 150 mg/12.5 mg tablets are peach
coloured, oval, film coated tablets, debossed with “ML 34” on one side
and plain on other side.
Irbesartan/Hydrochlorothiazide 300 mg/12.5 mg tablets are peach
coloured, oval, film coated tablets, debossed with “ML 33” on one side
and plain on other side.
Irbesartan/Hydrochlorothiazide 300 mg/25 mg tablets are pink coloured,
oval, film coated tablets, debossed with “ML 32” on one side and plain
on other side.

The tablets are supplied in blister packs containing 28 tablets.
Marketing Authorisation Holder
Activase Pharmaceuticals Limited
11 Boumpoulinas
Nicosia 1060, Cyprus
Manufacturer
Wilcare Pharma Limited
Building 6 Unit 14, Croxley Green Business Park,
Watford, England WD18 8YH
If you would like this leaflet in a different format or register a
complaint please contact the Marketing Authorisation Holder.
This leaflet was last revised in 01/2017

A0180-0181-0182/O/PIL/A1

Expand Transcript

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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