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IRBESARTAN/HYDROCHLOROTHIAZIDE 150/12.5 MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / IRBESARTAN

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Pharmacode Direction

• 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-Lupin comp)
• 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-Lupin comp. This could be a sign
that you are developing glaucoma, increased pressure in your
eye(s). You should discontinue Irbesartan-Lupin comp
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-Lupin comp should not be given to children and
adolescents (under 18 years).
Other medicines and Irbesartan-Lupin comp
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-Lupin comp may have an effect on other medicines.
Preparations containing lithium should not be taken with
Irbesartan-Lupin comp 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-Lupin” 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 for lowering blood cholesterol.
Irbesartan-Lupin comp with food and drink
Irbesartan-Lupin comp can be taken with or without food.
Due to the hydrochlorothiazide contained in Irbesartan-Lupin comp,
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-Lupin comp before you become pregnant or as soon as
you know you are pregnant and will advise you to take another
medicine instead of Irbesartan-Lupin comp. Irbesartan-Lupin comp
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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Irbesartan-Lupin comp 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-Lupin comp 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-Lupin comp
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 of Irbesartan-Lupin comp is one or two
tablets a day. Irbesartan-Lupin comp 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

180 mm

320 mm

4672

Irbesartan/
Hydrochlorothiazide
Package leaflet: Information for the patient
Irbesartan-Lupin comp 150 mg/12.5 mg Film-Coated Tablets
Irbesartan-Lupin comp 300 mg/12.5 mg Film-Coated Tablets
Irbesartan-Lupin comp 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 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 side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Irbesartan-Lupin comp is and what it is used for
2. What you need to know before you take Irbesartan-Lupin comp
3. How to take Irbesartan-Lupin comp
4. Possible side effects
5. How to store Irbesartan-Lupin comp
6. Contents of the pack and other information
1. What Irbesartan-Lupin comp is and what it is used for
Irbesartan-Lupin comp 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-Lupin comp work together
to lower blood pressure further than if either was given alone.
Irbesartan-Lupin comp 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-Lupin comp
Do not take Irbesartan-Lupin comp
• If you are allergic to irbesartan or any of the other ingredients of
this medicine (listed in section 6).
• If you are allergic to hydrochlorothiazide or any other
sulfonamide-derived medicines
• If you are more than 3 months pregnant (it is also better to avoid
Irbesartan-Lupin comp 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 a blood pressure lowering medicine containing
aliskiren.
Warnings and precautions
Talk to your doctor before taking Irbesartan-Lupin comp 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 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.
See also information under the heading “Do not take IrbesartanLupin comp”.
You must tell your doctor if you think you are (or might become)
pregnant. Irbesartan-Lupin comp 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

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 the Yellow Card Scheme Website:
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-Lupin comp
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.
Do not store above 25 °C.
Store in the original package in order to protect from moisture.
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-Lupin comp contains
The active substances are irbesartan and hydrochlorothiazide.
Each Irbesartan-Lupin comp 150 mg/12.5 mg film-coated tablet
contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Each Irbesartan-Lupin comp 300 mg/12.5 mg film-coated tablet
contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Each Irbesartan-Lupin comp 300 mg/25 mg film-coated tablet
contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
The other ingredients are mannitol, crospovidone, colloidal
anhydrous silica, poloxamer 188, povidone K 30, magnesium
stearate, hypromellose (E464), titanium dioxide (E171), macrogol
3350, iron oxide yellow (E172), iron oxide red (E172) and iron oxide
black (E172).
What Irbesartan-Lupin comp looks like and contents of the pack
Irbesartan-Lupin comp 150 mg/12.5 mg film-coated tablet are light
peach-coloured, biconvex, oval-shaped film coated tablets,
debossed with “IT1” on one side and plain on the other side. The
tablets have a length of 14 mm and width of 7 mm.
Irbesartan-Lupin comp 300 mg/12.5 mg film-coated tablet are light
peach-coloured, biconvex, oval-shaped film coated tablets,
debossed with “IT2” on one side and plain on the other side. The
tablets have a length of 19 mm and width of 8.5 mm.
Irbesartan-Lupin comp 300 mg/25 mg film-coated tablet are tan,
biconvex, oval-shaped film coated tablets, debossed with “IT3” on
one side and plain on the other side. The tablets have a length of 19
mm and width of 8.5 mm.
Irbesartan-Lupin comp is available in blister packs of 14, 28, 56 and
98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited
Victoria Court
Bexton Road
Knutsford
Cheshire
Wa16 0PF
United Kingdom
This medicinal product is authorised in the Member States of the
EEA under the following names:
United Kingdom: Irbesartan/Hydrochlorothiazide film-coated
tablets
This leaflet was last revised in November 2017
Code No. MP/DRUGS/25/8/2010
ID#: 254014

180 mm

320 mm

from the previous treatment to Irbesartan-Lupin comp.
Method of administration
Irbesartan-Lupin comp is for oral use. Swallow the tablets with a
sufficient amount of fluid (e.g. one glass of water). You can take
Irbesartan-Lupin comp 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-Lupin comp 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 Lupin comp than you should
If you accidentally take too many tablets, contact your doctor
immediately.
Children should not take Irbesartan Lupin comp
Irbesartan-Lupin comp 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-Lupin comp
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.
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 the above symptoms or get short of breath, stop
taking Irbesartan-Lupin comp and contact your doctor immediately.
The frequency of the side effects listed below is defined using the
following convention:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Side effects reported in clinical studies for patients treated with the
combination of irbesartan and hydrochlorothiazide were:
Common side effects (may affect up to 1 in10 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).
If any of these side effects causes you problems, talk to your
doctor.
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.
If any of these side effects causes you problems, talk to your
doctor.
Side effects reported since the launch of irbesartan/
hydrochlorothiazide
Some undesirable effects have been reported since 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, reduced number of platelets, 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 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 and decrease
in the number of platelets (a blood cell essential for the clotting of
the blood) have 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);

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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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