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IRBESARTAN AND HYDROCHLOROTHIAZIDE DR REDDYS 300MG/25 MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / IRBESARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Irbesartan and Hydrochlorothiazide 150 mg/12.5 mg Film-coated Tablets
Irbesartan and Hydrochlorothiazide 300 mg/12.5 mg Film-coated Tablets
Irbesartan and Hydrochlorothiazide 300 mg/25 mg Film-coated Tablets
Irbesartan and 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 possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Irbesartan/Hydrochlorothiazide is and what it is used for
2. What you need to know before you take Irbesartan/Hydrochlorothiazide
3. How to take Irbesartan/Hydrochlorothiazide
4. Possible side effects
5. How to store Irbesartan/Hydrochlorothiazide
6. Contents of the pack and other information
1. What Irbesartan/Hydrochlorothiazide is and what it is used for
Irbesartan/Hydrochlorothiazide 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 work together to lower blood pressure
further than if either was given alone.
Irbesartan/Hydrochlorothiazide 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
Do not take Irbesartan/Hydrochlorothiazide
• if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in
section 6)
• 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
Irbesartan/Hydrochlorothiazide 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 a blood
pressure lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Irbesartan/Hydrochlorothiazide 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, etc.), 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”.
You must tell your doctor if you think you are (or might become) pregnant.
Irbesartan/Hydrochlorothiazide 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)
• 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. This could be a 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 should not be given to children and adolescents (under 18 years).
Other medicines and Irbesartan/Hydrochlorothiazide
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 may have
an effect on other medicines. Preparations containing lithium should not be taken with
Irbesartan/Hydrochlorothiazide 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” 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)
• carbamazapine (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/Hydrochlorothiazide with food and drink
Irbesartan/Hydrochlorothiazide can be taken with or without food.
Due to the hydrochlorothiazide, 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 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. Irbesartan/Hydrochlorothiazide 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 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 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 contain 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
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/Hydrochlorothiazide is one or two tablets a day.
Irbesartan/Hydrochlorothiazide 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.
Method of administration
Irbesartan/Hydrochlorothiazide is for oral use. Swallow the tablets with a sufficient amount of fluid
(e.g. one glass of water). You can take Irbesartan/Hydrochlorothiazide 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 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 than you should
If you accidentally take too many tablets, contact your doctor immediately.
Children should not take Irbesartan/Hydrochlorothiazide
Irbesartan/Hydrochlorothiazide 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
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/Hydrochlorothiazide 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 irbesartan/hydrochlorothiazide
combination 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).
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 combination
Some undesirable effects have been reported since marketing of irbesartan/hydrochlorothiazide
combination. 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 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 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 at:
http://yellowcard.mhra.gov.uk/. By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Irbesartan/Hydrochlorothiazide
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 30°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/Hydrochlorothiazide tablets contain
The active substances are irbesartan and hydrochlorothiazide.
Each film-coated tablet of Irbesartan/Hydrochlorothiazide 150 mg/12.5 mg contains 150 mg irbesartan
and 12.5 mg hydrochlorothiazide.
Each film-coated tablet of Irbesartan/Hydrochlorothiazide 300 mg/12.5 mg contains 300 mg irbesartan
and 12.5 mg hydrochlorothiazide.
Each film-coated tablet of Irbesartan/Hydrochlorothiazide 300 mg/25 mg contains 300 mg irbesartan
and 25 mg hydrochlorothiazide.
The other ingredients are; Tablet core: lactose monohydrate, microcrystalline cellulose, crospovidone,
copovidone, colloidal anhydrous silica, magnesium stearate; Coating: Hypromellose 15 cps (E464),
lactose monohydrate, titanium dioxide, carnauba wax, iron oxide red (E172). The 150 mg/12.5 mg
and 300 mg/12.5 mg strengths contain macrogol 3000 and iron oxide yellow (E172) and the
300 mg/25 mg strength contains macrogol 3350 and iron oxide black (E172).
What Irbesartan/Hydrochlorothiazide looks like and contents of the pack
Irbesartan/Hydrochlorothiazide 150 mg/12.5 mg film-coated tablets are peach coloured, oval-shaped,
biconvex with ‘IH’ debossed on one side and ‘1’ on the other side.
Irbesartan/Hydrochlorothiazide 300 mg/12.5 mg film-coated tablets are peach coloured, oval-shaped,
biconvex with ‘IH’ debossed on one side and ‘2’ on the other side.
Irbesartan/Hydrochlorothiazide 300 mg/25 mg film-coated tablets are brown coloured, oval-shaped,
biconvex with ‘IH’ debossed on one side and ‘3’ on the other side.
Irbesartan/Hydrochlorothiazide is supplied in blister packs of 28, 56 or 98 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, United Kingdom
This leaflet was last revised in 02/2015

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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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