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

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 150 mg/12.5 mg
film-coated 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

You may need to have blood checks if you take:


if you suffer from liver problems


if you suffer from diabetes


Read all of this leaflet carefully before you start taking this medicine
- 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.
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. Further information
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
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.
Do not take Irbesartan/Hydrochlorothiazide Tablets


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
- 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 Irbesartan/
Hydrochlorothiazide Tablets”.
You must tell your doctor if you think 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
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


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.


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
Irbesartan/Hydrochlorothiazide Tablets in early pregnancy – see
pregnancy section)

Children and adolescents
Irbesartan/Hydrochlorothiazide Tablets should not be given to children and
adolescents (under 18 years).


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

Other medicines and Irbesartan/Hydrochlorothiazide Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.


if you have diabetes or impaired kidney function and you are treated
with a blood lowering medicine containing aliskiren

The hydrochlorothiazide contained in this medicine could produce a positive
result in an anti-doping test.

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.

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
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
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.
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
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.
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.

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.
If you take more Irbesartan/Hydrochlorothiazide Tablets than you
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
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.
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)



abnormal urination




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).




heart rate increased

and on the blister after EXP. The expiry date refers to the last day of that



This medicinal product does not require any special storage conditions.




sexual dysfunction (problems with sexual performance)


blood tests may show lowered levels of potassium and sodium in your

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 you have any of the side effects above, see a doctor straight away.
Side effects reported since the launch of Irbesartan/ Hydrochlorothiazide
Some undesirable effects have been reported since the marketing 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 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); 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 By reporting side effects
you can help provide more information on the safety of this medicine.

What Irbesartan/Hydrochlorothiazide Tablets contains
The active substances are irbesartan and hydrochlorothiazide. Each filmcoated tablet contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
The other ingredients are
Core: Carboxymethylcellulose Calcium (ECG-505), Colloidal silicon
dioxide (Aerosil 200), Povidone (PVP K29/32), Sodium Starch Glycolate
Type A (Glycolys), Talc & Magnesium Stearate.
Coating: Hypromellose 15 cp (E464), Lactose monohydrate, Titanium
Dioxide (E171) & Polyethylene glycol 3000, Iron oxide red (E172) & Iron
oxide yellow (E172)
What do Irbesartan/Hydrochlorothiazide Tablets look like ?
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.
What is in a pack of Irbesartan/Hydrochlorothiazide Tablets?
Irbesartan/Hydrochlorothiazide 150 mg/12.5 mg tablets are supplied in
blister packs of 28 tablets, 56 tablets and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Macleods Pharma UK Limited,

Wynyard Park House, Wynyard Avenue,
Wynyard, Billingham,TS225TB,
United Kingdom
Mawdsleys Brooks and Co Ltd.
Unit 22, Quest Park, Wheatley Hall Road,
Doncaster, DN2 4LT, United Kingdom.

PL 34771/0088
This medicinal product is authorised in the Member States under the
following names:
United Kingdom: Irbesartan/Hydrochlorothiazide 150 mg/12.5 mg tablets
Irbesartan/Hydrochlorothiazid Heumann 150 mg/12,5
mg filmtabletten
Irbesartan e Idroclorotiazide Macleods Pharma 150 mg/
12,5 mg compresse rivestite con film
Irbesartán/Hidroclorotiazida Viso Farmacéutica 150
mg/12,5 mg comprimidos recubiertos con película
This leaflet was last revised in {06/2015}


Uncommon side effects (may affect up to 1 in 100 people)
· diarrhoea

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

low blood pressure

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.


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.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.