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IRBESARTAN/HYDROCHLOROTHIAZIDE 300 MG/25 MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / IRBESARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Irbesartan/Hydrochlorothiazide 300 mg/25 mg
film-coated tablets

·

if you get excessive vomiting or diarrhoea

·

if you suffer from kidney problems or have a kidney transplant

Irbesartan/Hydrochlorothiazide

·

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.

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
1. WHAT IRBESARTAN/HYDROCHLOROTHIAZIDE TABLETS
IS AND WHAT IT IS 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 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

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
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.

·

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

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 an ACE-inhibitor or aliskiren (see also information under
the headings “Do not take Irbesartan/Hydrochlorothiazide Tablets” 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 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
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 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.
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.

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 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

This medicinal product does not require any special storage conditions.

·

flushing

·

swelling

·

sexual dysfunction (problems with sexual performance)

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.

·

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 you have any of the side effects above, see a doctor straight away.
Side effects reported since the launch of Irbesartan/ Hydrochlorothiazide
Tablets
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 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); 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.

6. FURTHER INFORMATION
What Irbesartan/Hydrochlorothiazide Tablets contains
The active substances are irbesartan and hydrochlorothiazide. Each filmcoated tablet contains 300 mg irbesartan and 25 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) & Iron oxide black (E172)
What do Irbesartan/Hydrochlorothiazide Tablets look like ?
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.
What is in a pack of Irbesartan/Hydrochlorothiazide Tablets?
Irbesartan/Hydrochlorothiazide 300 mg/25 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
Manufacturer
Mawdsleys Brooks and Co Ltd.
Unit 22, Quest Park, Wheatley Hall Road,
Doncaster, DN2 4LT, United Kingdom.

PL 34771/0090
This medicinal product is authorised in the Member States under the
following names:
United Kingdom: Irbesartan/Hydrochlorothiazide 300 mg/25 mg tablets
Germany:
Irbesartan/Hydrochlorothiazid Heumann 300 mg/25 mg
filmtabletten
Italy:
Irbesartan e Idroclorotiazide Macleods Pharma 300 mg/
25 mg compresse rivestite con film
Spain:
Irbesartán/Hidroclorotiazida Viso Farmacéutica 300 mg/
25 mg comprimidos recubiertos con película

This leaflet was last revised in {06/2015}

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.

PM01189205

Dosage
The usual dose of Irbesartan/Hydrochlorothiazide Tablets is one tablet 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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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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