Skip to Content

UK Edition. Click here for US version.

IRBESARTAN AND HYDROCHLOROTHIAZIDE BRISTOL 300/12.5MG FILM-COATED TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / IRBESARTAN

View full screen / Print PDF » Download PDF ⇩
Transcript
30 mm

8 mm

IRBESARTAN AND HYDROCHLOROTHIAZIDE
150/12.5 mg, 300/12.5 mg, 300/25 mg
FILM-COATED TABLETS
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 this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

1. What this medicine is and what it is used for
This medicine 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 this medicine work together to lower
blood pressure further than if either was given alone.

Same size artwork
420 mm x 170 mm
Front

This medicine 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 this
medicine
Do not take this medicine
• 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 medicine
• if you are more than 3 months pregnant. (It is also better to
avoid this medicine 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 blood pressure lowering medicine
containing aliskiren.
Warnings and precautions
Talk to your doctor before taking this medicine 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 this medicine”
You must tell your doctor if you think you are (or might become)
pregnant. This medicine 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 this
medicine)
• 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 this medicine. This could be a sign
that you are developing glaucoma, increased pressure in your
eye(s). You should discontinue treatment with this medicine
and seek medical attention.

Taking other medicines
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 this
medicine may have an effect on other medicines. Preparations
containing lithium should not be taken with this medicine 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 this medicine” 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.

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 this
medicine before you become pregnant or as soon as you know
you are pregnant and will advise you to take another medicine
instead of this medicine. This medicine 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 breastfeeding. This medicine 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. This medicine 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.
This medicine 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 this medicine
The hydrochlorothiazide contained in this medicine could produce a
positive result in an anti-doping test.

Taking with food and drink
This medicine can be taken with or without food.

Children and adolescents
This medicine should not be given to children and adolescents
(under 18 years).

Due to the hydrochlorothiazide contained in this medicine 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.

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 this medicine is one or two tablets a day.
It will usually be prescribed by your doctor when your previous
treatment did not reduce your blood pressure enough.

XXXXX

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Use in children and adolescents
This medicine should not be given to children under 18 years of
age. If a child swallows some tablets, contact your doctor
immediately.
Route and method of administration
This medicine is for oral use. Swallow the tablets with a sufficient
amount of fluid (e.g. one glass of water). You can take this medicine
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 this medicine
until your doctor tells you otherwise.
The score line on 300/25 mg tablet is not intended for breaking the
tablet.
The maximal blood pressure lowering effect should be reached 6-8
weeks after beginning treatment.
If you take more of this medicine than you should
If you accidentally take too many tablets, contact your doctor
immediately.
If you forget to take this medicine
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.
Stop taking this medicine and contact your doctor
immediately if you notice any of the below side effects:

Same size artwork
420 mm x 170 mm
Back

• Rare cases of allergic skin reactions (rash, hives), as well as
localised swelling of the face, lips and/or tongue, shortness of
breath
• Rapid heart beat (tachycardia) or altered heart beat
• Kidney problems -symptoms include nausea, vomiting,
changes in urine output, fatigue, weakness, loss of appetite,
difficulty in breathing
• Liver problems e.g. hepatitis and jaundice (symptoms include
abdominal pain, dark urine, feeling sick, yellowing of the skin
and whites of eyes)
• Inflammation of the pancreas characterised by severe upper
stomach pain, often with nausea and vomiting
• 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
• Lung problems including pneumonia or build-up of fluid in the
lungs
• Serious skin reactions like toxic epidermal necrolysis
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
Side effects reported in clinical studies for patients treated with
irbesartan and hydrochlorothiazide 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 cause you problems, talk to your
doctor.

Uncommon side effects (may affect up to 1 in 100 people):
• diarrhoea
• low blood pressure
• fainting
• 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 cause you problems, talk to your
doctor.
Post-marketing side effects
Some undesirable effects have been reported since 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, increased
level of potassium in your blood.
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;
sleep disorders; depression; blurred vision; increased sensitivity of
the skin to the sun; inflammation of blood vessels; weakness
and muscle spasm; 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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.

What these tablets look like and contents of the pack
• 150/12.5 mg: Light pink, oblong, biconvex film-coated tablets
• 300/12.5 mg: Light pink, oblong, biconvex film-coated tablets
• 300/25 mg: Pink, oblong, biconvex, film-coated tablets with a
scoreline on one side and plain on the other side.
• This medicine is available in blister packs of 14, 28, 56 or 98
tablets. Not all pack sizes may be marketed.

5. How to store this medicine
• 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 30ºC. Store in the original package in order
to protect from light and 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 this medicine contains
• The active substances are irbesartan and hydrochlorothiazide.
• Each tablet of 150/12.5 mg contains 150 mg irbesartan and
12.5 mg hydrochlorothiazide.
• Each tablet of 300/12.5 mg contains 300 mg irbesartan and
12.5 mg hydrochlorothiazide.
• Each tablet of 300/25 mg contains 300 mg irbesartan and 25 mg
hydrochlorothiazide.
• The other ingredients are:
Tablet core: microcrystalline cellulose, croscarmellose sodium,
lactose monohydrate, magnesium stearate, poloxamer
pregelatinised maize starch.
Film-coating (150/12.5 mg, 300/12.5 mg): Hypromellose,
Titanium dioxide (E171), Purified stearic acid, Microcrystalline
cellulose, Iron oxide yellow (E172), Iron oxide red (E172).
Film-coating (300/25 mg): Hypromellose, Titanium dioxide
(E171), Purified stearic acid, Microcrystalline cellulose, Iron
oxide red (E172), Iron oxide black (E172).

Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire, HP4 1EG,
United Kingdom
Telephone: 0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
Irbesartan and Hydrochlorothiazide
150/12.5 mg film-coated tablets; PL 17907/0517
Irbesartan and Hydrochlorothiazide
300/12.5 mg film-coated tablets; PL 17907/0518
Irbesartan and Hydrochlorothiazide
300/25 mg film-coated tablets; PL 17907/0519
This leaflet was last revised in March 2016.
To request a copy of this leaflet in Braille, large print or audio format,
contact the licence holder at the address (or telephone, fax, email)
above.

V8 02-03-16 D0

XXXXX

Your doctor will instruct you how to switch from the previous treatment
to this medicine.

Expand view ⇕

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.

Hide