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DAZIROK 300/12.5 MG TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Dazirok 150 mg/12.5 mg tablets
Dazirok 300 mg/12.5 mg tablets
Dazirok 300 mg/25 mg tablets
Irbesartan/hydrochlorothiazide
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, please 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 get serious, or you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1. What Dazirok is and what it is used for
2. Before you take Dazirok
3. How to take Dazirok
4. Possible side effects
5. How to store Dazirok
6. Further information

1. WHAT Dazirok IS AND WHAT IT IS USED FOR
Dazirok 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 Dazirok work together to lower blood pressure further than if either was given
alone.
Dazirok is used in the treatment of high blood pressure (essential hypertension), when treatment
with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.

2. BEFORE YOU TAKE Dazirok
Do not take Dazirok






if you are allergic (hypersensitive) to irbesartan or hydrochlorothiazide, or any of the other ingredients
of Dazirok or to medicines chemically related to sulfonamide (ask your doctor or pharmacist for further
clarification)
If you are more than 3 months pregnant. (It is also better to avoid [Dazirok] in early pregnancy – see
pregnancy section.)
if you have severe liver or kidney problems
if you have difficulty in producing urine
if you have a condition which is associated with persistently high calcium or low potassium

levels in your blood
Dazirok should not be given to children and adolescents (under 18 years).
Take special care with Dazirok
Tell your doctor if any of the following apply to you:
• if you get excessive vomiting or diarrhoea
• if you suffer from kidney problems, including kidney transplantation
• 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 Dazirokion of the hormone
aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
You must tell your doctor if you think that you are (or might become) pregnant. [Dazirok] 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 Dazirok)
• 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
Hydrochlorothiazide contained in this medicine could produce a positive result in an anti-doping test.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Diuretic agents such as the hydrochlorothiazide contained in Dazirok may have an effect on other
medicines. Preparations containing lithium should not be taken with Dazirok without close supervision by
your doctor.
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)

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
Taking Dazirok with food and drink

Dazirok can be taken with or without food.
Due to the hydrochlorothiazide contained in Dazirok, 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 and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your
doctor will normally advise you to stop taking Dazirok before you become pregnant or as soon as you know
you are pregnant and will advise you to take another medicine instead of Dazirok, Dazirok 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 breast-feeding. [Dazirok] is not recommended for
mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to
breast-feed.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. Dazirok 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.
Important information about some of the ingredients of Dazirok
Dazirok 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 Dazirok
Always take Dazirok exactly as your doctor has told you. You should check with your doctor or pharmacist
if you are not sure.
Dosage
Only for Irbesartan/hydrochlorothiazide 150 mg/12.5 mg tablets: The usual dose of Dazirok is one or two tablets a

day.
Only for Irbesartan/hydrochlorothiazide 300 mg /12.5 mg and 300 mg /25 mg tablets: The usual dose of Dazirok is
one tablet a day.
Dazirok will usually be prescribed by your doctor when your previous treatment for high blood pressure did
not provide appropriate blood pressure reduction. Your doctor will instruct you how to switch from the
previous treatment to Dazirok.

Method of administration
Dazirok is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You
can take Dazirok 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 Dazirok 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 Dazirok than you should
If you accidentally take too many tablets, contact your doctor immediately.
Children should not take Dazirok
Dazirok 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 Dazirok
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 Dazirok, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Dazirok can cause side effects, although not everybody gets them.
Some of these effects may be serious and may require medical attention.
As with similar medicines, 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 these symptoms or get short of breath, stop taking Dazirok and contact your doctor
immediately.
Side effects reported in clinical studies for patients treated with Dazirok were:
Common side effects (affect 1 to 10 users in 100):
• 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 (affect 1 to 10 users in 1000):
• 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.
Some undesirable effects have been reported since the marketing of Dazirok but the frequency for them to
occur is not known. These undesirable effects 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.
As for any combination of two active substances, side effects associated with each individual component
cannot be excluded.
In patients taking irbesartan alone, in addition to the side effects listed above, chest pain has also been
reported.
Additional side effects associated with the other component of Dazirok (hydrochlorothiazide) alone are:
loss of appetite; stomach irritation; stomach cramps; constipation; jaundice seen as 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.
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.
5. HOW TO STORE Dazirok
Keep out of the reach and sight of children.
Do not use Dazirok 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.
This medicinal Dazirok does not require any special storage conditions.
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.

6. FURTHER INFORMATION
What Dazirok contains
The active substances are irbesartan and hydrochlorothiazide.
Dazirok 150 mg /12.5 mg tablets
Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Dazirok 300 mg /12.5 mg tablets
Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Dazirok 300 mg /25 mg tablets
Each tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.

The other ingredients are: povidone, magnesium stearate, Cellulose microcrystalline, lactose
monohydrate, sodium croscarmellose, Sillica, colloidal anhydrous, hydrogenated castor oil and maize
starch.
What Dazirok looks like and contents of the pack
Each tablet of Dazirok 150 mg /12.5 mg, 300 mg /12.5 mg and 300 mg /25 mg tablets contain 150 mg /12.5
mg, 300 mg /12.5 mg and 300 mg /25 mg of irbesartan/hydrochlorothiazide.
Dazirok 150 mg /12.5 mg tablets are white, cylindrical, biconvex tablets, embossed 1H1 on one side.
Dazirok 300 mg /12.5 mg tablets are white, oblong, biconvex tablets, embossed 1H12 on one side.
Dazirok 300 mg /25 mg tablets are white, oblong, biconvex tablets, embossed 1H25 on one side.
Dazirok 150 mg /12.5 mg, 300 mg /12.5 mg and 300 mg /25 mg tablets are supplied in”pack sizes” of 14,
28, 56 or 98.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Laboratorios LICONSA, S.A.
Gran Vía Carlos III, 98, 7th floor
08028 Barcelona, SPAIN
Manufacturers:
LABORATORIOS LICONSA S.A.
Avd. Miralcampo, 7
Avda. Miralcampo, no 7
Poligono Industrial Miralcampo
19200 AZUQUECA DE HENARES (Guadalajara)
Spain
This medicinal Dazirok is authorised in the Member States of the EEA under the following names:

The Netherlands, Germany, Austria, United Kingdom

Dazirok 150/12.5, 300/12.5 and 300/25 mg tablets
This leaflet was last approved in:

Expand Transcript

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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