Irbesartan 150mg/12.5mg (Irbesartan, Diuretics) – електронний рецепт у Італії

Сторінка містить загальну інформацію. За персональною рекомендацією зверніться до лікаря. У разі гострих або небезпечних симптомів зверніться до екстрених служб.

Інструкція із застосування IRBESARTAN YDROKLOROTIATSIDE TSENTIVA

Зміст інструкції

Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tablets
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tablets
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg film-coated tablets
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg film-coated tablets
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg contains 300 mg of irbesartan and
Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets

Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tablets

irbesartan/hydrochlorothiazide

Read 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to others, even if their symptoms are the same as yours.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Irbesartan Hydrochlorothiazide Zentiva is and what it is used for
2. What you need to know before you take Irbesartan Hydrochlorothiazide Zentiva
3. How to take Irbesartan Hydrochlorothiazide Zentiva
4. Possible side effects
5. How to store Irbesartan Hydrochlorothiazide Zentiva
6. Contents of the pack and other information

1. What is Irbesartan Hydrochlorothiazide Zentiva and what it is used for

Irbesartan Hydrochlorothiazide Zentiva is a combination of two active substances: irbesartan and
hydrochlorothiazide.
Irbesartan belongs to a group of drugs known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to its
receptors, located in blood vessels, causing a narrowing of the latter. This leads to an
increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these
receptors, causing a relaxation of blood vessels and a lowering of blood pressure.
Hydrochlorothiazide belongs to a group of medicines (so-called thiazide diuretics) that
determine an increased production of urine with a consequent lowering of blood
pressure.
The two active ingredients of Irbesartan Hydrochlorothiazide Zentiva work together determining a
lowering of blood pressure values that is greater than that caused by the individual drugs administered
separately.

Irbesartan Hydrochlorothiazide Zentiva is used to treat high blood pressurewhen the
treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled its blood
pressure.

2. What you need to know before taking Irbesartan Hydrochlorothiazide Zentiva

Do not take Irbesartan Hydrochlorothiazide Zentiva

if you are allergicto irbesartan or to any of the other ingredients of this medicine (listed in section 6).
if you are allergicto hydrochlorothiazide or to any medicines derived from sulfonamides
if you are pregnant for more than 3 months(it is best to avoid taking Irbesartan Hydrochlorothiazide Zentiva even in the early stages of pregnancy - see section Pregnancy)
if you have serious problems with your liver or kidneys
if you have difficulty urinating
if your doctor finds that you have a persistently high level of calcium or a low level of potassiumin your blood
if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren

Warnings and precautions
Talk to your doctor before taking Irbesartan Hydrochlorothiazide Zentiva and if you are in any of the
following conditions:

excessive vomiting or diarrhoea
if you suffer from kidney disordersor have had a kidney transplant
if you suffer from heart disorders
if you suffer from liver disorders
if you suffer from diabetes
if you develop low blood sugar levels (symptoms can include sweating, weakness, hunger, dizziness, tremor, headache, flushing or pallor, numbness, fast and pounding heartbeat), especially if you are being treated for 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, subsequently, 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), especially if you suffer from kidney problems related to diabetes
aliskiren
if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Irbesartan Hydrochlorothiazide Zentiva
if you have had breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking it, consult your doctor immediately.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes
(such as potassium) in your blood at regular intervals.
See also what is stated in the section "Do not take Irbesartan Hydrochlorothiazide Zentiva”.
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Irbesartan Hydrochlorothiazide Zentiva is not recommended in early
pregnancy and should not be taken if you are more than 3 months pregnant, as it can
cause serious harm to the baby if taken during this period (see section Pregnancy).

Also, tell your doctor:

if you are following a low-salt diet
if you have symptoms such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting,or a heartbeat that is excessively fastwhich may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan Hydrochlorothiazide Zentiva)
if you have noticed an increase, faster than normal, in skin sensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, rash)
if you are going to have surgeryor receive anaesthetics

if you experience decreased vision or pain in one or both eyes while taking Irbesartan Hydrochlorothiazide Zentiva. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye (glaucoma) and can occur within a period ranging from a few hours to a week after taking Irbesartan Hydrochlorothiazide Zentiva. If left untreated, they can lead to

permanent vision loss. If you have previously had an allergy to penicillin or
sulfonamides, you may be at greater risk of developing this consequence. You should stop
Irbesartan Hydrochlorothiazide Zentiva and consult your doctor promptly.
Hydrochlorothiazide, contained in this medicine, can give positive results in doping tests.

Children and adolescents
Irbesartan Hydrochlorothiazide Zentiva should not be given to children and adolescents (under
18 years of age)

Other medicines and Irbesartan Hydrochlorothiazide Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Diuretic medicines like hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide Zentiva can
have an effect on other medicines. Preparations containing lithium should not be taken
together with Irbesartan Hydrochlorothiazide Zentiva unless under strict medical control.
The doctor may need to adjust the dose and / or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take
Irbesartan Hydrochlorothiazide Zentiva” and "Warnings and precautions”)

You may need blood tests if you are using:

potassium supplements
salt substitutes containing potassium
potassium-sparing diuretics or other diuretics
some laxatives
medicines for the treatment of gout
vitamin D supplements
medicines to control the heartbeat
medicines for diabetes (oral medicines such as repaglinide or insulin)
carbamazepine (a medicine for the treatment of epilepsy).

It is also important to tell your doctor if you are taking other medicines to lower your blood
pressure, steroids, cancer medicines, pain medicines, for arthritis or colestyramine and
colestipol to lower cholesterol levels in the blood.

Irbesartan Hydrochlorothiazide Zentiva with food and drink
Irbesartan Hydrochlorothiazide Zentiva can be taken with or without food.
Due to the hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide Zentiva, if you drink alcohol
during therapy with this medicine, you may feel more dizzy when standing up, especially when moving from a sitting to an upright position.

Pregnancy, breastfeeding and fertility
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant); your doctor will usually advise you to stop taking Irbesartan
Hydrochlorothiazide Zentiva before becoming pregnant or as soon as you find out you are
pregnant and will advise you to take another medicine instead of Irbesartan
Hydrochlorothiazide Zentiva. Irbesartan Hydrochlorothiazide Zentiva is not recommended in early
pregnancy and should not be taken if you are more than 3 months pregnant as it can
cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Irbesartan Hydrochlorothiazide
Zentiva is not recommended for women who are breastfeeding and your doctor may choose another
treatment for you if you wish to breastfeed, especially if the baby is newborn or premature.

Driving and operating machinery
It is unlikely that Irbesartan Hydrochlorothiazide Zentiva will affect your ability to drive vehicles
or operate machinery. However, dizziness or fatigue may occasionally occur during
treatment for high blood pressure. If this happens to you, talk to your doctor before driving vehicles or operating
machinery.

Irbesartan Hydrochlorothiazide Zentiva contains lactose.If you have been diagnosed with a
lactose intolerance, contact your doctor before taking this medicine.

Irbesartan Hydrochlorothiazide Zentiva contains sodium.This medicine contains less than 1
mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Irbesartan Hydrochlorothiazide Zentiva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

Dosage
The recommended dose of Irbesartan Hydrochlorothiazide Zentiva is one or two tablets a day.
Irbesartan Hydrochlorothiazide Zentiva will be prescribed by your doctor if previous therapy has not
sufficiently reduced your blood pressure. The doctor will advise you on how to switch from
previous treatment to treatment with Irbesartan Hydrochlorothiazide Zentiva.

Method of administration
Irbesartan Hydrochlorothiazide Zentiva is for oral use. Swallow the tablets with a sufficient
amount of liquid (for example a glass of water). You can take Irbesartan Hydrochlorothiazide
Zentiva with or without food. You should try to take the medicine at the same time each day. It is
important to continue the therapy unless otherwise indicated by your doctor.
The maximum blood pressure lowering effect should be achieved after 6-8 weeks
from the start of treatment.

Children should not take Irbesartan Hydrochlorothiazide Zentiva
Irbesartan Hydrochlorothiazide Zentiva should not be given to children under 18 years of age.
If a child swallows tablets, contact your doctor immediately.

If you take more Irbesartan Hydrochlorothiazide Zentiva than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan Hydrochlorothiazide Zentiva
If you forget to take a dose of the medicine, continue with the therapy as normal. Do not take a
double dose to make up for a missed dose.
If you have any doubts about 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 everyone will experience them.
Some of these effects may be serious and may require medical attention.
In patients treated with irbesartan, rare cases of allergic skin reactions (rash, hives) as well as localized swelling of the face, lips and/or tongue have been reported. If you experience any of the above symptoms or have difficulty breathing, stop taking Irbesartan Hydrochlorothiazide
Zentiva and contact your doctor immediately.
The frequency of the side effects listed below is defined using the following convention:
Common: may occur in up to 1 in 10 patients
Uncommon: may occur in up to 1 in 100 patients
Very rare: may occur in up to 1 in 10,000 patients
The side effects reported in clinical studies in patients treated with Irbesartan
Hydrochlorothiazide Zentiva were:

Common side effects(may occur in up to 1 in 10 patients)

nausea/vomiting
urinary disorders
fatigue
dizziness (even when moving from a sitting or lying position to an upright position)
blood tests may show increased levels of an enzyme that measures muscle and cardiac function (creatine kinase) or increased levels of substances that measure kidney function (azotemia, creatinine). Tell your doctor if any of these side effects cause you problems.

Uncommon side effects(may occur in up to 1 in 100 patients)

diarrhea
hypotension
weakness
fast heartbeat
hot flashes
swelling
sexual dysfunction (problems with sexual activity)
blood tests may show decreased levels of potassium and sodium in the blood. Tell your doctor if any of these side effects cause you problems.

Side effects reported after marketing of Irbesartan Hydrochlorothiazide
Zentiva
Since the marketing of Irbesartan Hydrochlorothiazide Zentiva, some side effects have been reported.
Side effects with unknown frequency are: headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, abnormal liver function and renal dysfunction, high levels of potassium in the blood and allergic reactions (rash, hives, localized 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 with any combination of two active substances, side effects associated with each of the
components cannot be excluded.

Side effects associated with irbesartan alone
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock), decreased number of red blood cells (anemia - symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and paleness) and decreased number of platelets (blood cells essential for blood clotting) have 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 characterized by severe pain in the upper part of the stomach, often with nausea and vomiting; sleep disturbances; depression; lack of white blood cells, which can lead to frequent infections, fever; decreased number of platelets (essential component for blood clotting), decreased number of red blood cells (anemia) characterized by fatigue, headache, shortness of breath during exercise, dizziness and paleness; kidney problems; lung problems including pneumonia or increased fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disorder characterized by peeling skin all over the body; lupus erythematosus, identified by a rash that may appear on the face, neck and scalp; allergic reactions; weakness and muscle spasm; altered heartbeat; lowering of blood pressure following a change in body position; swelling of the salivary glands; high levels of sugar in the blood; sugar in the urine; increases in certain types of fat in the blood; high levels of uric acid in the blood, which can cause gout.

Very rare side effects(may occur in up to 1 in 10,000 patients):

acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion). Not known (the frequency cannot be established based on available data): skin cancer and lip cancer (non-melanoma skin cancer); blurred vision; decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

It is known that the side effects associated with hydrochlorothiazide can increase with higher doses of
hydrochlorothiazide.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist .
You can also report side effects directly through the national reporting system
reported in Annex V .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Irbesartan Hydrochlorothiazide Zentiva

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 package and blister after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package to protect it from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Irbesartan Hydrochlorothiazide Zentiva contains

The active ingredients are irbesartan and hydrochlorothiazide. Each tablet of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
The other ingredients are: microcrystalline cellulose, reticulated sodium carboxymethylcellulose, lactose monohydrate, magnesium stearate, hydrated colloidal silica, pregelatinized corn starch, red and yellow iron oxides (E172). See section 2 “Irbesartan Hydrochlorothiazide Zentiva contains lactose”.

Description of the appearance of Irbesartan Hydrochlorothiazide Zentiva and package contents
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets are peach-colored, biconvex,
oval, with a heart imprinted on one side and the number 2775 on the other side.
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets are supplied in packs
containing blisters of 14, 28, 56, or 98 tablets. Packs containing divisible blisters
for unit dose of 56 x 1 tablet for hospital use are also available.
Not all pack sizes may be marketed.

Marketing authorisation holder
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer
Sanofi Winthrop Industrie
1 Rue de la vierge
Ambarès et Lagrave
33 565 Carbon Blanc Cedex
France
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel
37 100 Tours
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 280 86 420
[email protected]

Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]

България
Zentiva, k.s.
Тел: +35924417136
[email protected]

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]

Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]

Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]

Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]

Malta
Zentiva, k.s.
Tel: +356 2778 0890
[email protected]

Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]

Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]

Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]

Norge
Zentiva Denmark ApS
Tlf: +47 219 66 203
[email protected]

Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]

España
Zentiva, k.s.
Tel: +34 931 815 250
[email protected]

Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]

France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]

Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]

Hrvatska
Zentiva, d.o.o.
Tel: +385 1 6641 830
[email protected]

Ireland
Zentiva Denmark ApS
Tel: +353 766 803 944
[email protected]

România
ZENTIVA S.A.
Tel: +4 021.304.7597
[email protected]

Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]

Ísland
Zentiva, k.s.
Sími: +354 539 0650
[email protected]

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]

Italia
Zentiva Italia S.r.l.
Tel: +39-02-38598801
[email protected]

Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]

Κύπρος
Zentiva, k.s.
Τηλ: +357 240 30 144
[email protected]

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]

United Kingdom (Northern Ireland)
Zentiva, k.s.
Tel: +44 (0) 800 090 2408
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .

Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]

Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tablets

irbesartan/hydrochlorothiazide

Read 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to them, even if their symptoms are the same as yours.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What is Irbesartan Hydrochlorothiazide Zentiva and what it is used for
2. What you need to know before you take Irbesartan Hydrochlorothiazide Zentiva
3. How to take Irbesartan Hydrochlorothiazide Zentiva
4. Possible side effects
5. How to store Irbesartan Hydrochlorothiazide Zentiva
6. Contents of the pack and other information

1. What is Irbesartan Hydrochlorothiazide Zentiva and what it is used for

Irbesartan Hydrochlorothiazide Zentiva is a combination of two active substances: irbesartan and
hydrochlorothiazide.
Irbesartan belongs to a group of drugs known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to its
receptors, located in blood vessels, causing a narrowing of the latter. This leads to an
increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these
receptors, causing a relaxation of blood vessels and a lowering of blood pressure.
Hydrochlorothiazide belongs to a group of medicines (so-called thiazide diuretics) that
determine an increased production of urine with a consequent lowering of blood
pressure.
The two active ingredients of Irbesartan Hydrochlorothiazide Zentiva work together determining a
lowering of blood pressure values that is greater than that caused by the individual drugs administered
separately.

Irbesartan Hydrochlorothiazide Zentiva is used to treat high blood pressurewhen the
treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled its blood
pressure.

2. What you need to know before taking Irbesartan Hydrochlorothiazide Zentiva

Do not take Irbesartan Hydrochlorothiazide Zentiva

if you are allergicto irbesartan or to any of the other ingredients of this medicine (listed in section 6).
if you are allergicto hydrochlorothiazide or to any medicines derived from sulfonamides
if you are pregnant for more than 3 months(it is best to avoid taking Irbesartan Hydrochlorothiazide Zentiva even in the early stages of pregnancy - see section Pregnancy)
if you have severe liver or kidney problems
if you have difficulty urinating
if your doctor finds that you have a persistently high level of calcium or a low level of potassiumin your blood
if you suffer from diabetes or your kidney function is impairedand you are being treated with a medicine that lowers blood pressure, containing aliskiren

Warnings and precautions
Talk to your doctor before taking Irbesartan Hydrochlorothiazide Zentiva and if you are in any of the
following conditions:

excessive vomiting or diarrhea
if you suffer from kidney disordersor have had a kidney transplant
if you suffer from heart disorders
if you suffer from liver disorders
if you suffer from diabetesif you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, numbness, fast or pounding heartbeat), especially if you are being treated for diabetes
if you suffer from lupus erythematosus(also known as lupus or SLE)
if you suffer from primary aldosteronism(a condition related to excessive production of the hormone aldosterone, which causes sodium retention and, subsequently, 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), especially if you suffer from kidney problems related to diabetes
aliskiren
if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Irbesartan Hydrochlorothiazide Zentiva
if you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If after taking it, you experience shortness of breath or severe difficulty breathing, consult a doctor immediately.

The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also what is reported in the section "Do not take Irbesartan Hydrochlorothiazide Zentiva”
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Irbesartan Hydrochlorothiazide Zentiva is not recommended in early
pregnancy and should not be taken if you are pregnant for more than 3 months, as it may
cause serious harm to the baby if taken during this period (see section Pregnancy).

Also, tell your doctor:

if you are following a low-salt diet
if you have symptoms such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting,or a heartbeat that is too fastwhich may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan Hydrochlorothiazide Zentiva)
if you have noticed an increase, faster than normal, in skin sensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, rash)
if you are going to have surgeryor receive anesthesia

if you experience blurred vision or pain in one or both eyes while taking Irbesartan Hydrochlorothiazide Zentiva. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye (glaucoma) and can occur within a period ranging from a few hours to a week after taking Irbesartan Hydrochlorothiazide Zentiva. If left untreated, they can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at greater risk of developing this consequence. You should stop Irbesartan Hydrochlorothiazide Zentiva and consult a doctor promptly.
Hydrochlorothiazide, contained in this medicine, can give positive results in doping tests.

Children and adolescents
Irbesartan Hydrochlorothiazide Zentiva should not be given to children and adolescents (under
18 years of age)

Other medicines and Irbesartan Hydrochlorothiazide Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Diuretic medicines like hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide Zentiva can
have an effect on other medicines. Preparations containing lithium should not be taken
together with Irbesartan Hydrochlorothiazide Zentiva unless under strict medical control.
The doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also what is reported in the section: "Do not take
Irbesartan Hydrochlorothiazide Zentiva” and "Warnings and precautions”)

You may need blood tests if you are using:

potassium supplements
salt substitutes that contain potassium
potassium-sparing diuretics or other diuretics
some laxatives
medicines for the treatment of gout
vitamin D supplements
medicines to control the heartbeat
medicines for diabetes (oral medicines such as repaglinide or insulin)
carbamazepine (a medicine for the treatment of epilepsy).

It is also important to tell your doctor if you are taking other medicines to lower blood
pressure, steroids, cancer medicines, pain medicines, for arthritis or colestyramine and
colestipol to lower cholesterol levels in the blood.

Irbesartan Hydrochlorothiazide Zentiva with food and drink
Irbesartan Hydrochlorothiazide Zentiva can be taken with or without food.
Due to the hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide Zentiva, if you drink alcohol
during therapy with this medicine, while standing, you may feel more
dizzy, especially when moving from a sitting to an upright position.

Pregnancy, breastfeeding and fertility
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant); your doctor will usually advise you to stop taking Irbesartan
Hydrochlorothiazide Zentiva before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Irbesartan
Hydrochlorothiazide Zentiva. Irbesartan Hydrochlorothiazide Zentiva is not recommended in early
pregnancy and should not be taken if you are pregnant for more than 3 months as it may
cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Irbesartan Hydrochlorothiazide
Zentiva is not recommended for women who are breastfeeding and your doctor may choose another
treatment for you if you wish to breastfeed, especially if the baby is newborn or premature.

Driving and operating machinery
It is unlikely that Irbesartan Hydrochlorothiazide Zentiva will affect your ability to drive vehicles
or operate machinery. However, dizziness or fatigue may occasionally occur during
treatment for high blood pressure. If this happens to you, talk to your doctor before driving vehicles or using
machinery.

Irbesartan Hydrochlorothiazide Zentiva contains lactose.If you have been diagnosed with a
lactose intolerance, contact your doctor before taking this medicine.

Irbesartan Hydrochlorothiazide Zentiva contains sodium.This medicine contains less than 1
mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Irbesartan Hydrochlorothiazide Zentiva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

Dosage
The recommended dose of Irbesartan Hydrochlorothiazide Zentiva is one tablet a day. Irbesartan
Hydrochlorothiazide Zentiva will be prescribed by your doctor if previous therapy has not
sufficiently reduced your blood pressure. The doctor will advise you on how to switch from previous
treatment to treatment with Irbesartan Hydrochlorothiazide Zentiva.

Method of administration
Irbesartan Hydrochlorothiazide Zentiva is for oral use. Swallow the tablets with a sufficient
amount of liquid (for example a glass of water). You can take Irbesartan Hydrochlorothiazide
Zentiva with or without food. You should try to take the medicine at the same time each day. It is
important to continue therapy unless otherwise indicated by your doctor.
The maximum blood pressure lowering effect should be achieved after 6-8 weeks
from the start of treatment.

Children should not take Irbesartan Hydrochlorothiazide Zentiva
Irbesartan Hydrochlorothiazide Zentiva should not be given to children under 18 years of age.
If a child swallows tablets, contact your doctor immediately.

If you take more Irbesartan Hydrochlorothiazide Zentiva than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan Hydrochlorothiazide Zentiva
If you forget to take a dose of the medicine, continue therapy as normal. Do not take a
double dose to compensate for a missed dose.
If you have any doubts about 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 everyone gets them.
Some of these effects may be serious and may require medical attention.
In patients treated with irbesartan, rare cases of allergic skin reactions (rash, hives) as well as localized swelling of the face, lips and/or tongue have been reported. If you experience any of the above symptoms or have difficulty breathing, stop taking Irbesartan Hydrochlorothiazide
Zentiva 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
Very rare: may affect up to 1 in 10,000 people
The side effects reported in clinical studies in patients treated with Irbesartan
Hydrochlorothiazide Zentiva were:

Common side effects(may affect up to 1 in 10 people)

nausea/vomiting
urinary disorders
fatigue
dizziness (even when moving from a sitting or lying position to an upright position)
blood tests may show increased levels of an enzyme that measures muscle and cardiac function (creatine kinase) or increased levels of substances that measure kidney function (azotemia, creatinine). Tell your doctor if any of these side effects cause you problems.

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

diarrhea
hypotension
weakness
fast heartbeat
hot flashes
swelling
sexual dysfunction (problems with sexual activity)
blood tests may show decreased levels of potassium and sodium in the blood. Tell your doctor if any of these side effects cause you problems.

Side effects reported after marketing of Irbesartan Hydrochlorothiazide
Zentiva
Since Irbesartan Hydrochlorothiazide Zentiva became available, some side effects have been reported. Side effects with unknown frequency are: headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, abnormal liver function and kidney dysfunction, high levels of potassium in the blood and allergic reactions (rash, hives, localized 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 with any combination of two active substances, side effects associated with each of the
components cannot be ruled out.

Side effects associated with irbesartan alone
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock), decreased number of red blood cells (anemia - symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and paleness) and decreased number of platelets (blood cells essential for blood clotting) have 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 characterized by severe pain in the upper abdomen, often with nausea and vomiting; sleep disturbances; depression; lack of white blood cells, which can lead to frequent infections, fever; decreased number of platelets (an essential component for blood clotting), decreased number of red blood cells (anemia) characterized by fatigue, headache, shortness of breath during exercise, dizziness and paleness; kidney problems; lung problems including pneumonia or increased fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin condition characterized by scaling of the skin all over the body; lupus erythematosus, identified by a rash that may appear on the face, neck and scalp; allergic reactions; muscle weakness and spasm; altered heartbeat; lowering of blood pressure after a change in body position; swelling of the salivary glands; high levels of sugar in the blood; sugar in the urine; increases in certain types of fat in the blood; high levels of uric acid in the blood which can cause gout.

Very rare side effects(may affect up to 1 in 10,000 people):

acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Not known (the frequency cannot be estimated based on available data): skin and lip cancer (non-melanoma skin cancer); blurred vision; decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
It is known that the side effects associated with hydrochlorothiazide may increase with higher doses of
hydrochlorothiazide.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist .
You can also report side effects directly through the national reporting system reported in Annex V .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Irbesartan Hydrochlorothiazide Zentiva

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 package and on the blister after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package to protect it from moisture.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Irbesartan Hydrochlorothiazide Zentiva contains

The active ingredients are irbesartan and hydrochlorothiazide. Each tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
The other ingredients are: microcrystalline cellulose, cross-linked sodium carboxymethyl cellulose, lactose monohydrate, magnesium stearate, hydrated colloidal silica, pregelatinized corn starch, red and yellow iron oxides (E172). See section 2 “Irbesartan Hydrochlorothiazide Zentiva contains lactose”.

Description of the appearance of Irbesartan Hydrochlorothiazide Zentiva and package contents
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets are peach-colored, biconvex,
oval, with a heart imprinted on one side and the number 2776 on the other side.
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets are supplied in packs
containing blisters of 14, 28, 56, or 98 tablets. Packs containing divisible blisters are also available
for unit dose use of 56 x 1 tablet for hospital use.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
102 37 Prague 10
Czech Republic