Irbesartan and hydrochlorothiazide Zentiva: detailed information

Patient Information Leaflet

Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets

irbesartan/hydrochlorothiazide
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people. This medicine may be harmful to others, even if their symptoms are the same as yours.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Irbesartan Hydrochlorothiazide Zentiva is and what it is used for
What you need to know before taking Irbesartan Hydrochlorothiazide Zentiva
How to take Irbesartan Hydrochlorothiazide Zentiva
Possible side effects
How to store Irbesartan Hydrochlorothiazide Zentiva
Contents of the pack and other information

1. What Irbesartan Hydrochlorothiazide Zentiva is 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 medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to its receptors located on blood vessels, causing them to narrow. This leads to an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, resulting in relaxation of the blood vessels and a lowering of blood pressure.
Hydrochlorothiazide belongs to a group of medicines (so-called thiazide diuretics) that increase urine production, thereby lowering blood pressure.
The two active ingredients in Irbesartan Hydrochlorothiazide Zentiva work together to lower blood pressure to a greater extent than either medicine alone.
Irbesartan Hydrochlorothiazide Zentiva is used to treat high blood pressure when treatment with either irbesartan or hydrochlorothiazide alone has not adequately controlled your blood pressure.

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

Do not take Irbesartan Hydrochlorothiazide Zentiva

if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to hydrochlorothiazide or to any sulfonamide-derived medicines
if you are more than 3 months pregnant (it is best to avoid taking Irbesartan Hydrochlorothiazide Zentiva even in early pregnancy – see section Pregnancy)
if you have severe liver or kidney problems
if you have difficulty urinating
if your doctor has diagnosed you with persistently high calcium levels or low potassium levels in the blood
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

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

excessive vomiting or diarrhoea
if you have kidney disorders or have had a kidney transplant
if you have heart problems
if you have liver problems
if you have diabetes
if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and pounding heartbeat), especially if you are being treated for diabetes
if you have systemic lupus erythematosus (also known as lupus or SLE)
if you have primary hyperaldosteronism (a condition characterised by excessive production of the hormone aldosterone, leading to sodium retention and subsequently increased blood pressure)
if you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
- aliskiren
if you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Irbesartan Hydrochlorothiazide Zentiva
if you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking the medicine, consult a doctor immediately.

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

if you are on a low-salt diet
if you experience symptoms such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or a rapid heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan Hydrochlorothiazide Zentiva)
if you have noticed an increased, faster-than-normal sensitivity of the skin to sunlight, with symptoms of sunburn (such as redness, itching, swelling, rash)
if you are scheduled for surgery or need to take anaesthetics
- if you experience vision changes or eye 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 increased pressure in the eye (glaucoma), which may occur from a few hours to a week after taking Irbesartan Hydrochlorothiazide Zentiva. If left untreated, these conditions can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition. You must stop taking Irbesartan Hydrochlorothiazide Zentiva and contact your doctor immediately.
  Hydrochlorothiazide, contained in this medicine, may cause positive results in doping tests.
  Children and adolescents
  Irbesartan Hydrochlorothiazide Zentiva must not be given to children and adolescents (under 18 years of age).
  Other medicines and Irbesartan Hydrochlorothiazide Zentiva
  Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
  Diuretics such as hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide Zentiva may interact with other medicines. Preparations containing lithium must not be taken together with Irbesartan Hydrochlorothiazide Zentiva unless under strict medical supervision.
  Your doctor may consider it necessary to adjust your dose and/or take other precautions:
  If you are taking an ACE inhibitor or aliskiren (see also 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 agents or other diuretics
certain laxatives
medicines for the treatment of gout
vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral antidiabetics such as repaglinide or insulin)
carbamazepine (a medicine used to treat epilepsy)

It is also important to inform your doctor if you are taking other medicines to lower blood pressure, steroids, cancer treatments, painkillers, arthritis medicines, 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, drinking alcohol during treatment with this medicine may make you feel more dizzy, especially when standing up from a sitting or lying position.
Pregnancy, breastfeeding and fertility
Pregnancy
Inform your doctor if you think you are 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 know you are pregnant, and will recommend an alternative medicine. Irbesartan Hydrochlorothiazide Zentiva is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Irbesartan Hydrochlorothiazide Zentiva is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
It is unlikely that Irbesartan Hydrochlorothiazide Zentiva will affect your ability to drive or operate machinery. However, dizziness or fatigue may occasionally occur during treatment for high blood pressure. If this happens, talk to your doctor before driving or operating machinery.
Irbesartan Hydrochlorothiazide Zentiva contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them 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 exactly as prescribed by 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 daily.
Irbesartan Hydrochlorothiazide Zentiva will be prescribed by your doctor if your previous treatment has not sufficiently lowered your blood pressure. Your doctor will advise you on how to switch from your previous treatment to Irbesartan Hydrochlorothiazide Zentiva.
Method of administration
Irbesartan Hydrochlorothiazide Zentiva is for oral use. Swallow the tablets with sufficient liquid (for example, a glass of water). You may take Irbesartan Hydrochlorothiazide Zentiva with or without food. Try to take the medicine at the same time every day. It is important to continue treatment unless otherwise instructed by your doctor.
Maximum blood pressure-lowering effect should be achieved within 6–8 weeks after starting treatment.
Children must not take Irbesartan Hydrochlorothiazide Zentiva
Irbesartan Hydrochlorothiazide Zentiva must not be given to children under 18 years of age.
If a child swallows any 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, simply take your next dose as scheduled. Do not take a double dose to make up for the missed dose.
If you have any questions 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 everybody gets them.
Some of these side effects can be serious and may require medical attention.
Rare cases of skin allergic reactions (rash, urticaria), as well as localized swelling of the face, lips and/or tongue, have been reported in patients treated with irbesartan. If you experience any of these 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

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 (also when changing from a sitting or lying position to standing)
Blood tests may show increased levels of an enzyme that measures muscle and heart function (creatine kinase) or increased levels of substances that measure kidney function (azotemia, creatinine). Inform 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
Rapid heartbeat
Flushing
Swelling
Sexual dysfunction (problems with sexual activity)
Blood tests may show decreased levels of potassium and sodium in the blood. Inform 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. The side effects with unknown frequency are: headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and renal dysfunction, elevated potassium levels in the blood, and allergic reactions (rash, urticaria, 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 component cannot be excluded.

Side effects associated with irbesartan alone
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock), reduced number of red blood cells (anaemia – symptoms may include fatigue, headache, shortness of breath during physical activity, dizziness and pale appearance), and reduced number of platelets (blood cells essential for blood clotting) have 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 disorders; depression; lack of white blood cells, which may lead to frequent infections and fever; reduced number of platelets (a component essential for blood clotting); reduced number of red blood cells (anaemia) characterized by fatigue, headache, shortness of breath during exercise, dizziness and pale appearance; kidney problems; lung problems including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to sunlight; inflammation of blood vessels; a skin disorder characterized by peeling of the skin over the entire body; lupus erythematosus, identified by a rash that may appear on the face, neck and scalp; allergic reactions; weakness and muscle cramps; altered heartbeat; drop in blood pressure upon changing body position; swelling of the salivary glands; elevated blood sugar levels; sugar in the urine; increases in certain types of blood fats; elevated levels of uric acid in the blood which may cause gout.

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

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed 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 stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not dispose of any medicine via 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 substances are irbesartan and hydrochlorothiazide. Each Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose, cross-linked sodium carmellose, monohydrate lactose, magnesium stearate, hydrated colloidal silica, pregelatinized maize starch, red and yellow iron oxides (E172). See section 2 “Irbesartan Hydrochlorothiazide Zentiva contains lactose”.

Description of the appearance of Irbesartan Hydrochlorothiazide Zentiva and contents of the pack
Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets are peach-coloured, biconvex, oval, with a heart imprint 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 unit-dose blisters 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Zentiva, k.s. Zentiva, k.s.
Tél/Tel: +32 280 86 420 Tel: +370 52152025
[email protected] [email protected]

България Luxembourg/Luxemburg
Zentiva, k.s. Zentiva, k.s.
Тел: +35924417136 Tél/Tel: +352 208 82330
[email protected] [email protected]

Česká republika Magyarország
Zentiva, k.s. Zentiva Pharma Kft.
Tel: +420 267 241 111 Tel.: +36 1 299 1058
[email protected] [email protected]

Danmark Malta
Zentiva Denmark ApS Zentiva, k.s.
Tlf: +45 787 68 400 Tel: +356 2778 0890
[email protected] [email protected]

Deutschland Nederland
Zentiva Pharma GmbH Zentiva, k.s.
Tel: +49 (0) 800 53 53 010 Tel: +31 202 253 638
[email protected] [email protected]

Eesti Norge
Zentiva, k.s. Zentiva Denmark ApS
Tel: +372 52 70308 Tlf: +47 219 66 203
[email protected] [email protected]

Ελλάδα Österreich
Zentiva, k.s. Zentiva, k.s.
Τηλ: +30 211 198 7510 Tel: +43 720 778 877
[email protected] [email protected]

España Polska
Zentiva, k.s. Zentiva Polska Sp. z o.o.
Tel: +34 931 815 250 Tel: +48 22 375 92 00
[email protected] [email protected]

France Portugal
Zentiva France Zentiva Portugal, Lda
Tél: +33 (0) 800 089 219 Tel: +351 210601360
[email protected] [email protected]

Hrvatska România
Zentiva, d.o.o. ZENTIVA S.A.
Tel: +385 1 6641 830 Tel: +4 021.304.7597
[email protected] [email protected]

Ireland Slovenija
Zentiva Denmark ApS Zentiva, k.s.
Tel: +353 766 803 944 Tel: +386 360 00 408
[email protected] [email protected]

Ísland Slovenská republika
Zentiva, k.s. Zentiva, a.s.
Sími: +354 539 0650 Tel: +421 2 3918 3010
[email protected] [email protected]

Italia Suomi/Finland
Zentiva Italia S.r.l. Zentiva Denmark ApS
Tel: +39-02-38598801 Puh/Tel: +358 942 598 648
[email protected] [email protected]

Κύπρος Sverige
Zentiva, k.s. Zentiva Denmark ApS
Τηλ: +357 240 30 144 Tel: +46 840 838 822
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Zentiva, k.s. Zentiva, k.s.
Tel: +371 67893939 Tel: +44 (0) 800 090 2408
[email protected] [email protected]

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu .

Patient Information Leaflet

Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets

irbesartan/hydrochlorothiazide
Please 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 give it to other people. This medicine may be harmful to others, even if their symptoms are the same as yours.
If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Irbesartan Hydrochlorothiazide Zentiva is and what it is used for
What you need to know before taking Irbesartan Hydrochlorothiazide Zentiva
How to take Irbesartan Hydrochlorothiazide Zentiva
Possible side effects
How to store Irbesartan Hydrochlorothiazide Zentiva
Contents of the pack and other information

1. What Irbesartan Hydrochlorothiazide Zentiva is 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 medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to its receptors located on blood vessels, causing them to narrow. This leads to an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, resulting in relaxation of the blood vessels and a reduction in blood pressure.
Hydrochlorothiazide belongs to a group of medicines (so-called thiazide diuretics) that increase urine production, thereby lowering blood pressure.
The two active ingredients in Irbesartan Hydrochlorothiazide Zentiva work together to reduce blood pressure to a greater extent than either medicine given alone.
Irbesartan Hydrochlorothiazide Zentiva is used to treat high blood pressure when treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled your blood pressure.

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

Do not take Irbesartan Hydrochlorothiazide Zentiva

if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to hydrochlorothiazide or to any sulfonamide-derived medicines
if you are more than 3 months pregnant (it is better 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 has diagnosed you with persistently high calcium levels or low potassium levels in the blood
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

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

excessive vomiting or diarrhoea
if you have kidney disorders or have had a kidney transplant
if you have heart problems
if you have liver problems
if you have diabetes, or if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and pounding heartbeat), particularly if you are being treated for diabetes
if you have systemic lupus erythematosus (also known as lupus or SLE)
if you have primary hyperaldosteronism (a condition involving excessive production of the hormone aldosterone, leading to sodium retention and subsequently increased blood pressure)
if you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
- aliskiren
if you have previously had skin cancer or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Irbesartan Hydrochlorothiazide Zentiva.
if you have previously experienced breathing or lung problems (including lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking the medicine, consult a doctor immediately.

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

if you are on a low-salt diet
if you experience symptoms such as excessive thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an excessively rapid heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan Hydrochlorothiazide Zentiva)
if you have noticed an increased, abnormally rapid sensitivity of the skin to sunlight, with symptoms of sunburn (such as redness, itching, swelling, rash)
if you are scheduled for surgery or to receive anaesthetics
if you experience a decrease in 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 increased pressure in the eye (glaucoma), which may occur from a few hours to a week after taking Irbesartan Hydrochlorothiazide Zentiva. If left untreated, these conditions may lead to permanent loss of vision. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition. You must stop taking Irbesartan Hydrochlorothiazide Zentiva and consult your doctor promptly.
Hydrochlorothiazide, contained in this medicine, may lead to positive results in anti-doping tests.

Children and adolescents
Irbesartan Hydrochlorothiazide Zentiva must 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.
Diuretics such as hydrochlorothiazide contained in Irbesartan Hydrochlorothiazide Zentiva may interact with other medicines. Medicines containing lithium must not be taken together with Irbesartan Hydrochlorothiazide Zentiva unless under strict medical supervision.
Your doctor may consider it necessary to adjust the dose and/or take additional precautions:
If you are taking an ACE inhibitor or aliskiren (see also 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 agents or other diuretics
certain laxatives
medicines for the treatment of gout
vitamin D supplements
medicines to control heart rhythm
medicines for diabetes (oral antidiabetic agents such as repaglinide or insulin)
carbamazepine (a medicine used to treat epilepsy)

It is also important to inform your doctor if you are taking other medicines to lower blood pressure, steroids, cancer treatments, painkillers, 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 treatment with this medicine, you may feel more dizzy, especially when standing up from a sitting position.

Pregnancy, breastfeeding and fertility
Pregnancy
Inform 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 know you are pregnant, and will recommend an alternative medicine. Irbesartan Hydrochlorothiazide Zentiva is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Irbesartan Hydrochlorothiazide Zentiva is not recommended for women who are breastfeeding, and your doctor may choose a different treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
It is unlikely that Irbesartan Hydrochlorothiazide Zentiva will affect your ability to drive 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 or operating machinery.

Irbesartan Hydrochlorothiazide Zentiva contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Irbesartan Hydrochlorothiazide Zentiva contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet and is therefore essentially "sodium-free".

3. How to take Irbesartan Hydrochlorothiazide Zentiva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dosage
The recommended dose of Irbesartan Hydrochlorothiazide Zentiva is one tablet daily. Irbesartan Hydrochlorothiazide Zentiva will be prescribed by your doctor if your previous treatment has not sufficiently lowered your blood pressure. Your doctor will advise you on how to switch from your previous treatment to 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 may take Irbesartan Hydrochlorothiazide Zentiva with or without food. Try to take the medicine at the same time every day. It is important to continue treatment unless otherwise instructed by your doctor.
Maximum blood pressure lowering effect should be achieved within 6–8 weeks after starting treatment.
Children must not take Irbesartan Hydrochlorothiazide Zentiva
Irbesartan Hydrochlorothiazide Zentiva must not be given to children under 18 years of age.
If a child swallows any tablets, contact a 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, simply take your next dose at the usual time. Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use 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 can be serious and may require medical attention.
Rare cases of skin allergic reactions (rash, urticaria) as well as localized swelling of the face, lips and/or tongue have been reported in patients treated with irbesartan. If you experience any of these symptoms or have difficulty breathing, stop taking Irbesartan Hydrochlorothiazide Zentiva and contact your doctor immediately.

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 (also when moving from a sitting or lying position to standing)
blood tests may show increased levels of an enzyme measuring muscle and heart function (creatine kinase) or increased levels of substances measuring kidney function (azotemia, creatinine). Inform your doctor if any of these side effects cause you problems.

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

diarrhoea
hypotension
weakness
rapid heartbeat
hot flushes
swelling
sexual dysfunction (problems with sexual performance)
blood tests may show decreased levels of potassium and sodium in the blood. Inform your doctor if any of these side effects cause you problems.

Side effects reported after the marketing of Irbesartan Hydrochlorothiazide Zentiva
Since the marketing of Irbesartan Hydrochlorothiazide Zentiva, some side effects have been reported. The side effects with unknown frequency are: headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, liver function abnormalities and renal dysfunction, elevated blood potassium levels, and allergic reactions (rash, urticaria, 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 individual component cannot be excluded.

Side effects associated with irbesartan alone
In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock), reduced number of red blood cells (anaemia – symptoms may include tiredness, headache, shortness of breath during physical activity, dizziness and pale appearance), and reduced 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 characterised by severe pain in the upper abdomen, often with nausea and vomiting; sleep disorders; depression; lack of white blood cells, which may lead to frequent infections and fever; reduced number of platelets (essential component for blood clotting), reduced number of red blood cells (anaemia) characterised by fatigue, headache, shortness of breath during physical exertion, dizziness and pale appearance; kidney problems; lung problems including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to sunlight; inflammation of blood vessels; a skin disorder characterised by peeling of the skin over the entire body; lupus erythematosus, identified by a rash that may appear on the face, neck and scalp; allergic reactions; muscle weakness and muscle spasms; altered heartbeat; low blood pressure upon change in body position; swelling of the salivary glands; elevated blood sugar levels; sugar in the urine; increases in certain types of blood fats; elevated levels of uric acid in the blood which may cause gout.

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

acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion).

Not known (frequency cannot be estimated from the available data): skin and lip cancer (non-melanoma skin cancer); blurred vision; reduced vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

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, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V.
Reporting side effects 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 stated on the carton and blister after
Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Irbesartan Hydrochlorothiazide Zentiva contains

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

Description of the appearance of Irbesartan Hydrochlorothiazide Zentiva and contents of the pack
Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets are peach-coloured, biconvex, oval tablets with a heart imprint 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 unit-dose divisible blisters of 56 x 1 tablet for hospital use are also available.
Not all pack sizes may be marketed.