IRBESARTAN 150 mg /12.5 Mg Film-Coated Tablets

Зміст інструкції

1. Irbesartan/Idroclorotiazide Teva 150 mg/12,5 mg film-coated tablets
   1. What is Irbesartan/Idroclorotiazide Teva and what it is used for
   2. What you need to know before taking Irbesartan/Idriclorotiazide Teva
   3. How to take Irbesartan/Idroclorotiazide Teva
   4. Possible side effects
   5. How to store Irbesartan/Idroclorotiazide teva
   6. Package contents and other information
2. Irbesartan/Idroclorotiazide Teva 300 mg/12,5 mg film-coated tablets
   1. What is Irbesartan/Idroclorotiazide Teva and what is it used for
   2. What you need to know before taking Irbesartan/Idroclorotiazide Teva
   3. How to take Irbesartan/Idroclorotiazide Teva
   4. Possible side effects
   5. How to store Irbesartan/Idroclorotiazide teva
   6. Package contents and other information
3. Irbesartan/Idroclorotiazide Teva 300 mg/25 mg film-coated tablets
   1. What is Irbesartan/Idroclorotiazide Teva and what it is used for
   2. What you need to know before taking Irbesartan/Idroclorotiazide Teva
   3. How to take Irbesartan/Idroclorotiazide Teva
   4. Possible side effects
   5. How to store Irbesartan/Idroclorotiazide Teva
   6. Package contents and other information

Irbesartan/Idroclorotiazide Teva 150 mg/12,5 mg film-coated tablets

irbesartan/idroclorotiazide

Read this leaflet carefully before you start taking this medicine as 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 people 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/Idroclorotiazide Teva is and what it is used for
• 2. What you need to know before you take Irbesartan/Idroclorotiazide Teva
• 3. How to take Irbesartan/Idroclorotiazide Teva
• 4. Possible side effects
• 5. How to store Irbesartan/Idroclorotiazide Teva
• 6. Contents of the pack and other information

1. What is Irbesartan/Idroclorotiazide Teva and what it is used for

Irbesartan/Idroclorotiazide Teva 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 the 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/Idroclorotiazide Teva work together determining a lowering of blood pressure values that is greater than that caused by the individual drugs administered separately.
Irbesartan/Idroclorotiazide Teva is used for the treatment of high blood pressure (essential hypertension) when treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled its blood pressure.

2. What you need to know before taking Irbesartan/Idriclorotiazide Teva

Do not take Irbesartan/Idroclorotiazide Teva

• 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 medicines derived from sulfonamides
• if you are pregnant for more than 3 months (it is best to avoid Irbesartan/Idroclorotiazide Teva even in the early stages of pregnancy - see section Pregnancy)
• if you have severe problems with your liver or kidneys
• if you have difficulty urinating
• if you have a condition associated with a persistently high level of calcium or a low level of potassium in the blood
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Warnings and precautions
Talk to your doctor if you are in any of the following conditions:

• If you have excessive vomiting or diarrhea
• If you suffer from kidney disorders, including 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 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 high production of the hormone aldosterone, which causes 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" (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/Idroclorotiazide Teva.
• 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 Irbesartan/Idroclorotiazide Teva, 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 stated in the section "Do not take Irbesartan/Idroclorotiazide Teva"
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Irbesartan/Idroclorotiazide Teva is not recommended in early pregnancy and
should not be taken if you are pregnant for more than 3 months, as it can cause serious
harm to the baby if taken at this stage (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 an excessively fast heartbeat that may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Idroclorotiazide Teva)
• if you have noticed an increase, faster than normal, in the sensitivity of your skin to the sun with symptoms of sunburn (such as redness, itching, swelling, rash)
• if you are going to have surgery or receive anesthesia
• if you experience blurred vision or pain in one or both eyes while taking Irbesartan/Idroclorotiazide Teva. This may be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or that glaucoma is developing, an increase in eye pressure. You should stop Irbesartan/Idroclorotiazide Teva and consult your doctor.

Hydrochlorothiazide, contained in this medicine, may give positive results in doping tests.

Children and adolescents
Irbesartan/Idroclorotiazide Teva should not be given to children and adolescents (under
18 years of age). If a child swallows tablets, contact a doctor immediately.

Other medicines and Irbesartan/Idroclorotiazide Teva.
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines.
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 stated in "Do not take
Irbesartan/Idroclorotiazide Teva" and "Warnings and precautions”).
Diuretic medicines such as hydrochlorothiazide contained in Irbesartan/Idroclorotiazide Teva may have
an effect on other medicines. Preparations containing lithium should not be taken with
Irbesartan/Idroclorotiazide Teva unless under strict medical supervision.

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 your 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/Idroclorotiazide Teva with alcohol
Due to the hydrochlorothiazide contained in Irbesartan/Idroclorotiazide Teva, 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 and breastfeeding
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Usually your doctor will advise you to stop taking
Irbesartan/Idroclorotiazide Teva before becoming pregnant or as soon as you find out
you are pregnant and will advise you to take another medicine instead of
Irbesartan/Idroclorotiazide Teva. Irbesartan/Idroclorotiazide Teva is not recommended during
pregnancy, and should not be taken if you are pregnant for more than three months, 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 planning to start breastfeeding. Irbesartan/Idroclorotiazide Teva
is not recommended for women who are breastfeeding and your doctor may choose another
treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines
It is unlikely that Irbesartan/Idroclorotiazide Teva will affect your ability to drive vehicles or
use machines. However, occasionally, dizziness or fatigue may occur during
treatment for high blood pressure. If this happens to you, talk to your doctor before driving vehicles or using
machines.

Irbesartan/Idroclorotiazide Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e.
essentially ‘sodium-free’.

3. How to take Irbesartan/Idroclorotiazide Teva

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

Dosage
The recommended dose of Irbesartan/Idroclorotiazide Teva is one or two tablets a day.
Irbesartan/Idroclorotiazide Teva will be prescribed by your doctor if the previous antihypertensive
therapy has not provided an adequate lowering of blood pressure. The doctor will
advise you how to switch from the previous treatment to that with Irbesartan/Idroclorotiazide Teva.

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

If you take more Irbesartan/Idroclorotiazide Teva than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan/Idroclorotiazide Teva
If you forget to take a dose, continue normally with the therapy. 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.
Rare cases of allergic skin 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/Idroclorotiazide Teva and
contact your doctor immediately.
The side effects reported in clinical studies in patients treated with the combination of irbesartan and
hydrochlorothiazide 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 an increase in the levels of an enzyme that measures muscle and cardiac function (creatine kinase) or an increase in the 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 a decrease in potassium and sodium levels in the blood. Tell your doctor if any of these side effects cause you problems.

Some side effects have been reported after the marketing authorization of the combination of
irbesartan and hydrochlorothiazide. Side effects where the frequency is unknown. These side effects
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, 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 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), decreased number of platelets (blood cells essential for blood clotting) and low blood sugar levels have also been reported.

Side effects associated with hydrochlorothiazide monotherapy are: loss of appetite;
stomach irritation; stomach cramps; constipation; jaundice detected as 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; 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); lack of white blood cells, which can lead to frequent infections, fever;
decreased number of platelets (an essential component for blood clotting),
low levels 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 scaling of the skin all over the body; lupus erythematosus, identified by a rash that can appear on the face, neck and
scalp; allergic reactions; muscle weakness and spasm; altered heartbeat;
lowering of blood pressure following a change in body position;
swelling of the salivary glands; high blood sugar levels; 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).
Frequency ”not known”: skin and lip cancer (non-melanoma skin cancer)
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 effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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/Idroclorotiazide teva

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 the month.
For Irbesartan/Idroclorotiazide Teva packaged in white opaque PVC-PVdC-aluminium blisters:
do not store at temperatures above 30 °C.
For Irbesartan/Idroclorotiazide Teva packaged in aluminium-aluminium blisters: this medicine
requires no particular storage conditions.
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/Idroclorotiazide Teva contains

• The active ingredients are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartan/Idroclorotiazide Teva 150 mg/12.5 mg contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
• The excipients are: Tablet core: povidone, pregelatinized starch (corn), poloxamer 188, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica and magnesium stearate. Tablet coating for the 150 mg /12.5 mg dosage: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), red iron oxide, yellow iron oxide and black iron oxide.

Description of the appearance of Irbesartan/Idroclorotiazide Teva and package contents
Irbesartan/Idroclorotiazide Teva 150 mg /12.5 mg film-coated tablets are tablets of
light pink to pink color, film-coated, capsule-shaped. One side of the tablet is engraved
with the number “93”. The other side of the tablet is engraved with the number “7238”.
Irbesartan/hydrochlorothiazide Teva is available in packs of 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98
and 100 film-coated tablets in non-perforated blisters; packs of 50 x 1 film-coated tablets
in unit-dose blisters and packs of 28 film-coated tablets in non-perforated calendar blisters.
Not all pack sizes may be marketed.

Marketing authorisation holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturers:
Teva Operations Poland Sp.z.o.o
ul. Mogilska 80
31-546 Kraków
Poland
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen H-4042
Hungary
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл.: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Τel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS Α.Ε.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicine is available on the website of the European Medicines
Agency (EMA): http://www.ema.europa.eu/

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Irbesartan/Idroclorotiazide Teva 300 mg/12,5 mg film-coated tablets

irbesartan/idroclorotiazide

Read this leaflet carefully before you start taking this medicine as 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 people even if their symptoms are the same as yours.
• If you get any side effects, see your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Irbesartan/Idroclorotiazide Teva and what is it used for

Irbesartan/Idroclorotiazide Teva 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 the 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/Idroclorotiazide Teva act together determining a lowering of blood pressure values that is greater than that caused by the individual drugs administered separately.

Irbesartan/Idroclorotiazide Teva 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/Idroclorotiazide Teva

Do not take Irbesartan/Idroclorotiazide Teva

• 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 medicines related to sulfonamides if you are pregnant for more than 3 months (it is best to avoid Irbesartan/Idroclorotiazide Teva even in the early stages of pregnancy - see section Pregnancy)
• if you have severe liver or kidney problems
• if you have difficulty urinating
• if you have a condition associated with persistently high calcium levels or low potassium levels in the blood
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

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

• if you have excessive vomiting or diarrhea
• if you suffer from kidney disorders, including 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 may include sweating, weakness, hunger, dizziness, tremor, headache, flushing or paleness, 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/Idroclorotiazide Teva.
• 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 Irbesartan/Idroclorotiazide Teva, 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 stated under "Do not take Irbesartan/Idroclorotiazide Teva”.
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Irbesartan/Idroclorotiazide Teva is not recommended in early pregnancy and
should not be taken if you are pregnant for more than 3 months, as it can cause serious
harm to the baby if taken at this stage (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 very fast heartbeat that may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Idroclorotiazide Teva)
• if you have noticed an increase, faster than normal, in the sensitivity of your skin to the sun with symptoms of sunburn (such as redness, itching, swelling, rash)
• if you are going to have surgery or receive anesthesia
• if you experience blurred vision or pain in one or both eyes while taking Irbesartan/Idroclorotiazide Teva. This may be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or that glaucoma is developing, an increase in eye pressure. You should stop Irbesartan/Idroclorotiazide Teva and consult your doctor.

Hydrochlorothiazide, contained in this medicine, can give positive results in doping tests.

Children and adolescents
Irbesartan/Idroclorotiazide Teva should not be given to children and adolescents (under
18 years of age). If a child swallows tablets, contact a doctor immediately.

Other medicines andIrbesartan/Idroclorotiazide Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your 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 stated under: "Do not take
Irbesartan/Idroclorotiazide Teva" and "Warnings and precautions”)
Diuretic medicines such as hydrochlorothiazide contained in Irbesartan/Idroclorotiazide Teva can have
an effect on other medicines. Preparations containing lithium should not be taken together
with Irbesartan/Idroclorotiazide Teva unless under strict medical supervision.

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/Idroclorotiazide Teva with alcohol
Due to the hydrochlorothiazide contained in Irbesartan/Idroclorotiazide Teva, 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 and breastfeeding
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking
Irbesartan/Idroclorotiazide Teva before becoming pregnant or as soon as you find out
you are pregnant and will advise you to take another medicine instead of
Irbesartan/Idroclorotiazide Teva. Irbesartan/Idroclorotiazide Teva is not recommended during
pregnancy, and should not be taken if you are pregnant for more than three months, 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 planning to start breastfeeding. Irbesartan/Idroclorotiazide Teva
is not recommended for women who are breastfeeding and your doctor may choose another
treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines
It is unlikely that Irbesartan/Idroclorotiazide Teva will affect your ability to drive vehicles or
use machines. However, occasionally, dizziness or fatigue may occur during
treatment for high blood pressure. If this happens to you, talk to your doctor before driving vehicles or using
machines.

Irbesartan/Idroclorotiazide Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e.
essentially ‘sodium-free’.

3. How to take Irbesartan/Idroclorotiazide Teva

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

Dosage
The recommended dose of Irbesartan/Idroclorotiazide Teva is one tablet a day.
Irbesartan/Idroclorotiazide Teva will be prescribed by your doctor if the previous antihypertensive
therapy has not provided adequate lowering of blood pressure. The doctor will
advise you on how to switch from the previous treatment to that with Irbesartan/Idroclorotiazide Teva.

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

If you take more Irbesartan/Idroclorotiazide Teva than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan/Idroclorotiazide Teva
If you forget to take a dose, continue with 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 product, consult 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.
Rare cases of allergic skin reactions (rash, hives) 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/Idroclorotiazide Teva and
contact your doctor immediately.
The side effects reported in clinical studies in patients treated with the combination of irbesartan and
hydrochlorothiazide 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 an increase in the levels of an enzyme that measures muscle and cardiac function
  (creatine kinase) or an increase in the 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 a decrease in potassium and sodium levels in the blood. Tell your doctor if any
  of these side effects cause you problems.

Some side effects have been reported after the marketing authorization of the combination of
irbesartan and hydrochlorothiazide. Side effects where the frequency is not known are: headache,
tinnitus, cough, taste disturbances, indigestion, joint and muscle pain, abnormal liver function and
renal dysfunction, elevated potassium levels 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), decreased number of platelets (blood cells
essential for blood clotting) and low blood sugar levels have also been reported.

Side effects associated with hydrochlorothiazide monotherapy are: loss of appetite;
stomach irritation; stomach cramps; constipation; jaundice detected as 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; 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); 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, lack 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 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 following a change in body position; swelling of the salivary
glands; elevated blood sugar levels; sugar in the urine; increases in certain types of fat in the blood;
elevated uric acid levels 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).
Frequency ”not known”: skin and lip cancer (non-melanoma skin cancer)
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/Idroclorotiazide teva

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 the month.
For Irbesartan/Idroclorotiazide Teva packaged in white opaque PVC-PVdC-aluminium blisters:
do not store at temperatures above 30 °C.
For Irbesartan/Idroclorotiazide Teva packaged in aluminium-aluminium blisters: this medicine
requires no special storage conditions.
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/Idroclorotiazide Teva contains

• The active ingredients are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartan/Idroclorotiazide Teva 300 mg /12.5 mg contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: Tablet core: povidone, pregelatinized starch (corn), poloxamer 188, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silicon dioxide and magnesium stearate. Tablet coating for the 300 mg /12.5 mg dosage: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), red iron oxide, yellow iron oxide and black iron oxide.

Description of the appearance of Irbesartan/Idroclorotiazide Teva and package contents
Irbesartan/Idroclorotiazide Teva 300 mg /12.5 mg film-coated tablets are tablets of
light pink to pink color, film-coated, round. One side of the tablet is engraved with the
number “2”, the other side is smooth.
Irbesartan/idroclorotiazide Teva is available in packs of 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98
and 100 film-coated tablets, and in perforated unit-dose blisters of 50x1 film-coated tablets in non-perforated blisters; packs of 50 x 1 film-coated tablet in unit-dose blisters and packs of 28 film-coated tablets in non-perforated blisters.
Not all pack sizes may be marketed.

Marketing authorisation holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturers:
Teva Operations Poland Sp.z.o.o
ul. Mogilska 80
31-546 Kraków
Poland
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen H-4042
Hungary
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
For further information on this medicinal product, please contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл.: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Τel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS Α.Ε.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMA): http://www.ema.europa.eu/

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Irbesartan/Idroclorotiazide Teva 300 mg/25 mg film-coated tablets

irbesartan/idroclorotiazide

Read this leaflet carefully before you start taking this medicine as 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 people 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/Idroclorotiazide Teva is and what it is used for
• 2. What you need to know before you take Irbesartan/Idroclorotiazide Teva
• 3. How to take Irbesartan/Idroclorotiazide Teva
• 4. Possible side effects
• 5. How to store Irbesartan/Idroclorotiazide Teva
• 6. Contents of the pack and other information

1. What is Irbesartan/Idroclorotiazide Teva and what it is used for

Irbesartan/Idroclorotiazide Teva 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/Idroclorotiazide Teva work together, determining a lowering of blood pressure values that is greater than that caused by the individual drugs administered separately.

Irbesartan/Idroclorotiazide Teva is used for the treatment of high blood pressure(essential hypertension),when treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled your blood pressure.

2. What you need to know before taking Irbesartan/Idroclorotiazide Teva

Do not take Irbesartan/Idroclorotiazide Teva

• 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 medicines derived from sulfonamides (ask your doctor or pharmacist for further clarification) if you are pregnant for more than 3 months (it is best to avoid Irbesartan/Idroclorotiazide Teva even in the early stages of pregnancy - see section Pregnancy)
• if you have severe liver or kidney problems
• if you have difficulty urinating
• if you have a condition associated with a persistently high level of calcium or a low level of potassium in the blood
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

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

• if you have excessive vomiting or diarrhea
• if you suffer from kidney disorders, including 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 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 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/Idroclorotiazide Teva.
• 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 Irbesartan/Idroclorotiazide Teva, consult a doctor immediately.

The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in the blood at regular intervals.
See also what is stated in the section "Do not take Irbesartan/Idroclorotiazide Teva”.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Irbesartan/Idroclorotiazide Teva is not recommended in the early stages of pregnancy and
should not be taken if you are pregnant for more than 3 months, as it can cause serious
harm to the baby if taken at this stage (see the 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 an excessively fast heartbeat that may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Idroclorotiazide Teva)
• If you have noticed an increase, faster than normal, in skin sensitivity to the sun with symptoms of sunburn (such as redness, itching, swelling, rash)
• If you are going to have surgery or receive anesthetics
• If you experience changes in vision or pain in one or both eyes while taking Irbesartan/Idroclorotiazide Teva. This may be a sign of fluid accumulation in the vascular layer of the eye (choroidal effusion) or that glaucoma is developing, an increase in eye pressure. You should stop Irbesartan/Idroclorotiazide Teva and consult your doctor.

Hydrochlorothiazide, contained in this medicine, can give positive results in doping tests.

Children and adolescents
Irbesartan/Idroclorotiazide Teva should not be given to children and adolescents (under
18 years of age). If a child swallows tablets, contact a doctor immediately.

Other medicines and Irbesartan/Idroclorotiazide Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Your 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/Idroclorotiazide Teva" and "Warnings and precautions”).
Diuretic medicines like hydrochlorothiazide contained in Irbesartan/Idroclorotiazide Teva can have
an effect on other medicines. Preparations containing lithium should not be taken together
with Irbesartan/Idroclorotiazide Teva unless under strict medical control.

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 blood cholesterol levels.

Irbesartan/Idroclorotiazide Teva with food and drink
Due to the hydrochlorothiazide contained in Irbesartan/Idroclorotiazide Teva, 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 and breastfeeding
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting
a pregnancy). Usually your doctor will advise you to stop taking
Irbesartan/Idroclorotiazide Teva before starting a pregnancy or as soon as you find out
you are pregnant and will advise you to take another medicine instead of
Irbesartan/Idroclorotiazide Teva. Irbesartan/Idroclorotiazide Teva is not recommended during
pregnancy, and should not be taken if you are pregnant for more than three months, 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 planning to start breastfeeding. Irbesartan/Idroclorotiazide Teva
is not recommended for women who are breastfeeding and your doctor may choose another
treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines
It is unlikely that Irbesartan/Idroclorotiazide Teva will affect your ability to drive vehicles or
use machines. However, occasionally, dizziness or fatigue may occur during
treatment for high blood pressure. If this happens to you, talk to your doctor before driving vehicles or using
machines.

Irbesartan/Idroclorotiazide Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is
essentially ‘sodium-free’.

3. How to take Irbesartan/Idroclorotiazide Teva

Always take Irbesartan/Idroclorotiazide Teva exactly as your doctor has instructed. If you have
any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose of Irbesartan/Idroclorotiazide Teva is one tablet a day.
Irbesartan/Idroclorotiazide Teva will be prescribed by your doctor if previous antihypertensive
therapy has not provided adequate lowering of blood pressure. Your doctor will
advise you on how to switch from previous treatment to treatment with Irbesartan/Idroclorotiazide Teva.

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

If you take more Irbesartan/Idroclorotiazide Teva than you should
If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Irbesartan/Idroclorotiazide Teva
If you forget to take a dose, continue with 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 product, consult 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.
Rare cases of allergic skin reactions (rash, hives) 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/Idroclorotiazide Teva and
contact your doctor immediately.
The side effects reported in clinical studies in patients treated with the combination of irbesartan and
hydrochlorothiazide 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 an increase in the levels of an enzyme that measures muscle and cardiac function (creatine kinase) or an increase in the 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 a decrease in potassium and sodium levels in the blood. Tell your doctor if any of these side effects cause you problems.

Some side effects have been reported after the marketing authorization of the combination of
irbesartan and hydrochlorothiazide. Side effects where the frequency is not known. These side effects
are: headache, tinnitus, cough, taste disturbances, indigestion, joint and muscle pain,
abnormal liver function and kidney dysfunction, high potassium levels 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 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 pallor), decreased number of platelets (blood cells essential for blood
coagulation) and low blood sugar levels have also been reported.

Side effects associated with hydrochlorothiazide monotherapy are:
Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice detected as
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;
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
); lack of white blood cells, which can lead to frequent inflammation,
fever; decreased number of platelets (an essential component for blood
coagulation), decreased number of red blood cells (anemia) characterized by fatigue, headache,
shortness of breath during exercise, dizziness and pallor; kidney problems; lung
problems including pneumonia or increased fluid in the lungs; increased sensitivity of the skin to
sun; inflammation of blood vessels; a skin disorder characterized by peeling 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 following a change in body position;
swelling of the salivary glands; high blood sugar levels; sugar in the urine;
increases in certain types of fat in the blood; high uric acid levels 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).
Frequency "not known": skin and lip cancer (non-melanoma skin cancer).
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 effect, even if 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/Idroclorotiazide Teva

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 the month.
For Irbesartan/Idroclorotiazide Teva packaged in white opaque PVC-PVdC-aluminium blisters:
do not store at temperatures above 30 °C.
For Irbesartan/Idroclorotiazide Teva packaged in aluminium-aluminium blisters: this medicine
requires no special storage conditions.
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/Idroclorotiazide Teva contains

• The active ingredients are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartan/Idroclorotiazide Teva 300 mg /25 mg contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
• The excipients are: Tablet core: povidone, pregelatinized starch (corn), poloxamer 188, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica and magnesium stearate. Tablet coating for the 300 mg /25 mg dosage: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), red iron oxide, indigotine (FD&C Blue No.2 aluminum lake) and black iron oxide.

Description of the appearance of Irbesartan/Idroclorotiazide Teva and package contents
Irbesartan/Idroclorotiazide Teva 300 mg /25 mg film-coated tablets are tablets of color
from pink to dark pink, film-coated, round. One side of the tablet is engraved with the number "3",
the other side is smooth.
Irbesartan/idroclorotiazide Teva is available in packs of 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98
and 100 film-coated tablets in non-perforated blisters; packs of 50 x 1 film-coated tablet in
unit dose blisters and packs of 28 film-coated tablets in non-perforated calendar blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturers:
Teva Operations Poland Sp.z.o.o
ul. Mogilska 80
31-546 Kraków
Poland
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen H-4042
Hungary
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл.: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Τel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS Α.Ε.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicine is available on the website of the European Medicines
Agency (EMA): http://www.ema.europa.eu/

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666