Package Insert: Information for the Patient

Irbesartán/Hidroclorotiazida Teva 300mg/25mg Film-Coated Tablets

irbesartan / hydrochlorothiazide

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Irbesartán/Hidroclorotiazida Teva is an association of two active principles, irbesartán and hidroclorotiazida. Irbesartan belongs to a group of medications known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to blood vessel receptors, causing them to contract. This results in an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, relaxing blood vessels and reducing blood pressure. Hidroclorotiazida belongs to a group of medications (called thiazide diuretics) that increase the amount of urine eliminated, reducing blood pressure.

The two active principles of Irbesartán/Hidroclorotiazida act together to achieve a decrease in blood pressure greater than that obtained with each one separately.

Irbesartán/Hidroclorotiazida Teva is used to treat high blood pressure when treatment with irbesartan or hidroclorotiazida alone does not provide adequate control of your blood pressure.

Do not take Irbesartán/Hidroclorotiazida Teva

• if you are allergic to irbesartan or any of the other ingredients in this medication(listed in section 6)
• if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medication
• if you are more than 3 months pregnant (in any case, it is best to avoid taking this medication also at the beginning of your pregnancy – see Pregnancy section)
• if you have severe liver or kidney problems
• if you have difficulty urinating
• if your doctor detects that you have persistently elevated calcium levels or low potassium levels in your blood.
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure medication that contains aliskiren.

Warnings and precautions

Consult your doctor before starting to take Irbesartán/Hidroclorotiazida Tevaand in any of the following cases:

• if you have excessive vomiting or diarrhea
• if you have kidney problems, or have had a kidney transplant
• if you have heart problems
• if you have liver problems
• if you have diabetes
• if you have lupus erythematosus (also known as lupus or SLE)
• if you have primary aldosteronism (a condition related to the overproduction of the aldosterone hormone, which causes sodium retention, and subsequently, an increase in blood pressure)
• if you are taking any of the following medications used to treat high blood pressure (hypertension):

-a converting enzyme inhibitor (ACE inhibitor) (for example, enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskiren.

• if you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartán/Hidroclorotiazida Teva

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in your blood (such as potassium), at regular intervals.

See also the information under the heading “Do not take Irbesartán/Hidroclorotiazida Teva”.

If you are pregnant, if you suspect you may be pregnantor if you plan to become pregnant, you must inform your doctor.

It is not recommended to use Irbesartán/Hidroclorotiazida Teva at the beginning of pregnancy and in no case should it be administered from the third month of pregnancy because it may cause severe damage to your baby (see Pregnancy section).

You must also inform your doctor:

• if you are following a low-sodium diet
• if you experience any of the following symptoms, feeling of thirst, dry mouth, generalized weakness, feeling of drowsiness,muscle pains or cramps, nausea, vomiting, orrapid heart rate, as they may indicate excessive hydrochlorothiazide effect (contained in Irbesartán/Hidroclorotiazida Teva).
• if you experience increased sensitivity to the sunwith symptoms of sunburn (such as redness, itching, swelling, blisters) that occur more quickly than normal.
• if you are to undergo surgery (surgical intervention) or if you are to receive anesthetics
• if you experience changes in your vision or eye pain while taking Irbesartán/Hidroclorotiazida Teva. This could be a sign of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or development of glaucoma, increased pressure in your eyes. You must interrupt treatment with Irbesartán/Hidroclorotiazida Teva and seek medical attention.

The amount of hydrochlorothiazide contained in this medication may cause positive results in doping control.

Children and adolescents

Irbesartán/Hidroclorotiazida Teva should not be administered to children and adolescents (under 18 years old).

If a child swallows several tablets, contact your doctor immediately.

Use of Irbesartán/Hidroclorotiazida Teva with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Your doctor may need to modify your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Irbesartán/Hidroclorotiazida Teva” and “Warnings and precautions”).

Diuretics, such as hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida Teva, may affect other medications. Do not take with Irbesartán/Hidroclorotiazida Teva preparations containing lithium without your doctor's supervision.

You may need to have a blood test if you take:

• potassium supplements.
• sodium substitutes containing potassium.
• potassium-sparing medications or other diuretics (tablets that increase urine production).
• some laxatives.
• medications used to treat gout.
• vitamin D supplements.
• medications used to control heart rhythm.
• diabetes medications (oral agents or insulin)
• carbamazepine (a medication used to treat epilepsy)

It is also important to inform your doctor if you are taking other medications to lower your blood pressure, steroids, cancer medications, painkillers, medications for arthritis, or bile acid-binding resins or cholestyramine or colestipol to reduce cholesterol in the blood.

Taking Irbesartán/Hidroclorotiazida Teva with alcohol

Due to the hydrochlorothiazide contained in Irbesartán/Hidroclorotiazida Teva, if you drink alcohol while taking this medication, you may experience a greater feeling of dizziness when standing up, especially when getting up from a seated position.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may be pregnantor if you plan to become pregnant. Your doctor will usually advise you to stop taking Irbesartán/Hidroclorotiazida Teva before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. It is not recommended to use Irbesartán/Hidroclorotiazida Teva during pregnancy and in no case should it be administered from the third month of pregnancy as it may cause severe damage to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding as it is not recommended to administer Irbesartán/Hidroclorotiazida Teva to women during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially to newborns or premature babies.

Driving and operating machinery

It is unlikely that Irbesartán/Hidroclorotiazida Teva will affect your ability to drive vehicles or operate machinery. However, during hypertension treatment, occasional dizziness or fatigue may occur. If you experience these symptoms, speak with your doctor before driving or operating machinery.

Irbesartan/Hidroclorotiazida Teva contains sodium

This medication contains less than 1mmol of sodium (23mg) per coated tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Dose

The recommended dose of Irbesartán/Hidroclorotiazida Teva is one tablet per day. In general, your doctor will prescribe Irbesartán/Hidroclorotiazida Teva when previous treatments for hypertension have not provided adequate blood pressure reduction. Your doctor will instruct you on how to switch from previous treatments to Irbesartán/Hidroclorotiazida Teva.

Administration Form

Irbesartán/Hidroclorotiazida Teva is administered orally.Tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). You can take Irbesartán/Hidroclorotiazida Teva with or without food. You should try to take your daily dose at the same time each day. It is essential that you continue taking Irbesartán/Hidroclorotiazida Teva until your doctor advises you otherwise.

The maximum blood pressure-reducing effect should be achieved within 6-8 weeks after starting treatment.

If you take more Irbesartán/Hidroclorotiazida Teva than you should

If you accidentally take too many tablets, contact your doctor immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20, or visit the Emergency Department of the nearest Hospital.

If you forget to take Irbesartán/Hidroclorotiazida Teva

If you accidentally forget to take a dose, simply take your regular dose when it is next due. Do not take a double dose to compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Some of these side effects can be serious and may require medical attention.

In rare cases, cases of skin allergic reactions (skin rash, urticaria) have been reported in patients treated with irbesartan, as well as localized inflammation in the face, lips, and/or tongue. Ifyou have any of the previous symptoms orexperience shortness of breath,,stop taking Irbesartán/Hidroclorotiazida Teva and contact your doctor immediately..

The side effects reported in clinical studies for patients treated with Irbesartán/Hidroclorotiazida were:

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

• nausea/vomiting
• urination abnormalities
• fatigue
• dizziness (including that which occurs when standing up from a lying or sitting position)
• blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase) or elevated levels of substances that measure kidney function (blood urea nitrogen, creatinine).

If any of these side effects cause you problems,consult your doctor.

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

• diarrhea
• low blood pressure
• syncope
• tachycardia
• flushing
• swelling due to fluid retention (edema)
• sexual dysfunction (alterations in sexual function)
• blood tests may show low levels of sodium and potassium in the blood.

If any of these side effects cause you problems,consult your doctor.

Some side effects have been reported since the marketing of Irbesartán/Hidroclorotiazida Teva, but the frequency of their occurrence is unknown. The unknown frequency side effects are: headache, tinnitus, cough, alteration of taste, indigestion, joint and muscle pain, liver function alterations, kidney insufficiency, elevated potassium levels in the blood, and allergic reactions such as skin rash, urticaria, facial swelling, lip, mouth, tongue, or throat swelling. Cases of rare icterus (yellowing of the skin and/or white of the eyes) have also been observed.

As with all combinations of two active principles, the side effects associated with each component cannot be excluded.

Side effects associated only with irbesartan:

In addition to the side effects described above, chest pain, severe allergic reactions (anaphylactic shock), and a decrease in the number of platelets (an essential blood cell for blood coagulation) have also been observed.

Side effects associated with hydrochlorothiazide in monotherapy are:

Loss of appetite; stomach irritation; stomach cramps; constipation; icterus (yellowing of the skin and/or white of the eyes); pancreatitis characterized by severe upper stomach pain, often with nausea and vomiting; sleep disturbances; depression; blurred vision;diminished vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma];decreased white blood cells, which may lead to frequent infections, fever; decreased platelet count (essential blood cells for blood coagulation), decreased red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath during exercise, dizziness, and pallor; kidney disease; pulmonary alterations including pneumonia or fluid accumulation in the lungs; increased skin sensitivity to the sun; inflammation of blood vessels; a skin disease characterized by peeling of the skin on the entire body; cutaneous lupus erythematosus, identified by a rash that may appear on the face, neck, and scalp; allergic reactions; muscle weakness and spasms; alteration of heart rhythm; reduction of blood pressure after a change in body position; swelling of salivary glands; high blood sugar levels; sugar in the urine; increases in some types of blood fats; high levels of uric acid in the blood, which may cause gout.

“Unknown frequency”: 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 experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister after CAD. The expiration date is the last day of the month indicated.

Irbesartán/Hidroclorotiazida Teva packaged in white opaque PVC/PVdC/Aluminum blisters: do not store at a temperature above 30°C.

Irbesartán/Hidroclorotiazida Teva packaged in aluminum-aluminum blisters: this medication does not require special storage conditions.

Medicines should not be thrown into the drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Irbesartán/Hidroclorotiazida Teva

• The active principles are irbesartan and hidroclorotiazida.

Each film-coated tablet of Irbesartán/Hidroclorotiazida Teva 300mg/25mg contains 300mg of irbesartan and 25mg of hidroclorotiazida.

• The other components are:

Tablet core: povidone, pregelatinized maize starch, poloxamer 188, microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silica, and magnesium stearate.

Film coating for the 300mg/25mg dose: hypromellose, titanium dioxide, polyethylene glycol 6000 (macrogol), polyethylene glycol 400 (macrogol), red iron oxide, indigo carmine (aluminum lake FD&C blue #2), and black iron oxide.

Appearance of the product and contents of the pack

Irbesartán/Hidroclorotiazida Teva 300mg/25mg are film-coated tablets, pink to reddish-pink in color, and capsule-shaped. One face of the tablet is marked with the number “93”. The other face of the tablet is marked with the number “7469”.

Irbesartán/Hidroclorotiazida is available in the following pack sizes: 7, 14, 15, 20, 28, 30, 56, 60, 84, 90, 98, and 100 film-coated tablets in uncut blister packs: 50x1 film-coated tablet in a single-dose blister pack and 28 film-coated tablets in a non-precuted calendar blister pack.

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Holland

Responsible for manufacturing:

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

TEVA UK Ltd

Brampton Road

Hampden Park

Eastbourne, East Sussex

BN22 9AG UK

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Holland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information about this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/