Patient Information Leaflet

Irbesartán/Hidroclorotiazida Sandoz 300 mg/12.5 mg Film-Coated Tablets

irbesartan/hydrochlorothiazide

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Irbesartán/Hidroclorotiazida Sandoz and what it is used for

2.What you need to know before starting to take Irbesartán/Hidroclorotiazida Sandoz

3.How to take Irbesartán/Hidroclorotiazida Sandoz

4.Possible side effects

5.Storage of Irbesartán/Hidroclorotiazida Sandoz

6.Contents of the pack and additional information

Irbesartán/Hidroclorotiazida Sandoz is an association of two active principles, irbesartan and hydrochlorothiazide.

Irbesartanbelongs to a group of medicines known as angiotensin-II receptor antagonists. These act by relaxing blood vessels and reducing blood pressure.

Hydrochlorothiazidebelongs to a group of medicines called diuretics.

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

Irbesartán/Hidroclorotiazida Sandozis used for the treatment of high blood pressure (hypertension), when treatment with only irbesartan or only hydrochlorothiazide does not provide adequate control of your blood pressure.

Do not take Irbesartán/Hidroclorotiazida Sandoz if:

• You areallergicto irbesartán, hidroclorotiazida, or any of the other componentsof this medication (listed in section 6),
• You areallergicto any substance derivedfrom sulfonamides(e.g., other thiazides, some antibacterial medications such as cotrimoxazol, in case of doubt, consult your doctor),
• You arepregnantmore than 3 months (in any case, it is better to avoid taking this medication also at the beginning of pregnancy – see Pregnancy section),
• You havesevere liver damage,
• You havesevere kidney damageor your kidneys do not produce urine,
• You havepersistently elevated levels of calcium or low levels of potassiumin your blood,
• You havediabetes or kidney insufficiencyand are being treated with a medication to lower blood pressure that contains aliskirén.

Children and adolescents

Irbesartán/Hidroclorotiazida should not be administered to children and adolescents under 18 years.

Warnings and precautions

Consult your doctor or pharmacist before starting to take irbesartán/hidroclorotiazida.

These tablets are generally not recommended in the following cases if:

• You haveprimary aldosteronism(Conn's syndrome),a tumor of the adrenal glandsassociated with muscle weakness, excessive thirst, and frequent urination,
• You haveliver or kidney problems,
• You are takinglithiumfor mental problems (also see “Other medications and Irbesartán/Hidroclorotiazida Sandoz”),
• You are takingaliskirén, a medication for the treatment of high blood pressure.

You must inform your doctor if you are pregnant (or intend to become) pregnant.

It is not recommended to use irbesartán/hidroclorotiazida at the beginning of pregnancy, and in any case, it should not be administered from the third month of pregnancy, as it may cause serious damage to your baby (see Pregnancy section).

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking irbesartán/hidroclorotiazida. Your doctor will decide whether to continue treatment. Do not stop taking irbesartán/hidroclorotiazida on your own.

Inform your doctor or pharmacist if:

• You are taking any of the following medications used to treat high blood pressure:

-Aconverting enzyme inhibitor(ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes

-aliskirén,

• You are taking otherdiuretics,
• You are following alow-sodium diet,
• You have or have hadsevere vomiting and/or diarrhea,
• You have hadmyocardial infarction,
• You haverenal artery stenosis,
• You have had akidney transplantrecently,
• You havemitral or aortic stenosis(heart valve narrowing) or ’hypertrophic cardiomyopathy’ (a disease caused byincreased cardiac muscle mass),
• You arediabetic,
• You have a disease that causes joint pain, skin rash, and fever (you havesystemic lupus erythematosusalso known aslupusorLES),
• You experiencephotosensitivity(sensitivity of the skin to the sun),
• You havehigh levels of calcium or potassiumor are following alow-potassium diet,
• You are to receiveanesthetics(including dental anesthetics) before surgery,
• You experience symptoms such asabnormal thirst, dry mouth, generalized weakness, abnormal drowsiness, muscle pain or cramps, nausea, vomiting, orrapid heart rate, which may indicate excessive effects of hidroclorotiazida (contained in Irbesartán/Hidroclorotiazida Sandoz),
• You experiencedecreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (glaucoma) and may occur within a few hours to a week after taking Irbesartán/Hidroclorotiazida Sandoz. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it. You should interrupt treatment with Irbesartán/Hidroclorotiazida Sandoz and seek medical attention immediately.
• You have hadskin canceror if you develop anunusual skin lesionduring treatment. The treatment with hidroclorotiazida, particularly its 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 Sandoz,
• You have hadrespiratory or pulmonary problems(such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking irbesartán/hidroclorotiazida, seek medical attention immediately.

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

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

Consult your doctor if you are anathlete subject to doping controls, as Irbesartán/Hidroclorotiazida Sandoz contains an active ingredient that may cause positive results in doping control.

Other medications and Irbesartán/Hidroclorotiazida Sandoz

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:

• lithium(medication for thetreatment of mania or depression),
• Aconverting enzyme inhibitor(ACEI) oraliskirén(also see the information under the headings “Do not take Irbesartán/Hidroclorotiazida Sandoz” and “Warnings and other precautions”),
• potassium supplements,
• sodium-free salt supplements,
• potassium-sparingdiuretics,
• otherdiuretics,
• somelaxatives,
• medications for the treatment ofgout,
• therapeutic vitamin D supplements,
• medications for the controlof heart rate,
• medications for the treatment ofdiabetes(oral agents or insulin),
• steroids,
• medications for the treatment ofcancer,
• analgesicsormedications for arthritis,
• colestiramineandcolestipol, resins to reduce cholesterol in the blood,
• carbamazepine(a medication for thetreatment of epilepsy).

Taking Irbesartán/Hidroclorotiazida Sandoz with food and drinks

Do not drink alcohol while taking this medication, as alcohol and Irbesartán/Hidroclorotiazida Sandoz may increase its effects. If you drink alcohol while taking this medication, you may experience increased dizziness when standing up, especially when getting up from a seated position.

A diet excessively rich in salt may counteract the effect of this medication.

Irbesartán/Hidroclorotiazida Sandoz can be taken with or without food.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Pregnancy

You must inform your doctor if you think you may be pregnant or intend to become pregnant.Generally, your doctor will advise you to stop taking irbesartán/hidroclorotiazida before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. Irbesartán/hidroclorotiazida is not recommended for use during pregnancy, and in any case, it should not be administered from the third month of pregnancy, as it may cause serious damage to your baby when administered from that point on.

Lactation

Inform your doctor if you plan to start or are breastfeeding, as it is not recommended to administer irbesartán/hidroclorotiazida 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 machines

It is unlikely that irbesartán/hidroclorotiazida will affect your ability to drive vehicles or operate machines. However, during hypertension treatment, you may occasionally experience dizziness or fatigue. If you experience these symptoms, speak with your doctor before driving or operating machines.

Irbesartán/Hidroclorotiazida Sandoz contains lactose

If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Irbesartán/Hidroclorotiazida Sandoz contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will prescribe Irbesartán/Hidroclorotiazida Sandoz when previous treatments have not sufficiently reduced your blood pressure.

Your doctor will instruct you on how to switch from previous treatments to this medication.

Use in adults and the elderly

The usual dose is one tablet per day.

Use in children and adolescents (under 18 years)

Irbesartán/Hidroclorotiazida Sandoz is not recommended for children and adolescents under 18 years of age.

Take the tablets with a glass of water, preferably at the same time every day, with or without food.

If you take more Irbesartán/Hidroclorotiazida Sandoz than you should

If you take more tablets than you should, contact the nearest hospital or your doctor immediately. If this occurs, you may experience symptoms of low blood pressure such as dizziness or fatigue, which can be alleviated by lying down with your legs elevated.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Irbesartán/Hidroclorotiazida Sandoz

It is essential to take the medication every day. If you accidentally forget to take a dose or more, take it as soon as you remember and then continue with your regular treatment. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Irbesartán/Hidroclorotiazida Sandoz

Always consult your doctor if you want to stop taking this medication. Although you may feel well, it may be necessary to continue taking this medication.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following side effects, contact your doctor immediately:

• swelling of the face, lips, mouth, tongue, and throat (angioedema),
• difficulty breathing, dizziness (severe hypersensitivity).

These are symptoms of severe allergic reactions and should be treatedimmediately,usually in a hospital.

•Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion), this is a very rare adverse reaction (may affect up to 1 in 10,000 people).

Contact your doctor immediately if you experience:

• jaundice (yellowing of the skin and/or eyes).

Other side effects

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

• dizziness,
• nausea/vomiting,
• change in urination frequency,
• fatigue,
• increased urea nitrogen in the blood, creatinine, and creatine kinase.

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

• diarrhea,
• dizziness when standing up,
• syncope due to low blood pressure,
• rapid heart rate,
• swelling,
• flushing,
• sexual problems, changes in libido,
• low blood levels of potassium and sodium.

Unknown frequency(cannot be estimated from available data):

• eruptions, urticaria, itching,
• high levels of potassium in the blood,
• headache,
• tinnitus, buzzing, rumbling, and clicking in the ears,
• cough,
• indigestion (dyspepsia),
• loss of appetite,
• altered liver or kidney function (inflammation of the liver),
• joint and muscle pain,
• renal dysfunction.

As with all combinations of two active principles, the adverse effects associated with each component cannot be ruled out.

Side effects associated with irbesartan only

In addition to the side effects described above, the following have also been observed: chest pain, severe allergic reactions (anaphylactic shock), decrease in the number of red blood cells (anemia, symptoms may include fatigue, headache, difficulty breathing when exercising, dizziness, and pallor) and decrease in the number of platelets (essential blood cells for blood coagulation) and low blood glucose levels.

Rare(may affect up to 1 in 1,000 people)

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking irbesartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking irbesartan/hydrochlorothiazide on your own.

Side effects associated with hydrochlorothiazide only

Loss of appetite, stomach irritation, stomach cramps, constipation, jaundice (yellowing of the skin and/or white of the eyes), pancreatitis characterized by severe upper abdominal pain, often with nausea and vomiting, sleep disturbances, depression, blurred vision, lack of white blood cells, which may lead to frequent infections, fever, decrease in platelet count (essential cells for blood coagulation), decrease in red blood cells (anemia), characterized by fatigue, headache, difficulty breathing when exercising, dizziness, pallor; kidney disease, respiratory problems that include pneumonia or appearance of fluid in the lungs; increased skin sensitivity to the sun, inflammation of blood vessels, a skin disease characterized by peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified as a rash that may appear on the face, neck, and scalp, allergic reactions, weakness, and muscle spasms, altered heart rhythm, reduced blood pressure after a change in body position, swelling of salivary glands, increased blood sugar levels, sugar in urine, increased levels of some types of fats in the blood, elevated levels of uric acid in the blood, which may cause gout, short-sightedness, decreased vision or eye pain due to high pressure (possible signs of accumulation of fluid in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma), skin and lip cancer (non-melanoma skin cancer).

It is known that the adverse effects associated with hydrochlorothiazide may increase with higher doses of this.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es.

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 usethis medicationafter the expiration date that appears on the packaging, blister, and bottle after CAD/EXP. The expiration date is the last day of the month indicated.

PVC/PVDC/ALU Blister:

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from moisture.

HDPE Bottle and ALU/ALU Blister:

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Irbesartán/Hidroclorotiazida Sandoz

The active principles are irbesartan and hidroclorotiazida.

Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hidroclorotiazida.

Theother componentsare:

Core tablet:microcrystalline cellulose, lactose monohydrate (for further information, consult the end of section 2),croscarmellose sodium, anhydrous colloidal silica, 3mPas hypromellose, microcrystalline cellulose silicified and magnesium stearate.

Coating:6mPas hypromellose, hydroxypropylcellulose, macrogol 6000, lactose monohydrate(for further information, consult the end of section 2),di oxide titanium (E171), iron oxide (red and yellow) (E172) and talc.

Appearance of the product and contents of the package

Film-coated tablets, orange in color, biconvex and oval in shape, engraved with 300H on one face.

The tablets are packaged in PVC/PVDC/ALU or ALU/ALU blisters and are introduced into a cardboard box or packaged in aHDPE bottle with a PP cap and a silica gel desiccant capsule.

Package sizes

PVC/PVDC/Al blister:7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, and 100 film-coated tablets.

ALU /ALU blister: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, and 100 film-coated tablets.

HDPE bottle: 100 film-coated tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer:

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220 Lendava

Slovenia

or

Lek Pharmaceutical Company d.d.

Verovskova, 57

Ljubljana, 1526

Slovenia

or

Salutas Pharma GmbH

Otto Von Guericke Alle, 1

(Barleben) D-39179

Germany

or

Lek S.A

Ul Domaniewska50 C

(Warsaw) PL02-672

Poland

Last review date of this prospectus:February 2025.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicaments and Sanitary Products (AEMPS)http://www.aemps.gob.es/