IRBESARTAN/HYDROCHLOROTHIAZIDE SANDOZ 300 mg/12.5 mg FILM-COATED TABLETS

2. What you need to know before taking Irbesartan/Hydrochlorothiazide Sandoz

Do not take Irbesartan/Hydrochlorothiazide Sandoz if:

• you are allergicto irbesartan, hydrochlorothiazide, or any of the other ingredients of this medication (listed in section 6),
• you are allergicto any sulfonamide-derived substance(e.g., other thiazides, some antibacterial medications such as cotrimoxazole; if in doubt, consult your doctor),
• you are pregnant for more than 3 months(in any case, it is best to avoid taking this medication at the start of pregnancy – see the Pregnancy section),
• you have severe liver problems,
• you have severe kidney problemsor your kidneys do not produce urine,
• you have persistently elevated calcium or low potassium levelsin your blood,
• you have diabetes or kidney failureand are being treated with a blood pressure medication that contains aliskiren.

Children and adolescents

Irbesartan/hydrochlorothiazide should not be given to children and adolescents under 18 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take irbesartan/hydrochlorothiazide.

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

• you have primary aldosteronism(Conn's syndrome), a tumor of the adrenal glands associated with muscle weakness, excessive thirst, and frequent urination,
• you have liver or kidney problems,
• you are taking lithiumfor mental health problems (see also "Other medications and Irbesartan/Hydrochlorothiazide Sandoz"),
• you are taking aliskiren, a medication for the treatment of high blood pressure.

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

It is not recommended to use irbesartan/hydrochlorothiazide at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby.

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.

Tell your doctor or pharmacist if:

• you are taking any of the following medications for high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
• aliskiren,
• you are taking other diuretics,
• you are on a low-salt diet,
• you have severe vomiting and/or diarrhea,
• you have had a heart attack,
• you have narrowing of the arteries of the kidneys(renal artery stenosis),
• you have had a kidney transplantrecently,
• you have mitral or aortic valve narrowing(narrowing of the heart valves) or 'hypertrophic cardiomyopathy' (a disease caused by an increase in heart muscle mass),
• you are diabetic,
• if you have a disease that causes joint pain, skin rash, and fever (you have systemic lupus erythematosus, also known as lupus or SLE),
• if you experience a photosensitivity reaction(skin sensitivity to the sun) during treatment,
• if you have high calcium or potassium levelsor if you are on a low-potassium diet,
• if you are going to receive anesthetics(even at the dentist) before surgery,
• if you experience symptoms such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as they may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Sandoz),
• if you experience blurred vision or eye pain. They could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (glaucoma) and can occur within a few hours to a week after taking Irbesartan/Hydrochlorothiazide Sandoz. This can 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 discontinue treatment with Irbesartan/Hydrochlorothiazide Sandoz and seek immediate medical attention.
• if you have had skin canceror if you develop an unexpected skin lesionduring treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Irbesartan/Hydrochlorothiazide Sandoz,
• if you have had respiratory or lung problems(such as 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/hydrochlorothiazide, seek medical attention immediately.

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

See also the information under the heading "Do not take Irbesartan/Hydrochlorothiazide Sandoz".

Consult your doctor if you are an athlete undergoing doping tests, as Irbesartan/Hydrochlorothiazide Sandoz contains an active substance that may cause positive results in doping tests.

Other medications and Irbesartan/Hydrochlorothiazide Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. Your doctor may need to adjust your dose and/or take other precautions if you are taking:

• lithium(a medication for the treatment of mania or depression),
• an angiotensin-converting enzyme inhibitor(ACE inhibitor) or aliskiren(see also the information under the headings "Do not take Irbesartan/Hydrochlorothiazide Sandoz" and "Warnings and precautions"),
• potassium supplements,
• potassium-containing salt substitutes,
• potassium-sparing medications,
• other diuretics,
• certain laxatives,
• medications for the treatment of gout,
• vitamin D supplements,
• medications for heart rhythm control,
• medications for diabetes(oral agents or insulin),
• corticosteroids,
• medications for cancer treatment,
• analgesicsor medications for arthritis,
• cholestyramineand colestipol, resins for reducing cholesterol in the blood,
• carbamazepine(a medication for the treatment of epilepsy).

Taking Irbesartan/Hydrochlorothiazide Sandoz with food and drinks

Do not drink alcohol while taking this medication, as alcohol and Irbesartan/Hydrochlorothiazide Sandoz can increase their 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 that is too rich in salt may counteract the effect of this medication.

Irbesartan/Hydrochlorothiazide Sandoz can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You must inform your doctor if you think you may be pregnant or plan to become pregnant. Your doctor will usually advise you to stop taking irbesartan/hydrochlorothiazide before becoming pregnant or as soon as you become pregnant and recommend taking another blood pressure medication instead. Irbesartan/hydrochlorothiazide is not recommended during pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby when taken after this time.

Breastfeeding

Tell your doctor if you are about to start or are breastfeeding, as irbesartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially newborns or premature babies.

Driving and using machines

It is unlikely that irbesartan/hydrochlorothiazide will affect your ability to drive or use machines. However, during the treatment of high blood pressure, dizziness or fatigue may occasionally occur. If you experience these symptoms, talk to your doctor before driving or using machines.

Irbesartan/Hydrochlorothiazide Sandoz contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Irbesartan/Hydrochlorothiazide Sandoz contains sodium

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

3. How to take Irbesartan/Hydrochlorothiazide Sandoz

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

Generally, your doctor will prescribe Irbesartan/Hydrochlorothiazide Sandoz when previous treatments you have received have not sufficiently reduced your blood pressure.

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

Use in adults and the elderly

The normal dose is one tablet per day.

Use in children and adolescents (under 18 years of age)

Irbesartan/Hydrochlorothiazide 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 Irbesartan/Hydrochlorothiazide Sandoz than you should

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

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

If you forget to take Irbesartan/Hydrochlorothiazide Sandoz

It is important 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 usual treatment. Do not take a double dose to make up for forgotten doses.

If you stop taking Irbesartan/Hydrochlorothiazide Sandoz

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

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

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

Also, contact your doctor immediately if you experience:

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

Other Adverse Effects

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

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

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

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

Frequency Not Known(cannot be estimated from available data):

• rash, hives, itching,
• high blood potassium levels,
• headache,
• ringing, buzzing, roaring, and clicking in the ears,
• cough,
• indigestion (dyspepsia),
• loss of appetite,
• altered liver or kidney function (liver inflammation),
• joint and muscle pain,
• kidney dysfunction.

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

Adverse Effects Associated with Irbesartan Alone

Additionally, the following adverse effects have been observed, apart from those described above: chest pain, severe allergic reactions (anaphylactic shock), decreased red blood cell count (anemia, symptoms may include fatigue, headache, difficulty breathing during exercise, dizziness, and paleness) and decreased platelet count (cells essential 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.

Adverse Effects Associated with Hydrochlorothiazide Alone

Loss of appetite, stomach irritation, stomach cramps, constipation, jaundice (yellowing of the skin and/or eyes), pancreatitis characterized by severe upper stomach pain, often with nausea and vomiting, sleep disorders, depression, blurred vision, low white blood cell count, which can lead to frequent infections, fever, decreased platelet count (cells essential for blood coagulation), decreased red blood cell count (anemia), characterized by fatigue, headache, difficulty breathing during exercise, dizziness, paleness; kidney disease, lung problems including pneumonia or fluid accumulation in the lungs; increased skin sensitivity to sunlight, blood vessel inflammation, a skin disease characterized by skin peeling all over the body; cutaneous lupus erythematosus, 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 the salivary glands, increased blood sugar levels, sugar in urine, increased levels of certain fats in the blood, elevated blood uric acid levels, which can cause gout, short-sightedness, decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), skin and lip cancer (non-melanoma skin cancer).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Irbesartan/Hydrochlorothiazide Sandoz

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

Do not use this medicine after the expiration date shown on the packaging, blister, and bottle after CAD/EXP. The expiration date is the last day of the indicated month.

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 thrown away through the sewers or in the trash. Deposit the packaging and unused medicines in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Irbesartan/Hydrochlorothiazide Sandoz

The active ingredients are irbesartan and hydrochlorothiazide.

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

The other ingredientsare:

Tablet core:microcrystalline cellulose, lactose monohydrate (for more information, see the end of section 2), sodium croscarmellose, anhydrous colloidal silica, hypromellose 3mPas, silicified microcrystalline cellulose, and magnesium stearate.

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

Product Appearance and Package Contents

Film-coated tablets, peach-colored, biconvex, and oval-shaped, engraved with 300H on one side.

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

Package sizes

PVC/PVDC/ALU 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.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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 Domaniewska 50 C

(Warsaw) PL02-672

Poland

Date of the Last Revision of this Prospectus:February 2025.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/