IRBESARTAN/HYDROCHLOROTHIAZIDE SANDOZ 300 mg/25mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Irbesartan/Hydrochlorothiazide Sandoz 300 mg/25 mg film-coated tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Irbesartan/Hydrochlorothiazide Sandoz and what is it used for
2. What you need to know before you take Irbesartan/Hydrochlorothiazide Sandoz
3. How to take Irbesartan/Hydrochlorothiazide Sandoz
4. Possible side effects
5. Storage of Irbesartan/Hydrochlorothiazide Sandoz
6. Contents of the pack and further information

1. What is Irbesartan/Hydrochlorothiazide Sandoz and what is it used for

Irbesartan/Hydrochlorothiazide Sandoz is a combination of two active substances, irbesartan and hydrochlorothiazide.

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

Hydrochlorothiazidebelongs to a group of medicines called diuretics.

The two active substances in Irbesartan/Hydrochlorothiazide Sandoz work together to achieve a greater reduction in blood pressure than either substance alone.

Irbesartan/Hydrochlorothiazide Sandoz is used to treat high blood pressure (hypertension) when treatment with irbesartan or hydrochlorothiazide alone has not provided adequate control of your blood pressure.

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

Do not take Irbesartan/Hydrochlorothiazide Sandoz if:

• you are allergicto irbesartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6),
• you are allergicto any sulfonamide-derived substance(e.g., other thiazides, some antibacterial medicines such as co-trimoxazole; if in doubt, consult your doctor),
• you are more than 3 months pregnant(in any case, it is recommended to avoid taking this medicine during the first trimester of pregnancy – see section Pregnancy),
• you have severe liver problems,
• you have severe kidney problemsor your kidneys do not produce urine,
• you have persistently high calcium or low potassium levelsin your blood,
• you have diabetes or kidney problemsand are taking a medicine to lower your blood pressure 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 not usually recommended in the following cases, unless:

• you have primary aldosteronism(Conn's syndrome), a tumour of the adrenal glandsassociated with muscle weakness, excessive thirst, and frequent urination,
• you have liver or kidney problems,
• you are taking lithiumfor mental problems (see also “Other medicines and Irbesartan/Hydrochlorothiazide Sandoz”),
• you are taking aliskiren, a medicine to treat high blood pressure.

You must inform your doctor if you are pregnant (or think you might be pregnant).

It is not recommended to start taking irbesartan/hydrochlorothiazide during pregnancy, and in no case should it be taken after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

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 medicines for high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes
• aliskiren,
• you are taking other diuretics,
• you are on a low-salt diet,
• you have had 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 lupusor SLE),
• if you experience a photosensitivity reaction(skin sensitivity to sunlight) 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 signs such as abnormal thirst, dry mouth, general weakness, sleepiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as these may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Sandoz),
• if you experience blurred vision or eye pain. These 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 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 greater risk of developing it. You should stop treatment with Irbesartan/Hydrochlorothiazide Sandoz and seek medical attention immediately.
• 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 check 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 medicines and Irbesartan/Hydrochlorothiazide Sandoz

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

• lithium(a medicine for manic or depressive illness),
• 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 medicines,
• other diuretics,
• certain laxatives,
• medicines for gout,
• vitamin D supplements,
• medicines for heart rhythm problems,
• medicines for diabetes(oral or insulin),
• corticosteroids,
• medicines for cancer treatment,
• painkillersor medicines for arthritis,
• cholestyramineand colestipol, resins for lowering blood cholesterol,
• carbamazepine(a medicine for epilepsy treatment).

Taking Irbesartan/Hydrochlorothiazide Sandoz with food and drink

Do not drink alcohol while taking this medicine, as alcohol and Irbesartan/Hydrochlorothiazide Sandoz may increase their effects. If you drink alcohol while taking this medicine, you may have a greater feeling of dizziness when standing up, especially when getting up from a sitting position.

A diet that is too high in salt may counteract the effect of this medicine.

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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You must inform your doctor if you think you might be pregnant or are planning to become pregnant. Your doctor will normally advise you to stop taking irbesartan/hydrochlorothiazide before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take a different medicine to lower your blood pressure. 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 already breastfeeding, as it is not recommended to take irbesartan/hydrochlorothiazide during this time. Your doctor may decide to give you a different treatment that is more suitable if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

It is unlikely that irbesartan/hydrochlorothiazide will affect your ability to drive or use machines. However, during treatment for 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 some sugars, consult them before taking this medicine.

Irbesartan/Hydrochlorothiazide Sandoz contains sodium

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

3. How to take Irbesartan/Hydrochlorothiazide Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Irbesartan/Hydrochlorothiazide Sandoz will usually be prescribed when previous treatments have not sufficiently reduced your blood pressure.

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

Use in adults and the elderly

The normal dose is one tablet a 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 each day, with or without food.

If you take more Irbesartan/Hydrochlorothiazide Sandoz than you should

If you take more tablets than you should, contact your nearest hospital or 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, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Irbesartan/Hydrochlorothiazide Sandoz

It is important to take your medicine every day. If you accidentally forget to take a dose or more, take it as soon as you remember and then continue with your normal treatment. Do not take a double dose to make up for forgotten doses.

If you stop taking Irbesartan/Hydrochlorothiazide Sandoz

Always talk to your doctor before you stop taking this medicine. Even if you feel well, you may need to continue taking this medicine.

If you have any further questions on the use of this medicine, 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 in the face, lips, mouth, tongue, and throat (angioedema),
• difficulty breathing, dizziness (severe hypersensitivity).

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

• Acute respiratory distress (signs include severe difficulty breathing, 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 (yellow skin and/or eyes).

Other Adverse Effects

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

• dizziness,
• nausea/vomiting,
• alteration in urination frequency,
• fatigue,
• increase in 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.

Unknown Frequency(cannot be estimated from available data):

• rash, urticaria, 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 ingredients, 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), decrease in red blood cell count (anemia, symptoms may include fatigue, headache, difficulty breathing during exercise, dizziness, and paleness), and decrease in platelet count (cells essential for blood clotting) 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 (yellow skin and/or eyes), pancreatitis characterized by severe upper stomach pain, often with nausea and vomiting, sleep disorders, depression, blurred vision, lack of white blood cells, which can lead to frequent infections, fever, decrease in platelet count (cells essential for blood clotting), decrease in 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 the sun, blood vessel inflammation, a skin disease characterized by skin peeling all over the body; cutaneous lupus erythematosus, identified as a rash that can 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 increased 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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 pack, 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 30°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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. 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 25 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 3mPa.s, silicified microcrystalline cellulose, and magnesium stearate.

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

Appearance of the Product and Package Contents

Film-coated tablets, dark pink, biconvex, and oval-shaped, engraved with 300 on one side and 25H on the other.

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 desiccant silica gel capsule.

Package sizes

PVC/PVDC/ALU Blister: 7, 14, 28, 30, 56, 84, 90, 98, and 100 film-coated tablets.

ALU/ALU Blister: 7, 14, 28, 30, 56, 84, 90, 98, and 100 film-coated tablets.

HDPE Bottle: 100 and 250 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/