Irbesartan/hydrochlorothiazide Sandoz 300 mg/12.5 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

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

irbesartan/hydrochlorothiazide

Read the entire 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 the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

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

Irbesartán/Hidroclorotiazida Sandoz is a combination of two active substances, irbesartan and hydrochlorothiazide.

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

Hydrochlorothiazide belongs to a group of medicines called diuretics.

The two active substances in Irbesartán/Hidroclorotiazida Sandoz work together to achieve a greater reduction in blood pressure than either of them alone.

Irbesartán/Hidroclorotiazida Sandoz is used for the treatment of high blood pressure (hypertension), when treatment with either irbesartan or hydrochlorothiazide alone does not provide adequate blood pressure control.

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

Do NOT take Irbesartán/Hidroclorotiazida Sandoz if:

• you are allergic to irbesartan, hydrochlorothiazide, or any of the other components of this medicine (listed in section 6),
• you are allergic to any sulfonamide-derived substance (e.g., other thiazides, certain antibacterial medicines such as cotrimoxazole; if in doubt, consult your doctor),
• you are more than 3 months pregnant (in any case, it is better to avoid taking this medicine also during early pregnancy – see section Pregnancy),
• you have severe liver problems,
• you have severe kidney problems or your kidneys are not producing urine,
• you have persistently high levels of calcium or low levels of potassium in the blood,
• you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

Children and adolescents

Irbesartán/hydrochlorothiazide must not be given to children and adolescents under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with irbesartán/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,
• if you have liver or kidney problems,
• if you are taking lithium for mental health conditions (see also “Other medicines and Irbesartán/Hidroclorotiazida Sandoz”),
• if you are taking aliskiren, a medicine used to treat high blood pressure.

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

The use of irbesartán/hydrochlorothiazide is not recommended during early pregnancy, and under no circumstances should it be administered after the third month of pregnancy, as it may cause serious harm to your baby (see section Pregnancy).

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

Tell your doctor or pharmacist if:

• you are taking any of the following medicines used to treat 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 or currently have severe vomiting and/or diarrhea,
  • you have had a heart attack,
  • you have narrowing of the kidney arteries (renal artery stenosis),
  • you have recently had a kidney transplant,
  • you have mitral or aortic valve stenosis (narrowing of heart valves) or hypertrophic cardiomyopathy (a disease caused by increased cardiac muscle mass),
  • you are diabetic,
  • you have a disease causing joint pain, skin redness, and fever (you have systemic lupus erythematosus, also known as lupus or SLE),
  • you develop a photosensitivity reaction (skin sensitivity to sunlight) during treatment,
  • you have high levels of calcium or potassium or are on a low-potassium diet,
  • you are scheduled to receive anesthetics (including at the dentist) before surgery,
  • you experience symptoms such as unusual thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as these may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartán/Hidroclorotiazida Sandoz),
  • you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure (glaucoma), which may occur within hours to a week after taking Irbesartán/Hidroclorotiazida Sandoz. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk. You must stop treatment with Irbesartán/Hidroclorotiazida Sandoz and seek immediate medical attention.
  • you have had skin cancer or develop an unexpected skin lesion during 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 exposure to sunlight and UV rays while taking Irbesartán/Hidroclorotiazida Sandoz,
  • you have previously had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking irbesartán/hydrochlorothiazide, contact your doctor 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 Irbesartán/Hidroclorotiazida Sandoz”.

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

Other medicines and Irbesartán/Hidroclorotiazida Sandoz

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

• lithium (a medicine for the treatment of mania or depression),
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do NOT take Irbesartán/Hidroclorotiazida Sandoz” and “Warnings and other precautions”),
• potassium supplements,
• potassium-containing salt substitutes,
• potassium-sparing medicines,
• other diuretics,
• certain laxatives,
• medicines for the treatment of gout,
• therapeutic vitamin D supplements,
• medicines to control heart rhythm,
• medicines for diabetes (oral agents or insulin),
• steroids,
• medicines for cancer treatment,
• analgesics or medicines for arthritis,
• cholestyramine and colestipol, resins used to lower blood cholesterol,
• carbamazepine (a medicine for the treatment of epilepsy).

Taking Irbesartán/Hidroclorotiazida Sandoz with food and drinks

Do not drink alcohol while taking this medicine, as alcohol and Irbesartán/Hidroclorotiazida Sandoz may enhance each other's effects. If you drink alcohol while on this treatment, you may feel more dizzy when standing up, especially when rising from a sitting position.

A diet excessively high in salt may counteract the effect of this medicine.

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

Pregnancy and breastfeeding

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

Pregnancy

You must inform your doctor if you think you may be pregnant or plan to become pregnant. Usually, your doctor will advise you to stop taking irbesartán/hydrochlorothiazide before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive medicine. The use of irbesartán/hydrochlorothiazida is not recommended during pregnancy, and under no circumstances should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when used from that point onward.

Breastfeeding

Inform your doctor if you are planning to start or are currently breastfeeding, as irbesartán/hydrochlorothiazida is not recommended for women during this period. Your doctor may choose a treatment more suitable if you intend to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

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

Irbesartán/Hidroclorotiazida Sandoz contains lactose

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

Irbesartán/Hidroclorotiazida Sandoz contains sodium

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

3. How to take Irbesartan/Hydrochlorothiazide Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are in any doubt, consult your doctor or pharmacist again.

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

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

Use in adults and the elderly

The usual dose is one tablet daily.

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 prescribed, contact your nearest hospital or your doctor immediately. If this happens, you may experience symptoms of low blood pressure such as dizziness or fatigue. Lying down with your legs raised may help relieve these symptoms.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Irbesartan/Hydrochlorothiazide Sandoz

It is important to take the medicine every day. If you accidentally miss one or more doses, take it as soon as you remember and then continue with your usual treatment schedule. Do not take a double dose to make up for missed doses.

If you stop taking Irbesartan/Hydrochlorothiazide Sandoz

Always consult your doctor if you wish to stop taking this medicine. Even if you feel well, it may still be necessary for you to continue taking this medicine.

If you have any further questions about 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 everyone will experience them.

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

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

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

• Acute breathing difficulty (signs include severe shortness of breath, 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

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

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

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

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

Frequency not known (cannot be estimated from available data):

• rashes, urticaria, itching,
• high blood potassium levels,
• headache,
• ringing, buzzing, roaring, or clicking sounds 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 substances, adverse effects associated with each individual component cannot be excluded.

Adverse effects associated with irbesartan alone

In addition to the adverse effects described above, the following have also been observed: chest pain, severe allergic reactions (anaphylactic shock), reduced number of red blood cells (anaemia; symptoms may include tiredness, headache, shortness of breath on exertion, dizziness, and pallor), reduced number of platelets (blood 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 develop abdominal pain, nausea, vomiting, or diarrhoea 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 whites of the eyes), inflammation of the pancreas characterized by severe upper abdominal pain, often with nausea and vomiting, sleep disorders, depression, blurred vision, lack of white blood cells (which may lead to frequent infections and fever), reduced number of platelets (blood cells essential for blood clotting), reduced number of red blood cells (anaemia), characterized by tiredness, headache, shortness of breath on exertion, dizziness, and pallor; kidney disease, lung problems including pneumonia or fluid accumulation in the lungs; increased sensitivity of the skin to sunlight, inflammation of blood vessels, a skin disease characterized by peeling of the skin over the entire body; cutaneous lupus erythematosus, identified as a rash that may appear on the face, neck, and scalp, allergic reactions, muscle weakness and spasms, irregular heart rhythm, reduced blood pressure upon changing position, swelling of the salivary glands, increased blood sugar levels, sugar in urine, increased levels of certain types of fats in the blood, elevated blood uric acid levels (which may lead to gout), short sightedness, reduced 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 adverse effects associated with hydrochlorothiazide may increase with higher doses of the drug.

Reporting of adverse effects

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

By reporting adverse effects, you can help provide 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 expiry date stated on the packaging, blister pack, and bottle after CAD/EXP. The expiry date refers to the last day of the month indicated.

PVC/PVDC/ALU blister:

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

HDPE bottle and ALU/ALU blister:

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Irbesartan/Hydrochlorothiazide Sandoz

The active substances are irbesartan and hydrochlorothiazide.

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

The other components are:

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

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

Appearance of the medicinal product and contents of the pack

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

The tablets are packed in PVC/PVDC/ALU blisters or ALU/ALU blisters and placed in cardboard boxes, or packed in HDPE bottles with PP cap and closure containing a silica gel desiccant.

Pack 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 certain pack 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 Allee, 1

(Barleben) D-39179

Germany

or

Lek S.A.

Ul Domaniewska 50 C

(Warsaw) PL02-672

Poland

Date of the most recent revision of this leaflet: February 2025.

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