Package Insert: Information for the User

Irbesartan/Hydrochlorothiazide Pensa 300 mg/25 mg TabletEFG

Read this package insert carefully before starting to take the 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 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.

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

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

3. How to take Irbesartan/Hydrochlorothiazide Pensa

4. Possible adverse effects

5. Storage of Irbesartan/Hydrochlorothiazide Pensa

6. Contents of the pack and additional information

Irbesartán/hidroclorotiazida Pensais an association of two active principles, irbesartán and hidroclorotiazida.

Irbesartán 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. Irbesartán 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, which increase the amount of urine eliminated, thereby reducing blood pressure.

The two active principles ofirbesartán/hidroclorotiazida act together to achieve a decrease in systolic blood pressure greater than that obtained with each one separately.

Irbesartán/hidroclorotiazida is used to treat high blood pressure when treatment with only irbesartán or only hidroclorotiazida does not provide adequate control of your blood pressure.

Do not take Irbesartán/hidroclorotiazida Pensa

• if you are allergic to irbesartán or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to hydrochlorothiazide or any other medicine chemically related to sulfonamides (for more information ask your doctor or pharmacist)
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also at the beginning of your pregnancy-see section Pregnancy)
• if you have severe liver or kidney problems
• if you have difficulty urinating
• if your doctor detects that you have persistently elevated levels of calcium or low levels of potassium in your blood.
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure lowering medicine that contains aliskirén.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Irbesartán/hidroclorotiazida Pensa and in any of the following cases:

• ifyou have excessive vomiting or diarrhea
• if you have kidney problems or if you have had a kidney transplant
• if you have heart problems
• if you have liver problems
• if you have diabetes
• if you experience low blood sugar (symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing or paleness, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes
• if you have lupus erythematosus (also known as lupus or LES)
• if you have primary aldosteronism (a condition related to the excessive production of the hormone aldosterone, which causes sodium retention and, in turn, an increase in blood pressure).
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• • a converting enzyme inhibitor (ACEI) (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  • aliskirén
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, 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 the sun and UV rays while taking Irbesartan/hidroclorotiazida Pensa
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Irbesartan/hidroclorotiazida Pensa, seek medical attention immediately.

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

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 Pensa”

If you are pregnant, if you suspect you may be, or if you plan to become pregnant, inform your doctor. Irbesartan/hidroclorotiazida is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy because it may cause serious harm to your baby (see section Pregnancy)

You must also inform your doctor:

• if you are following a low-sodium diet
• if you experience any of the following symptoms: excessive thirst, dry mouth, generalized weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or rapid heartbeats, as they may indicate excessive hydrochlorothiazide effect (contained in Irbesartan/hidroclorotiazida Pensa)
• if you experience increased skin sensitivity to the sun with symptoms of sunburn (such as redness, itching, swelling, blisters) that occur more quickly than usual,
• if you are to undergo surgery (surgical intervention) or if you are to receive anesthetics.
• if you experience decreased vision or eye pain while taking Irbesartan/hidroclorotiazida Pensa. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or increased pressure in the eye (glaucoma) and may occur within a few hours to weeks after taking Irbesartan/hidroclorotiazida Pensa. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing it. You must interrupt treatment with Irbesartan/hidroclorotiazida Pensa and seek rapid medical attention.

The hydrochlorothiazide contained in this medicine may cause positive results in doping control.

Children and adolescents

Irbesartan Hidroclorotiazida Zentiva should not be administered to children and adolescents (under 18 years).

Other medicines and Irbesartan/hidroclorotiazida Pensa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription.

Diuretics, such as hydrochlorothiazide contained in Irbesartan/hidroclorotiazida Pensa, may affect other medicines. Do not take with Irbesartan/hidroclorotiazida Pensa preparations containing lithium without your doctor's supervision.

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

If you are taking an ACEI or aliskirén (see also the information under the headings “Do not take Irbesartan/hidroclorotiazida Pensa” and “Warnings and precautions”).

You may need to have blood tests if you take:

• potassium supplements,
• sodium-free salt substitutes containing potassium,
• potassium-sparing diuretics (tablets that increase urine production),
• some laxatives,
• medicines used in the treatment of gout,
• vitamin D supplements,
• medicines used to control heart rhythm,
• diabetes medicines (oral agents such as repaglinide or insulin).
• carbamazepine (a medicine used to treat epilepsy).

You should also inform your doctor if you are taking other medicines to lower your blood pressure, steroids, cancer medicines, analgesics, medicines for arthritis, or bile acid-binding resins or cholestyramine or colestipol to reduce cholesterol in the blood.

Taking Irbesartan/hidroclorotiazida Pensa with food, drinks, and alcohol

Irbesartan/hidroclorotiazida can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan/hidroclorotiazida Pensa, if you drink alcohol while taking this medicine, you may experience increased dizziness when standing up, especially when getting up from a seated position.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, or if you suspect you may be, or if you plan to become pregnant, consult your doctor before using this medicine. Your doctor will usually advise you to stop taking irbesartan/hidroclorotiazide before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medicine instead. Irbesartan/hidroclorotiazide is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby when administered from that time.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding, as it is not recommended to administer irbesartan/hidroclorotiazide 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 irbesartan/hidroclorotiazide 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, consult your doctor before driving or operating machines.

Irbesartan/hidroclorotiazida Pensa contains ricin oil, lactose, and sodium

This medicine may cause stomach discomfort and diarrhea due to the presence of hydrogenated ricin oil.

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

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

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

Dose

The recommended dose of irbesartán/hidroclorotiazida is one tablet per day. In general, your doctor will prescribe irbesartán/hidroclorotiazida when previous treatments you received did not sufficiently reduce your blood pressure. Your doctor will indicate how to switch from previous treatments to Irbesartán/hidroclorotiazida Pensa.

Administration Form

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

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

Use in Children and Adolescents

Children should not take Irbesartán/hidroclorotiazida Pensa.

Irbesartán/hidroclorotiazida should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If You Take More Irbesartán/hidroclorotiazida Pensa Than You Should

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

In case of overdose or accidental ingestion, go to a Medical Center or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the medication leaflet.

If You Forget to Take Irbesartán/hidroclorotiazida Pensa

If you accidentally forget to take a dose, simply take your regular dose when it is 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 may cause side effects, although not everyone will experience them.

Some of these side effects may 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. If you experience any of the above symptoms or have difficulty breathing, stop taking irbesartan/hydrochlorothiazide and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:

Frequent: may affect up to 1 in 10 people

Rare: may affect up to 1 in 100 people

Very rare: may affect up to 1 in 10,000 people

The side effects reported in clinical studies for patients treated with irbesartan/hydrochlorothiazide were:

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

• Nausea/vomiting
• Urinary anomalies
• 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 (urea nitrogen in the blood, creatinine).

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

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

• Dyspepsia
• Low blood pressure
• Syncope
• Tachycardia
• Flushing
• Edema (swelling due to fluid retention)
• Sexual dysfunction (alterations in sexual function)
• Blood tests may show low levels of sodium and potassium in your blood

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

Side effects since the commercialization of Irbesartan/hydrochlorothiazide Pensa

Since the commercialization of irbesartan/hydrochlorothiazide, some side effects have been reported. The side effects observed with unknown frequency are: headache, tinnitus, cough, alteration of taste, indigestion, joint and muscle pain, liver function alterations, kidney insufficiency, elevated potassium levels in your blood, and allergic reactions such as skin rash, urticaria, facial swelling, lip, mouth, tongue, or throat swelling.

Also, cases of jaundice (yellowing of the skin and/or white of the eyes) have been observed.

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

Side effects associated only with irbesartan

In addition to the side effects described above, chest pain, severe allergic reactions (anaphylactic shock), and decreased red blood cell count (anemia – symptoms may include fatigue, headaches, difficulty breathing when exercising, dizziness, and paleness) and decreased platelet count (a blood cell essential for blood coagulation) and low blood sugar levels have been observed.

Rare side effects (may affect at least 1 in 1,000 people): intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Side effects associated with hydrochlorothiazide in monotherapy

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; decreased platelet count (blood cells essential for blood coagulation), decreased red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath when exercising, dizziness, and paleness; kidney disease; pulmonary disorders 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; lupus erythematosus, which is 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.

Very rare side effects(may affect up to 1 in 10,000 people):

• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency(cannot be estimated from available data): skin and lip cancer (non-melanoma skin cancer); decreased 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].

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 or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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 use Irbesartán/hidroclorotiazida Pensa after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Irbesartán/hidroclorotiazida Pensa

• The active principles are irbesartan and hidroclorotiazida.
• The other components (excipients) are povidone (E-1201), microcrystalline cellulose (E-460), croscarmellose sodium, lactose monohydrate, magnesium stearate (E-470B), anhydrous colloidal silica, cornstarch without gluten, and hydrogenated ricin oil.

Appearance of the product and content of the packaging

Irbesartán/hidroclorotiazida Pensa 300 mg/25 mg tablets are presented in the form of oblong, biconvex, white tablets, marked with the code “IH25”, containing 300 mg of irbesartan and 25 mg of hidroclorotiazida.

Irbesartán/hidroclorotiazida Pensa 300 mg/25 mg tablets are presented in containers containing 28 tablets.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi 10, Industrial Estate Areta

31620 Huarte-Pamplona (Navarra) – Spain

Last review date of this prospectus: December 2024

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/