Irbesartan/hydrochlorothiazide Pensa 150 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Irbesartan/hydrochlorothiazide Pensa 150 mg/12.5 mg tablets EFG

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

• Keep this leaflet. 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors in blood vessels, causing them to constrict. This results in an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, relaxing the blood vessels and thereby reducing blood pressure.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which lower blood pressure by increasing the amount of urine produced.

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

Irbesartan/hydrochlorothiazide is used to treat high blood pressure when treatment with irbesartan alone or hydrochlorothiazide alone does not provide adequate control of blood pressure.

2. What you need to know before taking Irbesartan/hydrochlorothiazide Pensa

Do not take Irbesartan/hydrochlorothiazide Pensa

• if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to hydrochlorothiazide or to any other medicines chemically related to sulfonamides (for further information, consult your doctor or pharmacist)
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine during early pregnancy – see Pregnancy section)
• if you have severe liver or kidney problems
• if you have difficulty passing urine
• if your doctor finds you have persistently high levels of calcium or low levels of potassium in your blood
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Irbesartan/hydrochlorothiazide Pensa, and in any of the following cases:

• if you have excessive vomiting or diarrhoea
• if you have kidney problems or 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 levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes
• if you have systemic lupus erythematosus (also known as lupus or SLE)
• if you have primary hyperaldosteronism (a condition related to excessive production of the hormone aldosterone, leading to sodium retention and, in turn, increased blood pressure)
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
  • aliskiren
• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Irbesartan/hydrochlorothiazide Pensa
• if you have previously experienced breathing 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 Irbesartan/hydrochlorothiazide Pensa, seek medical help immediately.

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

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 Pensa”

If you are pregnant, think you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of irbesartan/hydrochlorothiazide is not recommended during the first trimester of pregnancy (first 3 months), and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby (see section Pregnancy)

You should also inform your doctor:

• if you are on a low-salt diet
• if you experience any of the following signs: feeling thirsty, 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 Irbesartan/hydrochlorothiazide Pensa)
• if you develop increased sensitivity of the skin to sunlight, with symptoms of sunburn (such as redness, itching, swelling, blisters) occurring more quickly than usual
• if you are going to have surgery (a surgical procedure) or will be given anaesthetics
• if you experience vision loss or eye pain in one or both eyes while taking Irbesartan/hydrochlorothiazide Pensa. 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 weeks after taking Irbesartan/hydrochlorothiazide Pensa. 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 Irbesartan/hydrochlorothiazide Pensa and seek prompt medical attention.

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

Children and adolescents

Irbesartan/hydrochlorothiazide Zentiva must not be given to children and adolescents (under 18 years of age).

Other medicines and Irbesartan/hydrochlorothiazide Pensa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Diuretics such as hydrochlorothiazide, contained in Irbesartan/hydrochlorothiazide Pensa, may interact with other medicines. You must not take preparations containing lithium together with Irbesartan/hydrochlorothiazide Pensa without medical supervision.

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Irbesartan/hydrochlorothiazide Pensa” and “Warnings and precautions”).

You may need to have blood tests if you are taking:

• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines or other diuretics (tablets that increase urine production)
• certain laxatives
• medicines used to treat gout
• vitamin D supplements
• medicines to control heart rhythm
• medicines for diabetes (oral agents such as repaglinide or insulin)
• carbamazepine (a medicine used to treat epilepsy)

It is also important to inform your doctor if you are taking other medicines to lower your blood pressure, steroids, cancer treatments, painkillers, medicines for arthritis, or cholestyramine or colestipol resins to reduce blood cholesterol.

Taking Irbesartan/hydrochlorothiazide Pensa with food, drinks and alcohol

Irbesartan/hydrochlorothiazide can be taken with or without food.

Due to the hydrochlorothiazide contained in Irbesartan/hydrochlorothiazide Pensa, if you drink alcohol while taking this medicine, you may feel more dizzy when standing up, especially when rising from a sitting position.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Generally, your doctor will advise you to stop taking irbesartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Irbesartan/hydrochlorothiazide is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby if used from that time.

Breast-feeding

Inform your doctor if you are planning to start or are currently breast-feeding, as irbesartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breast-feed, especially if your baby is a newborn or premature.

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 operating machinery.

Irbesartan/hydrochlorothiazide Pensa contains castor oil, lactose and sodium

This medicine may cause stomach discomfort and diarrhoea because it contains hydrogenated castor oil.

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

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

3. How to take Irbesartan/hydrochlorothiazide Pensa

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of irbesartan/hydrochlorothiazide is one or two tablets per day. Generally, your doctor will prescribe irbesartan/hydrochlorothiazide when previous treatments have not sufficiently reduced your blood pressure. Your doctor will advise you on how to switch from previous treatments to Irbesartan/hydrochlorothiazide Pensa.

Administration method

Irbesartan/hydrochlorothiazide is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). You may take irbesartan/hydrochlorothiazide with or without food. You should try to take your daily dose at the same time each day. It is important that you continue taking irbesartan/hydrochlorothiazide unless your doctor advises otherwise.

Maximum blood pressure-lowering effect should be achieved within 6–8 weeks after starting treatment.

Use in children and adolescents

Children must not take Irbesartan/hydrochlorothiazide Pensa.

Irbesartan/hydrochlorothiazide must not be given to children under 18 years of age. If a child accidentally swallows any tablets, contact your doctor immediately.

If you take more Irbesartan/hydrochlorothiazide 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 Toxicology Information Service at telephone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medication packaging and leaflet.

If you forget to take Irbesartan/hydrochlorothiazide Pensa

If you accidentally miss a dose, simply take your next scheduled dose at the usual time. Do not take a double dose to make up for missed doses.

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 may cause adverse effects, although not everyone will experience them.

Some of these effects may be serious and may require immediate medical attention.

Rare cases of skin allergic reactions (rash, urticaria) have been reported in patients treated with irbesartan, as well as localized swelling of 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 adverse effects listed below is defined using the following convention:

Frequent: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Very rare: may affect up to 1 in 10,000 people

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

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

• Nausea/vomiting
• Abnormal urination
• Fatigue
• Dizziness (including dizziness upon 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 (blood urea nitrogen, creatinine)

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

Uncommon adverse effects (may affect up to 1 in 100 people)

• Diarrhea
• Low blood pressure
• Fainting
• Palpitations
• Flushing
• Swelling due to fluid retention (edema)
• Sexual dysfunction (alterations in sexual function)
• Blood tests may show low levels of sodium and potassium in your blood

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

Adverse effects reported since marketing of Irbesartan/hydrochlorothiazide Pensa

Since the marketing of irbesartan/hydrochlorothiazida Pensa, some adverse effects have been reported. Adverse effects observed with frequency not known include: headache, tinnitus, cough, altered taste, indigestion, joint and muscle pain, liver function abnormalities and kidney failure, elevated potassium levels in the blood, and allergic reactions such as rash, urticaria, swelling of the face, lips, mouth, tongue or throat.

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

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

Adverse effects associated solely with irbesartan

In addition to the adverse effects described above, chest pain, severe allergic reactions (anaphylactic shock), decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, shortness of breath on exertion, dizziness and paleness), decreased number of platelets (a blood cell essential for blood clotting), and low blood sugar levels have also been observed.

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

Adverse effects associated with hydrochlorothiazide in monotherapy

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 stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; low white blood cell count, which may lead to frequent infections and fever; decreased number of platelets (blood cells essential for blood clotting), decreased number of red blood cells (anaemia) characterized by tiredness, headaches, shortness of breath on exertion, dizziness and paleness; kidney disease; lung disorders 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 all over the body; cutaneous lupus erythematosus, identified by a rash that may appear on the face, neck and scalp; allergic reactions; muscle weakness and spasms; irregular heartbeat; drop in blood pressure after a change in body position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increases in certain types of blood fats; high levels of uric acid in the blood, which may cause gout.

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

• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

Frequency not known (cannot be estimated from available data): skin and lip cancer (non-melanoma skin cancer); 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].

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

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects 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 Pensa

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

Do not use Irbesartan/hydrochlorothiazide Pensa after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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

6. Contents of the pack and other information

Composition of Irbesartán/hidroclorotiazida Pensa

• The active substances are irbesartan and hydrochlorothiazide.
• The other components (excipients) are povidone (E-1201), microcrystalline cellulose (E-460), sodium croscarmellose, lactose monohydrate, magnesium stearate (E-470B), colloidal anhydrous silica, gluten-free corn starch, and hydrogenated castor oil.

Appearance of the medicine and contents of the pack

Irbesartán/hidroclorotiazida Pensa 150 mg/12.5 mg tablets are cylindrical, biconvex, white tablets marked with the code "IH1" on one side, containing 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

Irbesartán/hidroclorotiazida Pensa 150 mg/12.5 mg tablets are available in packs containing 28 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi 10, Polígono Industrial Areta

31620 Huarte-Pamplona (Navarra) – Spain

Date of the most recent revision of this leaflet: December 2024

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