Package Leaflet: Information for the User

Losartan/Hydrochlorothiazide Pensa 100 mg/25 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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

2. Before taking Losartan/Hydrochlorothiazide Pensa

3. How to take Losartan/Hydrochlorothiazide Pensa

4. Possible side effects

5. Storage of Losartan/Hydrochlorothiazide Pensa

6. Further information

Losartán/Hidroclorotiazida Pensais a combination of an angiotensin II receptor antagonist(losartán) and a diuretic (hidroclorotiazida).

Losartán/Hidroclorotiazida Pensais indicated for the treatment of essential hypertension (high blood pressure).

Do not take Losartán/Hidroclorotiazida Pensa:

• if you are allergic (hypersensitive) to losartan, to hydrochlorothiazide or to any of the other components of this medicine.

• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g. other thiazides, some antibacterials such as cotrimoxazole, ask your doctor if you are unsure).

• if you are more than 3 months pregnant. (It is better to avoid Losartán/Hidroclorotiazida Pensa during the first months of pregnancy – see Pregnancy section).

• if you have severe liver failure.

• if you have severe kidney failure or your kidneys do not produce urine.

• if you have low levels of potassium or sodium, high levels of calcium that cannot be corrected with treatment.

• if you have gout.

• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Be especially careful with Losartán/Hidroclorotiazida Pensa:

Inform your doctor if you are pregnant (or if you suspect that you may be). Losartán/Hidroclorotiazida Pensa is not recommended for use at the start of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that time onwards (see Pregnancy section).

Consult your doctor or pharmacist before starting to take Losartán/Hidroclorotiazida Pensa:

• if you have previously experienced swelling of the face, lips, tongue or throat

• if you are taking diuretics (urine-producing medicines)

• if you are following a low-sodium diet

• if you have or have had excessive vomiting and/or diarrhoea

• if you have heart failure

• if you have narrowed arteries leading to the kidney (renal artery stenosis), if you only have one functioning kidney or if you have recently had a kidney transplant

• if you have atherosclerosis (narrowing of the arteries), angina (chest pain due to poor heart function)

• if you have mitral or aortic valve stenosis (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart valves)

• if you are diabetic

• if you have had gout

• if you have or have had an allergic reaction, asthma or a condition that causes joint pain, skin eruptions and fever (systemic lupus erythematosus)

• if you have high levels of calcium or low levels of potassium or if you are following a low-potassium diet

• if you need to have anaesthesia (even for dental treatment) or before surgery, or if you are to have tests to determine your parathyroid function, inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets

• if you have primary aldosteronism (a syndrome associated with an elevated secretion of aldosterone hormone by the adrenal gland due to a glandular alteration)

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• a 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 if you 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 cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartán/Hidroclorotiazida Pensa

• if you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few hours to a week after taking Losartán/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 Losartán/hidroclorotiazida Pensa, seek medical attention immediately.

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

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

See also the information under the heading “Do not take Losartán/Hidroclorotiazida Pensa”.

Other medicines

Inform your doctor or pharmacist if you are taking or have recently taken other medicines, including those purchased without a prescription.

Diuretics such as hydrochlorothiazide contained in Losartán/Hidroclorotiazida Pensa may interact with other medicines. Preparations containing lithium should not be taken with Losartán/Hidroclorotiazida Pensa without your doctor's careful monitoring. Special precautions may be necessary (e.g. blood tests) if you take potassium supplements, salt substitutes containing potassium or potassium-sparing medicines, diuretics (urine-producing tablets), some laxatives, medicines for gout treatment, heart rhythm-controlling medicines or diabetes medicines (oral or insulin).

It is also important for your doctor to know if you are taking other blood pressure-lowering medicines, steroids, cancer medicines, pain medicines, fungal infection medicines or arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping tablets; opioid pain medicines such as morphine, “pressor amines” such as adrenaline or other medicines in the same group; (oral diabetes medicines or insulin).

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

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Losartán/Hidroclorotiazida Pensa” and “Be especially careful with Losartán/Hidroclorotiazida Pensa”).

Please inform your doctor when you plan to have a contrast agent with iodine.

Losartán/Hidroclorotiazida Pensa with food and drinks

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida Pensa tablets may increase the effects of each other.

Excessive salt in the diet may counteract the effect of Losartán/Hidroclorotiazida Pensa tablets.

Losartán/Hidroclorotiazida Pensa tablets can be taken with or without food.

Pregnancy and breastfeeding:

Pregnancy

You must inform your doctor if you are pregnant (or if you suspect that you may be). Your doctor will usually recommend that you stop taking Losartán/Hidroclorotiazida Pensa before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Losartán/Hidroclorotiazida Pensa. Losartán/Hidroclorotiazida Pensa is not recommended for use at the start of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that time onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Losartán/Hidroclorotiazida Pensa is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Use in children and adolescents

There is no experience with the use of Losartán/Hidroclorotiazida in children. Therefore, Losartán/Hidroclorotiazida Pensa should not be administered to children.

Use in elderly patients

Losartán/Hidroclorotiazida Pensa acts with equal efficacy and is equally well tolerated by most elderly and young patients. Most elderly patients require the same dose as younger patients.

Driving and operating machinery

When starting treatment with this medicine, you should not perform tasks that may require special attention (e.g. driving a car or using hazardous machinery) until you know how you tolerate your medicine.

Important information about some of the components of Losartán/Hidroclorotiazida Pensa

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

Use in athletes:

This medicine contains hydrochlorothiazide, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for Losartán/Hidroclorotiazida Pensa, as indicated by your doctor. Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida Pensa, depending on your condition and if you are taking other medications. It is essential to continue taking Losartán/Hidroclorotiazida Pensa as prescribed by your doctor to maintain consistent blood pressure control.

Hypertension

For most patients with high blood pressure, the usual dose is one tablet of losartan/hidroclorotiazida 50 mg/12.5 mg per day to control blood pressure for 24 hours. The dose may be increased to one tablet of losartan/hidroclorotiazida 100 mg/25 mg (a stronger dose) per day. The maximum daily dose is one tablet of 100 mg of losartan/25 mg of hidroclorotiazida per day.

If you take more Losartán/Hidroclorotiazida Pensa than you should

In case of an overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention. An overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

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

If you forgot to take Losartán/Hidroclorotiazida Pensa

Try to take Losartán/Hidroclorotiazida Pensa at the same time each day as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule.

Like all medicines, Losartán/Hidroclorotiazida Pensa can cause side effects, although not everyone will experience them.

If you experience the following, stop taking the Losartán/Hidroclorotiazida Pensa tablets

Pensa and inform your doctor immediately or go to the nearest hospital emergency department:

A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat that may cause difficulty swallowing or breathing).

This is a serious but rare side effect that affects more than 1 in 10,000 patients but less than 1 in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

Frequent (affecting fewer than 1 in 10 but more than 1 in 100):

• Cough, respiratory infection, nasal congestion, sinusitis, breast disorder,
• Diarrhea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,

1. Elevated potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels.

Less frequent (affecting fewer than 1 in 100 but more than 1 in 1,000):

• Anemia, red or brown spots on the skin, (sometimes especially on the feet, legs, arms, and buttocks, with joint pain, swelling of the hands and feet, and abdominal pain), hematoma, reduced white blood cells, coagulation problems, and hematomas,
• Loss of appetite, elevated uric acid levels or manifest gout, elevated blood glucose levels, abnormal electrolyte levels in the blood,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory alteration,
• Tingling or similar sensations, pain in the extremities, tremor, migraine, fainting,
• Blurred vision, itching or stinging in the eyes, conjunctivitis, worsening vision, seeing things in yellow,
• Ringing, buzzing, sounds, or crackling in the ears,
• Low blood pressure that may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, transient ischemic attack (mini-stroke), heart attack, palpitations,
• Inflammation of blood vessels that often occurs with a skin rash or hematoma, sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nasal bleeding, runny nose, congestion, Constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain, Jaundice (yellowing of the eyes and skin), pancreatitis inflammation,
• Hives, itching, skin inflammation, skin rash, redness of the skin, light sensitivity, dry skin, flushing, sweating, hair loss,
• Pain in the arms, shoulders, hips, knees, or other joints, joint swelling, stiffness, muscle weakness,
• Frequent urination even at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased sexual appetite, impotence,
• Swelling of the face, fever.

Rare (affecting more than 1 in 10,000 and fewer than 1 in 1,000):

• Hepatitis (liver inflammation), abnormal liver function tests.
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Very rare (affecting fewer than 1 in 10,000 patients):

• Acute respiratory distress (symptoms include severe difficulty breathing, 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 high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma].

Reporting 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 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 medication.

Keep out of the reach and sight of children.

Do not useLosartán/Hidroclorotiazida Pensaafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below30°C.

Store in the original packaging.Keep the blister in the outer packaging. Do not open the blister until ready to take the tablet.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines that you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Losartán/Hidroclorotiazida Pensa

The active principles are losartan potassium and hidroclorotiazida.

Each Losartán/Hidroclorotiazida Pensa 100 mg/25 mg tablet contains, as active principles, 100 mg of losartan (potassium) and 25 mg of hidroclorotiazida.

Losartán/Hidroclorotiazida Pensa 100 mg/25 mg contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized cornstarch, and magnesium stearate (E-572).

Losartán/Hidroclorotiazida Pensa 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.

Losartán/Hidroclorotiazida Pensa 100 mg/25 mg also contains hydroxypropylcellulose, hypromellose, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance of the product and contents of the package

Losartán/Hidroclorotiazida Pensa 100 mg/25 mg is supplied as film-coated, yellow, uncoated tablets.

Losartán/Hidroclorotiazida Pensa 100 mg/25 mg is supplied in the following package sizes: Packets of 28 tablets.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara)

Spain

Last review date of this prospectus:February 2025

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