Losartan/hydrochlorothiazide Pensa 100/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartan/Hydrochlorothiazide Pensa 100 mg/25 mg film-coated tablets EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Losartan/Hydrochlorothiazide Pensa is and what it is used for
2. Before you take Losartan/Hydrochlorothiazide Pensa
3. How to take Losartan/Hydrochlorothiazide Pensa
4. Possible side effects
5. How to store Losartan/Hydrochlorothiazide Pensa
6. Further information

1. What Losartán/Hidroclorotiazida Pensa is and what it is used for

Losartán/Hidroclorotiazida Pensa is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).

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

2. Before taking Losartán/Hidroclorotiazida Pensa

Do not take Losartán/Hidroclorotiazida Pensa:

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

• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g. other thiazides, certain antibacterial agents such as cotrimoxazole; consult your doctor if you are unsure).

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

• if you have severe liver impairment.

• if you have severe renal impairment or your kidneys are not producing urine.

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

• if you have gout.

• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Take special care with Losartán/Hidroclorotiazida Pensa

Inform your doctor if you are pregnant (or suspect you might be). The use of Losartán/Hidroclorotiazida Pensa is not recommended during early pregnancy, and you must not take it after the third month of pregnancy, as it may cause serious harm to your baby when used from that stage onward (see Pregnancy section).

Consult your doctor or pharmacist before starting treatment with Losartán/Hidroclorotiazida Pensa:

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

• if you are taking diuretics (medicines for increasing urine output)

• if you are on a low-salt diet

• if you have had or currently have excessive vomiting and/or diarrhea

• if you have heart failure

• if you have narrowed arteries supplying the kidneys (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant

• if you have arterial narrowing (atherosclerosis), angina pectoris (chest pain due to poor heart function)

• if you have aortic or mitral valve stenosis (narrowing of heart valves) or hypertrophic cardiomyopathy (a condition causing thickening of the heart muscle)

• if you are diabetic

• if you have had gout

• if you have or have had allergic disorders, asthma, or a condition causing joint pain, skin rashes, and fever (systemic lupus erythematosus)

• if you have high calcium levels or low potassium levels, or if you are on a low-potassium diet

• if you require anesthesia (even at the dentist) or before surgery, or if you are undergoing tests to assess parathyroid function, inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets

• if you have primary hyperaldosteronism (a syndrome characterized by excessive aldosterone hormone secretion from the adrenal gland due to adrenal dysfunction)

• if you are taking any of the following medicines for 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV radiation while taking Losartán/Hidroclorotiazida Pensa.

• if you experience vision disturbances or eye pain, which could be signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure; these may occur within hours to a week after taking Losartán/Hidroclorotiazida Pensa.

• if you have had respiratory or pulmonary problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking Losartán/Hidroclorotiazida Pensa, seek medical attention immediately.

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea 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”.

Taking other medicines

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

Diuretics such as hydrochlorothiazide contained in Losartán/Hidroclorotiazida Pensa may interact with other medicines. Lithium-containing preparations should not be taken with Losartán/Hidroclorotiazida Pensa unless your doctor performs careful monitoring. Special precautionary measures (e.g., blood tests) may be required if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing agents, diuretics (water tablets), certain laxatives, medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral agents or insulin).

It is also important that your doctor knows if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, painkillers, antifungal medicines, arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping pills, opioid medicines such as morphine, "pressor amines" such as adrenaline, or other medicines in the same class.

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Losartán/Hidroclorotiazida Pensa” and “Take special care with Losartán/Hidroclorotiazida Pensa”).

Please inform your doctor if you are scheduled to receive iodinated contrast media while taking Losartán/Hidroclorotiazida Pensa.

Taking Losartán/Hidroclorotiazida Pensa with food and drinks

You are advised not to drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida Pensa tablets may enhance each other's effects.

Excessive dietary salt intake may counteract the effect of Losartán/Hidroclorotiazida Pensa tablets.

Losartán/Hidroclorotiazida Pensa may be taken with or without food.

Pregnancy and breastfeeding:

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking Losartán/Hidroclorotiazida Pensa before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of Losartán/Hidroclorotiazida Pensa is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when administered from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. The use of Losartán/Hidroclorotiazida Pensa is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you intend 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 given to children.

Use in elderly patients

Losartán/Hidroclorotiazida Pensa is equally effective and well tolerated in most elderly and younger patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

When starting treatment with this medicine, do not perform tasks that require special attention (e.g., driving a car or operating dangerous machinery) until you know how you react to the medicine.

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

This medicine contains lactose. If your doctor has informed 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 result in a positive test in doping controls.

3. How to take Losartán/Hidroclorotiazida Pensa

Follow exactly the instructions given by your doctor for taking Losartán/Hidroclorotiazida Pensa. Your doctor will determine the appropriate dose of Losartán/Hidroclorotiazida Pensa based on your condition and whether you are taking other medications. It is important to continue taking Losartán/Hidroclorotiazida Pensa as prescribed by your doctor to maintain consistent blood pressure control.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 tablet of losartan/hydrochlorothiazide 50 mg/12.5 mg once daily to control blood pressure over 24 hours. The dose may be increased to 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) once daily. The maximum daily dose is 1 tablet of 100 mg losartan/25 mg hydrochlorothiazide per day.

If you take more Losartán/Hidroclorotiazida Pensa than you should

In case of overdose, contact your doctor immediately or go directly to the hospital to receive immediate medical attention. Overdose may cause low 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 Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Losartán/Hidroclorotiazida Pensa

Try to take Losartán/Hidroclorotiazida Pensa every day as prescribed. However, if you miss a dose, do not take a double dose. Simply return to your regular dosing schedule.

4. Possible adverse effects

Like all medicines, Losartán/Hidroclorotiazida Pensa may produce adverse effects, although not everyone experiences them.

If you experience any of the following, stop taking Losartán/Hidroclorotiazida Pensa tablets immediately and contact your doctor right away or go to the nearest hospital emergency department:

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

This is a serious but rare adverse effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. It may require urgent medical attention or hospitalization.

The following adverse effects have been reported:

Common (affecting less than 1 in 10 but more than 1 in 100 people):

• Cough, respiratory infection, nasal congestion, sinusitis, sinus disorder,
• Diarrhea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• Elevated potassium levels (which may cause an abnormal heart rhythm), decreased hemoglobin levels.

Uncommon (affecting less than 1 in 100 but more than 1 in 1,000 people):

• 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), bruising, reduction in white blood cells, blood clotting disorders and bruising,
• Loss of appetite, elevated uric acid levels or overt gout, elevated blood glucose levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory impairment,
• Tingling or similar sensations, pain in the extremities, tremor, migraine, fainting,
• Blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• Ringing, buzzing, noises or crackling in the ears,
• Low blood pressure that may be associated with postural changes (feeling dizzy or weak upon standing), angina (chest pain), irregular heartbeat, stroke (transient ischemic attack, "mini-stroke"), heart attack, palpitations,
• Inflammation of blood vessels often associated with a skin rash or bruising, sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nosebleed, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, swelling of a salivary gland, toothache,
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
• Hives, itching, skin inflammation, rash, skin redness, photosensitivity, dry skin, flushing, sweating, hair loss,
• Pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness,
• Frequent urination, including at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased sexual appetite, impotence,
• Facial swelling, fever.

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

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

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

• Acute breathing difficulty (symptoms 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].

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Losartan/Hydrochlorothiazide Pensa

Keep out of the reach and sight of children.

Do not use Losartan/Hydrochlorothiazide Pensa after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Information for the user

Composition of Losartán/Hidroclorotiazida Pensa

The active substances are losartan potassium and hydrochlorothiazide.

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

Losartán/Hidroclorotiazida Pensa 100 mg/25 mg contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, 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 medicinal product and contents of the pack

Losartán/Hidroclorotiazida Pensa 100 mg/25 mg is supplied as yellow, film-coated tablets without a break line.

Losartán/Hidroclorotiazida Pensa 100 mg/25 mg is available in the following pack sizes: packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer

Laboratorios Liconsa, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

Date of the most recent review of this leaflet: February 2025

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/