Losartan/hydrochlorothiazide Pensa 50/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartan/Hydrochlorothiazide Pensa 50 mg/12.5 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 should not be given 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 severe, or if you notice any side effects not mentioned 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/Hydrochlorothiazide

Do not take Losartán/Hydrochlorothiazide Pensa:

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

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

• if you are more than 3 months pregnant. (It is also preferable to avoid Losartán/Hydrochlorothiazide 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 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 kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Take special care with Losartán/Hydrochlorothiazide Pensa

Inform your doctor if you are pregnant (or suspect you might be pregnant). The use of Losartán/Hydrochlorothiazide 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 to take Losartán/Hydrochlorothiazide Pensa:

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

• if you are taking diuretics (medicines to increase urine production)

• if you are on a low-salt diet

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

• if you have heart failure

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

• if you have narrowed arteries (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 an allergic disorder, 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 your parathyroid function, you must inform the doctor or healthcare staff that you are taking losartan potassium and hydrochlorothiazide tablets

• if you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to dysfunction of this gland)

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

• an angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), especially 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, particularly 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 Losartán/Hydrochlorothiazide Pensa.

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

• if you have had respiratory or lung problems (such as 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/Hydrochlorothiazide 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/Hydrochlorothiazide Pensa. Your doctor will decide whether to continue treatment. Do not stop taking Losartán/Hydrochlorothiazide Pensa on your own.

See also the information under the heading “Do not take Losartán/Hydrochlorothiazide 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/Hydrochlorothiazide Pensa may interact with other medicines. Lithium-containing preparations should not be taken with Losartán/Hydrochlorothiazide Pensa unless your doctor closely monitors you. Special precautionary measures (e.g., blood tests) may be necessary if you are taking potassium supplements, potassium-containing salt substitutes, or potassium-sparing medicines, diuretics (water tablets), certain laxatives, gout treatments, medicines to control heart rhythm, or diabetes medicines (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 tablets, opioid medicines such as morphine, "pressor amines" such as adrenaline or other drugs in this group, or oral diabetes medicines or insulin.

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

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

Please inform your doctor if you are scheduled to receive an iodinated contrast agent while taking Losartán/Hydrochlorothiazide Pensa.

Taking Losartán/Hydrochlorothiazide Pensa with food and drinks

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

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

Losartán/Hydrochlorothiazide 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 generally advise you to stop taking Losartán/Hydrochlorothiazide Pensa before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of Losartán/Hydrochlorothiazide 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 time.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. The use of Losartán/Hydrochlorothiazide Pensa is not recommended during breastfeeding, and your doctor will choose an alternative treatment 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/Hydrochlorothiazide in children. Therefore, Losartán/Hydrochlorothiazide Pensa must not be given to children.

Use in elderly patients

Losartán/Hydrochlorothiazide 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 ingredients of Losartán/Hydrochlorothiazide Pensa

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

Use in athletes:

This medicine contains hydrochlorothiazide, which may result in a positive doping test.

3. How to take Losartán/Hidroclorotiazida

Follow exactly the instructions for use of Losartán/Hidroclorotiazida Pensa as given by your doctor. Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida Pensa based on your condition and whether you are taking other medications. It is important to keep 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 2 film-coated tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg daily or switched to 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) daily. The maximum daily dose is 2 tablets of 50 mg losartan/12.5 mg hydrochlorothiazide daily or 1 tablet of 100 mg losartan/25 mg hydrochlorothiazide daily.

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, contact 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 daily as prescribed. However, if you miss a dose, do not take an extra 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 the following, stop taking Losartán/Hidroclorotiazida Pensa tablets immediately and contact your doctor 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 in swallowing or breathing).

This is a rare but serious 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):

• 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):

• Anaemia, red or brown spots on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and abdominal pain), bruising, reduction in white blood cells, blood clotting problems 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, somnolence, memory impairment,

• Tingling or similar sensations, limb pain, tremor, migraine, fainting,

• Blurred vision, eye irritation or itching, conjunctivitis, worsening of vision, seeing things in yellow,

• Ringing, buzzing, noises or crackling in the ears,

• Low blood pressure which may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), irregular heartbeats, stroke (transient ischaemic 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), nosebleeds, 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,

• Urticaria, itching, skin inflammation, skin rash, skin redness, photosensitivity, dry skin, flushing, sweating, hair loss,

• Pain in arms, shoulders, hip, knee or other joints, joint swelling, stiffness, muscle weakness,

• Frequent urination, even at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in urine,

• Decreased sexual appetite, impotence,

• Facial swelling, fever.

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

• 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 adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 Losartán/Hidroclorotiazida Pensa

Keep out of the reach and sight of children.

Do not use Losartán/Hidroclorotiazida Pensa after the expiry date 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.

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Additional Information

Composition of Losartán/Hidroclorotiazida Pensa

The active substances are losartan potassium and hydrochlorothiazide.

Each Losartán/Hidroclorotiazida Pensa 50 mg/12.5 mg tablet contains, as active substances, 50 mg of losartan (potassium) and 12.5 mg of hydrochlorothiazide.

Losartán/Hidroclorotiazida Pensa 50 mg/12.5 mg contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, and magnesium stearate (E-572).

Losartán/Hidroclorotiazida Pensa 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.

Losartán/Hidroclorotiazida Pensa 50 mg/12.5 mg also contains hydroxypropylcellulose, hypromellose, titanium dioxide (E-171), and yellow iron oxide (E-172).

Presentation of the product and contents of the pack

Losartán/Hidroclorotiazida Pensa 50 mg/12.5 mg is supplied as yellow, film-coated tablets.

Losartán/Hidroclorotiazida Pensa 50 mg/12.5 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 revision of this leaflet: February 2025

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