LOSARTAN HYDROCHLOROTHIAZIDE PENSA 50/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

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

2. Before you take Losartan/Hydrochlorothiazide

Do not take Losartan/Hydrochlorothiazide Pensa:

• if you are allergic (hypersensitive) to losartan, hydrochlorothiazide or any of the other ingredients 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 not sure).

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

• if you have severe hepatic impairment.

• if you have severe renal impairment or your kidneys do not produce urine.

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

• if you have gout.

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

Be especially careful with Losartan/Hydrochlorothiazide Pensa

Tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Losartan/Hydrochlorothiazide Pensa before you become pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Losartan/Hydrochlorothiazide Pensa. Losartan/Hydrochlorothiazide Pensa should not be used at the start of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after this time (see section Pregnancy).

Consult your doctor or pharmacist before starting to take Losartan/Hydrochlorothiazide Pensa:

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

• if you are taking diuretics (water tablets)

• if you are on a low-salt diet

• if you have had excessive vomiting and/or diarrhoea

• if you have heart failure

• if you have narrowings of the blood vessels to the kidneys (renal artery stenosis), if you only have one functioning kidney or if you have recently had a kidney transplant

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

• if you have narrowing of the aortic or mitral valve (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 had an allergic disorder, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematosus)

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

• if you need to have anaesthesia (even at the dentist) or before surgery, or if you are to have tests to check your parathyroid function, you should inform your doctor or healthcare staff that you are taking losartan potassium and hydrochlorothiazide tablets

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

• 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 if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartan/Hydrochlorothiazide Pensa

• if you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours to a week after taking Losartan/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 experience severe shortness of breath or difficulty breathing after taking Losartan/Hydrochlorothiazide Pensa, go to your doctor immediately.

Your doctor may check 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 diarrhoea after taking Losartan/Hydrochlorothiazide Pensa. Your doctor will decide whether to continue treatment. Do not stop taking Losartan/Hydrochlorothiazide Pensa on your own.

See also the information under the heading “Do not take Losartan/Hydrochlorothiazide Pensa”.

Taking other medicines

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

Diuretics like hydrochlorothiazide in Losartan/Hydrochlorothiazide Pensa can interact with other medicines. Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide Pensa without your doctor carrying out careful monitoring. Special precautions (e.g. blood tests) may be necessary if you take potassium supplements, salt substitutes containing potassium or potassium-sparing medicines, diuretics (water tablets), some laxatives, medicines for treating gout, medicines for controlling heart rhythm or for diabetes (oral or insulin).

It is also important that your doctor knows if you are taking other medicines to lower your blood pressure, steroids, medicines to treat cancer, painkillers, medicines to treat fungal infections or medicines for arthritis, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping tablets; opioid medicines such as morphine, "pressor amines" such as adrenaline or other medicines in the same group; (oral medicines for diabetes or insulins).

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

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

Please, when taking Losartan/Hydrochlorothiazide Pensa, inform your doctor when you are scheduled to have an iodine contrast medium.

Taking Losartan/Hydrochlorothiazide Pensa with food and drink

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

Excessive salt in the diet may counteract the effect of Losartan/Hydrochlorothiazide Pensa tablets.

Losartan/Hydrochlorothiazide Pensa can be taken with or without food.

Pregnancy and breastfeeding:

Pregnancy

You should tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Losartan/Hydrochlorothiazide Pensa before you become pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Losartan/Hydrochlorothiazide Pensa. Losartan/Hydrochlorothiazide Pensa should not be used at the start of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken after this time.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Losartan/Hydrochlorothiazide Pensa is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Use in children and adolescents

There is no experience with the use of Losartan/Hydrochlorothiazide in children. Therefore, Losartan/Hydrochlorothiazide Pensa should not be given to children.

Use in elderly patients

Losartan/Hydrochlorothiazide Pensa works as well and is as well tolerated by most elderly patients as by younger patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

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

Important information about some of the ingredients of Losartan/Hydrochlorothiazide Pensa

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

Use in athletes:

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

3. How to take Losartan/Hydrochlorothiazide

Follow exactly the instructions of administration of Losartan/Hydrochlorothiazide Pensa, as indicated by your doctor. Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide Pensa, depending on your condition and whether you are taking other medicines. It is important to keep taking Losartan/Hydrochlorothiazide Pensa while your doctor prescribes it to you to maintain constant control of your blood pressure.

High blood pressure

For most patients with high blood pressure, the usual dose is one losartan/hydrochlorothiazide 50 mg/12.5 mg tablet per day to control blood pressure over 24 hours. It can be increased to two losartan/hydrochlorothiazide 50 mg/12.5 mg film-coated tablets per day or changed to one losartan/hydrochlorothiazide 100 mg/25 mg film-coated tablet (a stronger dose) per day. The maximum daily dose is two losartan 50 mg/hydrochlorothiazide 12.5 mg tablets per day or one losartan 100 mg/hydrochlorothiazide 25 mg tablet per day.

If you take more Losartan/Hydrochlorothiazide Pensa than you should

In case of overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention. 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Losartan/Hydrochlorothiazide Pensa

Try to take Losartan/Hydrochlorothiazide Pensa as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your usual schedule.

4. Possible side effects

Like all medicines, Losartan/Hydrochlorothiazide Pensa can cause side effects, although not everybody gets them.

If you experience the following, stop taking Losartan/Hydrochlorothiazide Pensa tablets and inform your doctor immediately or go to the casualty department of your nearest hospital:

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

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

The following side 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,

• Diarrhoea, abdominal pain, nausea, indigestion,

• Muscle pain or cramps, leg pain, back pain,

• Insomnia, headache, dizziness,

• Weakness, tiredness, chest pain,

• High levels of potassium (which can cause an abnormal heart rhythm), decrease in haemoglobin 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 the hands and feet and abdominal pain), bruising, reduction in white blood cells, blood clotting problems and bruising,

• Loss of appetite, high levels of uric acid or gout, high blood sugar levels, abnormal blood electrolyte levels,

• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory disturbance,

• Numbness or similar sensations, pain in the limbs, tremor, migraine, fainting,
• Blurred vision, itching or burning in the eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• Ringing, buzzing, noises or clicking 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, stroke (transient stroke, "mini-stroke"), heart attack, palpitations,
• Inflammation of the blood vessels that is often associated with a skin rash or bruising,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nosebleeds, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach cramps, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• Jaundice (yellowing of the eyes and skin), pancreatitis,
• Hives, itching, skin inflammation, skin rash, flushing, sensitivity to light, dry skin, blushing, sweating, hair loss,
• Pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, weakness,
• Frequent urination even at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased sexual desire, impotence,
• Swelling of the face, fever.

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

• Hepatitis (inflammation of the liver), abnormal liver function tests.

• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

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

Frequency not known (cannot be estimated from the available data):

• Skin and lip cancer (non-melanoma skin cancer).
• Decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side 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 stated on the carton after EXP. The expiry date is the last day of the month stated.

Store below 30°C.

Store in the original package. Keep the blister in the outer packaging.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Additional Information

Composition of Losartan/Hydrochlorothiazide Pensa

The active ingredients are losartan potassium and hydrochlorothiazide.

Each Losartan/Hydrochlorothiazide Pensa 50 mg/12.5 mg tablet contains, as active ingredients, 50 mg of losartan (potassium) and 12.5 mg of hydrochlorothiazide.

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

Losartan/Hydrochlorothiazide Pensa 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.

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

Appearance of the Product and Packaging Contents

Losartan/Hydrochlorothiazide Pensa 50 mg/12.5 mg is supplied as yellow film-coated tablets.

Losartan/Hydrochlorothiazide Pensa 50 mg/12.5 mg is supplied in the following package sizes: Packages 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 Last Revision of this Leaflet: February 2025

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