Losartan/hydrochlorothiazide Tarbis 50/12.5 mg film-coated tablet EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Losartan potassium/Hydrochlorothiazide

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

• 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 only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Losartan/Hydrochlorothiazide Tarbis is and what it is used for
2. What you need to know before taking Losartan/Hydrochlorothiazide Tarbis
3. How to take Losartan/Hydrochlorothiazide Tarbis
4. Possible adverse effects
5. Storage of Losartan/Hydrochlorothiazide Tarbis
6. Contents of the pack and other information

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

Losartan/hydrochlorothiazide Tarbis is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body that binds to receptors present in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, thereby lowering blood pressure. Hydrochlorothiazide causes the kidneys to eliminate increased amounts of water and salts. This also helps reduce blood pressure.

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

2. What you need to know before taking Losartan/Hydrochlorothiazide Tarbis

Do not take Losartan/Hydrochlorothiazide Tarbis

• if you are allergic (hypersensitive) to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g. other thiazides, certain antibacterial agents such as cotrimoxazole; ask your doctor if you are unsure)

? if you are more than 3 months pregnant. (It is also better to avoid Losartan/Hydrochlorothiazide Tarbis 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, 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

Warnings and precautions

Talk to your doctor before taking Losartan/Hydrochlorothiazide Tarbis:

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

• if you have heart failure

• if you have narrowed arteries leading to the kidneys (renal artery stenosis), only one functioning kidney, or 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 have diabetes

• 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 levels of calcium or low levels of potassium, 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, you must inform your doctor or healthcare provider 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 a disorder of this gland)

• 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Losartan/Hydrochlorothiazide Tarbis.

• If you experience vision changes or eye pain, which could be signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, occurring within hours to one week after taking Losartan/Hydrochlorothiazide Tarbis.

  • If you have previously experienced respiratory 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 Losartan/Hydrochlorothiazide Tarbis, seek medical help immediately.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking losartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking losartan/hydrochlorothiazide 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 Losartan/Hydrochlorothiazide Tarbis”

Children and adolescents

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

Other medicines and Losartan/Hydrochlorothiazide Tarbis

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Diuretics such as hydrochlorothiazide contained in Losartan/Hydrochlorothiazide Tarbis may interact with other medicines. Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide Tarbis without careful monitoring by your doctor. Special precautionary measures (e.g. blood tests) may be necessary if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, diuretics ("water pills"), certain laxatives, gout medications, 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, pain medicines, antifungal medicines, arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping pills, opioid medicines such as morphine, "vasopressor 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 additional precautions:

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

Please inform your doctor if you are scheduled to receive iodine-containing contrast media while taking Losartan/Hydrochlorothiazide Tarbis.

Taking Losartan/Hydrochlorothiazide Tarbis with food, drinks, and alcohol

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

Excessive dietary salt intake may reduce the effectiveness of Losartan/Hydrochlorothiazide Tarbis tablets.

Losartan/Hydrochlorothiazide Tarbis may be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy

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

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. The use of Losartan/Hydrochlorothiazide Tarbis is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Losartan/Hydrochlorothiazide Tarbis contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Losartan/Hydrochlorothiazide Tarbis

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide Tarbis, depending on your condition and whether you are taking other medicines.

High blood pressure

For most patients with high blood pressure, the recommended dose is 1 tablet of Losartan/Hydrochlorothiazide Tarbis 50 mg/12.5 mg once daily to control blood pressure over 24 hours. This dose may be increased to 2 film-coated tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg daily or changed 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.

Use in children and adolescents

There is no experience with the use of Losartan/Hydrochlorothiazide in children. Therefore, Losartan/Hydrochlorothiazide Tarbis must not be administered to children.

Use in elderly patients

Losartan/Hydrochlorothiazide Tarbis works with equal effectiveness and is equally well tolerated by most elderly and younger patients. Most elderly patients require the same dose as younger patients.

If you take more Losartan/Hydrochlorothiazide Tarbis than you should

In case of overdose, contact your doctor immediately or go directly to the hospital to receive immediate medical attention.

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 medicine and the amount ingested.

Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forget to take Losartan/Hydrochlorothiazide Tarbis

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

If you stop taking Losartan/Hydrochlorothiazide Tarbis

It is important to continue taking Losartan/Hydrochlorothiazide Tarbis for as long as your doctor has prescribed it to maintain consistent blood pressure control.

4. Possible adverse effects

Like all medicines, Losartan/hydrochlorothiazide Tarbis may cause adverse effects, although not everyone experiences them.

If you experience the following, stop taking Losartan/hydrochlorothiazide Tarbis 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 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 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 the 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 manifest 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, limb pain, tremor, migraine, fainting,
• Blurred vision, burning or itching eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• Ringing, buzzing, noise or crackling in the ears,
• Low blood pressure which may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal 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), nosebleed, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation 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, hip, knee 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):

• 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 (may affect up to 1 in 10,000 patients):

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

Not known (frequency cannot be estimated from available data):

• Flu-like symptoms
• Muscle pain of unknown origin with dark urine (tea-colored) (rhabdomyolysis)
• Low sodium levels in blood (hyponatremia)
• Generally feeling unwell (malaise)
• Taste disturbance (dysgeusia)
• Vision impairment 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].

Skin and lip cancer (non-melanoma skin cancer). If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartan/Hydrochlorothiazide Tarbis

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store Losartan/Hydrochlorothiazide Tarbis in the original container.

Keep the blister in the outer packaging. Do not open the blister until you are ready to take the tablet.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Losartan/Hydrochlorothiazide Tarbis

The active substances are 50 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ).

The other components are microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), yellow iron oxide (E 172), and talc.

Losartan/Hydrochlorothiazide Tarbis contains 4.24 mg (0.108 mEq) of potassium.

Appearance of the medicinal product and contents of the pack

Losartan/Hydrochlorothiazide Tarbis is supplied as yellow, elongated, film-coated tablets with a score line on one side. The score line is intended only to facilitate breaking the tablet for ease of swallowing and not to divide the tablet into equal doses.

Losartan/Hydrochlorothiazide Tarbis 50 mg/12.5 mg is available in the following pack sizes: opaque white Al/PVC/PE/PVDC blisters in packs of 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-Barcelona

Spain

Manufacturer:

Amarox Pharma B.V.

Rouboslaan 32

2252TR Voorschoten

The Netherlands

This leaflet was approved in February 2025

Detailed and up-to-date 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/)