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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Losartán/Hidroclorotiazida STADA 50 mg/12.5 mg film-coated tablets EFG

Losartán/Hidroclorotiazida STADA 100 mg/25 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, since it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Losartán/Hidroclorotiazida STADA is and what it is used for
2. What you need to know before taking Losartán/Hidroclorotiazida STADA
3. How to take Losartán/Hidroclorotiazida STADA
4. Possible side effects
5. How to store Losartán/Hidroclorotiazida STADA
6. Contents of the pack and other information

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

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

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

2. What you need to know before taking Losartán/Hidroclorotiazida Stada

Do not take Losartán/Hidroclorotiazida Stada

• if you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, certain antibacterial medicines such as cotrimoxazole; ask your doctor if you are unsure),
• if you have severe liver impairment,
• 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 are more than 3 months pregnant (Losartan/hydrochlorothiazide is also best avoided in early pregnancy – see Pregnancy section),
• if you have severe renal impairment or your kidneys are not producing urine,
• if you have diabetes or kidney disease and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Losartán/Hidroclorotiazida Stada.

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

Inform your doctor if you are pregnant (or suspect you might be pregnant). The use of losartan/hydrochlorothiazide 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 point onward (see Pregnancy section).

It is important to inform your doctor before taking Losartán/Hidroclorotiazida Stada:

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

• if you have heart failure,

• if your liver function is impaired (see section 2 “Do not take Losartán/Hidroclorotiazida Stada”),

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

• if you have hardening of the 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 an allergic disorder, asthma, or a disease 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 the doctor or healthcare professional 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 adrenal dysfunction).

• 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.

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 Losartán/Hidroclorotiazida Stada”.

• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Losartán/Hidroclorotiazida Stada”).

• if you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to weeks after taking losartan/hydrochlorothiazide. This may lead to permanent vision loss if not treated. Your risk may be higher if you have previously been allergic to penicillin or sulfonamides.

• 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 sun and UV exposure while taking losartan/hydrochlorothiazide.

• if you have previously had breathing 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, contact your doctor immediately.

Children and adolescents

There is no experience with the use of losartan/hydrochlorothiazide in children. Therefore, losartan/hydrochlorothiazida must not be given to children.

Other medicines and Losartán/Hidroclorotiazida Stada

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

Tell your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, or other medicines that may increase serum potassium (e.g. medicines containing trimethoprim), as combination with losartan/hydrochlorothiazide is not recommended.

Diuretics such as hydrochlorothiazide contained in Losartán/Hidroclorotiazida Stada may interact with other medicines.

Lithium-containing preparations must not be taken with losartan/hydrochlorothiazide unless your doctor performs careful monitoring.

Special precautionary measures (e.g. blood tests) may be appropriate if you are taking other diuretics (water tablets), certain laxatives, medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral antidiabetics or insulin).

It is also important that your doctor knows if you are taking:

• other medicines to lower your blood pressure,
• steroids,
• cancer treatment medicines,
• 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 medicines in the same group,
• oral antidiabetic medicines or insulin.

Your doctor may need to adjust your dose and/or take other 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 Stada” and “Warnings and precautions”).

Please inform your doctor if you are planning to undergo an iodinated contrast medium procedure while taking losartan/hydrochlorothiazide.

Taking Losartán/Hidroclorotiazida Stada with food, drinks, and alcohol

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

Excessive dietary salt intake may counteract the effect of losartan/hydrochlorothiazide tablets.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking losartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. This medicine 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 used from that time.

Breastfeeding

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

Use in elderly patients

Losartán/Hidroclorotiazida Stada is equally effective and well tolerated in most elderly and younger adult 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.

Losartán/Hidroclorotiazida Stada contains lactose

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 Stada

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of losartán/hidroclorotiazida based on your condition and whether you are taking other medicines. It is important to keep taking losartán/hidroclorotiazida 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 losartán/hidroclorotiazida 50 mg/12.5 mg once daily to control blood pressure over 24 hours. This may be increased to 2 film-coated tablets of losartán/hidroclorotiazida 50 mg/12.5 mg per day or changed to 1 film-coated tablet of losartán/hidroclorotiazida 100 mg/25 mg (a stronger dose) per day. The maximum daily dose is 2 tablets of 50 mg losartán/12.5 mg hydrochlorothiazide per day or 1 tablet of 100 mg losartán/25 mg hydrochlorothiazide per day.

If you take more Losartán/Hidroclorotiazida Stada than you should

In case of overdose, contact your doctor immediately so you can receive immediate medical attention. Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

You may also call the Toxicology Information Service. Telephone: (91) 562 04 20, stating the name of the medicine and the amount taken. It is recommended to bring the medicine package and the package leaflet to the healthcare professional.

If you forget to take Losartán/Hidroclorotiazida Stada

Try to take losartán/hidroclorotiazida every day as prescribed. However, if you miss a dose, do not take an extra dose; simply return to your regular schedule.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience the following, stop taking losartan/hydrochlorothiazide tablets immediately and contact your doctor or go to the nearest hospital emergency department:

A severe allergic reaction (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 (may affect up to 1 in 10 people):

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorder,
• Diarrhoea, 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 haemoglobin levels,
• Changes in kidney function including kidney failure,
• Low blood sugar (hypoglycaemia).

Uncommon (may affect up to 1 in 100 people):

• 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, bleeding disorders, reduced platelet count,
• 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, vertigo,
• Low blood pressure which may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), irregular heartbeat, stroke (transient ischaemic attack (TIA), "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 (causing difficulty breathing), nosebleed, runny nose, congestion,
• Constipation, chronic constipation, flatulence, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
• Urticaria, 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 even at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased sexual appetite, impotence,
• Facial swelling, localized swelling (oedema), fever.

Rare (may affect up to 1 in 1,000 people):

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

Very rare (may affect up to 1 in 10,000 people):

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

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

• Flu-like symptoms,
• Muscle pain of unknown origin with dark-coloured (tea-coloured) urine (rhabdomyolysis),
• Low sodium levels in blood (hyponatraemia),
• Generally feeling unwell (malaise),
• Taste disturbance (dysgeusia),
• 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 effect, talk to 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: 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 Stada

Keep out of the sight and reach of children.

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

Store below 30°C.

Keep in the original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartan/Hydrochlorothiazide Stada

The active substances are potassium losartan and hydrochlorothiazide.

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

Each tablet of Losartan/Hydrochlorothiazide Stada 100 mg/25 mg contains, as active substances, 100 mg of losartan (potassium) and 25 mg of hydrochlorothiazide.

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

Appearance of the product and contents of the pack

Losartan/Hydrochlorothiazide Stada are yellow, film-coated tablets, without a break line.

They are supplied in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona), Spain

[email protected]

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