Leaflet: information for the user

Losartán/Hidroclorotiazida STADA 50 mg/12,5 mg film-coated tablets

Losartán/Hidroclorotiazida STADA 100 mg/25 mg film-coated tablets

Losartán potassium/Hidroclorotiazida

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

5.Storage of Losartán/Hidroclorotiazida Stada

6.Contents of the pack and additional information

Losartán/hidroclorotiazida is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hidroclorotiazida).The angiotensin II is a substance produced in the body that binds to receptors present in blood vessels, causing them to constrict. This results in an increase in blood pressure. Losartán prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure.Hidroclorotiazidacauses the kidneys to eliminate a greater amount of water and salts. This also helps to reduce blood pressure.

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

Do not take Losartán/Hidroclorotiazida Stada

• if you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients in this medicine (listed in section 6),
• if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibacterial medicines such as cotrimoxazole, ask your doctor if you are unsure),
• if you have severe liver failure,
• 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 (it is also recommended to avoid losartan/hydrochlorothiazide at the beginning of pregnancy – see the Pregnancy section),
• if you have severe kidney failure or your kidneys do not produce urine,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Losartan/Hidroclorotiazida Stada.

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

Inform your doctor if you are pregnant (or if you suspect you may be). Losartan/hydrochlorothiazide is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards (see the Pregnancy section).

It is essential to inform your doctor before taking Losartan/Hidroclorotiazida Stada:

• if you have previously experienced swelling of the face, lips, tongue, or throat
• if you are taking diuretics (urine-producing medicines)
• if you are following a low-sodium diet
• if you have excessive vomiting and/or diarrhea
• if you have heart failure
• if your liver function is altered (see section 2 “Do not take Losartan/Hidroclorotiazida Stada”)
• if you have narrowed arteries (arterial stenosis), if you only have one functioning kidney, or if you have recently undergone a kidney transplant
• if you have atherosclerosis, angina pectoris (chest pain due to heart dysfunction)
• if you have aortic or mitral valve stenosis (narrowing of the heart valves) or hypertrophic cardiomyopathy (a disease causing heart muscle thickening)
• if you are diabetic
• if you have had gout
• if you have or have had an allergic reaction, asthma, or a condition causing joint pain, skin eruptions, and fever (systemic lupus erythematosus)
• if you have high calcium levels or low potassium levels, or if you are following a low-potassium diet
• if you need anesthesia (even for dental procedures) or before surgery, or if you are undergoing tests to determine your parathyroid function, inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets
• if you have primary aldosteronism (a syndrome associated with an elevated secretion of aldosterone hormone by the adrenal gland due to glandular alteration)

• 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 renal function, blood pressure, and electrolyte levels in the blood (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 levels (see section 2 “Other medicines and Losartán/Hidroclorotiazida Stada”).

• if you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which can occur within a few hours to several weeks after taking losartan/hydrochlorothiazide. This can lead to permanent vision loss if not treated. You may be at higher risk of developing this if you have previously had an allergy to penicillin or sulfonamides.
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Hydrochlorothiazide treatment, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking losartan/hydrochlorothiazide.
• if you have had respiratory or pulmonary 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, seek medical attention immediately.

Children and adolescents

There is no experience with the use of losartan/hydrochlorothiazide in children. Therefore, losartan/hydrochlorothiazide should not be administered to children.

Other medicines and Losartán/Hidroclorotiazida Stada

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

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

Diuretics like hydrochlorothiazide in Losartán/Hidroclorotiazida Stada may interact with other medicines.

Lithium preparations should not be taken with losartan/hydrochlorothiazide without your doctor's careful monitoring.

Special precautions may be necessary (e.g. blood tests) if you are taking other diuretics (urine-producing medicines), some laxatives, medicines for gout treatment, heart rhythm-controlling medicines, or diabetes medicines (oral or insulin).

Your doctor should also be informed if you are taking:

• other blood pressure-lowering medicines
• steroids
• medicines for cancer treatment
• pain medicines
• medicines for fungal infections
• medicines for arthritis
• cholesterol-lowering resins like cholestyramine
• muscle relaxants
• sleeping pills
• opioid medicines like morphine
• "pressor amines" like adrenaline or other medicines in the same group
• oral diabetes medicines or insulin.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Losartán/Hidroclorotiazida Stada” and “Warnings and precautions”).

Please inform your doctor when you plan to undergo a contrast medium with iodine.

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

It is recommended not to drink alcohol while taking these tablets: alcohol and losartan/hydrochlorothiazide tablets may increase the effects of each other.

Excessive salt in the diet may counteract the effect of losartan/hydrochlorothiazide tablets.

Losartan/hydrochlorothiazide tablets can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

You should inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking losartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of losartan/hydrochlorothiazide. Losartan/hydrochlorothiazide is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards.

Lactation

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Losartan/hydrochlorothiazide is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Use in elderly patients

Losartan/hydrochlorothiazide acts with equal efficacy and is equally well tolerated by most elderly patients and young adults. Most elderly patients require the same dose as younger patients.

Driving and operating machinery

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

Losartán/Hidroclorotiazida Stada contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Use in athletes:

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of losartan/hidroclorotiazide based on your condition and if you are taking other medications. It is essential to continue taking losartan/hidroclorotiazide 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 one tablet of losartan/hidroclorotiazide 50 mg/12.5 mg per day to control blood pressure for 24 hours. It can be increased to two tablets of losartan/hidroclorotiazide 50 mg/12.5 mg per day or changed to one tablet of losartan/hidroclorotiazide 100 mg/25 mg (a higher dose) per day. The maximum daily dose is two tablets of 50 mg losartan/12.5 mg hidroclorotiazide per day or one tablet of 100 mg losartan/25 mg hidroclorotiazide per day.

If You Take More Losartán/Hidroclorotiazida Stada Than You Should

In case of an overdose, contact your doctor immediately for immediate medical attention. An overdose can cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

You can also call the Toxicological Information Service. Phone: (91) 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If You Forget to Take Losartán/Hidroclorotiazida Stada

Try to take losartan/hidroclorotiazide every day as prescribed. However, if you forget a dose, do not take an extra dose, simply return to your regular schedule.

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

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

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

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

The following side effects have been reported:

Frequent(may affect up to 1 in 10 people):

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, breast tenderness,
• Diarrhea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,

• Insomnia, headache, dizziness,

• Weakness, fatigue, chest pain,
• High potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels,
• Changes in renal function that include renal insufficiency,
• Low blood sugar (hypoglycemia).

Infrequent(may affect up to 1 in 100 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), hematoma, reduced white blood cell count, coagulation problems, reduced platelet count,

• Loss of appetite, high uric acid levels or manifest gout, high blood glucose levels, abnormal electrolyte levels in the blood,

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

• Tickling or similar sensations, pain in the extremities, tremor, migraine, fainting,
• Blurred vision, eye itching or stinging, conjunctivitis, worsening of vision, seeing things in yellow,

• Ringing, buzzing, or crackling sounds in the ears, vertigo
• 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 ischemic attack (TIA), "mini-stroke"), heart attack, palpitations,

• Swelling of blood vessels that often occurs with a skin rash or hematoma,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which causes difficulty breathing), nasal bleeding, runny nose, congestion,

• Constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain,

• Jaundice (yellowing of the eyes and skin), pancreatitis inflammation,
• Urticaria, itching, skin inflammation, skin rash, skin redness, light sensitivity, dry skin, flushing, sweating, hair loss,

• Pain in the arms, shoulders, hips, knees, or other joints, joint swelling, stiffness, muscle weakness,

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

• Decreased sexual appetite, impotence,
• Swelling of the face, localized swelling (edema), fever.

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

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

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

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

Frequency unknown(cannot be estimated from available data):

• Symptoms similar to the flu,
• Muscle pain of unknown origin with dark-colored urine (rhabdomyolysis),
• Low sodium levels in the blood (hyponatremia)
• Generally feeling unwell,
• Alteration of taste (dysgeusia)
• Skin cancer and lip cancer (non-melanoma skin cancer)
• Decreased vision or eye pain due to high 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 experienceany type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Store in the original packaging.

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

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Losartán/Hidroclorotiazida Stada

The active principles are losartan potassium and hydrochlorothiazide.

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

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

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

Appearance of the product and content of the packaging

Losartán/Hidroclorotiazida Stada are film-coated tablets, yellow in color, and unnotched.

They are presented in blister packs of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

Responsible for manufacturing

Laboratories Liconsa, S.A.

Avda. Miralcampo, Nº 7,

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara),

Spain

Date of the last review of this leaflet:February 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/