Patient Information Leaflet

Losartán/Hydrochlorothiazide Alter Generics 50 mg/12.5 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, ask your doctor or pharmacist.

• This medicine has been prescribed for you and should not be given to others, even if they have similar symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

Losartán/Hidroclorotiazida Alter Genéricos is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hidroclorotiazida).

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

Do not take Losartán/Hidroclorotiazida Alter Genéricos

• if you are allergic (hypersensitive) to losartan, to 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, some antibacterials such as cotrimoxazole, ask your doctor if you are unsure).
• if you are more than 3 months pregnant. (It is best to avoid Losartán/Hidroclorotiazida Alter Genéricos 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, 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 that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Losartán/Hidroclorotiazida Alter Genéricos

Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhea after taking Losartán/Hidroclorotiazida Alter Genéricos. Your doctor will decide whether to continue treatment. Do not stop taking Losartán/Hidroclorotiazida Alter Genéricos as monotherapy.

Inform your doctor if you are pregnant (or if you suspect you may be). It is not recommended to use Losartán/Hidroclorotiazida Alter Genéricos 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 Pregnancy section).

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

• 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 had excessive vomiting and/or diarrhea
• if you have heart failure
• if your liver function is altered (see section 2. Do not take Losartán/Hidroclorotiazida Alter Genéricos)
• if you have narrowed arteries leading to the kidney (renal artery stenosis), if you only have one functioning kidney or if you have recently had a kidney transplant
• if you have atherosclerosis (narrowing of the arteries), angina (chest pain due to poor heart function)
• if you have mitral or aortic valve stenosis (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 or have had an allergic reaction, asthma or a condition that causes joint pain, skin eruptions and fever (systemic lupus erythematosus)
• if you have high levels of calcium or low levels of potassium 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 the hormone aldosterone by the adrenal gland due to a glandular alteration).
• if you are taking any of the following blood pressure lowering medicines:
• • a converting enzyme inhibitor (ACE inhibitor) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.

Your doctor may need to monitor your kidney function, blood pressure and electrolyte levels in your blood (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Losartán/Hidroclorotiazida Alter Genéricos”.

Losartán/Hidroclorotiazida Alter Genéricos with other medicines

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

Diuretics such as hydrochlorothiazide in Losartán/Hidroclorotiazida Alter Genéricos may interact with other medicines.

Preparations containing lithium should not be taken with Losartán/Hidroclorotiazida Alter Genéricos without your doctor's careful monitoring. Special precautions may be necessary (e.g. blood tests) if you take potassium supplements, potassium-sparing salt substitutes or potassium-saving medicines, diuretics (urine-producing tablets), some laxatives, medicines for gout treatment, heart rhythm control medicines or diabetes medicines (oral or insulin).

Your doctor should also be informed if you are taking other blood pressure lowering medicines, steroids, cancer medicines, pain medicines, fungal infection medicines or 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 diabetes medicines or insulin).

Your doctor may need to modify 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 Alter Genéricos” and “Warnings and precautions”).

Please inform your doctor when you plan to have a contrast agent with iodine.

Losartán/Hidroclorotiazida Alter Genéricos with food and drinks

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida Alter Genéricos tablets may increase the effects of each other.

Excessive salt in the diet may counteract the effect of Losartán/Hidroclorotiazida Alter Genéricos tablets.

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

Pregnancy and breastfeeding

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 Losartán/Hidroclorotiazida Alter Genéricos before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Losartán/Hidroclorotiazida Alter Genéricos. It is not recommended to use Losartán/Hidroclorotiazida Alter Genéricos at the beginning of pregnancy, and in any case, it should not be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. It is not recommended to use Losartán/Hidroclorotiazida Alter Genéricos during breastfeeding, and your doctor will choose another treatment for you 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/Hidroclorotiazida in children. Therefore, Losartán/Hidroclorotiazida Alter Genéricos should not be administered to children.

Use in elderly patients

Losartán/Hidroclorotiazida Alter Genéricos acts with equal efficacy and is equally well tolerated by most elderly patients and young patients. 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 may require special attention (e.g. driving a car or using hazardous machinery) until you know how you tolerate your medicine.

Important information about some of the components of Losartán/Hidroclorotiazida Alter Genéricos

This medicine contains lactose. If your doctor has told you that you are intolerant to certain sugars, consult with him 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 Losartán/Hidroclorotiazida Alter Generics as indicated by your doctor. Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida Alter Generics, depending on your condition and if you are taking other medications. It is essential to continue taking Losartán/Hidroclorotiazida Alter Generics as prescribed by your doctor to maintain consistent blood pressure control.

Hypertension

For most patients with high blood pressure, the usual dose is 1 tablet of Losartán/Hidroclorotiazida 50 mg/12.5 mg per day to control blood pressure for 24 hours. It can be increased to 2 tablets of Losartán/Hidroclorotiazida 50 mg/12.5 mg per day or changed to 1 tablet of Losartán/Hidroclorotiazida 100 mg/25 mg (a higher dose) per day. The maximum daily dose is 2 tablets of 50 mg of Losartán/12.5 mg of Hidroclorotiazida per day or 1 tablet of 100 mg of Losartán/25 mg of Hidroclorotiazida per day.

If you take more Losartán/Hidroclorotiazida Alter Generics than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

An overdose may cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

If you forgot to take Losartán/Hidroclorotiazida Alter Generics

Try to take Losartán/Hidroclorotiazida Alter Generics at the same time each day as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule.

Like all medicines, Losartán/Hidroclorotiazida Alter Genéricos can cause side effects, although not everyone will experience them.

If you experience the following, stop taking Losartán/Hidroclorotiazida Alter Genéricos and inform your doctor immediately or go to the emergency service of your nearest hospital:

• A 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 (affecting less than 1 in 10 but more than 1 in 100):
• Cough, respiratory infection, nasal congestion, sinusitis, breast 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.
• Changes in renal function including renal insufficiency
• Low blood sugar (hypoglycemia)

Rare (affecting less than 1 in 100 but more than 1 in 1,000):

• 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, and hematomas,
• Loss of appetite, elevated uric acid levels or manifest gout, elevated blood glucose levels, abnormal electrolyte levels in the blood,
• Anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory alteration,
• Tingling or similar sensations, limb pain, tremor, migraine, fainting,
• Blurred vision, eye itching or stinging, conjunctivitis, worsening vision, seeing things in yellow,
• Ringing, buzzing, sounds, or crackling 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, transient ischemic attack (mini-stroke), heart attack, palpitations,
• Swelling of blood vessels that often occurs with a skin rash or hematoma,
• Throat itching, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nasal bleeding, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain,
• Jaundice (yellow discoloration of the eyes and skin), pancreatitis inflammation,
• Urticaria, itching, skin inflammation, skin rash, skin redness, light sensitivity, dry skin, flushing, sweating, hair loss,
• Arm, shoulder, hip, knee, or other joint pain, 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, fever.

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

•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 (affecting more than 1 in 100,000 and less than 1 in 10,000):

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

Unknown (frequency cannot be estimated from available data):

• Skin 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 hemorrhage) or acute angle-closure glaucoma).
• Symptoms similar to the flu
• Muscle pain of unknown origin with dark-colored urine (tea-colored urine) (rhabdomyolysis)
• Low sodium levels in the blood (hyponatremia)
• Generally feeling unwell (malaise).

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 medication.

Keep out of the sight and reach of children.

Do not use Losartán/Hidroclorotiazida Alter Generics after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store Losartán/Hidroclorotiazida Alter Generics in the original packaging.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines that you no longer need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Losartán/Hidroclorotiazida Alter Generics

The active principles are losartan potassium and hydrochlorothiazide. Each tablet of Losartán/Hidroclorotiazida Alter Generics 50 mg/12.5 mg contains, as active principles, 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

The other components (excipients) are: microcrystalline cellulose, lactose monohydrate, pregelatinized cornstarch and magnesium stearate.

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

Losartán/Hidroclorotiazida Alter Generics 50 mg/12.5 mg also contains hydroxypropylcellulose, hypromellose, titanium dioxide and Opadry white, as coating excipients.

Appearance of the product and content of the packaging

Losartán/Hidroclorotiazida Alter Generics 50 mg/12.5 mg are white or almost white, round, biconvex tablets with a notch on one face.

The notch is only for breaking the tablet if it is difficult to swallow whole.

Losartán/Hidroclorotiazida Alter Generics 50 mg/12.5 mg is presented in a pack of 28 tablets, in a PVC-aluminium blister.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Alter Laboratories, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Responsible for manufacturing:

Alter Laboratories, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

or

Alter Laboratories, S.A

C/ Zeus 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Last review date of this leaflet: February 2025

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