Package Insert: Information for the Patient

Losartán/Hydrochlorothiazide Alter Generic 100 mg/25 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, 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 (hydrochlorothiazide).

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, hidroclorotiazida or any of the other components of this medication.
• if you are allergic (hypersensitive) to other sulfamida-derived substances (e.g. other thiazides, some antibacterials such as cotrimoxazol, ask your doctor if you are unsure).
• if you are more than 3 months pregnant. (It is better 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 medication to lower blood pressure that contains aliskirén.

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 in 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 essential 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 medications)
• if you follow 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 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 undergone a kidney transplant
• if you have atherosclerosis (narrowing of the arteries), angina (chest pain due to heart dysfunction)
• 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 follow 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 hidroclorotiazida tablets
• if you have primary aldosteronism (a syndrome associated with an elevated secretion of aldosterone hormone by the adrenal gland due to a glandular alteration).
• if you are taking any of the following medications 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.
  • aliskirén.

Your doctor may need to monitor your renal 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”.

Taking Losartán/Hidroclorotiazida Alter Genéricos with other medications

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

Diuretics such as hidroclorotiazida contained in Losartán/Hidroclorotiazida Alter Genéricos may interact with other medications.

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 medications, diuretics (urine tablets), some laxatives, medications for gout treatment, medications for heart rhythm control or diabetes (oral medications or insulin).

It is also essential that your doctor knows if you are taking other medications to lower your blood pressure, steroids, cancer medications, pain medications, fungal infection medications or arthritis medications, cholesterol-lowering resins such as colestiramina, muscle relaxants, sleeping pills; opioid medications such as morphine, “pressor amines” such as adrenaline or other medications in the same group; (oral diabetes medications or insulin).

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

If you are taking an ACE inhibitor or aliskirén (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.

Taking Losartán/Hidroclorotiazida Alter Genéricos with food and drinks

It is recommended not to 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 can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You must 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 medication 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 medication.

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 medication, you should not perform tasks that require special attention (e.g. driving a car or operating hazardous machinery) until you know how you tolerate your medication.

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

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Use in athletes

This medication contains hidroclorotiazida, 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 based 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. The dose can be increased to 2 tablets of losartan/hidroclorotiazida 50 mg/12.5 mg per day or changed to 1 tablet of losartan/hidroclorotiazida 100 mg/25 mg (a higher dose) per day. The maximum daily dose is 2 tablets of 50 mg losartan/12.5 mg hidroclorotiazida per day or 1 tablet of 100 mg losartan/25 mg 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 medications, Losartán/Hidroclorotiazida Alter Genéricos may cause side effects, although not everyone will experience them.

If you experience the following, stop taking Losartán/Hidroclorotiazida Alter Genéricos and immediately inform your doctor or visit 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 (affecting fewer 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)

Poorly frequent (affecting fewer 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 cells, 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 disorders (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,
• Ringling, 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,
• Inflammation 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,
• 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, fever.

Rare (affecting more than 1 in 10,000 and fewer 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 fewer 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 unused medicines at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, 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 100 mg/25 mg contains, as active principles, 100 mg of losartan potassium and 25 mg of hydrochlorothiazide.

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

Losartán/Hidroclorotiazida Alter Generics 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.

Losartán/Hidroclorotiazida Alter Generics 100 mg/25 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 100 mg/25 mg are white, oblong tablets with a notch on one of the faces.

Losartán/Hidroclorotiazida Alter Generics 100 mg/25 mg is presented in a package of 28 tablets, in a PVC-aluminum 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.

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