Losartan/hydrochlorothiazide Alter Genericos 100 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Losartan/Hydrochlorothiazide Alter Genéricos 100 mg/25 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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 and you should not give it to other people, even if they have the same symptoms, as it may harm them.

• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Losartan/Hydrochlorothiazide Alter Genéricos is and what it is used for
2. Before you take Losartan/Hydrochlorothiazide Alter Genéricos
3. How to take Losartan/Hydrochlorothiazide Alter Genéricos
4. Possible side effects
5. How to store Losartan/Hydrochlorothiazide Alter Genéricos
6. Contents of the pack and other information

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

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

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

2. What you need to know before starting to take Losartan/Hydrochlorothiazide Alter Generics

Do not take Losartan/Hydrochlorothiazide Alter Generics

• if you are allergic (hypersensitive) to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine.
• 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. (Losartan/Hydrochlorothiazide Alter Generics should also be avoided during the first months of pregnancy – see Pregnancy section).
• if you have severe liver failure.
• if you have severe renal failure or your kidneys do not produce urine.
• if you have low levels of potassium or sodium, or high calcium levels 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

Consult your doctor or pharmacist before starting to take Losartan/Hydrochlorothiazide Alter Generics

• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly 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 exposure and UV radiation while taking Losartan/Hydrochlorothiazide Alter Generics.
• If you experience vision loss or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure. These may occur within hours to one week after taking losartan/hydrochlorothiazide.
• 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 Alter Generics, seek medical attention immediately.

Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Losartan/Hydrochlorothiazide Alter Generics. Your doctor will decide whether to continue treatment. Do not stop taking Losartan/Hydrochlorothiazide Alter Generics used as monotherapy.

Inform your doctor if you are pregnant (or suspect you might be). Use of Losartan/Hydrochlorothiazide Alter Generics is not recommended in early pregnancy, and you must not take it after 3 months of pregnancy as it may cause severe harm to your baby when administered from that point onward (see Pregnancy section).

It is important to inform your doctor before taking Losartan/Hydrochlorothiazide Alter Generics:

• 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 your liver function is impaired (see section 2. Do not take Losartan/Hydrochlorothiazide Alter Generics)
• if you have narrowed arteries supplying the kidneys (renal artery stenosis), only one functioning kidney, or have recently undergone kidney transplantation
• 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 are diabetic
• if you have had gout
• if you have or have had an allergic disorder, asthma, or a condition causing joint pain, skin rash, and fever (systemic lupus erythematosus)
• if you have high calcium levels or low potassium levels, 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, 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 gland dysfunction)
• 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), especially 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 Losartan/Hydrochlorothiazide Alter Generics.”

Taking Losartan/Hydrochlorothiazide Alter Generics with other medicines

Inform 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 Alter Generics can interact with other medicines.

Lithium-containing preparations should not be taken with Losartan/Hydrochlorothiazide Alter Generics unless your doctor performs careful monitoring. Special precautionary measures (e.g., blood tests) may be appropriate if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, diuretics (water tablets), certain laxatives, gout treatments, medicines to control heart rhythm, or diabetes medicines (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 tablets, opioid medicines such as morphine, vasopressors such as adrenaline, or other medicines in the same class.

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 Losartan/Hydrochlorothiazide Alter Generics” and “Warnings and precautions”).

Please inform your doctor when you plan to undergo iodinated contrast media procedures while taking Losartan/Hydrochlorothiazide Alter Generics.

Taking Losartan/Hydrochlorothiazide Alter Generics with food and drinks

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

Excessive dietary salt intake may counteract the effect of Losartan/Hydrochlorothiazide Alter Generics tablets.

Losartan/Hydrochlorothiazide Alter Generics may be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

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

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Losartan/Hydrochlorothiazide Alter Generics is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you intend to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Use in children and adolescents

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

Use in elderly patients

Losartan/Hydrochlorothiazide Alter Generics is equally effective and well tolerated in most elderly and younger 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 requiring special attention (e.g., driving a car or operating dangerous machinery) until you know how you react to the medicine.

Important information about some of the ingredients of Losartan/Hydrochlorothiazide Alter Generics

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Use in athletes

This medicine contains hydrochlorothiazide, which may result in a positive doping test.

3. How to take Losartan/Hydrochlorothiazide Alter Genericos

Follow exactly the administration instructions for Losartán/Hidroclorotiazida Alter Genéricos as indicated by your doctor. Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida Alter Genéricos based on your condition and whether you are taking other medications. It is important to continue taking Losartán/Hidroclorotiazida Alter Genéricos 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/Hydrochlorothiazide 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 per day or switched to 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) per day. The maximum daily dose is 2 tablets of losartan 50 mg/hydrochlorothiazide 12.5 mg per day or 1 tablet of losartan 100 mg/hydrochlorothiazide 25 mg per day.

If you take more Losartán/Hidroclorotiazida Alter Genéricos 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take Losartán/Hidroclorotiazida Alter Genéricos

Try to take Losartán/Hidroclorotiazida Alter Genéricos daily as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular dosing schedule.

4. Possible adverse effects

Like all medicines, Losartán/Hidroclorotiazida Alter Genéricos may cause adverse effects, although not everybody experiences them.

If you experience the following, stop taking Losartán/Hidroclorotiazida Alter Genéricos tablets immediately and contact your doctor 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 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 (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,
• Changes in kidney function including kidney failure,
• Low blood sugar (hypoglycemia).

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 hands and feet and abdominal pain), bruising, reduction in white blood cells, bleeding and bruising problems,
• Loss of appetite, increased uric acid levels or overt gout, increased blood glucose levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory disturbance,
• Tingling or similar sensations, limb pain, tremor, migraine, fainting,
• Blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• Ringing, buzzing, noises 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, swelling 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, hips, knees or other joints, joint swelling, stiffness, muscle weakness,
• Frequent urination including at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in 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 with 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 breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

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

• Skin and lip cancer (non-melanoma skin cancer),
• Decreased vision 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),
• Flu-like symptoms,
• Muscle pain of unknown origin with dark-coloured urine (tea-coloured) (rhabdomyolysis),
• Low sodium levels in blood (hyponatremia),
• General feeling of being unwell (malaise).

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, 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 Alter Genéricos

Keep out of the sight and reach of children.

Do not use Losartan/Hydrochlorothiazide Alter Genéricos after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep Losartan/Hydrochlorothiazide Alter Genéricos 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartan/Hydrochlorothiazide Alter Genéricos

The active substances are potassium losartan and hydrochlorothiazide. Each tablet of Losartan/Hydrochlorothiazide Alter Genéricos 100 mg/25 mg contains, as active substances, 100 mg of potassium losartan and 25 mg of hydrochlorothiazide.

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

Losartan/Hydrochlorothiazide Alter Genéricos 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.

Losartan/Hydrochlorothiazide Alter Genéricos 100 mg/25 mg also contains hydroxypropylcellulose, hypromellose, titanium dioxide, and Opadry White, as coating excipients.

Appearance of the medicinal product and contents of the pack

Losartan/Hydrochlorothiazide Alter Genéricos 100 mg/25 mg are white, oblong tablets, with a score line on one side.

Losartan/Hydrochlorothiazide Alter Genéricos 100 mg/25 mg is supplied in packs of 28 tablets in PVC-aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A

C/ Zeus 6

Polígono Industrial R2

28880 Meco (Madrid)

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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/