LOSARTAN HYDROCHLOROTHIAZIDE ALTER GENERICOS 50 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Losartan/Hydrochlorothiazide Alter Generics 50 mg/12.5 mg film-coated tablets EFG

Read the package leaflet carefully before starting to take the medicine.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the package leaflet:

1. What is Losartan/Hydrochlorothiazide Alter Generics and what is it used for
2. Before taking Losartan/Hydrochlorothiazide Alter Generics
3. How to take Losartan/Hydrochlorothiazide Alter Generics
4. Possible side effects
5. Storage of Losartan/Hydrochlorothiazide Alter Generics
6. Contents of the pack and further information

1. What is Losartan/Hydrochlorothiazide Alter Generics and what is it used for

Losartan/Hydrochlorothiazide Alter Generics is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).

Losartan/Hydrochlorothiazide Alter Generics is indicated for the treatment of essential hypertension (high blood pressure).

2. Before you start taking 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, some antibacterials such as cotrimoxazole; ask your doctor if you are not sure).
• if you are more than 3 months pregnant. (It is also recommended to avoid Losartan/Hydrochlorothiazide Alter Generics during the first months of pregnancy – see section Pregnancy).
• if you have severe hepatic impairment.
• if you have severe renal impairment or your kidneys do not produce urine.
• if you have low potassium or sodium levels, high calcium levels that cannot be corrected with treatment.
• if you have gout.
• if you have diabetes or renal impairment 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/Hydrochlorothiazide Alter Generics

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular its long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartan/Hydrochlorothiazide Alter Generics.
• If you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and can occur within a few hours to a week after taking losartan/hydrochlorothiazide.
• If you have had respiratory or lung 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 Alter Generics, seek medical attention immediately.

Consult 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 on your own.

Tell your doctor if you are pregnant (or think you may be). It is not recommended to use Losartan/Hydrochlorothiazide Alter Generics at the start of pregnancy, and you should not take it if you are more than 3 months pregnant, as it can cause serious harm to your baby when administered from that time on (see section Pregnancy).

It is essential that you inform your doctor before taking Losartan/Hydrochlorothiazide Alter Generics:

• if you have previously suffered from swelling of the face, lips, tongue, or throat
• if you are taking diuretics (medicines to urinate)
• if you are on a low-salt diet
• if you have had 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 that supply the kidneys (renal artery stenosis), if you only have one functioning kidney, or if you have recently had a kidney transplant
• if you have narrowing of the arteries (arteriosclerosis), angina pectoris (chest pain due to poor heart function)
• if you have narrowing of the aortic or mitral valve (heart valve narrowing) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart valves)
• if you are diabetic
• if you have had gout
• if you have had an allergic disorder, asthma, or a condition that causes joint pain, skin rashes, 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 need to have anesthesia (even at the dentist) or before surgery, or if you are going to have tests to determine your parathyroid function, you should inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets
• if you have primary hyperaldosteronism (a syndrome associated with high secretion of the hormone aldosterone by the adrenal gland due to a disorder of this gland).
• 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 diabetes-related kidney problems.
  • 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines.

Diuretics like hydrochlorothiazide contained in Losartan/Hydrochlorothiazide Alter Generics may interact with other medicines.

Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide Alter Generics without your doctor's careful monitoring. Special precautions may be necessary (e.g., blood tests) if you take potassium supplements, salt substitutes that contain potassium, or potassium-sparing medicines, diuretics (water pills), some laxatives, gout treatments, heart rhythm or diabetes medicines (oral or insulin).

It is also important that your doctor knows if you are taking other medicines to lower your blood pressure, steroids, cancer medicines, painkillers, antifungal medicines, or arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping pills; opioid medicines like morphine, "pressor amines" like adrenaline or other medicines in the same group; (oral diabetes medicines or insulins).

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 the information under the headings “Do not take Losartan/Hydrochlorothiazide Alter Generics” and “Warnings and precautions”).

Please, when taking Losartan/Hydrochlorothiazide Alter Generics, inform your doctor when you are scheduled to have an iodine contrast medium.

Taking Losartan/Hydrochlorothiazide Alter Generics with food and drinks

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

Excessive salt in your diet may counteract the effect of Losartan/Hydrochlorothiazide Alter Generics tablets.

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

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or think you may be). Your doctor will generally advise you to stop taking Losartan/Hydrochlorothiazide Alter Generics before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Losartan/Hydrochlorothiazide Alter Generics. It is not recommended to use Losartan/Hydrochlorothiazide Alter Generics at the start of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it can cause serious harm to your baby when administered from that time on.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. It is not recommended to use Losartan/Hydrochlorothiazide Alter Generics during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Consult your doctor or pharmacist before taking any medicine.

Use in children and adolescents

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

Use in elderly patients

Losartan/Hydrochlorothiazide Alter Generics works as well and is as well tolerated by most elderly patients as by younger patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

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

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

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Use in athletes

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

3. How to take Losartan/Hydrochlorothiazide Alter Generics

Follow the instructions for administration of Losartan/Hydrochlorothiazide Alter Generics exactly as indicated by your doctor. Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide Alter Generics, depending on your condition and whether you are taking other medicines. It is essential to keep taking Losartan/Hydrochlorothiazide Alter Generics as prescribed by your doctor to maintain constant control of your blood pressure.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 tablet of Losartan/Hydrochlorothiazide 50 mg/12.5 mg per day to control blood pressure for 24 hours. It can be increased to 2 film-coated tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg per day or changed 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 50 mg of losartan/12.5 mg of hydrochlorothiazide per day or 1 tablet of 100 mg of losartan/25 mg of hydrochlorothiazide per day.

If you take more Losartan/Hydrochlorothiazide 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

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

If you forget to take Losartan/Hydrochlorothiazide Alter Generics

Try to take Losartan/Hydrochlorothiazide Alter Generics as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule.

4. Possible side effects

Like all medicines, Losartan/Hydrochlorothiazide Alter Generics can cause side effects, although not everybody gets them.

If you experience the following, stop taking Losartan/Hydrochlorothiazide Alter Generics and inform your doctor immediately or go to the emergency department of your nearest hospital:

• A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat that can cause difficulty swallowing or breathing).
• This is a serious but rare side effect, affecting more than 1 patient in 10,000 but less than 1 patient in 1,000. You may need urgent medical attention or hospitalization.
• The following side 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,
• High potassium levels (which can cause an 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):

• 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), bruising, reduced white blood cell count, coagulation problems, and bruising,
• Loss of appetite, high uric acid levels or gout, high blood sugar levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory impairment,
• Numbness or similar sensations, pain in the limbs, tremor, migraine, fainting,
• Blurred vision, eye irritation or itching, conjunctivitis, worsening vision, seeing things in yellow,
• Ringing, buzzing, noises, or clicking 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, stroke (transient stroke, "mini-stroke"), heart attack, palpitations,
• Inflammation of blood vessels that is often associated with a skin rash or bruising,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nosebleeds, runny nose, congestion,
• Constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• Jaundice (yellowing of the eyes and skin), pancreatitis,
• Hives, itching, skin inflammation, skin rash, redness of the skin, sensitivity to light, 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 kidney function, including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased sexual desire, impotence,
• Swelling of the face, fever.

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

• Hepatitis (inflammation of the liver), 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 but less than 1 in 10,000):

• Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).

Not known (frequency cannot be estimated from the 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 effusion) or acute angle-closure glaucoma).
• Flu-like symptoms
• 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 of side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartan/Hydrochlorothiazide Alter Generics

Keep out of sight and reach of children.

Do not use Losartan/Hydrochlorothiazide Alter Generics after the expiration date stated on the packaging after CAD. The expiration date is the last day of the indicated month.

Do not store at a temperature above 30°C.

Store Losartan/Hydrochlorothiazide Alter Generics in the original packaging.

Keep the blister pack in 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. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartan/Hydrochlorothiazide Alter Generics

The active ingredients are losartan potassium and hydrochlorothiazide. Each Losartan/Hydrochlorothiazide Alter Generics 50 mg/12.5 mg tablet contains, as active ingredients, 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

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

Losartan/Hydrochlorothiazide Alter Generics 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.

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

Appearance of the Product and Package Contents

Losartan/Hydrochlorothiazide Alter Generics 50 mg/12.5 mg are white or almost white, round, biconvex tablets with a score line on one face.

The score line is only for breaking the tablet if you find it difficult to swallow whole.

Losartan/Hydrochlorothiazide Alter Generics 50 mg/12.5 mg are available in a package of 28 tablets, in a PVC-aluminum blister pack.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Alter Laboratories, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer:

Alter Laboratories, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

or

Alter Laboratories, S.A.

C/ Zeus 6

R2 Industrial Estate

28880 Meco (Madrid)

Spain

Date of the Last Revision of this Leaflet: February 2025

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