Losartan/hydrochlorothiazide Almus 50 mg/12.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Losartan/Hydrochlorothiazide Almus 50mg/12.5mg film-coated tablets EFG

Please read all of 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Losartan/Hydrochlorothiazide Almus is and what it is used for
2. What you need to know before taking Losartan/Hydrochlorothiazide Almus
3. How to take Losartan/Hydrochlorothiazide Almus
4. Possible side effects
5. How to store Losartan/Hydrochlorothiazide Almus
6. Contents of the pack and other information

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

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

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

2. What you need to know before taking Losartán/Hidroclorotiazida Almus

Do not take Losartán/Hidroclorotiazida Almus

• if you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g. other thiazides, certain antibacterials such as cotrimoxazole; ask your doctor if you are unsure).
• if you are more than 3 months pregnant. It is also advisable to avoid Losartán/Hidroclorotiazida Almus 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 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 containing aliskiren.

Warnings and precautions

Inform your doctor if you are pregnant (or suspect you might be). Use of Losartán/Hidroclorotiazida Almus is not recommended at the beginning of pregnancy, and you must not take it after the third month of pregnancy, as it may cause serious harm to your baby when used from this stage onward (see pregnancy section).

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

It is important that you inform your doctor before taking Losartán/Hidroclorotiazida Almus:

• 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 you have narrowing of the arteries supplying the kidneys (renal artery stenosis), if you only have one functioning kidney, or if you have recently undergone a kidney transplant

• if you have narrowing of the 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, you must inform the doctor or healthcare staff 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 dysfunction 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 kidney problems related to diabetes

• aliskiren

• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 exposure to sunlight and UV rays while taking Losartán/Hidroclorotiazida.

• if you experience a decrease in vision or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, and may occur within hours to a week after taking losartan/hydrochlorothiazide. This may lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamides, you may have a higher risk of developing this condition.

• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking Losartán/Hidroclorotiazida Almus, seek medical attention immediately.

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 Losartán/Hidroclorotiazida Almus”.

Taking Losartán/Hidroclorotiazida Almus 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 Losartán/Hidroclorotiazida Almus can interact with other medicines. Preparations containing lithium should not be taken with Losartán/Hidroclorotiazida Almus unless your doctor performs careful monitoring. Special precautionary measures (e.g. blood tests) may be required if you are taking potassium supplements, potassium-containing salt substitutes, or potassium-sparing medicines, diuretics (water tablets), certain laxatives, gout medications, medicines to control heart rhythm, or medicines for diabetes (oral agents or insulin). It is also important that your doctor knows if you are taking other blood pressure-lowering medicines, steroids, cancer treatments, painkillers, antifungal medicines, 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, or oral antidiabetic medicines or insulin.

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 Losartán/Hidroclorotiazida Almus” and “Warnings and precautions”).

Please inform your doctor if you are scheduled to receive iodinated contrast media while taking Losartán/Hidroclorotiazida Almus.

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

You are advised not to drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida Almus tablets may increase each other's effects.

Excessive dietary salt intake may counteract the effect of Losartán/Hidroclorotiazida Almus tablets.

Losartán/Hidroclorotiazida Almus may be taken with or without food.

Pregnancy and breastfeeding

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

You must inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking Losartán/Hidroclorotiazida Almus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Losartán/Hidroclorotiazida Almus. The use of Losartán/Hidroclorotiazida Almus is not recommended at the beginning of pregnancy, and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when administered from this point.

Breastfeeding:

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Losartán/Hidroclorotiazida Almus during breastfeeding is not recommended, 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 Losartán/Hidroclorotiazida in children. Therefore, Losartán/Hidroclorotiazida Almus must not be given to children.

Use in elderly patients

Losartán/Hidroclorotiazida Almus is equally effective and well tolerated by most elderly and younger patients. Most elderly patients require the same dose as younger patients.

Driving and use of machines

When starting treatment with this medicine, do not perform tasks that require special attention (e.g. driving a car or operating dangerous machinery) until you know how you react to the medicine.

Losartán/Hidroclorotiazida Almus contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Use in athletes:

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

3. How to take Losartán/Hidroclorotiazida Almus

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of Losartán/Hidroclorotiazida Almus based on your condition and whether you are taking other medicines. It is important to keep taking Losartán/Hidroclorotiazida Almus 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 losartan/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 daily or changed to 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) once daily. The maximum daily dose is 2 tablets of losartan 50 mg/hydrochlorothiazide 12.5 mg daily or 1 tablet of losartan 100 mg/hydrochlorothiazide 25 mg daily.

If you take more Losartán/Hidroclorotiazida Almus 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 phone number 91 562 04 20, indicating the medicine 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 Almus

Try to take Losartán/Hidroclorotiazida Almus every day 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, this medicine may cause adverse effects, although not everyone experiences them.

If you experience the following, stop taking Losartán/Hidroclorotiazida Almus tablets immediately and contact your doctor right away 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 (may affect up to 1 in 10 people):

• Cough, upper respiratory tract 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 (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 hands and feet, and abdominal pain), bruising, reduced white blood cell count, blood clotting problems, reduced platelet count,
• Loss of appetite, elevated uric acid levels or overt gout, elevated 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, vertigo,
• Low blood pressure which may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischemic 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, chronic constipation, flatulence, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
• Hives, itching, skin inflammation, skin 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, even at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in urine,
• Decreased sexual desire, impotence,
• Facial swelling, localized swelling (edema), fever.

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

• 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 (may affect less than 1 in 10,000 people):

• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion).

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

• Flu-like symptoms,
• Unexplained muscle pain with dark-colored urine (tea-colored urine) (rhabdomyolysis),
• Low sodium levels in blood (hyponatremia),
• General feeling of being unwell (malaise),
• Taste disturbance (dysgeusia),
• Skin and lip cancer (non-melanoma skin cancer),
• Decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

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 Losartán/Hidroclorotiazida Almus

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store Losartán/Hidroclorotiazida Almus in the original packaging. Do not store above 30°C. Keep the blister pack inside the outer packaging. Do not open the blister pack until ready to take the tablet.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Losartán/Hidroclorotiazida Almus

The active substances are losartan potassium and hydrochlorothiazide.

Each Losartán/Hidroclorotiazida Almus 50 mg/12.5 mg film-coated tablet contains, as active substances, 50 mg of losartan (potassium) and 12.5 mg of hydrochlorothiazide.

Losartán/Hidroclorotiazida Almus 50 mg/12.5 mg film-coated tablets contain the following inactive ingredients: Lactose monohydrate, Microcrystalline cellulose, Hydroxypropyl cellulose, Pregelatinized corn starch, Magnesium stearate.

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

Losartán/Hidroclorotiazida Almus 50 mg/12.5 mg film-coated tablets also contain: Opadry Y-1-7000 White: Hypromellose, Titanium dioxide (E-171), Polyethylene glycol 400.

Appearance of the product and pack contents

Losartán/Hidroclorotiazida Almus 50 mg/12.5 mg tablets are supplied as white, oblong, film-coated tablets, scored on one side.

Losartán/Hidroclorotiazida Almus 50 mg/12.5 mg film-coated tablets are available in packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra, 2710-228

Portugal

Date of the most recent review of this leaflet: February 2025

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