Patient Information

Losartán/Hidroclorotiazida Almus 50mg/12,5mg Film-Coated Tablets

Read this entire leaflet carefully before you start taking this medicine because 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Losartán/Hidroclorotiazida Almus

4.Possible side effects

5Storage of Losartán/Hidroclorotiazida Almus

6. Contents of the pack and additional information

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

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

Do not takeLosartán/Hidroclorotiazida Almus

• if you are allergic to losartan, hidroclorotiazida 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, some antibacterials such as cotrimoxazol, ask your doctor if you are unsure).
• If you are more than 3 months pregnant. It is also best to avoid Losartán/Hidroclorotiazida Almus 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 aliskirén.

Warnings and precautions

Inform your doctor if you are pregnant (or if you suspect that you may be). Losartán/Hidroclorotiazida Almus is not recommended for use at the start of pregnancy, and should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from this point onwards (see pregnancy section).

Consult your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea 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 to inform your doctor before taking Losartán/Hidroclorotiazida Almus:

• 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 diarrhoea.
• if you have heart failure.
• if you have narrowed arteries (arterial stenosis), if you only have one functioning kidney or if you have recently had a kidney transplant.
• if you have atherosclerosis, angina (chest pain due to poor heart function).
• if you have aortic or mitral 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 to have anaesthesia (including dental anaesthesia) or before surgery, or if you are to have 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 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.
• aliskirén.

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Losartán/Hidroclorotiazida.
• if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few hours to a week after taking losartan/hidroclorotiazida.This may lead to permanent loss of vision if not treated.If you have previously had an allergy to penicillin or sulfonamide, you may have a higher risk ofdeveloping this.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking Losartán/Hidroclorotiazida Almus, see your doctor immediately.

Your doctor may 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 Almus”.

Taking Losartán/Hidroclorotiazida Almus with other medicines

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

Diuretics such as the hidroclorotiazida contained inLosartán/Hidroclorotiazida Almusmay interact with other medicines. Preparations containing lithium should not be taken withLosartán/Hidroclorotiazida Almuswithout your doctor's careful monitoring. Special precautions may be necessary (e.g. blood tests) if you take potassium supplements, salt substitutes containing potassium or potassium-sparing medicines, diuretics (urine-producing tablets), some laxatives, medicines for gout treatment, heart rhythm control medicines or diabetes medicines (oral or insulin).

Your doctor should 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 colestiramina, 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 aliskirén (see also the information under the headings “Do not take Losartán/Hidroclorotiazida Almus” and “Warnings and precautions”).

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

Taking Losartán/Hidroclorotiazida Almus with food, drinks and alcohol

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

Excessive salt in the diet may counteract the effect ofLosartán/Hidroclorotiazida Almustablets.

Losartán/Hidroclorotiazida Almuscan be taken with or without food.

Pregnancy and breastfeeding

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

You should inform your doctor if you are pregnant (or if you suspect that you may be). Your doctor will usually recommend that you stop taking Losartán/Hidroclorotiazida Almus before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medicine instead of Losartán/Hidroclorotiazida Almus. Losartán/Hidroclorotiazida Almus is not recommended for use at the start of pregnancy, and in no case should it be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Lactation:

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Losartán/Hidroclorotiazida Almus is not recommended for use 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/Hidroclorotiazidain children. Therefore, Losartán/Hidroclorotiazida Almus should not be administered to children.

Use in elderly patients

Losartán/Hidroclorotiazida Almus 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 operating hazardous machinery) until you know how you tolerate your medicine.

Losartán/Hidroclorotiazida Almuscontains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Use in athletes:

This medicine contains hidroclorotiazida which may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide on the appropriate dose of Losartán/Hidroclorotiazida Almus, depending on your condition and if you are taking other medications. It is essential to continue taking Losartán/Hidroclorotiazida Almus 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 may 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 stronger dose) per day. The maximum daily dose is 2 tablets of 50 mg losartán/12.5 mg hidroclorotiazida per day or 1 tablet of 100 mg losartán/25 mg hidroclorotiazida per day.

If you take more Losartán/Hidroclorotiazida Almus 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 Almus

Try to take Losartán/Hidroclorotiazida Almus at the same time of day as you were prescribed. However, if you forget a dose, do not take an extra dose. Simply return to your regular schedule.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking the Losartán/Hidroclorotiazida Almus tablets and inform your doctor immediately or go to the nearest hospital emergency department:

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 fewer than 1 in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

Frequent (may affect up to 1 in 10 people):

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, breast tenderness,
• Diarrhea, abdominal pain, nausea, indigestion,
• Muscle pain, 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 renal function, including renal insufficiency
• Low blood sugar (hypoglycemia)

Poorly frequent (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 the hands and feet, and abdominal pain), hematoma, reduced white blood cell count, coagulation problems, reduced platelet count
• Loss of appetite, elevated uric acid levels or manifest gout, elevated blood glucose levels, abnormal electrolyte levels in the blood,
• Anxiety, nervousness, panic attacks (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory alteration,
• Tickling 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, vertigo
• 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,
• Sore throat, shortness of breath, bronchitis, pneumonia, water in the lungs (which may cause difficulty breathing), nasal bleeding, runny nose, congestion,
• Constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain,
• Jaundice (yellow discoloration of the eyes and skin), pancreatitis inflammation,
• Hives, itching, skin inflammation, skin rash, redness of the skin, 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, localized swelling (edema), fever.

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

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

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

Unknown (frequency cannot be estimated from available data):

• 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)
• Alteration of taste (dysgeusia)
• 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].

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 medicine.

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

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

StoreLosartán/Hidroclorotiazida Almusin the original packaging.Do not store at a temperature above 30°C.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. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Losartán/Hidroclorotiazida Almus

The active principles are losartan potassium and hydrochlorothiazide.

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

Losartán/Hidroclorotiazida Almus 50 mg/12.5 mg coated tablets with film coating contain the following inactive ingredients: Lactose monohydrate, Microcrystalline cellulose, Hydroxypropyl cellulose, Maize pregelatinized 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 coated tablets also contain: Opadry Y-1-7000 White: Hypromellose, Titanium dioxide (E-171), Polyethylene glycol 400.

Appearance of the product and content of the packaging

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

Losartán/Hidroclorotiazida Almus 50 mg/12.5 mg coated tablets are supplied in packs of 28 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Responsible manufacturer:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira

2710-089 Sintra

Portugal

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/