LOSARTAN/HYDROCHLOROTHIAZIDE ALMUS 100 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan/Hydrochlorothiazide Almus 100mg/25mg Film-Coated Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Losartan/Hydrochlorothiazide Almus and what is it used for
2. What you need to know before you take Losartan/Hydrochlorothiazide Almus
3. How to take Losartan/Hydrochlorothiazide Almus
4. Possible side effects

5 Storage of Losartan/Hydrochlorothiazide Almus

1. Contents of the pack and other information

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

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

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

2. What you need to know before you take Losartan/Hydrochlorothiazide Almus

Do not takeLosartan/Hydrochlorothiazide 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, some antibacterials such as cotrimoxazole, ask your doctor if you are not sure).
• If you are more than 3 months pregnant. It is also better to avoid Losartan/Hydrochlorothiazide Almus during the first months of pregnancy (see section on pregnancy).
• if you have severe hepatic impairment.
• if you have severe renal impairment or your kidneys are not producing 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 renal impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Warnings and precautions

Tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Losartan/Hydrochlorothiazide Almus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan/Hydrochlorothiazide Almus. Losartan/Hydrochlorothiazide Almus should not be used 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 this time on (see section on pregnancy).

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

It is important that you inform your doctor before taking Losartan/Hydrochlorothiazide Almus:

• if you have previously suffered from swelling of the face, lips, tongue, or throat
• if you are taking diuretics (water tablets)
• if you are on a low-salt diet
• if you have had excessive vomiting and/or diarrhea
• if you have heart failure
• if you have narrow arteries that supply blood to the kidneys (renal artery stenosis), if you only have one working 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 (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 had an allergic disorder, asthma, or a condition that causes joint pain, skin rash, and fever (systemic lupus erythematosus)
• if you have high levels of calcium or low levels of potassium, 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

• if you have had skin cancer or if you 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartan/Hydrochlorothiazide Almus.
• if you experience a decrease in vision or eye pain, they 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. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamide, you may have a higher risk of developing this.
• 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 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 Losartan/Hydrochlorothiazide Almus”.

Taking Losartan/Hydrochlorothiazide Almus with other medicines

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

Diuretics like hydrochlorothiazide contained in Losartan/Hydrochlorothiazide Almus may interact with other medicines. Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide Almus 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 tablets), some laxatives, medicines for gout, medicines to control heart rhythm or for diabetes (oral or insulin), or other blood pressure-lowering medicines.

It is also important that your doctor knows if you are taking other medicines to lower your blood pressure, steroids, medicines to treat cancer, painkillers, medicines to treat fungal infections, or medicines for arthritis, 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 medicines for diabetes or insulins).

Your doctor may need to change 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 Almus” and “Warnings and precautions”).

Please, when taking Losartan/Hydrochlorothiazide Almus, inform your doctor when you are scheduled to have a contrast medium with iodine.

Taking Losartan/Hydrochlorothiazide Almus with food, drinks, and alcohol

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

Excessive salt in the diet may counteract the effect of Losartan/Hydrochlorothiazide Almus tablets.

Losartan/Hydrochlorothiazide Almus can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should inform your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Losartan/Hydrochlorothiazide Almus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan/Hydrochlorothiazide Almus. Losartan/Hydrochlorothiazide Almus should not be used 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 this time on.

Breastfeeding:

Tell your doctor if you are breastfeeding or about to start breastfeeding. The use of Losartan/Hydrochlorothiazide Almus is not recommended during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Ask your doctor or pharmacist for advice before taking any medicine.

Use in children and adolescents

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

Use in elderly patients

Losartan/Hydrochlorothiazide Almus works just as well and is just as well tolerated by most elderly patients as it is 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.

Losartan/Hydrochlorothiazide Almuscontains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Use in athletes:

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

3. How to take Losartan/Hydrochlorothiazide Almus

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

Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide Almus, depending on your condition and whether you are taking other medicines. It is important to keep taking Losartan/Hydrochlorothiazide Almus as long as your doctor prescribes it 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 50mg/12.5mg per day to control blood pressure for 24 hours. It can be increased to 2 film-coated tablets of losartan/hydrochlorothiazide 50mg/12.5mg per day or changed to 1 film-coated tablet of losartan/hydrochlorothiazide 100mg/25mg (a stronger dose) per day. The maximum daily dose is 2 tablets of 50mg of losartan/12.5mg of hydrochlorothiazide per day or 1 tablet of 100mg of losartan/25mg of hydrochlorothiazide per day.

If you take moreLosartan/Hydrochlorothiazide Almusthan you should

In case of 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 takeLosartan/Hydrochlorothiazide Almus

Try to take Losartan/Hydrochlorothiazide Almus as prescribed every day. However, if you forget a dose, do not take an extra dose. Simply return to your usual schedule.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience the following, stop taking Losartan/Hydrochlorothiazide Almus tablets 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 that affects more than 1 in 10,000 patients but less than 1 in 1,000 patients. It may require urgent medical attention or hospitalization.

The following side 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 or leg cramps, back pain, chest pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• High levels of potassium (which can cause an abnormal heart rhythm), decrease in 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 the hands and feet, and abdominal pain), bruising, reduced white blood cell count, coagulation problems, low platelet count
• Loss of appetite, high levels of uric acid 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 of vision, seeing things in yellow,
• Ringing, buzzing, or other noises in the ears, dizziness
• Low blood pressure that may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), irregular heartbeat, 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, chronic constipation, gas, stomach disorders, stomach cramps, 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, 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 that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

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

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

• Flu-like symptoms
• Muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis)
• Low levels of sodium in the blood (hyponatremia)
• Generally feeling unwell (malaise)
• Altered 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 of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 Almus

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

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

Store Losartan/Hydrochlorothiazide Almus in the original package. Do not store above 30°C. Keep the blister in the outer packaging. Do not open the blister until you are ready to take the tablet.

Medicines should not be disposed of via wastewater or household waste. 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 Almus

The active ingredients are losartan potassium and hydrochlorothiazide.

Each Losartan/Hydrochlorothiazide Almus 100 mg/25 mg film-coated tablet contains, as active ingredients, 100 mg of losartan (potassium) and 25 mg of hydrochlorothiazide.

Losartan/Hydrochlorothiazide Almus 100 mg/25 mg film-coated tablets contain the following inactive ingredients: Lactose monohydrate, Microcrystalline cellulose, Hydroxypropyl cellulose, Pregelatinized corn starch, Magnesium stearate.

Losartan/Hydrochlorothiazide Almus 100 mg/25 mg film-coated tablets contain 8.48 mg (0.216 mEq) of potassium.

Losartan/Hydrochlorothiazide Almus 100 mg/25 mg film-coated tablets also contain: Opadry Y-1-7000 White:Hypromellose, Titanium dioxide (E-171), Polyethylene glycol 400.

Appearance and Packaging of the Product

Losartan/Hydrochlorothiazide Almus 100 mg/25 mg film-coated tablets are supplied as white, oblong, and scored film-coated tablets.

Losartan/Hydrochlorothiazide Almus 100 mg/25 mg film-coated tablets are supplied in packages of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 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 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/