LOSARTAN / HYDROCHLOROTHIAZIDE STADA 50/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Losartan/Hydrochlorothiazide STADA 100 mg/25 mg film-coated tablets EFG

Losartan potassium/Hydrochlorothiazide

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

1. Storage of Losartan/Hydrochlorothiazide Stada
2. Contents of the pack and other information

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

Losartan/hydrochlorothiazide is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body that binds to receptors present in blood vessels, causing them to narrow. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, which causes the blood vessels to relax, thereby reducing blood pressure. Hydrochlorothiazide causes the kidneys to eliminate more water and salts. This also helps to reduce blood pressure.

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

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

Do not take Losartan/Hydrochlorothiazide Stada

• if you are allergic to losartan, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibacterial medicines such as cotrimoxazole; ask your doctor if you are not sure),
• if you have severe hepatic impairment,
• if you have low potassium or sodium levels or high calcium levels that cannot be corrected by treatment,
• if you have gout,
• if you are more than 3 months pregnant (it is also recommended to avoid losartan/hydrochlorothiazide at the beginning of pregnancy – see the section on Pregnancy),
• if you have severe renal impairment or your kidneys are not producing urine,
• 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 Stada.

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

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

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

• 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 your liver function is impaired (see section 2 "Do not take Losartan/Hydrochlorothiazide Stada")
• if you have narrow 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 (atherosclerosis), angina pectoris (chest pain due to poor heart function)
• if you have narrowing of the aortic or mitral valve (valve stenosis) or hypertrophic cardiomyopathy (a disease that causes thickening of the heart muscle)
• if you are diabetic
• if you have had gout
• if you have had an allergic disorder, asthma, or a disease that causes joint pain, skin rashes, and fever (systemic lupus erythematosus)
• if you have high calcium levels or low potassium levels or 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 Stada".

• if you are taking other medicines that may increase potassium levels in the blood (see section 2 "Other medicines and Losartan/Hydrochlorothiazide Stada").

• 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 an increase in eye pressure and can occur within hours to weeks after taking losartan/hydrochlorothiazide. This can lead to permanent vision loss if not treated. You may be at greater risk of developing this if you have previously been allergic to penicillin or sulfonamides.
• if you have had skin cancer or if you 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while 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 shortness of breath or severe difficulty breathing after taking losartan/hydrochlorothiazide, seek medical attention immediately.

Children and adolescents

There is no experience with the use of losartan/hydrochlorothiazide in children. Therefore, losartan/hydrochlorothiazide should not be given to children.

Other medicines and Losartan/Hydrochlorothiazide Stada

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

Tell your doctor if you are taking potassium supplements, salt substitutes that contain potassium, potassium-sparing medicines, or other medicines that may increase potassium levels in the blood (e.g. trimetoprim-containing medicines), as combination with losartan/hydrochlorothiazide is not recommended.

Diuretics like hydrochlorothiazide in Losartan/Hydrochlorothiazide Stada may interact with other medicines.

Preparations containing lithium should not be taken with losartan/hydrochlorothiazide without careful monitoring by your doctor.

Special precautions may be necessary (e.g. blood tests) if you are taking other diuretics (water tablets), certain laxatives, medicines for gout, medicines to control 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
• corticosteroids
• anticancer medicines
• pain relievers
• antifungal medicines
• arthritis medicines
• cholesterol-lowering resins such as cholestyramine
• muscle relaxants
• sleeping tablets
• opioid medicines such as morphine
• "pressor amines" like adrenaline or other medicines of the same group
• oral diabetes medicines or insulins.

Your doctor may need to change your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Losartan/Hydrochlorothiazide Stada" and "Warnings and precautions").

Please, when taking losartan/hydrochlorothiazide, inform your doctor when you are scheduled to have a contrast medium with iodine.

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

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

Excessive salt in the diet may counteract the effect of losartan/hydrochlorothiazide tablets.

Losartan/hydrochlorothiazide tablets can be taken with or without food.

Pregnancy, breast-feeding, and fertility

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

Pregnancy

You should inform your doctor if you are pregnant (or think you may be). Your doctor will normally advise you to stop taking losartan/hydrochlorothiazide 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. It is not recommended to use this medicine at the start of pregnancy, and it must not be taken after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time onwards.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. It is not recommended to use losartan/hydrochlorothiazide during breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed.

Use in elderly patients

Losartan/hydrochlorothiazide works as well and is as well tolerated by most elderly patients as by younger adults. 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 Stada contains lactose

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 Stada

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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

If you take more Losartan/Hydrochlorothiazide Stada than you should

In case of overdose, contact your doctor immediately for medical attention. Overdose can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

You can also call the Toxicology Information Service. Phone: (91) 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Losartan/Hydrochlorothiazide Stada

Try to take losartan/hydrochlorothiazide every day as prescribed. However, if you miss a dose, do not take an extra dose, simply return to your usual schedule.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience the following, stop taking the losartan/hydrochlorothiazide 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 adverse 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 adverse effects have been reported:

Frequent(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,
• High potassium levels (which can cause an abnormal heart rhythm), decreased hemoglobin levels,
• Changes in renal function, including renal failure,
• Low blood sugar (hypoglycemia).

Infrequent(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,

• Lack of appetite, high uric acid levels or manifest gout, high blood glucose 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, itching or burning in the eyes, conjunctivitis, worsening vision, seeing things in yellow,

• Ringing, buzzing, noises, or clicking in the ears, vertigo
• Low blood pressure that may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischemic attack (TIA), "mini-stroke"), heart attack, palpitations,

• Inflammation of blood vessels, often associated with a skin rash or hematoma,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing difficulty breathing), nasal bleeding, runny nose, congestion,

• Constipation, chronic 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 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 with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Very Rare(may affect up to 1 in 10,000 people)

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

Frequency Not Known(cannot be estimated from the available data):

• Flu-like symptoms,
• Muscle pain of unknown origin with dark-colored urine (tea-colored), (rhabdomyolysis),
• Low sodium levels in the blood (hyponatremia)
• Generally feeling unwell (malaise),
• Taste disturbance (dysgeusia)
• 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-.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is 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 adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Losartan/Hydrochlorothiazide Stada

Keep out of sight and reach of children.

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

Store below 30°C.

Store 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 in the SIGRE collection point at your pharmacy. 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 Stada

The active ingredients are losartan potassium and hydrochlorothiazide.

Each Losartan/Hydrochlorothiazide Stada 50 mg/12.5 mg tablet contains, as active ingredients, 50 mg of losartan (potassium) and 12.5 mg of hydrochlorothiazide.

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

The other ingredients are microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, magnesium stearate, hydroxypropylcellulose, hypromellose, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance and Packaging of the Product

Losartan/Hydrochlorothiazide Stada are film-coated tablets, yellow in color, and without a score line.

They are available in blister packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

Manufacturer

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7,

Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara),

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/