Lavestra HCT 100 mg/12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lavestra HCT 100 mg/12.5 mg film-coated tablets

losartan potassium/hydrochlorothiazide

Read the 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Lavestra HCT is and what it is used for
2. What you need to know before taking Lavestra HCT
3. How to take Lavestra HCT
4. Possible adverse effects
5. How to store Lavestra HCT
6. Contents of the pack and other information

1. What Lavestra HCT is and what it is used for

Lavestra HCT 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 in the blood vessels, causing them to narrow. This results in an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, allowing the blood vessels to relax, thereby lowering blood pressure. Hydrochlorothiazide works by increasing the amount of water and salt passed by the kidneys. This also helps reduce blood pressure.

Lavestra HCT is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking Lavestra HCT

Do not take Lavestra HCT

• if you are allergic to losartan and/or hydrochlorothiazide or to 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, certain antibacterial agents such as cotrimoxazole; ask your doctor if you are unsure),
• if you have severe liver impairment,
• 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 are more than three months pregnant,
• if you have severe renal impairment or your kidneys are not producing urine,
• if you have diabetes or kidney impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Lavestra HCT.

Inform your doctor if you are pregnant (or might be pregnant). Lavestra HCT is not recommended during early 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 that stage onward (see section “Pregnancy and breastfeeding”).

It is important that you inform your doctor before taking Lavestra HCT:

• if you have previously experienced 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 or have had excessive vomiting and/or diarrhea,

• if you have heart failure,

• if you have impaired liver function (see section 2 “Do not take Lavestra HCT”),

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

• if you have narrowing of 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 have diabetes,

• if you have had gout,

• if you have or have had an allergic disorder, asthma, or a condition causing joint pain, skin rashes, 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 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 adrenal dysfunction),

• if you are taking other medicines that may increase serum potassium levels (see section 2 “Other medicines and Lavestra HCT”),

• if you have had skin cancer or 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV radiation while taking Lavestra HCT,

• 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 dyspnea or severe difficulty breathing after taking Lavestra HCT, seek medical attention immediately,

• 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 intraocular pressure, which may occur within hours to one week after taking this medicine. This may lead to permanent visual impairment if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk,

• 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), especially if you have kidney problems related to diabetes,

• 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 Lavestra HCT”.

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

Children and adolescents

There is no experience with the use of Lavestra HCT in children. Therefore, Lavestra HCT should not be given to children.

Other medicines and Lavestra HCT

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

Tell your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medicines, or other medicines that may increase serum potassium (e.g. medicines containing trimethoprim), as combination with Lavestra HCT is not recommended.

Diuretics such as hydrochlorothiazide contained in Lavestra HCT may interact with other medicines.

Preparations containing lithium should not be taken with Lavestra HCT unless your doctor performs careful monitoring.

Special precautionary measures (e.g. blood tests) may be appropriate if you are taking diuretics (water tablets), certain laxatives, medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral antidiabetics 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 Lavestra HCT” and “Warnings and precautions”).

It is also important that your doctor knows if you are taking:

• other medicines to lower your blood pressure,
• corticosteroids,
• cancer treatment medicines,
• painkillers,
• antifungal medicines,
• medicines for arthritis,
• cholesterol-lowering resins such as cholestyramine,
• muscle relaxants,
• sleeping tablets,
• opioid medicines such as morphine,
• "vasopressor amines" such as adrenaline or other medicines in the same group,
• oral antidiabetic medicines or insulin.

Please, when taking Lavestra HCT, inform your doctor if you are scheduled to undergo an iodinated contrast medium procedure.

Taking Lavestra HCT with food, drinks, and alcohol

You are advised not to drink alcohol while taking these tablets: alcohol and Lavestra HCT tablets may increase each other's effects.

Excessive dietary salt intake may counteract the effect of Lavestra HCT tablets.

Lavestra HCT may be taken with or without food.

Grapefruit juice should be avoided while taking losartan/hydrochlorothiazide tablets.

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.

Pregnancy

You must inform your doctor if you are pregnant (or might be pregnant). Your doctor will usually advise you to stop taking Lavestra HCT before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Lavestra HCT. Lavestra HCT is not recommended during early 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 that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Lavestra HCT is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you intend to breastfeed.

Use in elderly patients

Lavestra HCT works with equal effectiveness and is similarly well tolerated by most elderly and younger patients. Most elderly patients require the same dose as younger patients.

Driving and using 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.

Lavestra HCT contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Lavestra HCT

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

Your doctor will decide the appropriate dose of Lavestra HCT, depending on your condition and whether you are taking other medicines. It is important to keep taking Lavestra HCT as prescribed by your doctor to maintain consistent blood pressure control.

High blood pressure

For most patients with high blood pressure, the recommended dose is 1 tablet of losartan/hydrochlorothiazide 50 mg/12.5 mg once daily to control blood pressure over 24 hours. Your doctor may increase the dose to 2 tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg daily or to 1 tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) daily. The maximum dose is 2 tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg daily or 1 tablet of losartan/hydrochlorothiazide 100 mg/25 mg daily.

Lavestra HCT 100 mg/12.5 mg (100 mg of losartan/12.5 mg of hydrochlorothiazide) is available for patients treated with 100 mg losartan who require additional blood pressure control.

If you take more Lavestra HCT than you should

In case of overdose, contact your doctor immediately or go directly to the hospital to receive immediate medical attention.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Lavestra HCT

Try to take Lavestra HCT every day as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience the following, stop taking Lavestra HCT tablets immediately and contact your doctor 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, 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,
• 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 cells, coagulation disorders and 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 impairment,
• 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, or other noises in the ears or vertigo,
• Low blood pressure which may be associated with postural changes (feeling dizzy or weak upon standing), 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 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, hip, knee 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 appetite, impotence,
• Facial swelling, 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 presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

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

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

Frequency not known (frequency cannot be estimated from available data)

• Skin and lip cancer (non-melanoma skin cancer),
• Flu-like symptoms,
• Unexplained muscle pain with dark urine (tea-colored) (rhabdomyolysis),
• Low sodium levels in blood (hyponatremia),
• Feeling of general discomfort (malaise),
• Taste disturbance (dysgeusia),
• 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Lavestra HCT

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 EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lavestra HCT

• The active substances are potassium losartan and hydrochlorothiazide. Each Lavestra HCT tablet contains 100 mg of potassium losartan (equivalent to 91.52 mg of losartan) and 12.5 mg of hydrochlorothiazide.
• The other components are:

Tablet core: pregelatinized maize starch, microcrystalline cellulose, lactose monohydrate and magnesium stearate.

Film coating: hypromellose, macrogol 4000, talc and titanium dioxide (E171).

See section 2: "Lavestra HCT contains lactose".

Appearance of the product and contents of the pack

Film-coated tablets are white, oval-shaped, biconvex, with dimensions of 8 mm x 13 mm and a thickness of 4.4 – 5.1 mm.

Pack sizes:

7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90 and 98 film-coated tablets in Al/PVC/PVDC blisters, packed in a carton.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

For further information about this medicinal product, you may contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).