LAVESTRA HCT 100 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lavestra HCT 100 mg/12.5 mg film-coated tablets

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

1. What is Lavestra HCT and what is it 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 blood vessels, causing them to narrow. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, causing the blood vessels to relax, which in turn lowers blood pressure. Hydrochlorothiazide works by increasing the amount of urine produced by the kidneys, which also helps to lower blood pressure.

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

2. What you need to know before you take Lavestra HCT

Do not take Lavestra HCT

• if you are allergic to losartan and/or 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 antibacterials 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 pregnant for more than three months (it is also recommended to avoid Lavestra HCT during the first months of pregnancy - see section "Pregnancy and breast-feeding"),
• 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 Lavestra HCT.

Tell your doctor if you are pregnant (or might be). Your doctor will normally advise you to stop taking Lavestra HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lavestra HCT. It is not recommended to take Lavestra HCT at the start of pregnancy, and in no case should it be taken after the third month of pregnancy, as it may cause serious harm to your baby when taken after this point.

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

• 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 Lavestra HCT")
• if you have narrowings of the blood vessels 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 (arteriosclerosis), angina pectoris (chest pain due to poor heart function)
• if you have narrowing of the aortic or mitral valve (aortic or mitral stenosis) 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 rashes, and fever (systemic lupus erythematosus)
• if you have high calcium or low potassium levels 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 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 an abnormality of this gland)
• if you are taking other medicines that may increase potassium levels in the blood (see section 2 "Other medicines and Lavestra HCT")
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular its long-term use at high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays 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 shortness of breath or severe difficulty breathing after taking Lavestra HCT, go to your doctor 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 pressure in the eye, and can occur within hours to a week after taking this medicine. This can lead to permanent visual impairment if not treated. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing this
• 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.

Your doctor may check 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 HCTon 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

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. medicines that contain 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 without your doctor carrying out close monitoring.

Special precautions may be necessary (e.g. blood tests) if you are taking diuretics (water tablets), certain laxatives, medicines for gout, medicines to control heart rhythm, or for diabetes (oral medicines 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 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,
• medicines to treat cancer,
• medicines for pain relief,
• medicines to treat fungal infections,
• medicines for arthritis,
• resins used for high cholesterol, such as cholestyramine,
• muscle relaxants,
• sleeping tablets,
• opioid medicines such as morphine,
• "pressor amines" such as adrenaline or other medicines of the same group,
• oral medicines for diabetes or insulins.

Please inform your doctor when you are going to undergo a contrast medium with iodine.

Taking Lavestra HCT with food, drinks, and alcohol

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

Excessive salt in the diet may counteract the effect of Lavestra HCT tablets.

Lavestra HCT can be taken with or without food.

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

Pregnancy and breast-feeding

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 might be). Your doctor will normally advise you to stop taking Lavestra HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lavestra HCT. It is not recommended to take Lavestra HCT at the start of pregnancy, and in no case should it be taken after the third month of pregnancy, as it may cause serious harm to your baby when taken after this point.

Breast-feeding

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

Use in elderly patients

Lavestra HCT works as well and is as well tolerated by most elderly patients as 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.

Lavestra HCT contains lactose

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

3. How to take Lavestra HCT

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 Lavestra HCT, depending on your condition and whether you are taking other medicines. It is important to keep taking Lavestra HCT while your doctor prescribes it for you to maintain constant control of your blood pressure.

High blood pressure

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

Lavestra HCT 100 mg/12.5 mg (100 mg losartan/12.5 mg hydrochlorothiazide) is available for patients treated with losartan 100 mg, who need 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 for immediate medical attention.

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

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

If you forget to take Lavestra HCT

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

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

4. Possible side effects

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

If you experience any of the following, stop taking Lavestra HCT tablets and inform your doctor immediately or go to the casualty department of your nearest hospital:

A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat that may cause difficulty in swallowing or breathing).

This is a serious but rare side effect, affecting 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:

Common(may affect up to 1 in 10 people)

• Cough, respiratory infection, nasal congestion, sinusitis, sinus disorder,
• Diarrhea, abdominal pain, nausea, indigestion,
• Muscle or leg cramps, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• High potassium levels (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, blood clotting problems, and low platelet count,
• Loss of appetite, high uric acid or gout, high blood sugar, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory problems,
• Numbness or similar sensations, pain in the limbs, tremor, migraine, fainting,
• Blurred vision, itching or burning in the eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• Ringing, buzzing, or other noises in the ears or 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 the 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 upset, 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 occurs 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 difficulty breathing, fever, weakness, and confusion).

Frequency not known(frequency cannot be estimated from the 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 the blood (hyponatremia),
• General feeling of being unwell (malaise).
• Altered taste (dysgeusia).
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 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 carton after CAD. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the cartons and any unused medicines in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the cartons and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lavestra HCT

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

Core of the tablet: pregelatinized corn starch, microcrystalline cellulose, lactose monohydrate, and magnesium stearate.

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

See section 2: “Lavestra HCT contains lactose”.

Appearance and Package Contents of the Product

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

Package Size:

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

You can request more information about this medicine from 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:June 2025

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