Package Insert: Information for the User

Lavestra HCT 100 mg/12.5 mg Film-Coated Tablets

losartán potassium/hydrochlorothiazide

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult 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, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Lavestra HCT is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to constrict. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, causing blood vessels to relax, which in turn reduces blood pressure. Hydrochlorothiazide works by causing the kidneys to pass more water and salt. This also helps to reduce blood pressure.

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

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 antibiotics such as cotrimoxazole, ask your doctor if you are unsure). if you have severe liver failure,
• 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 (it is also recommended to avoid Lavestra HCT during the first months of pregnancy - see section “Pregnancy and breastfeeding”),
• if you have severe kidney failure or your kidneys do not produce urine,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medication containing aliskiren.

Warnings and precautions

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

Inform your doctor if you are pregnant (or may be). It is not recommended to use Lavestra HCT at the beginning of pregnancy and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards (see section on Pregnancy).

It is important to 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 (urine-producing medicines)
• if you are following a low-sodium diet
• if you have had excessive vomiting and/or diarrhea
• if you have heart failure
• if your liver function is altered (see section 2 “Do not take Lavestra HCT”)
• if you have narrow arteries leading to the kidney (renal artery stenosis), if you only have one functioning kidney, or if you have recently had a kidney transplant
• if you have atherosclerosis (narrowing of the arteries), 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 rashes, 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 anesthesia (even for dental procedures) or before surgery, or if you are undergoing tests to determine your parathyroid function, inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets
• if you have primary hyperaldosteronism (a syndrome associated with an elevated secretion of aldosterone hormone by the adrenal gland due to a glandular alteration)
• if you are taking other medications that may increase serum potassium levels (see section 2 “Other medicines and Lavestra HCT”)
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, 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 sun exposure and UV rays while taking Lavestra HCT
• if you have had respiratory or pulmonary 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 Lavestra HCT, seek medical attention immediately
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which can occur within a few hours to a week after taking this medication. This can lead to permanent visual impairment if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at a higher risk of developing it
• if you are taking any of the following blood pressure-lowering medications:

• 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 monitor your renal function, blood pressure, and serum electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Lavestra HCT”.

Children and adolescents

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

Other medicines and Lavestra HCT

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

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medications, or other medications that may increase serum potassium levels (e.g. trimethoprim-containing medications), as it is not recommended to combine them with Lavestra HCT.

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

Lithium preparations should not be taken with Lavestra HCT without your doctor's careful monitoring.

Special precautions may be necessary (e.g. blood tests) if you are taking diuretics (urine-producing tablets), some laxatives, medications for gout treatment, medications for heart rhythm control, or diabetes medications (oral medications or insulin).

Your doctor may need to modify 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 Lavestra HCT” and “Warnings and precautions”).

It is also important for your doctor to know if you are taking:

• other blood pressure-lowering medications,
• steroids,
• medications for cancer,
• pain medications,
• antifungal medications,
• arthritis medications,
• cholesterol-lowering resins such as cholestyramine,
• muscle relaxants,
• sleeping tablets,
• opioid medications such as morphine,
• "pressor amines" such as adrenaline or other medications in the same group,
• oral diabetes medications or insulin.

Please inform your doctor when you plan to undergo a contrast agent with iodine.

Taking Lavestra HCT with food, drinks, and alcohol

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

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

Lavestra HCT can be taken with or without food.

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

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.

Pregnancy

You should inform your doctor if you are pregnant (or if you may be). Your doctor will usually recommend that you stop taking Lavestra HCT as soon as you know you are pregnant and will recommend that you take another medication instead of Lavestra HCT. It is not recommended to use Lavestra HCT at the beginning of pregnancy, and in any case, it should not be administered from the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. It is not recommended to use Lavestra HCT during breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed.

Use in elderly patients

Lavestra HCT 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 medication, you should not perform tasks that require special attention (e.g. driving a car or operating hazardous machinery) until you know how you tolerate your medication.

Lavestra HCT contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

Hypertension

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

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

If you take more Lavestra HCT than you should

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

An 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested..

If you forget to take Lavestra HCT

Try to take Lavestra HCT at the same time each 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 other questions about the use of this medication, ask your doctor or pharmacist.

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 Lavestra HCT tablets and inform your doctor immediately or go to the emergency service of your nearest hospital:

A 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, respiratory infection, nasal congestion, sinusitis, breast 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 may cause an abnormal heart rhythm), decreased hemoglobin levels,
• Changes in renal function, including renal failure,
• Low blood sugar (hypoglycemia).

Occasional(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 cells, coagulation problems, and reduced platelet count,
• Loss of appetite, high uric acid levels or manifest gout, high 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,
• Tingling or similar sensations, pain in the extremities, tremor, migraine, fainting,
• Blurred vision, itching or stinging in the eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• Ringing, buzzing, sounds, or crackling in the ears or 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,
• Throat itching, shortness of breath, bronchitis, pneumonia, fluid 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,
• Urticaria, itching, skin inflammation, skin rash, skin redness, 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 libido, 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.

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

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

Frequency unknown(the frequency cannot be estimated from available data)

• Skin and lip cancer (non-melanoma skin cancer),
• Symptoms similar to the flu,
• Mysterious muscle pain with dark-colored urine (rhabdomyolysis),
• Low sodium levels in the blood (hyponatremia),
• General feeling of discomfort (discomfort).
• Alteration of taste (dysgeusia).
• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do 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 about the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Lavestra HCT

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

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

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

See section 2: “Lavestra HCT contains lactose”.

Appearance of the product and contents of the package

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 a blister pack of Al/PVC/PVDC and in a box.

Only some package sizes may be commercially available.

Marketing authorization holder and manufacturer

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

For further information about this medicinal product, please 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 with the following names:

Last review date of this leaflet:August 2023

For detailed information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).