Package Insert: Information for the Patient

Lavestra HCT 50 mg/12.5 mg Film-Coated Tablets

losartan 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 must 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 present 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 causes the kidneys to eliminate a greater amount of water and salts. 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 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, some antibacterial medicines such as cotrimoxazole, ask your doctor if you are unsure);
• if you are more than three months pregnant. (It is also best to avoid taking Lavestra HCT in the first trimester of pregnancy - see Pregnancy);
• if you have severe liver failure;
• if you have severe kidney failure or your kidneys do not produce 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 kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

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

If you suspect that you may be pregnant (or could be), you must inform your doctor. It is not recommended to use Lavestra HCT at the start of pregnancy and it should not be taken if you are more than 3 months pregnant because it may cause serious harm to your baby if used during this period (see Pregnancy section).

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 (urine 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 kidney function is impaired (see section 2 “Do not take Lavestra HCT”)
• if you have narrowed 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 to have an anaesthetic (even at the dentist) or before surgery, or if you are to have tests to determine your parathyroid function, you must inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets,
• if you have primary aldosteronism (a syndrome associated with an elevated secretion of aldosterone hormone by the adrenal gland due to a glandular alteration),
• 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 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 and may occur within hours or weeks of taking this medicine. This may lead to permanent visual impairment if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may have a higher risk of developing it.

• 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 monitor your kidney 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 given to children.

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.

Other medicines and Lavestra HCT

Inform your doctor or pharmacist if you are taking,have takenrecentlyor may have to take any other medicine

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

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

Lithium-containing 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 tablets), some laxatives, medicines for gout treatment, heart rhythm control medicines or diabetes medicines (oral 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 that your doctor knows if you are taking:

• other blood pressure-lowering medicines,
• steroids,
• chemotherapy medicines,
• analgesics,
• antifungal medicines,
• arthritis medicines,
• cholesterol-lowering resins such as cholestyramine,
• muscle relaxants,
• sleeping tablets,
• opioid medicines such as morphine,
• “pressor amines” such as adrenaline or other medicines in the same group,
• oral diabetes or insulin medicines.

Please inform your doctor when you plan to undergo a contrast medium containing 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 sodium in the diet may counteract the effect of losartan and hydrochlorothiazide tablets.

Lavestra HCT can be taken with or without food.

It is recommended to avoid grapefruit juice while taking losartan/hydrochlorothiazide tablets.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you think you may be pregnant (or could be). Your doctor will usually advise you to stop taking Lavestra HCT before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medicine instead of losartan/hydrochlorothiazide. Lavestra HCT is not recommended at the start of pregnancy, and it should not be taken if you are more than three months pregnant, as it may cause serious harm to your baby if used during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. It is not recommended to use Lavestra HCT in breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breastfeed.

Driving and operating machinery

When starting treatment with this medicine, 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 medicine.

Lavestra HCT containslactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

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.

High Blood Pressure

For most patients with high blood pressure, the recommended dose is 1 tablet of Lavestra HCT 50 mg/12.5 mg per day to control blood pressure for 24 hours. Your doctor may increase the dose to 2 tablets of Lavestra HCT 50 mg/12.5 mg per day or 1 tablet of Lavestra HCT 100 mg/25 mg per day. The maximum dose is 2 tablets of Lavestra HCT 50 mg/12.5 mg per day or 1 tablet of Lavestra HCT 100 mg/25 mg per day.

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 an overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Lavestra HCT

Do not take a double dose to compensate for missed doses.

Try to take Lavestra HCT at the same time each day as prescribed. However, if you forget 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 may cause side effects, although not everyone will experience them.

If you experience the following, stop taking 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 may affect more than 1 in 10,000 people. 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,
• Elevated potassium levels (which may 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 cells, coagulation problems, and reduced platelet count,
• Loss of appetite, elevated uric acid levels or manifest gout, elevated blood glucose levels, abnormal electrolyte levels in the blood,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory alteration,
• Tickling or similar sensations, limb pain, tremors, migraine, fainting,
• Blurred vision, eye itching or stinging, conjunctivitis, worsening vision, seeing things in yellow,
• Ringing, buzzing, or clicking sounds 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 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.

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(cannot be estimated from available data)

• Skin and lip cancer (non-melanoma skin cancer),
• Symptoms similar to the flu,
• Unexplained muscle pain with dark-colored urine (rhabdomyolysis),
• Low sodium levels in the blood (hyponatremia),
• General feeling of 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 experienceany type of side effect, consult your doctor or pharmacist, even if it ispossibleside 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:www.notificaram.es. By reporting side effects, you can contribute to providing more information on 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).

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Lavestra HCT

• The active principles are losartan potassium and hydrochlorothiazide.

Each film-coated tablet contains 50 mg of losartan potassium (equivalent to 45.76 mg of losartan) and 12.5 mg of hydrochlorothiazide.

• The other components are pregelatinized cornstarch, microcrystalline cellulose, lactose monohydrate, and magnesium stearate in the core of the tablet and hypromellose, macrogol 4000, quinoline yellow (E104), talc, and titanium dioxide (E171) in the film coating. See section 2: “Lavestra HCT contains lactose”.

Appearance of the product and contents of the package

The film-coated tablets are yellow, oval, moderately biconvex with a groove on one face and with dimensions of 6 mm x 12 mm (oval shape) and a thickness of 3.8 – 4.7 mm.

The groove is only for breaking and facilitating swallowing, but not for dividing into equal doses

The tablets are presented in boxes containing 10, 28, 30, 50, 56, 60, 90, and 98 film-coated tablets in PVC/PVDC//Al blisters.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

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/