Lorista HD 100 mg/25 mg film-coated tablets (losartan + hydrochlorothiazide) – for high blood pressure

Lorista HD contains two active substances: losartan potassium and hydrochlorothiazide. Losartan belongs to the angiotensin II receptor antagonists – it prevents angiotensin II from binding to receptors in blood vessels, so the vessels relax and blood pressure falls. Hydrochlorothiazide is a thiazide diuretic: it increases urine output and helps lower high blood pressure.

In Serbia it is authorised as Lorista® HD, 100 mg/25 mg, film-coated tablets (manufacturer Krka d.d. Novo Mesto, marketing authorisation holder Krka-Farma d.o.o. Belgrade), in packs of 28 tablets. It is intended for adults with high blood pressure not adequately controlled with losartan or hydrochlorothiazide alone.

What is Lorista HD used for and how should it be taken?

Key facts about the medicine

What is Lorista HD used for?

According to the package leaflet, Lorista HD is used to treat high blood pressure (essential hypertension) in patients whose blood pressure is not adequately controlled with losartan or hydrochlorothiazide alone.

According to the SmPC, the combination of losartan and hydrochlorothiazide is not used as initial therapy for hypertension, but when blood pressure is not adequately controlled with one of the two medicines. Lorista HD is the highest strength and is used in patients for whom the 50 mg/12.5 mg dose is not sufficient.

How is it taken and dosed?

• Lorista HD (100 mg losartan / 25 mg hydrochlorothiazide) is used when an adequate effect is not achieved with 50 mg/12.5 mg (Lorista H) once daily.
• The dose is one Lorista HD tablet once daily, which is also the maximum daily dose.
• The blood pressure-lowering effect is reached 3–4 weeks after starting treatment.
• Swallow the film-coated tablet whole (do not chew or break) with enough water, once daily, with or without food, at about the same time each day.
• In moderate kidney impairment (creatinine clearance 30–50 mL/min) the starting dose does not need adjusting; use is not recommended in patients on haemodialysis, and in severe impairment (creatinine clearance below 30 mL/min) the medicine must not be used.
• Before starting treatment, the doctor corrects reduced fluid volume and/or low blood sodium. The doctor decides how long treatment lasts.

Special patient groups

• Children and adolescents (under 18): no data on use – the medicine is not used.
• Elderly: dose adjustment is usually not needed.
• Kidney impairment: see dosing – contraindicated in severe impairment and anuria, not recommended on haemodialysis.
• Liver impairment: in mild to moderate impairment the SmPC advises lower losartan doses; must not be used in severe impairment, cholestasis or biliary obstruction.

Contraindications – when the medicine must not be used

Do not take Lorista HD if you:

• are allergic to losartan, hydrochlorothiazide or any of the other ingredients;
• are allergic to sulphonamides (e.g. other thiazides, some antibiotics such as co-trimoxazole);
• have severe liver impairment, cholestasis (blocked bile flow) or biliary obstruction;
• have an electrolyte imbalance that cannot be controlled (low sodium, low potassium or high calcium in the blood);
• have gout;
• are more than 3 months pregnant;
• have severe kidney impairment or your kidneys do not produce urine;
• have diabetes or impaired kidney function and are taking aliskiren.

Warnings and precautions

Before starting treatment, tell your doctor if you have previously had breathing or lung problems after taking hydrochlorothiazide; have had angioedema; take diuretics or are on a salt-restricted diet; have or recently had severe diarrhoea or vomiting; have heart failure; impaired liver function; narrowing of the kidney arteries, only one functioning kidney or a recent kidney transplant; atherosclerosis or angina; narrowing of the heart valves (aortic or mitral stenosis) or hypertrophic cardiomyopathy; diabetes; gout; allergies, asthma or systemic lupus erythematosus; high calcium or low potassium; primary hyperaldosteronism; or if you take an ACE inhibitor or aliskiren, or medicines that raise potassium.

If you need anaesthesia (including at the dentist), surgery or a test of parathyroid function, tell the doctor that you take losartan and hydrochlorothiazide. Contact your doctor if you get abdominal pain, nausea, vomiting or diarrhoea after taking the medicine. If you have had an allergy to penicillin or sulphonamides, the risk of choroidal effusion/acute glaucoma is higher. Your doctor will regularly check kidney function, blood pressure and electrolytes. During long-term treatment your doctor will request regular blood and urine tests. The medicine contains lactose monohydrate.

Interactions with other medicines, food and drink

Tell your doctor about all medicines you take. Particularly important are:

• lithium – only under close medical supervision;
• potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics (spironolactone, triamterene, amiloride) and other medicines that raise potassium (e.g. trimethoprim-containing medicines);
• laxatives, calcium salts, gout medicines (probenecid, sulfinpyrazone, allopurinol), heart rhythm medicines (quinidine, disopyramide, amiodarone, sotalol, etc.), digitalis glycosides;
• other blood pressure medicines (e.g. methyldopa), corticosteroids, cancer medicines (cyclophosphamide, methotrexate), NSAIDs (including COX-2 inhibitors and acetylsalicylic acid at anti-inflammatory doses), salicylates, ciclosporin, carbamazepine;
• antifungals (fluconazole, amphotericin B), certain anti-infectives (rifampicin, intravenous erythromycin, pentamidine), antipsychotics (thioridazine, chlorpromazine, sulpiride, pimozide, haloperidol, droperidol), barbiturates and antidepressants, anticholinergics, baclofen, amifostine, intravenous vincamine;
• colestyramine and colestipol, muscle relaxants, opioids (e.g. morphine), adrenaline and similar pressor amines, oral antidiabetics (e.g. metformin) or insulin, mizolastine, terfenadine, cisapride, bepridil, diphemanil, halofantrine and glycyrrhizin (from liquorice);
• ACE inhibitors and aliskiren – the doctor may change the dose or take other precautions. Hydrochlorothiazide can also affect the results of parathyroid function tests.

Tell your doctor you take this medicine before an X-ray examination with an iodine-based contrast agent. Do not drink alcohol during treatment (mutual enhancement of effects); a high salt intake may reduce the effect of the medicine; avoid grapefruit juice.

Pregnancy and breast-feeding

• Pregnancy: tell your doctor if you think you are pregnant or are planning a pregnancy; your doctor will prescribe another treatment. The medicine is not recommended in the first three months of pregnancy and must not be taken after the third month, as it may seriously harm the baby.
• Breast-feeding: if you are breast-feeding or plan to, you need to stop taking the medicine, as hydrochlorothiazide may stop milk production.

Driving and using machines

Lorista HD may cause dizziness and drowsiness and reduce your ability to drive and use machines, especially at the start of treatment and when the dose is increased. If such effects occur, do not drive or use machines.

Possible side effects

Contact a doctor or the nearest healthcare facility immediately if you have a severe allergic reaction (rash, itching, swelling of the face, lips, tongue and throat with difficulty breathing or swallowing – angioedema; rare) or acute respiratory distress syndrome (severe shortness of breath, fever, weakness, confusion; very rare).

• Common (up to 1 in 10): abdominal pain, nausea, diarrhoea, indigestion; weakness, tiredness, chest pain; muscle cramps and pain, back and leg pain; headache, dizziness, insomnia; impaired kidney function and kidney failure; cough, upper respiratory tract infections, blocked nose, sinusitis; high blood potassium, slight decrease in haematocrit and haemoglobin; low blood sugar.
• Uncommon (up to 1 in 100): anaemia, Henoch-Schönlein purpura, bruising, haemolysis; low blood pressure and drop on standing, angina, heart rhythm disorders, second-degree AV block, cerebrovascular event, heart attack, palpitations; vertigo, ringing in the ears, blurred vision, burning eyes, conjunctivitis, reduced visual acuity, yellow vision; constipation, toothache, dry mouth, wind, gastritis, vomiting; swelling, fever, loss of appetite; gout, joint pain and swelling, arthritis, fibromyalgia, muscle weakness; nervousness, tingling, peripheral neuropathy, tremor, migraine, fainting, anxiety, panic disorders, confusion, depression, sleep disorders, drowsiness, memory problems; night-time and frequent urination, urinary tract infections, glucose in urine, interstitial nephritis; decreased sex drive, impotence; sore throat, bronchitis, nosebleed, lung changes (pneumonia, pulmonary oedema); hair loss, dry skin, redness, sensitivity to sunlight, itching, rash, hives, sweating; vasculitis; blood count changes (agranulocytosis, aplastic and haemolytic anaemia, leukopenia, thrombocytopenia); raised blood sugar and uric acid, low potassium and sodium; inflamed salivary glands, jaundice, pancreatitis; toxic epidermal necrolysis (severe skin reactions with blisters and peeling).
• Rare (up to 1 in 1,000): angioedema and anaphylactic reactions, hepatitis, increased ALT. Very rare: acute respiratory distress, increased liver enzymes and bilirubin.
• Frequency not known: skin and lip cancer (non-melanoma), reduced vision or eye pain (choroidal effusion or acute angle-closure glaucoma), flu-like symptoms, weakness, liver function disorders, rhabdomyolysis, taste disturbance, dose-dependent orthostatic effects, cutaneous lupus erythematosus.

Suspected side effects can be reported to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: contact your doctor or emergency service immediately. Possible symptoms: drop in blood pressure, strong and fast heartbeat, slow pulse, electrolyte disturbances and dehydration.
• Missed dose: do not take a double dose; continue taking the medicine as prescribed.
• Stopping treatment: do not stop the medicine without talking to your doctor, even if you feel well.

Related information

For additional support with home blood pressure monitoring, see also the category Blood pressure devices – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• Active substances: losartan potassium 100 mg and hydrochlorothiazide 25 mg per film-coated tablet.
• Tablet core: pregelatinised starch; microcrystalline cellulose; lactose monohydrate; magnesium stearate.
• Film coating: hypromellose; macrogol 4000; talc; titanium dioxide (E171); quinoline yellow (E104).
• Pack: carton with 2 blisters of 14 film-coated tablets (28 in total).
• Marketing authorisation holder: Krka-Farma d.o.o. Belgrade, Jurija Gagarina 26/V/II, Belgrade. Manufacturer: Krka d.d., Novo Mesto, Šmarješka cesta 6, Novo Mesto, Slovenia.

Storage

• Store below 30 °C in the original package to protect from moisture.
• Keep out of the sight and reach of children.
• Do not use after the expiry date; return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

What is the difference between Lorista H and Lorista HD?

Lorista H contains 50 mg losartan and 12.5 mg hydrochlorothiazide, while Lorista HD contains twice as much – 100 mg and 25 mg. Lorista HD is used when the 50 mg/12.5 mg dose is not enough to control blood pressure.

May I take two Lorista HD tablets a day?

No – one Lorista HD tablet once daily is the maximum daily dose according to the leaflet.

May I breast-feed while taking Lorista HD?

No – if you are breast-feeding or plan to, the leaflet says you need to stop the medicine, as hydrochlorothiazide may stop milk production. Your doctor will choose another treatment.

Does Lorista HD affect driving?

It can – the medicine may cause dizziness and drowsiness, especially at the start of treatment and when the dose is increased. If you notice these effects, do not drive or use machines.

Sources

• ALIMS – Summary of Product Characteristics, Lorista® HD 100 mg/25 mg film-coated tablets (SmPC, Serbian)
• ALIMS – Package leaflet, Lorista® HD 100 mg/25 mg film-coated tablets (PIL, Serbian)

Sources checked on: 25 October 2026.