Lorista h

Patient Information Leaflet

Lorista H, 50 mg + 12.5 mg, film-coated tablets
losartanum kalicum + hydrochlorothiazidum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm others, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Lorista H is and what it is used for

Lorista H 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 vessel walls, causing them to narrow. This leads to increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in blood vessel dilation and consequently lowering blood pressure. Hydrochlorothiazide works by increasing the excretion of water and salts through the kidneys, which also helps reduce blood pressure.
Lorista H is indicated for the treatment of essential hypertension (high blood pressure).

2. Important information before taking Lorista H

When not to take Lorista H

• if the patient is allergic to losartan and (or) hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to sulfonamide-derived substances (e.g. other thiazide-type drugs, some antibacterial agents such as co-trimoxazole); in case of doubt, consult a physician,
• if the patient is more than three months pregnant (use of Lorista H should also be avoided in early pregnancy - see section "Pregnancy and breastfeeding"),
• if the patient has severe liver function disorders, biliary obstruction or conditions causing biliary tract obstruction,
• if the patient has severe kidney function impairment (creatinine clearance <30 ml/min),
• if the kidneys are not producing urine,
• if the patient has low blood potassium or sodium levels, or high blood calcium levels that cannot be corrected by treatment,
• if the patient has gout,
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Lorista H, discuss the following with your doctor or pharmacist:

• if the patient has previously experienced facial, lip, throat or tongue swelling,
• if the patient is taking diuretics (water tablets),
• if the patient is on a low-salt diet,
• if the patient has had or currently has severe vomiting and/or diarrhoea,
• if the patient has heart failure,
• if the patient has liver function disorders (see section 2 "When not to take Lorista H"),
• if the patient has narrowing of the blood vessels leading to the kidneys (renal artery stenosis), or if the patient has only one functioning kidney, or if the patient has recently undergone kidney transplantation,
• if the patient has narrowed arteries (arteriosclerosis), angina pectoris (chest pain due to impaired heart function),
• if the patient has "aortic or mitral valve stenosis" (narrowing of heart valves) or "hypertrophic cardiomyopathy" (a disease causing thickening of the heart muscle),
• if the patient has diabetes,
• if the patient has previously had gout,
• if the patient has had or currently has allergies, asthma or a disease causing joint pain, skin rash and fever (systemic lupus erythematosus),
• if the patient has high blood calcium levels or low blood potassium levels, or if the patient is on a low-potassium diet,
• if the patient requires anaesthesia (even at the dentist) or is scheduled for surgery, or if parathyroid function testing is planned, it is essential to inform the doctor or medical staff that the patient is taking Lorista H,
• if the patient has primary hyperaldosteronism (a syndrome associated with increased aldosterone hormone excretion by the adrenal glands due to adrenal gland abnormalities),
• if the patient is taking other medicines that may increase serum potassium levels (see section 2 "Lorista H and other medicines"),
• if the patient has previously had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially in high doses over a prolonged period, may increase the risk of certain types of non-melanoma skin cancers and lip cancer. While taking Lorista H, protect the skin from sunlight and UV radiation,
• if the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or breathing difficulties after taking Lorista H, seek immediate medical help,
• if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure – these may occur from several hours to weeks after taking Lorista H. If left untreated, they may lead to permanent vision loss. Patients who previously had an allergic reaction to penicillin or sulfonamides may be at higher risk of developing this condition.
• if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney problems related to diabetes,
• aliskiren.

The treating physician may monitor kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals.
See also information under the heading: "When not to take Lorista H".
If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Lorista H, discuss this with the doctor. The doctor will decide on further treatment. Do not make independent decisions to stop taking Lorista H.
Inform the doctor about pregnancy, suspected pregnancy or plans to become pregnant. Use of Lorista H is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may have very harmful effects on the unborn child if used beyond the third month of pregnancy (see "Pregnancy and breastfeeding").

Lorista H and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor about potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, or other medicines that may increase serum potassium levels (e.g. medicines containing trimethoprim), as concomitant use with Lorista H is not recommended.
Diuretics such as hydrochlorothiazide contained in Lorista H may interact with other medicines. Do not take lithium preparations and Lorista H simultaneously without strict medical supervision. Special precautions (e.g. blood tests) may be necessary if the patient is taking other diuretics, certain laxatives, medicines used to treat gout, or medicines used to control heart rhythm or diabetes (oral antidiabetic medicines or insulin). It is also important for the doctor to know if the patient is taking other blood pressure-lowering medicines, corticosteroids, cancer medicines, painkillers, antifungal or anti-inflammatory medicines, bile acid sequestrants used to treat high cholesterol such as cholestyramine, muscle relaxants, sleeping medicines, opioid medicines such as morphine, "pressor amines" such as adrenaline or other medicines from the same group, or oral antidiabetic medicines or insulin.
The treating physician may need to adjust the dose and/or take additional precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also information under the headings "When not to take Lorista H" and "Warnings and precautions").

Also inform the doctor about taking Lorista H before undergoing procedures involving iodine-containing contrast agents.

Lorista H with food, drink and alcohol
Lorista H may be taken regardless of meals.
It is recommended that the patient avoids alcohol while taking Lorista H, as alcohol and Lorista H tablets may mutually enhance their effects.
Excessive dietary salt intake may counteract the effect of Lorista H.
Avoid drinking grapefruit juice while taking Lorista H tablets.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before taking this medicine.

Pregnancy
Inform the doctor about pregnancy, suspected pregnancy or plans to become pregnant. The doctor will usually advise discontinuing Lorista H before planned pregnancy or as soon as possible after pregnancy is confirmed, and will recommend an alternative medicine instead of Lorista H. Lorista H is not recommended for use in early pregnancy and must not be used beyond the third month of pregnancy, as it may seriously harm the unborn child if taken during this period.

Breastfeeding
Inform the doctor about breastfeeding or plans to breastfeed. Lorista H is not recommended during breastfeeding. The doctor may prescribe alternative treatment if the patient wishes to breastfeed, especially if her baby is a newborn or premature infant.

Use in children and adolescents
There is no experience with the use of Lorista H in children and adolescents; therefore, it should not be used in this patient group.

Use in elderly patients
Lorista H is equally effective and well tolerated in most elderly patients as in younger patients. Most elderly patients require the same dosage as younger patients.

Driving and operating machinery
When starting treatment with Lorista H, the patient should not perform tasks requiring high concentration (e.g. driving a car or operating dangerous machinery) until it is known how the patient tolerates this medicine.

Lorista H contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before starting treatment with this medicine.

3. How to use Lorista H

This medicine should always be taken 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 Lorista H based on your condition and other medicines you are taking. It is important to continue taking Lorista H for as long as your doctor recommends in order to maintain consistent blood pressure control.

High blood pressure
For most patients with high blood pressure, one tablet of Lorista H containing 50 mg losartan and 12.5 mg hydrochlorothiazide once daily is sufficient to control blood pressure over a 24-hour period. Your doctor may increase the dose to two tablets of Lorista H containing 50 mg losartan and 12.5 mg hydrochlorothiazide once daily, or switch you to one tablet of Lorista HD containing 100 mg losartan and 25 mg hydrochlorothiazide (higher strength) once daily. The maximum recommended daily dose is two tablets of Lorista H containing 50 mg losartan and 12.5 mg hydrochlorothiazide or one tablet of Lorista HD containing 100 mg losartan and 25 mg hydrochlorothiazide.

Taking more Lorista H than recommended
If you take too much Lorista H, contact your doctor immediately so appropriate measures can be taken without delay. Overdose may cause low blood pressure, rapid heartbeat, slow heartbeat, changes in blood composition, and dehydration.

If you miss a dose of Lorista H
Try to take Lorista H every day as directed by your doctor. If you miss a dose, do not take a double dose to make up for the missed dose. Continue taking the medicine as before.

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 will experience them.
If the following adverse effect occurs, stop taking Lorista H and consult your doctor immediately or go to the emergency department of the nearest hospital:
Severe allergic reaction (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, occurring in more than 1 in 10,000 patients, but in fewer than 1 in 1,000 patients. Urgent medical intervention or hospitalization may be required.

The following adverse effects have been reported:

Common (may occur in up to 1 in 10 patients):

• Cough, upper respiratory tract infection, nasal mucosal congestion, sinusitis, sinus disorders,
• Diarrhoea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• Increased potassium levels in blood (which may cause heart rhythm disturbances), decreased haemoglobin levels,
• Kidney function disorders, including kidney failure,
• Low blood sugar levels (hypoglycaemia).

Uncommon (may occur in up to 1 in 100 patients):

• Anaemia, red or brown skin spots (usually mainly on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and stomach pain), bruising, decreased white blood cell count, coagulation disorders and decreased platelet count,
• Loss of appetite, increased uric acid levels or overt gout, increased blood sugar levels, disturbances in blood electrolyte levels,
• Anxiety, nervousness, panic disorder (recurrent panic attacks), disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disturbances,
• Tingling and numbness, limb pain, tremors, migraine, fainting,
• Blurred vision, burning or stinging sensation in the eye, conjunctivitis, worsening of vision, yellow vision,
• Sensation of ringing, buzzing, humming or pulsation in the ears, vertigo of labyrinthine origin,
• Low blood pressure, which may be related to postural changes (feeling dizzy or weak upon standing), angina (chest pain), heart rhythm disturbances, stroke (transient ischaemic attack, "mini-stroke"), heart attack, palpitations,
• Vasculitis, often accompanied by skin rash or bruising,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing breathing difficulties), nosebleed, runny nose, nasal mucosal congestion,
• Constipation, inability to pass stool, flatulence, upset stomach, stomach cramps, vomiting, dryness of the oral mucosa, sialadenitis, toothache,
• Jaundice (yellowing of eyes and skin), pancreatitis,
• Urticaria, itching, dermatitis, rash, skin redness, photosensitivity, dry skin, hot flushes with redness, especially of the face, excessive sweating, hair loss,
• Pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, decreased muscle strength,
• Frequent urination, including at night, kidney function disorders, including nephritis, urinary tract infection, presence of glucose in urine,
• Decreased libido, impotence,
• Facial swelling, localized swelling, fever.

Rare (may occur in up to 1 in 1,000 patients):

• Hepatitis, abnormal liver function test results,
• Angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Very rare (may occur in up to 1 in 10,000 patients):

• Acute respiratory failure (symptoms include severe shortness of breath, fever, fatigue and confusion).

Not known (frequency cannot be estimated from available data):

• Influenza-like symptoms,
• Low sodium levels in blood (hyponatraemia),
• General malaise,
• Malignant skin and lip tumours (non-melanoma skin cancers),
• Unexplained muscle pain with associated dark (tea-coloured) urine (rhabdomyolysis),
• Taste disturbances,
• Visual impairment or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the vascular membrane surrounding the eye – excessive fluid accumulation between choroid and sclera – or acute angle-closure glaucoma).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Lorista H

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Keep in the original packaging to protect from moisture.
HDPE container:
After first opening the container, the medicinal product should be used within 100 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Lorista H contains

• The active substances in this medicine are losartan potassium and hydrochlorothiazide. Each coated tablet contains 50 mg of losartan potassium, equivalent to 45.76 mg of losartan, and 12.5 mg of hydrochlorothiazide.
• The other ingredients are maize starch gelatinised, microcrystalline cellulose, lactose monohydrate, magnesium stearate in the tablet core; hypromellose, polyethylene glycol 4000, quinoline yellow (E 104), talc, titanium dioxide (E 171) in the tablet coating. See section 2 "Lorista H contains lactose".

What Lorista H looks like and contents of the pack
Yellow, oval, moderately biconvex coated tablets, with a breakline on one side;
tablet dimensions: 6 mm x 12 mm (oval shape), thickness 3.8 - 4.7 mm. The breakline on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.
Tablets are available in cardboard boxes containing:

• 10, 14, 28, 30, 56, 60, 84, 90, 98 or 112 coated tablets in blisters,
• 100 coated tablets in a white plastic container with a white closure providing evidence of first opening.

Not all pack sizes may be marketed.
Marketing Authorisation Holder:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer/Importer:
KRKA Polska Sp. z o.o., Równoległa 5, 02-235 Warsaw, Poland
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
This medicinal product is authorised in the European Economic Area and Great Britain (Northern Ireland) under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw
Tel. 22 57 37 500