Lorista hd

Package leaflet: Information for the user

Lorista HD, 100 mg + 25 mg, film-coated tablets
potassium losartan + hydrochlorothiazide
Please read all of this leaflet carefully before 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 personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

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

Lorista HD is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which, by binding to receptors in blood vessel walls, causes narrowing of the vessels. This leads to increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in blood vessel dilation and consequently lowering of blood pressure. Hydrochlorothiazide works by increasing the excretion of water and salts through the kidneys. This also helps reduce blood pressure.
Lorista HD is indicated for the treatment of essential hypertension (high blood pressure).

2. Important information before using Lorista HD

When not to use Lorista HD

• if the patient is allergic to losartan and (or) hydrochlorothiazide or any of the other components of this medicine (listed in section 6),
• if the patient is allergic to sulfonamide-derived substances (e.g. other thiazide-type diuretics, certain 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 HD should also be avoided in early pregnancy – see section "Pregnancy and breastfeeding"),
• if the patient has severe liver function disorders, biliary stasis, or conditions causing biliary tract obstruction,
• if the patient has severe renal impairment (creatinine clearance <30 ml/min),
• if the kidneys are not producing urine,
• if the patient has severe hypokalaemia, hyponatraemia, or hypercalcaemia that cannot be corrected by treatment,
• if the patient has gout,
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

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

• if the patient has previously experienced swelling of the face, lips, throat, or tongue,
• if the patient is taking diuretics,
• 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 use Lorista HD"),
• if the patient has renal artery stenosis (narrowing of blood vessels leading to the kidneys), only one functioning kidney, or has recently undergone kidney transplantation,
• if the patient has arterial stenosis (arterial narrowing), angina pectoris (chest pain due to impaired heart function),
• if the patient has "aortic or mitral valve stenosis" (heart valve narrowing) or "hypertrophic cardiomyopathy" (a disease causing thickening of the heart muscle),
• if the patient has diabetes,
• if the patient has had gout,
• if the patient has or has had allergies, asthma, or a disease causing joint pain, skin rash, and fever (systemic lupus erythematosus),
• if the patient has high calcium levels or low potassium levels in the blood, 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 tests are planned, it is essential to inform the doctor or medical staff about taking Lorista HD,
• if the patient has primary hyperaldosteronism (a syndrome associated with increased aldosterone hormone excretion by the adrenal glands due to adrenal abnormalities),
• if the patient is taking other medicines that may increase serum potassium levels (see section 2 "Lorista HD and other medicines"),
• if the patient has previously had skin cancer or develops unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially at high doses over a prolonged period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Lorista HD, protect the skin from sunlight and UV radiation,
• if the patient has previously experienced breathing or lung problems after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If the patient develops severe shortness of breath or difficulty breathing after taking Lorista HD, 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 HD. If left untreated, they may lead to permanent vision loss. If the patient previously had an allergic reaction to penicillin or sulfonamides, they 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 disorders related to diabetes,
• aliskiren.

The treating physician may monitor kidney function, blood pressure, and electrolyte levels (e.g. potassium) in regular intervals.
See also information under the heading "When not to use Lorista HD".
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Lorista HD,
discuss this with the doctor. The doctor will decide on further treatment. Do not independently
decide to stop taking Lorista HD.
Inform your doctor if you are pregnant, suspect pregnancy, or are planning pregnancy. Use of Lorista HD
is not recommended during early pregnancy and must not be taken beyond the third month of pregnancy, as it may
have very harmful effects on the foetus if used after the third month of pregnancy (see "Pregnancy
and breastfeeding").
Lorista HD and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Inform your doctor about potassium supplements, potassium-containing salt substitutes, potassium-sparing agents, or other medicines that may increase serum potassium levels (e.g. medicines containing trimethoprim), as concomitant use with Lorista HD is not recommended.
Diuretics such as hydrochlorothiazide contained in Lorista HD may interact with other medicines.
Do not take lithium preparations together with Lorista HD 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, anticancer medicines, painkillers, antifungal medicines or medicines used to treat joint inflammation, bile acid sequestrants used to treat high cholesterol such as cholestyramine, muscle relaxants, sleeping medicines, opioids such as morphine, "vasopressor amines" such as adrenaline or other medicines in this group, or oral antidiabetic medicines or insulin.
The treating physician may need to adjust the dose and/or apply additional precautions:

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

Also inform your doctor about taking Lorista HD before planned administration of iodine-containing contrast agents.
Lorista HD with food, drink, and alcohol
Lorista HD may be taken regardless of meals.
It is recommended that the patient does not drink alcohol while taking Lorista HD, as alcohol
and Lorista HD tablets may mutually enhance their effects.
Excessive dietary salt intake may counteract the effect of Lorista HD.
Avoid drinking grapefruit juice while taking Lorista HD 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 using this medicine.
Pregnancy
Inform your doctor if you are pregnant, suspect pregnancy, or are planning pregnancy. The doctor will usually advise discontinuing Lorista HD before a planned pregnancy or as soon as possible after pregnancy is confirmed, and will recommend an alternative medicine to replace Lorista HD. Lorista HD 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 of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Lorista HD is not recommended during breastfeeding, and 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 HD in children and adolescents; therefore, it should not be used in this patient group.
Use in elderly patients
Lorista HD is equally effective and well tolerated in most elderly patients as in younger patients. Most elderly patients require the same dose as younger patients.
Driving and operating machinery
When starting treatment with Lorista HD, the patient should not perform tasks requiring special concentration (e.g. driving a car or operating dangerous machinery) until it is known how the patient tolerates this medicine.
Lorista HD contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before starting treatment with this medicine.

3. How to use Lorista HD

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist. Your doctor will determine the appropriate dose of Lorista HD
depending on your condition and other medications you are taking. It is important to continue taking
Lorista HD for as long as your doctor recommends in order to maintain consistent blood pressure control.

High blood pressure
In 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 for 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 per day.

Taking more Lorista HD than recommended
In case of overdose, contact your doctor immediately so appropriate measures can be taken without delay.
Overdose may cause low blood pressure, palpitations, slowed heart rate, changes in blood composition,
and dehydration.

Missing a dose of Lorista HD
Try to take Lorista HD 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, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the following adverse reaction occurs, you must stop taking
Lorista HD and immediately consult a doctor 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 reaction 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 reactions have been reported:

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

• cough, upper respiratory tract infection, nasal mucosa 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 blood potassium levels (which may cause heart rhythm disturbances), decreased haemoglobin levels,
• kidney function disorders, including kidney failure,
• low blood sugar (hypoglycaemia).

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

• anaemia, red or brownish 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 sensations, 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 of dizziness or weakness upon standing), angina pectoris (chest pain), heart rhythm disturbances, stroke (transient ischaemic attack, "mini-stroke"), myocardial infarction, palpitations,
• vasculitis, often accompanied by skin rash or bruising,
• sore throat, shortness of breath, bronchitis, pneumonia, presence of fluid in the lungs (causing breathing difficulties), nosebleed, rhinitis, nasal mucosa 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, skin inflammation, 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 kidney inflammation, urinary tract infection, presence of glucose in urine,
• decreased libido, impotence,
• facial swelling, localised swelling, fever.

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

• hepatitis, abnormal liver function test results,
• intestinal angioedema: 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).

Unknown frequency (cannot be estimated from available data):

• influenza-like symptoms,
• low blood sodium levels (hyponatraemia),
• general malaise,
• malignant skin and lip tumours (non-melanoma skin cancers),
• unexplained muscle pain with accompanying dark (tea-coloured) urine (rhabdomyolysis),
• taste disturbances,
• impaired vision or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive fluid accumulation between choroid and sclera – or acute angle-closure glaucoma).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lorista HD

Keep the medicine out of the 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 stated month.
Do not store above 30°C.
Store 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 required. These measures help protect the environment.

6. Contents of the packaging and other information

What Lorista HD contains

• The active substances are losartan potassium and hydrochlorothiazide. Each coated tablet contains 100 mg of losartan potassium, equivalent to 91.52 mg of losartan, and 25 mg of hydrochlorothiazide.
• Other ingredients are: tablet core: pregelatinized corn starch, microcrystalline cellulose, monohydrate lactose, magnesium stearate; tablet coating: hypromellose 6 cP, macrogol 4000, quinoline yellow (E 104), talc, titanium dioxide (E 171). See section 2 "Lorista HD contains lactose".

What Lorista HD looks like and contents of the pack
Yellow, oval, slightly biconvex coated tablets, 8 mm x 15 mm in size and 5.1–6.1 mm thick.
Tablets are available in cardboard boxes containing:

• 10, 28, 30, 60, 90 or 112 coated tablets in blisters,
• 100 coated tablets in a white plastic container with a white closure designed to show evidence of 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, 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 on this medicinal product, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. 22 57 37 500