Loreblok Hct

Package Leaflet: Information for the User

Loreblok HCT, 50 mg+12.5 mg, Film-Coated Tablets

Losartan Potassium+Hydrochlorothiazide

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package 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 only. 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Loreblok HCT and what is it used for
• 2. Important information before taking Loreblok HCT
• 3. How to take Loreblok HCT
• 4. Possible side effects
• 5. How to store Loreblok HCT
• 6. Contents of the pack and other information

1. What is Loreblok HCT and what is it used for

Loreblok HCT is a combination medicine that contains 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 results in increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to widen and thereby reducing blood pressure. Hydrochlorothiazide works by increasing the flow of water and salt through the kidneys. This also helps to reduce blood pressure. Loreblok HCT is indicated for the treatment of primary hypertension (high blood pressure).

2. Important information before taking Loreblok HCT

When not to take Loreblok HCT

• if you are allergic to losartan, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6)
• if you have been diagnosed with an allergy to other sulfonamides (e.g. other thiazide diuretics, certain antibacterial drugs such as cotrimoxazole - in case of doubt, consult your doctor)
• after the third month of pregnancy (also in the early stages of pregnancy, you should avoid taking Loreblok HCT - see section "Pregnancy and breastfeeding")
• if you have severe liver dysfunction
• if you have severe kidney dysfunction or if your kidneys do not produce urine
• if you have low potassium, low sodium or high calcium levels in your blood that cannot be corrected by treatment
• if you have gout (currently)
• if you have diabetes or kidney dysfunction and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting to take Loreblok HCT, you should discuss it with your doctor or pharmacist: If you experience worsening vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye, which can occur within a few hours to weeks after taking Loreblok HCT. Untreated symptoms can lead to permanent vision loss. People who have previously been allergic to penicillin or sulfonamides may be more prone to these symptoms. It is essential to tell your doctor before starting Loreblok HCT:

• if you have had breathing or lung problems after taking hydrochlorothiazide in the past (including pneumonia or fluid accumulation in the lungs). If you experience severe shortness of breath or difficulty breathing after taking Loreblok HCT, seek medical attention immediately.
• if you have ever had facial, lip, throat or tongue swelling
• if you are taking diuretics
• if you are on a low-salt diet
• if you have had severe vomiting and/or diarrhea
• if you have heart failure
• if you have liver dysfunction (see section 2 "When not to take Loreblok HCT")
• if you have narrowing of the arteries supplying blood to the kidneys (renal artery stenosis) or if you have only one functioning kidney or if you have recently had a kidney transplant
• if you have narrowing of the arteries (arteriosclerosis), angina pectoris (chest pain due to insufficient blood flow to the heart)
• if you have narrowing of the aortic or mitral valve or hypertrophic cardiomyopathy (a disease that causes thickening of the heart muscle)
• if you have diabetes
• if you have had gout (in the past)
• if you have had an allergy, asthma or a condition that causes joint pain, skin rash and fever (systemic lupus erythematosus)
• if you have high calcium or low potassium levels in your blood or if you are on a low-potassium diet
• if you are scheduled to receive anesthesia for surgery (even dental surgery) or if you will be undergoing parathyroid function tests - inform your doctor or medical staff that you are taking a medicine containing losartan potassium and hydrochlorothiazide
• if you have been diagnosed with primary hyperaldosteronism (a condition related to excessive secretion of aldosterone hormone by the adrenal glands, caused by adrenal gland abnormalities)
• if you are taking any of the following medicines for high blood pressure:
• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have diabetic kidney disease
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure and electrolyte levels (e.g. potassium). See also section "When not to take Loreblok HCT".
• if you are taking other medicines that may increase potassium levels in your blood (see section 2 "Loreblok HCT with other medicines").
• if you have had skin cancer or if you develop an unexpected skin change during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During Loreblok HCT treatment, protect your skin from sunlight and UV radiation.

You should inform your doctor if you are pregnant or planning to become pregnant. Your doctor will usually advise you to stop taking Loreblok HCT before planned pregnancy and recommend an alternative medicine instead of Loreblok HCT. It is not recommended to take Loreblok HCT during pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm your baby (see section "Pregnancy and breastfeeding").

Children and Adolescents

There is no experience with the use of Loreblok HCT in children. Therefore, Loreblok HCT should not be used in children.

Loreblok HCT with other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, and about any medicines you plan to take. Tell your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medicines or other medicines that may increase potassium levels in your blood (e.g. trimetoprim-containing medicines), as it is not recommended to take these medicines with Loreblok HCT. Diuretics, such as hydrochlorothiazide in Loreblok HCT, may interact with other medicines. Do not take lithium-containing products and Loreblok HCT without close medical supervision. Special precautions (e.g. blood tests) may be necessary if you are taking other diuretics, certain laxatives, gout medicines or medicines to control heart rhythm or antidiabetic medicines (oral or insulin). Your doctor may recommend a dose change and/or take other precautions:

• if you are taking an ACE inhibitor or aliskiren (see also sections "When not to take Loreblok HCT" and "Warnings and precautions").

Tell your doctor if you are taking:

• other blood pressure-lowering medicines
• corticosteroids
• anticancer medicines
• analgesics
• antifungal medicines
• medicines for arthritis
• cholesterol-lowering resins such as cholestyramine
• muscle relaxants
• sleeping pills
• opioid analgesics such as morphine
• amines that increase blood pressure, such as adrenaline or other medicines from the same group
• oral antidiabetic medicines or insulin
• excessive amounts of licorice-containing products (e.g. herbal medicines or candies) - when taken with Loreblok HCT, they may exacerbate electrolyte disturbances, particularly low potassium levels in the blood.

You should also inform your doctor if you are taking Loreblok HCT before scheduled administration of iodine-containing contrast agents.

Loreblok HCT with food, drink and alcohol

It is recommended not to consume alcohol while taking Loreblok HCT, as alcohol and Loreblok HCT may enhance each other's effects. Excessive salt intake in your diet may reduce the effect of Loreblok HCT. Loreblok HCT can be taken with or without food. You should avoid drinking grapefruit juice while taking Loreblok HCT tablets.

Pregnancy and breastfeeding

Pregnancy If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will usually advise you to stop taking Loreblok HCT before planned pregnancy and recommend an alternative medicine instead of Loreblok HCT. It is not recommended to take Loreblok HCT during pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm your baby. Breastfeeding You should inform your doctor if you are breastfeeding or planning to breastfeed. It is not recommended to take Loreblok HCT while breastfeeding. If you want to breastfeed, your doctor may recommend an alternative medicine. Before taking any medicine, consult your doctor or pharmacist.

Use in elderly patients

Loreblok HCT is equally effective and well-tolerated in elderly patients as in younger adult patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

Do not perform tasks that require special attention while starting treatment with Loreblok HCT (e.g. driving or operating hazardous machinery) until you know your individual reaction to the medicine.

Loreblok HCT contains lactose

Loreblok HCT contains 56.90 mg of lactose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Loreblok HCT

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. Your doctor will determine the appropriate dose of Loreblok HCT, depending on your condition and other medicines you are taking. It is essential to continue taking Loreblok HCT for as long as your doctor recommends, to maintain consistent blood pressure control. High blood pressure: The usual dose of Loreblok HCT for most patients with high blood pressure is 1 tablet of 50 mg + 12.5 mg per day, to control blood pressure for 24 hours. Your doctor may increase the dose to 2 tablets of Loreblok HCT 50 mg + 12.5 mg per day. The maximum daily dose is 2 tablets of Loreblok HCT 50 mg+12.5 mg.

What to do if you take more Loreblok HCT than you should

In case of overdose, contact your doctor immediately to get the necessary medical help. Overdose may cause low blood pressure, rapid heartbeat, slow heart rate, changes in blood composition and dehydration.

What to do if you forget to take Loreblok HCT

Try to take Loreblok HCT every day as directed by your doctor. However, if you miss a dose, do not take a double dose. Return to your usual dosing schedule. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Loreblok HCT can cause side effects, although not everybody gets them. If you experience any of the following symptoms, stop taking Loreblok HCT and consult your doctor or go to the emergency department of your nearest hospital immediately: Severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing). This is a severe but rare side effect that occurs more frequently than 1 in 10,000 patients but less frequently than 1 in 1,000 patients. You may need urgent medical attention or hospitalization. Very rare (may occur less frequently than 1 in 10,000):

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

Other side effects may occur: Common (may occur less frequently than 1 in 10):

• cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorders
• diarrhea, abdominal pain, nausea, indigestion
• muscle or leg pain, back pain
• insomnia, headache, dizziness
• weakness, fatigue, chest pain
• high potassium levels (which may cause heart rhythm disturbances), low hemoglobin levels
• kidney dysfunction, including kidney failure
• low blood sugar (hypoglycemia).

Uncommon (occur less frequently than 1 in 100):

• anemia, red or brown spots on the skin (sometimes mainly on the feet, legs, arms and buttocks, with joint pain, swelling of the hands and feet and stomach pain), bruising, decreased white blood cell count, blood clotting disorders and decreased platelet count
• loss of appetite, high uric acid levels in the blood or overt gout, high blood sugar levels, electrolyte disturbances in the blood
• anxiety, nervousness, anxiety disorder with panic attacks (recurring panic attacks), disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disorders
• tingling or numbness or similar sensations, limb pain, tremors, migraine, fainting
• blurred vision, burning or stinging sensation in the eye, conjunctivitis, decreased visual acuity, yellow vision
• ringing, buzzing, clicking or tapping in the ears, dizziness of labyrinthine origin
• low blood pressure, which may be associated with a change in body position (feeling of "emptiness" in the head or weakness when standing up), angina pectoris (chest pain), heart rhythm disturbances, cerebrovascular incident (transient ischemic attack, "mini-stroke"), myocardial infarction, rapid heartbeat
• vasculitis, often accompanied by skin rash or purpura
• throat pain, shortness of breath, bronchitis, pneumonia, fluid accumulation in the lungs (which makes breathing difficult), nosebleeds, rhinitis, nasal congestion
• constipation, inability to pass stools, gas, gastritis, stomach cramps, vomiting, dry mouth, salivary gland inflammation, toothache
• jaundice (yellowing of the eyes and skin), pancreatitis
• hives, itching, skin inflammation, rash, redness of the skin, photosensitivity, dry skin, flushing (especially of the face), excessive sweating, hair loss
• shoulder, arm, hip, knee or other joint pain, joint swelling, stiffness, weakness
• frequent urination, also at night, kidney dysfunction, including kidney inflammation, urinary tract infection, sugar in the urine
• decreased libido, impotence
• facial swelling, localized swelling, fever.

Rare (occur less frequently than 1 in 1,000):

• hepatitis, abnormal liver function test results.

Unknown (frequency cannot be estimated from the available data):

• flu-like symptoms
• unexplained muscle pain with accompanying dark (tea-colored) urine (rhabdomyolysis)
• low sodium levels in the blood (hyponatremia)
• general malaise
• taste disturbances (dysgeusia)
• malignant skin and lip tumors (non-melanoma skin cancer)
• vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or acute angle-closure glaucoma).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring 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 By reporting side effects, you can help provide more information on the safety of this medicine. You can also report side effects to the marketing authorization holder.

5. How to store Loreblok HCT

Keep this medicine out of the sight and reach of children. PVC/LDPE/PVDC/Aluminum blisters: Store in a temperature below 25°C. OPA/Aluminum/PVC/Aluminum blisters: There are no special storage precautions. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Loreblok HCT contains

• The active substances are losartan potassium and hydrochlorothiazide.
• Each film-coated tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.
• The other ingredients are: core - microcrystalline cellulose, lactose, maize starch, colloidal anhydrous silica, magnesium stearate; coating - hypromellose, hydroxypropylcellulose, titanium dioxide (E 171), quinoline yellow (E 104).

What Loreblok HCT looks like and contents of the pack

Light yellow, oval, biconvex film-coated tablets with a score line on both sides. Dimensions: approximately 6.1 x 11.4 mm. The tablet can be divided into equal doses. Pack sizes: 28 or 98 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation Orionintie 1 FI-02200 Espoo Finland

Manufacturer

Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland For more detailed information on this medicine, please contact the local representative of the marketing authorization holder: Orion Pharma Poland Sp. z o. o. [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Finland: Losartan/Hydrochlorothiazide Orion 50 mg/12,5 mg and 100 mg/25 mg tablet, film-coated; Losartan/Hydrochlorothiazide Orion 50 mg/12,5 mg and 100 mg/25 mg film-coated tablet Poland: Loreblok HCT Date of last revision of the package leaflet:27.01.2023