Loreblok hct

Package leaflet: Information for the user

Loreblok HCT, 50 mg+12.5 mg, coated tablets
Losartanum kalicum + Hydrochlorothiazidum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

Loreblok HCT is a combination medicine containing an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body that binds to receptors in the walls of blood vessels, 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. This also helps reduce blood pressure.
Loreblok HCT is indicated for the treatment of essential hypertension (high blood pressure).

2. Important information before using Loreblok HCT

When not to use Loreblok HCT

• if the patient is allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has had an allergic reaction to other sulfonamide-derived drugs (e.g. other thiazide diuretics, certain antibacterial agents such as co-trimoxazole – consult a doctor if in doubt)
• after the 3rd month of pregnancy (Loreblok HCT should also be avoided during early pregnancy – see section “Pregnancy and breastfeeding”)
• if there is severe liver dysfunction
• if there is severe kidney dysfunction or if the kidneys are not producing urine
• if there is low potassium, low sodium, or high calcium levels in the blood that cannot be corrected by treatment
• if gout is present (currently)
• if the patient has diabetes or kidney dysfunction and is being treated with an antihypertensive medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Loreblok HCT, discuss the following with your doctor or pharmacist:
If the patient experiences worsening of vision or eye pain. These may be symptoms of fluid accumulation
in the vascular membrane surrounding the eye (excessive fluid accumulation between the choroid
and sclera) or increased intraocular pressure, which may occur within hours to weeks after taking Loreblok HCT.
Untreated, these symptoms may lead to permanent vision loss.
Patients who have previously experienced allergy to penicillin or sulfonamides may be at higher risk
of developing these symptoms.
It is important to inform your doctor before starting treatment with Loreblok HCT:

• if the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or difficulty breathing occurs after taking Loreblok HCT, seek immediate medical help.
• if there has ever been swelling of the face, lips, throat, or tongue
• if the patient is taking diuretic medicines
• if the patient is on a low-salt diet
• if there have been or are severe vomiting and/or diarrhoea
• if heart failure is present
• if there are or have been liver function disorders (see section 2 “When not to use Loreblok HCT”)
• if there is renal artery stenosis (narrowing of the arteries supplying blood to the kidneys), or if the patient has only one functioning kidney, or if the patient has recently received a kidney transplant
• if there is arterial stenosis (arteriosclerosis), angina pectoris (chest pain due to insufficient blood flow to the heart)
• if the patient has aortic or mitral valve stenosis (heart valve narrowing) or hypertrophic cardiomyopathy (a disease causing thickening of the heart muscle)
• if diabetes is present
• if gout has occurred in the past
• if the patient has had or currently has an allergy, asthma, or a disorder causing joint pain, skin rash, and fever (systemic lupus erythematosus)
• if there is high calcium or low potassium levels in the blood, or if the patient is on a low-potassium diet
• if general anaesthesia is planned for a surgical procedure (even for dental procedures) or if parathyroid function tests are to be performed – inform the doctor or medical staff that the patient is taking a medicine containing potassium losartan and hydrochlorothiazide
• if primary hyperaldosteronism (a condition associated with increased aldosterone hormone secretion by the adrenal glands due to adrenal abnormalities) has been diagnosed
• if the patient is taking any of the following medicines used to treat high blood pressure:
  • an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney dysfunction related to diabetes,
  • aliskiren. The treating doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section “When not to use Loreblok HCT”.
• if the patient is taking other medicines that may increase serum potassium levels (see section 2 “Loreblok HCT with other medicines”).
• if the patient has previously had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, especially at high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Loreblok HCT, protect the skin from sunlight and UV radiation.

Inform your doctor if pregnancy is suspected (or planned).
Use of Loreblok HCT is not recommended during early pregnancy and must not be used after
the 3rd month of pregnancy, as it may seriously harm the unborn child (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 medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking 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 of these medicines with Loreblok HCT is not recommended.
Diuretics such as hydrochlorothiazide contained in Loreblok HCT may interact with other medicines.
Do not take lithium preparations together with Loreblok HCT 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, medicines used to control heart rhythm, or antidiabetic medicines (oral agents or insulin).
The treating doctor may recommend a dose adjustment and/or additional precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also sections “When not to use Loreblok HCT” and “Warnings and precautions”).

Inform your doctor if the patient is taking:

• other antihypertensive medicines
• steroids
• anticancer medicines
• painkillers
• medicines used to treat fungal infections
• medicines used to treat arthritis
• resins used in high cholesterol, such as cholestyramine
• muscle relaxants
• sleeping tablets
• opioid medicines, such as morphine
• vasopressor amines, such as adrenaline or other medicines from the same group
• oral antidiabetic medicines or insulin
• excessive amounts of products containing liquorice (e.g. herbal remedies or sweets) – when taken with Loreblok HCT, these may worsen electrolyte imbalances, especially low potassium levels in the blood.

Also inform your doctor about taking Loreblok HCT before planned administration
of iodinated contrast agents.
Loreblok HCT with food, drink, and alcohol
It is recommended not to consume alcohol while taking Loreblok HCT; alcohol and Loreblok HCT
may enhance each other's effects.
Excessive salt intake in the diet may reduce the effectiveness of Loreblok HCT.
Loreblok HCT may be taken with or without food.
Avoid drinking grapefruit juice while taking Loreblok HCT tablets.
Pregnancy and breastfeeding
Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy,
she should consult a doctor or pharmacist before using this medicine.
The doctor will usually recommend discontinuing Loreblok HCT before a planned pregnancy or immediately
after pregnancy is confirmed, and will recommend an alternative medicine instead of Loreblok HCT.
Use of Loreblok HCT is not recommended during pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Loreblok HCT is not recommended during breastfeeding. If the patient wishes to breastfeed, the doctor may recommend using another medicine.
Before taking any medicine, consult a doctor or pharmacist.
Use in elderly patients
Loreblok HCT is equally effective and well tolerated in most elderly patients as in younger adults. Most elderly patients require the same dose as younger patients.
Driving and operating machinery
Do not perform tasks requiring high concentration when starting treatment with Loreblok HCT (e.g. driving or operating dangerous machinery) until the individual response to the medicine is known.
Loreblok HCT contains lactose
Loreblok HCT contains 56.90 mg of lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Loreblok HCT

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult 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 important to continue taking Loreblok HCT for as long as your doctor
has instructed, in order 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 once daily,
to control blood pressure over 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.

Taking more Loreblok HCT than prescribed
In case of overdose, contact your doctor immediately to obtain appropriate medical assistance.
Overdose may cause low blood pressure, palpitations, slow heart rate, changes in blood composition, and dehydration.

Missing a dose of 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 regular dosing schedule.

If you have any further doubts 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 any of the following symptoms occur, discontinue use of Loreblok HCT immediately
and consult a doctor or go immediately 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 in swallowing or breathing). This is a serious, although rare, adverse reaction occurring
in more than 1 in 10,000 patients, but less frequently than 1 in 1,000.
Urgent medical intervention or hospitalization may be required.
Very rarely (may occur in less than 1 in 10,000 people):

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

Other adverse reactions may occur:
Common (may occur in less than 1 in 10 people):

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

Uncommon (occur in less than 1 in 100 people):

• anemia, red or brown spots on the skin (sometimes mainly on the feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and stomach pain), bruising, decreased white blood cell count, blood clotting disorders and decreased platelet count
• loss of appetite, increased blood uric acid levels or overt gout, increased blood sugar levels, disturbances in blood electrolyte levels
• anxiety, nervousness, panic disorder with panic attacks (recurrent panic attacks), disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disturbances
• tingling and numbness or similar sensations, limb pain, tremor, migraine, fainting
• blurred vision, burning or pricking sensation in the eye, conjunctivitis, reduced visual acuity, yellow vision
• sensation of ringing, buzzing, clicking or thumping in the ears, vertigo
• low blood pressure, which may be related to change in body position (feeling of "emptiness" in the head or weakness upon standing), angina (chest pain), heart rhythm disturbances, cerebrovascular event (transient ischemic attack, "mini-stroke"), myocardial infarction, palpitations
• vasculitis, often accompanied by skin rash or purpura
• sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing difficulty breathing), nosebleeds, nasal mucosal inflammation, nasal mucosal congestion
• constipation, inability to pass stool, flatulence, gastritis, 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, sudden flushing (especially of the face), excessive sweating, alopecia
• pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness
• 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 (occur in less than 1 in 1,000 people):

• hepatitis, abnormal liver function test results.

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

• influenza-like symptoms
• unexplained muscle pain with accompanying dark (tea-colored) urine (rhabdomyolysis)
• low sodium levels in blood (hyponatremia)
• general malaise
• taste disturbances (dysgeusia)
• malignant skin and lip tumors (non-melanoma skin cancers)
• decreased vision 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 reactions
If any adverse reactions occur, including any adverse reactions not listed in this
leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported 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/Aluminium blisters:
Store below 25 °C.
OPA/Aluminium/PVC/Aluminium blisters:
No special storage instructions.
Do not use this medicine after the expiry date stated on the cardboard box and blister.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures 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 coated tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.
• Other ingredients are: core – microcrystalline cellulose, lactose, pregelatinized maize starch, anhydrous colloidal silica, talc, 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 coated tablets with a dividing groove on both sides.
Dimensions approximately 6.1 x 11.4 mm. The tablet can be divided into equal doses.
Pack sizes: 28 or 98 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]
This medicinal product is authorised in the European Economic Area countries under the following names:
Finland: Losartan/Hydrochlorothiazide Orion 50 mg/12.5 mg and 100 mg/25 mg tabletti, kalvopäällysteinen; Losartan/Hydrochlorothiazide Orion 50 mg/12.5 mg and 100 mg/25 mg filmdragerad tablett
Poland: Loreblok HCT