Package leaflet: Information for the user

Losacor HCT, 50 mg + 12.5 mg, film-coated tablets
Losartanum kalicum + Hydrochlorothiazidum
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, pharmacist, or nurse.
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, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Losacor HCT is and what it is used for
What you need to know before you take Losacor HCT
How to take Losacor HCT
Possible side effects
How to store Losacor HCT
Contents of the pack and other information

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

Losacor HCT 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 blood vessels 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.
Losacor HCT is indicated for the treatment of essential hypertension (high blood pressure).

2. Important information before using Losacor HCT

When not to use Losacor HCT

if the patient is allergic to losartan potassium, 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 diuretics, certain antibacterial agents such as co-trimoxazole); in case of doubt, consult a physician,
if the patient has severe liver dysfunction,
if the patient has low blood potassium, low blood sodium, or high blood calcium levels that cannot be corrected by treatment,
if the patient has gout,
after the third month of pregnancy (It is also advisable to avoid using Losacor HCT during early pregnancy – see section "Pregnancy"),
if the patient has severe kidney dysfunction or anuria (kidneys not producing urine),
if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Losacor HCT, consult a doctor, pharmacist, or nurse.
Sudden vision disturbances or eye pain may occur. These may be symptoms of fluid accumulation in the avascular membrane surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure – these may appear from a few hours to a week after taking Losacor HCT.
Inform your doctor if you suspect (or are planning) pregnancy. Use of Losacor HCT is not recommended during early pregnancy and must be avoided after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnacy").
Before starting treatment with Losacor HCT, inform your doctor:

if the patient has previously experienced angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4. "Possible side effects")
if the patient is taking diuretics
if the patient is on a salt-restricted diet
if the patient has had or currently has severe vomiting and/or diarrhea
if the patient has heart failure
if the patient has liver dysfunction (see section 2 "When not to use Losacor HCT")
if the patient has renal artery stenosis (narrowing or blockage of blood vessels leading to the kidneys), has only one functioning kidney, or has recently undergone kidney transplantation
if the patient has arterial stenosis (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 weakening of the heart muscle)
if the patient has diabetes
if the patient has had gout
if the patient has had or currently has allergies, asthma, or symptoms causing joint pain, skin rash, and fever (systemic lupus erythematosus)
if the patient has high blood calcium or low blood potassium levels, or is on a low-potassium diet
if the patient requires anesthesia (even at the dentist) or is scheduled for surgery, or if the patient is undergoing parathyroid function tests, the patient must inform the doctor or medical staff about taking tablets containing losartan potassium and hydrochlorothiazide
if the patient has primary hyperaldosteronism (a condition associated with increased aldosterone hormone excretion by adrenal glands due to adrenal abnormalities)
if the patient is taking any of the following medicines for high blood pressure:
angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), particularly if the patient has kidney problems related to diabetes
aliskiren
if the patient has previously had skin cancer or develops unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially in high doses over a prolonged period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. During treatment with Losacor HCT, protect the skin from sunlight and UV radiation.

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 use Losacor HCT".
Children and adolescents
There is no experience with the use of Losacor HCT in children and adolescents. Therefore, Losacor HCT should not be used in children and adolescents.
Elderly patients
Losacor HCT is equally effective and well tolerated in most elderly patients as in younger patients. Most elderly patients require the same dosage as younger individuals.
Losacor HCT and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Diuretics such as hydrochlorothiazide contained in Losacor HCT may interact with other medicines.
Do not take lithium preparations together with Losacor HCT without strict medical supervision.
Special precautions (e.g. blood tests) may be necessary if the patient is taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, other diuretics, certain laxatives, medicines used to treat gout, medicines used to control heart rhythm, or diabetes medicines (oral agents 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 "When not to use Losacor HCT" and "Warnings and precautions").
It is also important for the doctor to know if the patient is taking:

other antihypertensive medicines
corticosteroids
anticancer medicines
painkillers
antifungal medicines
medicines used to treat arthritis
bile acid sequestrants used for high cholesterol, such as cholestyramine
muscle relaxants
sleeping tablets
opioid medicines such as morphine
vasoactive amines that increase blood pressure, such as adrenaline or other medicines in the same class
oral antidiabetic medicines or insulin

Also inform your doctor about taking Losacor HCT before undergoing procedures involving iodinated contrast agents.
Losacor HCT with food, drink, and alcohol
Patients are advised not to drink alcohol while taking these tablets: alcohol and Losacor HCT tablets may enhance each other's effects.
Excessive dietary salt intake may counteract the effect of Losacor HCT tablets.
Losacor HCT may be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you suspect or are planning pregnancy. The doctor will usually recommend discontinuing Losacor HCT before planned pregnancy or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Use of Losacor HCT is not recommended during early pregnancy and must be avoided after the 3rd month of pregnancy, as it may seriously harm the unborn child.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Use of Losacor HCT is not recommended during breastfeeding. If the patient wishes to breastfeed, the doctor may recommend an alternative treatment.
Driving and operating machinery
When starting treatment with this medicine, the patient should not perform tasks requiring special attention (e.g. driving a car or operating dangerous machinery) until it is known how the medicine is tolerated.
Losacor HCT contains lactose. In case of intolerance to certain sugars, consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose unit, i.e. the medicine is considered "sodium-free".

3. How to use Losacor HCT

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt, consult
your doctor or pharmacist.
Your doctor will decide the appropriate dose of Losacor HCT depending on your condition and
other medicines you are taking. It is important to continue taking Losacor HCT for as long as your
doctor recommends, in order to maintain consistent blood pressure control.
High blood pressure
The usual dose for most patients with high blood pressure is 1 (one) tablet of Losacor HCT 50 mg + 12.5 mg daily to control blood pressure for up to 24 hours. Your doctor may increase the dose to 2 (two) tablets of Losacor HCT 50 mg + 12.5 mg once daily. The maximum daily dose is 2 (two) tablets of Losacor HCT 50 mg + 12.5 mg once daily.
The tablets should be swallowed with a glass of water.
The tablets may be taken independently of meals.
Losacor HCT, 50 mg + 12.5 mg
The break line on the tablet is only intended to facilitate splitting the tablet to make swallowing easier.
Taking more Losacor HCT than prescribed
In case of overdose, contact your doctor immediately so that appropriate measures can be taken without delay. Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.
If you forget to take Losacor HCT
Try to take Losacor HCT every day as prescribed by your doctor. However, if you miss a dose, do not take a double dose. Return to your regular dosing schedule.
Stopping Losacor HCT
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects listed below occur, discontinue use of
the medicine Losacor HCT immediately and contact your doctor or go to the emergency department of the nearest hospital:
Severe allergic reactions (rash, itching, swelling of the face, lips, mouth or throat, which may
cause difficulty in swallowing or breathing).
This is a serious, but rare adverse effect, occurring in more than 1 in 10,000
patients, but in less than 1 in 1,000 patients. Urgent medical intervention
or hospitalization may be necessary.

The following adverse effects have been reported:

Common (affects less than 1 in 10 people taking the medicine, but more than 1 in
100 people taking the medicine):

Cough, upper respiratory tract infection, nasal mucosal congestion, sinusitis, sinus disorders
Diarrhea, 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 hemoglobin levels in blood
Kidney function disorders, including kidney failure
Low blood sugar levels (hypoglycemia)

Uncommon (affects less than 1 in 100 people taking the medicine, but more than 1 in
1,000 people taking the medicine):

Anemia, red or brown spots on the skin (sometimes mainly on feet, legs, arms and buttocks with joint pain, swelling of hands and feet, and stomach pain), bruising, decreased number of white blood cells in blood, coagulation disorders, decreased platelet count
Loss of appetite, increased uric acid levels or gout, increased blood sugar levels, disturbed electrolyte levels in blood
Anxiety, nervousness, panic disorders (recurrent panic attacks), disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disturbances
Tingling and numbness sensations, limb pain, tremor, migraine, fainting
Blurred vision, burning or stinging sensation in the eye, conjunctivitis, decreased visual acuity, yellow vision
Sensation of ringing, buzzing, noise or crackling in the ears, vertigo (dizziness of labyrinthine origin)
Low blood pressure, which may be related to postural changes (feeling of emptiness in the head or weakness upon standing), angina (chest pain), irregular heartbeat, stroke (‘mini-stroke’), heart attack, palpitations
Inflammation of blood vessels, often associated with skin rash or purpura
Sore throat, shortness of breath, bronchitis, pneumonia, presence of fluid in the lungs (causing difficulty in breathing), nosebleed, runny nose, congestion
Constipation, inability to pass stool, flatulence, upset stomach, stomach cramps, vomiting, dry mouth, sialadenitis, toothache
Jaundice (yellowing of eyes and skin), pancreatitis
Urticaria, itching, skin inflammation, rash, skin redness, photosensitivity, dry skin, hot flushes with redness, sweating, hair loss
Pain in arms, shoulders, hips, knees or other joints, joint inflammation, swelling, stiffness, muscle weakness
Frequent urination, including at night; kidney function disorders, including nephritis; urinary tract infection, presence of sugar in urine
Decreased libido, impotence
Facial swelling, localized swelling, fever

Rare (affects more than 1 in 10,000 people taking the medicine, but less than 1 in 1,000 people
taking the medicine):

Hepatitis, altered liver function test results

Frequency not known:

Influenza-like symptoms
Unexplained muscle pain with accompanying dark (tea-colored) urine (rhabdomyolysis)
Low sodium levels in blood (hyponatremia)
General malaise
Taste disturbances
Malignant skin and lip tumors (non-melanoma skin cancer)
Visual impairment or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the uvea, the vascular layer 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 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
Phone: +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.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Losacor HCT

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister after “EXP:” and on the
carton after: “Expiry date (EXP):”. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines should 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 Losacor HCT contains
The active substances are losartan potassium and hydrochlorothiazide.
Losacor HCT, 50 mg + 12.5 mg
Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.
Other components are:
tablet core: microcrystalline cellulose, lactose monohydrate; maize starch, pregelatinized;
sodium carboxymethylstarch (type A), magnesium stearate;
coating Opadry White 20A18334: hydroxypropylcellulose, hypromellose 6cP, titanium dioxide (E
171).
What Losacor HCT looks like and contents of the pack
Losacor HCT, 50 mg + 12.5 mg: white, elongated, biconvex tablets with dimensions of approximately 13.7 × 6.7 mm, with a break line on both sides.
The tablets are packed in PVC/PE/PVDC/Aluminium blisters.
Pack sizes: 7, 10, 14, 28, 30, 56, 60 and 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
Specifar S.A.
1, 28 Octovriou str., Ag. Varvara
12351 Athens
Greece
This medicinal product is authorised in the European Economic Area Member States under the following names:
Netherlands: Kaliumlosartan+HCTZ/Biofarm 50 mg/12.5 mg, filmomhulde tabletten
Poland: Losacor HCT, 50 mg + 12.5 mg, film-coated tablets