Losacor Hct

Package Leaflet: Information for the User

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

Losartan Potassium + Hydrochlorothiazide

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Losacor HCT and What is it Used For
• 2. Important Information Before Taking Losacor HCT
• 3. How to Take Losacor HCT
• 4. Possible Side Effects
• 5. How to Store Losacor HCT
• 6. Contents of the Package and Other Information

1. What is Losacor HCT and What is it 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 that, by binding to receptors in blood vessel walls, causes them to narrow. This results in increased blood pressure.
Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to widen and, as a result, lowering blood pressure. Hydrochlorothiazide works by increasing the flow of water and salt through the kidneys. This also helps to lower blood pressure.
Losacor HCT is indicated for the treatment of primary hypertension (high blood pressure).

2. Important Information Before Taking Losacor HCT

When Not to Take Losacor HCT

• after the third month of pregnancy (it is also recommended to avoid taking Losacor HCT in early pregnancy - see section "Pregnancy"),

Warnings and Precautions

Before starting to take Losacor HCT, the doctor, pharmacist, or nurse should be consulted.
Occurrence of vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between the choroid and sclera) or increased pressure within the eye — they may occur within a few hours to a week after taking Losacor HCT.
The doctor should be informed about suspected (or planned) pregnancy. It is not recommended to take Losacor HCT in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus (see section "Pregnancy").
Before starting to take Losacor HCT, the doctor should be informed:

• angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), particularly if the patient has diabetic kidney disease.
• aliskiren,

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
See also the information under the heading "When Not to Take 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 as effective and well-tolerated in most elderly patients as it is in younger patients. Most elderly patients require the same doses as younger patients.

Losacor HCT with Other Medications

The doctor or pharmacist should be told about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take.
Diuretics such as hydrochlorothiazide in Losacor HCT may interact with other medications.
Without close medical supervision, the patient should not take lithium preparations with Losacor HCT.
Special precautions (e.g., blood tests) may be necessary if the patient is taking potassium supplements, potassium-containing salt substitutes, or potassium-sparing diuretics, certain laxatives, medications for gout, or medications for controlling heart rhythm or diabetes (oral or insulin).
The doctor may need to adjust the dose and/or take other precautions if the patient is taking an ACE inhibitor or aliskiren (see also the information under the headings "When Not to Take Losacor HCT" and "Warnings and Precautions").
It is also important for the doctor to know if the patient is taking:

• other blood pressure-lowering medications,
• corticosteroids,
• anticancer medications,
• analgesics,
• antifungal medications,
• medications for arthritis,
• cholesterol-lowering resins such as cholestyramine,
• muscle relaxants,
• sleeping pills,
• opioid medications such as morphine,
• amines that increase blood pressure, such as adrenaline or other medications from the same group,
• oral antidiabetic medications or insulins.

The doctor should also be informed about the use of Losacor HCT before scheduled administration of iodine-based contrast agents.

Losacor HCT with Food, Drink, and Alcohol

It is recommended that the patient does not drink alcohol while taking these tablets: alcohol and Losacor HCT tablets may increase their effects.
Salt in the diet in excessive amounts may counteract the effects of Losacor HCT tablets.
Losacor HCT can be taken with or without food.

Pregnancy and Breastfeeding

Pregnancy
The doctor should be informed about suspected (or planned) pregnancy. The doctor will usually recommend stopping Losacor HCT before planned pregnancy or as soon as pregnancy is confirmed and recommend taking another medication instead of Losacor HCT. It is not recommended to take Losacor HCT in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may have a very harmful effect on the fetus.
Breastfeeding
The doctor should be informed about breastfeeding or the intention to breastfeed. It is not recommended to take Losacor HCT during breastfeeding. If the patient wants to breastfeed, the doctor may recommend alternative treatment.

Driving and Operating Machines

When starting treatment with this medication, the patient should not perform tasks that require special attention (e.g., driving a car or operating hazardous machinery) until it is known how the patient tolerates the medication.
Losacor HCT contains lactose. In case of intolerance to some sugars, the doctor should be consulted before taking this medication.
The medication contains less than 1 mmol (23 mg) of sodiumper recommended dose, which means the medication is considered "sodium-free".

3. How to Take Losacor HCT

This medication should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
The doctor will decide on the appropriate dose of Losacor HCT, depending on the patient's condition and other medications being taken. It is essential to continue taking Losacor HCT for as long as the doctor recommends to maintain consistent blood pressure control.

High Blood Pressure

The usual dose for most patients with high blood pressure is 1 (one) Losacor HCT tablet of 50 mg + 12.5 mg per day to control blood pressure for up to 24 hours. The doctor may increase the dose to 2 (two) Losacor HCT tablets of 50 mg + 12.5 mg once a day. The maximum daily dose is 2 (two) Losacor HCT tablets of 50 mg + 12.5 mg once a day.
The tablets should be swallowed with a glass of water.
The tablets can be taken with or without food.
Losacor HCT, 50 mg + 12.5 mg
The dividing line on the tablet is only to facilitate breaking and does not affect the efficacy of the medication.

Taking More Than the Recommended Dose of Losacor HCT

In case of overdose, the doctor should be contacted immediately to take prompt action. Overdose may cause low blood pressure, rapid heartbeat, slow pulse, changes in blood composition, and dehydration.

Missing a Dose of Losacor HCT

The patient should try to take Losacor HCT every day as directed by the doctor. However, if a dose is missed, a double dose should not be taken. The patient should return to their regular dosing schedule.

Stopping Losacor HCT Treatment

In case of further doubts about taking this medication, the doctor or pharmacist should be consulted.

4. Possible Side Effects

Like all medications, Losacor HCT can cause side effects, although not everyone gets them.
In case of the following side effects, the patient should stop taking Losacor HCT and contact their doctor or go to the emergency department of the nearest hospital immediately:
Severe allergic reactions (rash, itching, swelling of the face, lips, mouth, or throat, which may cause difficulty swallowing or breathing).
This is a severe but rare side effect, occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients. Urgent medical attention or hospitalization may be necessary.
The following side effects have been reported:

• Frequent (affects less than 1 in 10 people taking the medication but more than 1 in 100 people taking the medication):
• cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorders,
• diarrhea, abdominal pain, nausea, indigestion,
• muscle pain or cramps, leg pain, back pain,
• insomnia, headache, dizziness,
• weakness, fatigue, chest pain,
• high potassium levels in the blood (which may cause heart rhythm disturbances), low hemoglobin levels in the blood,
• kidney function disorders, including kidney failure,
• low blood sugar (hypoglycemia),

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

• 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, decreased platelet count,
• loss of appetite, increased uric acid or gout, increased blood sugar levels, disturbed electrolyte levels in the blood,
• anxiety, nervousness, panic disorders (recurring panic attacks), disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disorders,
• tingling and numbness, limb pain, tremors, migraine, fainting,
• blurred vision, burning or stinging sensation in the eye, conjunctivitis, decreased visual acuity, yellow vision,
• ringing, buzzing, or hissing in the ears, dizziness of labyrinthine origin,
• low blood pressure, which may be associated with postural changes (feeling of emptiness in the head or weakness when standing up), angina pectoris (chest pain), disturbed heart rhythm, stroke, heart attack, palpitations,
• vasculitis, which is often associated with skin rash or purpura,
• sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause breathing difficulties), nosebleeds, runny nose, congestion,
• constipation, inability to pass stools, gas, upset stomach, stomach cramps, vomiting, dry mouth, salivary gland inflammation, toothache,
• jaundice (yellowing of the eyes and skin), pancreatitis,
• hives, itching, skin inflammation, rash, skin redness, sensitivity to light, dry skin, hot flashes with redness,
• shoulder, arm, hip, knee, or other joint pain, arthritis, swelling, stiffness, muscle weakness,
• frequent urination, also at night; kidney function disorders, including kidney inflammation; urinary tract infections, sugar in the urine,
• decreased libido, impotence,
• facial swelling, localized swelling, fever,

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

• hepatitis, abnormal liver function test results,

Frequency Not Known:

• flu-like symptoms,
• unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis),
• low sodium levels in the blood (hyponatremia),
• general malaise,
• taste disorders,
• malignant tumors of the skin and lips (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 accumulation of fluid between the choroid and sclera - or acute angle-closure glaucoma),

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Losacor HCT

The medication should be stored out of sight and reach of children.
This medication should not be taken after the expiration date stated on the blister pack after "EXP:" and on the carton after "Expiration Date (EXP):". The expiration date refers to the last day of the month.
Do not store above 30°C.
Medications should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Losacor HCT Contains

The active substances of Losacor HCT 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 ingredients are:
tablet core:microcrystalline cellulose, lactose monohydrate; maize starch; sodium carboxymethylcellulose (type A), magnesium stearate;
Opadry White 20A18334 coating:hydroxypropylcellulose, hypromellose 6cP, titanium dioxide (E 171).

What Losacor HCT Looks Like and Contents of the Package

Losacor HCT, 50 mg + 12.5 mg: white, oval, biconvex tablets with dimensions of approximately 13.7 × 6.7 mm, with a dividing line on both sides.
The tablets are packaged in PVC/PE/PVDC/Aluminum blisters.
Package sizes: 7, 10, 14, 28, 30, 56, 60, and 90 film-coated tablets.
Not all package sizes may be marketed.

Marketing Authorization 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 Authorized in the Member States of the European Economic Area 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
Date of Last Revision of the Leaflet:16.09.2020