Lisiprol Hct

Leaflet accompanying the packaging: information for the user

LISIPROL HCT, 20 mg + 25 mg, tablets

Lisinopril+ Hydrochlorothiazide

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Lisiprol HCT is used to treat high blood pressure (hypertension).
This medicine contains two active substances - lisinopril and hydrochlorothiazide.
Lisinopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). Its action is to dilate blood vessels.
Hydrochlorothiazide belongs to a group of medicines called diuretics (water pills).
It helps to remove water and electrolytes, such as sodium, from the urine.
These medicines work together to lower blood pressure.

2. Important information before taking Lisiprol HCT

When not to take Lisiprol HCT

• if the patient is allergic to lisinopril, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to ACE inhibitors or sulfonamide derivatives. If the patient is not sure if this applies to them, they should consult a doctor;
• if the patient has ever had a sudden swelling of the hands, feet, ankles, face, lips, tongue or throat, especially after taking an ACE inhibitor. Difficulty swallowing or breathing may also occur;
• if the patient has hereditary angioedema (a condition that makes the patient more prone to swelling);
• if the patient has severe kidney problems;
• if the patient is unable to urinate;
• if the patient has severe liver problems;
• after the 3rd month of pregnancy (it is also recommended to avoid taking Lisiprol HCT in early pregnancy - see "Pregnancy and breastfeeding");
• if the patient has diabetes or kidney problems and is taking a blood pressure-lowering medicine containing aliskiren;
• if the patient has taken or is taking a combination medicine containing sacubitril and valsartan (used to treat a certain type of long-term (chronic) heart failure in adults), as the risk of angioedema (rapid swelling of the skin and mucous membranes) increases.

Do not take Lisiprol HCT if any of the above points apply to the patient. If the patient has any doubts, they should consult a doctor or pharmacist before taking Lisiprol HCT.

Warnings and precautions

Before starting to take Lisiprol HCT, the patient should discuss it with their doctor or pharmacist:

• if the patient has a narrowing (stenosis) of the aorta (heart artery), heart valves (mitral valves) or renal artery;
• if the patient has an increased thickness of the heart muscle (called hypertrophic cardiomyopathy);
• if the patient has vascular disorders (collagen vascular disease);
• if the patient has low blood pressure. The patient may experience symptoms such as dizziness or fainting, especially when standing up;
• if the patient has kidney problems or is undergoing dialysis or has had a kidney transplant;
• if the patient has liver problems;
• if the patient has diabetes;
• if the patient has recently had diarrhea or vomiting;
• if the doctor has advised the patient to control their salt intake;
• if the patient has high cholesterol levels or is undergoing LDL apheresis;
• if the patient has ever had a condition called systemic lupus erythematosus (SLE);
• if the patient is black, as Lisiprol HCT may be less effective in this racial group. The patient is also more likely to experience a side effect - angioedema (severe allergic reaction with swelling of the hands, feet, ankles, face, lips, tongue and/or throat);
• if the patient is taking any of the following medicines for high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g. valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes,
• aliskiren; if the patient is taking any of the following medicines, as the risk of angioedema (rapid swelling of the skin and mucous membranes) increases:
• racecadotril, used to treat diarrhea,
• medicines used to prevent rejection of a transplanted organ and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, used to treat diabetes;
• tissue plasminogen activator (a medicine that dissolves blood clots), usually given in a hospital.
• if the patient has had a malignant skin tumor or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of malignant skin tumors and lip cancer (non-melanoma skin cancer). During treatment with Lisiprol HCT, the patient should protect their skin from sunlight and UV radiation.
• if the patient has had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient experiences severe shortness of breath or difficulty breathing after taking Lisiprol HCT, they should seek medical attention immediately.
• 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 the choroid and sclera) or increased pressure inside the eye - they can occur within a few hours to weeks after taking Lisiprol HCT. Untreated, it can lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, they may be at increased risk of developing these symptoms.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood.
See also the section "When not to take Lisiprol HCT".
In case of pregnancy (or suspected pregnancy), the patient should consult a doctor. It is not recommended to take Lisiprol HCT during early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").
If the patient has any doubts about whether any of the above conditions apply to them, they should consult a doctor or pharmacist before taking Lisiprol HCT.
Allergy treatment, such as bee sting allergy
The patient should inform their doctor if they are undergoing or planning to undergo desensitization treatment for allergies (e.g. bee sting allergy). Taking Lisiprol HCT during such treatment may cause severe allergic reactions.
Surgical procedures
The patient should inform their doctor or dentist that they are taking Lisiprol HCT if they are planning to undergo surgery (including dental surgery). During local or general anesthesia, low blood pressure (hypotension) may occur if the patient is also taking Lisiprol HCT.

Children and adolescents

The safety and efficacy of Lisiprol HCT in children and adolescents under 18 years of age have not been established.

Lisiprol HCT and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is important because Lisiprol HCT may affect the action of some medicines, and some medicines may affect the action of Lisiprol HCT. The doctor may recommend a dose change and/or take other precautions.
In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• other blood pressure-lowering medicines (antihypertensive medicines),
• angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "When not to take Lisiprol HCT" and "Warnings and precautions"),
• medicines that lower potassium levels in the blood (hypokalemia), such as other diuretics (including potassium-sparing diuretics), laxatives, corticosteroids (e.g. prednisone), ACTH (hormone), amphotericin (antifungal medicine), and salicylate derivatives,
• non-steroidal anti-inflammatory medicines (NSAIDs), such as aspirin, ibuprofen or indomethacin, used to treat muscle pain or arthritis,
• medicines used to treat depression (tricyclic and tetracyclic antidepressants),
• medicines used to treat mental illnesses, such as lithium,
• aspirin (acetylsalicylic acid) in doses greater than 3 g per day,
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent rejection of a transplanted organ; and heparin, a medicine used to thin the blood to prevent clots);
• calcium salts or vitamin D supplements,
• medicines used to treat diabetes (insulin or oral antidiabetic medicines, such as sulfonylurea derivatives) - when taking thiazide diuretics, it may be necessary to adjust the dose of the antidiabetic medicine,
• asthma medicines,
• medicines used to treat nasal congestion or sinusitis or other cold medicines (including over-the-counter medicines),
• immunosuppressive medicines,
• allopurinol (used to treat gout),
• medicines used to treat heart rhythm disorders (such as procainamide),
• medicines used to treat heart problems (e.g. digoxin) or other medicines used to treat heart rhythm disorders,
• medicines containing gold, such as aurothioglucose sodium, given by injection, used to treat rheumatoid arthritis,
• amphotericin B by injection (to treat fungal infections),
• carbenoxolone (to treat esophageal ulcers and inflammation of the mouth and lips),
• corticosteroids (steroid medicines),
• corticotropin (hormone),
• laxatives,
• cholestyramine and colestipol (used to lower cholesterol levels, prevent diarrhea, or relieve itching),
• muscle relaxants, such as tubocurarine,
• amantadine (a medicine used against influenza A virus or to treat Parkinson's disease),
• sotalol (a beta-blocker),
• lovastatin (used to lower cholesterol levels),
• dextran sulfate (used in LDL apheresis to lower cholesterol levels in the blood),
• medicines used during cancer chemotherapy (e.g. cyclophosphamide, methotrexate),
• other medicines that can cause a type of irregular heartbeat called torsade de pointes.

The following medicines may increase the risk of angioedema (symptoms of angioedema include swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing):

• medicines that dissolve blood clots (tissue plasminogen activator), usually given in a hospital;
• medicines used to prevent rejection of a transplanted organ and to treat cancer (e.g. sirolimus, everolimus) and other medicines belonging to the group of so-called mTOR inhibitors - see the section "Warnings and precautions";
• vildagliptin, used to treat diabetes;
• racecadotril, used to treat diarrhea.

Lowering blood pressure may be enhanced by alcohol, barbiturates, or anesthetics. When changing body position to standing, the patient may experience dizziness.

Lisiprol HCT with food, drink, and alcohol

The patient should ask their doctor about the possibility of consuming alcoholic beverages while taking Lisiprol HCT. Alcohol may enhance the side effects of Lisiprol HCT.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Lisiprol HCT before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Lisiprol HCT. It is not recommended to take Lisiprol HCT during early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus.
Breastfeeding
The patient should inform their doctor about breastfeeding or intending to breastfeed. It is not recommended to take Lisiprol HCT during breastfeeding, especially when breastfeeding a newborn or premature baby. The doctor may recommend taking another medicine.

Driving and using machines

This medicine may occasionally cause fatigue or dizziness, which may affect the ability to drive and use machines, especially at the beginning of treatment or when changing the dose or in combination with alcohol. If the patient experiences such symptoms, they should not drive or operate tools or machines.
Before the patient engages in the above activities, they should wait until they know how they react to the medicine.

3. How to take Lisiprol HCT

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
If the patient has already started taking Lisiprol HCT, the doctor may perform blood tests. The doctor may then adjust the dose accordingly for the individual patient.
Taking the medicine
The tablet should be swallowed with water.
The patient should try to take the medicine at the same time every day. It does not matter whether Lisiprol HCT is taken before or after meals.
Lisiprol HCT should be taken for as long as the doctor recommends. The treatment is long-term. It is important to take Lisiprol HCT every day.
First dose
The patient should be particularly careful when taking the first dose or increasing the dose of Lisiprol HCT. A greater decrease in blood pressure may occur than with subsequent doses.
Dizziness or fainting may occur. If such symptoms occur, it may be helpful to lie down. In case of any doubts, the patient should consult a doctor as soon as possible.
Adults
The recommended dose is one tablet once a day. The doctor will prescribe tablets of the appropriate strength for the individual patient.

Use in children

Lisiprol HCT is not recommended for use in children.

Overdose of Lisiprol HCT

In case of taking a higher dose of Lisiprol HCT than recommended by the doctor, the patient should immediately consult a doctor or go to the hospital. The patient should take the packaging of the medicine with them so that the tablets can be identified.

Missing a dose of Lisiprol HCT

In case of missing a dose, the patient should take it as soon as they remember, unless it is almost time for the next dose. In this case, the patient should not take the missed dose at all.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Lisiprol HCT

The patient should not stop taking the tablets, even if they feel well, unless the doctor recommends it.
If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Lisiprol HCT can cause side effects, although not everybody gets them.
Lisiprol HCT contains two medicines: lisinopril and hydrochlorothiazide. The following side effects have been observed for each of these medicines when taken separately. This also means that they may occur when taking Lisiprol HCT.
The doctor may occasionally take blood samples to check if Lisiprol HCT has any effect on blood parameters.

Possible side effects of lisinopril

Severe allergic reactions(rare, may occur in up to 1 in 1000 patients)
If the patient experiences a severe allergic reaction, they should stop taking Lisiprol HCT
and immediately consult a doctor.Symptoms may include sudden onset of:

• Swelling of the face, lips, tongue, or throat. This can cause difficulty swallowing and/or breathing.
• Severe or sudden swelling of the hands, feet, or ankles.
• Difficulty breathing (including wheezing and chest tightness).
• Severe itching of the skin (with hives).

Severe liver problems(very rare, may occur in up to 1 in 10,000 patients)
Symptoms may include:

• Yellowing of the skin or eyes, dark urine, or loss of appetite.

If such symptoms occur, the patient should immediately consult a doctor.
Other possible side effects:
Common (may occur in up to 1 in 10 patients):

• Headache,
• Dizziness or fainting, especially when standing up quickly,
• Fainting,
• Diarrhea,
• Vomiting,
• Cough,
• Kidney problems (visible in blood tests).

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

• Mood changes, including feeling depressed,
• Feeling of tingling,
• Feeling of spinning (dizziness),
• Changes in taste,
• Difficulty sleeping,
• Heart attack or stroke, related to a significant decrease in blood pressure,
• Abnormal heart rhythm,
• Change in finger or toe color,
• Nasal congestion,
• Nausea,
• Abdominal pain and indigestion,
• Changes in liver function test results,
• Rash,
• Itching,
• Impotence,
• Feeling of weakness,
• Feeling of fatigue,
• Increased levels of certain substances in the blood (urea, creatinine, and potassium).

Rare (may occur in up to 1 in 1000 patients):

• Changes in blood cells or other blood components. Symptoms may include feeling tired and pale skin,
• Disorientation,
• Changes in sense of smell,
• Dry mouth,
• Rash with red, raised, itchy patches (hives),
• Hair loss (alopecia),
• Psoriasis (skin disorder),
• High levels of urea in the blood due to kidney failure,
• Blood infection,
• Kidney failure,
• Breast enlargement in men,
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH),
• Low sodium levels in the blood, which can cause weakness, fatigue, headache, nausea, vomiting, and muscle cramps.

Very rare (may occur in up to 1 in 10,000 patients):

• Disorders of the bone marrow or decreased blood cell and/or platelet count. The patient may experience fatigue, infection (which can be severe), fever, shortness of breath, or a tendency to bruise or bleed easily,
• Swollen lymph nodes,
• Exacerbation of immune system reactions (autoimmune diseases),
• Low blood sugar levels (hypoglycemia). Symptoms may include feeling hungry or weak, sweating, and rapid heartbeat,
• Sudden wheezing or shortness of breath (bronchospasm),
• Pneumonia (which can cause shortness of breath),
• Sinusitis (feeling of pain and fullness in the cheek and eye socket areas),
• Eosinophilic pneumonia - symptoms include:
• Sinusitis,
• Flu-like symptoms,
• Increasing shortness of breath,
• Abdominal pain and skin rash,
• Feeling of tingling or numbness in the hands and feet.
• Pancreatitis, which can cause moderate to severe abdominal pain,
• Intestinal edema. This can cause sudden abdominal pain, diarrhea, or vomiting,
• Sweating,
• Severe skin disorders or rash. Symptoms include redness, blisters, and peeling of the skin, which can develop rapidly and include blisters in the mouth and nose,
• Decreased urine output or no urine output.

Frequency not known (cannot be estimated from the available data):

• Seeing, feeling, or hearing things that do not exist (hallucinations),
• Redness of the skin.

Possible side effects of hydrochlorothiazide:
Very rare (may occur in up to 1 in 10,000 patients):

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

Frequency not known (cannot be estimated from the available data):

• Salivary gland inflammation,
• Decreased white blood cell and/or platelet count. The patient may experience fatigue, infection (which can be severe), fever, shortness of breath, or a tendency to bruise or bleed easily,
• Loss of appetite,
• Increased blood sugar levels (hyperglycemia),
• Presence of sugar in the urine,
• Increased uric acid levels in the blood,
• Changes in electrolyte levels in the blood (e.g. low sodium and potassium levels). The patient may experience muscle weakness, thirst, tingling, cramps, and nausea,
• Increased or high levels of fats in the blood (including cholesterol),
• Anxiety,
• Depression,
• Difficulty sleeping,
• Feeling of tingling,
• Dizziness,
• Blurred vision or yellow vision, decreased vision, 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]. If symptoms such as eye pain or decreased vision occur suddenly, the patient should immediately inform their doctor, as treatment may be necessary to prevent permanent vision loss.
• Feeling of spinning (dizziness of labyrinthine origin),
• Feeling of fainting (especially when standing up),
• Vascular damage, causing red or purple spots on the skin,
• Difficulty breathing. If there is inflammation or fluid in the lungs, shortness of breath may occur,
• Irritation of the stomach,
• Diarrhea,
• Constipation,
• Pancreatitis, which can cause moderate to severe abdominal pain,
• Yellowing of the skin and eyes (jaundice),
• Skin disorders, including photosensitivity rash, rash, severe rash that develops rapidly with blisters or peeling of the skin, and possible blisters in the mouth and nose,
• Allergic reactions,
• Muscle cramps and weakness,
• Kidney problems, which can be severe (detected in blood tests),
• Fever,
• Weakness,
• Malignant skin tumors and lip cancer (non-melanoma skin cancer).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. 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.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Lisiprol HCT

Keep 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 month stated.
Do not store above 25°C.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lisiprol HCT contains

The active substances of the medicine are: 20 mg of lisinopril (as lisinopril dihydrate) and 25 mg of hydrochlorothiazide.
The other ingredients are: mannitol, indigo carmine, lacquer, cornstarch, cornstarch paste, magnesium stearate, anhydrous calcium hydrogen phosphate.

What Lisiprol HCT looks like and contents of the pack

The tablets are light blue, 11 mm in diameter, flat on both sides, with beveled edges.
The pack contains 28 tablets.

Marketing authorization holder and manufacturer

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
phone: (22) 755 50 81
In order to obtain more detailed information, the patient should contact
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet:

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