Lisiprol Hct

Leaflet accompanying the packaging: patient information

Lisiprol HCT, 10 mg+12.5 mg, tablets

Lisiprol HCT, 20 mg+12.5 mg, tablets

Lisinopril + Hydrochlorothiazide

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

• Keep this leaflet, so you can read it again if you need to.
• 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 those 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 packaging and other information

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

Lisiprol HCT is used to treat high blood pressure (hypertension).
The 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 based on the dilation of blood vessels.
Hydrochlorothiazide belongs to a group of medicines called diuretics (water pills). It helps the body get rid of excess water and salts, such as sodium, excreted in 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, 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 as described above). If the patient is not sure, they should consult a doctor;
• 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 currently taking sacubitril/valsartan, a medicine used to treat a certain type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, e.g. in the throat) 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 the following 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 problems (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 and 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 population. 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 or throat);
• if the patient is taking any of the following medicines used to treat 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 has had skin cancer in the past 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 skin cancer 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 in the past. If the patient experiences severe shortness of breath or difficulty breathing after taking Lisiprol HCT, they should seek medical help immediately.
• if the patient experiences vision loss 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 — these can occur within a few hours to a few weeks after taking Lisiprol HCT. Untreated, this can lead to permanent vision loss. If the patient has previously been allergic to penicillin or sulfonamides, they are at greater risk.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood.
See also the "When not to take Lisiprol HCT" section.
If the patient is taking any of the following medicines, the risk of angioedema (rapid swelling of tissues under the skin, e.g. in the throat) increases:

• sirolimus, everolimus, temsirolimus and other mTOR inhibitors (used to prevent transplant rejection and treat cancer);
• tissue plasminogen activator (a medicine that dissolves blood clots), usually given in a hospital;
• wildagliptin, a medicine used to treat diabetes;
• racecadotril, a medicine used to treat diarrhea.

In case of pregnancy (or suspected pregnancy), the patient should consult a doctor. It is not recommended to take Lisiprol HCT in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby (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 to reduce allergic reactions to bee stings. 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.
Taking Lisiprol HCT may affect the results of some blood tests
Hydrochlorothiazide in this medicine may cause positive results in doping tests.

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 includes medicines available without a prescription and herbal medicines. 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 medicines used to treat high blood pressure (antihypertensive medicines),
• angiotensin II receptor antagonists (AIIRA) or aliskiren (see also "When not to take Lisiprol HCT" and "Warnings and precautions"),
• medicines that lower potassium levels in the blood (hypokalemia), such as diuretics (water pills), laxatives, corticosteroids (e.g. prednisone), ACTH (hormone), amphotericin (an antifungal medicine), carbenoxolone (a medicine used to treat ulcers or inflammation of the esophagus and mouth) and salicylate derivatives,
• non-steroidal anti-inflammatory medicines (NSAIDs), such as aspirin, ibuprofen or indomethacin, used to treat muscle and joint pain,
• medicines used to treat depression (tricyclic and tetracyclic antidepressants),
• medicines used to treat mental illnesses, such as lithium,
• aspirin in doses greater than 3 g per day,
• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection and treat cancer, and heparin, a medicine used to thin the blood to prevent blood clots);
• calcium salts or vitamin D supplements,
• antidiabetic medicines (insulin and 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),
• cardiac glycosides (e.g. digoxin) or other medicines used to treat heart rhythm disorders,
• gold injections (such as sodium aurothiomalate) used to treat rheumatoid arthritis,
• cholestyramine and colestipol (used to lower cholesterol levels, prevent diarrhea or relieve itching),
• muscle relaxants, such as tubocurarine,
• amantadine (an antiviral medicine, used to treat influenza A virus, also used to treat Parkinson's disease),
• sotalol (a beta-blocker),
• lovastatin (used to lower cholesterol levels),
• iron oxide yellow (E 172) (used in LDL apheresis to lower cholesterol levels in the blood),
• anticancer medicines (e.g. cyclophosphamide, methotrexate),
• other medicines that can cause a type of irregular heartbeat called torsades 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 used to dissolve blood clots (tissue plasminogen activators, usually given in a hospital),
• medicines used to prevent transplant rejection and treat cancer (sirolimus, everolimus, temsirolimus and other mTOR inhibitors). See "Warnings and precautions",
• wildagliptin, a medicine used to treat diabetes,
• racecadotril, a medicine used to treat diarrhea.

Alcohol, barbiturates or anesthetics may enhance the blood pressure-lowering effect. When changing 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 as soon as pregnancy is confirmed and recommend taking a different medicine instead of Lisiprol HCT. It is not recommended to take Lisiprol HCT in early pregnancy and it should not be taken after the 3rd month of pregnancy, as it may seriously harm the baby.
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 a different 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 engaging in the above activities, the patient 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 a meal.
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
Special care should be taken when taking the first dose or increasing the dose of Lisiprol HCT. A greater decrease in blood pressure may occur than after 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 contact their 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.
If necessary, the doctor may increase the dose to two tablets once a day.

Use in children

Lisiprol HCT is not recommended for use in children.

Overdose of Lisiprol HCT

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

Missed 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 Lisiprol HCT

The patient should not stop taking the tablets, even if they feel well, unless the doctor recommends it.
In case of any further doubts about taking this medicine, the patient 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 taking Lisiprol HCT has any effect on blood parameters.
Possible side effects of lisinopril
Severe allergic reactions(rare, may occur in less than 1 in 1000 patients)

If the patient experiences a severe allergic reaction, they should stop taking Lisiprol HCT and contact their doctor immediately.

Symptoms may include sudden:

• swelling of the face, lips, tongue or throat - this may 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 raised bumps).

Severe liver problems(very rare, may occur in less than 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 contact their doctor immediately.

Other possible side effects:
Common (may occur in less than 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 less than 1 in 100 patients):

• mood changes, including feeling depressed,
• tingling sensation,
• feeling of spinning (vertigo),
• changes in taste,
• difficulty sleeping,
• heart attack or stroke,
• abnormal heart rhythm,
• change in color of fingers and toes,
• runny nose,
• nausea,
• stomach pain and indigestion,
• changes in liver function test results,
• rash,
• itching,
• impotence (erectile dysfunction),
• feeling of weakness,
• feeling of fatigue,
• increased levels of certain substances in the blood (urea, creatinine and potassium).

Rare (may occur in less than 1 in 1000 patients):

• changes in blood cell counts 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 bumps (hives),
• hair loss (alopecia),
• psoriasis (skin disorder),
• high levels of urea in the blood due to kidney failure,
• kidney failure,
• breast enlargement in men,
• syndrome of inappropriate antidiuretic hormone secretion (SIADH),
• low sodium levels in the blood, which may cause weakness, fatigue, headache, nausea, vomiting and muscle cramps.

Very rare (may occur in less than 1 in 10,000 patients):

• bone marrow or blood cell disorders, which may cause tiredness, infections (which may 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 may cause shortness of breath),
• sinusitis (feeling of pain and fullness in the cheeks and eye sockets),
• eosinophilic pneumonia - symptoms include:
• sinusitis,
• flu-like symptoms,
• increasing shortness of breath,
• stomach and intestine pain,
• skin rash,
• tingling or numbness of hands and feet.
• pancreatitis, which may cause moderate to severe abdominal pain,
• intestinal angioedema. This can cause sudden abdominal pain, diarrhea or vomiting,
• sweating,
• severe skin or rash reactions. Symptoms include redness, blistering and peeling of the skin, which can develop quickly and include blistering in the mouth and nose,
• reduced urine output or no urine output.

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

• seeing, feeling or hearing things that are not there (hallucinations),
• redness of the skin.

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

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

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

• salivary gland inflammation,
• decrease in white blood cell or platelet count. The patient may experience tiredness, infection (which may 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,
• tingling sensation,
• dizziness,
• vision disturbances, which may cause yellow vision,
• temporary vision disturbances,
• severe eye pain with redness and sudden vision disturbances. If the patient suddenly experiences eye pain and redness, they should inform their doctor immediately; to avoid permanent vision loss, treatment may be necessary,
• 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),
• vertigo (dizziness of inner ear origin),
• feeling of fainting (especially when standing up),
• vascular damage, causing red or purple spots on the skin,
• breathing difficulties. If there is inflammation or fluid in the lungs, shortness of breath may occur,
• stomach upset,
• diarrhea,
• constipation,
• pancreatitis, which may cause moderate to severe abdominal pain,
• jaundice (yellowing of the skin or eyes),
• skin disorders, including sensitivity to sunlight, rash, severe rash, which can develop quickly with blistering and peeling of the skin, and possibly blistering in the mouth and nose,
• allergic reactions,
• muscle cramps and weakness,
• kidney problems, which may be severe (detected in blood tests),
• fever,
• weakness,
• non-melanoma skin cancer (skin and lip cancer).

The list of possible side effects should not be a cause for concern, as they may not occur.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 collected on the safety of the medicine.

5. How to store Lisiprol HCT

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging (EXP:). The expiry date refers to the last day of the month.
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 packaging and other information

What Lisiprol HCT contains

The active substances of the medicine are: lisinopril (as dihydrate) and hydrochlorothiazide
Lisiprol HCT, 10 mg+12.5 mg, tablets
Each tablet contains 10 mg of lisinopril (as 10.88 mg of lisinopril dihydrate)
and 12.5 mg of hydrochlorothiazide.
Lisiprol HCT, 20 mg+12.5 mg, tablets
Each tablet contains 20 mg of lisinopril (as 21.76 mg of lisinopril dihydrate)
and 12.5 mg of hydrochlorothiazide.
Other ingredients are:
mannitol (E 421)
indigo carmine (E 132), lake
corn starch
pregelatinized corn starch
calcium hydrogen phosphate dihydrate
pregelatinized corn starch (partially pregelatinized)
magnesium stearate and only in Lisiprol HCT, 20 mg+12.5 mg, tablets
iron oxide yellow (E 172)

What Lisiprol HCT looks like and contents of the pack

Lisiprol HCT, 10 mg+12.5 mg, tablets
Round, flat, light blue tablets with some darker color variations, approximately 8 mm in diameter, with beveled edges and engraved with "C43" on one side.
Lisiprol HCT, 20 mg+12.5 mg, tablets
Round, flat, light green tablets with some darker color variations, approximately 8 mm in diameter, with beveled edges and engraved with "C44" on one side.
The packaging contains 30 tablets.

Marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
POLAND

Manufacturer

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
POLAND
Gedeon Richter Plc.,
Gyömrői út 19-21,
Budapest H-1103
HUNGARY
To obtain more detailed information about the medicine and its names in other European Economic Area member states, 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: January 2022

((logo of the marketing authorization holder))
((pharmaceutical company logo))