Lisiprol Hct

Package Leaflet: Information for the Patient

Lisiprol HCT, 10 mg+12.5 mg, tablets

Lisiprol HCT, 20 mg+12.5 mg, tablets

Lisinopril + Hydrochlorothiazide

Before taking Lisiprol HCT, carefully read this leaflet as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

• 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 widen the blood vessels.
Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets). It helps the body get rid of excess water and salts, such as sodium, which are 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 you are allergic to lisinopril, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to ACE inhibitors or sulfonamide-derived substances. If you are not sure if this applies to you, consult your doctor;
• if you have ever had angioedema (a sudden swelling of the hands, feet, ankles, face, lips, tongue or throat), especially after taking an ACE inhibitor. You may also have had difficulty swallowing or breathing;
• if you have hereditary angioedema (a condition that makes you more prone to angioedema);
• if you have severe kidney problems;
• if you are unable to urinate;
• if you have severe liver problems;
• if you are more than 3 months pregnant (see also "Pregnancy and breastfeeding" section);
• if you have diabetes or kidney problems and are taking aliskiren, a medicine used to lower blood pressure;
• if you are 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 the tissues under the skin, e.g. in the throat) is increased.

Do not take Lisiprol HCT if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Lisiprol HCT.

Warnings and precautions

Before taking Lisiprol HCT, discuss with your doctor or pharmacist:

• if you have narrowing (stenosis) of the aorta (heart artery), heart valves (mitral valves) or renal artery;
• if you have increased thickness of the heart muscle (called hypertrophic cardiomyopathy);
• if you have blood vessel disorders (collagen vascular disease);
• if you have low blood pressure. You may feel dizzy or lightheaded, especially when standing up;
• if you have kidney problems or are on dialysis or have had a kidney transplant;
• if you have liver problems;
• if you have diabetes;
• if you have recently had diarrhea or vomiting;
• if your doctor has told you to control your salt intake;
• if you have high cholesterol levels and are undergoing LDL apheresis;
• if you have ever had systemic lupus erythematosus (SLE), a condition characterized by joint and muscle pain, skin rash and fever;
• if you are black, as Lisiprol HCT may be less effective in this population. You are also more likely to experience angioedema (a severe allergic reaction with swelling of the hands, feet, ankles, face, lips, tongue or throat);
• if you are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as sartan - e.g. valsartan, telmisartan, irbesartan, especially if you have kidney problems related to diabetes,
• aliskiren;
• if you have had skin cancer 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, protect your skin from sunlight and UV radiation.
• if you have had breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or difficulty breathing after taking Lisiprol HCT, seek medical attention immediately.
• if you experience 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, it can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you are at greater risk.

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

• 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), consult your 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 baby (see "Pregnancy and breastfeeding" section).
If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Lisiprol HCT.
Allergy treatment, such as bee venom allergy
Tell your doctor if you are undergoing or plan to undergo desensitization treatment to reduce allergic reactions to bee venom. Taking Lisiprol HCT during such treatment may cause severe allergic reactions.
Surgical procedures
Tell your doctor or dentist that you are taking Lisiprol HCT if you are scheduled for surgery (including dental surgery). During local or general anesthesia, low blood pressure (hypotension) may occur if you are also taking Lisiprol HCT.
Taking Lisiprol HCT may affect the results of some blood tests
Hydrochlorothiazide in this medicine may cause positive results in anti-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 with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take, including those 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.
Your doctor may recommend a dose change and/or take other precautions.
In particular, tell your doctor or pharmacist if you 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 tablets), laxatives, corticosteroids (e.g. prednisone), ACTH (hormone), amphotericin (antifungal medicine), carbenoxolone (medicine used to treat ulcers or inflammation of the esophagus and mouth) and salicylate derivatives,
• non-steroidal anti-inflammatory drugs (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 disorders, such as lithium,
• aspirin, used 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,
• medicines used to treat diabetes (insulin and oral hypoglycemic agents, such as sulfonylurea derivatives) - when taking thiazide diuretics, it may be necessary to adjust the dose of the hypoglycemic agent,
• 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 (antiviral medicine, used to treat influenza A virus, also used to treat Parkinson's disease),
• sotalol (beta-blocker),
• lovastatin (used to lower cholesterol levels),
• iron oxide (used to treat LDL apheresis to lower blood cholesterol levels),
• 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" section,
• wildagliptin, a medicine used to treat diabetes,
• racecadotril, used to treat diarrhea.

Alcohol, barbiturates or anesthetics may increase the lowering of blood pressure. When changing position to standing, dizziness may occur.

Lisiprol HCT with food, drink and alcohol

Ask your doctor if you can drink alcohol while taking Lisiprol HCT. Alcohol may increase the side effects of Lisiprol HCT.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant. Your doctor will usually recommend stopping Lisiprol HCT before planned pregnancy or as soon as possible after confirming pregnancy, and will recommend taking a different 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 baby.
Breastfeeding
Tell your doctor if you are breastfeeding or planning to breastfeed. It is not recommended to take Lisiprol HCT while breastfeeding, especially if you are breastfeeding a newborn or premature baby. Your doctor may recommend a different medicine.

Driving and using machines

This medicine may occasionally cause fatigue or dizziness, which may affect your ability to drive or operate machinery, especially at the beginning of treatment or when changing the dose or in combination with alcohol. If you experience these symptoms, do not drive or operate machinery.
Wait until you know how the medicine affects you before performing these activities.

3. How to take Lisiprol HCT

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
If you have already started taking Lisiprol HCT, your doctor may perform blood tests. Your doctor may then adjust the dose accordingly for you.
Taking the medicine
Swallow the tablet with water.
Try to take the medicine at the same time every day. It does not matter whether you take Lisiprol HCT before or after food.
Take Lisiprol HCT for as long as your doctor recommends. The treatment is long-term. It is important to take Lisiprol HCT every day.
First dose
Be especially careful when taking the first dose or increasing the dose of Lisiprol HCT. There may be a greater decrease in blood pressure than with subsequent doses.
Dizziness or lightheadedness may occur. If you experience these symptoms, it may help to lie down. If you have any doubts, consult your doctor as soon as possible.
Adults
The recommended dose is one tablet once a day. Your doctor will prescribe tablets of the appropriate strength for you.
If necessary, your doctor may increase the dose to two tablets once a day.

Use in children

Lisiprol HCT is not recommended for use in children.

Overdose

If you take more Lisiprol HCT than you should, contact your doctor or go to the hospital immediately. Take the medicine package with you so that the tablets can be identified.

Missed dose

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In this case, do not take the missed dose at all.
Do not take a double dose to make up for a forgotten dose.

Stopping treatment

Do not stop taking the tablets, even if you feel better, unless your doctor tells you to.
If you have any further questions about taking this medicine, ask your 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 alone. This also means that they may occur when taking Lisiprol HCT.
Your doctor may occasionally take blood samples to check if Lisiprol HCT has any effect on your blood counts.
Possible side effects of lisinopril
Severe allergic reactions(rare, may affect up to 1 in 1,000 people)

If you experience a severe allergic reaction, stop taking Lisiprol HCT and contact your 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 tightness in the chest),
• severe itching of the skin (with raised lumps).

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

• yellowing of the skin or eyes, dark urine or loss of appetite. If you experience these symptoms, contact your doctor immediately.

Other possible side effects:
Common (may affect up to 1 in 10 people):

• headache,
• dizziness or lightheadedness, especially when standing up quickly,
• fainting,
• diarrhea,
• vomiting,
• cough,
• kidney problems (seen in blood tests).

Uncommon (may affect up to 1 in 100 people):

• 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,
• abdominal pain and indigestion,
• changes in liver function test results,
• rash,
• itching,
• impotence (inability to achieve an erection),
• feeling of weakness,
• feeling tired,
• increased levels of certain substances in the blood (urea, creatinine and potassium).

Rare (may affect up to 1 in 1,000 people):

• 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 patches (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, tiredness, headache, nausea, vomiting and muscle cramps.

Very rare (may affect up to 1 in 10,000 people):

• bone marrow or blood cell disorders, which may cause tiredness, infections (which may be serious), fever, shortness of breath or a tendency to bruise or bleed easily,
• lymph node swelling,
• 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,
• abdominal pain and gastrointestinal symptoms,
• 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 reactions or rash. 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 available data):

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

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

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

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

• salivary gland inflammation,
• reduced white blood cell or platelet count. You may feel tired, get infections (which may be serious), 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). You may feel muscle weakness, thirst, tingling, cramps and nausea,
• increased cholesterol and triglyceride levels in the blood,
• anxiety,
• depression,
• difficulty sleeping,
• tingling sensation,
• dizziness,
• visual disturbances, which may cause yellow vision,
• transient visual disturbances,
• severe eye pain with redness and sudden visual disturbances. If you experience sudden pain and redness in the eye, tell your doctor immediately; to avoid permanent vision loss, treatment may be necessary,
• eye pain or blurred vision 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,
• gastric irritation,
• diarrhea,
• constipation,
• pancreatitis, which may cause moderate to severe abdominal pain,
• jaundice (yellowing of the skin or eyes),
• skin disorders, including photosensitivity rash, rash, severe rash that develops 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 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocides of the Office for Registration of Medicinal Products, Medical Devices and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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, you can help provide more information on the safety of this medicine.

5. How to store Lisiprol HCT

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the packaging (EXP:). The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lisiprol HCT contains

The active substances 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) 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
Light blue, round, flat tablets with occasional discoloration of a darker color, approximately 8 mm in diameter, with beveled edges and engraved with "C43" on one side.
Lisiprol HCT, 20 mg+12.5 mg, tablets
Light green, round, flat tablets with occasional discoloration of a darker color, approximately 8 mm in diameter, with beveled edges and engraved with "C44" on one side.
The pack 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 on the medicine and its names in other EU member states, contact
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22) 755 96 48
lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet: January 2022

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