Lisiprol hct

Patient Information Leaflet

LISIPROL HCT, 20 mg + 25 mg, tablets
Lisinoprilum + Hydrochlorothiazidum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Lisiprol HCT is and what it is 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 Lisiprol HCT is and what it is 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 known as angiotensin-converting enzyme (ACE) inhibitors. It works by widening blood vessels.
Hydrochlorothiazide belongs to a group of medicines called diuretics (water pills). It helps remove water and electrolytes, such as sodium, from the body through urine.
These medicines work together to lower blood pressure.

2. Important information before using Lisiprol HCT

When not to use 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 to sulfonamide-derived substances. If the patient is unsure whether this applies, they should consult their doctor;
• if the patient has ever experienced sudden swelling of the hands, feet, ankles, face, lips, tongue, or throat, particularly if it occurred during treatment with 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 the swelling described above). If the patient is unsure whether this applies, they should consult their doctor;
• if the patient has severe kidney problems;
• if the patient is unable to pass urine;
• if the patient has severe liver problems;
• during the third trimester of pregnancy (use of Lisiprol HCT should also be avoided in early pregnancy – see section "Pregnancy and breastfeeding");
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient is taking or has taken a combination medicine containing sacubitril and valsartan (used to treat certain types of chronic (long-term) heart failure in adults), as this increases the risk of angioedema (rapid swelling of tissue under the skin, such as in the throat).

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

Warnings and precautions

Before starting Lisiprol HCT, discuss with your doctor or pharmacist if:

• the patient has narrowing (stenosis) of the aorta (the main artery from the heart), heart valves (mitral valves), or renal artery;
• the patient has thickening of the heart muscle (called hypertrophic cardiomyopathy);
• the patient has blood vessel disorders (collagen vascular disease);
• the patient has low blood pressure. The patient may experience symptoms such as dizziness or lightheadedness, especially when standing up;
• the patient has kidney problems or is undergoing dialysis or has received a kidney transplant;
• the patient has liver problems;
• the patient has diabetes;
• the patient has recently had diarrhoea or vomiting;
• the doctor has advised the patient to monitor salt intake in their diet;
• the patient has high cholesterol levels or is undergoing LDL apheresis;
• the patient has ever had systemic lupus erythematosus (SLE);
• the patient is of Black race, as Lisiprol HCT may be less effective in people of this race. The patient may also be more likely to experience a side effect – angioedema (a severe allergic reaction with swelling of the hands, feet, ankles, face, lips, tongue, and/or throat);
• the patient is taking any of the following medicines used to treat high blood pressure:
  • an angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes,
  • aliskiren;
• the patient is taking any of the following medicines, as there is an increased risk of angioedema (rapid swelling of tissues such as in the throat):
  • racecadotril, used to treat diarrhoea,
  • medicines used to prevent rejection of transplanted organs and to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
  • vildagliptin, used to treat diabetes;
  • tissue plasminogen activator (a medicine that dissolves blood clots), usually administered in hospital.
• if the patient has previously had skin cancer or develops an unexpected skin change during treatment. Treatment with hydrochlorothiazide, especially in high doses over a long period, may increase the risk of certain types of skin and lip cancers (non-melanoma skin cancer). While taking Lisiprol HCT, the patient should protect their skin from sunlight and UV radiation.
• if the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing after taking Lisiprol HCT, they should seek immediate medical help.
• if the patient experiences blurred vision or eye pain. These may be symptoms of fluid accumulation in the uvea (the vascular layer surrounding the eye) or increased intraocular pressure – these may occur from a few hours to weeks after taking Lisiprol HCT. Untreated, this may 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 blood levels of electrolytes (e.g. potassium).

See also the section "When not to use Lisiprol HCT".

If the patient is pregnant (or suspects pregnancy), they should consult their doctor. Lisiprol HCT is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").

If the patient has any doubts whether any of the above conditions apply, they should consult their doctor or pharmacist before taking Lisiprol HCT.

Allergy treatment, such as allergy to insect venom

Inform the doctor if desensitization treatment for insect venom allergy (allergy immunotherapy) is being or will be performed. Taking Lisiprol HCT during such treatment may cause severe allergic reactions.

Surgical procedures

Inform the doctor or dentist that the patient is taking Lisiprol HCT if a surgical procedure (including dental surgery) is planned. Low blood pressure (hypotension) may occur during local or general anaesthesia 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

Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This is important because Lisiprol HCT may affect the action of certain medicines, and some medicines may affect the action of Lisiprol HCT. The doctor may recommend a dose adjustment and/or additional precautions.

In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• other blood pressure-lowering medicines (antihypertensives),
• an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to use Lisiprol HCT" and "Warnings and precautions"),
• medicines that reduce potassium levels in the blood (hypokalaemia), such as other diuretics (including potassium-sparing diuretics), laxatives, corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), and salicylate derivatives,
• non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or indomethacin, used to treat muscle pain or joint inflammation,
• medicines used to treat depression (tricyclic and tetracyclic antidepressants),
• medicines used to treat psychiatric disorders, such as lithium,
• aspirin (acetylsalicylic acid) at doses exceeding 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 co-trimoxazole, used for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots);
• calcium salts or vitamin D supplements,
• antidiabetic medicines (insulin or oral antidiabetic medicines, such as sulfonylurea derivatives) – dosage adjustments of antidiabetic medicines may be necessary when thiazide diuretics are used,
• anti-asthma medicines,
• medicines used for nasal or sinus congestion or other cold remedies (including over-the-counter medicines),
• medicines that suppress the body's immune response (immunosuppressants),
• allopurinol (used to treat gout),
• medicines used to treat heart rhythm disorders (e.g. procainamide),
• medicines used to treat heart conditions (e.g. digoxin) or other medicines used for heart rhythm disorders,
• gold-containing medicines, such as sodium aurothiomalate, administered by injection, used to treat rheumatoid arthritis,
• amphotericin B by injection (to treat fungal infections),
• carbenoxolone (to treat ulcers and inflammatory conditions of the oesophagus, mouth, and lip area),
• glucocorticosteroids (steroid medicines),
• corticotropin (a hormone),
• medicines used to treat constipation (laxatives),
• cholestyramine and colestipol (used to lower cholesterol, prevent diarrhoea, or relieve itching),
• muscle relaxants, such as tubocurarine,
• amantadine (a medicine used against influenza A virus or in the treatment of Parkinson's disease),
• sotalol (a beta-blocker),
• lovastatin (used to lower cholesterol levels),
• dextran sulfate (used in a treatment called LDL apheresis to lower blood cholesterol levels),
• medicines used during chemotherapy for malignant tumours (e.g. cyclophosphamide, methotrexate),
• other medicines that affect heart function and may cause ventricular tachycardia of the torsade de pointes type.

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

• medicines that dissolve blood clots (tissue plasminogen activator), usually administered in hospital;
• medicines most commonly used to prevent organ transplant rejection (sirolimus, everolimus) and to treat cancer (temsirolimus), and other medicines belonging to the group of so-called mTOR inhibitors – see section "Warnings and precautions";
• vildagliptin, used to treat diabetes;
• racecadotril, used to treat diarrhoea.

The blood pressure-lowering effect may be enhanced by alcohol, barbiturates, or anaesthetics. The patient may experience dizziness when changing to an upright position.

Lisiprol HCT with food, drink, and alcohol

Ask the doctor whether it is safe to consume alcoholic beverages while being treated with Lisiprol HCT. Alcohol may worsen the side effects of Lisiprol HCT.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

Inform the doctor of any pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually advise discontinuing Lisiprol HCT before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Lisiprol HCT is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding

Inform the doctor if the patient is breastfeeding or intends to breastfeed. Lisiprol HCT is not recommended during breastfeeding, especially when breastfeeding a newborn or premature infant. The doctor may recommend an alternative medicine.

Driving and using machines

This medicine may occasionally cause fatigue or dizziness, which may affect the ability to drive or operate machinery, particularly at the beginning of treatment, during dose changes, or when combined with alcohol. If such symptoms occur, the patient should not drive or operate tools or machinery. The patient should wait until they know how the medicine affects them before engaging in such activities.

3. How to take Lisiprol HCT

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the 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 according to the individual patient's needs.

Taking the medicine

Swallow the tablet with water.

Try to take the medicine at the same time every day. It does not matter whether Lisiprol HCT is taken before or after meals.

Continue taking Lisiprol HCT for as long as the doctor recommends. Treatment is long-term. It is important to take Lisiprol HCT daily.

Taking the first dose

Exercise particular caution when taking the first dose or increasing the dose of Lisiprol HCT. Blood pressure may drop more than with subsequent doses.

Dizziness or lightheadedness may occur. If such symptoms occur, lying down may help. If in doubt, contact the doctor immediately.

Adults

The recommended dose is one tablet once daily. 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.

Taking more Lisiprol HCT than prescribed

If more Lisiprol HCT has been taken than prescribed, contact a doctor or go to a hospital immediately. Bring the medicine packaging so the tablets can be identified.

Missing a dose of Lisiprol HCT

If a dose is missed, take it as soon as remembered, unless it is almost time for the next dose. In that case, skip the missed dose.

Do not take a double dose to make up for a missed dose.

Stopping Lisiprol HCT

Do not stop taking the tablets, even if the patient feels well, unless the doctor advises otherwise.

If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Lisiprol HCT contains two active substances: lisinopril and hydrochlorothiazide. The following adverse
reactions have been observed with each of these medicines when used separately. This means they may also
occur during treatment with Lisiprol HCT.
Your doctor may from time to time take blood samples to check whether Lisiprol HCT is affecting
your blood parameters.

Possible adverse reactions associated with lisinopril

Severe allergic reactions (rare, may occur in up to 1 in 1,000 patients)
If a patient experiences a severe allergic reaction, treatment with Lisiprol HCT must be discontinued
and medical advice must be sought immediately. Symptoms may include sudden onset of:

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

Severe liver function disorders (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 in a patient, seek immediate medical advice.

Other possible adverse reactions:

Common (may occur in up to 1 in 10 patients):

• Headache,
• Dizziness or lightheadedness, especially when standing up quickly,
• Fainting,
• Diarrhoea,
• Vomiting,
• Cough,
• Kidney disorders (detected in blood tests).

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

• Mood changes, including depression,
• Tingling sensation,
• Sensation of spinning (dizziness),
• Changes in taste perception,
• Difficulty in falling asleep,
• Heart attack or stroke, associated with a large drop in blood pressure,
• Irregular heartbeat,
• Change in the colour of fingers and toes,
• Nasal mucosal inflammation,
• Nausea,
• Abdominal pain and indigestion,
• Changes in blood test results indicating liver function disorders,
• Rash,
• Itching,
• Inability to achieve erection (impotence),
• Feeling of weakness,
• Feeling of fatigue,
• Increased blood levels of certain substances (urea, creatinine and potassium).

Rare (may occur in up to 1 in 1,000 patients):

• Disorders affecting certain blood cells or other blood components. Symptoms may include fatigue and pale skin,
• Disorientation,
• Changes in the perception of smell,
• Dryness of the oral mucosa,
• Rash with dark red, raised, itchy eruptions (urticaria),
• Hair loss (alopecia),
• Psoriasis (skin disorders),
• High blood urea levels due to kidney failure,
• Blood infection,
• Kidney failure,
• Breast enlargement in men,
• Syndrome of inappropriate antidiuretic hormone secretion (SIADH),
• Low blood sodium levels, which may 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 reduced numbers of blood cells and (or) platelets. The patient may notice fatigue, infections (which may be severe), fever, shortness of breath or a tendency to bruise or bleed more easily,
• Swelling of lymph nodes,
• Worsening of immune reactions (autoimmune diseases),
• Low blood sugar levels (hypoglycaemia). Symptoms may include hunger or weakness, sweating and rapid heartbeat,
• Sudden wheezing or shortness of breath (bronchospasm),
• Lung inflammation (which may cause shortness of breath),
• Sinusitis (feeling of pain and fullness in the cheek and eye areas),
• Eosinophilic pneumonia – symptoms include:
• sinusitis,
• flu-like symptoms,
• increasing shortness of breath,
• stomach and intestinal pain,
• skin rash,
• tingling or numbness in hands and feet.
• Pancreatitis, which may cause moderate to severe upper abdominal pain,
• Intestinal mucosal oedema. This may cause sudden abdominal pain, diarrhoea or vomiting,
• Sweating,
• Severe skin disorders or rashes. Symptoms include redness, blistering and peeling of the skin, which may develop rapidly and involve blistering in the mouth and nose,
• Reduced urine output or absence of urine.

Frequency unknown (cannot be estimated from available data):

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

Possible adverse reactions associated with 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 unknown (cannot be estimated from available data):

• Inflammation of the salivary glands,

• Decreased number of white blood cells and (or) platelets. The patient may experience fatigue, infections (which may be severe), fever, shortness of breath or a tendency to bruise or bleed more easily,

• Loss of appetite,

• Increased blood glucose levels (hyperglycaemia),

• Presence of glucose in the urine,

• Increased blood levels of uric acid,

• Changes in blood electrolyte levels (e.g. low sodium and potassium levels). The patient may experience muscle weakness, thirst, tingling sensations, cramps and nausea,

• Increased or high levels of blood lipids (including cholesterol),

• Restlessness,

• Depression,

• Difficulty in falling asleep,

• Tingling sensation,

• Dizziness,

• Blurred vision or yellow vision, visual impairment or eye pain due to elevated pressure [possible symptoms of fluid accumulation in the uvea
  surrounding the eye (excessive fluid accumulation between the choroid and sclera) or
  acute angle-closure glaucoma]. If symptoms such as eye pain or reduced visual acuity occur suddenly, medical advice must be sought immediately, as treatment may be required to prevent permanent vision loss.

• Sensation of spinning (vestibular dizziness),

• Feeling of fainting (especially when standing up),

• Damage to blood vessels, causing red or purple spots on the skin,

• Difficulty in breathing. If there is inflammation or fluid in the lungs, shortness of breath may occur,

• Gastric irritation,

• Diarrhoea,

• Constipation,

• Pancreatitis, which may cause moderate to severe upper abdominal pain,

• Yellowing of the skin and eyes (jaundice),

• Skin disorders, including rash caused by sensitivity to sunlight, rash, severe rash appearing rapidly with blisters or peeling of the skin and possibly blisters in the mouth, onset or worsening of lupus-like reactions or occurrence of unusual skin reactions,

• Allergic reactions,

• Muscle cramps and weakness,

• Kidney function disorders, which may be severe (detected in blood tests),

• Fever,

• Weakness,

• Malignant skin and lip tumours (non-melanoma skin cancers).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this 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 stated month.
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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Lisiprol HCT contains
The active substances are: 20 mg of lisinopril (as lisinopril dihydrate) and 25 mg of
hydrochlorothiazide.
Other ingredients: mannitol, indigo carmine, lac, corn starch, pregelatinized corn starch,
magnesium stearate, anhydrous calcium hydrogen phosphate.

What Lisiprol HCT looks like and contents of the pack
Light blue tablets, 11 mm in diameter, flat on both sides, with bevelled edges.
The pack contains 28 tablets.

Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Tel.: (22) 755 50 81

For further information, please 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
[email protected]
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