Uldiulan

Leaflet included in the packaging: patient information

Uldiulan, 12.5 mg, tablets
Uldiulan, 25 mg, tablets
Uldiulan, 50 mg, tablets
Chlortalidonum
It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• It is necessary to keep this leaflet, so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific reason. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Uldiulan and what is it used for
• 2. Important information before using Uldiulan
• 3. How to take Uldiulan
• 4. Possible side effects
• 5. How to store Uldiulan
• 6. Package contents and other information

1. What is Uldiulan and what is it used for

Uldiulan is a long-acting diuretic that lowers blood pressure.
Uldiulan is used to treat:

• edema (fluid accumulation) of cardiac, hepatic, and renal origin
• high blood pressure (hypertension)
• heart failure

2. Important information before using Uldiulan

When not to use Uldiulan:

• if the patient is allergic to chlortalidone or other thiazides and sulfonamides (possible cross-reactions; caution is recommended in patients with asthma) or any of the other ingredients of this medicine listed in section 6;
• if the patient is unable to urinate (urine production below 100 mg/24 hours)
• if the patient has severe renal impairment (severely limited urine production; creatinine clearance <30 ml min and or serum creatinine concentration> 1.8 mg/100 mL);
• if the patient has acute renal inflammation (acute interstitial nephritis)
• if the patient has severe liver impairment or liver failure with impaired consciousness (pre-coma and coma hepaticum);
• if the blood calcium level is higher than normal (hypercalcemia);
• if the patient has low sodium levels in the blood (hyponatremia);
• if the patient has untreated low potassium levels in the blood (hypokalemia) or increased potassium loss (e.g., vomiting, diarrhea);
• if the blood uric acid level is increased or if the patient has gout or cholelithiasis
• if the patient is pregnant (see Pregnancy and breastfeeding).

Precautions and precautions

Before starting treatment with Uldiulan, the patient should discuss it with their doctor, pharmacist, or
nurse:
Renal impairment:
In the case of kidney disease, caution should be exercised when using Uldiulan.
If the patient has mild or moderate renal impairment (creatinine clearance 30-60 mL/min and/or serum creatinine concentration 1.1-1.8 mg/100 mL), the dosage should be adjusted according to therapeutic needs and tolerance (see section 3. How to take Uldiulan).
If the patient has severe renal impairment (creatinine clearance below 30 mL/min and/or serum creatinine concentration > 1.8 mg/100 mL), thiazide diuretics and thiazide-like diuretics, including chlortalidone, lose their diuretic effect (see section 2).
In patients with kidney disease, Uldiulan may cause an increase in total nitrogen content in the blood (azotemia). In the case of impaired renal function, the cumulative effects of the medicine may occur.
Long-term use of diuretics may result in a pseudo-Bartter syndrome with edema. Edema is the result of increased renin levels and consequently increased aldosterone production (secondary hyperaldosteronism).
Hepatic impairment
If the patient has impaired liver function or progressive liver disease, caution should be exercised when using Uldiulan. Because minor changes in water and electrolyte balance caused by thiazide diuretics, including Uldiulan, in patients with liver cirrhosis may lead to hepatic coma (see section 2. When not to use Uldiulan).
Metabolic and hormonal effects:
Patients with diabetes or gout should be closely monitored by their doctor.
Thiazide therapy may affect glucose tolerance. If the patient has overt diabetes, the metabolic situation may worsen, and it may be necessary to adjust the insulin dose or oral hypoglycemic agents. During thiazide therapy, latent diabetes may be revealed.
Chlortalidone may increase serum uric acid levels, but gout attacks are rare during long-term treatment.
In patients treated with diuretics (thiazides and thiazide-like diuretics), including chlortalidone, minimal and partially reversible increases in total cholesterol levels in serum, low-density lipoproteins (LDL), or triglycerides have been reported.
Electrolyte imbalance disorders:
During thiazide therapy, serum electrolytes (especially potassium, sodium, and calcium) should be regularly monitored.
Control of serum electrolyte levels is particularly recommended in the elderly and/or in patients with fluid accumulation in the abdominal cavity (ascites) due to liver cirrhosis and/or in patients with fluid accumulation in tissues (edema) due to kidney disease. In such conditions, chlortalidone should be administered with caution and only in patients with normal potassium levels without signs of potassium loss.
Treatment with thiazide diuretics, including chlortalidone, is associated with electrolyte and water balance disorders (potassium and sodium deficiency in the blood, acid-base balance disorders in the blood, caused by hypochloremia). Indications of electrolyte balance disorders include dry mouth, thirst, weakness, lethargy, drowsiness, anxiety, pain, or muscle cramps, muscle weakness, low blood pressure (hypotension), decreased urine production (oliguria), rapid heartbeat (tachycardia), and gastrointestinal disorders, such as nausea and vomiting.
Potassium deficiency in the blood (hypokalemia) can cause increased sensitivity of the heart and enhance its toxic effects on digitalis glycosides (heart failure medications).
The risk of hypokalemia is highest in patients with liver cirrhosis, in patients with increased diuresis, in patients without adequate oral electrolyte intake, and in patients treated with corticosteroids ("cortisone"), ACTH, digitalis glycosides (heart failure medications), or laxatives (see section 2. Uldiulan and other medicines). These patients should be closely monitored.
Similarly, as with all thiazide diuretics, potassium excretion in the urine induced by chlortalidone is dose-dependent, and its degree varies among individual patients. At a dose of 25 mg/day, the decrease in serum potassium levels averages 0.5 mmol/l. During constant treatment, serum potassium levels should be monitored at the beginning of treatment and 3-4 weeks later. After this period and if the potassium balance is not disturbed by additional factors (e.g., vomiting, diarrhea, changes in kidney function, etc.), serum potassium levels can be regularly monitored every 4-6 months.
If necessary, Uldiulan can be combined with oral potassium supplements or a potassium-sparing diuretic (e.g., triamterene). In the case of combination therapy, serum potassium levels should be monitored. If hypokalemia is accompanied by clinical symptoms (e.g., muscle weakness, paresis, and changes in the ECG), Uldiulan should be discontinued.
It is recommended to avoid combination therapy with Uldiulan and a product containing potassium or a potassium-sparing diuretic in patients treated with ACE inhibitors (medicines used to treat, for example, hypertension), unless absolutely necessary.
In the case of fluid accumulation in tissues (edema), during heat, dehydration (hypotonic hyponatremia) may occur. Chloride deficiency is usually mild and does not require treatment.
Chlortalidone may decrease calcium excretion in the urine and cause a transient and slight increase in serum calcium levels without known disturbances in calcium metabolism. A significant increase in serum calcium levels (hypercalcemia) may be a sign of hidden hyperparathyroidism. Thiazides should be discontinued before parathyroid function tests.
It has been shown that thiazides increase magnesium excretion in the urine. This can lead to magnesium deficiency (hypomagnesemia).
Impaired heart function
In patients with severe heart failure with significant fluid accumulation in tissues (edema), it may happen that chlortalidone is no longer absorbed.
Other effects
Allergic reactions may occur in patients with a history of allergies or asthma, with or without asthma.
If the patient experiences vision deterioration 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 intraocular pressure, which may occur within a few hours to a week after taking Uldiulan. This can lead to permanent vision loss if left untreated. If the patient has previously been allergic to penicillin or sulfonamides, they may be more susceptible to its development.
Special recommendations
During treatment with Uldiulan, serum electrolyte levels (especially potassium, sodium, and calcium), creatinine, and urea, serum lipids (cholesterol and triglycerides), uric acid, and blood sugar levels should be regularly monitored.
During treatment with Uldiulan, patients should ensure adequate fluid intake and, due to increased potassium loss, consume potassium-rich foods (e.g., bananas, vegetables, nuts).
Treatment of high blood pressure with Uldiulan requires regular monitoring.
Treatment with Uldiulan should be discontinued after consulting a doctor:

• if the patient experiences uncontrollable electrolyte disturbances (especially potassium and sodium deficiency in the blood);
• if the patient experiences allergic reactions;
• if the patient experiences severe gastrointestinal problems;
• if the patient experiences central nervous system disorders;
• if the patient experiences pancreatitis;
• if the patient experiences changes in blood morphology: decreased red or white blood cell count or platelet count (anemia, leukopenia, thrombocytopenia);
• if the patient experiences acute cholecystitis (cholecystitis);
• if the patient experiences vasculitis (vasculitis);
• if the patient experiences worsening of existing myopia;
• if the patient experiences severe kidney problems (serum creatinine concentration > 1.8 mg/100 mL or creatinine clearance less than 30 mL/min).

Children and adolescents

Since there are no adequate data on the treatment of children, chlortalidone should not be administered to children.

Elderly patients

In patients aged 65 or older, the efficacy of Uldiulan may be increased. The doctor must adjust the dose accordingly (see section 3. How to take Uldiulan).

Doping

The use of Uldiulan may result in positive doping test results. The health consequences of using Uldiulan as a doping agent cannot be predicted, and it cannot be excluded that it poses a serious risk to health.

Uldiulan and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The administration of chlortalidone may affect the action of the following medicinal products or substances:

Contraindicated combinations:

Lithium (a medicine used to treat mental disorders):
Concomitant administration of chlortalidone with lithium may lead to increased cardiotoxic and neurotoxic effects of lithium through decreased lithium excretion. If diuretic administration is unavoidable, it is necessary to closely monitor lithium levels in the blood and adjust the dose.

Combinations that require caution:

Substances that can cause irregular heartbeat leading to death (torsades de pointes, ventricular arrhythmia with impaired impulse conduction in the heart):

• certain medicines used to treat irregular heartbeat (class Ia anti-arrhythmic agents, e.g., quinidine, hydroquinidine, disopyramide) and class III anti-arrhythmic agents (e.g., amiodarone, sotalol)
• specific medicines used to treat mental disorders (antipsychotic agents): phenothiazines (e.g., chlorpromazine, cyanemazine, levomepromazine, thioridazine, trifluperazine), benzamides (e.g., amisulpride, sulpiride, sultopride, tiapride), butyrophenones (e.g., droperidol, haloperidol)
• others: bepridil, cisapride, difemanil, erythromycin administered intravenously, halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine administered intravenously

If these medicines are administered concomitantly with Uldiulan, there is an increased risk of ventricular arrhythmias (ventricular arrhythmia, especially torsades de pointes), particularly due to potassium deficiency in the blood (hypokalemia). Serum potassium levels must be determined and, if necessary, corrected before starting combination therapy. It is recommended to regularly monitor serum electrolyte levels and ECG. It is best to use substances that do not cause torsades de pointesin the case of hypokalemia.
ACE inhibitors (medicines used to treat high blood pressure, such as captopril, enalapril)
Treatment with chlortalidone and additional administration of ACE inhibitors (e.g., captopril, enalapril) at the beginning of treatment is associated with a risk of significant blood pressure drop and worsening of kidney function.
In this connection, diuretic treatment should be discontinued for 2-3 days before starting ACE inhibitor treatment to reduce the possibility of a significant blood pressure drop at the beginning of treatment.
Medicines used to treat pain and rheumatic diseases (non-steroidal anti-inflammatory agents, e.g., indomethacin, acetylsalicylic acid), including COX-2 inhibitors, salicylates
Non-steroidal anti-inflammatory agents (e.g., indomethacin, acetylsalicylic acid), including COX-2 inhibitors, salicylates, may reduce the antihypertensive and diuretic effects of chlortalidone.
In the case of high-dose salicylate administration, the toxic effect of salicylates on the central nervous system may be enhanced.
In patients who experience a decrease in circulating blood volume (hypovolemia) during treatment with Uldiulan, concomitant use of non-steroidal anti-inflammatory agents may lead to acute kidney failure.
Diuretics and potassium-excreting agents (e.g., furosemide), glucocorticoids (cortisone-containing medicines), ACTH, carbenoxolone (medicines used to treat gastrointestinal ulcers), penicillin G, salicylates, stimulant laxatives
Concomitant use of Uldiulan and the above-mentioned medicines may lead to electrolyte balance disorders, particularly increased potassium loss. This is especially important during treatment with digitalis glycosides (heart failure medications). Serum potassium levels must be closely monitored and, if necessary, corrected.
Other diuretics, other antihypertensive agents (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, vasodilators, methyldopa, guanethidine), nitrates, barbiturates, antipsychotic agents, antidepressant agents (tricyclic antidepressants), alcohol
The antihypertensive effect of Uldiulan may be enhanced by the above-mentioned medicines or by alcohol consumption.
Digitalis glycosides (heart failure medications):
In the case of concomitant treatment with digitalis glycosides, it should be noted that chlortalidone may cause potassium deficiency (hypokalemia) and/or magnesium deficiency (hypomagnesemia) in the blood. This increases the sensitivity of heart muscle to digitalis glycosides and, accordingly, increases the effect and side effects of digitalis glycosides.
The following combinations may cause interactions
Insulin, oral hypoglycemic agents (oral antidiabetic agents), uricosuric agents used to treat gout, sympathomimetic agents (e.g., contained in nose drops and eye drops), noradrenaline (norepinephrine), adrenaline (epinephrine)
The effect of these medicines may be weakened by concomitant use of chlortalidone. It may be necessary to adjust the dose of insulin or oral hypoglycemic agents.
Non-depolarizing muscle relaxants (curare-like agents), e.g., tubocurarine chloride
The effect of curare-like muscle relaxants may be enhanced or prolonged by chlortalidone. If it is not possible to discontinue Uldiulan before using muscle relaxants, the anesthesiologist should be informed about the use of Uldiulan.
Allopurinol (a medicine used to treat gout)
Chlortalidone may increase the frequency of allergic reactions to allopurinol.
Amantadine
Chlortalidone may increase the risk of side effects caused by amantadine.
Beta-blockers, diazoxide (medicines used to treat high blood pressure)
Concomitant administration of chlortalidone and beta-blockers or diazoxide may increase the risk of hyperglycemia (high blood sugar levels).
Cytostatic agents (medicines that inhibit tumor growth, e.g., cyclophosphamide, fluorouracil, methotrexate)
Chlortalidone may decrease the excretion of cytotoxic agents (e.g., cyclophosphamide, fluorouracil, methotrexate) by the kidneys. Concomitant administration of cytotoxic agents may enhance their toxic effect on the bone marrow (especially granulocytopenia).
Calcium salts, vitamin D
Concomitant administration of chlortalidone with vitamin D or calcium salts may enhance the increase in serum calcium levels due to decreased urinary excretion.
Anticholinergic agents (e.g., atropine, biphenhydramine)
The bioavailability of thiazide diuretics may be increased by anticholinergic agents (e.g., atropine, biphenhydramine), mainly due to decreased gastrointestinal motility and gastric emptying rate.
Cholestyramine, colestipol (medicines that reduce blood lipid levels)
Concomitant administration of cholestyramine or colestipol may decrease the absorption of chlortalidone from the gastrointestinal tract. Therefore, Uldiulan should be taken at least 1 hour before or 4-6 hours after administration of these medicines.

Uldiulan with food, drink, and alcohol

It is recommended to avoid drinking alcohol during treatment with Uldiulan, as Uldiulan may enhance the effects of alcohol, e.g., impairing reaction ability.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Uldiulan should not be used if the patient is pregnant or trying to conceive (see section 2. When not to use Uldiulan). Chlortalidone, the active substance of Uldiulan, may reduce blood flow to the placenta. Thiazides and thiazide-like diuretics also penetrate fetal circulation and may cause electrolyte balance disorders. Thrombocytopenia has been reported in newborns. If the patient becomes pregnant during treatment with Uldiulan, they should immediately inform their doctor.
Breastfeeding
Uldiulan should not be used during breastfeeding, as the active substance of Uldiulan passes into breast milk and may harm the baby.

Driving and using machines

Uldiulan may affect the patient's ability to react to a certain extent, so that the ability to drive a car, use machinery, or operate equipment may be impaired. This applies especially at the beginning of treatment, when increasing the dose, when using in combination with other blood pressure-lowering medicines, when changing medicines, and when using in combination with alcohol.

Uldiulan contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking Uldiulan.

Uldiulan contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Uldiulan

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
It is necessary to carefully follow the recommendations to avoid reducing the effectiveness of Uldiulan.
The dosage should be based on the disease progression and individual patient response during treatment.
The lowest effective dose should be selected to maintain optimal effectiveness.
The doctor will carefully adjust the dose of Uldiulan if the patient has impaired circulation in the coronary arteries (coronary artery disease or myocardial infarction), as in the case of post-myocardial infarction or stroke.
The recommended dose is:

Edema (fluid accumulation) of cardiac, hepatic, and renal origin and heart failure

The recommended initial dose is 25 to 50 mg/day, and in severe cases, it may be increased to 100 to 200 mg/day. The dose for nephrotic edema should not exceed 50 mg/day.
Usually, the maintenance dose is the lowest effective dose, e.g., 25 to 50 mg/day.
Hypertension (high blood pressure)
Initial dose:
12.5 - 50 mg of chlortalidone per day.
Maintenance dose:
12.5 - 25 mg of chlortalidone per day.
The initial dose should be individually reduced.

Use in children and adolescents

Since there are no adequate data on the treatment of children, chlortalidone should not be administered to children.
Elderly patients (> 65 years) and patients with impaired renal function
If the patient is elderly and/or has mild or moderate renal impairment (creatinine clearance 30-60 mL/min and/or serum creatinine concentration 1.1-1.8 mg/100 mL), the dose should be adjusted according to therapeutic needs and tolerance (see section 2. Precautions and precautions).
Thiazide diuretics and thiazide-like diuretics, including chlortalidone, lose their diuretic effect in the case of severe renal impairment, which means creatinine clearance <30 ml min and or serum creatinine concentration> 1.8 mg/100 mL (see section 2. When not to use Uldiulan).
Patients with impaired liver function
If the patient has impaired liver function, Uldiulan should be dosed by the doctor according to the applicable restrictions. In the case of severe liver impairment, Uldiulan should not be used (see section 2. When not to use Uldiulan).
Patients with impaired heart function
In the case of severe heart failure with significant fluid accumulation in tissues (edema), it may happen that Uldiulan is no longer absorbed.
Method of administration
Uldiulan tablets should be swallowed whole, without chewing, with a sufficient amount of liquid (e.g., a glass of water).
In the case of a single dose, the tablet should be taken in the morning with breakfast. In the case of twice-daily administration, the tablets should be taken additionally during the evening meal.
It is not recommended to consider increasing the dose after 2-3 weeks.
Duration of treatment
The duration of treatment will be decided by the doctor.
After long-term use of Uldiulan, treatment should not be discontinued abruptly. It is recommended to use gradually decreasing doses of Uldiulan for several days (gradual dose reduction).
If the patient feels that the effect of Uldiulan is too weak or too strong, they should consult their doctor.

Taking a higher dose of Uldiulan than recommended

In case of accidental ingestion of a higher dose of Uldiulan than recommended, the patient should immediately inform their doctor or contact the nearest emergency department.
The doctor will decide what measures to take based on the symptoms.
In case of overdose and/or severe symptoms, the patient should immediately seek medical help to be hospitalized and receive intensive medical care.
The symptoms of acute or chronic overdose depend on the degree of fluid and electrolyte loss.
Overdose symptoms may include:

• dizziness and fainting, nausea, drowsiness, headache, rapid heartbeat (tachycardia),
• low blood pressure (hypotension) and circulation disorders with low blood pressure when changing position from sitting to lying down (orthostatic regulation disorders)
• electrolyte balance disorders (potassium and/or sodium deficiency in the blood) with irregular heartbeat and muscle cramps (e.g., leg cramps).

Severe dehydration and decreased circulating blood volume (hypovolemia) may cause blood thickening (hemoconcentration), cramps, thirst, lethargy, confusion, and circulatory collapse and acute kidney failure.
Potassium deficiency in the blood (hypokalemia) may result in unusual fatigue, muscle weakness, tingling (e.g., tingling and feeling of cold) in the hands and feet (paresthesia), paralysis, apathy, excessive gas in the digestive tract (flatulence), and constipation (obstipation) or hypokalemic coma.

Missing a dose of Uldiulan

In case of missing a dose, the patient should not take a double dose to make up for the missed tablet, but continue taking the usual dose according to the typical dosing schedule, as directed by the doctor.

Discontinuing Uldiulan

The patient should not discontinue or stop treatment with Uldiulan without prior consultation with their doctor.
Before discontinuing treatment, the doctor may recommend continuing to take Uldiulan in a small dose for several days (gradual dose reduction).
If the patient has further questions about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Uldiulan can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they should immediately inform their doctor or pharmacist:
Very common (may affect more than 1 in 10 people):

• low potassium levels in the blood (hypokalemia), mainly at higher doses, which may cause muscle weakness, muscle tremors, or irregular heartbeat
• increased uric acid levels in the blood (hyperuricemia), which may lead to joint pain (gout attacks in predisposed patients)
• increased lipid levels in the blood (cholesterol and triglycerides)

Common (may affect up to 1 in 10 people):

• low sodium and magnesium levels in the blood (hyponatremia/hypomagnesemia)
• high blood sugar levels (hyperglycemia), which may cause fatigue,
• high sugar levels in the urine (glycosuria)
• in patients with overt diabetes, the metabolic situation may worsen, and it may be necessary to adjust the insulin dose or oral hypoglycemic agents
• increased levels of nitrogenous substances (urea, creatinine), especially at the beginning of treatment
• headache, dizziness, weakness
• low blood pressure (hypotension)
• circulation disorders with low blood pressure when changing position from sitting to lying down (orthostatic regulation disorders)
• rapid heartbeat (tachycardia)
• loss of appetite, dry mouth, gastrointestinal disorders, nausea, vomiting, digestive tract disorders, stomach pain, constipation, diarrhea
• skin allergic reactions, such as redness (rash), hives, itching
• decreased muscle tone, muscle cramps, impotence

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

• low platelet count (thrombocytopenia) with unusual bleeding or bruising
• low white blood cell count (leukopenia)
• severe decrease in specific white blood cells associated with increased susceptibility to infections and severe general symptoms (agranulocytosis)
• increased levels of specific white blood cells (eosinophilia)
• increased calcium levels in the blood (hypercalcemia), which may cause excitement
• sensory disturbances (such as tingling and numbness) in the hands, feet, and mouth (paresthesia)
• vision disturbances, decreased tear production
• irregular heartbeat
• liver dysfunction (cholestasis) or yellowing of the skin and eyes (jaundice)
• increased sensitivity of the skin to sunlight (photosensitivity reaction), e.g., redness (rash)
• inflammation of blood vessels with pain or without pain (vasculitis)

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

• electrolyte balance disorders (hypochloremic alkalosis)
• allergic fluid accumulation in the lungs (idiosyncratic pulmonary edema)
• respiratory problems (pneumonia and pulmonary edema symptoms)
• abdominal pain with nausea, vomiting, or fever (pancreatitis symptoms);
• allergic kidney inflammation (allergic interstitial nephritis)

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

• worsening vision or eye pain caused by high 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).

Many side effects will disappear without modifying the treatment. The patient should consult their doctor if any of the symptoms persist or worsen.

Reporting side effects

If the patient experiences any side effects, including any side effects not mentioned in the leaflet, they should inform 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, it is possible to gather more information on the safety of the medicine.

5. How to store Uldiulan

Store at a temperature below 30°C
The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
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. Package contents and other information

What Uldiulan contains

• The active substance is chlortalidone: Each tablet contains 12.5 mg of chlortalidone.
• Excipients: microcrystalline cellulose, lactose monohydrate, Povidone (K-30), sodium carboxymethylcellulose (type A), magnesium stearate.
• The active substance is chlortalidone: Each tablet contains 25 mg of chlortalidone.
• Excipients: microcrystalline cellulose, lactose monohydrate, Povidone (K-30), sodium carboxymethylcellulose (type A), yellow iron oxide (E172), red iron oxide (E172), magnesium stearate.
• The active substance is chlortalidone: Each tablet contains 50 mg of chlortalidone.
• Excipients: microcrystalline cellulose, lactose monohydrate, Povidone (K-30), sodium carboxymethylcellulose (type A), yellow iron oxide (E172), magnesium stearate.

What Uldiulan looks like and contents of the pack

Uldiulan 12.5 mg: White, round, and convex tablets (5.0 mm ± 0.2 mm) without a dividing line.
Uldiulan 25 mg: Light red to reddish tablets, round, and convex (7.0 mm ± 0.2 mm) without a dividing line.
Uldiulan 50 mg: Yellow tablets, round, and convex (9.0 mm ± 0.2 mm) without a dividing line.
Uldiulan is available in blisters of 10, 20, 30, 50, 60, and 100 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schlossplatz 1,
8502 Lannach,
Austria
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira
2710-089 Sintra
Portugal