Uldiulan

Leaflet included in the packaging: patient information

Uldiulan, 12.5 mg, tablets
Uldiulan, 25 mg, tablets
Uldiulan, 50 mg, tablets
Chlortalidonum
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• 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 experience any side effects, including those not listed in this leaflet, tell your 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 taking Uldiulan
• 3. How to take Uldiulan
• 4. Possible side effects
• 5. How to store Uldiulan
• 6. Contents of the pack 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 taking Uldiulan

When not to take Uldiulan:

• if you are allergic to chlortalidone or other thiazides and sulfonamides (possible cross-reactions; caution is advised in patients with asthma)
• if you are unable to urinate (urine production below 100 mg/24 hours)
• if you have severe renal impairment (severely limited urine production; creatinine clearance <30 ml min and or serum creatinine concentration>1.8 mg/100 mL)
• if you have acute kidney inflammation (acute interstitial nephritis)
• if you have severe liver impairment or liver failure with impaired consciousness (pre-coma and coma)
• if you have high calcium levels in the blood (hypercalcemia)
• if you have low sodium levels in the blood (hyponatremia)
• if you have untreated low potassium levels in the blood (hypokalemia) or excessive potassium loss (e.g., vomiting, diarrhea)
• if you have increased uric acid levels in the blood or have had gout or kidney stones
• if you are pregnant (see Pregnancy and breastfeeding)

Precautions and warnings

Before starting Uldiulan, discuss with your doctor, pharmacist, or nurse:

Renal impairment:
In case of kidney disease, caution should be exercised when taking Uldiulan.
If you have 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 you have 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. When not to take Uldiulan).
In patients with kidney disease, Uldiulan may cause an increase in total nitrogen content in the blood (azotemia). In case of impaired renal function, the cumulative effects of the drug 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).
Liver impairment
If you have impaired liver function or progressive liver disease, caution should be exercised when taking Uldiulan. Since minor changes in water-electrolyte balance caused by thiazide diuretics, including Uldiulan, may lead to hepatic coma in patients with cirrhosis of the liver (see section 2. When not to take Uldiulan).
Metabolic and hormonal effects:
Patients with diabetes or gout should be closely monitored by their doctor.
Thiazide therapy may affect glucose tolerance. If you have 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.
Patients on long-term diuretic therapy (thiazides and thiazide-like diuretics), including chlortalidone, have reported minimal and partially reversible increases in total cholesterol levels in serum, low-density lipoprotein (LDL), or triglycerides.
Electrolyte imbalance disorders:
During thiazide therapy, regular monitoring of serum electrolytes (especially potassium, sodium, and calcium) is recommended.
Control of serum electrolyte levels is particularly indicated 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 cases, 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 imbalance 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 heart sensitivity and potentiate 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 steady-state 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 renal 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 (medications used to treat, for example, hypertension), unless absolutely necessary.
In the case of fluid accumulation in tissues (edema), during heat, hypovolemic hyponatremia (dilutional hyponatremia) may occur. Hypochloremia 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 (severe edema), it may happen that chlortalidone is no longer absorbed.
Other effects
Allergic reactions may occur in patients with a history of allergy or asthma.

• if you experience worsening vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure, which can occur within a few hours to a week after taking Uldiulan. This can lead to permanent vision loss if left untreated.

Special recommendations
During treatment with Uldiulan, regular monitoring of serum electrolyte levels (especially potassium, sodium, and calcium), creatinine, and urea, serum lipids (cholesterol and triglycerides), uric acid, and blood sugar levels is recommended.
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 you experience untreated electrolyte disturbances (especially potassium and sodium deficiency in the blood)
• if you experience allergic reactions
• if you experience severe gastrointestinal problems
• if you experience central nervous system disorders
• if you experience pancreatitis
• if you experience changes in blood morphology: decreased red or white blood cell count or platelet count (anemia, leukopenia, thrombocytopenia)
• if you experience acute gallbladder inflammation (cholecystitis)
• if you experience blood vessel inflammation (vasculitis)
• if you experience worsening of existing myopia
• if you experience 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 over 65 years of age, the efficacy of Uldiulan may be increased. The doctor must adjust the dose accordingly (see section 3. How to take Uldiulan).

Doping

Taking Uldiulan may result in positive doping test results. The health consequences of taking Uldiulan as a doping agent cannot be predicted, and it cannot be ruled out that it poses a serious health risk.

Uldiulan and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
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 due to decreased lithium excretion. If diuretic administration is unavoidable, careful monitoring of lithium blood levels and adjustment of the dose is necessary.

Combinations that require caution:

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

• certain medications used to treat irregular heartbeat (anti-arrhythmic drugs of class Ia, e.g., quinidine, hydroquinidine, and class III, e.g., amiodarone, sotalol)
• specific medications used to treat mental disorders (antipsychotic drugs): 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 medications are administered concomitantly with Uldiulan, there is an increased risk of ventricular arrhythmias (ventricular arrhythmias, 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. Regular monitoring of serum electrolyte levels and ECG is recommended. It is best to use substances that do not cause torsades de pointes in the event of hypokalemia.
ACE inhibitors (medications 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 start of treatment is associated with a risk of significant blood pressure drop and worsening of renal 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 start of treatment.
Medications used to treat pain and rheumatic diseases (non-steroidal anti-inflammatory drugs, e.g., indomethacin, acetylsalicylic acid), including COX-2 inhibitors, salicylates
Non-steroidal anti-inflammatory drugs (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, there may be an increase in the toxic effects of salicylates on the central nervous system.
In patients who experience a decrease in circulating blood volume during Uldiulan treatment, concomitant use of non-steroidal anti-inflammatory drugs may lead to acute renal failure.
Diuretics and potassium-excreting drugs (e.g., furosemide), corticosteroids (cortisone-containing medications), ACTH, carbenoxolone (medications used to treat gastrointestinal ulcers), penicillin G, salicylates, laxatives
Concomitant administration of Uldiulan and the above-mentioned medications may lead to electrolyte imbalance, particularly increased potassium loss. This is especially important during treatment with digitalis glycosides (heart failure medications). Serum potassium levels must be very carefully monitored and, if necessary, corrected.
Other diuretics (diuretics), other antihypertensive drugs (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, vasodilators, methyldopa, guanethidine), nitrates, barbiturates, medications used to treat mental disorders (phenothiazines), medications used to treat depression (tricyclic antidepressants), alcohol
The antihypertensive effect of Uldiulan may be enhanced by the above-mentioned medications 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 the heart muscle to digitalis glycosides and accordingly increases the effect and side effects of digitalis glycosides.
Other interactions that may occur:
Insulin, oral hypoglycemic agents (oral antidiabetic drugs), uricosuric agents used to treat gout, sympathomimetic agents (e.g., noradrenaline [norepinephrine], adrenaline [epinephrine])
The effect of these medications may be reduced by concomitant administration of chlortalidone. It may be necessary to adjust the dose of insulin or oral hypoglycemic agents.
Non-depolarizing muscle relaxants (e.g., curare derivatives):
The effect of curare-like muscle relaxants may be enhanced or prolonged by chlortalidone. If it is not possible to discontinue Uldiulan before administering muscle relaxants, the anesthesiologist should be informed about Uldiulan administration.
Allopurinol (a medication 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 (medications used to treat high blood pressure):
There is an increased risk of high blood sugar levels (hyperglycemia) after concomitant administration of chlortalidone and beta-blockers or diazoxide.
Cytostatics (anticancer medications, e.g., cyclophosphamide, fluorouracil, methotrexate):
Chlortalidone may reduce the excretion of cytotoxic medications (e.g., cyclophosphamide, fluorouracil, methotrexate) by the kidneys. Concomitant administration of cytotoxic medications may increase their toxic effects on the bone marrow (especially granulocytopenia).
Calcium salts, vitamin D:
Concomitant administration of chlortalidone with vitamin D or calcium salts may increase serum calcium levels due to decreased urinary excretion.
Anticholinergic agents (e.g., atropine, biperiden):
The bioavailability of thiazide diuretics may be increased by anticholinergic agents (e.g., atropine, biperiden), mainly due to decreased gastrointestinal motility and gastric emptying rate.
Cholestyramine, colestipol (medications used to lower blood lipid levels):
Concomitant administration of cholestyramine or colestipol may reduce 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 medications.
Cyclosporine:
Concomitant treatment with cyclosporine may increase the risk of elevated uric acid levels in the blood (hyperuricemia) and gout-related complications.

Uldiulan with food, drink, and alcohol

Alcohol consumption should be avoided during Uldiulan treatment, as Uldiulan may enhance the effects of alcohol, e.g., impaired reaction ability.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to have a child, consult your doctor or pharmacist before taking this medication.
Pregnancy
Uldiulan should not be taken if you are pregnant or trying to conceive (see section 2. When not to take 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 imbalance. Thrombocytopenia has been reported in newborns. If you become pregnant during Uldiulan treatment, inform your doctor immediately.
Breastfeeding
Uldiulan should not be taken during breastfeeding, as the active substance of Uldiulan passes into breast milk and may harm the baby.

Driving and using machines

Uldiulan may affect your ability to react to a certain extent, so that your 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 taking Uldiulan in combination with other blood pressure-lowering medications, when changing medications, or when consuming alcohol.

Uldiulan contains lactose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking Uldiulan.

Uldiulan contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Uldiulan

Take this medication always as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Follow the instructions carefully to avoid reducing the effectiveness of Uldiulan.
The dosage should be based on the disease progression and individual patient response during treatment.
Choose the lowest effective dose to maintain optimal effectiveness.
Your doctor will carefully adjust the dose of Uldiulan if you have impaired circulation in the blood vessels (coronary artery disease or cerebral arteriosclerosis), as in the case of post-myocardial infarction or post-stroke conditions.
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 to 50 mg of chlortalidone per day.
Maintenance dose: 12.5 to 25 mg of chlortalidone per day.
The initial dose should be adjusted individually.

Administration 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 you are elderly and/or have 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 warnings).
Thiazide diuretics and thiazide-like diuretics, including chlortalidone, lose their diuretic effect in 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 take Uldiulan).
Patients with liver impairment
If you have liver impairment, Uldiulan should be dosed by your doctor according to the applicable restrictions. In case of severe liver impairment, Uldiulan should not be taken (see section 2. When not to take Uldiulan).
Patients with heart impairment
In case of severe heart failure with significant fluid accumulation in tissues (severe 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.
Do not consider increasing the dose after 2-3 weeks.
Duration of treatment
The duration of treatment will be decided by your doctor.
After long-term use of Uldiulan, therapy should not be discontinued abruptly. Uldiulan should be administered with gradually decreasing doses over several days (gradual dose reduction).
If you feel that the effect of Uldiulan is too weak or too strong, consult your doctor.

Taking a higher dose of Uldiulan than recommended

In case of accidental ingestion of a higher dose of Uldiulan than recommended, inform your doctor or contact the nearest emergency department immediately.
Your doctor will decide what measures to take based on the symptoms.
In case of overdose and/or severe symptoms, seek immediate medical attention to be hospitalized and receive intensive medical care.
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 imbalance (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 may cause blood concentration (hemoconcentration), cramps, convulsions, lack of energy (lethargy), confusion, and circulatory collapse and acute renal failure.
Potassium deficiency in the blood (hypokalemia) may result in unusual fatigue, muscle weakness, tingling (paresthesia), paralysis, apathy, excessive gas in the digestive tract (flatulence), and constipation (obstipation) or hypokalemic coma.

Missing a dose of Uldiulan

In case of a missed dose, do 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 your doctor.

Discontinuing Uldiulan

Do not stop or discontinue Uldiulan treatment without prior consultation with your doctor.
Before discontinuing treatment, your doctor may recommend continuing Uldiulan in a lower dose for several days (gradual dose reduction).
If you have any further questions about Uldiulan, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Uldiulan can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, inform your doctor or pharmacist immediately:

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 twitching, 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,
• increased glucose levels in the urine (glycosuria)
• in patients with overt diabetes, the metabolic situation may worsen, and latent diabetes may be revealed
• 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 upset, 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 white blood cell count (eosinophilia)
• increased calcium levels in the blood (hypercalcemia), which may cause excitement
• sensory disturbances (such as tingling and numbness) in hands, feet, and mouth (paresthesia)
• vision disturbances, decreased tear production
• irregular heartbeat
• liver dysfunction (cholestasis) or yellowing of the skin or eyes (jaundice)
• increased skin sensitivity to sunlight (photosensitivity reaction), e.g., redness (rash)
• blood vessel inflammation (vasculitis) with pain or without pain, of allergic origin

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

• electrolyte and acid-base balance disorders in the blood (hypochloremic alkalosis)
• allergic fluid accumulation in the lungs (idiosyncratic pulmonary edema)
• breathing difficulties (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, which 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 (possible symptoms of acute angle-closure glaucoma).

Many side effects will disappear without modifying the treatment. Consult your doctor if any of the symptoms persist or worsen.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your 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, you can help provide more information on the safety of this medication.

5. How to store Uldiulan

Store below 30°C
Keep this medication out of the sight and reach of children.
Do not use this medication 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. Ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the pack 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 score line.
Uldiulan 25 mg: Light red to reddish tablets, round, and convex (7.0 mm ± 0.2 mm) without a score line.
Uldiulan 50 mg: Yellow tablets, round, and convex (9.0 mm ± 0.2 mm) without a score 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

To obtain more detailed information on this medicinal product, contact the local representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Phone: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of the last revision of the leaflet: