Package leaflet: Information for the patient

Uldiulan, 12.5 mg, tablets
Uldiulan, 25 mg, tablets
Uldiulan, 50 mg, tablets
Chlortalidone
Please read carefully this leaflet before taking the medicine, because it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Uldiulan is and what it is used for
Important information before taking Uldiulan
How to take Uldiulan
Possible side effects
How to store Uldiulan
Contents of the pack and other information

1. What Uldiulan is and what it is used for
Uldiulan is a long-acting diuretic medicine that lowers blood pressure.
Uldiulan is used to treat:

Oedema (fluid retention) of cardiac, hepatic or renal origin
High blood pressure (hypertension)
Heart failure

2. Important information before taking Uldiulan
Do not take Uldiulan:

if you are allergic to chlortalidone or to other thiazides and sulfonamides (possible cross-reactions; caution is advised in patients with bronchial asthma), or to any of the other ingredients of this medicine listed in section 6;
if you are unable to pass urine (urine production below 100 mL/24 hours);
if you have severe renal failure (with markedly reduced urine production; creatinine clearance < 30 mL/min and/or serum creatinine concentration > 1.8 mg/100 mL);
if you have acute kidney inflammation (acute glomerulonephritis);
if you have severe liver failure or liver failure with disturbances of consciousness (pre-coma or hepatic coma);
if your blood calcium level is higher than normal (hypercalcaemia);
if you have low blood sodium levels (hyponatraemia);
if you have persistent low blood potassium levels (hypokalaemia) or increased potassium loss (e.g. vomiting, diarrhoea) that does not respond to treatment;
if your blood uric acid level is elevated or if you have a history of gout or gallstones;
if you are pregnant (see Pregnancy and breast-feeding).

Warnings and precautions
Before starting treatment with Uldiulan, discuss this with your doctor, pharmacist or nurse:
Renal failure:
Caution is required when using Uldiulan in patients with kidney disease.
If you have mild or moderate renal failure (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 failure (creatinine clearance < 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 blood nitrogen content (azotaemia). Impaired kidney function may lead to cumulative effects of the medicine.
Long-term use of diuretics may result in a pseudo-Bartter syndrome with oedema. Oedema is due to increased renin concentration and consequently increased aldosterone production (secondary hyperaldosteronism).
Liver failure:
Caution is required when using Uldiulan in patients with impaired liver function or progressive liver disease. Small disturbances in water and electrolyte balance caused by thiazide diuretics, including Uldiulan, may lead to hepatic coma in patients with cirrhosis (see section 2. When not to take Uldiulan).
Metabolic and hormonal effects:
Patients with diabetes or gout should be monitored particularly closely by their doctor.
Thiazide therapy may affect glucose absorption (glucose tolerance). If overt diabetes is present, the metabolic condition may worsen, so it may be necessary to adjust the dose of insulin or oral antidiabetic medicines. Latent diabetes may become apparent during thiazide therapy.
Chlortalidone may increase serum uric acid concentration, but gout attacks are rare during long-term treatment.
In patients treated long-term with diuretics (thiazides and thiazide-like diuretics), including chlortalidone, slight and partially reversible increases in total plasma cholesterol, low-density lipoproteins (LDL) or triglycerides have been reported.
Electrolyte imbalance:
Serum electrolytes (especially potassium, sodium and calcium) should be monitored regularly during thiazide therapy.
Monitoring of serum electrolyte levels is particularly recommended in elderly patients and/or patients with ascites due to liver cirrhosis and/or patients with oedema due to kidney disease. In such conditions, chlortalidone should be administered only under strict supervision and only in patients with normal potassium levels and no signs of volume depletion.
Treatment with thiazide diuretics, including chlortalidone, may lead to disturbances in water and electrolyte balance (low blood potassium and sodium, acid-base imbalances due to chloride deficiency (hypochloraemic alkalosis)). Signs of water and electrolyte imbalance include: dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), reduced urine output (oliguria), rapid heartbeat (tachycardia), and gastrointestinal disturbances such as nausea and vomiting.
Low blood potassium (hypokalaemia) may increase cardiac sensitivity and enhance the toxic effects of cardiac glycosides (digitalis preparations).
The risk of hypokalaemia is highest in patients with liver cirrhosis, those with increased diuresis, those without adequate oral electrolyte intake, and those treated simultaneously with corticosteroids ("cortisone"), ACTH, cardiac glycosides (digitalis preparations to support heart function) or laxatives (see section 2. Uldiulan with other medicines). These patients should be monitored particularly closely.
As with all thiazide diuretics, potassium excretion in urine induced by chlortalidone is dose-dependent, and the extent varies between individual patients. With a dose of 25 mg/day, serum potassium concentration decreases on average by 0.5 mmol/L. During continuous treatment, serum potassium concentration should be monitored at the beginning of treatment and again after 3–4 weeks. After this period, and if potassium balance is not disturbed by additional factors (e.g. vomiting, diarrhoea, changes in kidney function, etc.), serum potassium concentration may be monitored regularly every 4–6 months.
If necessary, Uldiulan may be combined with oral potassium supplements or potassium-sparing diuretics (e.g. triamterene). In combination therapy, serum potassium concentration should be monitored. If hypokalaemia is accompanied by clinical symptoms (e.g. muscle weakness, paralysis, changes in ECG), treatment with Uldiulan should be discontinued.
Avoid combination therapy with Uldiulan and potassium-containing medicines or potassium-sparing diuretics in patients treated simultaneously with ACE inhibitors (medicines used to treat, for example, hypertension), unless absolutely necessary.
In cases of tissue fluid accumulation (oedema), sodium deficiency in tissues (hyponatraemia due to dilution) may occur during hot weather. Chloride deficiency is usually mild and does not require treatment.
Chlortalidone may reduce calcium excretion in urine and cause transient and slight increases in serum calcium concentration without known disturbances in calcium metabolism. A significant increase in serum calcium concentration (hypercalcaemia) may indicate hidden overactivity of the parathyroid glands (hyperparathyroidism). Thiazides should be discontinued before testing parathyroid function.
It has been shown that thiazides increase magnesium excretion in urine. This may lead to magnesium deficiency (hypomagnesaemia).
Impaired heart function:
In patients with severe heart failure with significant fluid accumulation in body tissues (marked oedema), chlortalidone may no longer be effectively absorbed.
Other effects:
Hypersensitivity reactions may occur in patients with a history of allergy or bronchial asthma, or without 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 choroid and sclera) or increased intraocular pressure, which may occur within hours to a week after taking Uldiulan. This may lead to permanent vision loss if not treated. If you have previously experienced an allergy to penicillin or sulfonamides, you may be more susceptible to developing such reactions.
Special recommendations:
During treatment with Uldiulan, serum electrolyte concentrations (especially potassium, sodium and calcium), creatinine and urea, serum lipids (cholesterol and triglycerides), uric acid and blood glucose should be monitored regularly.
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 consultation with your doctor:

if you develop persistent electrolyte disturbances (especially potassium and sodium deficiency in blood) that do not respond to treatment;
if you develop hypersensitivity reactions (allergies);
if you develop serious gastrointestinal problems;
if you develop disturbances of the central nervous system;
if you develop pancreatitis;
if you develop blood count abnormalities: reduced number of red or white blood cells or platelets (anaemia, leukopenia, thrombocytopenia);
if you develop acute gallbladder inflammation (cholecystitis);
if you develop blood vessel inflammation (vasculitis);
if you experience worsening of existing myopia;
if you develop serious kidney problems (serum creatinine concentration > 1.8 mg/100 mL or creatinine clearance < 30 mL/min).

Children and adolescents
Since adequate data on treatment in children are not available, chlortalidone should not be given to children.
Elderly patients
In patients aged 65 years or older, the effectiveness of Uldiulan may be increased. The doctor must adjust the dose appropriately (see section 3. How to take Uldiulan).
Doping
Use of Uldiulan may lead to positive results in anti-doping tests. The health consequences of using Uldiulan as a doping agent cannot be predicted, and serious health risks cannot be ruled out.
Uldiulan with other medicines
Tell your doctor or pharmacist about all medicines you are currently 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:
Combinations not recommended:
Lithium (medicine used to treat psychiatric disorders):
Concomitant administration of chlortalidone with lithium may lead, through reduced lithium excretion, to increased cardiotoxic and neurotoxic effects of lithium. If administration of diuretics is unavoidable, serum lithium concentration must be monitored very closely and the dose adjusted accordingly.
Combinations requiring caution:
Substances that may cause irregular heartbeat leading to death (torsade de pointes, ventricular fibrillation with disturbances in the conduction of electrical impulses in the heart):

certain medicines used for irregular heart rhythm (antiarrhythmic class Ia (e.g. quinidine, hydroquinidine, disopyramide) and antiarrhythmic class III (e.g. amiodarone, sotalol)
specific medicines used for mental disorders (antipsychotics): phenothiazines (e.g. chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (e.g. amisulpride, sulpiride, sultopride, tiapride), butyrophenones (e.g. droperidol, haloperidol)
others: bepridil, cisapride, difemanil, intravenous erythromycin, halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, intravenous vinca alkaloids

If these medicines are administered simultaneously with Uldiulan, there is an increased risk of ventricular arrhythmias (ventricular rhythm disturbances, especially torsade de pointes), particularly due to low blood potassium (hypokalaemia). Serum potassium concentration must be measured and, if necessary, corrected before starting combination therapy. Serum electrolytes and ECG should be monitored regularly. It is best to use substances that do not cause torsade de pointes in the case of low blood potassium (hypokalaemia).
ACE inhibitors (medicines used to treat high blood pressure, such as captopril, enalapril)
Treatment with chlortalidone and additional use of ACE inhibitors (e.g. captopril, enalapril) at the beginning of treatment is associated with a risk of significant drop in blood pressure and worsening of kidney function.
Therefore, diuretic treatment should be discontinued 2–3 days before starting ACE inhibitor therapy to reduce the possibility of a significant drop in blood pressure at the beginning of treatment.
Medicines used for pain and rheumatic diseases (non-steroidal anti-inflammatory drugs (e.g. indometacin, acetylsalicylic acid) including COX-2 inhibitors, salicylates
Non-steroidal anti-inflammatory drugs (e.g. indometacin, acetylsalicylic acid), including COX-2 inhibitors and salicylates, may reduce the antihypertensive and diuretic effects of chlortalidone.
When high doses of salicylates are taken, salicylate toxicity to the central nervous system may be intensified.
In patients in whom reduced circulating blood volume (hypovolaemia) occurs during treatment with Uldiulan, concomitant use of non-steroidal anti-inflammatory drugs may lead to acute kidney failure.
Diuretics and potassium-excreting agents (potassium-wasting diuretics (e.g. furosemide), glucocorticosteroids (cortisone-containing medicines), ACTH, carbenoxolone (medicines used to treat peptic ulcer disease), penicillin G, salicylates, stimulant laxatives, parenteral amphotericin B (medicines used to treat fungal infections)
Concomitant use of Uldiulan and the above-mentioned medicines may lead to disturbances in electrolyte balance, particularly increased potassium loss. This is especially important during treatment with cardiac glycosides (digitalis preparations). Serum potassium concentration must be monitored very closely and, if necessary, corrected.
Other diuretics, other antihypertensive medicines (e.g. beta-blockers, calcium antagonists, ACE inhibitors, vasodilators, methyldopa, guanethidine), nitrates, barbiturates, medicines used for mental disorders (phenothiazines), medicines used to treat depression (tricyclic antidepressants), alcohol
The antihypertensive effect of Uldiulan may be enhanced by the above-mentioned medicines or by alcohol consumption.
Cardiac glycosides (digitalis preparations: medicines that strengthen heart performance)
When treating simultaneously with cardiac glycosides, it should be noted that during chlortalidone treatment, low blood potassium (hypokalaemia) and/or low blood magnesium (hypomagnesaemia) may occur. This increases the sensitivity of the heart muscle to cardiac glycosides and thus increases the effect and adverse effects of cardiac glycosides.
The following combinations may cause interactions
Insulin, oral antidiabetic medicines (oral antidiabetics, sulfonylurea derivatives), uric acid-lowering medicines used in gout, medicines acting on the sympathetic nervous system (sympathomimetics, e.g. contained in nasal and eye drops, cough syrup) (noradrenaline) [norepinephrine], adrenaline [epinephrine]
The effect of these medicines may be weakened when chlortalidone is used concomitantly.
It may be necessary to adjust the dose of insulin or oral antidiabetic medicines.
Non-depolarising muscle relaxants (curare derivatives) (muscle relaxants), e.g. tubocurarine chloride
The effect of curare-like muscle relaxants may be enhanced or prolonged by chlortalidone. If Uldiulan cannot be discontinued before administration of curare-like muscle relaxants, the anaesthesiologist must be informed about Uldiulan use.
Allopurinol (medicine used to treat gout)
Chlortalidone may increase the frequency of hypersensitivity reactions to allopurinol.
Amantadine
Chlortalidone may increase the risk of adverse effects caused by amantadine.
Beta-blockers, diazoxide (medicines used to treat high blood pressure)
There is an increased risk of high blood sugar (hyperglycaemia) when chlortalidone is administered concomitantly with beta-blockers or diazoxide.
Anticancer drugs (drugs that inhibit tumour growth, e.g. cyclophosphamide, fluorouracil, methotrexate)
Chlortalidone may reduce kidney excretion of cytotoxic drugs (e.g. cyclophosphamide, fluorouracil, methotrexate). Concomitant administration of cytotoxic drugs may intensify their toxic effects on bone marrow (especially reduction in the number of certain white blood cells [granulocytopenia]).
Calcium salts, vitamin D
Concomitant administration of chlortalidone with vitamin D or calcium salts intensifies the increase in serum calcium concentration due to inhibition of urinary excretion.
Anticholinergic medicines (e.g. atropine, biperiden)
The bioavailability of thiazide diuretics may be increased by anticholinergic medicines (e.g. atropine, biperiden), most likely due to reduced gastrointestinal motility and delayed gastric emptying.
Cholestyramine, colestipol (medicines that reduce blood lipid concentration)
Concomitant administration of cholestyramine or colestipol reduces 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.
Cyclosporine
Concomitant treatment with cyclosporine may increase the risk of elevated blood uric acid concentration (hyperuricaemia) and complications such as gout.
Uldiulan with food, drink and alcohol
Avoid drinking alcohol during administration of Uldiulan, as Uldiulan intensifies the effects of alcohol, e.g. reaction ability may be impaired.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or plan to have a baby, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Uldiulan if you are pregnant or trying to become pregnant (see section 2. When not to take Uldiulan). Chlortalidone, the active substance in Uldiulan, may reduce blood flow in the placenta. Thiazides and thiazide derivatives also pass into the foetal circulation and may cause electrolyte imbalances. Thrombocytopenia has been reported in newborns. Inform your doctor immediately if you become pregnant during treatment with Uldiulan.
Breast-feeding
Do not use Uldiulan during breast-feeding, as the active substance of Uldiulan passes into breast milk and may harm the child.
Driving and using machines
Uldiulan may alter reaction ability during normal use in such a way that the ability to drive a car, use tools or operate machinery may be limited. This especially applies at the beginning of treatment, when increasing the dose, when used in combination with other blood pressure-lowering medicines, when changing medicines, and when combined with alcohol.
Uldiulan contains lactose
If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.
Uldiulan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Uldiulan

This medicine should always be taken according to your doctor's or pharmacist's instructions. If you have any doubts, consult your doctor or pharmacist.
Follow the instructions carefully to avoid reducing the effectiveness of Uldiulan.
Dosage should be based on the course of the disease and the individual response of the patient during treatment.
The lowest effective dose should be selected to maintain optimal effectiveness.
Your doctor will carefully adjust the dose of Uldiulan if you have circulatory disorders in the coronary vessels (coronary heart disease or cerebral atherosclerosis), such as after a heart attack or stroke.
Recommended dose:
Oedema (fluid accumulation) of cardiac, hepatic or renal origin and heart failure
The recommended initial dose is 25 to 50 mg/day; in severe cases, it may be increased to 100 to 200 mg/day. The dose for nephrotic oedema should not exceed 50 mg/day.
The usual maintenance dose is the lowest effective dose, e.g. 25 to 50 mg/day.
High blood pressure (hypertension)
Initial dose:
12.5 to 50 mg chlortalidone per day.
Maintenance dose:
12.5 to 25 mg chlortalidone per day.
The initial dose should be individually reduced.
Use in children and adolescents
Since adequate data on treatment in children are not available, chlortalidone should not be given to children.
Elderly patients (> 65 years) and patients with impaired kidney 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. Warnings and precautions).
Thiazide diuretics and thiazide-like diuretics, including chlortalidone, lose their diuretic effect in cases of severe renal failure, defined as 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 impaired liver function
If you have impaired liver function, Uldiulan should be dosed by your doctor according to the applicable precautions. Uldiulan should not be used in cases of severe liver failure (see section 2. When not to take Uldiulan).
Patients with impaired heart function
In cases of severe heart failure with marked fluid accumulation in tissues (oedema), Uldiulan may no longer be effectively absorbed.
Method of administration
Uldiulan tablets should be swallowed whole, without chewing, with an adequate amount of liquid (e.g. a glass of water).
For a single daily dose, take the tablet in the morning with breakfast. If taking twice daily, take an additional tablet during the evening meal.
Do not consider increasing the dose after 2–3 weeks.
Duration of treatment
Your doctor will decide how long treatment should last.
After long-term use of Uldiulan, therapy should not be stopped abruptly. Gradually reduce the dose of Uldiulan over several days (tapering).
If you feel the effect of Uldiulan is too weak or too strong, consult your doctor.
Taking more Uldiulan than recommended
If you accidentally take more Uldiulan than recommended, inform your doctor immediately or contact the nearest emergency department.
Your doctor will decide, based on symptoms, what measures should be taken.
In case of overdose and/or severe symptoms, seek immediate medical help for hospital admission and intensive medical care.
Symptoms of acute or chronic overdose depend on the degree of fluid and electrolyte loss.
Symptoms of overdose may include:

dizziness and fainting, nausea, drowsiness, headache, rapid pulse (tachycardia),
low blood pressure (hypotension) and circulatory disturbances with low blood pressure upon changing position from sitting to lying down (orthostatic regulation disturbances),
electrolyte imbalance (low blood potassium and/or sodium) with irregular heartbeat and muscle cramps (e.g. leg cramps).

Severe dehydration and reduced circulating blood volume (hypovolaemia) may lead to blood thickening (haemoconcentration), cramps, tremors, lack of energy (lethargy), confusion, circulatory collapse and acute kidney failure.
Low blood potassium (hypokalaemia) results in unusual fatigue, muscle weakness, irritations (e.g. tingling and cold sensation) in hands and feet (paraesthesiae), paralysis, apathy, excessive gas in the gastrointestinal tract (bloating) and constipation (paralytic ileus) or disturbances of consciousness up to coma associated with potassium deficiency (hypokalaemic coma).
Missing a dose of Uldiulan
If you miss a dose, do not take a double dose to make up for the missed tablet; instead, continue taking your usual dose according to the regular dosing schedule as advised by your doctor.
Stopping Uldiulan treatment
Do not stop or discontinue treatment with Uldiulan without first consulting your doctor.
Before stopping treatment, your doctor may advise continuing Uldiulan at a low dose for several days (gradual dose reduction).
If you have further questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, you should immediately inform your doctor or
pharmacist:
Very common (may occur in more than 1 in 10 people):

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

Common (may occur in less than 1 in 10 people):

low sodium and magnesium levels in the blood (hyponatraemia/hypomagnesaemia)
high blood sugar levels (hyperglycaemia), which may cause fatigue
increased glucose in urine (glucosuria)
in patients with overt diabetes, metabolic control may worsen, latent diabetes may become apparent
increased levels of nitrogen-containing substances (urea, creatinine), particularly at the beginning of treatment
headache, dizziness, fatigue
low blood pressure (hypotension)
circulatory disturbances with low blood pressure, fainting upon changing position from sitting to lying down (orthostatic regulation disorders)
palpitations
loss of appetite, dry mouth, gastrointestinal discomfort, nausea, vomiting, stomach upset, stomach pain, constipation, diarrhoea
allergic skin reactions, such as skin redness (urticaria), hives, itching
reduced skeletal muscle tone, muscle cramps, inability to achieve erection

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

low platelet count (thrombocytopenia) with unusual bleeding or bruising
low white blood cell count (leukopenia)
severe deficiency of specific white blood cells associated with increased susceptibility to infections and severe general symptoms (agranulocytosis)
increased number of certain white blood cells (eosinophilia)
increased calcium levels in the blood (hypercalcaemia), which may cause agitation
sensory disturbances (such as tingling and numbness) in hands, feet and mouth (paraesthesia)
visual disturbances, reduced tear production
irregular heartbeat
bile stasis in the liver (intrahepatic cholestasis) or yellowing of the skin or eyes (jaundice)
increased skin sensitivity to sunlight (photosensitivity reaction), e.g. skin redness (urticaria)
inflammation of blood vessels with or without pain of allergic origin (vasculitis)

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

disturbances in acid-base balance in the blood (hypochloraemic alkalosis)
allergic accumulation of fluid in the lungs (idiosyncratic pulmonary oedema)
breathing problems (symptoms of pneumonia and pulmonary oedema)
abdominal pain with nausea, vomiting or fever (symptoms of pancreatitis)
allergic inflammation of the kidneys (allergic interstitial nephritis)

Frequency unknown (cannot be estimated from available data):

worsening of vision or eye pain caused by high pressure (possible symptoms of fluid accumulation in the uvea, the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera), or acute angle-closure glaucoma)

Many adverse reactions will resolve without modification of treatment. You should contact your doctor
if any of these symptoms persist or worsen.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor or pharmacist. Adverse reactions may be reported
directly to
Department of Monitoring Adverse Reactions of Medicinal Products, 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 may also be reported to the responsible entity.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Uldiulan

Store below 30°C.
Keep the medicine out of the 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 stated month.
Medicines must 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 package 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 carboxymethyl starch (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 carboxymethyl starch (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 carboxymethyl starch (type A), yellow iron oxide (E172), magnesium stearate.

What Uldiulan looks like and contents of the pack
Uldiulan 12.5 mg: White, round, convex tablets (5.0 mm ± 0.2 mm) without a break line.
Uldiulan 25 mg: Light pink to reddish, round, convex tablets (7.0 mm ± 0.2 mm) without a break line.
Uldiulan 50 mg: Yellow, round, convex tablets (9.0 mm ± 0.2 mm) without a break line.
Uldiulan is available in blister packs containing 10, 20, 30, 50, 60 and 100 tablets per cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]