HYGROTON

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Hygroton, 50 mg, tablets
Chlortalidonum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Hygroton is and what it is used for
2. Important information before taking Hygroton
3. How to take Hygroton
4. Possible side effects
5. How to store Hygroton
6. Contents of the pack and other information

1. What Hygroton is and what it is used for

Hygroton is a diuretic medicine that reduces the amount of salt and water in the body by increasing urine output. With prolonged use, it helps lower and control arterial blood pressure.

Hygroton is used in:
Arterial hypertension: as monotherapy or in combination with other antihypertensive medicines.
Mild to moderate, chronic, stable heart failure (weakening of the heart muscle).
Edema of various origins:

• resulting from circulatory failure
• ascites (accumulation of fluid in the abdominal cavity) caused by hepatic cirrhosis (advanced liver fibrosis) in clinically stable patients under close supervision
• edema associated with nephrotic syndrome (non-specific kidney function disorders)
• Nephrogenic diabetes insipidus (a kidney-related disorder causing excessive thirst and urine production).

2. Important information before using Hygroton

When not to use Hygroton:
if the patient is allergic to chlorthalidone or any of the other ingredients of this
medicine (listed in section 6);
if anuria (lack of urine excretion), severe renal insufficiency (inadequate kidney function), or severe hepatic insufficiency (inadequate liver function) is present;
if treatment-resistant hypokalemia (low potassium levels in the blood), conditions leading to increased potassium loss, hyponatremia (low sodium levels in the blood), or hypercalcemia (abnormally high calcium levels in the blood) occur;
if symptomatic hyperuricemia (gouty diathesis or history of uric acid deposits) is present;
if arterial hypertension occurs in pregnant women (see section "Pregnancy and breastfeeding");
if medicines containing lithium are used concomitantly;
if untreated Addison's disease (a disorder occurring due to insufficient amounts of certain hormones produced by the adrenal glands) is present.

Warnings and precautions

Before starting treatment with Hygroton, discuss it with your doctor or pharmacist.

Exercise particular caution when using Hygroton

You must inform your doctor immediately if you have:
liver function disorders or progressive liver diseases;
severe kidney disease;
gout;
low potassium or sodium levels, or high calcium levels.

• Low potassium levels in the blood may cause muscle weakness, muscle cramps, or irregular heartbeat.
• Low sodium levels in the blood may cause fatigue, confusion, muscle twitching, seizures, or coma.
• High calcium levels in the blood may cause loss of appetite, fatigue, or muscle weakness.
  diabetes;
  treatment for elevated blood cholesterol (hypercholesterolemia);
  if the patient is taking other medicines, also read section "Hygroton and other medicines";
  if blurred vision or eye pain occurs. These may be symptoms of fluid accumulation in the avascular membrane surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure, which may occur within hours to a week after taking Hygroton. This may lead to permanent vision loss if not treated. Patients who previously had an allergic reaction to penicillin or sulfonamides may be at increased risk of such symptoms.

Due to increased electrolyte excretion, a strict low-salt diet is not recommended.
If any of the above warnings apply to the patient, or have applied in the past, discuss this with your doctor. Your doctor will take these factors into account during treatment. It is important that your doctor regularly monitors your condition to ensure the medicine is working properly. Regular blood tests may be necessary, especially in patients over 65 years of age, those with cardiac disorders, liver or kidney dysfunction, or those taking potassium supplements. Periodic monitoring of electrolyte levels should be performed, with attention to possible development of hyponatremia, hypokalemia, hypomagnesemia, and hypercalcemia.

Children and adolescents

Hygroton may cause dizziness and affect concentration, especially at the beginning of treatment. Parents/guardians must ensure that children/adolescents do not drive or operate machinery until such effects subside.

Hygroton and other medicines

Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take. Dosage adjustment may be necessary, and in some cases discontinuation of the medicine may be required.

Inform your doctor if the patient is taking:
lithium (a medicine used in the treatment of psychiatric disorders);
curare-like agents (muscle relaxants used during anesthesia);
medicines used to treat arterial hypertension (e.g. guanethidine, methyldopa, β-blockers, vasodilators, calcium channel blockers, ACE inhibitors);
glucocorticosteroids;
adrenocorticotropic hormone;
β2-mimetics (bronchodilators);
amphotericin and carbenoxolone;
cardiac glycosides (medicines used in heart diseases);
non-steroidal anti-inflammatory drugs (e.g. indomethacin);
allopurinol (a medicine used in gout);
amantadine (a medicine used in Parkinson's disease);
diazoxide;
cytotoxic agents (e.g. cyclophosphamide, methotrexate) – medicines used in cancer treatment;
cholinolytic agents (e.g. atropine, biperiden);
ion-exchange resins such as cholestyramine (a medicine used in elevated blood cholesterol);
vitamin D or calcium salts;
cyclosporine (an immunosuppressive medicine used to prevent organ transplant rejection, also used e.g. in rheumatic diseases and dermatological disorders);
medicines used in diabetes treatment. Doses of insulin and oral hypoglycemic agents may need to be re-adjusted.

Hygroton with food, drink, and alcohol

Avoid drinking alcohol unless otherwise advised by your doctor. Alcohol may further lower blood pressure and/or increase the likelihood of dizziness or fainting.

Pregnancy and breastfeeding

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

Do not use Hygroton during pregnancy or breastfeeding.

Pregnancy
Do not use Hygroton if the patient is pregnant or planning to become pregnant (see section "When not to use Hygroton"). If pregnancy occurs during treatment with Hygroton, inform your doctor immediately.

Breastfeeding
Do not use Hygroton if the patient is breastfeeding, as the active ingredient passes into human milk and may harm the infant.
For safety reasons, it is recommended to discontinue breastfeeding during treatment with Hygroton.

Driving and operating machinery

Hygroton, especially at the beginning of treatment, may impair patient reactions, e.g. when driving vehicles or operating mechanical equipment. Therefore, before driving, operating machinery, or performing other activities requiring quick reactions, the patient should determine how Hygroton affects them.

Hygroton contains sodium and monohydrate lactose.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Hygroton

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt, consult
your doctor.
At the beginning of treatment, the lowest possible dose should be used. The dose is determined based on
the individual patient's response to the medicine.
The recommended single dose, taken daily or every other day, should be taken in the morning with food.

Arterial hypertension
The recommended initial dose is 25 mg once daily. Full therapeutic effect with a single daily dose occurs after 3–4 weeks. If blood pressure reduction is inadequate with doses of 25 mg or 50 mg daily, combination therapy with other antihypertensive medicines is recommended.

Heart failure (weakening of the heart muscle)
The recommended initial dose is 25–50 mg daily; in severe cases, this dose may be increased to 100–200 mg daily. The usual maintenance dose is the lowest effective dose, e.g. 25–50 mg, administered either daily or every other day. If the patient's response is inadequate, cardiac glycosides or angiotensin-converting enzyme inhibitors, or both of these drug groups, may additionally be used (see section 2).

Edema of specific origin
The lowest effective dose should be determined based on the individual patient's response to the medicine and should be used only for a limited period. The dose should not exceed 50 mg daily.

Nephrogenic diabetes insipidus (a kidney-related disorder causing excessive thirst and urine production)
The recommended initial dose in adults is 100 mg twice daily. The usual maintenance dose is 50 mg daily.

Use in children
The lowest effective dose should be used. Dosage must be determined by the doctor.

Elderly patients and patients with impaired renal function
The lowest effective dose determined by the doctor should be used.

Taking more Hygroton than recommended
If you take more medicine than prescribed or if someone else takes this medicine by mistake, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: dizziness, nausea, drowsiness, reduced circulating blood volume, hypotension, and electrolyte disturbances, accompanied by cardiac arrhythmias and muscle cramps.
If the patient is conscious, while waiting for medical help, you may try to induce vomiting.

Missed dose of Hygroton
If you miss a dose of Hygroton, contact your doctor. Do not take a double dose to make up for the missed dose.

Stopping treatment with Hygroton
Expected symptoms of disease upon discontinuation of Hygroton treatment.
No withdrawal symptoms are known.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The patient should consult a doctor as soon as possible if any of the following symptoms occur:
Very common: low blood potassium levels, which may cause muscle weakness, muscle twitching, or irregular heartbeat.
Common: urticaria and other types of skin rash; low blood sodium levels, which may cause fatigue, confusion, muscle twitching, seizures, or coma; low magnesium levels; high blood sugar levels, which may cause fatigue, tiredness, or thirst.
Rare: sore throat, fever, or chills (symptoms of blood disorders); yellowing of the eyes or skin (jaundice); sensation of pricking and burning, bleeding, or unexpected bruising (symptoms of thrombocytopenia); blurred vision; irregular heartbeat; presence of glucose in urine (a sign detected by a doctor or nurse during urine testing); worsening of diabetes; increased blood calcium levels, which may cause restlessness, eye pain, or abdominal pain.
Very rare: abdominal pain with nausea, vomiting, or fever (symptoms of pancreatitis); breathing difficulties (symptoms of lung inflammation and pulmonary edema); kidney inflammation or blood vessel inflammation with or without pain; pain or difficulty during urination; vasculitis, often with skin rash; low blood chloride levels, symptoms include dryness of the mouth, thirst, gastrointestinal disturbances (including nausea, vomiting), weakness, lethargy, drowsiness, restlessness, seizures, confusion, headache, muscle pain or cramps, hypotension.
Frequency not known: visual impairment or eye pain due to increased 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 resolve without the need to discontinue treatment. However, inform your doctor if any of the following effects persist or cause problems:
Very common: increased blood cholesterol levels; increased blood uric acid levels.
Common: dizziness or feeling faint when standing up from lying or sitting position; stomach discomfort; unusual tiredness or weakness (sometimes a sign of potassium loss); loss of appetite; difficulty achieving erection or decreased libido.
Rare: headache; vomiting; nausea; diarrhea; stomach pain; constipation; joint pain (symptoms of gout); increased skin sensitivity to light.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Hygroton

Keep this medicine out of sight and reach of children.
Protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Translation of some information on the immediate packaging:
Ch.-B./verw. bis: siehe Prägeung – Batch number/Expiry date – see embossing
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 packaging and other information

What Hygroton contains
The active substance is chlorthalidone. One tablet contains 50 mg of chlorthalidone.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium carboxymethyl starch (type A), povidone K 30, colloidal anhydrous silica, magnesium stearate, yellow iron oxide (E 172).

What Hygroton looks like and contents of the pack
Flat, round, light yellow, speckled tablets with bevelled edges and a division line on one side.
Hygroton is available in packs containing 20 tablets.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Germany, the country of export:
Trommsdorff GmbH & Co. KG
Trommsdorffstr. 2-6
D-52477 Alsdorf
Germany

Manufacturer:
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

Parallel Importer:
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Poland

Repackaged in:
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

German Marketing Authorisation Number (country of export): 7703.01.00
Parallel Import Authorisation Number: 194/25