Higroton

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Hygroton, 50 mg, tablets

Chlortalidonum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a 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 the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Hygroton and what is it 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 is Hygroton and what is it used for

Hygroton is a diuretic medicine that reduces the amount of salt and water in the body by increasing the amount of urine excreted. During long-term use, it helps to lower and regulate blood pressure.
Hygroton is used in:
Hypertension:as monotherapy or in combination with other antihypertensive medicines.

Mild to moderate, chronic, stable heart failure (weakness of the heart muscle).

Edema of specific origin

• due to circulatory failure
• ascites (fluid accumulation in the abdominal cavity) caused by liver cirrhosis (late stage of liver scarring) in stable patients under close control
• edema in the course of nephrotic syndrome (non-specific kidney disorders). Simple renal diabetes insipidus(a disease related to kidney function that causes excessive thirst and urination).

2. Important information before taking Hygroton

When not to take Hygroton:

if the patient is allergic to chlortalidone or any of the other ingredients of this medicine (listed in section 6);
if there is anuria (lack of urine excretion), severe kidney failure (insufficient kidney function) and severe liver failure (insufficient liver function);
if there is refractory hypokalemia (low potassium levels in the blood) or conditions leading to increased potassium loss, hyponatremia (low sodium levels in the blood) and hypercalcemia (abnormally high calcium levels in the blood);
if there is symptomatic hyperuricemia (gout or presence of uric acid deposits in the history);
if there is hypertension in pregnant women (see section " Pregnancy and breastfeeding");
if lithium-containing medicines are taken simultaneously;
if there is untreated Addison's disease (a disorder that occurs when there are insufficient amounts of certain hormones produced in the body by the adrenal glands).

Warnings and precautions

Before starting to take Hygroton, you should discuss it with your doctor or pharmacist.
You should be particularly careful when taking Hygroton
You must inform your doctor if you have:
liver function disorders or progressive liver diseases;
severe kidney disease;
gout;
low potassium, sodium or high calcium levels in the blood

• Low potassium levels in the blood can cause muscle weakness, muscle tremors or irregular heart rhythm.
• Low sodium levels in the blood can cause fatigue, confusion, muscle tremors, convulsions or coma.
• High calcium levels in the blood can cause loss of appetite, fatigue or muscle weakness. diabetes; taking therapy for high cholesterol levels in the blood (hypercholesterolemia); if you are taking other medicines, you should also read the section " Hygroton and other medicines"; if you experience vision loss 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 pressure inside the eye, which can occur within a few hours to a week after taking Hygroton. This can lead to permanent vision loss if left untreated. If you have previously been allergic to penicillin or sulfonamides, you may be at higher risk of developing such symptoms.

Due to increased electrolyte excretion, a strict diet with limited salt intake is not recommended.
If any of the above warnings apply to you or have applied in the past, you should discuss this with your doctor. Your doctor will take this information into account during treatment. It is important for your doctor to regularly monitor your condition to check if the medicine is working properly.
Regular blood sampling may be necessary, especially in patients over 65 years old, with cardiac disorders, liver or kidney function disorders, or patients taking potassium. The patient's electrolyte levels should be periodically measured and monitored for the occurrence 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 vehicles or operate machinery until such effects have subsided.

Hygroton and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.It may be necessary to change the dose, and in some cases, discontinue the medicine.
You should inform your doctor if you are taking:
lithium (a medicine used to treat mental disorders);
curare-like compounds (muscle relaxants used during anesthesia);
medicines used to treat hypertension (e.g., guanethidine, methyldopa, β-adrenolytics, vasodilators, calcium channel blockers, ACE inhibitors);
glucocorticoids;
adrenocorticotropic hormone;
β2-mimetics (bronchodilators);
amphotericin and carbenoxolone;
cardiac glycosides (medicines used to treat heart diseases);
non-steroidal anti-inflammatory medicines (e.g., indomethacin);
allopurinol (a medicine used to treat gout);
amantadine (a medicine used to treat Parkinson's disease);
diazoxide;
cytotoxic products (e.g., cyclophosphamide, methotrexate) - medicines used to treat cancer;
cholinolytic medicines (e.g., atropine, bipiperidine);
ion-exchange resins such as cholestyramine (a medicine used to treat high cholesterol levels in the blood);
vitamin D or calcium salts;
cyclosporine (a medicine that weakens the immune system to protect against organ rejection, also used to treat rheumatic diseases and dermatological disorders);
medicines used to treat diabetes. It may be necessary to re-establish insulin doses and oral hypoglycemic medicines.

Hygroton with food, drink, and alcohol

You should avoid consuming alcohol, unless you have discussed it with your doctor. Alcohol may further lower blood pressure and (or) increase the likelihood of dizziness or fainting.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.
Hygroton should not be used during pregnancy and breastfeeding.
Pregnancy
Hygroton should not be used if you are pregnant or plan to have a child (see section " When not to take Hygroton"). If you become pregnant during treatment with Hygroton, you should immediately inform your doctor.
Breastfeeding
Hygroton should not be used if you are breastfeeding, as the active substance of Hygroton passes into human milk and may have a harmful effect on the baby.
For safety reasons, breastfeeding should be discontinued during treatment with Hygroton.

Driving and using machines

Hygroton, especially at the beginning of treatment, may impair patients' reactions, e.g., when driving vehicles or operating machinery. Therefore, before starting to drive a vehicle, operate machinery, or perform other activities that require quick reactions, you should check how Hygroton affects you.

Hygroton contains sodium and lactose monohydrate.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".
If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Hygroton

This medicine should always be taken according to your doctor's recommendations. In case of doubts, you should consult your doctor.
At the beginning of treatment, you should take the lowest possible dose. This dose is determined based on the individual patient's response to the medicine.
The recommended single dose, given once daily or every other day, should be taken in the morning with a meal.

Hypertension

A starting dose of 25 mg per day is recommended. The full therapeutic effect during single-dose administration occurs after 3-4 weeks. If the reduction in blood pressure is insufficient during administration of 25 mg or 50 mg per day, combination therapy with other antihypertensive medicines is recommended.

Heart failure (weakness of the heart muscle)

The recommended starting dose is 25 mg to 50 mg per day; in severe cases, the dose may be increased to 100 mg to 200 mg per day. The average maintenance dose is the smallest effective dose, e.g., 25-50 mg given daily or every other day. If the patient's response is insufficient, additional cardiac glycosides or angiotensin-converting enzyme inhibitors or both groups of medicines may be used (see section 2).

Edema of specific origin

The smallest effective dose should be determined based on the individual patient's response to the medicine and used only for a limited time. The dose should not exceed 50 mg per day.
Simple renal diabetes insipidus(a disease related to kidney function that causes excessive thirst and urination)
The recommended starting dose in adults is 100 mg twice daily. The usual maintenance dose is 50 mg per day.

Use in children

The smallest effective dose should be used. The dosage is determined by the doctor.

Elderly patients and patients with impaired renal function

The smallest effective dose should be used, as determined by the doctor.

Overdose of Hygroton

In case of taking a dose of Hygroton that is higher than recommended or taking the medicine by a person it was not prescribed for, you should immediately consult a doctor or pharmacist.
In case of overdose, the following symptoms may occur: dizziness, nausea, drowsiness, decreased blood volume, hypotension, and electrolyte disturbances with accompanying heart rhythm disorders and muscle cramps.
If the patient is conscious, while waiting for the doctor, you can try to induce vomiting.

Missed dose of Hygroton

In case of missing a dose of Hygroton, you should contact your doctor. You should not take a double dose to make up for the missed dose.

Discontinuation of Hygroton

Expected symptoms of the disease in case of discontinuation of Hygroton treatment.
No withdrawal symptoms are known.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Hygroton can cause side effects, although not everybody gets them.

You should consult your doctor as soon as possible if you experience any of the following symptoms:

Very common:low potassium levels in the blood, which can cause muscle weakness, muscle tremors, or irregular heart rhythm.
Common:hives and other forms of skin rash; low sodium levels in the blood, which can cause fatigue, confusion, muscle tremors, convulsions, or coma; low magnesium levels; high blood sugar levels, which can cause fatigue, tiredness, or thirst.
Uncommon:sore throat, fever, or chills (symptoms of blood disorders); yellowing of the eyes or skin (jaundice); sensation of tingling and burning, bleeding, or unexpected bruising (symptoms of thrombocytopenia); blurred vision; irregular heartbeat; presence of sugar in the urine (a symptom visible after the doctor or nurse performs a urine test); worsening of diabetes;
high calcium levels in the blood, which can cause excitement, eye pain, abdominal pain.
Rare:abdominal pain with nausea, vomiting, or fever (symptoms of pancreatitis); difficulty breathing (symptoms of pneumonia and pulmonary edema); kidney inflammation or blood vessel inflammation with or without pain; pain or difficulty when urinating;
blood vessel inflammation, often with skin rash; low chloride levels in the blood, symptoms include dry mouth, thirst, gastrointestinal disorders (including nausea, vomiting), weakness, lethargy, drowsiness, restlessness, convulsions, confusion, headache, pain, or muscle cramps, hypotension.
Frequency not known:vision loss or eye pain due to increased 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 disappear without the need to discontinue treatment. You should tell your doctor if any of the following side effects persist or cause a problem:

Very common:increased cholesterol levels in the blood; increased uric acid levels in the blood.
Common:dizziness or feeling of emptiness in the head when standing up from a lying or sitting position; stomach discomfort; unusual fatigue or weakness (sometimes a symptom of potassium loss), loss of appetite; difficulty in achieving an erection or decreased libido.
Uncommon:headaches; vomiting; nausea; diarrhea; stomach pain; constipation; joint pain (symptoms of gout); increased sensitivity of the skin to light.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Hygroton

The medicine should be stored in a place that is 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 specified month.

Translation of some information on the immediate packaging:

Ch.-B./verw. bis: see imprint – Batch number/Expiry date – see imprint
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Hygroton contains

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

What Hygroton looks like and contents of the pack

Flat, round, light yellow, speckled tablets with beveled edges and a dividing line on one side.
Hygroton is available in a pack containing 20 tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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

Repackaged by:

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
Marketing authorization number in Germany, the country of export:7703.01.00

Parallel import authorization number: 194/25

Date of approval of the leaflet: 03.06.2025

[Information about the trademark]