Higroton

Leaflet attached to the packaging: patient information

Hygroton, 50 mg, tablets

Chlortalidone

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.
• In case of any doubts, 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 their symptoms 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. Package contents 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 for:

Hypertension:as monotherapy or in combination with other antihypertensive medicines

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

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, causing excessive thirst and urination)

2. Important information before taking Hygroton

When not to take Hygroton:

• if the patient is allergic to chlortalidone or any other component of this medicine (listed in section 6);
• if there is anuria (lack of urine excretion), severe kidney failure, and severe liver failure;
• if there is resistant 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 by the adrenal glands).

Warnings and precautions

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

Particular caution should be exercised when taking Hygroton

The doctor should be informed without fail in the event of:

• 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 may cause muscle weakness, muscle twitching, or irregular heart rhythm; 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;
• therapy for high cholesterol levels in the blood (hypercholesterolemia);
• if the patient is taking other medicines, they should also read the section "Hygroton and other medicines";
• if there is a decrease in 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 may occur within a few hours to a week after taking Hygroton. This may lead to permanent vision loss if left untreated. If the patient has previously been allergic to penicillin or sulfonamides, they may be at higher risk of developing such symptoms.

Due to the increased excretion of electrolytes, a strict diet with limited salt intake is not recommended.

If any of the above warnings apply to the patient or have applied in the past, they should discuss this with their doctor. The doctor will take this information into account during treatment. It is essential for the doctor to regularly monitor the patient's condition to check if the medicine is working correctly.

Regular blood tests may be necessary, especially for patients over 65 years old, with cardiovascular disorders, liver or kidney function disorders, or patients taking potassium. The patient's electrolyte levels should be periodically checked, 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

It may be necessary to change the dose, and in some cases, discontinue the medicine.

The doctor should be informed if the patient is 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);
• glucocorticosteroids;
• adrenocorticotropic hormone;
• β-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;
• cyclosporin (a medicine that weakens the immune system to protect against organ rejection, also used e.g., to treat rheumatic diseases and dermatological disorders);
• medicines used to treat diabetes. It may be necessary to re-establish insulin and oral hypoglycemic doses.

Hygroton with food, drink, and alcohol

Alcohol should be avoided, unless discussed with the 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Hygroton should not be taken during pregnancy and breastfeeding.

Pregnancy

Hygroton should not be taken if the patient is pregnant or plans to have a child (see section "When not to take Hygroton"). If the patient becomes pregnant during treatment with Hygroton, they should immediately inform their doctor.

Breastfeeding

Hygroton should not be taken if the patient is breastfeeding, as the active substance of Hygroton passes into human milk and may have a harmful effect on the child.

For safety reasons, breastfeeding should be discontinued during treatment with Hygroton.

Driving and using machines

Hygroton, especially at the beginning of treatment, may affect the patient's 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, the patient should check how Hygroton affects them.

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

3. How to take Hygroton

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor should be consulted.

At the beginning of treatment, the lowest possible dose should be used. 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

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

Heart failure (heart muscle weakness)

The recommended initial 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, cardiac glycosides or angiotensin-converting enzyme inhibitors, or both, may be added (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, causing excessive thirst and urination)

The recommended initial 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 kidney function

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

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, the doctor or pharmacist should be consulted immediately.

In case of overdose, the following symptoms may occur: dizziness, nausea, drowsiness, decreased circulating blood volume, hypotension, and electrolyte disturbances with accompanying heart rhythm disorders and muscle cramps.

If the patient is conscious, while waiting for the doctor, they can try to induce vomiting.

Missed dose of Hygroton

In case of missing a dose of Hygroton, the doctor should be contacted.

A double dose should not be taken 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.

In case of any further doubts regarding the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

The patient should consult their doctor as soon as possible if they experience any of the following symptoms:

Very common:low potassium levels in the blood, which may cause muscle weakness, muscle twitching, or irregular heart rhythm.

Common:hives and other forms of skin rash; low sodium levels in the blood, which may cause fatigue, confusion, muscle twitching, seizures, or coma; low magnesium levels; high blood sugar levels, which may 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 may cause excitement, eye pain, abdominal pain.

Rare:abdominal pain with nausea, vomiting, or fever (symptoms of pancreatitis); breathing difficulties (symptoms of pneumonia and pulmonary edema); kidney or blood vessel inflammation with or without pain; pain or difficulty 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, seizures, confusion, headache, pain, or muscle cramps, hypotension.

Frequency not known:decreased vision 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. The doctor should be told if any of the following side effects persist or cause problems:

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 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 any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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, tel.: +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, more information can be collected on the safety of the medicine.

5. How to store Hygroton

The medicine should be stored 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.

Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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, corn starch, sodium carmellose, magnesium stearate, colloidal anhydrous silica, yellow iron oxide (E 172).

What Hygroton looks like and what the package contains

Flat, round, light yellow tablets with beveled edges. On one side of the tablet, there is the inscription "Z/A" and a dividing line. The other side does not have any markings.

Hygroton is available in a package containing 20 or 28 tablets.

Marketing authorization holder and manufacturer Marketing authorization holder:

Amdipharm Limited

Temple Chambers, 3 Burlington Road

Dublin 4

Ireland

Manufacturer:

CENEXI

52, rue Marcel et Jacques Gaucher

94120 Fontenay-sous-Bois

France

Date of last revision of the leaflet: 30 05 2023