Astorid

Leaflet attached to the packaging: patient information

ASTORID, 5 mg, tablets
Torasemidum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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 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 ASTORID and what is it used for
• 2. Important information before taking ASTORID
• 3. How to take ASTORID
• 4. Possible side effects
• 5. How to store ASTORID
• 6. Package contents and other information

1. What is ASTORID and what is it used for

ASTORID is a diuretic and antihypertensive medication, belonging to the group of loop diuretics.
ASTORID is used to treat and prevent fluid retention in tissues (edema) and (or) fluid accumulation in body cavities (effusions), which may occur in connection with heart function disorders (heart failure) and to treat primary arterial hypertension.

2. Important information before taking ASTORID

When not to take ASTORID:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• in renal failure with no urine output (anuria);
• in severe liver function disorders (e.g., hepatic coma) until improvement or resolution of this condition;
• in cases of very low blood pressure (hypotension);
• in cases of decreased blood volume (hypovolemia);
• if the patient has sodium or potassium deficiency (hyponatremia, hypokalemia);
• in urinary bladder emptying disorders (e.g., due to pathological prostate enlargement);
• during breastfeeding;
• in patients with gout;
• with a high degree of cardiac conduction disorders (e.g., sinoatrial block, atrioventricular block II or III degree);
• with concurrent treatment with certain antibiotics (aminoglycosides, cephalosporins);
• in cases of renal function disorders caused by nephrotoxic substances.

Warnings and precautions

Before starting to take ASTORID, discuss it with your doctor or pharmacist.
Since there are no sufficient study results, ASTORID should not be used in the following cases:

• pathological changes in acid-base balance;
• pathological changes in blood morphology (e.g., thrombocytopenia or anemia in patients without renal function disorders);
• urinary flow disorders should be corrected before starting torasemide treatment;
• in patients with cardiac arrhythmia, the administration of loop diuretics may pose a potential life threat due to changes in electrolyte levels (potassium, sodium, calcium, magnesium). Regular blood tests for electrolyte levels, especially potassium and calcium, should be performed.

Impact on doping tests
Taking ASTORID may result in positive doping test results. Using ASTORID as a doping aid can be hazardous to health.

ASTORID and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Taking ASTORID enhances the effect of other blood pressure-lowering medicines, especially angiotensin-converting enzyme (ACE) inhibitors. Administering ACE inhibitors additionally or directly after ASTORID treatment may cause a sudden drop in blood pressure.
The risk of renal failure caused by ACE inhibitors may increase.
Potassium deficiency caused by ASTORID may lead to enhanced side effects of concurrently administered digitalis preparations.
ASTORID may reduce the effectiveness of diabetes medications.
Probenecid (a medicine used to treat gout) and some anti-inflammatory medicines (e.g., indomethacin, acetylsalicylic acid) may decrease the diuretic and antihypertensive effect of ASTORID. Diuretics may increase the risk of renal failure caused by such anti-inflammatory agents.
In the case of treatment with high doses of salicylates (e.g., painkillers and rheumatism treatment), their effect on the central nervous system may increase after taking ASTORID. In patients taking salicylates, the risk of gout attacks increases.
ASTORID may lead to an increase in the following side effects, especially when taken in high doses:
hearing damage, kidney damage by aminoglycoside antibiotics (e.g., kanamycin, gentamicin, tobramycin), cisplatin preparations (cancer medications that inhibit cell division), nephrotoxic agents, cephalosporins (infection treatment medications).
ASTORID may affect (enhance or weaken) the effect of theophylline (a medication used to treat asthma), as well as the muscle relaxant effect of curare-like medications. It is recommended to monitor theophylline blood levels.
Laxatives and adrenal cortex hormones (minerals, glucocorticoids, e.g., cortisone) may increase potassium loss caused by ASTORID.
Concurrent treatment with ASTORID and lithium may increase lithium blood levels, as well as potentiate lithium's cardiotoxic and nephrotoxic effects.
ASTORID may reduce the sensitivity of blood vessels to vasoconstrictor agents (e.g., adrenaline, noradrenaline).
Concurrent use of ASTORID with cholestyramine (a lipid-lowering medication) may decrease the absorption of ASTORID from the gastrointestinal tract, and thus its effect.
Torasemide is metabolized in the liver by enzymes (cytochrome P450 CYP2C8 and CYP2C9). It may interact with other medications metabolized by these same enzymes. Therefore, concurrent administration of such medications should be closely monitored to avoid undesirable blood levels of these medications. This interaction has been demonstrated, for example, for coumarin derivatives (e.g., Marcumar). Drug-drug interactions may be critical for substances with a narrow therapeutic index.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
There is insufficient knowledge about the effect of ASTORID on unborn children.
Animal studies on torasemide (the active substance in ASTORID) have not shown any harmful effects on fertility. However, after administering high doses of the active substance, an adverse effect on the unborn animal and the mother was observed.
Until further data are available, ASTORID should only be given to pregnant women when the doctor considers it absolutely necessary. In such cases, only the smallest effective dose should be used.
There is insufficient data on the penetration of torasemide, the active substance of ASTORID, into breast milk. The risk to newborns/children cannot be excluded. Loop diuretics may decrease milk production. Therefore, ASTORID should not be administered to a breastfeeding patient. If the doctor decides that it is necessary to use ASTORID during lactation, breastfeeding should be discontinued.

Driving and operating machinery

ASTORID may alter reaction time and impair the ability to drive vehicles, operate machinery, or work at heights, even if taken as intended.
This applies especially to the initial treatment period, the time after dose increase, the period after medication change, or the period after starting additional treatment with another medication, as well as interactions with alcohol.

ASTORID contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking ASTORID.

3. How to take ASTORID

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, consult your doctor or pharmacist.

Dosage

Adults
Primary arterial hypertension
The recommended initial dose is half a tablet (2.5 mg of torasemide) of ASTORID per day.
The antihypertensive effect begins in the first week of treatment, and the full therapeutic effect is achieved after approximately 12 weeks of treatment.
If blood pressure does not normalize after 12 weeks of treatment with a dose of half a tablet (2.5 mg of torasemide) per day, the dose can be increased to 1 tablet (5 mg of torasemide) per day.
The dose should not be increased above 1 tablet (5 mg of torasemide) of ASTORID per day, as this will not lead to further blood pressure reduction.
Edema and effusions
Unless the doctor recommends otherwise, treatment starts with 1 tablet of ASTORID (5 mg of torasemide) per day.
This dose is usually also the maintenance dose.
Treatment with 2 tablets of ASTORID (10 mg of torasemide) per day is indicated if the dose of 1 tablet of ASTORID (5 mg of torasemide) per day is not sufficiently effective.
In such cases, 2 tablets of ASTORID (corresponding to 10 mg of torasemide) are taken per day; depending on the severity of symptoms, the dose can be increased to 20 mg of torasemide.
If a dose of 10 mg of torasemide or more per day is needed, a pharmaceutical form containing 10 mg of torasemide is also available.
Use in children
The safety and efficacy of torasemide in children under 12 years of age have not been established.
In adolescents (12-18 years), the dosage is the same as in adults.
Patients with renal impairment
In patients with renal impairment, renal excretion is decreased, but the total blood concentration does not change significantly.
Patients with hepatic impairment
In patients with mild to moderate hepatic impairment, there is no need to adjust the dose, as the half-lives of torasemide and its metabolites are only slightly prolonged in these patients.
Torasemide should not be used in patients with severe hepatic impairment, with impaired consciousness (hepatic coma) (see section 2).
Special caution should be exercised in patients with liver cirrhosis and ascites. Special caution should be exercised when using torasemide in patients with a history of reversible brain disorders due to inadequate liver detoxification (hepatic encephalopathy).
Elderly patients
No dose modification is required in elderly patients.
Method of administration
Tablets should be taken in the morning, without chewing, with a liquid. ASTORID can be taken with or without food.
Duration of treatment
The duration of treatment with ASTORID is determined by the doctor.
If you feel that the effect of ASTORID is too strong or too weak, consult your doctor or pharmacist.

Taking a higher dose of ASTORID than recommended

Accidental or intentional ingestion of too much ASTORID may lead to excessive urine production, potentially life-threatening, with fluid and electrolyte loss, possible impaired consciousness, confusion, decreased blood pressure, circulatory collapse, and gastrointestinal disorders.
In such cases, contact your doctor immediately, who will recommend the appropriate course of action.

Missing a dose of ASTORID

Taking a lower dose or missing a dose of ASTORID reduces the medicine's effectiveness.
This may manifest in symptoms such as weight gain, increased fluid retention in the body (edema).
Take the missed dose as soon as possible. However, do not take the missed dose if it is almost time for the next dose. Do not take a double dose to make up for the missed dose, but continue treatment with the recommended dose.

Stopping treatment with ASTORID

Stopping or prematurely ending treatment may lead to worsening of symptoms.
Under no circumstances should the prescribed treatment with ASTORID be changed or discontinued without consulting a doctor.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Possible side effects:

Common (may affect up to 1 in 10 people):

• increased acid-base balance disorders (metabolic alkalosis);
• potassium deficiency (hypokalemia), especially when taking a low-potassium diet, vomiting, diarrhea, abusing laxatives, as well as in patients with chronic liver function disorders;
• depending on the dose and duration of treatment, water and electrolyte balance disorders may occur, particularly fluid loss in the blood (hypovolemia), potassium and (or) sodium deficiency (hypokalemia and (or) hyponatremia);
• headaches, dizziness;
• gastrointestinal disorders (e.g., loss of appetite, abdominal pain, nausea, vomiting, diarrhea, constipation), especially at the beginning of treatment;
• increased activity of certain liver enzymes (gamma-GT) in the blood;
• muscle cramps (especially at the beginning of treatment);
• fatigue, weakness (especially at the beginning of treatment);
• increased levels of uric acid, glucose, and lipids in the blood (triglycerides, cholesterol).

Uncommon (occurring in less than 1 in 100 people):

• numbness and feeling of cold in the limbs (paresthesia);
• dryness in the mouth;
• increased levels of urea and creatinine in the blood. In cases of urinary retention, urinary retention may occur.

Rare (occurring in less than 1 in 10,000 people):

• decreased red blood cell, white blood cell, and platelet count (decreased erythrocyte, leukocyte, and thrombocyte count);
• allergic reactions, such as itching, rash, hypersensitivity to light, and severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis);
• vision disorders;
• ringing in the ears, hearing loss;
• due to blood thickening, low blood pressure (hypotension), circulatory disorders, and decreased blood flow to the heart muscle may occur, which may cause, for example, arrhythmia, chest tightness (angina pectoris), acute heart attack, or sudden loss of consciousness (syncope);
• thromboembolic complications caused by blood thickening;
• pancreatitis.

Frequency not known (cannot be estimated from available data):

• decreased blood flow to the brain, confusion.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Poland
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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store ASTORID

Keep the medicine out of sight and reach of children.
There are no special recommendations for storing the medicine.
Do not use this medicine after the expiration date stated on the blister pack and carton after: "EXP". The expiration date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What ASTORID contains

• The active substance of ASTORID is torasemide. Each tablet contains 5 mg of torasemide.
• The other ingredients are: lactose monohydrate, cornstarch, colloidal silicon dioxide, magnesium stearate.

What ASTORID looks like and what the package contains

White to light cream-colored tablets, round, with a nominal diameter of 5 mm, convex on both sides, with a dividing line on one side.
The tablet can be divided into equal doses.
ASTORID is available in a package containing 30 tablets, in a carton box.

Marketing authorization holder and manufacturer

Polfarmex S.A.
Józefów 9
99-300 Kutno
Poland
Phone: +48 24 357 44 44
Fax: +48 24 357 45 45
Email: [email protected]

Date of last revision of the leaflet: February 2025