Package leaflet: Information for the patient

ASTORID, 5 mg, tablets
Torasemidum
Please read the entire 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 questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents

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

1. What ASTORID is and what it is used for

ASTORID is a diuretic and antihypertensive medicine belonging to the group of
loop diuretics.
ASTORID is used to treat and prevent recurrence of fluid retention
in tissues (cardiac oedema) and (or) fluid accumulation in body cavities (effusions), which may
occur due to heart function disorders (heart muscle insufficiency), as well as in the treatment of primary arterial hypertension.

2. Important information before using ASTORID

When not to take ASTORID:

if the patient is allergic to the active substance or any of the other components of this medicine (listed in section 6);
in renal failure with absence of urine production (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 reduced circulating 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;
in high-grade cardiac conduction disturbances (e.g. sinoatrial block, second- or third-degree atrioventricular block);
when undergoing concomitant treatment with certain antibiotics (aminoglycosides, cephalosporins);
in kidney dysfunction caused by nephrotoxic substances.

Warnings and precautions
Before starting treatment with ASTORID, consult your doctor or pharmacist.
As there are currently insufficient study results, ASTORID should not be used in the following cases:

pathological disturbances in acid-base balance;
pathological changes in blood morphology (e.g. thrombocytopenia or anemia in patients without kidney dysfunction);
urinary flow disorders should be corrected before initiating torasemide treatment;
in patients with cardiac arrhythmia, administration of loop diuretics may pose a life-threatening risk due to changes in electrolyte levels (potassium, sodium, calcium, magnesium). Regular blood tests to monitor electrolyte composition, especially potassium and calcium, are required.

Effect on doping tests
Use of ASTORID may result in positive anti-doping test results. Using ASTORID as a doping aid may be hazardous to health.

ASTORID with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Treatment with ASTORID enhances the blood pressure-lowering effect of other antihypertensive drugs, especially angiotensin-converting enzyme (ACE) inhibitors. Concomitant or immediate administration of ACE inhibitors after ASTORID treatment may cause a rapid drop in blood pressure. The risk of kidney failure caused by ACE inhibitors may increase.
Potassium deficiency induced by ASTORID may lead to increased adverse effects of concomitantly administered digitalis preparations.
ASTORID may reduce the effectiveness of antidiabetic medications.
Probenecid (a drug used in the treatment of gout) and certain anti-inflammatory drugs (e.g. indomethacin, acetylsalicylic acid) may reduce the diuretic and antihypertensive effects of ASTORID. Diuretics may increase the risk of kidney failure caused by such anti-inflammatory agents.
When treating with high doses of salicylates (e.g. painkillers and drugs used in rheumatism treatment), their effects on the central nervous system may increase after administration of ASTORID. In patients taking salicylates, the risk of recurrent gout attacks increases.
ASTORID may intensify the following adverse effects, especially when high doses are used:
hearing and kidney damage caused by aminoglycoside antibiotics (e.g. kanamycin, gentamicin, tobramycin), cisplatin preparations (drugs used in cancer treatment that inhibit cell division), nephrotoxic drugs, cephalosporins (drugs used to treat infections).
ASTORID may influence (enhance or reduce) the effect of theophylline (a drug used in asthma treatment), as well as the muscle-relaxing effect of drugs similar to curare. Monitoring of blood theophylline levels is recommended.
Laxatives and adrenal cortex hormones (mineralocorticoids, glucocorticoids, e.g. cortisone) may increase potassium loss caused by ASTORID.
Concomitant treatment with ASTORID and lithium may increase lithium blood levels and may also potentiate the cardiotoxic and nephrotoxic effects of lithium.
ASTORID may reduce arterial sensitivity to vasoconstrictive drugs (e.g. adrenaline, noradrenaline).
Concomitant use of ASTORID with cholestyramine (a lipid-lowering drug) may reduce gastrointestinal absorption of ASTORID and thus its effectiveness.
Torasemide is metabolized in the liver by enzymes (cytochrome P450 CYP2C8 and CYP2C9). It may interact with other drugs metabolized by the same enzymes. Therefore, concomitant administration of such drugs should be closely monitored to avoid undesirable blood concentrations of these drugs. This interaction has been demonstrated, for example, with 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 she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
There is insufficient knowledge regarding the effects of ASTORID on the unborn child.
Animal studies with torasemide (the active substance) in ASTORID did not show any harmful effects on fertility. However, after administration of high doses of the active substance, adverse effects on the unborn animal and the mother were observed.
Until further data are available, ASTORID should be administered to pregnant women only if the physician considers it absolutely necessary. In such cases, only the lowest effective dose should be used.
There are insufficient data on the passage of torasemide, the active substance of ASTORID, into human breast milk. Risk to newborns/infants cannot be excluded. Loop diuretics may reduce milk production. Therefore, ASTORID must not be administered to patients during breastfeeding. If the physician decides that ASTORID treatment is necessary during lactation, breastfeeding must 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 when used as directed. This particularly applies during the initial treatment period, after dose increase, after switching medications, or when starting additional treatment with another drug, as well as in combination with alcohol.

ASTORID contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking ASTORID.

3. How to use ASTORID

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Dosage
Adults
Primary arterial hypertension
The recommended initial dose is half a tablet (2.5 mg torasemide) of ASTORID per day.
Antihypertensive effects begin during the first week of treatment, and full therapeutic effect is
achieved after approximately 12 weeks of treatment.
If blood pressure has not normalized after 12 weeks of treatment with a dose of half a tablet (2.5 mg
torasemide) per day, the dose may be increased to 1 tablet (5 mg torasemide) per day.
The dose should not exceed 1 tablet (5 mg torasemide) of ASTORID per day, as this will not
further reduce blood pressure.
Edema and effusions
Unless otherwise directed by a physician, treatment should be initiated with 1 tablet of ASTORID (5 mg torasemide) per day.
This dose is usually also the maintenance dose.
Treatment with 2 tablets of ASTORID (10 mg torasemide) per day is indicated if the dose of 1 tablet of ASTORID (5 mg torasemide) per day is insufficiently effective.
In such cases, 2 tablets of ASTORID (corresponding to 10 mg of torasemide) are taken daily; depending on the severity of symptoms, the dose may be increased up to 20 mg of torasemide.
If a dose of 10 mg of torasemide or more per day is required, 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 impaired renal function, renal excretion is reduced, but total blood concentration does not change significantly.
Patients with hepatic impairment
In patients with mild to moderate liver dysfunction, dosage adjustment is not necessary, as the half-lives of torasemide and its metabolites are only slightly prolonged in these patients.
Torasemide must not be used in patients with severe liver dysfunction or disturbances of consciousness (hepatic coma) (see section 2).
Particular caution is required in patients with liver cirrhosis and ascites. Special caution should be exercised when administering torasemide to patients with a history of reversible brain disturbances due to impaired hepatic detoxification function (hepatic encephalopathy).
Elderly patients
Dosage modification is not required in elderly patients.
Method of administration
Tablets should be taken in the morning, whole, with liquid. ASTORID may be taken with or without food.
Duration of treatment
The duration of treatment with ASTORID is determined by the attending physician.
If the effect of ASTORID appears too strong or too weak, consult a physician or pharmacist.
Overdose of ASTORID
Accidental or intentional ingestion of an excessive amount of ASTORID may lead to excessive diuresis, potentially dangerous fluid and electrolyte loss, possible disturbances of consciousness, confusion, hypotension, circulatory collapse, and gastrointestinal symptoms.
In such cases, contact a physician immediately for appropriate management.
Missed dose of ASTORID
Taking too low a dose or missing a dose of ASTORID reduces the effectiveness of the medicine.
This may manifest, among others, as weight gain and increased fluid retention (edema).
The missed dose should be taken as soon as possible. However, if it is close to the time for the next dose, the missed dose should not be taken. Do not take a double dose to make up for a missed dose; continue treatment with the recommended dose.
Discontinuation of ASTORID
Stopping or prematurely discontinuing treatment may lead to worsening of symptoms.
Under no circumstances should the prescribed treatment with ASTORID be changed or discontinued without consulting a physician.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Possible adverse reactions:

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

increased acid-base imbalance (metabolic alkalosis);
potassium deficiency (hypokalaemia), particularly when combined with a low-potassium diet, vomiting, diarrhoea, laxative abuse, and also in patients with chronic liver function disorders;
depending on dose and duration of treatment, disturbances in water and electrolyte balance may occur, particularly loss of blood volume (hypovolaemia), potassium deficiency and (or) sodium deficiency (hypokalaemia and (or) hyponatraemia);
headache, dizziness;
gastrointestinal disturbances (e.g. loss of appetite, abdominal pain, nausea, vomiting, diarrhoea, constipation), especially at the beginning of treatment;
increased activity of certain liver enzymes (gamma-GT) in 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 (triglycerides, cholesterol) in blood.

Uncommon (may affect up to 1 in 100 people):

numbness and cold sensation in the extremities (paraesthesia);
dryness of the mouth;
increased levels of urea and creatinine in blood. In case of urinary disorders, urine retention may occur.

Very rare (may affect up to 1 in 10,000 people):

reduced number of red blood cells, white blood cells and platelets (reduction in erythrocytes, leukocytes and thrombocytes);
allergic reactions, for example itching, rash, photosensitivity and severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis);
visual disturbances;
tinnitus, hearing loss;
due to blood concentration, low blood pressure (hypotension), circulatory disturbances and reduced blood flow to the myocardium may occur. This may lead, for example, to cardiac arrhythmias, chest pain (angina pectoris), acute myocardial infarction or sudden loss of consciousness (fainting);
thromboembolic complications caused by blood concentration;
pancreatitis.

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

reduced cerebral blood flow, confusional states.

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

5. How to store ASTORID

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the specified month.
Medicines should 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 pack and other information

What the medicine ASTORID contains

The active substance is torasemide. Each tablet contains 5 mg of torasemide.
The other ingredients are: lactose monohydrate, maize starch gelatinised, colloidal anhydrous silica, magnesium stearate.

What the medicine ASTORID looks like and contents of the pack
White to off-white tablets, round, with a nominal diameter of 5 mm, biconvex, with a break line on one side.
The tablet can be divided into equal doses.
ASTORID is available in packs containing 30 tablets, in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: + 48 24 357 44 44
Fax: + 48 24 357 45 45
e-mail: [email protected]