Astorid

Package leaflet: Information for the patient

ASTORID, 20 mg, tablets
Torasemidum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents

1. What ASTORID is and what it is used for
2. Important information before taking ASTORID
3. How to take ASTORID
4. Possible side effects
5. How to store ASTORID
6. 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 impaired heart function (heart muscle failure).

2. Important information before using ASTORID

When not to take ASTORID:

• if the patient is allergic to the active substance or to any of the other components of this medicine (listed in section 6);
• in renal failure with absence of urine production (anuria);
• in severe impairment of liver function (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 disorders of bladder emptying (e.g. due to pathological enlargement of the prostate gland);
• 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 cases of kidney dysfunction caused by nephrotoxic substances.

Warnings and precautions
Before starting treatment with ASTORID, consult your doctor or pharmacist.
Due to insufficient clinical data available so far, 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 renal impairment);
• urinary flow disorders should be corrected before initiating treatment with torasemide;
• in patients with cardiac arrhythmia, administration of loop diuretics may pose a potential life-threatening risk due to changes in electrolyte levels (potassium, sodium, calcium, magnesium). Regular blood tests to monitor electrolyte levels, 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 and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Concomitant use of ASTORID enhances the effect of other blood pressure-lowering medicines, especially angiotensin-converting enzyme (ACE) inhibitors. Administration of ACE inhibitors together with or immediately after ASTORID may cause a rapid drop in blood pressure. There may be an increased risk of renal impairment caused by ACE inhibitors.
Potassium deficiency induced by ASTORID may lead to increased adverse effects of concomitantly administered digitalis preparations.
ASTORID may reduce the effectiveness of antidiabetic medicines.
Probenecid (a medicine 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 renal impairment caused by such anti-inflammatory agents.
In patients receiving high-dose salicylates (e.g. painkillers and in rheumatism treatment), their effects on the central nervous system may be enhanced after administration of ASTORID. In patients taking salicylates, the risk of recurrent gout attacks increases.
ASTORID may exacerbate 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 (medicines used in cancer treatment that inhibit cell division), nephrotoxic agents, cephalosporins (medicines used to treat infections).
ASTORID may affect (enhance or reduce) the action of theophylline (a medicine used in asthma treatment), as well as the muscle-relaxing effects of drugs similar to curare. Monitoring of theophylline blood levels is recommended.
Laxatives and adrenal cortex hormones (mineralocorticoids, glucocorticosteroids, e.g. cortisone) may increase potassium loss induced by ASTORID.
Concomitant use of ASTORID and lithium may increase lithium blood levels and may also potentiate lithium's cardiotoxic and nephrotoxic effects.
ASTORID may reduce arterial sensitivity to vasoconstrictive drugs (e.g. adrenaline, noradrenaline).
Concomitant use of ASTORID with cholestyramine (a lipid-lowering medicine) 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. Such interactions have been demonstrated, for example, with coumarin derivatives (e.g. Marcumar).
Drug-drug interactions may be critically important for substances with a narrow therapeutic index.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
There is insufficient knowledge regarding the effects of ASTORID on unborn children.
Animal studies with torasemide (the active substance) in ASTORID did not show harmful effects on fertility. However, administration of high doses of the active substance resulted in adverse effects on the unborn animal and the mother.
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 treatment with ASTORID 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 after starting additional treatment with another medicine, 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 the medicine ASTORID

This medicine should always be taken exactly as directed by your doctor or pharmacist. In case of doubt,
consult your doctor or pharmacist.
Adults
Recommended dose:
Unless otherwise prescribed by your doctor, treatment should be initiated at a dose of 5 mg torasemide per day.
Tablets with the appropriate strength of active substance are available for this purpose.
This dose is usually also the maintenance dose.
Treatment with 1 tablet of ASTORID (corresponding to 10 mg torasemide) per day is indicated
if the dose of 5 mg torasemide per day is insufficiently effective.
In such cases, take 1 tablet of ASTORID (corresponding to 10 mg torasemide) per day. If efficacy is inadequate,
the dose may be increased to 2 tablets of ASTORID (corresponding to 20 mg torasemide) per day,
depending on the severity of symptoms.
In individual cases, the dose may be increased up to 40 mg torasemide per day.
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 kidney function, renal excretion is reduced, but total plasma concentration does not change significantly.
Patients with hepatic impairment
Dose adjustment is not necessary in patients with mild to moderate liver dysfunction, since 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).
Special caution is required in patients with liver cirrhosis and ascites. Particular care should be taken when administering torasemide to patients with reversible brain disorders in their medical history due to impaired hepatic detoxification function (hepatic encephalopathy).
Elderly patients
Dose modification is not required in elderly patients.
Method of administration
Tablets should be taken whole in the morning, unchewed, with liquid. ASTORID may be taken with or without food.
Duration of treatment
The duration of treatment with ASTORID is determined by the treating physician.
If you feel that the effect of ASTORID is too strong or too weak, consult your doctor or pharmacist.
Taking more ASTORID than recommended
Accidental or intentional ingestion of an excessive amount of ASTORID may lead to excessive diuresis, potentially dangerous, with loss of fluids and electrolytes, possible disturbances in consciousness, confusion, drop in blood pressure, circulatory collapse, and gastrointestinal symptoms.
In such a case, contact your doctor immediately. The doctor will recommend appropriate management.
Missing a dose of ASTORID
Taking too low a dose or missing a dose of ASTORID reduces the effectiveness of the medicine.
This may manifest, for example, as weight gain and increased fluid retention (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 a missed dose; instead, continue treatment with the recommended dose.
Stopping ASTORID treatment
Stopping or prematurely discontinuing treatment may lead to worsening of symptoms.
Under no circumstances should you alter or discontinue the prescribed treatment with ASTORID without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Possible adverse effects:
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, overuse of laxatives, or in patients with chronic liver dysfunction;
• depending on dose and duration of treatment, disturbances in water and electrolyte balance may occur, particularly loss of fluid in the blood (hypovolemia), potassium 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);
• elevated levels of uric acid, glucose, and lipids (triglycerides, cholesterol) in blood.

Uncommon (affects 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 urination disorders, urinary retention may occur.

Very rare (affects fewer than 1 in 10,000 people):

• reduced number of red blood cells, white blood cells, and platelets (decreased erythrocytes, leukocytes, and thrombocytes);

• allergic reactions, such as itching, rash, photosensitivity, and severe skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis);

• visual disturbances;

• ringing in the ears (tinnitus), hearing loss;

• due to blood concentration, low blood pressure (hypotension), circulatory disturbances, and reduced blood flow to the heart muscle may occur. This may lead to, for example, heart rhythm disorders (arrhythmia), chest pain (angina pectoris), acute myocardial infarction, or sudden loss of consciousness (fainting);

• thromboembolic complications due to blood concentration;

• pancreatitis.

Frequency unknown (cannot be estimated from available data):

• reduced blood flow to the brain, confusion states.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 181C
PL-02-222 Warsaw
Tel.: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store ASTORID

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the blister and the outer carton
after "EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the pack and other information

What ASTORID contains

• The active substance is torasemide. Each tablet contains 20 mg of torasemide.
• The other ingredients are: monohydrate lactose, maize starch, colloidal anhydrous silica, magnesium stearate.

What ASTORID looks like and contents of the pack
White to off-white tablets, oblong, measuring 12.0 x 5.4 mm, biconvex, with a breakline on one side.
The breakline is not intended for breaking the tablet.
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]