ASTORID 20 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is ASTORID and what is it used for
3. Important information before taking ASTORID
   1. When not to take ASTORID:
   2. Warnings and precautions
   3. ASTORID and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. ASTORID contains lactose
4. How to take ASTORID
   1. Taking a higher dose of ASTORID than recommended
   2. Missing a dose of ASTORID
   3. Stopping treatment with ASTORID
5. Possible side effects
   1. Possible side effects:
   2. Reporting side effects
6. How to store ASTORID
7. Contents of the pack and other information
   1. What ASTORID contains
   2. What ASTORID looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

ASTORID, 20 mg, tablets
Torasemide

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your 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. Contents of the pack and other information

1. What is ASTORID and what is it used for

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

2. Important information before taking ASTORID

When not to take ASTORID:

• if you are 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. liver coma) until improvement or resolution of this condition;
• in case of very low blood pressure (hypotension);
• in case of reduced blood volume (hypovolemia);
• if you have a sodium or potassium deficiency (hyponatremia, hypokalemia);
• in urinary retention 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 case 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 arrhythmias, the administration of loop diuretics may pose a potential life threat due to changes in electrolyte concentrations (potassium, sodium, calcium, magnesium). Regular blood tests for electrolyte composition, 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 the 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 reduce 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 the intensification of the following side effects, especially when taking high doses:
hearing damage, kidney damage by aminoglycoside antibiotics (e.g. kanamycin, gentamicin, tobramycin), cisplatin preparations (anticancer drugs, cell division inhibitors), nephrotoxic agents, cephalosporins (antibiotics used to treat infections).
ASTORID may affect (enhance or reduce) the effect of theophylline (a medicine used to treat asthma), as well as the muscle-relaxing effect of curare-like medicines. 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.
Concomitant 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).
Concomitant use of ASTORID with cholestyramine (a lipid-lowering agent) may reduce 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 medicines metabolized by these same enzymes. Therefore, concomitant administration of such medicines should be closely monitored to avoid undesirable blood levels of these medicines. 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 you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is no sufficient 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 administration of high doses of the active substance, an unfavorable effect on the unborn animal and the mother was observed.
Until further data are available, ASTORID should only be given to pregnant women if the doctor considers it absolutely necessary. In such cases, only the smallest effective dose should be used.
There are no sufficient data on the passage of torasemide, the active substance of ASTORID, into breast milk. The risk to newborns/infants cannot be excluded. Loop diuretics may reduce milk production. Therefore, ASTORID should not be given to a breastfeeding woman. If the doctor decides that it is necessary to use ASTORID during lactation, breastfeeding should be discontinued.

Driving and using machines

ASTORID may change 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 changing the medicine, or the period after starting additional treatment with another medicine, as well as interactions with alcohol.

ASTORID contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking ASTORID.

3. How to take ASTORID

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Adults
Recommended dose:
Unless your doctor has told you otherwise, treatment starts with a dose of 5 mg of torasemide per day.
For this purpose, tablets with the appropriate strength of the active substance are available.
This dose is usually also the maintenance dose.
Treatment with 1 tablet of ASTORID (corresponding to 10 mg of torasemide) per day is recommended if the dose of 5 mg of torasemide per day is not sufficiently effective.
In such cases, 1 tablet of ASTORID (corresponding to 10 mg of torasemide) is taken per day. If the effectiveness is insufficient, the dose can be increased to 2 tablets of ASTORID (corresponding to 20 mg of torasemide) per day, depending on the severity of the symptoms.
In individual cases, the dose can be increased to 40 mg of 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 for adults.
Patient with renal impairment
In patients with renal impairment, renal excretion is reduced, but the total blood concentration does not change significantly.
Patient 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 reversible brain disorders in the history resulting from insufficient liver detoxification (hepatic encephalopathy).
Elderly patients
No dose adjustment 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, talk to 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 excretion, potentially life-threatening, with fluid and electrolyte loss, possible impaired consciousness, confusion, blood pressure drop, circulatory collapse, and gastrointestinal disorders.
In such a case, contact your doctor immediately, who will advise on the appropriate course of action.

Missing a dose of ASTORID

Taking a lower dose or missing a dose of ASTORID reduces the effectiveness of the medicine.
This may manifest as, for example, the following symptoms: 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 stopped without consulting a doctor.
If you have any further questions about the use of this medicine, ask 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 disturbances of acid-base balance (metabolic alkalosis);
• potassium deficiency (hypokalemia), especially when taking a potassium-poor diet, vomiting, diarrhea, abusing laxatives, as well as in patients with chronic liver function disorders;
• depending on the dose and duration of treatment, disturbances of water and electrolyte balance may occur, in particular 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);
• elevated levels of uric acid, glucose, and lipids in the blood (triglycerides, cholesterol).

Uncommon (affects 1 to 10 users in 100):

• numbness and feeling of cold in the limbs (paresthesia);
• dry mouth;
• elevated levels of urea and creatinine in the blood. In case of urinary retention, urine retention may occur.

Rare (affects 1 to 10 users in 1,000):

• reduced number of red blood cells, white blood cells, and platelets (reduced number of erythrocytes, leukocytes, and thrombocytes);
• allergic reactions, e.g. 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 reduced blood flow to the heart muscle may occur. This may cause, for example,

for example, heart rhythm disorders (arrhythmia), chest tightness (angina pectoris), acute heart attack, or sudden loss of consciousness (fainting);

• thromboembolic complications caused by blood thickening;
• pancreatitis.

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

• reduced blood flow in the brain, confusion.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
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, you can help 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.
There are no special precautions for storage.
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 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: lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate.

What ASTORID looks like and contents of the pack

White to light cream-colored tablets, 12.0 x 5.4 mm in size, biconvex, with a score line on one side.
The score line is not intended for breaking the tablet.
ASTORID is available in a pack containing 30 tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Polfarmex S.A.
Józefów 9
99-300 Kutno
Poland (Poland)
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: [email protected]

Date of last revision of the leaflet: