Setronon

Leaflet attached to the packaging: patient information

Setronon, 8 mg, coated tablets

Ondansetron

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, pharmacist, or nurse.
• 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, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Setronon and what is it used for
• 2. Important information before taking Setronon
• 3. How to take Setronon
• 4. Possible side effects
• 5. How to store Setronon
• 6. Contents of the pack and other information

1. What is Setronon and what is it used for

Setronon contains the active substance ondansetron. This substance belongs to a group of antiemetic medicines.
Ondansetron is a 5HT3 receptor antagonist. It works by blocking the action of 5HT3 receptors located in the peripheral and central nervous system.
Setronon is used:

• to prevent and treat nausea and vomiting caused by chemotherapy and radiotherapy for cancer (in adults);
• to prevent nausea and vomiting after surgery (in adults);
• to prevent and treat nausea and vomiting caused by chemotherapy (in children).

If you need more information about taking this medicine, ask your doctor, nurse, or pharmacist.

2. Important information before taking Setronon

When not to take Setronon

• if you are allergic to ondansetron or any of the other ingredients of this medicine (see section 6).
• if you are taking apomorphine (used to treat Parkinson's disease).

If you are unsure about taking Setronon, consult your doctor, pharmacist, or nurse.

Warnings and precautions

Before taking Setronon, discuss with your doctor, pharmacist, or nurse if:

• you are allergic to medicines similar to ondansetron, such as granisetron or palonosetron;
• you have liver disease;
• you have intestinal obstruction;
• you have or may have a prolonged QT interval (a section measured in an ECG). Setronon can cause a prolonged QT interval (leading to heart rhythm disturbances) in a dose-dependent manner. In patients taking this medicine, rare cases of life-threatening heart rhythm disturbances (torsades de pointes) have been observed. This mainly concerns patients with electrolyte disturbances (abnormal levels of potassium, sodium, and magnesium in the body), patients with congenital long QT syndrome (a heart condition characterized by irregular heartbeat), heart failure, bradycardia (abnormally slow and irregular heartbeat), or patients taking medicines that cause a prolonged QT interval;
• you are taking medicines belonging to the group of selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) used to treat depression and/or anxiety disorders, as concomitant use with Setronon may cause serotonin syndrome. If concomitant use of Setronon and these medicines is necessary, the patient will be under medical supervision. The syndrome includes headache, hallucinations, accelerated thinking, confusion, anxiety, insomnia, temporary concentration problems, elevated body temperature, muscle stiffness, seizures, excessive sweating, hypertension, rapid heartbeat, nausea, vomiting, diarrhea, skin redness, and dilated pupils. If these symptoms occur, tell your doctor.

Before taking Setronon, correct hypokalemia (low potassium levels in the blood) and hypomagnesemia (low magnesium levels in the blood).
If you are unsure whether the above situations apply to you, consult your doctor or pharmacist before taking Setronon.

Tell your doctor or pharmacist immediately if you experience any of the following symptoms during and after treatment with Setronon:

• if you experience sudden chest pain or tightness in the chest (myocardial ischemia).

Setronon and other medicines

Tell your doctor, nurse, or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This includes medicines that are available without a prescription and herbal medicines. This is important because Setronon may affect the action of some medicines. Also, some other medicines may affect the action of Setronon.
In particular, tell your doctor, nurse, or pharmacist if you are taking any of the following medicines:

• carbamazepine or phenytoin, used to treat epilepsy;
• rifampicin, used to treat infections such as tuberculosis;
• tramadol, a pain reliever;
• medicines that affect the heart, including those that affect the QT interval;
• medicines that cause electrolyte disturbances;
• medicines used to treat cancer (especially anthracyclines);
• antibiotics such as erythromycin or ketoconazole;
• medicines from the group of selective serotonin reuptake inhibitors (SSRIs) used to treat depression and/or anxiety disorders, including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
• medicines from the group of serotonin-norepinephrine reuptake inhibitors (SNRIs) used to treat depression and/or anxiety disorders, including venlafaxine and duloxetine.

If you are unsure whether the above situations apply to you, consult your doctor, nurse, or pharmacist before taking Setronon.

Pregnancy and breastfeeding

Do not take Setronon during the first trimester of pregnancy. Setronon may harm the fetus. This is because Setronon may slightly increase the risk of cleft lip and/or cleft palate [a hole or gap in the upper lip and/or palate].
If you are already pregnant, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking Setronon. If you are a woman of childbearing age, you may be advised to use effective contraception.
Before starting treatment with Setronon, your doctor will check if you are pregnant and, if necessary, perform a pregnancy test. Sexually active women should use effective contraception while taking Setronon.
Ask your doctor about effective methods of contraception.
Do not breastfeed while taking Setronon, as small amounts of the medicine pass into breast milk. Consult your doctor or midwife.

Driving and using machines

Setronon has not been shown to affect the ability to drive or use machines.

Setronon contains lactose monohydrate

One Setronon tablet contains 95.6 mg of lactose monohydrate. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking Setronon.

Setronon contains sodium

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

3. How to take Setronon

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor, nurse, or pharmacist. The prescribed dose of the medicine depends on the type of treatment you are undergoing.

Adults Prevention and treatment of nausea and vomiting caused by chemotherapy with moderate emetogenic potential and radiotherapy for cancer

On the day of chemotherapy or radiotherapy:

• the usual dose is 2 tablets of 4 mg or 1 tablet of 8 mg (a total of 8 mg of ondansetron) taken 1-2 hours before treatment and 2 tablets of 4 mg or 1 tablet of 8 mg (a total of 8 mg of ondansetron) 12 hours later.

In subsequent days:

• the usual dose is 2 tablets of 4 mg or 1 tablet of 8 mg (a total of 8 mg of ondansetron) twice a day;
• such a dose can be taken for up to 5 days.

If the prescribed chemotherapy causes severe nausea and vomiting, on the first day of treatment, the patient may receive ondansetron only intravenously, intramuscularly, or rectally. The dose will be determined by the doctor. In subsequent days, the medicine is taken as in the case of chemotherapy with moderate emetogenic potential.
Prevention and treatment of nausea and vomiting after surgery
To prevent nausea and vomiting after surgery, the usual dose for adults is 4 tablets of 4 mg or 2 tablets of 8 mg (a total of 16 mg of ondansetron) taken 1 hour before surgery.
To treat nausea and vomiting in the postoperative period, it is recommended to administer ondansetron intravenously or intramuscularly.

Children aged 6 months and older and adolescents Prevention and treatment of nausea and vomiting caused by cancer chemotherapy

Your doctor will decide what dose to use.
On the day of chemotherapy:

• the first dose of ondansetron is usually given intravenously by a doctor or nurse before starting chemotherapy;
• 12 hours after chemotherapy, the medicine is usually given orally in the following doses:
  • for children with a body weight of up to 10 kg, tablets are not given, but syrup is used instead.
  • for children with a body weight over 10 kg - 1 tablet of 4 mg (a total of 4 mg of ondansetron).

In subsequent days:

• oral doses as above, twice a day, for up to 5 days.

The maximum daily dose is 32 mg of ondansetron in divided doses.

Prevention and treatment of nausea and vomiting after surgery

In children aged 1 month and older and adolescents, it is recommended to use ondansetron in the form of an injection solution.

Patient with moderate or severe liver disease

Do not take a dose greater than 8 mg per day.
Setronon should start working within 1-2 hours of taking the dose.

If vomiting occurs within 1 hour of taking the dose:

• take the same dose again;
• in other cases, do not take a higher dose than prescribed by your doctor.

If you still have nausea, inform your doctor or nurse.

Taking a higher dose of Setronon than recommended:

If an adult or childtakes a higher dose of Setronon than recommended, seek medical attention immediately. Take the packaging of the medicine with you.
In most cases of overdose, symptoms similar to side effects are observed (see section 4).

Missing a dose of Setronon

If you miss a dose of Setronon, if you have nausea or vomitingyou should:

• take the dose of Setronon as soon as possible, and then
• take the next dose at the usual time (as directed by your doctor);
• do not take a double dose to make up for the missed dose.

If you miss a dose of Setronon, if you do not have nausea or vomitingyou should:

• take the next dose at the usual time (as directed by your doctor);
• do not take a double dose to make up for the missed dose.

4. Possible side effects

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

Some side effects may be serious

Stop taking Setronon and seek medical attention immediately if you experience any of the following symptoms:

Severe allergic reactions

These occur rarely in people taking Setronon. If you experience an allergic reaction, stop taking the medicine and seek medical attention immediately. Symptoms may include:

• sudden wheezing, chest pain or tightness;
• swelling of the eyelids, face, lips, mouth, or tongue;
• red spots or patches on the skin (hives);
• fainting.

Myocardial ischemia

Symptoms include:

• sudden chest pain or
• tightness in the chest

Other side effects include:

Other possible side effects include the following effects listed below. If these effects become severe, tell your doctor, pharmacist, or healthcare provider.

Very common (occurring in more than 1 in 10 patients)

• headache.

Common (occurring in less than 1 in 10 patients)

• feeling of warmth or skin redness;
• constipation.

Uncommon (occurring in less than 1 in 100 patients)

• hiccups;
• low blood pressure, which may cause fainting or dizziness;
• slow or irregular heartbeat (heart rhythm disturbances);
• chest pain;
• seizures;
• abnormal body movements or tremors;
• changes in liver function test results.

Rare (occurring in less than 1 in 1,000 patients)

• dizziness;
• blurred vision;
• heart rhythm disturbances (sometimes causing sudden loss of consciousness), including life-threatening ventricular tachycardia of the torsades de pointes type.

Very rare (occurring in less than 1 in 10,000 patients)

• widespread rash with blisters and skin peeling, covering a large area of the body (toxic epidermal necrolysis);
• visual impairment or transient blindness, which usually resolves within 20 minutes.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 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 Setronon

Keep the medicine out of the sight and reach of children.
Store in a temperature below 30°C.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the 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. This will help protect the environment.

6. Contents of the pack and other information

What Setronon contains

The active substance of the medicine is ondansetron. Each coated tablet contains 8 mg of ondansetron in the form of ondansetron hydrochloride dihydrate.
The other ingredients of the medicine are: microcrystalline cellulose, lactose monohydrate, corn starch, magnesium stearate.
The coating contains: Opadry II white: hypromellose 15cP, lactose monohydrate, titanium dioxide (E 171), macrogol 4000, sodium citrate (E 331).

What Setronon looks like and contents of the pack

• white or almost white, round, biconvex, coated tablets with the inscription PA on one side and 934 on the other side of the tablet.

The medicine is available in packs containing 10 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53,
00-113 Warsaw
tel.: (22) 345 93 00
Manufacturer
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80,
31-546 Kraków

Date of last revision of the leaflet: