Atossa

Leaflet attached to the packaging: patient information

Atossa, 8 mg, coated tablets

Ondansetron

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Atossa and what is it used for

Atossa contains the active substance ondansetron, which belongs to the group of antiemetic medicines, specifically selective serotonin receptor antagonists (5HT).

Indications for use

Atossa is used:

• to prevent and control nausea and vomiting caused by chemotherapy (in adults and children with a body surface area greater than 1.2 m) and radiation therapy for cancer (in adults),
• to prevent nausea and vomiting after surgical operations (in adults).

Please consult a doctor, pharmacist, or nurse if the patient needs additional information about taking the medicine.

2. Important information before taking Atossa

When not to take Atossa:

• if the patient is allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking apomorphine (used to treat Parkinson's disease). If the above situations apply to the patient, they should discuss this with their doctor before taking Atossa.

Warnings and precautions

Before starting treatment with Atossa, the patient should discuss the following with their doctor or pharmacist:

• if the patient is allergic to other medicines similar to ondansetron, such as granisetron or palonosetron,
• if the patient has or may have a prolonged QT interval (a section measured in an EKG recording). Atossa can cause a prolongation of the QT interval (resulting in heart rhythm disturbances) in a dose-dependent manner. In patients taking this medicine, rare cases of life-threatening arrhythmias (Torsade de Pointes) have been observed. This is especially true for 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 prolong the QT interval,
• if the patient has had heart problems (e.g., heart failure, which can cause shortness of breath and swelling of the ankles),
• if the patient is taking medicines that belong to the group of selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs) (used to treat depression and/or anxiety disorders), or buprenorphine (used to treat opioid addiction or severe pain) at the same time. Concurrent use of Atossa with these medicines may cause serotonin syndrome. If concurrent use of Atossa and these medicines is necessary, the patient will be under close medical supervision. Serotonin syndrome includes symptoms such as headache, hallucinations, accelerated thinking, confusion, agitation, insomnia, temporary difficulties with concentration, elevated body temperature, muscle stiffness, seizures, excessive sweating, hypertension, rapid heartbeat, nausea, vomiting, diarrhea, flushing, and dilated pupils. If these symptoms occur, the patient should inform their doctor,
• if the patient has intestinal obstruction,
• if the patient has recently had their tonsils removed, as treatment with ondansetron may mask symptoms of internal bleeding,
• if the patient has liver function disorders - in these patients, a dose of more than 8 mg of Atossa per day should not be used.

Before taking Atossa, the patient should correct hypokalemia (low potassium levels in the blood) and hypomagnesemia (low magnesium levels in the blood).

The patient should immediately inform their doctor or pharmacist if they experience

any of the following symptoms during or after treatment with Atossa:

• if the patient experiences sudden chest pain or a feeling of pressure in the chest (myocardial ischemia).

Children and adolescents

In the case of using ondansetron in children and adolescents in combination with chemotherapy that is toxic to the liver, the doctor should carefully monitor for liver function disorders.

Atossa and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is important because Atossa may affect the action of some medicines. Also, some other medicines may affect the action of Atossa.

• apomorphine - concurrent use of this medicine with apomorphine (used to treat Parkinson's disease) is contraindicated, as it may cause a drop in blood pressure and loss of consciousness;
• phenytoin or carbamazepine used to treat epilepsy, as this may decrease the level of ondansetron in the blood;
• rifampicin used to treat infections such as tuberculosis, as this may decrease the level of ondansetron in the blood;
• tramadol - a pain reliever, as the action of tramadol may be weakened;
• antiarrhythmic medicines used to treat heart rhythm disorders;
• beta-adrenergic blockers used to treat certain heart diseases or eye diseases, anxiety, and to prevent migraines;
• medicines that affect the heart, including those that affect the QT interval;
• medicines that cause electrolyte disturbances;
• medicines used to treat cancer (especially anthracyclines and trastuzumab);
• antibiotics (such as erythromycin) or antifungal medicines (such as 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, and escitalopram;
• medicines from the group of serotonin and norepinephrine reuptake inhibitors (SNRIs) used to treat depression and/or anxiety disorders, including venlafaxine and duloxetine,
• buprenorphine (used to treat opioid addiction or severe pain).

If the patient is not sure whether the above situations apply to them, they should consult their doctor, nurse, or pharmacist before taking Atossa.

Atossa with food and drink

Atossa can be taken with food and drink. The tablets should be swallowed with a glass of water.

Pregnancy, breastfeeding, and fertility

Atossa should not be used during the first trimester of pregnancy, as it may slightly increase the risk of cleft lip and/or palate. If the patient is already pregnant, suspects pregnancy, or plans to become pregnant, they should consult their doctor or pharmacist before taking Atossa.

If the patient can become pregnant, they will receive advice on the use of effective contraception.

During treatment with Atossa, breastfeeding should be avoided, as small amounts of ondansetron pass into breast milk. The patient should consult their doctor or midwife.

Driving and using machines

It has not been shown that Atossa impairs the performance of tasks or causes sedation.

Atossa contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking Atossa.

3. How to take Atossa

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

The doctor will decide on the appropriate dosage for the patient. The prescribed dose of the medicine depends on the treatment used in the patient.

The 8 mg Atossa tablet should be swallowed whole, with a glass of water.

The 8 mg Atossa tablets are not divisible - they should not be divided.

There are oral medicines available on the market that contain ondansetron with a lower strength - 4 mg.

There are also medicines available on the market that contain ondansetron in a form for rectal use and parenteral use.

Prevention of nausea and vomiting caused by chemotherapy with moderate emetogenic potential and radiation therapy for cancer

Adults

On the day of chemotherapy or radiation therapy:

• the recommended oral dose is 8 mg taken 1-2 hours before chemotherapy or radiation therapy, and then 8 mg orally after 12 hours,

In subsequent days:

• the recommended oral dose is 8 mg twice a day, which can be used for up to 5 days.

In chemotherapy with high emetogenic potential

If chemotherapy or radiation therapy may cause severe nausea or vomiting, the doctor may decide to administer the first dose of ondansetron in an injectable or rectal form.

The doctor will decide on the dose. In subsequent days, the medicine is used as in the case of chemotherapy with moderate emetogenic potential (see above).

Children from 6 months and adolescents

The doctor will decide on the dose depending on the size of the child (body surface area) or body weight.

The 8 mg Atossa tablets are not suitable for use in children.

In such cases, the doctor will prescribe ondansetron in the form of a syrup or for injection.

Prevention of nausea and vomiting after surgical operations

Adults

The recommended oral dose is 16 mg of ondansetron 1 hour before surgery.

In the treatment of nausea and vomiting in the postoperative period, it is recommended to administer ondansetron intravenously or intramuscularly.

Children over 1 month and adolescents

In the prevention of nausea and vomiting after surgical operations in children, ondansetron is used in the form of an injection (slow intravenous injection).

Special patient populations

Elderly patients

Usually, no dose adjustment or change in administration frequency is necessary.

Patients with moderate or severe liver function disorders

A dose of more than 8 mg of ondansetron per day should not be used.

Atossa should start working within 1-2 hours of taking the dose.

In case of vomiting within 1 hour of taking the dose:

• the patient should take the same dose again;
• in other cases, the patient should not take a higher dose than recommended by the doctor. If the patient still has nausea, they should inform their doctor or nurse.

Use of a higher than recommended dose of Atossa

If an adult or child takes a higher dose of Atossa than recommended, they should immediately contact their doctor or go to the hospital.

The patient should take the packaging of the medicine with them.

In most cases of overdose, symptoms similar to side effects are observed (see section 4).

Missing a dose of Atossa

If the patient misses a dose and has nausea or vomiting:

• they should take Atossa as soon as possible,
• then take the next tablet at the usual time (according to the doctor's instructions),
• they should not take a double dose to make up for the missed dose.

If the patient misses a dose but does not have nausea:

• they should take the next dose at the usual time (according to the doctor's instructions),
• they should not take a double dose to make up for the missed dose.

Stopping treatment with Atossa

It may happen that nausea and vomiting return.

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Some side effects may be serious

The patient should STOP taking Atossa and seek immediate medical attention if they experience any of the following symptoms:

Severe allergic reactions: occur rarely in people taking ondansetron. Symptoms may include:

• sudden wheezing, chest pain or tightness,
• swelling of the eyelids, face, lips, mouth, or tongue,
• skin rash, which may be itchy, red, or inflamed, in various parts of the body,
• fainting.

Myocardial ischemia. Symptoms include:

• sudden chest pain or
• a feeling of pressure in the chest.

Other possible side effects:

Other possible side effects include the following side effects. The patient should inform their doctor, pharmacist, or healthcare provider if these symptoms become serious.

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

• headache.

Common (occurring in less than 1 in 10 patients but more than 1 in 100 patients)

• feeling of warmth (sudden flushing) or feeling of heat;
• constipation;
• changes in liver function test results (if Atossa tablets are taken with cisplatin, in other cases this side effect occurs infrequently).

Uncommon (occurring in less than 1 in 100 patients but more than 1 in 1000 patients)

• seizures;
• involuntary movements of the body or tremors, rolling of the eyes;
• irregular heartbeat (arrhythmia);
• slow heartbeat (bradycardia);
• chest pain;
• low blood pressure, which may cause dizziness or fainting;
• hiccups;
• changes in liver function test results.

Rare (occurring in less than 1 in 1000 patients but more than 1 in 10,000 patients)

• dizziness,
• vision disturbances, such as blurred vision.
• heart rhythm disturbances (sometimes causing sudden loss of consciousness), including life-threatening arrhythmias (Torsade de Pointes) .

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

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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

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, it is possible to gather more information on the safety of the medicine.

5. How to store Atossa

Store in a temperature below 25°C, protect from moisture.

The medicine should be stored in a place that is out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Atossa contains

• The active substance of Atossa is ondansetron (in the form of ondansetron hydrochloride dihydrate). One tablet contains 8 mg of ondansetron.
• The other excipients are: lactose monohydrate, microcrystalline cellulose, maize starch, colloidal silicon dioxide, magnesium stearate, hypromellose, macrogol 6000, glycerol, titanium dioxide (E171), yellow iron oxide (E172).

What Atossa looks like and contents of the pack

Yellow, smooth, convex tablets.

One pack contains 10 tablets, in blisters of aluminum/PVC, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Egis Pharmaceuticals PLC

Keresztúri út 30-38

1106 Budapest, Hungary

Manufacturer

Egis Pharmaceuticals PLC

1106 Budapest

Bökényföldi út 118-120

Hungary

To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:

EGIS Polska Sp. z o.o.

ul. Komitetu Obrony Robotników 45 D

02-146 Warsaw

Phone number: +48 22 417 92 00

Date of last revision of the leaflet: 01.06.2022