Mylan Ondansetron 4 mg/2 ml Injection

What MYLAN ONDANSETRON is: MYLAN ONDANSETRON contains the active substance ondansetron, which belongs to a group of medicines called anti-emetics.

What it is used for:

• Preventing and treating nausea and vomiting caused by chemotherapy and radiotherapy for cancer.
• Preventing and treating nausea and vomiting after an operation.

MYLAN ONDANSETRON should not be administered to you:

• if you are hypersensitive (allergic) to ondansetron or any of the other ingredients of MYLAN ONDANSETRON (listed in section 6);
• if you have a heart disorder (e.g. long QT syndrome);
• if you are taking or receiving apomorphine (medicine used to treat Parkinson’s disease);
• if you are taking or receiving other medicines that cause long QT syndrome;
• if you are allergic (hypersensitive) to ondansetron or any of the other ingredients in MYLAN ONDANSETRON injection;
• if you have just had an operation and are pregnant or breastfeeding your baby (see “Pregnancy and breastfeeding and fertility”);
• if you are within the first 12 weeks of pregnancy (see “Take special care with MYLAN ONDANSETRON”);
• if you have liver problems or liver disease.

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection if:

• you have previously had hypersensitivity reactions to similar medicines, e.g. granisetron or dolasetron;
• you have ever had heart problems (e.g. congestive heart failure which causes shortness of breath and swollen ankles);
• you have an uneven heartbeat (dysrhythmias);
• you are pregnant, as MYLAN ONDANSETRON should not be taken during the first 12 weeks of pregnancy. MYLAN ONDANSETRON increases the risk of unborn babies developing a cleft palate and/or lip (see “Pregnancy and breastfeeding and fertility”);
• you have liver problems or poor liver function – you may need a lower dose of MYLAN ONDANSETRON;
• you have problems with the levels of salts in your blood, such as potassium and magnesium (this will be determined by blood tests);
• you have a blockage in your gut (when there is a delay in the time that your stomach takes to work out and you are constipated);
• you are taking serotonin antidepressants, it may cause you to develop a condition called serotonin syndrome (this may cause you to have a high fever, feel agitated, confused, or make you tremble and you may have abrupt contractions of your muscles).

Children and adolescents

Experience is currently limited, but MYLAN ONDANSETRON was effective and well tolerated in children over the age of 4 years to prevent nausea and vomiting from chemotherapy.

Other medicines and MYLAN ONDANSETRON

Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines).

Tell your doctor if you are taking any of the following medicines:

• cancer medicines (such as anthracyclines (doxorubicin, daunorubicin or trastuzumab) may cause heart disorders;
• apomorphine (medicine used to treat Parkinson’s disease). Together this may cause low blood pressure and fainting as well as heart disorders);
• tramadol (for relief of pain – may reduce the pain effect);
• phenytoin, carbamazepine (used to treat epilepsy);
• medicines which may result in long QT syndrome (heart rhythm disorder);
• rifampicin (medicine used to treat infections like tuberculosis (TB));
• erythromycin (an antibiotic);
• ketoconazole (used to treat fungal infections);
• amiodarone (anti-arrhythmic medicine used to treat an uneven heartbeat);
• beta-blocker medicines, such as atenolol or timolol (used to treat certain heart or eye problems, anxiety or prevent migraines);
• SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram;
• SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.

MYLAN ONDANSETRON with food and drink and alcohol

You will not be able to drink or eat during the period of receiving MYLAN ONDANSETRON.

Pregnancy, breastfeeding and fertility:

You should not receive MYLAN ONDANSETRON if you are pregnant (see “Do not receive MYLAN ONDANSETRON”).

Do not share medicines prescribed for you with any other person.

• You will never be expected to give yourself a MYLAN ONDANSETRON injection. It will be given to you by a doctor or nurse who is trained in the administration of MYLAN ONDANSETRON.
• MYLAN ONDANSETRON injection will usually be given to you by a doctor or nurse by slow injection into a vein (intravenously) or into the muscle (intramuscularly) before treatment.
• The usual dose is: If you are receiving chemotherapy or radiation treatment that could cause nausea and vomiting or after undergoing an operation: The dose is individual to each patient and will be determined by your doctor.

On the day of chemotherapy or radiotherapy:

• The usual adult dose is 8 mg given by a slow injection into your vein or an injection into your muscle, just before your treatment, and another 8 mg twelve hours later.
• After chemotherapy, your medicine will usually be given by mouth as 8 mg tablets.

On the following days:

• The usual adult dose is 8 mg twice a day.
• This may be given for up to 5 days.

Elderly:

• Your doctor will determine what treatment you should receive.

Children:

• Experience is currently limited, but MYLAN ONDANSETRON was effective and well tolerated in children over the age of 4 years. The doctor will decide on your dose depending on the child’s size (body surface area) or weight.
• MYLAN ONDANSETRON will be given as an injection into the vein, just before your child’s treatment. After chemotherapy, your child’s medicine will usually be given by mouth twelve hours later.

To prevent nausea and vomiting after an operation

Adults:

• The usual dose for adults is 4 mg given by a slow injection into your vein or an injection into your muscle after your operation. For prevention of nausea and vomiting, MYLAN ONDANSETRON will be given to you just before your operation.

Children:

• For children aged over 2 years and adolescents the doctor will decide the dose. The maximum dose is 4 mg given as a slow injection into the vein after the operation. For prevention of nausea and vomiting, MYLAN ONDANSETRON will be given just before the operation.

If you have liver disease or liver problems:

• Your doctor will give you a lower dose of MYLAN ONDANSETRON (not more than 8 mg).

If you have the impression that the effect of MYLAN ONDANSETRON is too strong or too weak, tell your doctor or pharmacist.

MYLAN ONDANSETRON can have side effects. Not all side effects reported for MYLAN ONDANSETRON are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MYLAN ONDANSETRON, please consult your healthcare provider for advice.

If any of the following happens, stop receiving MYLAN ONDANSETRON and tell your doctor immediately or go to the casualty department at your nearest hospital:

• sudden wheezing and chest pain or chest tightness;
• swelling of your eyelids, face, lips, mouth, throat or tongue;
• low blood pressure (which can make you feel lightheaded or dizzy);
• skin rash - red spots or lumps under your skin (hives) anywhere on your body;
• shock;
• myocardial ischemia with symptoms such as sudden chest pain and chest tightness.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to MYLAN ONDANSETRON. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• an uneven heartbeat or disturbance in your heart rhythm;
• chest pain;
• fits (seizures).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

The following side effects have been reported frequently:

• headache;
• a feeling of warmth or flushing;
• changes to liver function test results (could be frequent if you receive MYLAN ONDANSETRON with a cancer medicine called cisplatin).

The following side effects have been reported less frequently:

• constipation;
• pain, redness and burning at the site of injection;
• unusual body movements or shaking;
• dizziness (during rapid intravenous administration);
• blurred or poor vision or temporary loss of eyesight;
• depression;
• hiccups.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of MYLAN ONDANSETRON.

• Store all medicines out of reach of children.
• Store at or below 25 °C.
• Store in the original package/container.
• Keep the container in the outer carton.
• Protect from light.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label/carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).