Consumer Information for: PMS-ONDANSETRON ODT

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-ONDANSETRON ODT. Talk about any health conditions or problems you may have, including if you:

• have had an allergic reaction to medicines that are similar to pmsONDANSETRON ODT such as medicines containing granisetron or palonosetron.
• are pregnant or planning to become pregnant. pms-ONDANSETRON ODT is not recommended for use during pregnancy.
• are breast feeding or planning to breastfeed. pms-ONDANSETRON ODT can pass into your breast milk and affect your baby.
• have liver problems.
• have signs of intestinal obstruction or blockage.
• have or have had heart or blood vessel problems, including if you are at a higher risk for these problems. Risk factors include, but are not limited to, if you:
• have family members who have or have had heart or blood vessel problems,
• smoke
• have high blood pressure,
• have high cholesterol levels,
• have diabetes, or
• are overweight.
• have a condition called phenylketonuria, as pms-ONDANSETRON ODT contains aspartame
• are taking medications that affect the serotonin in your body (e.g., serotonergic and neuroleptic medications). If you are unsure, ask your healthcare professional.
• have QT/QTc prolongation (a heart rhythm condition) or a family history of QT/QTc prolongation.
• are taking medications that may lead to QT/QTc prolongation or electrolyte imbalances. If you are unsure, ask your healthcare professional.
• have low blood levels of potassium, magnesium, or calcium.

Other warnings you should know about:

Serotonin syndrome: pms-ONDANSETRON ODT can cause serotonin syndrome, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin syndrome if you take pmsONDANSETRON ODT with certain anti-depressants or migraine medications.

Serotonin syndrome symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Myocardial ischemia (lack of blood flow to the heart): Treatment with pms-ONDANSETRON ODT can cause myocardial ischemia which can lead to a heart attack. This may happen shortly after pms-ONDANSETRON ODT administration. Some symptoms of myocardial ischemia can include sudden chest pain, pressure or discomfort, feeling faint, feeling anxious, shortness of breath, irregular heartbeat, nausea, and sudden heavy sweating. Your healthcare professional will monitor your health during and after administration of pms-ONDANSETRON ODT. However, if you notice any symptoms of myocardial ischemia, tell your healthcare professional right away. They may reduce or stop your treatment, and may recommend another therapy.

QT/QTc prolongation: pms-ONDANSETRON ODT can affect the electrical activity of your heart known as QT/QTc prolongation. This effect can be measured with an electrocardiogram (ECG). In rare cases, QT/QTc prolongation can cause changes to the rhythm of your heart (e.g., fast, slow or irregular heartbeats). This can lead to dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting, or death. You are at a higher risk if you have a heart disease, are taking certain interacting medicines, are a female, or are over the age of 65 years. It is important to follow the instructions of your healthcare professional with regard to dosing or any special tests. If you experience any symptoms of a possible heart rhythm problem, you should seek immediate medical attention.

Severe allergic reactions: pms-ONDANSETRON ODT can cause allergic reactions in certain individuals. Symptoms of a severe allergic reaction can include wheezing, sudden chest pain, tightness of the chest, heart throbbing, swelling of eyelids, face or lips, or develop a skin rash, skin lumps or hives. If you notice any signs of a severe allergic reaction, contact your healthcare professional immediately. Do not take any more medicine unless your healthcare professional tells you to do so.

Pregnancy:

• If you are pregnant, there are specific risks for your unborn baby that you must discuss with your healthcare professional.
• If you are able to get pregnant, you may be asked to take a pregnancy test before starting your treatment with pms-ONDANSETRON ODT.
• You should use effective birth control while you are taking pms-ONDANSETRON ODT, and for at least 2 days after stopping pms-ONDANSETRON ODT. Ask your healthcare professional about options of effective birth control.
• If you become pregnant while taking pms-ONDANSETRON ODT, tell your healthcare professional right away.