Details for: MYLAN-ONDANSETRON
Company: MYLAN PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02297868 | MYLAN-ONDANSETRON | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) | 4 MG | TABLET | ORAL |
| 02297876 | MYLAN-ONDANSETRON | ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) | 8 MG | TABLET | ORAL |
Summary Reports
Summary Safety Review - Serotonin blocking drugs (serotonin antagonists) ALOXI® (palonosetron), ANZEMET® (dolasetron), KYTRIL® (granisetron) and generics, and ZOFRAN® (ondansetron) and generics - Serotonin Syndrome
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
The name of your medicine is Mylan-Ondansetron
Tablets (ondansetron hydrochloride dihydrate). This
medicine is one of a group called antiemetics.
Mylan-Ondansetron is used for:
- the prevention of nausea (feeling of sickness) and vomiting during treatment for cancer (chemotherapy and radiotherapy).
- the prevention and treatment of nausea and vomiting after surgery.
What it does
Treatments such as general anaesthesia, cancer chemotherapy and radiotherapy are thought to cause the release of a natural substance (serotonin), which can cause you to feel sick and to vomit. MylanOndansetron helps to stop this from happening, thus preventing you from vomiting or feeling sick.
When it should not be used
Do not take Mylan-Ondansetron if:
- you have a history of hypersensitivity (an allergic reaction) to any ingredient in Mylan-Ondansetron.
- you are taking apomorphine (used to treat Parkinson’s disease).
What the medicinal ingredient is
Mylan-Ondansetron tablets contain ondansetron hydrochloride dihydrate as the medicinal ingredient.
What the non-medicinal ingredients are
Mylan-Ondansetron tablets contain the following nonmedicinal ingredients: Lactose monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate, hypromellose, titanium dioxide, polyethlene glycol, polydextrose, triacetin and yellow iron oxide.
What dosage form it comes in
Mylan-Ondansetron tablets are supplied in two strengths, one contains 4 milligrams of ondansetron and the other contains 8 milligrams of ondansetron. Your doctor will decide which strength you need.
Warnings and precautions
Mylan-Ondansetron is not recommended for use
during pregnancy.
Breastfeeding is not recommended during
treatment with Mylan-Ondansetron. The
ingredients can pass into your breast milk and may
affect your baby.
Mylan-Ondansetron may harm your unborn baby.
If you are a woman of childbearing age, your
doctor or healthcare provider will check if you are
pregnant and perform a pregnancy test if necessary
before starting treatment with Mylan-Ondansetron.
You should use effective birth control during
treatment with Mylan-Ondansetron. Ask your
doctor about options of effective birth control.
BEFORE you use Mylan-Ondansetron talk to your
doctor or pharmacist if:
- you have a history of hypersensitivity (an allergic reaction) to any ingredient in Mylan-Ondansetron.
- you have had an allergic reaction to medicines similar to Mylan-Ondansetron such as medicines containing granisetron or palonosetron.
- you are pregnant or likely to become pregnant.
- you are breast feeding.
- you have liver problems.
- you have signs of intestinal obstruction.
- you have a history of heart problems.
Serotonin Syndrome is a rare but potentially lifethreatening reaction that may occur if you take MylanOndansetron with certain other medications. It may cause serious changes in how your brain, muscles and digestive system work. Be sure to tell your healthcare professional all the medicines you are taking.
Interactions with this medication
As with most medicines, interactions with other drugs
are possible. To avoid potentially life -threatening
reactions tell your healthcare professional about ALL
the medications you take, including those prescribed
by other doctors, vitamins, minerals, natural
supplements or alternative medicines. It is important
that your doctor know about all your medication so
that you get the best possible treatment. Tell your
doctor if you are taking carbamazepine, phenytoin, or
rifampicin. If you are taking any medicines containing
tramadol, Mylan-Ondansetron may decrease its
effectiveness.
Also, make sure you tell your doctor or pharmacist if
you are taking:
- Drugs used to treat heart rhythm disorders
- Other drugs that may disturb heart rhythm
- Antipsychotics
- Antidepressants
- Antibiotics or antifungals
- Opioid analgesics (painkillers)
- Other drugs to treat nausea and vomiting
- Asthma drugs
- Cancer drugs
- Diuretics
- Other drugs that affect serotonin including SSRI*s, SNRI**s, triptans, MAOIs*** (including the antibiotic linezolid and methylene blue), drugs that contain tryptophan, or St. John’s Wort.
**SNRI (Serotonin Noradrenalin Reuptake Inhibitors) – used to treat depression or anxiety, e.g. duloxetine, venlafaxine, desvenlafaxine.
***MAOIs (Monoamine Oxidase Inhibitors) – used to treat depression, Parkinson’s disease, e.g., phenelzine, rasagiline, selegiline.
Proper use of this medication
The label on the container of your medicine should
tell you how often to take your medicine and how
many doses you should take each time. If not, or if
you are not sure, consult your doctor or pharmacist.
Do not take more doses, or take them more often than
your doctor prescribes. If, however, you vomit within
one hour of taking your medicine, you should take the same amount of medicine again. If vomiting persists,
consult your doctor.
Usual Dose
Chemotherapy Induced Nausea and Vomiting
Based on how likely you are to experience nausea
and/or vomiting, caused by your cancer treatment,
your doctor will tell you the amount you need to take
and how frequently.
Adult: You may receive Mylan-Ondansetron before
and/or after chemotherapy. The dose of MylanOndansetron is between 8 and 24 mg a day (taken
orally) for up to 5 days depending on the potential of
your chemotherapy treatment to cause you to vomit
and/or have nausea.
Children (4 to 12 years of age): After chemotherapy,
take 4 mg orally every 8 hours for up to 5 days.
Radiotherapy Induced Nausea and Vomiting
Adult: Take 8 mg orally 1 to 2 hours before
radiotherapy. After therapy, take 8 mg orally every 8
hours for up to 5 days after a course of treatment.
Prevention of Post-Operative Nausea and Vomiting
Adult: Take 16 mg orally one hour before
anaesthesia.
If you have a liver problem, your dose may be alte red.
Please follow the instructions of your doctor.
Overdose
Missed Dose
If you miss a dose and do not feel sick, take the next
dose when it is due.
If you forget to take your medicine and feel sick or
vomit, take a dose as soon as possible.
If your doctor decides to stop the treatment, do not
keep any leftover medicine unless your doctor tells
you to.
Side effects and what to do about them
You may experience headaches, a feeling of
warmness, flushing or constipation, while taking
Mylan-Ondansetron. Although uncommon, low blood
pressure and hiccups have also been reported.
There is no need to stop taking your medicine, but you
should tell your doctor about these symptoms at your
next visit.
If your nausea (feeling of sickness) or vomiting do not
improve while taking Mylan-Ondansetron, consult
your doctor for further advice.
If you feel unwell or have any symptoms that you do
not understand, you should contact your doctor
immediately.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist | Stop taking drug and seek immediate emergency assistance | |
|---|---|---|---|
| Uncommon | |||
| Heart problems such as fast/slow heartbeat, chest pain | ✔ | ||
| Seizures | ✔ | ||
| Upward rolling of the eyes, abnormal muscular stiffness / bodymovements / shaking | ✔ | ||
| Rare | |||
| Eye problems such as blurred vision | ✔ | ||
| Immediate allergic reaction and symptoms such as swelling of the mouth, throat, difficulty in breathing, rash, hives, increased heart rate | ✔ | ||
| Disturbance in heart rhythm (dizziness, palpitations, fainting) | ✔ | ||
| Serotonin Syndrome: Symptoms of Serotonin Syndrome have been observed while taking ondansetron hydrochloride with certain other medications. Symptoms include: - agitation, confusion, restlessness, hallucinations, mood changes, unconsciousness, coma -fast heartbeat, changes in blood pressure -Muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination -nausea, vomiting, diarrhea, fever, sweating, shivering | ✔ | ||
| Very Rare | |||
| Eye problems such as temporary blindness | ✔ | ||
| Signs of serious skin reactions (skin rash, redness of the skin, blistering of the lips, eyes or mouth, and skin peeling) | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Mylan-Ondansetron, contact your doctor or pharmacist.
How to store
Keep your medicine in a safe place where children
cannot reach it. Your medicine may harm them.
Your Mylan-Ondansetron Tablets should be kept at
room temperature in a well closed container and
protected from light. Do not refrigerate or freeze.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
Remember: This medicine is for you. Only a doctor
can prescribe it for you. Never give it to someone
else. It may harm them even if their symptoms are the
same as yours.
This leaflet does not contain the complete information
about your medicine. If any questions remain unanswered or you are not sure about something, you
should ask your doctor or pharmacist.
You may want to read this leaflet again. Please Do
Not Throw It Away until you have finished your
medicine.
This document can be found at: www.mylan.ca
The full Product Monograph for health professionals
can be obtained by contacting the sponsor, Mylan
Pharmaceuticals ULC at: 1-844 596-9526
This leaflet was prepared by Mylan Pharmaceuticals
ULC Etobicoke, Ontario M8Z 2S6
Last revised: April 9, 2019
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-844 596-95261
www.mylan.ca