4 mg and 8 mg film-coated tablets
Ondansetron
What Ondansetron STADA is and what it is used for
Ondansetron Stada contains a medicine called ondansetron. This belongs to a group of medicines called antiemetics (medicines for nausea and vomiting).
Ondansetron Stada is used for:
- to prevent nausea and vomiting during chemotherapy (in children and adults) or radiation therapy for cancer (adults only).
- to prevent nausea and vomiting after surgery (adults only).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Ondansetron contained in Ondansetron Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Ondansetron STADA
Do not take Ondansetron Stada if:
- you are taking apomorphine (used to treat Parkinson’s disease )
- you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
If you are not sure, talk to your doctor, nurse, or pharmacist before taking Ondansetron Stada.
Warnings and cautions
Talk to your doctor or pharmacist before taking Ondansetron Stada if:
- you have ever had heart problems (eg heart failure causing shortness of breath and swollen ankles)
- you have an irregular heart rhythm ( arrhythmia )
- if you are allergic to ondansetron-like medicines, such as granisetron or palonosetron
- you have liver problems
- you have a blockage or obstruction in the intestine
- You have problems with the salt levels in your blood, such as potassium , sodium and magnesium .
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Ondansetron Stada.
Other medicines and Ondansetron STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ondansetron Stada can affect the way some medicines work. Some other medicines may also affect the way Ondansetron Stada works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- carbamazepine or phenytoin used to treat epilepsy
- rifampicin used to treat certain types of infections such as tuberculosis (TB)
- antibiotics such as erythromycin or ketoconazole
- antiarrhythmic drugs for irregular heartbeat
- beta blockers for certain heart or eye diseases, anxiety or to prevent migraines
- tramadol, a painkiller
- heart medicines (such as haloperidol or methadone )
- cancer drugs (especially anthracyclines and trastuzumab)
- 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.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Ondansetron Stada.
Pregnancy and breastfeeding
You should not use Ondansetron Stada during the first three months of pregnancy (first trimester). The reason is that Ondansetron Stada may increase the risk slightly that a child is born with cleft lip and/or cleft palate (opening or division in the upper lip or palate). If you are already pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking Ondansetron Stada. If you are a woman of childbearing potential, you may be advised to use contraception.
Do not breast-feed if you are taking Ondansetron Stada as small amounts of the drug are excreted in breast milk. Ask your doctor or midwife for advice.
Driving and using machines
There should be no effect on the ability to drive or use machines. However, if you get any side effects such as dizziness, tiredness, or visual disturbances, your ability to drive or use machines may be affected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Ondansetron STADA contains Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Ondansetron STADA
The tablets should be swallowed
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The dose you have been prescribed depends on the treatment you receive.
To prevent nausea and vomiting during chemotherapy or radiation therapy
On the day of chemotherapy or radiation therapy
- The usual dose for adults is 8 mg taken one to two hours before treatment and another 8 mg twelve hours after treatment.
In the following days
- The usual dose is 8 mg twice daily
- this can be given for up to five days.
Use in children (from 6 months of age) and adolescents
The doctor will determine the dose depending on the size of the child (body surface area) or weight.
- The usual dose for a child is up to 4 mg twice daily
- this can be given for up to five days.
To prevent nausea and vomiting after surgery
The usual dose for adults is 16 mg before surgery.
Use in children (from 1 month of age) and adolescents
It is recommended that ondansetron be given as an injection.
Patients with moderate or severe liver problems
The total daily dose should not exceed 8 mg.
Ondansetron begins to work within one to two hours after taking the dose.
If you vomit within an hour after taking a dose
- take the same dose again
- otherwise, do not take more Ondansetron Stada than the recommended dose one listed above in this section.
Contact your doctor or pharmacist if you continue to feel unwell.
If you take more Ondansetron Stada than you should:
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice. Take the medicine pack with you.
If you forget to take Ondansetron Stada:
If you forget to take a dose and feel sick or vomit
- take Ondansetron Stada as soon as you remember
- take the next tablet at the usual time
- Do not take a double dose to make up for a forgotten dose .
If you forget to take a dose and do not feel unwell
- take the next dose at the usual time
- Do not take a double dose to make up for a forgotten dose .
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions (may affect up to 1 in 1,000 people)
If you get an allergic reaction, stop taking the tablets immediately and contact a doctor immediately. The characters can be:
- sudden wheezing and chest pain or pressure over the chest
- swelling of eyelids, face, lips, mouth or tongue
- skin rash – red spots or lumps under the skin ( hives ) anywhere on the body
- collapse.
Other side effects include:
Very common (may affect more than 1 user in 10):
- headache
Common (may affect up to 1 in 10 people):
- feeling hot or redness
- constipation
- changes in liver function values (if you are taking Ondansetron Stada with a medicine called cisplatin, otherwise this side effect is less common)
Uncommon(may affect up to 1 in 100 people):
- hiccup.
- low blood pressure , which can make you feel dizzy or dizzy
- irregular heartbeat
- chest pain
- seizures
- unusual body movements or tremors
Rare (may affect up to 1 in 1,000 people):
- dizziness or fainting
- dimsyn
- heart rhythm disturbances (which sometimes cause sudden unconsciousness)
Very rare (may affect up to 1 in 10,000 people):
- poor eyesight or temporary vision loss, vision usually returns within 20 minutes.
How to store Ondansetron STADA
No special storage instructions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
The active substance is ondansetron (as hydrochloride dihydrate).
Each tablet contains 4 mg and 8 mg ondansetron, respectively.
Other ingredients are:
Tablet core: microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, magnesium stearate
Tablet coatings: hypromellose, hydroxypropyl cellulose, propylene glycol, sorbitan oleate, sorbic acid, vanillin, titanium dioxide (E171), quinoline yellow (E104).
What the medicine looks like and contents of the pack
4 mg tablets: An outer carton containing PVC / Aluminum blister of 6, 9, 10, 15, 30, 50, or 100 tablets.
8 mg tablets: An outer carton containing PVC / Aluminum blister of 6, 9, 10, 15, 30, 50, or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer:
Pharmathen SA, 6 Dervenakion str., 15351 Pallini, Greece
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark