2 mg / ml solution for injection
ondansetron
What Ondansetron Hexal is and what it is used for
Adults
Ondansetron Hexal is given prophylactically and as a treatment for nausea and vomiting in connection with chemotherapy, radiation therapy, or surgery.
Ondansetron Hexal belongs to a group of medicines called serotonin ( 5-HT 3 ) receptor antagonists and works by blocking the signals in the body that cause nausea and vomiting.
Children
Ondansetron Hexal is given prophylactically and as a treatment for nausea and vomiting in connection with chemotherapy for children who are 6 months and older and in connection with surgery for children who are 1 month and older.
Ondansetron contained in Ondansetron Hexal may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Hexal
Do not use Ondansetron Hexal
- if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
- if you are hypersensitive to other medicines belonging to the group serotonin ( 5-HT 3 ) – receptor antagonist (eg granisetron , dolasetron). Then you may also be hypersensitive to Ondansetron Hexal.
- if you are taking apomorphine, a medicine used to treat Parkinson’s disease .
Warnings and cautions
Talk to your doctor or pharmacist before using Ondansetron Hexal:
- if you have a blockage or obstruction in the intestine (intestinal obstruction).
- if you have impaired liver function
- during surgery of the tonsils .
- if you have heart problems, such as irregular heartbeat ( arrhythmia ) and if you are taking any medicines for this problem.
- if you have a problem with the salt balance in the blood.
- if you use other drugs that affect the same signaling system in the brain as Ondansetron Hexal e.g. antidepressants
Contact your doctor if you have breathing problems, as breathing problems can be a precursor to a hypersensitivity reaction.
Other medicines and Ondansetron Hexal
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Ondansetron Hexal if you are taking apomorphine (for Parkinson’s disease ).
Ondansetron Hexal and some other medicines may affect each other’s effects. You must tell your doctor if you are taking medicines that contain:
- phenytoin or carbamazepine (antiepileptic medicines ) .
- rifampicin ( antibiotic for tuberculosis ).
- tramadol (painkiller).
- SSRIs (selective serotonin reuptake inhibitors) including citalopram , fluoxetine , fluvoxamine, paroxetine , escitalopram and sertraline – are used to treat depression and / or anxiety.
- SNRIs (selective serotonin – and norepinephrine reuptake inhibitors) including venlafaxine and duloxetine – are used to treat depression and / or anxiety.
Concomitant use of Ondansetron Hexal with medicinal products that may cause ECG changes may lead to further ECG changes.
The risk of irregular heartbeat may increase when Ondansetron Hexal is used concomitantly with anthracyclines.
When using Ondansetron Hexal and other drugs that affect the same signaling system in the brain e.g. drugs for depression, the serotonergic syndrome has been reported.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should not use Ondansetron Hexal during the first three months of pregnancy (first trimester). The reason is that Ondansetron Hexal may increase the risk of a child giving birth with cleft lip and/or cleft palate (opening or splitting 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 Hexal. If you are a woman of childbearing potential, you may be advised to use contraception.
Breast-feeding
Children who are breastfed may be affected. Ondansetron Hexal should not be used if you are breast-feeding other than on a doctor’s prescription.
Driving and using machines
Studies show that Ondansetron Hexal does not affect your ability to drive or use machines. However, some side effects (blurred vision, dizziness) may occur.
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.
Ondansterone Hexal contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’.
How to use Ondansetron Hexal
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Ondansetron Hexal is given by a doctor or nurse
Nausea and vomiting associated with chemotherapy and radiation therapy:
Adults: The usual dose is 8 mg given as an injection or infusion before chemotherapy or radiation therapy. Thereafter, treatment is usually continued with ondansetron tablets.
Ondansetron Hexal can also be given in the following ways in connection with severe nausea-inducing chemotherapy:
- 8 mg given as an injection immediately before chemotherapy, possibly followed by an additional dose of 8 mg up to a maximum daily dose of 32 mg.
- Alternatively, up to 16 mg is given as a continuous infusion for at least 15 minutes immediately before chemotherapy.
A single dose of more than 16 mg must not be given due to an increased risk of severe heart rhythm disturbances with a rapid, irregular heartbeat (see section 4).
After 24 hours, the treatment is usually switched to ondansetron tablets.
Older:
In patients 75 years of age or older, the first intravenous dose of Ondansetron Hexal should not exceed 8 mg. This dose may be followed by two additional 8 mg intravenous doses given at least 4 hours apart. All intravenous doses should be given as a continuous infusion over at least 15 minutes.
Children and adolescents (aged 6 months to 17 years):
Dose one is individual and is calculated by the doctor based on the child’s weight or body surface area.
Ondansetron Hexal is given as an injection immediately before chemotherapy and the dose should not exceed 8 mg. If dose one is calculated based on body weight, two additional intravenous doses may be given at 4-hour intervals. Oral dosing can be started 12 hours later and continued for up to 5 days. The total daily dose should not exceed the maximum adult dose of 32 mg.
Nausea and vomiting after surgery:
Adults, prevention and treatment:
The usual dose is 4 mg one hour before anesthesia.
Elderly, prevention and treatment:
Experience in the treatment of nausea after surgery in elderly patients is limited. However, Ondansetron Hexal is well tolerated by patients over 65 years of age in chemotherapy and radiation therapy
Children and adolescents (aged 1 month to 17 years), prevention and treatment:
Dose one is individual and is calculated by the doctor based on the weight of the child.
A single dose of ondansetron is given as a slow intravenous injection (for at least 30 seconds) at a maximum dose of 4 mg either before, during, or after anesthesia.
Hepatic impairment:
The daily dose should not exceed 8 mg if you have moderate to severe hepatic impairment.
If you take more Ondansetron Hexal than you should
A doctor or nurse will give you or your child Ondansetron Hexal, so it is unlikely that you or your child will receive too much. If you think you or your child have taken too much or missed a dose, tell your doctor or nurse.
Symptoms of overdose:
Blurred vision, double vision, dizziness, headache, fatigue, fast or slow heartbeat, low blood pressure, severe constipation, involuntary muscle cramps, muscle twitching, restlessness, overactivity, hallucinations are conceivable.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a healthcare professional immediately if you get any of the following severe allergic reactions:
- hypersensitivity reaction with fever, rash, swelling and sometimes drop in blood pressure (anaphylactic shock , rare)
- severe widespread skin damage (skin detachment of the epidermis and superficial mucous membranes), ( toxic epidermal necrolysis , very rare).
Other possible side effects:
Very common (may affect more than 1 user in 10):
- headache.
Common (may affect up to 1 in 10 people):
- feeling of heat, hot flashes
- constipation
- local reactions at the injection site (for intravenous administration ).
Uncommon (may affect up to 1 in 100 people):
- movement disorders, involuntary muscle twitching, painful movements. Eye cramps when the eyes are forced in a certain direction, which can give a dizzy-like experience.
- seizures
- irregular heartbeat or slow heartbeat
- chest pain
- low blood pressure
- hiccup
- elevated liver values in liver function tests.
Rare (may affect up to 1 in 1,000 people):
- hypersensitivity reaction er
- transient vision changes such as blurred vision (occurs mainly during injection therapy)
- dizziness (with rapid injection administration).
Very rare (may affect up to 1 in 10,000 people):
- transient blindness, usually transient within 20 minutes (occurs mainly during injection therapy).
How to store Ondansetron Hexal
Keep this medicine out of the sight and reach of children.
Store the ampoules in the outer carton. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the label or carton after EXP. 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 hydrochloride dihydrate equivalent to ondansetron 2 mg / ml.
- The other ingredients are citric acid monohydrate (E 330), sodium citrate dihydrate (E 331), sodium chloride and water for injections.
What the medicine looks like and contents of the pack
Clear solution.
Glass ampoules; 5 x 2 ml, 25 x 2 ml, 5 x 4 ml, 25 x 4 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Hexal A / S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark