2 mg / ml solution for injection
ondansetron
What Ondansetron Hameln is and what it is used for
Ondansetron Hameln belongs to a group of medicines called antiemetics, medicines for nausea and vomiting. Some treatments with cancer drugs ( chemotherapy ) and radiation therapy can cause nausea or vomiting. You may also feel nauseous and vomit after an operation. Ondansetron Hameln may help reduce these effects.
Ondansetron contained in Ondansetron Hameln may also be approved for the treatment of other diseases 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 receive Ondansetron Hameln
Do not use Ondansetron Hameln
- if you are allergic (hypersensitive) to ondansetron or any of the other ingredients of Ondansetron Hameln or to other medicines belonging to the same group (eg granisetron or dolasetron).
- If you are taking apomorphine (a medicine used to treat Parkinson’s disease )
Warnings and cautions
Talk to your doctor or pharmacist before taking Ondansetron Hameln
– if you are hypersensitive to other medicines for the treatment of nausea or vomiting
– if you have a blockage in the intestine or suffer from severe constipation, Ondansetron may worsen the blockage in the intestine or constipation
– if you have heart problems (eg heart failure causing shortness of breath and swollen ankles).
– you have an irregular heartbeat ( arrhythmia ).
– if your tonsils are to be removed
– if your liver does not work as well as it should
– if you have problems with salt levels in your blood, such as potassium, sodium, and magnesium
Other medicines and Ondansetron Hameln
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines.
Tell your doctor, nurse, or pharmacist if you are taking any of the following medicines:
– Phenytoin or carbamazepine, is used to treat epilepsy.
– Rifampicin, is used to treat certain infections such as tuberculosis (TB).
– Tramadol, a painkiller
Antibiotics such as erythromycin or ketoconazole
Antiarrhythmic drugs used to treat irregular heartbeat
Beta-blocking drugs are used to treat certain heart or eye problems, anxiety, or to prevent migraines.
– Medicines that affect the heart (eg haloperidol or methadone ),
SSRIs (Selective Serotonin Reuptake Inhibitors) are used to treat depression and/or anxiety. This includes medicines containing fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, and escitalopram.
– SNRI ( Serotonin -noradrenaline reuptake inhibitor) is used to treat depression and/or anxiety. This applies to medicines containing venlafaxine, duloxetine,
– anthracyclines (cancer drugs)
Some medicines may affect the effect of Ondansetron, or Ondansetron may affect the effectiveness of other medicines. This includes:
apomorphine (a medicine used to treat Parkinson’s disease ): a sharp drop in blood pressure and unconsciousness have been reported with the concomitant use of ondansetron and apomorphine.
– tramadol (painkiller): Ondansetron reduce the analgesic effect of tramadol.
– phenytoin, carbamazepine (epilepsy medicines), and rifampicin ( antibiotics ): these medicines may lower the concentration of ondansetron in the blood.
Pregnancy and breastfeeding
You should not use Ondansetron Hameln during the first three months of pregnancy (first trimester). The reason is that Ondansetron Hameln 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 Hameln. If you are a woman of childbearing potential, you may be advised to use contraception.
Ondansetron passes into breast milk. Therefore, mothers receiving ondansetron should NOT breast-feed.
Driving and using machines
Ondansetron has no or negligible effect on the ability to drive and use machines.
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 Hameln contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’.
How to use Ondansetron Hameln
Method of administration
Ondansetron Hameln is given as an intravenous injection (into a vein) or, after dilution, as an intravenous infusion (for a long time). It is usually given by a doctor or nurse.
Dosage Your
a doctor will determine the right dose of ondansetron for you.
The dose varies depending on your medical treatment ( chemotherapy or surgery), your liver function, and whether it is given as an injection or infusion.
During chemotherapy or radiation therapy, the usual dose is one for adults 8 – 32 mg ondansetron per day. For the treatment of nausea and vomiting after surgery, a single dose of 4 mg ondansetron is usually given.
Children and young people
Children older than 6 months and adolescents
The doctor determines the dose one. For chemotherapy or radiation, the usual dose for children and adolescents is 4 mg.
Children older than 1 month and adolescents
The doctor determines the dose one. For the treatment of nausea and vomiting after surgery, a maximum dose of 4 mg is given in a vein.
Dose adjustment
Patients with hepatic impairment:
In patients with liver problems, the dose should be adjusted to a maximum daily dose of no more than 8 mg ondansetron.
Older
There is limited experience with the use of ondansetron for the prophylaxis and treatment of postoperative nausea and vomiting (PONV) in the elderly. However, ondansetron is well tolerated by patients over 65 years of age who are being treated with chemotherapy.
There is limited experience regarding the use of ondansetron as a preventive measure and in the treatment of nausea and vomiting that may occur after surgery (PONV) in the elderly. However, ondansetron is well tolerated by patients over 65 years of age who are being treated with chemotherapy (cancer treatment).
Patients with renal impairment or who are slow metabolizers of sparteine / debrisoquine:
No adjustments of the daily dose, dosing interval, or route of administration are necessary.
Duration of treatment
Your doctor will decide how long your ondansetron treatment should last.
Following intravenous administration of Ondansetron Hameln, treatment with other forms of ondansetron can be continued.
If you use more Ondansetron Hameln than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
At present, there is only limited information on overdose with ondansetron. In a few patients, the following effects have been observed after overdose: visual disturbances, severe constipation, low blood pressure, and unconsciousness. In all cases, the symptoms disappeared completely.
There is no specific antidote for ondansetron. For this reason, only the symptoms should be treated in case of suspected overdose.
Tell your doctor if any of these symptoms occur.
A doctor or nurse will give you or your child Ondansetron Hameln, 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (may affect up to 1 in 100 people):
– Chest pain, heart arrhythmias (changes in how your heart beats), and bradycardia (slow heart rate). Chest pain and heart arrhythmias can in some cases be fatal.
Rare (may affect up to 1 in 1,000 people):
– Immediate allergic (hypersensitivity) reactions (reaction in which the body reacts with an excessive immune response to a foreign substance), including life-threatening allergic reactions. These reactions can be: swelling of the hands, feet, ankles, face, lips, mouth, or throat which can cause difficulty swallowing and breathing. In addition, rash or itching and hives.
Hypersensitivity reactions were also observed in patients who were sensitive to medical products from the same group.
Tell your doctor immediately if you experience symptoms that indicate an allergic reaction.
Very common (may affect more than 1 user in 10):
– Headache.
Common (may affect up to 1 in 10 people):
Experience of redness or heat.
– It is known that ondansetron prolongs the time of passage through the colon and can cause constipation in some patients.
– Local reactions at the injection site.
Uncommon (may affect up to 1 in 100 people):
– Involuntary movement disorders, e.g. jerky eye movements, abnormal muscle contractions that can cause distorted or jerky body movements, seizures (eg epileptic seizures).
– Hypotension (low blood pressure ).
– Hiccups.
Asymptomatic increases in liver function. These reactions were observed mainly in patients receiving chemotherapy with cisplatin.
Hypersensitivity reactions around the injection site (eg rash, hives, itching ) may occur, which sometimes extend along the vein into which the medicine is injected.
Rare (may affect up to 1 in 1,000 people):
Transient changes in the electrocardiogram ( ECG ) (instrumental control of the electronic processes that normally take place when the heart is beating), mainly after intravenous administration of ondansetron. QTc extension (including torsades de pointes ).
Dizziness with rapid intravenous administration.
Transient visual disturbances (eg blurred vision) with rapid intravenous administration.
Very rare (may affect up to 1 in 10,000 people):
– Depression.
– In individual cases, transient blindness has been reported in patients receiving chemotherapy, including cisplatin. Most reported cases went over in 20 minutes. Some cases of transient blindness were reported to be of cortical origin (from the cerebral cortex).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How to store Ondansetron Hameln
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the ampoule label and carton. The expiration date is the last day of the specified month.
Store the ampoules in the outer carton. Sensitive to light.
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.
Each ampoule of 2 ml contains 4 mg ondansetron.
Each 4 ml ampoule contains 8 mg ondansetron.
Each milliliter contains 2 mg of ondansetron as ondansetron hydrochloride dihydrate.
The other ingredients are sodium chloride, sodium citrate dihydrate, citric acid monohydrate, and water for injections.
What the medicine looks like and contents of the pack
Ondansetron 2 mg/ml is a clear and colorless liquid in colorless glass ampoules containing 2 ml or 4 ml solution for injection.
Pack sizes: 5 and 10 ampoules
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
hameln pharma gmbh, Inselstraße 1, 31787 Hameln, Germany
Manufacturer:
Siegfried Hameln GmbH, Langes Feld 13, 31789 Hameln, Germany
hameln rds as, Horná 36, 900 01 Modra, Slovakia
HBM Pharma sro, Sklabinská 30, 03680 Martin, Slovakia
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