2 mg / ml solution for injection / infusion
ondansetron
What Ondansetron Accord is and what it is used for
Ondansetron Accord contains the active substance ondansetron, which belongs to a group of medicines called antiemetics.
Ondansetron Accord is given to
- counteract nausea and vomiting
- in adults and children from 6 months of age, who are treated with cytotoxic drugs ( chemotherapy ) for cancer.
- in adults treated with radiation for cancer.
- counteract nausea and vomiting in adults and children from 1 month of age who have undergone surgery.
If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist.
Ondansetron contained in Ondansetron Accord 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 or your child receive Ondasetron Accord
Do not use Ondansetron Accord
- if you or your child are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6) or to similar medicines such as granisetron or dolasetron.
- if you or your child are currently taking apomorphine (a medicine used to treat Parkinson’s disease ).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Ondansetron Accord
- if you or your child has a bowel obstruction or suffers from severe constipation. Ondansetron may aggravate these conditions.
- if you or your child have impaired liver function.
- if you or your child have or have had heart problems or are taking heart medication (eg heart failure that causes shortness of breath and swollen ankles).
- if you or your child has an irregular heartbeat ( arrhythmia )
- if you or your child are allergic to medicines similar to ondansetron, such as granisetron or palonosetron
- if you or your child are going to have their tonsils removed. Ondansetron can mask the symptoms of internal bleeding
- if you or your child have problems with blood salt levels, such as potassium , sodium and magnesium
If you are not sure if any of the above applies to you or your child, talk to a doctor, nurse, or pharmacist before you or your child receive Ondansetron Accord.
Other medicines and Ondansetron Accord
Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines, herbal remedies, or supplements.
In particular, tell your doctor, nurse, or pharmacist if you or your child are taking any of the following medicines:
- Phenytoin (used to treat epilepsy and cardiac arrhythmias ). The effect of ondansetron may be weakened.
- Carbamazepine (used to treat epilepsy and nerve pain). The effect of ondansetron may be weakened.
- Rifampicin used to treat infections such as tuberculosis (TB). The effect of ondansetron may be weakened.
- Antibiotics , such as erythromycin or ketoconazole
- Antiarrhythmics (for the treatment of irregular heartbeat), e.g. amiodarone
- Beta-blockers , used against certain heart and eye diseases as well as against anxiety or to prevent migraine attacks (eg atenolol, timolol ).
- Tramadol (used for pain relief). The analgesic effect of tramadol may be weakened.
- Apomorphine (a medicine used to treat Parkinson’s disease ). Severe hypotension and unconsciousness have been reported with apomorphine when co-administered with ondansetron.
- Drugs that affect the heart (eg haloperidol or methadone )
- Cancer drugs (especially anthracyclines , eg doxorubicin, daunorubicin or trastuzumab).
- SSRIs (selective serotonin reuptake inhibitors) used to treat depression and / or anxiety, including citalopram , fluoxetine , paroxetine , sertraline , fluvoxamine, citalopram , escitalopram
- SNRIs (selective serotonin and norepinephrine reuptake inhibitors) used to treat depression and / or anxiety, including venlafaxine , duloxetine
Contact your doctor. It may be necessary to adjust dose one.
Ondansetron Accord with food and drink
Ondansetron Accord can be taken independently of food and drink.
Pregnancy, breastfeeding and fertility
Pregnancy
You should not use Ondansetron Accord during the first three months of pregnancy (first trimester). The reason is that Ondansetron Accord 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 Accord. If you are a woman of childbearing potential, you may be advised to use contraception.
Breast-feeding
Ondansetron can pass into breast milk. Therefore, mothers receiving Ondansetron Accord should not breast-feed.
If you are breast-feeding, talk to your doctor or pharmacist before taking this medicine
Driving and using machines
Ondansetron Accord does not affect your ability to drive or use machines.
Ondansetron Accord contains excipients
This medicine contains 2.5 mmol (equivalent to 57.9 mg) sodium per maximum daily dose of 32 mg ondansetron. This should be considered by patients on a low-salt diet.
How to use Ondansetron Accord
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Ondansetron Accord is usually administered by a nurse or doctor. The dose you are prescribed depends on the medical treatment you are receiving.
Prevention of nausea and vomiting during chemotherapy and radiation therapy
Adults
The recommended dose for adults on the day of chemotherapy or radiation therapy is 8 mg as an injection into a vein or muscle immediately before treatment and then an additional 8 mg 12 hours later. The usual intravenous dose for adults does not exceed 8 mg.
The following days
- After chemotherapy, you will usually receive your medicine in the form of 8 mg ondansetron tablets or 10 ml (8 mg) oral solution .
- Oral dose of ondansetron can be started 12 hours after the last intravenous dose and lasts for up to 5 days.
In case of severe nausea and vomiting, you or your child may receive a higher dose of Ondansetron Accord than normal. This is up to your doctor.
Prevention of nausea and vomiting during chemotherapy
Children from 6 months and adolescents
Dose one is determined by the doctor, based on the child’s weight or body surface area.
The day the chemotherapy is to be given
- The first dose is an injection into a vein, immediately before the baby is treated. After chemotherapy in children, ondansetron is usually given in the form of tablets or oral solution .
- In the following days, oral dosing of ondansetron can be started 12 hours after the last intravenous dose and lasts for up to 5 days.
Prevention and treatment of nausea and vomiting after surgery
Adults:
- The usual dose for adults is 4 mg as an injection into a vein or muscle. In preventive treatment, a dose is given immediately before the operation.
Children:
- For children from 1 month and adolescents, the dose is decided by a doctor. The maximum dose is 4 mg as a slow intravenous injection . In preventive treatment, a dose is given immediately before the operation.
Patients with moderate to severe hepatic impairment
The total daily dose should not exceed 8 mg.
If you or your child continues to feel sick or vomit
Ondansetron injection should start working shortly after injection. If you or your child continue to feel sick or vomit, tell your doctor or nurse.
If you use more Ondansetron Accord than you should
Ondansetron will be given to you or your child by a doctor or nurse, so it is unlikely that you or your child will receive too much. If you think you or your child has taken too much or missed a dose, tell your doctor or nurse for advice.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
SERIOUS SIDE EFFECTS AR
Allergic reactions
If you or your child has an allergic reaction, talk to a doctor or hospital staff immediately. Signs may include:
- sudden wheezing and chest pain or a tightening sensation over the chest
- swelling of eyelids, face, lips, mouth or tongue
- skin rash – red spots or bumps under the skin ( hives ) somewhere on the body
- collapse
Minor side effects are
| Very common: May affect more than 1 user in 10 | Headache |
| Usual: May affect up to 1 in 10 users | Feeling of hot flashes and heatConstipationAlteration of certain values in liver function tests (if you are receiving ondansetron injections while taking the drug cisplatin; otherwise this is a less common side effect )Irritation and redness at the injection site |
| Uncommon: May affect up to 1 in 100 users | Seizures (seizures or convulsions)Abnormal body movements or tremorsIrregular heartbeat chest pain low blood pressure that can cause dizziness and faintingHiccup |
| Rare: May affect up to 1 in 1,000 users | Dizziness or intoxicationDimsynDisorders of the heart rhythm (which can sometimes lead to sudden loss of consciousness) |
| Very rare: May affect up to 1 in 10,000 patients | Impaired vision and temporary blindness, usually transient within 20 minutes |
How to store Ondansetron Accord
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 ampoule after EXP and on the outer carton after EXP. The expiration date refers to the last day of the specified month.
No special temperature instructions. Store the ampoules in the outer carton. Sensitive to light.
Do not use this medicine if the container is damaged or if the solution shows particles/crystals.
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 pack and other information
Content declaration
The active substance in Ondansetron Accord is ondansetron (as hydrochloride dihydrate).
Each ml solution for injection / infusion contains 2 mg ondansetron (as ondansetron hydrochloride dihydrate).
Each 2 ml ampoule contains 4 mg ondansetron (as ondansetron hydrochloride dihydrate).
Each 4 ml ampoule contains 8 mg ondansetron (as ondansetron hydrochloride dihydrate).
The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, sodium hydroxide, and/or hydrochloric acid for pH adjustment and water for injections.
What the medicine looks like and contents of the pack
Ondansetron Accord is a clear, colorless solution for injection/infusion, in clear glass ampoules/amber.
Ondansetron Accord 2 mg / ml is supplied in pack sizes of 5 x 2 ml and 5 x 4 ml ampoules , as well as 10 x 2 ml and 10 x 4 ml ampoules .
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF, UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland