4 mg and 8 mg film-coated tablets
ondansetron
What Ondansetron Bluefish is and what it is used for
Ondansetron Bluefish belongs to a group of medicines called antiemetics. Ondansetron inhibits the effect of the neurotransmitter serotonin in the brain. Serotonin causes nausea and vomiting.
Ondansetron Bluefish is used to prevent or treat nausea and vomiting during chemotherapy and radiation therapy. Ondansetron Bluefish can also be used to prevent or treat nausea and vomiting after surgery.
Ondansetron Bluefish is used for the prevention or treatment of nausea and vomiting during chemotherapy in children aged ≥ 6 months and for the prevention and treatment of nausea and vomiting after surgery in children aged ≥ 1 month.
Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you take Ondansetron Bluefish
Do not take Ondansetron Bluefish
- if you are allergic (hypersensitive) to ondansetron or any of the other ingredients of Ondansetron Bluefish.
- if you are taking apomorphine (used to treat Parkinson’s disease ).
Warnings and cautions
- if you are allergic to other medicines belonging to the group of serotonin antagonists (eg granisetron, dolasetron). Then you may also be hypersensitive to ondansetron.
- if you have a blockage or obstruction in the intestine (intestinal obstruction) or constipation. Then you need to be monitored by your doctor.
- if you are going to have tonsillectomy or have recently had tonsillectomy, then treatment with Ondansetron Bluefish may mask the symptoms of internal bleeding.
- if you have arrhythmias / conduction disturbances in your heart and are being treated with anesthetics , antiarrhythmics or beta- blockers at the same time . This is due to the limited experience of such concomitant treatment.
- if you have impaired liver function.
- If a child is being treated with ondansetron together with hepatotoxic cytotoxic drugs , it should be closely monitored for hepatic impairment.
Tell your doctor if any of the above warnings affect you.
When testing blood and urine, always inform the laboratory that you are being treated with Ondansetron Bluefish.
Other medicines and Ondansetron Bluefish
Ondansetron Bluefish and some other medicines may affect each other’s effects.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines, or vitamins and minerals.
You must tell your doctor that you are taking Ondansetron Bluefish if your doctor starts treating you with the following medicines:
Medicines for epilepsy ( phenytoin or carbamazepine) that may reduce the effect of Ondansetron Bluefish.
Antibiotics (rifampicin), can reduce the effect of Ondansetron Bluefish.
Painkillers (tramadol), the effect of which can be reduced by Ondansetron Bluefish. Based on reports of severe hypotension and loss of consciousness when ondansetron was given with apomorphine (used to treat Parkinson’s disease ), apomorphine should not be used concomitantly with Ondansetron Bluefish.
Contact your doctor. It may be necessary to adjust your dose.
Ondansetron Bluefish with food and drink
Ondansetron Bluefish can be taken with food and drink. The tablets should be taken with a glass of water.
Pregnancy and breastfeeding
You should not use Ondansetron Bluefish during the first three months of pregnancy (first trimester). The reason is that Ondansetron Bluefish may increase the risk of a baby being born 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 Bluefish. If you are a woman of childbearing potential, you may be advised to use effective contraception.
You should not breast-feed while taking Ondansetron Bluefish.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ondansetron Bluefish does not affect the ability to drive safely or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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.
Important information about some of the ingredients of Ondansetron Bluefish
Ondansetron Bluefish 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 take Ondansetron Bluefish
Always take Ondansetron Bluefish exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Nausea and vomiting caused by chemotherapy or radiation therapy
Adults: The usual dose is 8 mg 1-2 hours before chemotherapy or radiation therapy, followed by 8 mg every 12 hours for up to 5 days. Your doctor may have decided to give you your first dose as an injection.
Elderly: Same dose as for adults.
Pediatric population:
Nausea and vomiting caused by chemotherapy in children aged ≥6 months and adolescents. Dose one is individual and is calculated by the doctor based on the child’s size/area. Ondansetron is given as an injection immediately before chemotherapy and oral dosing can be started 12 hours later and continued for up to 5 days. The total daily dose for adults of 32 mg must not be exceeded.
Treatment and prevention of nausea and vomiting after surgery
Adults, prevention and treatment: The usual dose is 16 mg one hour before anesthesia or 8 mg one hour before anesthesia, followed by 8 mg after 8 hours and 8 mg after 16 hours. Your doctor may have decided to give you the medicine as an injection.
Elderly, prevention and treatment: The experience of treating elderly patients is limited. However, Ondansetron Bluefish is well tolerated by patients over 65 years of age during chemotherapy (see above).
Pediatric population:
Nausea and vomiting after surgery in children aged ≥ 1 month and adolescents:
Oral formulation: No studies have been performed on the oral use of ondansetron to prevent or treat nausea or vomiting after surgery; slow intravenous injection is recommended for this purpose.
Hepatic impairment: The daily dose should not exceed 8 mg if you have moderate to severe hepatic impairment.
The tablets should be taken with a glass of water.
Always follow your doctor’s prescription. There are differences in what different patients need. Changes to your treatment should only be made in consultation with your doctor.
If you take more Ondansetron Bluefish 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.
Symptoms of overdose may include changes in vision, severe constipation, low blood pressure, and irregular heartbeat.
If you forget to take Ondansetron Bluefish
Do not take a double dose to make up for a forgotten dose.
Possible side effects
Like all medicines, Ondansetron Bluefish can cause side effects, although not everybody gets them.
Very common side effects (affects more than 1 user in 10): Headache.
Common side effects (affects more than 1 user in 100 but less than 1 in 10 users): Feeling of heat/swelling, constipation.
Uncommon side effects (affects more than 1 in 1,000 people but less than 1 in 100 people): Seizures, hiccups, low blood pressure, irregular or slow heartbeat, chest pain, involuntary movements, involuntary eye movements. Sometimes a change in liver function has been observed.
Rare side effects (affects more than 1 user in 10,000 but less than 1 in 1000 users): Skin rash (hives), dizziness, and transient vision changes (eg blurred vision). These side effects have mainly been reported when ondansetron is given intravenously.
Anaphylactic shock, such as swollen tongue and throat and difficulty breathing. If any of these symptoms occur, seek medical attention immediately.
Severe heart rhythm disorders with a rapid, irregular heartbeat.
Very rare (affects less than 1 user in 10,000): Blindness, often transient within 20 minutes. This side effect has mainly been reported when ondansetron is given intravenously.
If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist to ensure that any side effects are reported to the National Medicines Agency and to improve the knowledge of any side effects.
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 Bluefish
Keep out of sight and reach of children.
No special storage instructions.
Do not use Ondansetron Bluefish after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
The medicine 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 is ondansetron. One tablet contains 4 mg and 8 mg ondansetron, respectively.
Other ingredients are:
Tablet core: microcrystalline cellulose, lactose monohydrate, magnesium stearate, corn starch
Film coating: hypromellose, macrogol, and dyes (titanium dioxide E171).
What the medicine looks like and contents of the pack
Appearance
Tablets 4 mg: White, round, biconvex film-coated tablet, debossed with 4 on one side and glossy on the other.
Tablets 8 mg: White, round, biconvex film-coated tablet, debossed with 8 on one side, and glossy with a scoreline on the other side.
Pack sizes
4 mg blister: 5, 10, 15, 30, 50, 60 and 100 film-coated tablets.
8 mg blister: 5, 10, 15, 30, 50, 60 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden
This medicinal product is authorized under the European Economic Area under the names:
Denmark : Ondansetron Bluefish
Finland : Ondansetron Bluefish 4 mg tablet, calvopäällysteine
Ondansetron Bluefish 8 mg tablet, calvapäällysteine
Iceland: Ondansetron Bluefish 4 mg tablets, Ondansetron Bluefish 8 mg tablets
Norway: Ondansetron Bluefish 4 mg tablets, film-coated
Ondansetron Bluefish 8 mg tablets, film-coated
Sweden: Ondansetron Bluefish 4 mg film-coated tablets
Ondansetron Bluefish 8 mg film-coated tablets