4 mg, 8 mg orodispersible tablet
Ondansetron
What Ondansetron Orifarm is and what it is used for
Ondansetron Orifarm 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 is used to prevent or treat nausea and vomiting caused by chemotherapy or radiation therapy. In addition, ondansetron can be used to prevent or treat nausea and vomiting after surgery.
An orodispersible tablet is a special kind of tablet that dissolves very quickly when placed on the tongue.
Ondansetron contained in Ondansetron Orifarm 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 take Ondansetron Orifarm
Do not take Ondansetron Orifarm
- if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
- if you are taking apomorphine (used to treat Parkinson’s disease ).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Ondansetron Orifarm.
- if you have bowel obstruction or constipation, as you will need special medical attention.
- if you are allergic to other medicines in the group of selective serotonin receptor antagonists (5-HT3 receptor antagonists) (eg granisetron, dolasetron). In that case, it is possible that you are also allergic to ondansetron.
- if you are going to have or have recently had your tonsils removed, as treatment with Ondansetron Orifarm may mask the symptoms of internal bleeding.
- if you are a cardiac patient (with arrhythmias or conduction disorders) and therefore are being treated with another medicine at the same time, e.g. anesthetics, antiarrhythmics or beta- blockers , as there is limited experience with this.
- if you have impaired liver function.
Always tell your laboratory staff when taking blood and urine samples that you are being treated with Ondansetron Orifarm.
Other medicines and Ondansetron Orifarm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor if you are being treated with:
- epilepsy drugs ( phenytoin , carbamazepine)
- antibiotics (rifampicin, erythromycin, ketoconazole )
- painkillers (tramadol)
- drugs used to treat heart problems such as abnormal heart rhythm ( amiodarone ) and high blood pressure (atenolol, timolol )
- other drugs that, like Ondansetron Orifarm, affect the neurotransmitter serotonin in the brain such as drugs used to treat depression
- cancer drugs (doxorubicin, daunorubicin, trastuzumab)
Contact your doctor. It may be necessary to adjust dose one.
Ondansetron Orifarm with food and drink
Ondansetron Orifarm can be taken independently of meals.
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.
If you are a woman of childbearing potential, you may be advised to use contraception.
Pregnancy:
You should not use Ondansetron Orifarm during the first three months of pregnancy (first trimester). The reason is that Ondansetron Orifarm may increase the risk slightly that a child is born with cleft lip and/or cleft palate (opening or splitting in the upper lip or palate).
Breast-feeding:
You should not breast-feed while taking Ondansetron Orifarm.
Driving and using machines
Ondansetron Orifarm 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 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.
Ondansetron contains aspartame and sorbitol
Ondansetron Orifarm 4 mg contains 0.88 mg aspartame per tablet and Ondansetron Orifarm 8 mg contains 1.76 mg aspartame per tablet.
Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
Ondansetron Orifarm 4 mg contains 3 mg – 8.4 mg sorbitol per tablet and Ondansetron Orifarm 8 mg contains 6 mg – 16.9 mg sorbitol per tablet.
How to take Ondansetron Orifarm
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Dose one is always determined by your doctor who adjusts dose one for you to achieve the best effect.
You should tell your doctor or pharmacist if you think the effect of the Ondansetron Orifarm is too strong or too weak.
Treatment and prevention of nausea and vomiting in connection with chemotherapy or radiation therapy
Adults and the elderly:
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 decide to give you the first dose as an injection.
Children (6 months or older) and adolescents under 18 years:
Dose one is individual and depends on the child’s size/body surface area. Ondansetron Orifarm should not be used to treat children with a total body area of less than 0.6 m 2.
Treatment and prevention of nausea and vomiting after surgery
Adults
16 mg one hour before anesthesia, alternatively 8 mg one hour before anesthesia followed by a further 8 mg after 8 and 16 hours. Your doctor may choose to give you the medicine as an injection.
Children (1 month or older) and adolescents under 18 years:
No studies have been performed on the prevention or treatment of nausea or vomiting after surgery.
Older:
There is limited experience with the use of ondansetron for the prevention and treatment of nausea and vomiting after surgery in the elderly. However, ondansetron is well tolerated by patients over 65 years of age during chemotherapy (see section above).
Hepatic impairment:
The daily dose should not exceed 8 mg if you have moderate to severe hepatic impairment.
To remove the orodispersible tablet from the blister:
Do not take the orodispersible tablet out of the blister or pierce the foil until you are ready to take it.
Important: Do not try to push the orodispersible tablet through the foil, like a regular tablet, as it is fragile and will break then.
Follow these instructions carefully:
- Tear along the blister perforations to loosen a blister assembly.
- Pull the tab to lift the foil from a blister unit.
- Gently push up the orodispersible tablet.
- Place the orodispersible tablet on the tongue. It will dissolve very quickly, then swallow with or without water.
If you take more Ondansetron Orifarm 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.
The symptoms of overdose are visual disturbances, severe constipation, low blood pressure, and disturbances in the heart rhythm.
If you forget to take Ondansetron Orifarm
Do not take a double dose to make up for a forgotten dose.
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.
If any of the following allergic reactions occur, stop taking Ondansetron Orifarm and contact your doctor immediately or go to the emergency department of the nearest hospital:
- Severe itchy skin, rash.
- Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may make it difficult to swallow or breathe.
- Collapse.
Very common (may affect more than 1 user in 10):
Headache.
Common (may affect up to 1 in 10 people):
A feeling of redness and warmth. Constipation.
Uncommon (may affect up to 1 in 100 people):
Cramps. Hiccup. Low blood pressure, irregular heartbeat, chest pain, and slow heart rate. Involuntary movements. Involuntary eye movements. Altered liver function.
Rare (may affect up to 1 in 1,000 people):
Hives ( urticaria ). Dizziness, transient blurred vision especially during intravenous administration.
Severe allergic reaction including the swollen tongue, swollen throat, difficulty breathing, and anaphylactic shock reaction. Severe heart rhythm disturbances with a rapid, irregular heartbeat (sometimes causing sudden unconsciousness).
Very rare (may affect up to 1 in 10,000 people):
Transient blindness, especially during intravenous administration. Most of these cases of blindness passed within 20 minutes.
Has been reported (occurs in an unknown number of users):
Toxic epidermal necrolysis is a potentially serious skin condition with blistering and flaking of the skin.
How to store Ondansetron Orifarm
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 blister or pack after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 4 mg or 8 mg.
- The other ingredients are: mannitol (E421), sorbitol (E420), crospovidone, colloidal hydrated silica, microcrystalline cellulose, aspartame (E951), sodium stearyl fumarate, magnesium stearate, strawberry flavor.
What the medicine looks like and contents of the pack
4 mg: White, flat, round, 7 mm, orodispersible tablet.
8 mg: White, flat, round, 10 mm, orodispersible tablet.
Blister: 6, 7, 10, 14, 28, 30 tablets.
Single-dose blisters: 6×1, 7×1, 10×1, 14×1, 28×1, 30×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark
Local representative
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com
This medicinal product is authorized under the European Economic Area under the names:
| Denmark | Ondansetron Orifarm |
| Sweden | Ondansetron Orifarm |