4 mg, 8 mg film-coated tablets
ondansetron (as hydrochloride)
What Ondansetron Aurobindo is and what it is used for
This medicine contains ondansetron, which belongs to a group of medicines called antiemetics, which are medicines for nausea and vomiting.
Ondansetron Aurobindo is used for treating nausea and vomiting caused by certain drug treatments, such as chemotherapy or radiation therapy for cancer (in adults and children). It is also used to prevent nausea and vomiting in patients after surgery (adults only).
Ondansetron contained in Ondansetron Aurobindo may also be approved for the treatment of other conditions not mentioned in this information. 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 Aurobindo
Do not take Ondansetron Aurobindo
- if you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
- if you have an allergic (hypersensitive) reaction to other antiemetics (for example granisetron or dolasetron).
- if you are taking apomorphine (used to treat Parkinson’s disease )
Warnings and cautions
Talk to your doctor or pharmacist before taking Ondansetron Aurobindo
- if you have a bowel obstruction or suffer from severe constipation
- if you are going to have surgery to remove the polyps or tonsils
- if you suffer from heart problems (eg heart failure that causes shortness of breath and swollen ankles)
- if you have an uneven heart rhythm ( arrhythmia )
- if you suffer from liver problems.
- if you have problems with the levels of salts in the blood, e.g. potassium , sodium and magnesium .
If any of the above apply to you, tell your doctor before starting treatment with Ondansetron Aurobindo.
Other medicines and Ondansetron Aurobindo
Ondansetron Aurobindo can affect other medicines and other medicines can affect Ondansetron Aurobindo.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important to tell your doctor if you are taking any of the following medicines:
- Drugs used to treat epilepsy ( phenytoin , carbamazepine)
- Rifampicin (used to treat infections such as tuberculosis (TBC), an antibiotic )
- Tramadol (a medicine used to treat pain)
- Drugs that affect the heart (such as haloperidol or methadone )
- Drugs for the treatment of heart problems such as abnormal heartbeats ( antiarrhythmics , such as amiodarone ) and / or high blood pressure ( beta blockers , such as atenolol, timolol )
- Beta-blockers used to treat certain heart or eye problems, anxiety or to prevent migraines
- Cancer drugs (especially anthracyclines , such as doxorubicin, daunorubicin, and monoclonal antibodies , such as trastuzumab) as they may interact with ondansetron and cause cardiac arrhythmias .
- Antibiotics (such as erythromycin or ketoconazole )
- SSRIs (selective serotonin reuptake inhibitors) used to treat depression and / or anxiety, including fluoxetine , paroxetine , sertraline , fluvoxamine, citalopram , escitalopram
- SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and / or anxiety, including venlafaxine , duloxetine.
Pregnancy, breastfeeding and fertility
Pregnancy:
You should not use Ondansetron Aurobindo during the first three months of pregnancy (first trimester). The reason is that Ondansetron Aurobindo 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). 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 Aurobindo. It is recommended that sexually active, fertile women use effective contraception (methods that result in less than 1% pregnancy rate) during treatment with ondansetron.
Breast-feeding:
You should not breast-feed your infant during treatment with ondansetron. Ask your doctor or pharmacist for advice before taking any medicine.
Fertility
There are no data on the effects of ondansetron on human fertility.
Driving and using machines
Ondansetron Aurobindo is unlikely to affect your ability to drive or 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 Aurobindo contains lactose
Ondansetron Aurobindo 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 Aurobindo
Always take this medicine as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Treatment of nausea (nausea and vomiting) in patients treated with chemotherapy or radiation therapy:
Adults (including the elderly): The recommended dose is 8 mg ondansetron 1 to 2 hours before chemotherapy or radiation therapy, followed by 8 mg ondansetron after 12 hours. To prevent delayed or further nausea, 8 mg ondansetron can be given twice daily for up to 5 days after treatment.
Infants and children (6 months and older) and adolescents (under 18 years):
The doctor decides which dose of ondansetron to give. This depends on the size and weight of the baby.
- The usual dose one for a child is up to 4 mg twice daily
- this can be given for up to 5 days.
Patients with hepatic impairment:
The total daily dose should not exceed 8 mg.
For the prevention of nausea (nausea and vomiting) after surgery:
Adults: The recommended dose is 16 mg before surgery or an 8 mg tablet one hour before surgery and thereafter
- another 8 mg tablet eight hours after the first dose and then
- another 8 mg tablet eight hours after the second dose .
If you vomit within one hour after taking a dose of 8 mg:
- Take another 8 mg tablet.
- Otherwise, do not take more ondansetron tablets than indicated on the label.
Tell your doctor or nurse if you continue to feel unwell.
Children from 1 month of age and adolescents:
- It is recommended that ondansetron be given as an injection .
If you take more ondansetron than you should
If you have taken too many tablets, you must contact a doctor immediately or go to the nearest emergency room. Take the medicine pack with you, even if the tablets are empty, so that your doctor knows which tablets you have taken.
Overdose can cause symptoms such as vision problems, low blood pressure (which can cause dizziness or fainting), or irregular heartbeat.
If you or your child have taken too much medicine or if e.g. If a child has ingested the medicine by mistake, you should immediately contact a doctor or hospital for risk assessment and advice. Bring the medicine pack with you if you go to the hospital.
If you forget to take Ondansetron Aurobindo
If you forget to take a dose, take the next tablet as soon as you remember, provided it is not soon for the next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Ondansetron Aurobindo
Do not stop taking your tablets without consulting a doctor, even if you are feeling well.
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.
If you get any of the following side effects, stop taking your tablets and contact your doctor immediately:
- An allergic reaction. Symptoms may include:
- sudden wheezing and chest pain or pressure over the chest
- swelling of the eyelids, face, lips, mouth, tongue or throat
- breathing difficulties
- collapse
- skin rash – red spots or bumps under the skin ( hives ) anywhere on the body
- seizures
- chest pain
- transient vision loss that usually resolves within 20 minutes.
Side effects of ondansetron
If you are worried about any side effects, talk to your doctor. If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
Very common (may affect more than 1 user in 10):
- Headache
Common (may affect up to 1 in 10 people):
- Redness and feeling of heat
- Constipation
- Local burning sensation (after insertion of suppositories).
- Local reactions at the injection site
Uncommon (may affect up to 1 in 100 people):
- Uncontrollable body movements, including rolling up movements with the eyes
- Seizures. Seek medical attention immediately if this occurs.
- Dizziness (with rapid intravenous administration )
- Irregular heartbeat, fast or slow pulse
- Chest pain. Seek medical attention immediately if this occurs.
- Low blood pressure
- Hiccup
- Elevated hepatic function values (usually in patients treated with chemotherapy in the form of cisplatin)
Rare (may affect up to 1 in 1,000 people):
- An immediate allergic reaction that can be severe and include symptoms such as sudden wheezing and chest pain or pressure over the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse or rash. Seek medical attention immediately if this occurs.
- Visual disturbances, e.g. blurred vision (however, this has almost always occurred with injection of ondansetron and not with tablets).
- The effect on the heart rhythm can be seen on an ECG (an electrical curve of the heart). Symptoms may include dizziness or loss of consciousness.
Very rare (may affect up to 1 in 10,000 people):
- Transient vision loss that usually resolves within 20 minutes. Seek medical attention immediately if this occurs. Transient vision loss has been reported almost exclusively with ondansetron injection and not with tablets, and usually when cisplatin chemotherapy is co-administered.
How to store Ondansetron Aurobindo
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the blister and 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 pack and other information
Content declaration
- The active substance is ondansetron hydrochloride.
4 mg : Each tablet contains 4 mg ondansetron (as ondansetron hydrochloride dihydrate).
8 mg : Each tablet contains 8 mg ondansetron (as ondansetron hydrochloride dihydrate). - The other ingredients are Tablet core: Lactose , anhydrous, cellulose, microcrystalline (E460), starch , pregelatinized (corn), magnesium stearate (E572). Film coating : 4 mg : Hypromellose (E464), triacetin (E1518), titanium dioxide (E171). 8 mg : Hypromellose (E464), triacetin (E1518), titanium dioxide (E171), yellow iron oxide (E172).
What the medicine looks like and contents of the pack
Film-coated tablet.
Ondansetron Aurobindo 4 mg film-coated tablets
White to off-white, oval, film-coated tablets with “E” debossed on one side and “01” on the other side.
Ondansetron Aurobindo 8 mg film-coated tablets
Yellow, oval, film-coated tablets with “E” debossed on one side and “02” on the other side.
Ondansetron Aurobindo 4 mg and 8 mg film-coated tablets are available in packs of 3, 4, 6, 7, 10, 14, 15, 20, 28, 30, 40, 49, 50, 60, 90, 100, 200, 300 and 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana FRN 1913
Malta
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block
Odyssey Business Park
West End Road Ruislip
HA4 6QD
UK
For further information on this medicine, please contact your local representative: for
Orion Pharma AB, Danderyd
medinfo@orionpharma.com