4 mg and 8 mg film-coated tablets
ondansetron
What Ondansetron Teva is and what it is used for
Ondansetron Teva belongs to a group of medicines called anti-emetics that prevent nausea and vomiting.
Ondansetron Teva is used for:
- Treatment of nausea and vomiting in connection with chemotherapy or radiation therapy.
- Prevention and treatment of nausea and vomiting in connection with surgery.
Ondansetron contained in Ondansetron Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 Teva
Do not take Ondansetron Teva
- If you are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6).
- If you have previously had an allergic reaction to treatment with other similar medicines (eg granisetron, tropisetron 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 Teva if you:
- Have liver problems.
- Has a bowel obstruction or suffers from severe constipation.
- Has undergone bowel surgery.
- Has operated on pharyngeal herring or tonsils.
- Have had heart problems, including irregular heartbeat ( arrhythmia ).
- Have problems with the salt balance in the blood, such as potassium , sodium and magnesium .
Other medicines and Ondansetron Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use apomorphine (a medicine used to treat Parkinson’s disease ). There are reports of sharply reduced blood pressure and unconsciousness when ondansetron was co-administered with apomorphine.
Ondansetron Teva may alter the effects and/or side effects of certain other medicines, including:
- Phenytoin (used to treat epilepsy ).
- Carbamazepine (used to treat epilepsy ).
- Rifampicin (used to treat tuberculosis ).
- Tramadol (for the treatment of moderate to moderate pain).
- Drugs that affect the heart (such as haloperidol and methadone ).
- Drugs used to treat irregular heartbeat (anti-arrhythmia).
- Beta-blocking drugs (used to treat heart problems, eye problems, anxiety or to prevent migraines ).
- Anti-cancer drugs (especially anthracyclines ).
- Medicines to treat infections (eg erythromycin, ketoconazole ).
If you are taking blood samples to check your liver function while using Ondansetron Teva, you must tell your doctor that you are using Ondansetron Teva, as this may affect your test results.
Pregnancy and breastfeeding
- You should not use Ondansetron Teva during the first three months of pregnancy (first trimester). The reason is that Ondansetron Teva 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 Teva. If you are a woman of childbearing potential , you may be advised to use contraception.
- Do not breast-feed if you are taking Ondansetron Teva as small amounts of the drug are excreted in breast milk. Consult a doctor.
Driving and using machines
Ondansetron Teva is not expected 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 Teva contains lactose and sodium
Ondansetron Teva 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.
Ondansetron Teva contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, ie it is essentially ‘sodium-free’.
How to take Ondansetron Teva
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The tablets should be swallowed whole, preferably with water.
Ondansetron Teva 8 mg film-coated tablet: The breaker is not intended to divide the tablet into equal doses but only to facilitate swallowing.
The recommended dose is:
Treatment of nausea and vomiting associated with chemotherapy and radiation therapy:
- Adults (including the elderly)
8 mg is taken 1 to 2 hours before chemotherapy or radiation therapy, followed by 8 mg 12 hours later. 24 hours after chemotherapy or radiation therapy, a dose of 8 mg can be taken twice daily for up to 5 days.
- Children (from 6 months of age) and adolescents
Ondansetron Teva can initially be given as a single intravenous injection more than 15 minutes before chemotherapy, followed by tablets that can be given two to three times daily for up to 5 days after chemotherapy. Dosage one of the tablets depends on the baby’s body size and dose one is determined by your doctor.
Prevention of nausea and vomiting after surgery:
- Adults (including the elderly)
A dose of 16 mg one hour before anesthesia, alternatively 8 mg one hour before anesthesia followed by two additional doses of 8 mg at 8-hour intervals.
- Children (from 1 month of age) and adolescents
An intravenous injection containing Ondansetron Teva is recommended.
Patients with liver problems The
total daily dose should not exceed 8 mg.
Ondansetron Teva begins to work within one to two hours after taking the dose. If you vomit within one hour after taking a dose, take a new dose. Otherwise, you should continue to take your tablets according to the prescribed dose, but do not take more tablets than your doctor has recommended. Contact your doctor if you continue to feel unwell.
If you take more Ondansetron Teva than you should
If you or your child have taken too much Ondansetron Teva, contact a doctor immediately, visit a hospital for risk assessment and advice. Bring the medicine pack.
If you have taken too much medicine, this can cause symptoms such as vision problems, severe constipation, dizziness, or weakness.
If you forget to take Ondansetron Teva
If you forget to take a tablet and feel unwell or vomit, take the tablet as soon as you remember and continue treatment as before. If you forget to take a tablet but do not feel sick or vomit, wait to take the tablet until it is time for you to take the next dose. Take the remaining dose at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Ondansetron Teva
Do not stop taking your tablets without consulting a doctor, even if you feel better.
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 the tablets immediately and contact your doctor immediately or go to the emergency department of the nearest hospital:
Uncommon (may affect up to 1 in 100 people):
- Seizures.
Rare (may affect up to 1 in 1,000 people):
- Allergic reaction (which causes swelling of the face, lips, tongue or throat, or which causes difficulty in breathing or swallowing, or which causes skin rash).
- Collapse.
- Disorders of the heart rhythm (which sometimes cause sudden unconsciousness).
Other side effects are:
Very common (may affect more than 1 user in 10)
- Headache
Common (may affect up to 1 in 10 people)
- Feeling of heat or redness .
- Constipation.
- Changes in liver function values (if you are taking Ondansetron Teva with a medicine called cisplatin, otherwise this side effect is uncommon).
Uncommon (may affect up to 1 in 100 people)
- Hiccup.
- Low blood pressure , which can make you feel dizzy or dizzy.
- Irregular heartbeat or chest pain.
- Seizures.
- Unusual body movements or tremors.
Rare (may affect up to 1 in 1,000 people)
- Dizziness or fainting.
- Dimsyn.
Very rare (may affect up to 1 in 10,000 people)
- Poor vision or temporary loss of vision, vision usually returns within 20 minutes.
How to store Ondansetron Teva
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 and the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage instructions.
Medicines should not be disposed of via wastewater. 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
- Ondansetron Teva 4 mg film-coated tablet: The active substance is ondansetron. Each film-coated tablet contains 4 mg ondansetron (as ondansetron hydrochloride dihydrate).Ondansetron Teva 8 mg film-coated tablet: The active substance is ondansetron. Each film-coated tablet contains 8 mg ondansetron (as ondansetron hydrochloride dihydrate).
- The other ingredients are:
Tablet core: lactose monohydrate , sodium starch glycolate, microcrystalline cellulose, pregelatinised maize starch and magnesium stearate,
Coating: hypromellose, titanium dioxide (E171), macrogol (400 & 6,000) and yellow iron oxide (E172).
What the medicine looks like and contents of the pack
- Ondansetron Teva 4 mg film-coated tablets are yellow, oval, film-coated tablets debossed with “4” on one side and smooth on the other.
- Ondansetron Teva 8 mg film-coated tablets are yellow, oval, film-coated tablets debossed with “8” on one side and scored on the other.
- Ondansetron Teva 4 mg film-coated tablets are available in packs of 2, 4, 5, 6, 10, 15, 30, 50, 100 and 500 film-coated tablets and as hospital packs of 10×1 and 50×1 film-coated tablets
- Ondansetron Teva 8 mg film-coated tablets are available in packs of 2, 4, 5, 6, 9, 10, 15, 18, 30, 50, 100 and 500 film-coated tablets and as hospital packs of 10×1 and 50×1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva Sweden AB
Box 1070
251 10 Helsingborg