


Ask a doctor about a prescription for ONDANSETRON QUALIGEN 8 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ondansetron Qualigen 8 mg
film-coated tablets EFG
Read all of this leaflet carefully before you start taking this medicine.
Contents of the pack
Ondansetron Qualigen 8 mg film-coated tablets come in the form of film-coated tablets. Each pack contains 6 or 15 film-coated tablets.
Ondansetron belongs to a group of medicines called antiemetics.
It is used to prevent nausea and vomiting caused by certain medical treatments.
Do not takeOndansetron Qualigen
Be cautious withOndansetron Qualigen
Use of other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, as it may be necessary to stop treatment or adjust the dose of one of them.
Especially, tell your doctor if you are taking the following medicines:
Use in children
Do not use in children under 2 years of age.
Pregnancy
Consult your doctor or pharmacist before taking any medicine.
Ondansetron Qualigen should not be used during the first trimester of pregnancy. This is because Ondansetron Qualigen may slightly increase the risk of a baby being born with a cleft lip and/or cleft palate (openings or fissures in the upper lip or palate). If you are already pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking Ondansetron Qualigen. If you are a woman of childbearing age, you are advised to use an effective contraceptive method.
Breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Ondansetron from the tablets may pass into breast milk. Therefore, it is recommended that breastfeeding mothers do not breastfeed their babies if they are taking this medicine.
Driving and using machines
Ondansetron does not affect the ability to drive and use machines.
Important information about some of the ingredients of Ondansetron Qualigen 8 mg tablets
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
Follow these instructions unless your doctor has given you different instructions. Consult your doctor or pharmacist if you have any doubts.
Remember to take your medicine.
Your doctor will tell you how long to take Ondansetron Qualigen. Do not stop treatment before then.
Ondansetron Qualigen 8 mg tablets are taken orally. Swallow the tablets whole, with a little water.
Nausea and vomiting caused by chemotherapy or radiotherapy
Adults:
One tablet (8 mg) orally, 1-2 hours before the medical treatment that may cause nausea and vomiting, and then one tablet (8 mg) 12 hours later.
To prevent nausea and vomiting on subsequent days, continue taking one tablet (8 mg) every 12 hours for 5 days.
Nausea and vomiting caused by chemotherapy
Children over 6 months and adolescents:
The doctor will decide the dose based on the child's weight or body surface area.
Normally, 12 hours after chemotherapy, the child will receive ondansetron orally. The usual dose is 4 mg twice a day and may continue for up to 5 days.
Postoperative nausea and vomiting
Adults:
To prevent nausea and vomiting after surgery, 2 tablets (16 mg) orally, 1 hour before anesthesia.
Children:
There is no data available on the oral administration of ondansetron for the prevention of postoperative nausea and vomiting in children.
If you think the effect of Ondansetron Qualigen is too strong or too weak, tell your doctor or pharmacist.
If you take moreOndansetron Qualigenthan you should
Overdose symptoms may include vision problems, low blood pressure (which can cause dizziness or fainting), and palpitations (irregular heartbeat).
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.
If you or your child take more Ondansetron Qualigen than you should, talk to a doctor or go to the nearest hospital immediately. Take the medicine with you.
If you forget to takeOndansetron Qualigen
Do not take a double dose to make up for forgotten doses. Do not increase or decrease the dose without your doctor's authorization.
If you forget to take a dose and experience discomfort or vomiting, take another dose as soon as possible. Then continue as indicated.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
Like all medicines, Ondansetron Qualigen can have side effects, although not everyone gets them.
Very common side effects(in more than 1 in 10 patients).
Common side effects(between 1 and 10 in 100 patients).
You do not need to stop taking the medicine, but on your next visit to the doctor, tell them if you have experienced any of the following symptoms:
Uncommon side effects(between 1 and 10 in 1,000 patients).
Tell your doctor immediately if you experience:
Rare side effects(between 1 and 10 in 10,000 patients).
- Allergic reactions to the medicine: if you experience any of the following symptoms, stop taking the medicine immediately and tell your doctor immediately:
Very rare side effects(in less than 1 in 10,000 patients)
Side effects of unknown frequency: cannot be estimated
The signs include:
If you experience any of the side effects, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
No special storage conditions are required. Keep in the original packaging.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Composition of Ondansetron Qualigen 8 mg tablets
Core: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, magnesium stearate (E470b)
Coating: hypromellose (E464), titanium dioxide (E171), macrogol.
Appearance of the product and packaging contents
Ondansetron Qualigen 8 mg comes in the form of film-coated tablets. The tablets are elongated, biconvex, white, and have the inscription "8" on one side.
They come in packs of 6 or 15 film-coated tablets.
Other presentations
Ondansetron Qualigen 4 mg film-coated tablets EFG: packs of 6 or 15 film-coated tablets.
Ondansetron Qualigen 4 mg injectable solution EFG: packs containing 5 or 50 ampoules.
Ondansetron Qualigen 8 mg injectable solution EFG: packs containing 5 or 50 ampoules.
Marketing authorization holder
Neuraxpharm Spain, S.L.U. Avda. Barcelona 69
04970 Sant Joan Despí (Barcelona) Spain
Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
04970 Sant Joan Despí (Barcelona) Spain
This leaflet was last revised in February 2022
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