ONDANSETRON QUALIGEN 8 mg FILM-COATED TABLETS

Introduction

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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• 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.

Contents of the pack

1. What Ondansetron Qualigen is and what it is used for
2. Before taking Ondansetron Qualigen
3. How to take Ondansetron Qualigen
4. Possible side effects
5. Storage of Ondansetron Qualigen
6. Further information

1. What is ONDANSETRON QUALIGEN and what is it used for

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.

2. BEFORE TAKING ONDANSETRON QUALIGEN

Do not takeOndansetron Qualigen

• If you are allergic to ondansetron or any of the other ingredients of Ondansetron Qualigen.
• If you have had an allergic reaction (hypersensitivity) to other antiemetics (e.g. granisetron or dolasetron).

Be cautious withOndansetron Qualigen

• If you are hypersensitive (allergic) to other medicines for nausea or vomiting.
• If you have a blockage in the intestine or if you suffer from severe constipation. Ondansetron may increase the blockage or constipation.
• If you have heart problems.
• If you are undergoing a tonsil operation.
• If your liver is not working properly.

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:

• Phenytoin, carbamazepine (medicines to treat epilepsy), as they decrease the effect of ondansetron.
• Rifampicin (antibiotic to treat certain infections), as it decreases the effect of ondansetron.
• Tramadol (pain reliever), as ondansetron may reduce the analgesic effect of tramadol.
• Medicines used to treat heart problems (antiarrhythmics and/or beta blockers).

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.

3. HOW TO TAKE ONDANSETRON QUALIGEN

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.

4. Possible side effects

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).

• Headache.

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:

• Feeling of heat or flushing.
• Constipation.

Uncommon side effects(between 1 and 10 in 1,000 patients).

Tell your doctor immediately if you experience:

• Rapid upward movements of the eyes, abnormal muscle stiffness/movements of the body/tremors.
• Seizures.
• Slow or irregular heartbeat.
• Low blood pressure.
• Hiccup.
• Increased levels in blood test results for liver function, although they do not produce symptoms.

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:

• Sudden "pips" and pain or pressure in the chest.
• Swelling of the eyelids, face, lips, mouth, or tongue.
• Rash or hives on any part of the body.

• Blurred vision.

Very rare side effects(in less than 1 in 10,000 patients)

• Transient blindness, which usually resolves within 20 minutes.

Side effects of unknown frequency: cannot be estimated

• Myocardial ischemia

The signs include:

• sudden chest pain or
• chest pressure

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.

5. Storage of ONDANSETRON QUALIGEN

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.

6. FURTHER INFORMATION

Composition of Ondansetron Qualigen 8 mg tablets

• The active ingredient is ondansetron (as hydrochloride, dihydrate). Each tablet contains 8 mg of ondansetron.
• The other ingredients (excipients) are:

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