Ondansetron Qualigen 4 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ondansetron Qualigen 4 mg

film-coated tablets EFG

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet Contents

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. How to store Ondansetron Qualigen
6. Further information

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

Ondansetron Qualigen 4 mg tablets are presented as film-coated tablets. Each package 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 take Ondansetrón Qualigen

• If you are allergic to ondansetrón or to any of the other components of Ondansetrón Qualigen.
• If you have or have had an allergic (hypersensitive) reaction to other antiemetics (for example, granisetron or dolasetron).

Take special care with Ondansetrón Qualigen

• If you are hypersensitive (allergic) to other medicines for nausea or vomiting.
• If you have intestinal blockage or suffer from severe constipation. Ondansetrón may worsen the blockage or constipation.
• If you have heart problems.
• If you are undergoing tonsillectomy surgery.
• If your liver is not functioning properly.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one or more of them.

In particular, inform your doctor if you are taking the following medicines:

• Phenytoin, carbamazepine (medicines used to treat epilepsy), as they reduce the effect of ondansetrón.
• Rifampicin (an antibiotic used to treat certain infections), as it reduces the effect of ondansetrón.
• Tramadol (a pain reliever), as ondansetrón 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 using any medicine.

Ondansetrón Qualigen must not be used during the first trimester of pregnancy. This is because Ondansetrón Qualigen may slightly increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip or in the palate). If you are already pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Ondansetrón Qualigen. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

Breast-feeding

Consult your doctor or pharmacist before using any medicine.

Ondansetrón from the tablets may pass into breast milk. Therefore, it is recommended that breastfeeding mothers do not breastfeed while taking this medicine.

Driving and using machines

Ondansetrón does not affect the ability to drive or operate machinery.

Important information about some of the components of Ondansetrón Qualigen 4 mg tablets

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. HOW TO TAKE ONDANSETRON QUALIGEN

Follow these instructions unless your doctor has given you different ones. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will determine how long you should be treated with Ondansetron Qualigen. Do not stop treatment early.

Ondansetron Qualigen 4 mg tablets are administered orally. Swallow the tablets whole with a little water.

Nausea and vomiting caused by chemotherapy and radiotherapy

Adults:

Two tablets (8 mg) orally, 1–2 hours before the medical treatment likely to cause nausea and vomiting, followed by two tablets (8 mg) 12 hours later.

To prevent nausea and vomiting in the following days, continue taking two tablets (8 mg) every 12 hours for 5 days.

Children:

One tablet (4 mg) of Ondansetron Qualigen 12 hours after the medical treatment likely to cause nausea and vomiting. To prevent nausea and vomiting in the following days, continue taking one tablet (4 mg) twice daily for 5 days.

Postoperative nausea and vomiting

Adults:

Four tablets (16 mg) orally, 1 hour before anesthesia.

There is no experience with ondansetron in the prevention and treatment of postoperative nausea and vomiting in children under 2 years of age.

If you feel that the effect of Ondansetron Qualigen is too strong or too weak, tell your doctor or pharmacist.

If you take more Ondansetron Qualigen than you should

Symptoms of overdose may include vision problems, low blood pressure (which may cause dizziness or fainting), and palpitations (irregular heartbeat).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and amount ingested.

If you or your child takes more Ondansetron Qualigen than prescribed, speak to a doctor or go immediately to the nearest hospital. Take the medication with you.

If you forget to take Ondansetron 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 directed.

If you have any further questions about using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Ondansetron Qualigen may cause adverse effects, although not everyone gets them.

Very common adverse effects (in more than 1 in every 10 patients):

• Headache.

Common adverse effects (in between 1 and 10 in every 100 patients):

It is not necessary to stop taking the medicine; however, during your next visit to the doctor, inform your doctor if you have experienced any of the following symptoms:

• Feeling of warmth or flushing.
• Constipation.

Uncommon adverse effects (in between 1 and 10 in every 1,000 patients):

Inform your doctor immediately if you experience:

• Upward and rotational eye movements, abnormal muscle stiffness, body movements, or tremor.
• Seizures.
• Slow or irregular heartbeat.
• Lower than normal blood pressure (hypotension).
• Hiccups.
• Increased levels in blood test results indicating liver function, although these do not cause symptoms.

Rare adverse effects (in between 1 and 10 in every 10,000 patients):

• Allergic reactions to the medicine: if any of the following symptoms occur, stop taking the medicine immediately and contact your doctor immediately:

• Sudden whistling sound, chest pain or tightness in the chest.

• Swelling of the eyelids, face, lips, mouth, or tongue.

• Skin rash or hives anywhere on the body.

• Blurred vision.

Very rare adverse effects (in less than 1 in every 10,000 patients):

• Transient blindness, which usually resolves within 20 minutes.

Adverse effects with unknown frequency: frequency cannot be estimated from the available data

• Myocardial ischemia

Signs include:

• Sudden chest pain or
• Chest tightness

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform 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 container after EXP. The expiry date refers to 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 and containers you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Ondansetron Qualigen

• The active substance is ondansetron (as hydrochloride, dihydrate). Each tablet contains 4 mg of ondansetron.
• The other components (excipients) are:

Core: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, magnesium stearate (E470b)

Coating: hypromellose (E464), titanium dioxide (E171), macrogol.

Appearance of the medicinal product and contents of the pack

Ondansetron Qualigen 4 mg is presented as film-coated tablets. The tablets are elongated, biconvex, white in colour and marked with the inscription “4” on one side.

Packaged in packs of 6 or 15 tablets.

Other presentations

Ondansetron Qualigen 8 mg film-coated tablets EFG: packs of 6 or 15 film-coated tablets.

Ondansetron Qualigen 4 mg solution for injection EFG: packs containing 5 or 50 ampoules.

Ondansetron Qualigen 8 mg solution for injection 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