PATIENT INFORMATION LEAFLET

Ondansetrón Qualigen 8 mg

film-coated tablets

1. What Ondansetrón Qualigen is and what it is used for

2. Before taking Ondansetrón Qualigen

3. How to take Ondansetrón Qualigen

4. Possible side effects

5. Storage of Ondansetrón Qualigen

6. Further information

Ondansetrón Qualigen 8 mg tablets are presented in the form of film-coated tablets. Each package contains 6 or 15 film-coated tablets.

Ondansetrón belongs to a group of medicines called antiemetics.

It is used to prevent vomiting and nausea caused by certain medical treatments.

Do not takeOndansetrón Qualigen

• If you are allergic to ondansetrón or any of the other components of Ondansetrón Qualigen.
• If you have or have had an allergic reaction (hypersensitivity) with other antiemetics (for example, granisetrón or dolasetrón).

Be especially careful withOndansetrón Qualigen

• If you are hypersensitive (allergic) to other medications for nausea or vomiting.
• If you have a blockage in the intestine or if you suffer from severe constipation. Ondansetrón may increase the blockage or constipation.
• If you have heart problems.
• If you are undergoing an operation for tonsils.
• If your liver does not function as it should.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, even those acquired without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Especially, inform your doctor if you are using the following medications:

-Phenytoin, carbamazepine (medications for treating epilepsy), as they decrease the effect of ondansetrón.

-Rifampicin (antibiotic for treating certain infections), as it decreases the effect of ondansetrón.

-Tramadol (pain medication), as ondansetrón may reduce the analgesic effect of tramadol.

- Medications used to treat heart problems (antiarrhythmics and/or beta-blockers).

Use in children

Do not use in children under 2 years.

Pregnancy

Consult your doctor or pharmacist before using any medication.

Ondansetrón Qualigen should 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 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 using Ondansetrón Qualigen. If you are a fertile woman, it is recommended that you use an effective contraceptive method.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

It is likely that the ondansetrón from the tablets may pass into the milk. Therefore, it is recommended that mothers who are breastfeeding do not breastfeed their children while taking this medication.

Driving and operating machines

Ondansetrón does not affect the ability to drive and operate machines.

Important information about some of the components of Ondansetrón Qualigen 8 mg tablets

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

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 medication.

Your doctor will tell you the duration of your treatment with Ondansetrón Qualigen. Do not stop treatment before.

Ondansetrón Qualigen 8 mg tablets are administered orally. Swallow the tablets whole, with a little water.

Nausea and vomiting caused by chemotherapy or radiation therapy

Adults:

One tablet (8 mg) orally, 1-2 hours before the potentially nausea-causing medical treatment, and then one tablet (8 mg) 12 hours later.

To prevent nausea and vomiting on the following 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:

Your doctor will decide the dose based on your child's weight or body surface area.

Normally, 12 hours after chemotherapy, your child will receive ondansetrón 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, two tablets (16 mg) orally, 1 hour before anesthesia.

Children:

No data is available on the oral administration of ondansetrón for the prevention of postoperative nausea and vomiting in children.

If you estimate that the action of Ondansetrón Qualigen is too strong or too weak, inform your doctor or pharmacist.

If you take moreOndansetrón Qualigenthan you should

The 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you or your child takes more Ondansetrón Qualigen than you should, talk to a doctor or go immediately to the nearest hospital. Bring the medication with you.

If you forgot to takeOndansetrón Qualigen

Do not take a double dose to compensate for the missed doses. Do not increase or decrease the dose without your doctor's authorization.

In case you forget to take a dose and experience discomfort or vomiting, take another as soon as possible. Then continue as indicated.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all Qualigen Ondansetrón medications, it may have side effects, although not everyone will experience them.

Very common side effects(in more than 1 in 10 patients).

- Headache.

Common side effects(between 1 and 10 in every 100 patients).

You do not need to stop taking the medication, but inform your doctor if you have experienced any of the following symptoms at your next visit:

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

Inform your doctor immediately in case of:

-Upward rolling eye movements, abnormal muscle stiffness/muscle movements/tremors.

-Seizures.

-Slow or irregular heartbeats.

-Low blood pressure (hypotension).

-Hypophagia.

-Increases in liver function test results, although they do not produce symptoms.

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

-Allergies to the medication: if any of the following symptoms appear, stop taking the medication immediately and inform your doctor immediately:

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

-Transient blindness, which usually resolves in 20 minutes.

Side effects of unknown frequency: cannot be estimated

The signs include:

• Sudden chest pain or
• chest pressure

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

No requires special conservation conditions. Keep in the original packaging.

Keep out of the reach and sight of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. This will help protect the environment.

Composition of Ondansetrón Qualigen 8 mg tablets

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

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

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

Appearance of the product and contents of the package

Ondansetrón Qualigen 8 mg is presented in film-coated tablets. The tablets are elongated, biconvex, white in color, and bear the inscription “8” on one face.

They are available in packages of 6 or 15 tablets.

Other presentations

Ondansetrón Qualigen 4 mg film-coated tablets EFG: packages of 6 or 15 film-coated tablets.

Ondansetrón Qualigen 4 mg EFG injectable solution: packages containing 5 or 50 ampoules.

Ondansetrón Qualigen 8 mg EFG injectable solution: packages containing 5 or 50 ampoules.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.Avda. Barcelona 69

04970 Sant Joan Despí (Barcelona) Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

04970 Sant Joan Despí (Barcelona) Spain

This leaflet was revised in February 2022