Leaflet: information for the user

Ondansetrón Normon 8 mg film-coated tabletsEFG

Ondansetrón

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Ondansetrón Normon

3. How to take Ondansetrón Normon

4. Possible side effects

5. Storage of Ondansetrón Normon

6. Contents of the pack and additional informationl

Ondansetrón Normon belongs to a group of medicines called antiemetics. Ondansetrón is a 5HT3 receptor antagonist. It acts by inhibiting 5HT3 receptors on neurons located in the central and peripheral nervous systems.

Ondansetrón Normon is used for:

- preventing nausea and vomiting caused by:

- chemotherapy in the treatment of cancer in adults and children over 6 months of age.

- radiation therapy in the treatment of cancer in adults.

- preventing postoperative nausea and vomiting in adults.

• Do not take Ondansetrón Normon

If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

If you have or have had an allergic reaction (hypersensitivity) with other anti-nausea or anti-vomiting medications (for example, granisetron or dolasetron).

If you are taking apomorphine (a medication used to treat Parkinson's disease).

If you consider this applies to you, do not take Ondansetrón Normon and consult your doctor.

• Warnings and precautions

Consult your doctor or pharmacist before starting to take Ondansetrón Normon 8 mg tablets.

- IF YOU HAVE A BOWEL OBSTRUCTION OR SEVERE CONSTIPATION. ONDANSETRÓN NORMON MAY WORSEN THE OBSTRUCTION OR CONSTIPATION.

- IF YOU HAVE EVER HAD HEART PROBLEMS, INCLUDING IRREGULAR HEARTBEAT (ARRHYTHMIA).

- IF YOU ARE UNDERGOING A TONSILLECTOMY.

- IF YOU HAVE LIVER PROBLEMS.

IF YOU ARE TO UNDERGO ANY DIAGNOSTIC TESTS (INCLUDING BLOOD, URINE, SKIN TESTS THAT USE ALLERGENS, ETC.) INFORM YOUR DOCTOR THAT YOU ARE TAKING THIS MEDICATION, AS IT MAY ALTER THE RESULTS.

• Other medications and Ondansetrón Normon

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Particularly, it is essential to inform your doctor if you are taking any of the following medications, as it may be necessary to interrupt treatment or adjust the dose of one of them.

• rifampicin(an antibiotic used to treat infections such as tuberculosis).
• tramadol(a medication used to treat pain).
• phenytoin or carbamazepine(medications used to treat epilepsy).
• medications used to treatheart problemssuch as arrhythmias (antiarrhythmics) and/or to treathigh blood pressure(beta-blockers).
• haloperidol or methadone(medications that can affect the heart).
• anthracyclines and trastuzumab(medications used to treat cancer).
• fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram(selective serotonin reuptake inhibitors, used to treatdepressionand/oranxiety).
• venlafaxine, duloxetine(inhibitors of serotonin and noradrenaline reuptake, used to treatdepressionand/oranxiety).

Inform your doctor or pharmacistif you are taking any of these medications.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist.

Pregnancy

Ondansetrón Normon should not be used during the first trimester of pregnancy. This is because Ondansetrón Normon may slightly increase the risk of a baby being born with cleft lip and/or palate (openings or clefts in the upper lip or palate). If you are already pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using Ondansetrón Normon, as Ondansetrón Normon may cause harm to the fetus. If you are a fertile woman, your doctor or nurse should check if you are pregnant and perform a pregnancy test before starting treatment with Ondansetrón Normon.

IF YOU ARE A FERTILE WOMAN, YOUR DOCTOR OR NURSE SHOULD CHECK IF YOU ARE PREGNANT AND PERFORM A PREGNANCY TEST BEFORE STARTING TREATMENT WITH ONDANSETRÓN NORMON.

FERTILE WOMEN SHOULD USE AN EFFECTIVE CONTRACEPTIVE METHOD DURING TREATMENT WITH ONDANSETRÓN NORMON. CONSULT YOUR DOCTOR ABOUT THE OPTIONS FOR CONTRACEPTIVE METHODS.

If you become pregnant during treatment with Ondansetrón Normon, inform your doctor.

Fertility

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

Breastfeeding

It is not recommended to breastfeed during treatment with Ondansetrón Normon. The ingredients of Ondansetrón Normon (ondansetrón) may pass into breast milk and may affect your baby.

Driving and operating machinery

IT IS UNLIKELY THAT ONDANSETRÓN NORMON WILL AFFECT YOUR ABILITY TO DRIVE AND OPERATE MACHINES.

Ondansetrón Normoncontainslactose

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

Ondansetron Normon is administered orally.

Your doctor will tell you exactly how much Ondansetron Normon you should take. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medication. Swallow the whole tablets with a little water. Your doctor will tell you how long you should take Ondansetron Normon. Do not stop treatment before.

Nausea and vomiting caused by chemotherapy and radiation therapy.

Adults

One tablet (8 mg) orally, 1-2 hours before the potentially nauseating medical treatment, 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

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 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

No data are available on the oral administration of Ondansetron Normon for the prevention and treatment of postoperative nausea and vomiting in children.

Dose adjustments

Patients with liver insufficiency

In patients with liver problems, the dose should be adjusted to a maximum of 8 mg per day of Ondansetron Normon.

Older patients, patients with renal insufficiency or slow metabolizers of sparteine/debrisoquine

No adjustment of the daily dose or frequency of the dose or route of administration is necessary.

Treatment duration

Your doctor will decide the duration of your treatment with Ondansetron Normon. Do not stop treatment before.

If you think the effect of Ondansetron Normon is too strong or too weak, tell your doctor or pharmacist.

If you take more Ondansetron Normon than you should

In case of overdose, symptoms that may appear are: vision problems, low blood pressure (which may cause dizziness or fainting) and palpitations (irregular heartbeat).

If you or your child has taken more Ondansetron Normon than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service (Telephone 91 562 04 20) or go to the nearest emergency hospital. It is recommended to bring the packaging and the leaflet with the medication to the healthcare professional.

If you forgot to take Ondansetron Normon

Do not take a double doseto compensate for the missed doses. Do not increase or decrease the doses 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 taking the medication as directed.

If you forget to take a dose and do not experience discomfort, wait for the next dose and do not continue taking the medication as directed.

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

Like all medicines, this medicine can have side effects, although not everyone will experience them.

Very common side effects

May affect more than 1 in 10 patients taking Ondansetrón Normon:

• headache

Common side effects

May affect up to 1 in 10 patients taking Ondansetrón Normon:

• sensation of heat or flushing
• constipation

Rare side effects

May affect up to 1 in 100 patients taking Ondansetrón Normon:

• eye movements, abnormal muscle stiffness, body movements, tremor
• seizures
• slow or irregular heartbeats
• low blood pressure (hypotension)
• hypo
• increased levels in liver function test results.

Very rare side effects

May affect fewer than 1 in 1,000 patients taking Ondansetrón Normon:

• sudden onset of wheezing and chest pain or tightness
• swelling of eyelids, face, lips, mouth, or tongue
• skin rash or urticaria anywhere on the body
• alteration in heart rhythm (in some cases may cause sudden loss of consciousness)
• blurred vision.

→ If you experience any of these symptoms, stop taking the medicine immediately and inform your doctor.

Very rare side effects

May affect fewer than 1 in 10,000 patients taking Ondansetrón Normon:

• transient blindness, which usually resolves in 20 minutes
• electrocardiogram alterations
• extensive skin rash with blisters and peeling, affecting a large area of the body (toxic epidermal necrolysis).

→ Inform your doctor immediately if you experience any of these symptoms.

Unknown frequency

• myocardial ischemia: symptoms include sudden chest pain or tightness.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usewww.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not take this medication 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 thrown down the drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Keep this medication out of the sight and reach of children.

Ondansetrón Normon Composition

- The active ingredient is ondansetrón

- The other components are: microcrystalline cellulose, pregelatinized cornstarch (gluten-free), lactose, magnesium stearate, hypromellose, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance of the product and contents of the packaging.

Ondansetrón Normon 8 mg are film-coated tablets. The tablets are yellow, elongated, and biconvex. They are available in packs of 6 and 15 tablets.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos, Madrid (SPAIN)

Other presentations

Ondansetrón Normon 4 mg film-coated tablets

Last review date of this leaflet: February 2022

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/69379/P_69379.html