Ondansetron Normon 8 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ondansetron Normon 8 mg film-coated tablets EFG

Ondansetron

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Ondansetron Normon is and what it is used for
2. What you need to know before taking Ondansetron Normon
3. How to take Ondansetron Normon
4. Possible adverse effects
5. How to store Ondansetron Normon
6. Contents of the pack and other information

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

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

Ondansetron Normon is used to:

• prevent nausea and vomiting caused by:
• chemotherapy in the treatment of cancer in adults and children over 6 months of age.
• radiotherapy in the treatment of cancer in adults.
• prevent postoperative nausea and vomiting in adults.

2. What you need to know before taking Ondansetrón Normon

• Do not take Ondansetrón Normon

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

If you have ever had or currently have an allergic reaction (hypersensitivity) to other medicines used for nausea or vomiting (for example, granisetron or dolasetron).

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

If any of the above applies to you, do not take Ondansetrón Normon and consult your doctor.

• Warnings and precautions

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

• IF YOU HAVE AN INTESTINAL BLOCKAGE OR SUFFER FROM SEVERE CONSTIPATION. ONDANSETRÓN NORMON MAY WORSEN THE BLOCKAGE OR CONSTIPATION.
• IF YOU HAVE EVER HAD HEART PROBLEMS, INCLUDING IRREGULAR HEARTBEAT (ARRHYTHMIA).
• IF YOU ARE UNDERGOING TONSILLECTOMY SURGERY.
• IF YOU HAVE LIVER PROBLEMS.

IF YOU ARE DUE TO HAVE ANY DIAGNOSTIC TESTS (INCLUDING BLOOD TESTS, URINE TESTS, SKIN TESTS USING ALLERGENS, ETC.), INFORM YOUR DOCTOR THAT YOU ARE TAKING THIS MEDICINE, AS IT MAY AFFECT THE RESULTS.

• Other medicines and Ondansetrón Normon

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

In particular, it is important to inform your doctor if you are taking any of the following medicines, as it may be necessary to interrupt treatment or adjust the dose of one or more of them:

• rifampicin (an antibiotic used to treat infections such as tuberculosis).
• tramadol (a medicine used to treat pain).
• phenytoin or carbamazepine (medicines used to treat epilepsy).
• medicines used to treat heart problems, such as irregular heartbeat (antiarrhythmics) and/or to treat high blood pressure (beta-blockers).
• haloperidol or methadone (medicines that may affect the heart).
• anthracyclines and trastuzumab (medicines used to treat cancer).
• fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram (selective serotonin reuptake inhibitors, used to treat depression and/or anxiety).
• venlafaxine, duloxetine (serotonin-noradrenaline reuptake inhibitors, used to treat depression and/or anxiety).

Inform your doctor or pharmacist if you are taking any of these medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 cleft palate (openings or splits in the upper lip or the roof of the mouth). If you are already pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Ondansetrón Normon, as it may harm the unborn baby. Women of childbearing age are advised to use an effective method of contraception.

IF YOU ARE A WOMAN OF CHILDBEARING AGE, YOUR DOCTOR OR NURSE WILL CHECK WHETHER YOU ARE PREGNANT AND WILL PERFORM A PREGNANCY TEST BEFORE STARTING TREATMENT WITH ONDANSETRÓN NORMON.

WOMEN OF CHILDBEARING AGE SHOULD USE AN EFFECTIVE METHOD OF CONTRACEPTION DURING TREATMENT WITH ONDANSETRÓN NORMON. CONSULT YOUR DOCTOR ABOUT CONTRACEPTIVE OPTIONS.

If you become pregnant while taking Ondansetrón Normon, inform your doctor.

Fertility

If you are a woman of childbearing age, you are advised to use an effective method of contraception.

Breastfeeding

Breastfeeding is not recommended during treatment with Ondansetrón Normon. The ingredients of Ondansetrón Normon (ondansetron) may pass into breast milk and may affect your baby.

Driving and use of machines

IT IS UNLIKELY THAT ONDANSETRÓN NORMON WILL AFFECT YOUR ABILITY TO DRIVE OR USE MACHINES.

Ondansetrón Normon contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Ondansetron Normon

Ondansetron Normon is administered orally.

Your doctor will tell you exactly how much Ondansetron Normon to take. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine. Swallow the tablets whole with a little water. Your doctor will indicate how long your treatment with Ondansetron Normon should last. Do not stop treatment prematurely.

Nausea and vomiting caused by chemotherapy and radiotherapy

Adults

One tablet (8 mg) orally, 1 to 2 hours before medical treatment that may cause nausea and vomiting, followed by one tablet (8 mg) 12 hours later. To prevent nausea and vomiting in subsequent days, continue taking one tablet (8 mg) every 12 hours for 5 days.

Nausea and vomiting caused by chemotherapy

Children over 6 months of age and adolescents

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

Usually, 12 hours after chemotherapy, your child will receive ondansetron orally. The usual dose is 4 mg twice daily and may continue for up to 5 days.

Postoperative nausea and vomiting

Adults

To prevent nausea and vomiting after surgery, take 2 tablets (16 mg) orally, 1 hour before anesthesia.

Children

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

Dose adjustments

Patients with hepatic impairment

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

Elderly patients, patients with renal impairment, or slow metabolizers of sparteine/debrisoquine

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

Duration of treatment

Your doctor will decide how long your treatment with Ondansetron Normon should last. Do not stop treatment prematurely.

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

If you take more Ondansetron Normon than you should

In case of overdose, symptoms that may occur include: 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 prescribed, contact your doctor or pharmacist immediately, call the Toxicology Information Service (Telephone 91 562 04 20), or go to the nearest hospital emergency department. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Ondansetron Normon

Do not take a double dose to make up for missed 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 taking the medicine as directed.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

Very common adverse effects

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

• headache

Common adverse effects

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

• sensation of warmth or flushing
• constipation

Uncommon adverse effects

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

• upward rolling eye movements, abnormal muscle stiffness, body movements, tremor
• seizures
• slow or irregular heartbeat
• lower than normal blood pressure (hypotension)
• hiccups
• increased levels in blood test results assessing liver function

Rare adverse effects

May affect less than 1 in 1,000 patients taking Ondansetron Normon:

• sudden onset of chest pain, tightness or whistling in the chest
• swelling of the eyelids, face, lips, mouth or tongue
• skin rash or hives anywhere on the body
• changes in heart rhythm (sometimes may cause sudden loss of consciousness)
• blurred vision

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

Very rare adverse effects

May affect less than 1 in 10,000 patients taking Ondansetron Normon:

• transient blindness, which usually resolves within 20 minutes
• changes in the electrocardiogram
• widespread skin rash with blisters and peeling affecting a large part of the body surface (toxic epidermal necrolysis)

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

Frequency not known

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ondansetron Normon

No special storage conditions are required. Keep in the original packaging.

Do not use this medicine after the expiry date stated on the container, following "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

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

6. Contents of the pack and other information

Composition of Ondansetron Normon

• The active substance is ondansetron.
• The other components are: microcrystalline cellulose, pregelatinized corn starch (gluten-free), lactose, magnesium stearate, hypromellose, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance of the medicinal product and contents of the pack

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

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos, Madrid (SPAIN)

Other presentations

Ondansetron Normon 4 mg film-coated tablets

Date of the most recent review of this leaflet: February 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address:

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