ONDANSETRON NORMON 8 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ondansetron Normon 8 mg Film-Coated Tablets EFG

Ondansetron

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

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

Ondansetron Normon is used to:

• prevent nausea and vomiting caused by:
• cancer chemotherapy in adults and children over 6 months of age.
• radiotherapy in adults.
• prevent post-operative nausea and vomiting in adults.

2. What you need to know before you take Ondansetron Normon

• Do not take Ondansetron Normon

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

If you have had an allergic reaction to other medicines for nausea or vomiting (e.g. granisetron or dolasetron).

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

If you think any of these apply to you, do not take Ondansetron Normon and consult your doctor.

• Warnings and precautions

Tell your doctor or pharmacist before you start taking Ondansetron Normon 8 mg film-coated tablets.

• IF YOU HAVE A BLOCKAGE IN YOUR INTESTINE OR IF YOU SUFFER FROM SEVERE CONSTIPATION. ONDANSETRON NORMON MAY INCREASE THE BLOCKAGE OR CONSTIPATION.
• IF YOU HAVE EVER HAD HEART PROBLEMS, INCLUDING IRREGULAR HEARTBEAT (ARRHYTHMIA).
• IF YOU ARE HAVING A TONSILLECTOMY
• IF YOU HAVE LIVER PROBLEMS.

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

• Other medicines and Ondansetron Normon

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

In particular, it is important to tell your doctor if you are taking any of the following medicines, as it may be necessary to stop treatment or adjust the dose of one 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 problemssuch as irregular heartbeats (antiarrhythmics) and/or to treat high blood pressure(beta blockers).
• haloperidol or methadone(medicines that can affect the heart).
• anthracyclines and trastuzumab(medicines used to treat cancer).
• fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram(Selective serotonin reuptake inhibitors, used to treat depressionand/or anxiety)
• venlafaxine, duloxetine(Serotonin and noradrenaline reuptake inhibitors, used to treat depressionand/or anxiety)

Tell your doctor or pharmacistif 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 have a baby, ask your doctor or pharmacist for advice.

Pregnancy

Ondansetron Normon should not be used during the first trimester of pregnancy. This is because Ondansetron Normon may slightly increase the risk of a baby being born with a cleft lip and/or cleft palate (openings or gaps in the upper lip or palate). If you are already pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Ondansetron Normon, as Ondansetron Normon may harm the fetus. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

IF YOU ARE A WOMAN OF CHILDBEARING AGE, YOUR DOCTOR OR NURSE SHOULD CHECK IF YOU ARE PREGNANT AND PERFORM A PREGNANCY TEST BEFORE YOU START TREATMENT WITH ONDANSETRON NORMON.

WOMEN OF CHILDBEARING AGE SHOULD USE AN EFFECTIVE METHOD OF CONTRACEPTION DURING TREATMENT WITH ONDANSETRON NORMON. ASK YOUR DOCTOR ABOUT CONTRACEPTION OPTIONS.

If you become pregnant during treatment with Ondansetron Normon, tell your doctor.

Fertility

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

Breastfeeding

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

Driving and using machines

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

Ondansetron Normoncontains

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Ondansetron Normon

Ondansetron Normon is taken by mouth.

Your doctor will tell you exactly how much Ondansetron Normon to take. If you are unsure, ask your doctor or pharmacist.

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

Nausea and vomiting caused by chemotherapy and radiotherapy.

Adults

One tablet (8 mg) by mouth, 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

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 by mouth. The usual dose is 4 mg twice a day and may continue for up to 5 days.

Post-operative nausea and vomiting.

Adults

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

Children

There is no data available on the oral administration of Ondansetron Normon for the prevention and treatment of post-operative nausea and vomiting in children.

Dose adjustments

Patient with liver impairment

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

Patient with advanced age, patients with renal impairment or slow metabolizers of sparteine/debrisoquine

No dose adjustment is necessary.

Duration of treatment

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

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

If you or your child has taken more Ondansetron Normon than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service (Telephone 91 562 04 20) or go to the emergency department of the nearest hospital. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Ondansetron Normon

Do not take a double doseto make up for forgotten doses. Do not increase or decrease the dose without consulting your doctor.

If you forget to take a dose and have nausea 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 have nausea or vomiting, wait for the next dose and do not continue taking the medicine as directed.

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

4. Possible side effects

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

Very common side effects

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

• headache

Common side effects

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

• feeling of warmth or flushing
• constipation

Uncommon side effects

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

• rotating upward movements of the eyes, abnormal muscle stiffness, body movements, tremor
• seizures
• slow or irregular heartbeat
• low blood pressure
• hypo
• increased levels in blood tests to check liver function.

Rare side effects

May affect up to 1 in 1,000 people taking Ondansetron Normon:

• sudden onset of wheezing or chest pain or tightness
• swelling of the eyelids, face, lips, mouth or tongue
• skin rash or hives anywhere on the body
• abnormal heart rhythm (which can sometimes cause sudden loss of consciousness)
• blurred vision.

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

Very rare side effects

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

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

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

Frequency not known

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

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

Reporting of side effects

If you experience any side effects, tell your doctor, pharmacist or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side 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 package.

Do not take this medicine after the expiry date which is stated on the package after “EXP”. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

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

6. Contents of the pack and further information

Composition of Ondansetron Normon

• The active substance is ondansetron
• The other ingredients 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 product and pack contents.

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 authorisation 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 last revision of this leaflet: February 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es

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

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