Ondansetron Normon 4 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the user
Ondansetron Normon 4 mg film-coated tablets EFG
Ondansetron
Read the entire leaflet carefully before you start taking this medicine, as 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 other people, even if they have the same symptoms as you, because it may 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
- What Ondansetron Normon is and what it is used for
- What you need to know before taking Ondansetron Normon
- How to take Ondansetron Normon
- Possible side effects
- How to store Ondansetron Normon
- 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 located on neurons in the central and peripheral nervous system.
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 Ondansetron Normon
Do not take Ondansetron Normon
If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
If you have ever had an allergic reaction (hypersensitivity) to other medicines 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 apply to you, do not take Ondansetron Normon and consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Ondansetron Normon.
- IF YOU HAVE AN INTESTINAL BLOCKAGE OR IF YOU SUFFER FROM SEVERE CONSTIPATION. ONDANSETRON NORMON MAY WORSEN THE BLOCKAGE OR CONSTIPATION.
- IF YOU HAVE EVER HAD HEART PROBLEMS, INCLUDING IRREGULAR HEARTBEAT (ARRHYTHMIA).
- IF YOU ARE UNDERGOING TONSIL SURGERY.
- IF YOU HAVE LIVER PROBLEMS.
IF YOU ARE TO UNDERGO ANY DIAGNOSTIC TESTS (INCLUDING BLOOD AND URINE TESTS, SKIN TESTS USING ALLERGENS, ETC.), INFORM YOUR DOCTOR THAT YOU ARE TAKING THIS MEDICINE, AS IT MAY AFFECT TEST RESULTS.
Other medicines and Ondansetron Normon
Tell 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 and Norepinephrine 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
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 cleft lip and/or cleft palate (openings or splits in the upper lip or 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 Ondansetron Normon, as it may cause harm to the fetus. 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 ONDANSETRON NORMON.
WOMEN OF CHILDBEARING AGE MUST USE AN EFFECTIVE METHOD OF CONTRACEPTION DURING TREATMENT WITH ONDANSETRON NORMON. CONSULT YOUR DOCTOR ABOUT CONTRACEPTIVE OPTIONS.
If you become pregnant during treatment with Ondansetron 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 Ondansetron Normon. The ingredients of Ondansetron Normon (ondansetron) may pass into breast milk and may affect your baby.
Driving and use of machines
IT IS UNLIKELY THAT ONDANSETRON NORMON WILL AFFECT YOUR ABILITY TO DRIVE OR OPERATE MACHINES.
Ondansetron Normon contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him 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 determine the duration of your treatment with Ondansetron Normon. Do not stop treatment early.
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 2 tablets (8 mg) 12 hours later. To prevent nausea and vomiting in the following days, continue taking 2 tablets (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 4 tablets (16 mg) orally, 1 hour before anesthesia.
Children
There are no data available on the oral administration of Ondansetron Normon for the prevention 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 the duration of your treatment with Ondansetron Normon. Do not stop treatment early.
If you feel that the effect of Ondansetron Normon 4 mg 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 4 mg 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 approval.
If you miss a dose and experience discomfort or vomiting, take another dose as soon as possible. Then continue taking the medicine as directed.
If you miss a dose and do not experience discomfort, wait until the next scheduled dose and 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 everyone 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 checking liver function
Rare adverse effects
May affect less than 1 in 1,000 patients taking Ondansetron Normon:
- sudden onset of whistling sounds and pain or tightness 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 inform 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 tightness in the chest.
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, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: 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 after "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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
6. Package contents and additional 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 4 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 8 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 for Medicines and Health Products (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 leaflet and packaging. You can also access this information at the following internet address:
https://cima.aemps.es/cima/dochtml/p/69378/P_69378.html