Ondansetron Bluefish 8 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ondansetron Bluefish 8 mg orodispersible tablets EFG

ondansetron

Read the entire leaflet carefully before starting to take 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Package leaflet:

1. What Ondansetron Bluefish orodispersible tablets are and what they are used for
2. What you need to know before taking Ondansetron Bluefish orodispersible tablets
3. How to take Ondansetron Bluefish orodispersible tablets
4. Possible side effects
5. How to store Ondansetron Bluefish orodispersible tablets
6. Contents of the pack and other information

1. What Ondansetron Bluefish orodispersible tablets are and what they are used for

Ondansetron Bluefish orodispersible tablets are tablets that rapidly dissolve when placed on the tongue.

This medicine contains ondansetron, which belongs to a group of medicines called antiemetics used to prevent nausea and vomiting.

Ondansetron orodispersible tablets can be used for:

• Preventing nausea and vomiting caused by cytotoxic chemotherapy in children and adults
• Preventing postoperative nausea and vomiting in children and adults
• Preventing nausea and vomiting caused by radiotherapy in adults

If you are not sure why this treatment has been prescribed for you, please consult your doctor.

2. What you need to know before taking Ondansetrón Bluefish orodispersible tablets

Do not take Ondansetrón Bluefish orodispersible tablets

• if you are allergic to ondansetron or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking apomorphine (used for the treatment of Parkinson's disease)

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Ondansetrón Bluefish orodispersible tablets:

• if you are pregnant or may become pregnant soon,
• if you are breastfeeding,
• if you have liver problems,
• if you have intestinal obstruction or suffer from severe constipation,
• in children under 2 years of age or with a body surface area less than 0.6 m².

Other medicines and Ondansetrón Bluefish orodispersible tablets

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines such as phenytoin, carbamazepine, rifampicin, or tramadol.

Pregnancy and breastfeeding

Ondansetrón Bluefish orodispersible tablets should not be used during the first trimester of pregnancy. This is because Ondansetrón Bluefish orodispersible tablets 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 in the roof of the mouth). If you are already pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using Ondansetrón Bluefish orodispersible tablets. If you are a woman of childbearing age, you are advised to use an effective method of contraception.

Ondansetron may pass into breast milk. Therefore, breastfeeding mothers are advised not to breastfeed their infants while taking Ondansetrón Bluefish orodispersible tablets.

Driving and use of machines

Ondansetrón Bluefish orodispersible tablets do not affect the ability to drive or operate machinery.

Ondansetrón Bluefish orodispersible tablets contain aspartame, glucose, maltodextrin, sorbitol, sulfur dioxide, and sodium

Ondansetrón Bluefish orodispersible tablets contain aspartame (E 951). This medicine contains 1.76 mg of aspartame in each 8 mg orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Ondansetrón Bluefish orodispersible tablets contain sorbitol (E 420). This medicine contains 16.9 mg of sorbitol in each 8 mg orodispersible tablet.

Ondansetrón Bluefish orodispersible tablets contain glucose and maltodextrin. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

May cause dental caries.

Ondansetrón Bluefish orodispersible tablets contain sulfur dioxide (E 220). This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains "sulfur dioxide".

Ondansetrón Bluefish orodispersible tablets contain sodium. This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

3. How to take Ondansetron Bluefish orodispersible tablets

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

After starting treatment

Ondansetron orodispersible tablets begin to work within 1-2 hours. If you vomit before 1 hour has passed, take another identical dose. Otherwise, do not take additional tablets or reduce the interval between doses. Consult your doctor if discomfort persists.

Treatment and prevention of nausea and vomiting related to chemotherapy and/or radiotherapy

Adults

The recommended dose is 8 mg, 1 to 2 hours before chemotherapy, followed by 8 mg every 12 hours thereafter for 5 days. Your doctor will decide whether you should receive an injection instead of tablets.

Elderly

The same dose as for adults.

Children over 2 years of age and adolescents under 18 years of age:

The dose is individual and depends on the child's size/body surface area. Ondansetrón Bluefish must not be used in children with a total body surface area less than 0.6 m².

Children from 6 months of age and adolescents

• The recommended dose is up to 4 mg twice daily
• May be administered for 5 days

Prevention of postoperative nausea and vomiting

Adults

The usual dose is 16 mg before anesthesia, or alternatively, 8 mg one hour before anesthesia followed by additional doses of 8 mg at 8 and 16 hours. Your doctor will decide whether an injection should be given instead of tablets.

Elderly

Experience with ondansetron in elderly patients is limited. Ondansetron is well tolerated in patients over 65 years of age receiving chemotherapy (please see previous section).

Patients with moderate or severe hepatic impairment: the total daily dose should not exceed 8 mg.

Patients who are poor metabolizers of sparteine/debrisoquine: no adjustment of dose or dosing regimen is required.

Do not remove the tablets or pierce the blister pack until ready to take the medication.

The tablets should be taken as indicated:

Do not remove Ondansetron Bluefish orodispersible tablets or pierce the blister pack until you are ready to take the medicine.

To prevent damage to the tablets, it is important not to press on the tablet before piercing the blister (Figure A).

The tablets in each blister are separated by perforations. Separate each tablet along the perforations (Figure 1). The protective film should be carefully removed starting from the corner marked with the arrow (Figure 2 and 3).

The tablets should be taken out with dry hands and placed on the tongue (Figure 4). The tablet will disintegrate, after which it can be swallowed with water.

Figure A. Figure 1.

Figure 2. Figure 3.

Figure 4.

If you take more Ondansetron Bluefish orodispersible tablets than you should

If you or your child takes more Ondansetron Bluefish than prescribed, speak to a doctor or go immediately to the nearest hospital. Take the medicine with you. You may also call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ondansetron Bluefish orodispersible tablets

Do not take a double dose to make up for forgotten doses.

If you miss a dose and experience nausea or vomiting, take one Ondansetron Bluefish tablet as soon as possible, then continue treatment as directed. If you miss a dose but do not have nausea or vomiting, take the next dose as prescribed.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

Some people may be allergic to medicines. If any of the following symptoms appear shortly after taking Ondansetron, stop taking the medicine and inform your doctor immediately.

• Sudden onset of "wheezing" and pain or tightness in the chest.
• Swelling of the eyelids, face, lips, mouth, or tongue.
• Skin rash or hives anywhere on the body.
• Collapse

Other possible adverse effects:

Very common (may affect more than 1 in 10 people)

• Headache.

Frequent (may affect up to 1 in 10 people)

• Constipation.
• Feeling of warmth or flushing.

Uncommon (may affect up to 1 in 100 people)

• Arrhythmias, chest pain without depression of the ST segment, palpitations (irregular heartbeat) or slow heartbeat.
• Asymptomatic increase in blood test results indicating liver function.
• Seizures, involuntary body movements including extrapyramidal reactions such as dystonic reactions, including upward rolling eye movements, and dyskinesia have been observed without clinically relevant consequences.
• Hiccups.
• Low blood pressure (hypotension).

Rare (may affect up to 1 in 1,000 people)

• Immediate allergic reaction, which can be severe, such as swelling of the mouth and throat causing breathing difficulties.
• Dizziness has also occurred when ondansetron is administered intravenously, which in most cases can be prevented or resolved by increasing the infusion period.
• Vision problems (e.g., blurred vision) associated with injectable ondansetron.

Very rare (may affect up to 1 in 10,000 people)

• Temporary loss of vision, almost always after injectable administration.

Most cases of blindness resolved within 20 minutes. Most patients had received chemotherapeutic agents, including cisplatin. Some reported cases of transient blindness were of cortical origin.

The strawberry flavour contains sulphur dioxide (E220), which may cause rare hypersensitivity reactions and bronchospasm.

Frequency not known (cannot be estimated from available data)

Myocardial ischaemia

Signs include:

• sudden chest pain or
• tightness in the chest

If you consider any of the side effects you experience to be severe, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Ondansetron Bluefish orodispersible tablets

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

Store in the original packaging to protect from light.

Store below 30°C.

Do not use this medicine after the expiry date stated on the carton and blister pack after “EXP.”. The expiry date refers to the last day of the month indicated.

Do not use this medicine if there are any visible signs of deterioration, such as discoloration or broken tablets.

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

6. Contents of the pack and other information

Composition of Ondansetron Bluefish orodispersible tablets

• The active substance is ondansetron. Each orodispersible tablet contains 8 mg of ondansetron.
• The other excipients are: aspartame (E951), crospovidone type B, magnesium stearate (E572), microcrystalline cellulose (E460), Pharmaburst™ C1 (containing mannitol (E421), sorbitol (E420), crospovidone (type A) and colloidal silicon dioxide), strawberry flavour (containing glucose, maltodextrin, arabic gum (E414) 2.3% and sulfur dioxide (E220)), stearoyl fumarate and sodium.

Appearance of the product and pack sizes of Ondansetron Bluefish orodispersible tablets

Orodispersible tablet

Orodispersible tablet, white, flat, round and bevelled-edged.

Ondansetron Bluefish orodispersible tablets are available in packs of: 6, 10, 14, 20, 30, 50, 60, 100 orodispersible tablets in aluminium/OPA//PVC blisters.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Bluefish Pharmaceuticals AB

P.O. Box 49013,

100 28 Stockholm,

Sweden

Manufacturer:

Bluefish Pharmaceuticals AB,

Gävlegatan 22,

113 30 Stockholm,

Sweden

Sofarimex Industria Química e Farmacêutica S.A.

Av. das Indústrias - Alto do Colaride, Cacem, 2735-213

Portugal

Further information about this medicinal product is available from the local representative of the Marketing Authorisation Holder:

Bluefish Pharma S.L.U.,

P.O. Box 36007

2832094 Madrid, Branch 36

This package leaflet is available in braille or for people with visual impairments upon request.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

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

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