ONDANSETRON BLUEFISH 4 mg ORALLY DISINTEGRATING TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ondansetron Bluefish 4 mg orodispersible 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Ondansetron Bluefish orodispersible tablets are and what they are used for
2. What you need to know before you take Ondansetron Bluefish orodispersible tablets
3. How to take Ondansetron Bluefish orodispersible tablets
4. Possible side effects
5. Storage of Ondansetron Bluefish orodispersible tablets
6. Pack contents and further information

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

Ondansetron Bluefish orodispersible tablets are a fast-dissolving tablet when placed on the tongue.

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

Ondansetron orodispersible tablets can be used for:

• Stopping the effects of nausea and vomiting caused by cytotoxic chemotherapy in children and adults
• Preventing post-operative nausea and vomiting in children and adults
• Stopping the effects of nausea and vomiting caused by radiotherapy in adults

If you are not sure why you have been prescribed this treatment, ask your doctor.

2. What you need to know before you take Ondansetron Bluefish orodispersible tablets

Do not take Ondansetron Bluefish orodispersible tablets

• if you are allergic to ondansetron or 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

Tell your doctor, pharmacist, or nurse before you start taking Ondansetron Bluefish orodispersible tablets:

• if you are pregnant or might become pregnant soon,
• if you are breast-feeding
• if you have liver problems
• if you have bowel obstruction or severe constipation
• if it is for children under 2 years or with a body surface area of less than 0.6 m2.

Other medicines and Ondansetron Bluefish orodispersible tablets

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

Pregnancy and breast-feeding

Ondansetron Bluefish orodispersible tablets should not be used during the first trimester of pregnancy. This is because Ondansetron Bluefish orodispersible tablets 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 in the roof of the mouth). If you are already pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using Ondansetron 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, it is recommended that breast-feeding mothers should not breast-feed their babies if they are taking Ondansetron Bluefish orodispersible tablets.

Driving and using machines

Ondansetron Bluefish orodispersible tablets do not affect the ability to drive or use machines.

Ondansetron Bluefish orodispersible tablets contain aspartame, glucose, maltodextrin, sorbitol, sulphur dioxide, and sodium

Ondansetron Bluefish orodispersible tablets contain aspartame (E 951). This medicine contains 0.88 mg of aspartame in each 4 mg orodispersible tablet.

Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria (a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly).

Ondansetron Bluefish orodispersible tablets contain sorbitol (E 420). This medicine contains 8.4 mg of sorbitol in each 4 mg orodispersible tablet.

Ondansetron Bluefish orodispersible tablets contain glucose and maltodextrin. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

It may cause cavities.

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

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

3. How to take Ondansetron Bluefish orodispersible tablets

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

After starting treatment

Ondansetron orodispersible tablets start to work within 1-2 hours. If you vomit within 1 hour of taking the tablet, take another dose. Otherwise, do not take more tablets or reduce the time between doses. Consult your doctor if the discomfort persists.

Treatment and prevention of nausea and vomiting associated with chemotherapy and/or radiotherapy

Adults

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

Elderly

The same dose as for adults.

Children over 2 years and adolescents under 18 years:

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

Children from 6 months and adolescents

• The recommended dose is up to 4 mg twice a day
• It can be administered for 5 days

Prevention of post-operative 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 if you should be given an injection instead of tablets.

Elderly

There is limited experience in the use of ondansetron in the elderly. Ondansetron is well tolerated by patients over 65 years with chemotherapy (see previous section).

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

Patient with poor sparteine/debrisoquine metabolism:no alteration of dose or dosing frequency is needed.

Do not remove the tablets from the blister pack until you are ready to take the medicine.

The tablets should be taken as follows:

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

To prevent the tablet from breaking, it is important not to press the tablet until the blister pack is opened (Figure A).

The tablets in each blister pack are separated by perforations. Separate each tablet by following the perforations (Figure 1). The coating film should be removed with care. Starting from the corner marked with the arrow (Figure 2 and 3).

The tablets should be removed 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 take more Ondansetron Bluefish than you should, talk to a doctor or go to the nearest hospital immediately. Take the medicine with you. You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ondansetron Bluefish orodispersible tablets

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

If you forget a dose and feel nauseous or vomit, take an Ondansetron Bluefish tablet as soon as possible and then continue with the treatment as indicated. If you forget a dose but do not feel nauseous or vomit, take the next dose as indicated.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some people may be allergic to the medicine, in case any of the following symptoms appear soon after taking Ondansetron, stop taking the medicine and inform your doctor immediately.

• Sudden appearance of "pips" and pain or oppression in the chest.
• Swelling of eyelids, face, lips, mouth, or tongue.
• Rash on the skin or hives anywhere on the body.
• Collapse

Other possible side effects:

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

• Headache

Common (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 with or without ST segment depression, palpitations (irregular heartbeat) or slow heartbeat
• Asymptomatic increase in liver function test results
• Seizures, involuntary body movements including extrapyramidal reactions such as dystonic reactions, including upward rolling movements of the eyes and dyskinesia have been observed without clinically significant consequences
• Hiccup
• 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 that causes difficulty breathing
• There have also been cases of dizziness when ondansetron is administered intravenously, which in most cases is prevented or resolved with an increase in the infusion period
• Vision problems (e.g., blurred vision) associated with ondansetron by injection

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

• Temporary loss of vision almost always by injection

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

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

Frequency not known (cannot be estimated from the available data)

Myocardial ischemia

The signs include:

• sudden chest pain or
• chest oppression

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Vigilance System for Human Use: www.notificaram.es. By reporting side effects, 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 package to protect from light.

Store below 30°C.

Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP.". The expiry date is the last day of the month shown.

Do not use this medicine if you notice visible signs of deterioration, such as discoloration or broken tablets.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to your usual pharmacy for disposal. This will help protect the environment.

6. Pack contents and further information

Composition of Ondansetron Bluefish orodispersible tablets

The active substance is ondansetron. Each orodispersible tablet contains 4 mg of ondansetron.

The other excipients are: aspartame (E951), crospovidone type B, magnesium stearate (E572), microcrystalline cellulose (E460), Pharmaburst TM C1, (which contains mannitol (E421), sorbitol (E420), crospovidone (type A) and colloidal silicon dioxide), strawberry flavor, (which contains glucose, maltodextrin, gum arabic (E414) 2.3% and sulphur dioxide (E220)), stearic acid fumarate and sodium.

Appearance of the product and pack contents

Orodispersible tablet.

White, flat, round, and beveled orodispersible tablet.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Sucursal 36

This leaflet is available for the blind or for those with visual impairments upon request.

This medicine is authorized in the Member States of the European Economic Area under the following names

Date of last revision of this leaflet: June 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/