Ondansetron Bluefish

Leaflet accompanying the packaging: information for the user

Ondansetron Bluefish, 4 mg orodispersible tablets

Ondansetron Bluefish, 8 mg orodispersible tablets

Ondansetron

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Ondansetron Bluefish and what is it used for
• 2. Important information before taking Ondansetron Bluefish
• 3. How to take Ondansetron Bluefish
• 4. Possible side effects
• 5. How to store Ondansetron Bluefish
• 6. Contents of the pack and other information

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

Ondansetron Bluefish is available as an orodispersible tablet that dissolves quickly when placed on the tongue. Ondansetron Bluefish contains ondansetron, which belongs to a group of medicines that prevent nausea and vomiting, known as antiemetics.

Ondansetron Bluefish can be used:

• -to treat nausea and vomiting caused by cytotoxic chemotherapy in children and adults;
• -to prevent nausea and vomiting in the post-operative period in children and adults;
• -to treat nausea and vomiting caused by radiotherapy in adults.

If you have any doubts about why this medicine has been prescribed for you, you should consult your doctor.

2. Important information before taking Ondansetron Bluefish

When not to take Ondansetron Bluefish

• 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 to treat Parkinson's disease).

Warnings and precautions

Before starting treatment with Ondansetron Bluefish, you should discuss it with your doctor, pharmacist, or nurse

• if you are pregnant or planning to become pregnant in the near future;
• if you are breastfeeding;
• if you have liver disease;
• if you have blocked intestines or if you have severe constipation;
• in children under 2 years of age or with a body surface area below 0.6 m².

Ondansetron Bluefish and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, such as phenytoin, carbamazepine, rifampicin, tramadol.

Pregnancy and breastfeeding

Ondansetron Bluefish should not be used during the first trimester of pregnancy. This is because Ondansetron Bluefish may slightly increase the risk of cleft lip and/or palate. If you are already pregnant, suspect you are pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before taking Ondansetron Bluefish. If you are a woman of childbearing age, you may be advised to use effective contraception.

Ondansetron is likely to pass into breast milk. Therefore, breastfeeding is not recommended during treatment with Ondansetron Bluefish.

Driving and using machines

Ondansetron Bluefish does not affect the ability to drive or use machines.

Ondansetron Bluefish contains aspartame, glucose, maltodextrin, sorbitol, sulfur dioxide, and sodium

Ondansetron Bluefish contains aspartame (E 951). The medicine contains 0.88 mg of aspartame in each 4 mg orodispersible tablet and 1.76 mg of aspartame in each 8 mg orodispersible tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Ondansetron Bluefish contains sorbitol (E 420). The medicine contains 8.4 mg of sorbitol in each 4 mg orodispersible tablet and 16.9 mg of sorbitol in each 8 mg orodispersible tablet.

Ondansetron Bluefish contains glucose and maltodextrin. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine. It may have a harmful effect on teeth.

Ondansetron Bluefish contains sulfur dioxide (E 220). The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Ondansetron Bluefish contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per orodispersible tablet, which means that the medicine is considered "sodium-free".

3. How to take Ondansetron Bluefish

This medicine should always be taken exactly as advised by your doctor. If you are unsure, consult your doctor or pharmacist.

After starting treatment:

The effect of Ondansetron Bluefish should start within 1 or 2 hours after taking the dose.

If you experience nausea within an hour of taking the dose, you should take the same dose again. If nausea occurs later than an hour after taking the medicine, do not take more tablets than recommended in the leaflet. If nausea persists, consult your doctor.

Treatment and prevention of nausea and vomiting caused by chemotherapy or radiotherapy:

Adults:

8 mg 1 to 2 hours before the start of chemotherapy or radiotherapy, and then 8 mg every 12 hours for 5 days. Your doctor may recommend the first dose to be given as an injection.

Elderly patients:

The dosage is the same as for adults.

Use in children (aged 2 and above) and adolescents (below 18 years):

The dose is determined individually and depends on the child's size/body surface area. Ondansetron Bluefish should not be used in children with a body surface area below 0.6 m².

Children over 6 months and adolescents

• Typically, the dose is up to 4 mg twice a day
• The medicine can be given for up to 5 days

Treatment and prevention of post-operative nausea and vomiting:

Adults, treatment, and prevention:

16 mg 1 hour before surgery or alternatively 8 mg 1 hour before anesthesia, and then two further doses of 8 mg at 8-hour intervals. Your doctor may recommend the first dose to be given as an injection.

Elderly patients, treatment, and prevention:

Experience with the use of ondansetron in elderly patients is limited. Ondansetron is well-tolerated in patients over 65 years of age receiving chemotherapy (see above).

Patient with mild or moderate hepatic impairment:

The total daily dose should not exceed 8 mg.

Patient with slow sparteine and debrisoquine metabolism:

No dose adjustment is required.

The tablet(s) should be taken as follows:

Do not remove the Ondansetron Bluefish tablets from the blister or punch a hole in the foil until it is time to take the medicine.

It is important not to push the tablet through the foil to avoid breaking it (Fig. A).

In each blister, the tablets are separated from each other by a perforation. Tear off a tablet along the perforation (Fig.1). Carefully remove the protective foil. The foil should be torn off from the corner marked with an arrow (Fig.2 and 3).

Remove the tablet from the packaging with dry hands and place it on the tongue (Fig. 4). When the tablet dissolves, it can be swallowed with water.

Fig. A.

Fig. 1.

Fig. 2.

Fig. 3.

Fig. 4.

Overdose of Ondansetron Bluefish

If an adult or child takes more Ondansetron Bluefish than recommended, they should immediately consult a doctor or go to the hospital. Take the medicine packaging with you.

Missed dose of Ondansetron Bluefish

Do not take a double dose to make up for a missed dose.

If you miss a dose and experience nausea and vomiting, take Ondansetron Bluefish as soon as possible and continue taking the next doses as before.

If you miss a dose and do not experience nausea and vomiting, take the next dose as instructed in the leaflet.

4. Possible side effects

Like all medicines, Ondansetron Bluefish can cause side effects, although not everybody gets them.

Some patients may be allergic to certain medicines. If any of the following side effects occur soon after taking Ondansetron Bluefish, stop taking the medicine and contact your doctor immediately:

• Sudden wheezing and chest pain or tightness
• Swelling of the eyelids, face, lips, mouth, or tongue
• Rash, red spots or hives on the skin
• Collapsing

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)

• Abnormal heart rhythm, chest pain with or without ST segment depression, slow heart rate.
• Asymptomatic increases in liver enzyme activity.
• Seizures, movement disorders, including extrapyramidal symptoms, such as dystonic reactions, oculogyric crisis, and involuntary movements without significant or lasting effects on the patient's clinical condition.
• Hiccup.
• Low blood pressure.

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

• Immediate hypersensitivity reactions, sometimes severe, including anaphylactic reactions.
• Dizziness during intravenous administration, which can usually be prevented or relieved by prolonging the infusion time.
• Transient blurred vision during intravenous administration.

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

• -Transient blindness, mainly during intravenous administration.

In most cases, blindness resolved within 20 minutes. Most patients were receiving chemotherapeutic agents, including cisplatin. In some cases of transient blindness, a cortical origin was described.

The strawberry flavoring contains sulfur dioxide (E220), which may rarely cause severe hypersensitivity reactions and bronchospasm.

If any of the side effects get 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, including those not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ondansetron Bluefish

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

Store in the original packaging to protect from light.

Store at a temperature below 30°C.

Do not use this medicine after the expiry date stated on the carton or blister after "Expiry Date" or "EXP". The expiry date refers to the last day of the month.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ondansetron Bluefish contains

• -The active substance is ondansetron. Each orodispersible tablet contains 4 mg or 8 mg of ondansetron.
• -The other ingredients are aspartame (E 951), crospovidone type B, magnesium stearate, microcrystalline cellulose, Pharmaburst TM C1 (containing mannitol (E 421), sorbitol (E 420), crospovidone (type A), and colloidal silica), strawberry flavor [(containing glucose, maize maltodextrin, potato maltodextrin, arabic gum (2.3%), and sulfur dioxide (E 220)], sodium stearyl fumarate.

What Ondansetron Bluefish looks like and contents of the pack

Orodispersible tablets.

Ondansetron Bluefish 4 mg and 8 mg are white, flat, round tablets with beveled edges.

Ondansetron Bluefish is available in packs containing 6 x 1, 10 x 1, 14 x 1, 20 x 1, 30 x 1, 50 x 1, 60 x 1, 100 x 1 tablets in unit-dose blisters OPA/Aluminum/PVC/Aluminum.

Not all pack sizes may be marketed.

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

A patient leaflet for the blind and partially sighted will be produced in other formats on request.

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

Date of last revision of the leaflet:24.11.2020