Ondansetron bluefish

Package leaflet: Information for the user

Ondansetron Bluefish, 4 mg orodispersible tablets
Ondansetron Bluefish, 8 mg orodispersible tablets
Ondansetronum
Please read all of this leaflet carefully before 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, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet:

1. What Ondansetron Bluefish is and what it is used for
2. What you need to know 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 Ondansetron Bluefish is and what it is used for

Ondansetron Bluefish is available as a tablet that dissolves rapidly when placed on the tongue. Ondansetron Bluefish contains the active substance ondansetron, which belongs to a group of medicines that prevent nausea and vomiting, known as antiemetic medicines.
Ondansetron Bluefish may be used:

• to treat nausea and vomiting caused by cytotoxic chemotherapy in children and adults;
• to prevent nausea and vomiting after surgery 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, please consult your doctor.

2. Important information before using Ondansetron Bluefish

When not to use Ondansetron Bluefish

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

Warnings and precautions
Before starting to use Ondansetron Bluefish, discuss this with your doctor, pharmacist,
or nurse

• if the patient is pregnant or plans to become pregnant soon;
• if the patient is breastfeeding;
• if the patient has liver disease;
• if the patient has a blocked bowel or suffers from 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 medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 cleft palate [an opening or fissure in the upper lip and/or palate]. If the patient is already pregnant, suspects pregnancy, or plans to become pregnant, she should consult her doctor or pharmacist before using Ondansetron Bluefish. If the patient is a woman of childbearing age, she 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 operating machinery
Ondansetron Bluefish has no influence on the ability to drive or operate machinery.
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 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 the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. It may be harmful to teeth.
Ondansetron Bluefish contains sulfur dioxide (E 220). The medicine may rarely cause severe allergic reactions and bronchospasm.
Ondansetron Bluefish contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per orodispersible tablet, meaning the medicine is considered "sodium-free".

3. How to use Ondansetron Bluefish

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
After starting treatment:
The effect of Ondansetron Bluefish should begin within 1 or 2 hours after taking a dose.
If nausea occurs within one hour of taking the dose, the same dose should be taken again.
If nausea occurs more than one hour after taking the medicine, do not take more tablets than
recommended in the leaflet. If nausea persists, contact your doctor.
Treatment and prevention of nausea and vomiting caused by chemotherapy or radiotherapy:
Adults:
8 mg 1 to 2 hours before starting chemotherapy or radiotherapy, followed by 8 mg every
12 hours for 5 days. Your doctor may recommend that the first dose is given as an injection.
Elderly patients:
Dosage is the same as for adults.
Use in children (aged 2 years and above) and adolescents (< 18 years):
The dose is individually adjusted and depends on the child's body size/surface area. Ondansetron Bluefish
must not be used in children with a total body surface area below 0.6 m².
Children over 6 months of age and adolescents:

• The usual dose is up to 4 mg twice daily
• The medicine may be given for up to 5 days

Treatment and prevention of postoperative nausea and vomiting:
Adults, treatment and prevention:
16 mg one hour before surgery or alternatively 8 mg one hour before anaesthesia, followed by
two further 8 mg doses given at 8-hour intervals. Your doctor may recommend that the first dose
is given as an injection.
Elderly patients, treatment and prevention:
Experience with ondansetron in elderly patients is limited. Ondansetron is well tolerated in patients
over 65 years of age receiving chemotherapy (see above).
Patients with mild or moderate hepatic impairment:
The total daily dose should not exceed 8 mg.
Patients who are poor metabolizers of mephenytoin and debrisoquine:
No dose adjustment or change in dosing frequency is required.
Tablets should be taken as follows:
Do not remove Ondansetron Bluefish tablets from the blister or pierce the foil until it is time to take the medicine.
It is important not to push the tablet out of its cavity to avoid breaking it (Fig. A).
In each blister, tablets are separated from each other by perforations. Detach the cavity containing one tablet along the perforation (Fig. 1). Carefully remove the protective foil. Peel off the protective foil starting 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 disintegrates, it can be swallowed with water.
Fig. A. Fig. 1.

Fig. 2. Fig. 3.

Fig. 4.

Taking more Ondansetron Bluefish than recommended
If an adult or child takes more Ondansetron Bluefish than recommended, contact a doctor immediately
or go to a 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 a dose is missed and nausea or vomiting occurs, take Ondansetron Bluefish as soon as possible and continue taking the following doses as previously scheduled.
If a dose is missed and no nausea or vomiting occurs, take the next dose as indicated in the leaflet.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everyone will experience them.
Some patients may be allergic to certain medicines. If any of the following
side effects occur shortly after taking Ondansetron Bluefish, you must stop
taking the medicine and contact your doctor immediately:

• Sudden wheezing and breathlessness, chest pain or tightness in the chest
• Swelling of the eyelids, face, lips, mouth or tongue
• Skin rash – red spots or hives (skin welts) anywhere on the body
• Collapse

Other possible side effects:
Very common (may occur in more than 1 in 10 people)

• Headache.

Common (may occur in up to 1 in 10 people)

• Constipation.
• Feeling of warmth or flushing.

Uncommon (may occur in up to 1 in 100 people)

• Heart rhythm disturbances, chest pain with or without ST-segment depression, slow heart rate.
• Asymptomatic increase in liver enzyme activity.
• Seizures, movement disorders including extrapyramidal symptoms such as dystonic reactions, oculogyric crisis (involuntary upward deviation of the eyes), and disturbances in voluntary movements, without significant or lasting impact on the patient's clinical condition.
• Hiccups.
• Low blood pressure.

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

• Immediate hypersensitivity reactions, sometimes severe, including anaphylactic reactions.
• Dizziness during intravenous administration, which in most cases can be prevented or resolved by prolonging the infusion time.
• Transient visual disturbances (e.g. blurred vision) during intravenous administration.

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

• Transient loss of vision, primarily during intravenous administration.

In most cases, blindness resolved within 20 minutes. Most patients were receiving
chemotherapeutic agents, including cisplatin. In some cases of transient vision loss,
a cortical origin has been described.
The strawberry flavouring contains sulfur dioxide (E220), which in rare cases may cause
severe allergic reactions and bronchospasm.
If any of the side effects worsen or if any side effects not listed in this leaflet occur,
inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, including any not mentioned
in this leaflet, tell your doctor, pharmacist or nurse. Side effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions,
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 authorisation holder.
Reporting side effects helps 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 foil under "Expiry date" or "EXP". The expiry date refers to the last day of the stated month.
Do not use this medicine if there are visible signs of deterioration, such as discoloration or broken tablets.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package 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™ C1 (containing mannitol (E 421), sorbitol (E 420), crospovidone (type A) and colloidal anhydrous silica), strawberry flavour [(containing glucose, maize maltodextrin, potato maltodextrin, gum arabic (2.3%) and sulphur 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 bevelled edges.
Ondansetron Bluefish is available in packages 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 orodispersible tablets in unit dose blisters OPA/Aluminium/PVC/Aluminium.
Not all pack sizes may be marketed.
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
This medicinal product is authorised in the Member States of the European Economic Area under the following names: