Ondansetron bluefish 4 mg comprimidos bucodispersables efg
Introduction
Ondansetrón Bluefish 4 mg buccal tablets EFG
ondansetrón
Read this leaflet carefully before you start taking the medicine, because 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 or nurse.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4
Contents of the leaflet:
- What Ondansetrón Bluefish buccal tablets are and what they are used for
- What you need to know before you start taking Ondansetrón Bluefish buccal tablets
- How to take Ondansetrón Bluefish buccal tablets
- Possible side effects
- Storage of Ondansetrón Bluefish buccal tablets
- Contents of the pack and additional information
1. What is Ondansetrón Bluefish buccal tablets and what is it used for
Ondansetrón Bluefish buccal tablets are a fast-dissolving tablet when placed on the tongue.
This medication contains ondansetrón, which belongs to a group of medications called antiemetics that can be used to prevent nausea and vomiting.
Ondansetrón buccal tablets may be used for:
- To stop nausea and vomiting caused by cytotoxic chemotherapy in children and adults
- To prevent postoperative nausea and vomiting in children and adults
- To stop nausea and vomiting caused by radiation therapy in adults
If you are unsure why you have been prescribed this treatment, consult your doctor.
2. What you need to know before starting to take Ondansetrón Bluefish buccal tablets
Do not take Ondansetrón Bluefish buccal tablets
- if you are allergic to ondansetron or any of the other ingredients of this medication (listed in section 6).
- if you are taking apomorphine (used for Parkinson's treatment)
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take Ondansetrón Bluefish buccal 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 severe constipation
- if you are children under 2 years old or with a body surface area of less than 0.6 m2.
Other medications and Ondansetrón Bluefish buccal tablets
Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication such as phenytoin, carbamazepine, rifampicin, tramadol.
Pregnancy and lactation
Ondansetrón Bluefish buccal tablets should not be used during the first trimester of pregnancy. This is because Ondansetrón Bluefish buccal tablets may slightly increase the risk of a baby being born with cleft lip and/or palate (openings or clefts in the upper lip or palate). If you are already pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using Ondansetrón Bluefish buccal tablets. If you are a fertile woman, it is recommended to use an effective contraceptive method.
Ondansetron may pass into breast milk. Therefore, mothers breastfeeding while taking Ondansetrón Bluefish buccal tablets are advised not to breastfeed their children.
Driving and operating machinery
Ondansetrón Bluefish buccal tablets do not affect the ability to drive or operate machinery.
Ondansetrón Bluefish buccal tablets contain aspartame, glucose, maltodextrin, sorbitol, sulfur dioxide, and sodium
Ondansetrón Bluefish buccal tablets contain aspartame (E 951).This medication contains 0.88 mg of aspartame in each 4 mg buccal tablet.
Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.
Ondansetrón Bluefish buccal tablets contain sorbitol (E 420).This medication contains 8.4 mg of sorbitol in each 4 mg buccal tablet.
Ondansetrón Bluefish buccal tablets contain glucose and maltodextrin.If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.
It may cause tooth decay.
Ondansetrón Bluefish buccal tablets contain sulfur dioxide (E 220).This medication may cause severe allergic reactions and bronchospasm (sudden sensation of choking) because it contains “sulfur dioxide”.
Ondansetrón Bluefish buccal tablets contain sodium.This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially “sodium-free”.
3. How to take Ondansetrón Bluefish buccal tablets
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
After starting treatment
Ondansetron buccal tablets start to act within 1-2 hours. If you vomit before 1 hour has passed, take another identical dose. Otherwise, do not take more tablets or reduce the time between doses. Consult your doctor if symptoms persist.
Treatment and prevention of nausea and vomiting related to chemotherapy and/or radiation therapy
Adults
The recommended dose is 8mg, 1 to 2 hours before chemotherapy, followed by 8mg every 12 hours later for 5 days. Your doctor will decide if you should receive an injection instead of tablets.
Seniors
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 less than 0.6 m2.
Children from 6 months and adolescents
- The recommended dose is up to 4mg twice a day
- It can be administered for 5 days
Prevention of postoperative nausea and vomiting
Adults
The usual dose is 16mg before anesthesia, or alternatively, 8mg 1 hour before anesthesia, followed by additional doses of 8mg at 8 and 16 hours. Your doctor will decide if you should receive an injection instead of tablets.
Seniors
There is limited experience with the use of ondansetron in the elderly. Ondansetron is well tolerated by patients over 65 years old with chemotherapy (please see the previous section).
Patients with moderate or severe liver impairment:The total daily dose should not exceed 8mg.
Patients with poor sparteine/debrisoquine metabolism:No adjustment or change in dosage is required.
Do not remove the tablets or perforate the blister pack until you are ready to take the medication.
The tablets should be taken as indicated:
Do not remove Ondansetron Bluefish buccal tablets or perforate the blister pack until you are ready to take the medication.
To prevent the tablets from breaking, it is essential not to press the tablet until the blister pack is perforated (Figure A).
The tablets in each blister pack are separated by perforations. Separate each tablet by following the perforations (Figure 1). The film coating should be removed carefully. 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, and then it can be ingested with water.
Figure A.4. Possible Adverse Effects Other possible side effects: Most cases of blindness have resolved within 20 minutes. Most patients had received chemotherapy agents, including cisplatin. Some of the reported cases of transient blindness were of cortical origin. The strawberry flavor contains sulfur dioxide (E220) which may cause rare hypersensitivity reactions and bronchospasm. Frequency not known (cannot be estimated from available data) The signs include: If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist. Reporting of side effects If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication. Keep this medication out of the sight and reach of children. Store in the original packaging to protect it from light. Store below 30°C. Do not use this medication after the expiration date that appears on the box and the blister pack after “CAD.” The expiration date is the last day of the month indicated. Do not use this medication if you observe visible signs of deterioration, such as discoloration or broken tablets. Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at your local pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment. Composition of Ondansetron Bluefish buccal dispersible tablets The active ingredient is ondansetron. Each buccal dispersible 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 sulfur dioxide (E220)), stearate and sodium fumarate. Appearance of the product and contents of the packaging of the packaging Buccal dispersible tablet. Buccal dispersible tablet, white, flat, round and beveled. Ondansetron Bluefish buccal dispersible tablets are available in packaging of: 6, 10, 14, 20, 30, 50, 60, 100 buccal dispersible tablets in aluminum/OPA/PVC blister. Only some sizes of packaging may be commercially available. Holder of the marketing authorization and responsible for the manufacturing Holder of the marketing authorization: Bluefish Pharmaceuticals AB P.O. Box 49013, 100 28 Stockholm, Sweden Responsible for manufacturing: 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 holder of the marketing authorization: Bluefish Pharma S.L.U., AP 36007 2832094 Madrid, Sucursal 36 This leaflet is available in braille or for those with visual impairments upon request. This medicine is authorized in the member states of the European Economic Area with the following names Country Germany Ondansetron Bluefish 4mg schmelztabletten Denmark Ondansetron Bluefish 4mg smeltetabletter Spain Ondansetron Bluefish 4mg comprimidos bucodispersibles EFG Norway Ondansetron Bluefish 4mg smeltetabletter Poland Ondansetron Bluefish United Kingdom (Northern Ireland) Ondansetron 4mg orodispersible tablets Sweden Ondansetron Bluefish 4mg munsönderfallande tabletter Last reviewed date of this leaflet: June 2022 The detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ Very common(may affect more than 1 in 10 people)
Common(may affect up to 1 in 10 people)
Uncommon(may affect up to 1 in 100 people)
Rare(may affect up to 1 in 1,000 people)
Very rare(may affect up to 1 in 10,000 people)
5. Conservation of Ondansetron Bluefish buccal tablets
6. Contents of the packaging and additional information
Medicine name
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